REVATIO

In the US, REVATIO (sildenafil systemic) is a member of the drug class agents for pulmonary hypertension and is used to treat Pulmonary Arterial Hypertension.

US matches:

• Revatio


• Revatio Injection


• Revatio Intravenous

UK matches:

• Revatio 0.8mg/ml solution for injection (SPC)
• Revatio 20 mg film-coated tablets (SPC)

Ingredient matches for REVATIO

Sildenafil

Sildenafil is reported as an ingredient of REVATIO in the following countries:

• Bulgaria

Sildenafil citrate (a derivative of Sildenafil) is reported as an ingredient of REVATIO in the following countries:

• Australia


• Austria


• Belgium


• Canada


• Croatia (Hrvatska)


• Czech Republic


• Denmark


• Finland


• France


• Germany


• Hungary


• Ireland


• Israel


• Italy


• Japan


• Netherlands


• Norway


• Romania


• Singapore


• Slovakia


• Slovenia


• Spain


• Sweden


• Switzerland


• United Kingdom


• United States


• Venezuela

International Drug Name Search

Glossary

SPC	Summary of Product Characteristics (UK)

Click for further information on drug naming conventions and International Nonproprietary Names.

Topiragen

topiramate

Dosage Form: tablet, coated
Topiragen™ (topiramate) Tablets

Rx only

DESCRIPTION

Topiramate is a sulfamate-substituted monosaccharide. Topiragen™ (topiramate) Tablets are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration.

Topiramate is a white crystalline powder with a bitter taste. Topiramate is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.37. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:

Topiragen™ (topiramate) Tablets contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, partially hydrolyzed polyvinyl alcohol, polyethylene glycol, sodium starch glycolate, talc, titanium dioxide, iron oxide yellow (50 mg and 100 mg only), and iron oxide red (50 mg and 200 mg only).

CLINICAL PHARMACOLOGY

Mechanism of Action:

The precise mechanisms by which topiramate exerts its anticonvulsant effects are unknown; however, preclinical studies have revealed four properties that may contribute to topiramate's efficacy for epilepsy. Electrophysiological and biochemical evidence suggests that topiramate, at pharmacologically relevant concentrations, blocks voltage-dependent sodium channels, augments the activity of the neurotransmitter gamma-aminobutyrate at some subtypes of the GABA-A receptor, antagonizes the AMPA/kainate subtype of the glutamate receptor, and inhibits the carbonic anhydrase enzyme, particularly isozymes II and IV.

Pharmacodynamics:

Topiramate has anticonvulsant activity in rat and mouse maximal electroshock seizure (MES) tests. Topiramate is only weakly effective in blocking clonic seizures induced by the GABAA receptor antagonist, pentylenetetrazole. Topiramate is also effective in rodent models of epilepsy, which include tonic and absence-like seizures in the spontaneous epileptic rat (SER) and tonic and clonic seizures induced in rats by kindling of the amygdala or by global ischemia.

Pharmacokinetics:

Absorption of topiramate is rapid, with peak plasma concentrations occurring at approximately 2 hours following a 400 mg oral dose. The relative bioavailability of topiramate from the tablet formulation is about 80% compared to a solution. The bioavailability of topiramate is not affected by food.

The pharmacokinetics of topiramate are linear with dose proportional increases in plasma concentration over the dose range studied (200 to 800 mg/day). The mean plasma elimination half-life is 21 hours after single or multiple doses. Steady state is thus reached in about 4 days in patients with normal renal function. Topiramate is 15-41% bound to human plasma proteins over the blood concentration range of 0.5-250 μg/mL. The fraction bound decreased as blood concentration increased.

Carbamazepine and phenytoin do not alter the binding of topiramate. Sodium valproate, at 500 μg/mL (a concentration 5-10 times higher than considered therapeutic for valproate) decreased the protein binding of topiramate from 23% to 13%. Topiramate does not influence the binding of sodium valproate.

Metabolism and Excretion:

Topiramate is not extensively metabolized and is primarily eliminated unchanged in the urine (approximately 70% of an administered dose). Six metabolites have been identified in humans, none of which constitutes more than 5% of an administered dose. The metabolites are formed via hydroxylation, hydrolysis, and glucuronidation. There is evidence of renal tubular reabsorption of topiramate. In rats, given probenecid to inhibit tubular reabsorption, along with topiramate, a significant increase in renal clearance of topiramate was observed. This interaction has not been evaluated in humans. Overall, oral plasma clearance (CL/F) is approximately 20 to 30 mL/min in humans following oral administration.

Pharmacokinetic Interactions

(see also Drug Interactions):

Antiepileptic Drugs

Potential interactions between topiramate and standard AEDs were assessed in controlled clinical pharmacokinetic studies in patients with epilepsy. The effect of these interactions on mean plasma AUCs are summarized under PRECAUTIONS (Table 4).

Special Populations:

Renal Impairment:

The clearance of topiramate was reduced by 42% in moderately renally impaired (creatinine clearance 30-69 mL/min/1.73m2) and by 54% in severely renally impaired subjects (creatinine clearance <30 mL/min/1.73m2) compared to normal renal function subjects (creatinine clearance >70 mL/min/1.73m2). Since topiramate is presumed to undergo significant tubular reabsorption, it is uncertain whether this experience can be generalized to all situations of renal impairment. It is conceivable that some forms of renal disease could differentially affect glomerular filtration rate and tubular reabsorption resulting in a clearance of topiramate not predicted by creatinine clearance. In general, however, use of one-half the usual starting and maintenance dose is recommended in patients with moderate or severe renal impairment (see PRECAUTIONS: Adjustment of Dose in Renal Failure and DOSAGE AND ADMINISTRATION).

