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EDARBI Tablets (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Edarbi 20 mg tablets. Edarbi 40 mg tablets. Edarbi 80 mg tablets.

Qualitative and quantitative composition

Edarbi 20 mg tablets: Each tablet contains 20 mg of azilsartan medoxomil (as potassium). Edarbi 40 mg tablets: Each tablet contains 40 mg of azilsartan medoxomil (as potassium). Edarbi 80 mg tablets: Each ...

Pharmaceutical form

Tablet. Edarbi 20 mg tablets: White to nearly white round tablets, 6.0 mm in diameter, debossed ASL on one side and 20 on the other. Edarbi 40 mg tablets: White to nearly white round tablets, 7.6 mm in ...

Therapeutic indications

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

Posology and method of administration

Posology The recommended starting dose is 40 mg once daily. The dose may be increased to a maximum of 80 mg once daily for patients whose blood pressure is not adequately controlled at the lower dose. ...

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). The concomitant use of Edarbi with aliskiren-containing ...

Special warnings and precautions for use

Activated renin-angiotensin-aldosterone system (RAAS) In patients whose vascular tone and renal function depend predominantly on the activity of the RAAS (e.g. patients with congestive heart failure, severe ...

Interaction with other medicinal products and other forms of interaction

Concomitant use not recommended Lithium Reversible increases in serum lithium concentrations and toxicity have been reported during concurrent use of lithium and angiotensin-converting enzyme inhibitors. ...

Fertility, pregnancy and lactation

Pregnancy The use of angiotensin II receptor antagonists is not recommended during the first trimester of pregnancy (see section 4.4). The use of angiotensin II receptor antagonists is contraindicated ...

Effects on ability to drive and use machines

Azilsartan medoxomil has no or negligible influence on the ability to drive and use machines. However it should be taken into account that occasionally dizziness or tiredness may occur.

Undesirable effects

Summary of the safety profile Edarbi at doses of 20, 40 or 80 mg has been evaluated for safety in clinical studies in patients treated for up to 56 weeks. In these clinical studies, adverse reactions associated ...

Overdose

Symptoms Based on pharmacological considerations, the main manifestation of an overdose is likely to be symptomatic hypotension and dizziness. During controlled clinical studies in healthy subjects, once ...

Pharmacodynamic properties

Pharmacotherapeutic group: Agents acting on the renin-angiotensin system, angiotensin II antagonists, plain ATC Code: C09CA09 Mechanism of action Azilsartan medoxomil is an orally active prodrug that is ...

Pharmacokinetic properties

Following oral administration, azilsartan medoxomil is rapidly hydrolyzed to the active moiety azilsartan in the gastrointestinal tract and/or during absorption. Based on in vitro studies, carboxymethylenebutenolidase ...

Preclinical safety data

In preclinical safety studies, azilsartan medoxomil and M-II, the major human metabolite, were examined for repeated-dose toxicity, reproduction toxicity, mutagenicity and carcinogenicity. In the repeated-dose ...

List of excipients

Mannitol (E421) Fumaric acid (E297) Sodium hydroxide Hydroxypropylcellulose (E463) Croscarmellose sodium Microcrystalline cellulose (E460) Magnesium stearate (E572)

Incompatibilities

Not applicable.

Shelf life

Shelf life: 3 years.

Special precautions for storage

Store in the original package in order to protect from light and moisture. This medicinal product does not require any special temperature storage conditions.

Nature and contents of container

Aluminum blisters Pack sizes: 14, 28, 56 or 98 tablets; or Aluminum blisters integrated with desiccant. Pack sizes: 14, 28, 30, 56, 90 or 98 tablets. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Takeda Pharma A/S, Dybendal Alle 10, 2630, Taastrup, Denmark

Marketing authorization number(s)

EU/1/11/734/001 14 tablets EU/1/11/734/002 28 tablets EU/1/11/734/012 30 tablets EU/1/11/734/003 56 tablets EU/1/11/734/013 90 tablets EU/1/11/734/004 98 tablets EU/1/11/734/005 14 tablets EU/1/11/734/006 ...

Date of first authorization / renewal of the authorization

Date of first authorisation: 7 December 2011

Πηγαίο έγγραφο

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