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EPROSARTAN Film-coated tablet (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Eprosartan Mylan 300 mg Film-coated tablets.

Qualitative and quantitative composition

Each film-coated tablet contains 367.90 mg of eprosartan mesilate equivalent to 300 mg of eprosartan. Excipient with known effect: 21.390 mg of lactose monohydrate per 300 mg tablet. For the full list ...

Pharmaceutical form

Film-coated tablet. <u>300 mg:</u> A white to off-white, film coated, oval, biconvex, bevelled edge tablet imprinted with M EN1 in black ink on one side of the tablet and blank on the other side.

Therapeutic indications

Eprosartan is indicated for the treatment of essential hypertension. Eprosartan is indicated in adults.

Posology and method of administration

Posology The recommended dose is 600 mg eprosartan once daily. Achievement of maximal blood pressure reduction in most patients may take 2 to 3 weeks of treatment. Eprosartan may be used alone or in combination ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Second and third trimester of pregnancy (see sections 4.4 and 4.6). Severe hepatic impairment. Haemodynamically ...

Special warnings and precautions for use

Hepatic impairment When eprosartan is used in patients with mild to moderate hepatic impairment, special care should be exercised due to the fact that there is limited experience in this patient population. ...

Interaction with other medicinal products and other forms of interaction

Elevated serum potassium levels have been observed in placebo controlled clinical trials. Experience from other drugs affecting the renin-angiotensin-aldosterone system indicate that concomitant use of ...

Pregnancy and lactation

Pregnancy The use of AIIRAs is not recommended during the first trimester of pregnancy (see section 4.4). The use of AIIRAs is contra-indicated during the second and third trimester of pregnancy (see sections ...

Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines has been performed. Based on its pharmacodynamic properties, eprosartan is unlikely to affect this ability. When driving vehicles or operating ...

Undesirable effects

The most commonly reported adverse drug reactions of patients treated with eprosartan are headache and unspecific gastrointestinal complaints, occurring in approximately 11% and 8%, respectively, of patients. ...

Overdose

Limited data are available with regard to overdose in humans. There have been individual reports from postmarketing experience where doses up to 12,000 mg had been ingested. Most patients reported no symptoms. ...

Pharmacodynamic properties

Pharmacotherapeutic group: Angiotensin II antagonists, plain ATC code: C09CA02 Mechanism of action Eprosartan is a potent, synthetic, orally active non-biphenyl non-tetrazole angiotensin II receptor antagonist, ...

Pharmacokinetic properties

Absorption Absolute bioavailability following a single 300 mg oral dose of eprosartan is about 13%, due to limited oral absorption. Eprosartan plasma concentrations peak at one to two hours after an oral ...

Preclinical safety data

Acute toxicity There were no mortalities in rats and mice dosed at up to 3000 mg/kg BW and in dogs given up to 1000 mg/kg BW. Chronic toxicity In chronic toxicity studies eprosartan did not produce any ...

List of excipients

<u>Tablet core:</u> Lactose monohydrate Microcrystalline cellulose (Avicel PH101) Pregelatinised maize starch Silica, colloidal anhydrous Polysorbate 80 Povidone (K-12) Microcrystalline cellulose (Avicel ...

Incompatibilities

Not applicable.

Shelf life

3 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

White HDPE bottle with a white opaque polypropylene screw cap with induction sealing liner. Pack size of 500 film-coated tablets Aluminium foil blisters laminated with PVC on one side and coated with a ...

Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Marketing authorization holder

Generics [UK] Limited t/a Mylan, Station Close, Potters Bar, Hertfordshire, EN6 1TL

Marketing authorization number(s)

PL 04569/1227

Date of first authorization / renewal of the authorization

14/03/2012

Date of revision of the text

26/02/2018

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