Hemodialysis:

Topiramate is cleared by hemodialysis. Using a high efficiency, counterflow, single pass-dialysate hemodialysis procedure, topiramate dialysis clearance was 120 mL/min with blood flow through the dialyzer at 400 mL/min. This high clearance (compared to 20-30 mL/min total oral clearance in healthy adults) will remove a clinically significant amount of topiramate from the patient over the hemodialysis treatment period. Therefore, a supplemental dose may be required (see DOSAGE AND ADMINISTRATION).

Hepatic Impairment:

In hepatically impaired subjects, the clearance of topiramate may be decreased; the mechanism underlying the decrease is not well understood.

Age, Gender, and Race:

The pharmacokinetics of topiramate in elderly subjects (65-85 years of age, N=16) were evaluated in a controlled clinical study. The elderly subject population had reduced renal function [creatinine clearance (-20%)] compared to young adults. Following a single oral 100 mg dose, maximum plasma concentration for elderly and young adults was achieved at approximately 1-2 hours. Reflecting the primary renal elimination of topiramate, topiramate plasma and renal clearance were reduced 21% and 19%, respectively, in elderly subjects, compared to young adults. Similarly, topiramate half-life was longer (13%) in the elderly. Reduced topiramate clearance resulted in slightly higher maximum plasma concentration (23%) and AUC (25%) in elderly subjects than observed in young adults. Topiramate clearance is decreased in the elderly only to the extent that renal function is reduced. As recommended for all patients, dosage adjustment may be indicated in the elderly patient when impaired renal function (creatinine clearance rate ≤ 70 mL/min/1.73 m2) is evident. It may be useful to monitor renal function in the elderly patient (see Special Populations: Renal Impairment, PRECAUTIONS: Adjustment of Dose in Renal Failure and DOSAGE AND ADMINISTRATION).

Clearance of topiramate in adults was not affected by gender or race.

Pediatric Pharmacokinetics:

Pharmacokinetics of topiramate were evaluated in patients ages 4 to 17 years receiving one or two other antiepileptic drugs. Pharmacokinetic profiles were obtained after one week at doses of 1, 3, and 9 mg/kg/day. Clearance was independent of dose.

Pediatric patients have a 50% higher clearance and consequently shorter elimination half-life than adults. Consequently, the plasma concentration for the same mg/kg dose may be lower in pediatric patients compared to adults. As in adults, hepatic enzyme-inducing antiepileptic drugs decrease the steady state plasma concentrations of topiramate.

CLINICAL STUDIES

The studies described in the following sections were conducted using topiramate tablets.

Epilepsy

Monotherapy Controlled Trial

The effectiveness of topiramate as initial monotherapy in adults and children 10 years of age and older with partial onset or primary generalized seizures was established in a multicenter, randomized, double-blind, parallel-group trial.

The trial was conducted in 487 patients diagnosed with epilepsy (6 to 83 years of age) who had 1 or 2 well-documented seizures during the 3-month retrospective baseline phase who then entered the study and received topiramate 25 mg/day for 7 days in an open-label fashion. Forty-nine percent of subjects had no prior AED treatment and 17% had a diagnosis of epilepsy for greater than 24 months. Any AED therapy used for temporary or emergency purposes was discontinued prior to randomization. In the double-blind phase, 470 patients were randomized to titrate up to 50 mg/day or 400 mg/day. If the target dose could not be achieved, patients were maintained on the maximum tolerated dose. Fifty eight percent of patients achieved the maximal dose of 400 mg/day for ≥ 2 weeks, and patients who did not tolerate 150 mg/day were discontinued. The primary efficacy assessment was a between group comparison of time to first seizure during the double-blind phase. Comparison of the Kaplan-Meier survival curves of time to first seizure favored the topiramate 400 mg/day group over the topiramate 50 mg/day group (p=0.0002, log rank test; Figure 1). The treatment effects with respect to time to first seizure were consistent across various patient subgroups defined by age, sex, geographic region, baseline body weight, baseline seizure type, time since diagnosis, and baseline AED use.

Figure 1: Kaplan-Meier Estimates of Cumulative Rates for Time to First Seizure

Adjunctive Therapy Controlled Trials in Patients With Partial Onset Seizures

The effectiveness of topiramate as an adjunctive treatment for adults with partial onset seizures was established in six multicenter, randomized, double-blind, placebo-controlled trials, two comparing several dosages of topiramate and placebo and four comparing a single dosage with placebo, in patients with a history of partial onset seizures, with or without secondarily generalized seizures.

Patients in these studies were permitted a maximum of two antiepileptic drugs (AEDs) in addition to topiramate tablets or placebo. In each study, patients were stabilized on optimum dosages of their concomitant AEDs during the baseline phase lasting between 4 and 12 weeks. Patients who experienced a prespecified minimum number of partial onset seizures, with or without secondary generalization, during the baseline phase (12 seizures for 12-week baseline, 8 for 8-week baseline, or 3 for 4-week baseline) were randomly assigned to placebo or a specified dose of topiramate tablets in addition to their other AEDs.

Following randomization, patients began the double-blind phase of treatment. In five of the six studies, patients received active drug beginning at 100 mg per day; the dose was then increased by 100 mg or 200 mg/day increments weekly or every other week until the assigned dose was reached, unless intolerance prevented increases. In the sixth study (119), the 25 or 50 mg/day initial doses of topiramate were followed by respective weekly increments of 25 or 50 mg/day until the target dose of 200 mg/day was reached. After titration, patients entered a 4, 8, or 12-week stabilization period. The numbers of patients randomized to each dose, and the actual mean and median doses in the stabilization period are shown in Table 1.

Adjunctive Therapy Controlled Trial in Pediatric Patients Ages 2-16 Years With Partial Onset Seizures

The effectiveness of topiramate as an adjunctive treatment for pediatric patients ages 2 -16 years with partial onset seizures was established in a multicenter, randomized, double-blind, placebo-controlled trial, comparing topiramate and placebo in patients with a history of partial onset seizures, with or without secondarily generalized seizures.

Patients in this study were permitted a maximum of two antiepileptic drugs (AEDs) in addition to topiramate tablets or placebo. In this study, patients were stabilized on optimum dosages of their concomitant AEDs during an 8-week baseline phase. Patients who experienced at least six partial onset seizures, with or without secondarily generalized seizures, during the baseline phase were randomly assigned to placebo or topiramate tablets in addition to their other AEDs.

Following randomization, patients began the double-blind phase of treatment. Patients received active drug beginning at 25 or 50 mg per day; the dose was then increased by 25 mg to 150 mg/day increments every other week until the assigned dosage of 125, 175, 225, or 400 mg/day based on patients' weight to approximate a dosage of 6 mg/kg per day was reached, unless intolerance prevented increases. After titration, patients entered an 8-week stabilization period.

Adjunctive Therapy Controlled Trial in Patients With Primary Generalized Tonic-Clonic Seizures

The effectiveness of topiramate as an adjunctive treatment for primary generalized tonic-clonic seizures in patients 2 years old and older was established in a multicenter, randomized, double-blind, placebo-controlled trial, comparing a single dosage of topiramate and placebo.

Patients in this study were permitted a maximum of two antiepileptic drugs (AEDs) in addition to topiramate or placebo. Patients were stabilized on optimum dosages of their concomitant AEDs during an 8-week baseline phase. Patients who experienced at least three primary generalized tonic-clonic seizures during the baseline phase were randomly assigned to placebo or topiramate in addition to their other AEDs.

Following randomization, patients began the double-blind phase of treatment. Patients received active drug beginning at 50 mg per day for four weeks; the dose was then increased by 50 mg to 150 mg/day increments every other week until the assigned dose of 175, 225, or 400 mg/day based on patients' body weight to approximate a dosage of 6 mg/kg per day was reached, unless intolerance prevented increases. After titration, patients entered a 12-week stabilization period.

Adjunctive Therapy Controlled Trial in Patients With Lennox-Gastaut Syndrome

The effectiveness of topiramate as an adjunctive treatment for seizures associated with Lennox-Gastaut syndrome was established in a multicenter, randomized, double-blind, placebo-controlled trial comparing a single dosage of topiramate with placebo in patients 2 years of age and older.

Patients in this study were permitted a maximum of two antiepileptic drugs (AEDs) in addition to topiramate or placebo. Patients who were experiencing at least 60 seizures per month before study entry were stabilized on optimum dosages of their concomitant AEDs during a 4-week baseline phase. Following baseline, patients were randomly assigned to placebo or topiramate in addition to their other AEDs. Active drug was titrated beginning at 1 mg/kg per day for a week; the dose was then increased to 3 mg/kg per day for one week then to 6 mg/kg per day. After titration, patients entered an 8-week stabilization period. The primary measures of effectiveness were the percent reduction in drop attacks and a parental global rating of seizure severity.

Table 1: Topiramate Dose Summary During the Stabilization Periods of Each of Six Double-Blind, Placebo-Controlled, Add-On Trials in Adults with Partial Onset Seizures b

a Placebo dosages are given as the number of tablets. Placebo target dosages were as follows: Protocol Y1, 4 tablets/day; Protocols YD and Y2, 6 tablets/day; Protocol Y3 and 119, 8 tablets/day; Protocol YE, 10 tablets/day.
b Dose-response studies were not conducted for other indications or pediatric partial onset seizures.
Protocol	Stabilization Dose	Placeboa	Target Topiramate Dosage (mg/day)
			200	400	600	800	1,000
YD	N Mean Dose Median Dose	42 5.9 6.0	42 200 200	40 390 400	41 556 600	- - -	- - -
YE	N Mean Dose Median Dose	44 9.7 10.0	- - -	- - -	40 544 600	45 739 800	40 796 1,000
Y1	N Mean Dose Median Dose	23 3.8 4.0	- - -	19 395 400	- - -	- - -	- - -
Y2	N Mean Dose Median Dose	30 5.7 6.0	- - -	- - -	28 522 600	- - -	- - -
Y3	N Mean Dose Median Dose	28 7.9 8.0	- - -	- - -	- - -	25 568 600	- - -
119	N Mean Dose Median Dose	90 8 8	157 200 200	- - -	- - -	- - -	- - -

In all add-on trials, the reduction in seizure rate from baseline during the entire double-blind phase was measured. The median percent reductions in seizure rates and the responder rates (fraction of patients with at least a 50% reduction) by treatment group for each study are shown below in Table 2. As described above, a global improvement in seizure severity was also assessed in the Lennox-Gastaut trial.

Table 2: Efficacy Results in Double-Blind, Placebo-Controlled, Add-On Epilepsy Trials

Comparisons with placebo: a p=0.080; b p< 0.010; c p< 0.001; d p< 0.050; e p=0.065; f p< 0.005; g p=0.071; h Median % reduction and % responders are reported for PGTC Seizures; i Median % reduction and % responders for drop attacks, i.e., tonic or atonic seizures; j Percent of subjects who were minimally, much, or very much improved from baseline.
*For Protocols YP and YTC, protocol-specified target dosages (<9.3 mg/kg/day) were assigned based on subject's weight to approximate a dosage of 6 mg/kg per day; these dosages corresponded to mg/day dosages of 125, 175, 225, and 400 mg/day.
Protocol		Efficacy Results			Placebo	Target Topiramate Dosage (mg/day)
						200	400	600	800	1,000	≈ 6 mg/kg/day*
Partial Onset Seizures Studies in Adults
YD			N		45	45	45	46	-	-	-
			Median % Reduction		11.6	27.2a	47.5b	44.7c	-	-	-
			% Responders		18	24	44d	46d	-	-	-
YE			N		47	-	-	48	48	47	-
			Median % Reduction		1.7	-	-	40.8c	41.0c	36.0c	-
			% Responders		9	-	-	40c	41c	36d	-
Y1			N		24	-	23	-	-	-	-
			Median % Reduction		1.1	-	40.7e	-	-	-	-
			% Responders		8	-	35d	-	-	-	-
Y2			N		30	-	-	30	-	-	-
			Median % Reduction		-12.2	-	-	46.4f	-	-	-
			% Responders		10	-	-	47c	-	-	-
Y3			N		28	-	-	-	28	-	-
			Median % Reduction		-20.6	-	-	-	24.3c	-	-
			% Responders		0	-	-	-	43c	-	-
119			N		91	168	-	-	-	-	-
Median % Reduction					20.0	44.2c	-	-	-	-	-
% Responders					24	45c	-	-	-	-	-
Studies in Pediatric Patients
YP			N		45	-	-	-	-	-	41
			Median % Reduction		10.5	-	-	-	-	-	33.1d
			% Responders		20	-	-	-	-	-	39
Primary Generalized Tonic-Clonich
YTC			N		40	-	-	-	-	-	39
			Median % Reduction		9.0	-	-	-	-	-	56.7d
			% Responders		20	-	-	-	-	-	56c
Lennox-Gastaut Syndromei
YL			N		49	-	-	-	-	-	46
			Median % Reduction		-5.1	-	-	-	-	-	14.8d
			% Responders		14	-	-	-	-	-	28g
Improvement in Seizure Severityj					28	-	-	-	-	-	52d

Subset analyses of the antiepileptic efficacy of topiramate tablets in these studies showed no differences as a function of gender, race, age, baseline seizure rate, or concomitant AED.

INDICATIONS AND USAGE

Monotherapy Epilepsy

Topiragen™ (topiramate) Tablets are indicated as initial monotherapy in patients 10 years of age and older with partial onset or primary generalized tonic-clonic seizures.

Effectiveness was demonstrated in a controlled trial in patients with epilepsy who had no more than 2 seizures in the 3 months prior to enrollment. Safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials.

Adjunctive Therapy Epilepsy

Topiragen™ (topiramate) Tablets are indicated as adjunctive therapy for adults and pediatric patients ages 2-16 years with partial onset seizures, or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with Lennox-Gastaut syndrome.

CONTRAINDICATIONS

Topiragen™ (topiramate) Tablets are contraindicated in patients with a history of hypersensitivity to any component of this product.

WARNINGS

Acute Myopia and Secondary Angle Closure Glaucoma

A syndrome consisting of acute myopia associated with secondary angle closure glaucoma has been reported in patients receiving topiramate. Symptoms include acute onset of decreased visual acuity and/or ocular pain. Opthalmologic findings can include myopia, anterior chamber shallowing, ocular hyperemia (redness) and increased intraocular pressure. Mydriasis may or may not be present. This syndrome may be associated with supraciliary effusion resulting in anterior displacement of the lens and iris, with secondary angle closure glaucoma. Symptoms typically occur within 1 month of initiating topiramate therapy. In contrast to primary narrow angle glaucoma, which is rare under 40 years of age, secondary angle closure glaucoma associated with topiramate has been reported in pediatric patients as well as adults. The primary treatment to reverse symptoms is discontinuation of topiramate as rapidly as possible, according to the judgment of the treating physician. Other measures, in conjunction with discontinuation of topiramate, may be helpful.

Elevated intraocular pressure of any etiology, if left untreated, can lead to serious sequelae including permanent vision loss.

Oligohidrosis and Hyperthermia

Oligohidrosis (decreased sweating), infrequently resulting in hospitalization, has been reported in association with topiramate use. Decreased sweating and an elevation in body temperature above normal characterized these cases. Some of the cases were reported after exposure to elevated environmental temperatures.

The majority of the reports have been in children. Patients, especially pediatric patients, treated with topiramate should be monitored closely for evidence of decreased sweating and increased body temperature, especially in hot weather. Caution should be used when topiramate is prescribed with other drugs that predispose patients to heat-related disorders; these drugs include, but are not limited to, other carbonic anhydrase inhibitors and drugs with anticholinergic activity.

SUICIDAL BEHAVIOR and IDEATION

Antiepileptic drugs (AEDs), including Topiramate Tablets, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.

Pooled analyses of 199 placebo-controlled clinical trials (mono- and adjunctive therapy) of 11 different AEDs showed that patients randomized to one of the AEDs had approximately twice the risk (adjusted Relative Risk 1.8, 95% CI:1.2, 2.7) of suicidal thinking or behavior compared to patients randomized to placebo. In these trials, which had a median treatment duration of 12 weeks, the estimated incidence rate of suicidal behavior or ideation among 27,863 AED-treated patients was 0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately one case of suicidal thinking or behavior for every 530 patients treated. There were four suicides in drug-treated patients in the trials, none in placebo-treated patients, but the number is too small to allow any conclusion about drug effect on suicide.

The increased risk of suicidal thoughts or behavior with AEDs was observed as early as one week after starting drug treatment with AEDs and persisted for the duration of treatment assessed. Because most trials included in the analysis did not extend beyond 24 weeks, the risk of suicidal thoughts or behavior beyond 24 weeks could not be assessed.

The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed. The finding of increased risk with AEDs of varying mechanisms of action and across a range of indications suggests that the risk applies to all AEDs used for any indication. The risk did not vary substantially by age (5 to 100 years) in the clinical trails analyzed.

Table 3 shows absolute and relative risk by indication for all evaluated AEDs.

Table 3: Risk by Indication for Antiepileptic Drugs in the Pooled Analysis

Indication

Omeprazol Rimafar

Omeprazol Rimafar may be available in the countries listed below.

Ingredient matches for Omeprazol Rimafar

Omeprazole

Omeprazole is reported as an ingredient of Omeprazol Rimafar in the following countries:

• Spain

International Drug Name Search

Rofenid

Rofenid may be available in the countries listed below.

Ingredient matches for Rofenid

Ketoprofen

Ketoprofen is reported as an ingredient of Rofenid in the following countries:

• Belgium


• India


• Luxembourg

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Sylador

Sylador may be available in the countries listed below.

Ingredient matches for Sylador

Tramadol

Tramadol hydrochloride (a derivative of Tramadol) is reported as an ingredient of Sylador in the following countries:

• Brazil

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Docpara

Docpara may be available in the countries listed below.

Ingredient matches for Docpara

Paracetamol

Paracetamol is reported as an ingredient of Docpara in the following countries:

• Luxembourg

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Valproat AbZ

Valproat AbZ may be available in the countries listed below.

Ingredient matches for Valproat AbZ

Valproic Acid

Valproic Acid sodium (a derivative of Valproic Acid) is reported as an ingredient of Valproat AbZ in the following countries:

• Germany

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Takayasu's Arteritis Medications

Definition of Takayasu's Arteritis: A thrombo-obliterative process of the great vessels stemming from the aortic arch, occurring generally in young women. Radial and carotid pulses are typically obliterated. Skin changes are due to the disturbed circulation. There may be loss of hair and atrophy of the skin and its appendages with underlying muscle atrophy.

Drugs associated with Takayasu's Arteritis

The following drugs and medications are in some way related to, or used in the treatment of Takayasu's Arteritis. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Learn more about Takayasu's Arteritis

Harvard Health Guide:

• Symptoms and treatment for Takayasu's Arteritis

Drug List:

Azasan

Imuran

Fioricet with Codeine

Generic Name: butalbital, acetaminophen, caffeine, and codeine (Oral route)

bue-TAL-bi-tal, a-seet-a-MIN-oh-fen, KAF-een, KOE-deen FOS-fate

Oral route(Capsule)

This product contains butalbital, acetaminophen, caffeine, and codeine phosphate. Acetaminophen has been associated with cases of acute liver failure, including cases of death and transplantation. Most of the cases of liver injury are associated with the use of acetaminophen doses that exceed 4000 milligrams per day and often involve more than one acetaminophen containing product .

Commonly used brand name(s)

In the U.S.

• Fioricet with Codeine


• Phrenilin with Caffeine and Codeine

Available Dosage Forms:

• Capsule

Therapeutic Class: Opioid/Barbiturate Combination

Pharmacologic Class: Barbiturate

Chemical Class: Methylxanthine

Uses For Fioricet with Codeine

Butalbital, acetaminophen, caffeine, and codeine combination is a pain reliever and relaxant. It is used to treat tension headaches. Butalbital belongs to the group of medicines called barbiturates. Barbiturates act in the central nervous system (CNS) to produce their effects.

Codeine is a narcotic analgesic that acts in the CNS to relieve pain. Many of its side effects are also caused by actions in the CNS.

When you take butalbital or codeine for a long time, your body may get used to it so that larger amounts are needed to produce the same effects. This is called tolerance to the medicine. Also, butalbital and codeine may become habit-forming (causing mental or physical dependence) when it is used for a long time or in large doses. Physical dependence may lead to withdrawal side effects when you stop taking the medicine. In patients who get headaches, the first symptom of withdrawal may be new (rebound) headaches.

Caffeine may help to relieve headaches. However, caffeine can also cause physical dependence when it is used for a long time. This may lead to withdrawal (rebound) headaches when you stop taking it.

Butalbital, acetaminophen, caffeine and codeine combination may also be used for other kinds of headaches or other kinds of pain as determined by your doctor.

Butalbital, acetaminophen, caffeine, and codeine combination is available only with your doctor's prescription.

Before Using Fioricet with Codeine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

• For butalbital: Although barbiturates such as butalbital often cause drowsiness, some children become excited after taking them.


• For acetaminophen: Acetaminophen has been tested in children and, in effective doses, has not been shown to cause different side effects or problems than it does in adults.


• For caffeine: There is no specific information comparing use of caffeine in children up to 12 years of age with use in other age groups. However, caffeine is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

• For butalbital: Certain side effects, such as confusion, excitement, or mental depression, may be especially likely to occur in elderly patients, who are usually more sensitive than younger adults to the effects of the butalbital in this combination medicine.


• For acetaminophen: Acetaminophen has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.


• For caffeine: Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of caffeine in the elderly with use in other age groups.


• For codeine: Breathing problems may be especially likely to occur in elderly patients, who are usually more sensitive than younger adults to the effects of codeine.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Naltrexone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adinazolam


• Alfentanil


• Alprazolam


• Amobarbital


• Anileridine


• Anisindione


• Aprobarbital


• Bromazepam


• Brotizolam


• Buprenorphine


• Butabarbital


• Butalbital


• Butorphanol


• Carisoprodol


• Chloral Hydrate


• Chlordiazepoxide


• Chlorzoxazone


• Clobazam


• Clonazepam


• Clorazepate


• Codeine


• Dantrolene


• Dezocine


• Diazepam


• Dicumarol


• Estazolam


• Ethchlorvynol


• Fentanyl


• Flunitrazepam


• Flurazepam


• Halazepam


• Hydrocodone


• Hydromorphone


• Ketazolam


• Levorphanol


• Lorazepam


• Lormetazepam


• Medazepam


• Meperidine


• Mephenesin


• Mephobarbital


• Meprobamate


• Metaxalone


• Methocarbamol


• Methohexital


• Midazolam


• Morphine


• Morphine Sulfate Liposome


• Nalbuphine


• Nitrazepam


• Nordazepam


• Opium


• Oxazepam


• Oxycodone


• Oxymorphone


• Pentazocine


• Pentobarbital


• Phenindione


• Phenobarbital


• Phenprocoumon


• Prazepam


• Primidone


• Propoxyphene


• Quazepam


• Quetiapine


• Remifentanil


• Secobarbital


• Sodium Oxybate


• Sufentanil


• Tapentadol


• Temazepam


• Thiopental


• Triazolam

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acenocoumarol


• Cannabis


• Carbamazepine


• Imipramine


• Isoniazid


• Phenytoin


• Prednisone


• Warfarin


• Zidovudine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Cabbage


• Ethanol

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse (or history of) or


• Drug abuse or dependence (or history of)—Dependence on butalbital and codeine may develop; also, acetaminophen may cause liver damage in people who abuse alcohol

• Asthma (or history of), emphysema, or other chronic lung disease or


• Brain disease or head injury or


• Colitis or


• Convulsions (seizures) (history of) or


• Emphysema or other chronic lung disease or


• Enlarged prostate or problems with urination or


• Gallbladder disease or gallstones or


• Hepatitis or other liver disease or


• Hyperactivity (in children) or


• Kidney disease—The chance of serious side effects may be increased

• Type 2 diabetes mellitus or


• Mental depression or


• Overactive thyroid or


• Porphyria (or history of)—Butalbital can make these conditions worse

• Heart disease (severe)—The caffeine can make some kinds of heart disease worse

Proper Use of butalbital, acetaminophen, caffeine, and codeine

This section provides information on the proper use of a number of products that contain butalbital, acetaminophen, caffeine, and codeine. It may not be specific to Fioricet with Codeine. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If butalbital, acetaminophen, caffeine, and codeine combination is taken regularly (for example, every day), it may become habit-forming (causing mental or physical dependence). The caffeine can also increase the chance of dependence. Dependence is especially likely to occur in patients who take these medicines to relieve frequent headaches. Taking too much of this medicine may also lead to liver damage or other medical problems.

This medicine will relieve a headache best if you take it as soon as the headache begins. If you get warning signs of a migraine, take this medicine as soon as you are sure that the migraine is coming. This may even stop the headache pain from occurring. Lying down in a quiet, dark room for a while after taking the medicine also helps to relieve headaches.

People who get a lot of headaches may need to take a different medicine to help prevent headaches. It is important that you follow your doctor's directions about taking the other medicine, even if your headaches continue to occur. Headache-preventing medicines may take several weeks to start working. Even after they do start working, your headaches may not go away completely. However, your headaches should occur less often, and they should be less severe and easier to relieve than before. This will reduce the amount of headache relievers that you need. If you do not notice any improvement after several weeks of headache-preventing treatment, check with your doctor.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (capsules):
  
  • For tension headaches:
    
    • Adults—One or 2 capsules every four hours as needed. You should not take more than six capsules a day.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Fioricet with Codeine

Check with your doctor:

• If the medicine stops working as well as it did when you first started using it. This may mean that you are in danger of becoming dependent on the medicine. Do not try to get better pain relief by increasing the dose.


• If you are having headaches more often than you did before you started taking this medicine. This is especially important if a new headache occurs within 1 day after you took your last dose of this medicine, headaches begin to occur every day, or a headache continues for several days in a row. This may mean that you are dependent on the medicine. Continuing to take this medicine will cause even more headaches later on. Your doctor can give you advice on how to relieve the headaches.

Check the labels of all nonprescription (over-the-counter [OTC]) or prescription medicines you now take. If any contain a barbiturate, acetaminophen, caffeine, or codeine, check with your health care professional . Taking them together with this medicine may cause an overdose.

Codeine is changed to morphine in the body. Some people change codeine to morphine more quickly than others. These individuals are called "ultra-rapid metabolizers of codeine".Contact your doctor immediately if you experience extreme sleepiness, confusion, or shallow breathing. These symptoms may indicate that you are an "ultra-rapid metabolizer of codeine". As a result, there is too much morphine in the body and more side effects of morphine than usual

If a nursing mother is an ultra-rapid metabolizer of codeine, it could lead to a morphine overdose in the nursing baby and cause very serious side effects . For nursing mothers taking this medicine:

• Talk to your doctor if you have any questions about taking codeine or about how this medicine may affect your baby.


• Call your doctor if you become extremely tired and have difficulty caring for your baby.


• Your baby should generally nurse every two to three hours and should not sleep more than four hours at a time.


• Check with your doctor or hospital emergency room immediately if your baby shows signs of increased sleepiness (more than usual), difficulty breast-feeding, difficulty breathing, or limpness. These may be symptoms of an overdose and need immediate medical attention .

The butalbital and codeine in this medicine will add to the effects of alcohol and other central nervous system (CNS) depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; other prescription pain medicine; narcotics; other barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Also, drinking large amounts of alcoholic beverages regularly while taking this medicine may increase the chance of liver damage or stomach problems, especially if you take more of this medicine than your doctor ordered or if you take it regularly for a long time. Therefore, do not drink alcoholic beverages, and check with your doctor before taking any of the medicines listed above, while you are using this medicine.

This medicine may cause some people to become drowsy, dizzy, or lightheaded. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert and clearheaded.

Before you have any medical tests, tell the person in charge that you are taking this medicine. Caffeine interferes with the results of certain tests that use dipyridamole (e.g., Persantine) to help show how well blood is flowing to your heart. Caffeine should not be taken for 8 to 12 hours before the test. The results of other tests may also be affected by butalbital, acetaminophen, caffeine and codeine combination.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine. Serious side effects can occur if your medical doctor or dentist gives you certain medicines without knowing that you have taken butalbital or codeine.

If you have been taking large amounts of this medicine, or if you have been taking it regularly for several weeks or more, do not suddenly stop taking it without first checking with your doctor. Your doctor may want you to reduce gradually the amount you are taking before stopping completely in order to lessen the chance of withdrawal side effects.

If you think you or anyone else may have taken an overdose of this medicine, get emergency help at once. Taking an overdose of this medicine or taking alcohol or CNS depressants with this medicine may lead to unconsciousness or possibly death. Signs of butalbital or codeine overdose include severe drowsiness, confusion, severe weakness, shortness of breath or unusually slow or troubled breathing, slurred speech, staggering, and unusually slow heartbeat. Signs of severe acetaminophen poisoning may not occur until 2 to 4 days after the overdose is taken, but treatment to prevent liver damage or death must be started within 24 hours or less after the overdose is taken.

Fioricet with Codeine Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare

• Bleeding or crusting sores on lips


• chest pain


• fever with or without chills


• convulsions, hallucinations, trembling, and/or uncontrolled muscle movements


• hive-like swellings (large) on eyelids, face, lips, and/or tongue


• mental depression


• muscle cramps or pain


• red, thickened, or scaly skin


• shortness of breath, troubled breathing, tightness in chest, or wheezing


• skin rash, itching, or hives


• sores, ulcers, or white spots in mouth (painful)


• sore throat

Symptoms of overdose

If you are a nursing mother and you notice any of the following symptoms of overdose in your baby, get emergency help immediately:

• Anxiety, confusion, excitement, irritability, nervousness, restlessness, or trouble in sleeping (severe)


• cold and clammy skin


• convulsions (seizures)


• diarrhea, especially if occurring together with increased sweating, loss of appetite, and stomach cramps or pain


• dizziness, light-headedness, drowsiness, or weakness, (severe)


• frequent urination


• hallucinations (seeing, hearing, or feeling things that are not there)


• increased sensitivity to touch or pain


• muscle trembling or twitching


• nausea or vomiting, sometimes with blood


• ringing or other sounds in ears


• seeing flashes of "zig-zag" lights


• shortness of breath or unusually slow or troubled breathing


• slow, fast, or irregular heartbeat


• slurred speech


• staggering


• swelling, pain, or tenderness in the upper abdomen or stomach area


• unusual movements of the eyes


• Difficulty breathing


• difficulty nursing


• increased sleepiness (more than usual)


• limpness

Check with your doctor as soon as possible if any of the following side effects occur:

Less common

• Confusion (mild)


• mental depression


• unusual excitement (mild)

Rare

• Bloody or black, tarry stools


• bloody urine


• pinpoint red spots on skin


• swollen or painful glands


• unusual bleeding or bruising


• unusual tiredness or weakness (mild)

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Bloated or "gassy" feeling


• dizziness or light-headedness (mild)


• drowsiness (mild)


• nausea, vomiting, or stomach pain (occurring without other symptoms of overdose)

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Fioricet with Codeine side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Fioricet with Codeine resources

• Fioricet with Codeine Side Effects (in more detail)
• Fioricet with Codeine Dosage
• Fioricet with Codeine Use in Pregnancy & Breastfeeding
• Drug Images
• Fioricet with Codeine Drug Interactions
• Fioricet with Codeine Support Group
• 7 Reviews for Fioricet with Codeine - Add your own review/rating

• Fioricet with Codeine Prescribing Information (FDA)


• Fioricet with Codeine Concise Consumer Information (Cerner Multum)


• Fioricet with Codeine MedFacts Consumer Leaflet (Wolters Kluwer)


• Phrenilin with Caffeine and Codeine Prescribing Information (FDA)

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Micardis 80mg Tablets

Micardis 80 mg tablets

Telmisartan

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet. You may need to read it again.


• If you have any further questions, ask your doctor or pharmacist.


• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.


• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

• 1. What Micardis is and what it is used for


• 2. Before you take Micardis


• 3. How to take Micardis


• 4. Possible side effects


• 5. How to store Micardis


• 6. Further information

What Micardis Is And What It Is Used For

Micardis belongs to a class of medicines known as angiotensin II receptor antagonists. Angiotensin II is a substance produced in your body which causes your blood vessels to narrow, thus increasing your blood pressure. Micardis blocks the effect of angiotensin II so that the blood vessels relax, and your blood pressure is lowered.

Micardis is used to treat essential hypertension (high blood pressure). ‘Essential’ means that the high blood pressure is not caused by any other condition.

High blood pressure, if not treated, can damage blood vessels in several organs, which could lead sometimes to heart attack, heart or kidney failure, stroke, or blindness. There are usually no symptoms of high blood pressure before damage occurs. Thus it is important to regularly measure blood pressure to verify if it is within the normal range.

Micardis is also used to reduce cardiovascular events (i.e. heart attack or stroke) in patients who are at risk because they have a reduced or blocked blood supply to the heart or legs, or have had a stroke or have high risk diabetes. Your doctor can tell you if you are at high risk for such events.

Before You Take Micardis

Do not take Micardis

• if you are allergic (hypersensitive) to telmisartan or any other ingredients included in Micardis tablets (see section Further information for a list of other ingredients).


• if you are more than 3 months pregnant. (It is also better to avoid Micardis in early pregnancy – see pregnancy section.)


• if you have severe liver problems such as cholestasis or biliary obstruction (problems with drainage of the bile from the liver and gall bladder) or any other severe liver disease.

If any of the above applies to you, tell your doctor or pharmacist before taking Micardis.

Take special care with Micardis

Please tell your doctor if you are suffering or have ever suffered from any of the following conditions or illnesses:

• Kidney disease or kidney transplant.


• Renal artery stenosis (narrowing of the blood vessels to one or both kidneys).


• Liver disease.


• Heart trouble.


• Raised aldosterone levels (water and salt retention in the body along with imbalance of various blood minerals).


• Low blood pressure (hypotension), likely to occur if you are dehydrated (excessive loss of body water) or have salt deficiency due to diuretic therapy (‘water tablets’), low-salt diet, diarrhoea, or vomiting.


• Elevated potassium levels in your blood.


• Diabetes.

You must tell your doctor if you think you are (or might become) pregnant. Micardis is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).

In case of surgery or anaesthesia, you should tell your doctor that you are taking Micardis.

The use of Micardis in children and adolescents up to the age of 18 years is not recommended.

As with all other angiotensin antagonists, Micardis may be less effective in lowering the blood pressure in black patients.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Your doctor may need to change the dose of these other medicines or take other precautions. In some cases you may have to stop taking one of the medicines. This applies especially to the medicines listed below taken at the same time with Micardis:

• Lithium containing medicines to treat some types of depression.


• Medicines that may increase blood potassium levels such as salt substitutes containing potassium, potassium-sparing diuretics (certain ‘water tablets’), ACE inhibitors, angiotensin II receptor antagonists, NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen), heparin, immunosuppressives (e.g. cyclosporin or tacrolimus), and the antibiotic trimethoprim.


• Diuretics (‘water tablets’), especially if taken in high doses together with Micardis, may lead to excessive loss of body water and low blood pressure (hypotension).

As with other blood pressure lowering medicines, the effect of Micardis may be reduced when you take NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen) or corticosteroids.

Micardis may increase the blood pressure lowering effect of other medicines used to treat high blood pressure.

Taking Micardis with food and drink

You can take Micardis with or without food.

Pregnancy and breast-feeding

Pregnancy

You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Micardis before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Micardis. Micardis is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. Micardis is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.

Driving and using machines

No information is available on the effect of Micardis on the ability to drive or operate machinery. Some people feel dizzy or tired when they are treated for high blood pressure. If you feel dizzy or tired, do not drive or operate machinery.

Important information about some of the ingredients of Micardis

Micardis contains sorbitol.

If you are intolerant to some sugars, consult your doctor before taking Micardis.

How To Take Micardis

Always take Micardis exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual dose of Micardis is one tablet a day. Try to take the tablet at the same time each day. You can take Micardis with or without food. The tablets should be swallowed with some water or other non-alcoholic drink. It is important that you take Micardis every day until your doctor tells you otherwise. If you have the impression that the effect of Micardis is too strong or too weak, talk to your doctor or pharmacist.

For treatment of high blood pressure, the usual dose of Micardis for most patients is one 40 mg tablet once a day to control blood pressure over the 24 hour period. However, sometimes your doctor may recommend a lower dose of 20 mg or a higher dose of 80 mg. Alternatively, Micardis may be used in combination with diuretics (‘water tablets’) such as hydrochlorothiazide which has been shown to have an additive blood pressure lowering effect with Micardis.

For reduction of cardiovascular events, the usual dose of Micardis is one 80 mg tablet once a day. At the beginning of the preventive therapy with Micardis 80mg, blood pressure should be frequently monitored.

If your liver is not working properly, the usual dose should not exceed 40 mg once daily.

If you take more Micardis than you should

If you accidentally take too many tablets, contact your doctor, pharmacist, or your nearest hospital emergency department immediately.

If you forget to take Micardis

If you forget to take a dose, do not worry. Take it as soon as you remember then carry on as before. If you do not take your tablet on one day, take your normal dose on the next day. Do not take a double dose to make up for forgotten individual doses.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible Side Effects

Like all medicines, Micardis can cause side effects, although not everybody gets them. These side effects may occur with certain frequencies, which are defined as follows:

• very common: affects more than 1 user in 10


• common: affects 1 to 10 users in 100


• uncommon: affects 1 to 10 users in 1,000


• rare: affects 1 to 10 users in 10,000


• very rare: affects less than 1 user in 10,000


• not known: frequency cannot be estimated from the available data.

Common side effects may include:

Low blood pressure (hypotension) in users treated for reduction of cardiovascular events.

Uncommon side effects may include:

Upper respiratory tract infections (e.g. sore throat, inflamed sinuses, common cold), urinary tract infections, deficiency in red blood cells (anaemia), high potassium levels, feeling sad (depression), fainting (syncope), difficulty falling asleep, feeling of spinning (vertigo), slow heart rate (bradycardia), low blood pressure (hypotension) in users treated for high blood pressure, dizziness on standing up (orthostatic hypotension), shortness of breath, abdominal pain, diarrhoea, discomfort in the abdomen, bloating, vomiting, increased sweating, itching, drug rash, muscle pain (myalgia), back pain, muscle cramps, kidney impairment including acute kidney failure, pain in the chest, feeling of weakness, and increased level of creatinine in the blood.

Rare side effects may include:

Low platelet count (thrombocytopenia), allergic reaction (e.g. rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), feeling anxious, impaired vision, fast heart beat (tachycardia), upset stomach, dry mouth, abnormal liver function, severe drug rash, redness of skin, rapid swelling of the skin and mucosa (angioedema), eczema (a skin disorder), joint pain (arthralgia), pain in extremity, flu-like-illness, increased levels of uric acid, hepatic enzymes or creatine phosphokinase in the blood, and decreased haemoglobin (a blood protein).

Side effects of unknown frequency may include:

Increase in certain white blood cells (eosinophilia), severe allergic reaction (anaphylactic reaction), hives (urticaria), tendon pain, and sepsis* (often called “blood poisoning”, is a severe infection with whole-body inflammatory response which can lead to death).

*In a long-term study involving more than 20,000 patients, more patients treated with telmisartan experienced sepsis compared with patients who received no telmisartan. The event may have happened by chance or could be related to a mechanism currently not known.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How To Store Micardis

Keep out of the reach and sight of children.

Do not use Micardis after the expiry date which is stated on the carton after “EXP”. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions. You should store your medicine in the original package in order to protect the tablets from moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further Information

What Micardis contains

The active substance is telmisartan. Each tablet contains 80 mg telmisartan.

The other ingredients are povidone, meglumine, sodium hydroxide, sorbitol (E420) and magnesium stearate.

What Micardis looks like and contents of the pack

Micardis 80 mg tablets are white, oblong-shaped and engraved with the code number ‘52H’ on one side and the company logo on the other side.

Micardis is available in blister packs containing 14, 28, 30, 56, 84, 90 or 98 tablets, or unit dose blister packs containing 28 x 1 tablets.

Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder

Boehringer Ingelheim International GmbH

Binger Str. 173

D-55216 Ingelheim am Rhein

Germany

Manufacturer

Boehringer Ingelheim Pharma GmbH & Co. KG

Binger Str. 173

D-55216 Ingelheim am Rhein

Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

United Kingdom

Boehringer Ingelheim Ltd.

Tel:+44 1344 424 600

This leaflet was last approved in 11/2009

Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/.

62567-08