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 Περιεχόμενα  Φάρμακα Α - Ζ  Συγχορήγηση

TANATRIL Tablet (2014)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Tanatril 5 mg tablets.

Qualitative and quantitative composition

Imidapril hydrochloride 5 mg. Excipient with known effect: Lactose, 54 mg per tablet. For the full list of excipients, see section 6.1

Pharmaceutical form

Tablets. Off-white oblong biconvex tablets with a plane edge, scored on both sides. The tablet can be divided into equal doses.

Therapeutic indications

Tanatril is indicated for the treatment of essential hypertension in adults (See sections 4.3, 4.4, 4.5 and 5.1).

Posology and method of administration

Posology Adults Treatment should be initiated with 5 mg once a day. If optimum control of blood pressure has not been achieved after at least 3 weeks of treatment, the daily dose should be increased to ...

Contraindications

Hypersensitivity to the active substance or any other ACE inhibitor or to any of the excipients listed in section 6.1. History of angioneurotic oedema associated with previous ACE inhibitor therapy. Hereditary/idiopathic ...

Special warnings and precautions for use

Hypotension Imidapril like other ACE inhibitors may cause a profound fall in blood pressure especially after the first dose. Symptomatic hypotension is rare in uncomplicated hypertensive patients. It is ...

Interaction with other medicinal products and other forms of interaction

Potassium sparing diuretics alone or in combination or potassium supplements Imidapril, like other ACE inhibitors, attenuates diuretic induced potassium loss. Potassium sparing diuretics, e.g. spironolactone, ...

Fertility, pregnancy and lactation

Pregnancy The use of ACE inhibitors is not recommended during the first trimester of pregnancy (see section 4.4). The use of ACE inhibitors is contraindicated during the second and third trimester of pregnancy ...

Effects on ability to drive and use machines

Tanatril has minor influence on the ability to drive and use machines. It should be taken into account that occasionally dizziness or weariness may occur. No studies on the effects on the ability to drive ...

Undesirable effects

Summary of the safety profile The incidence of adverse events in hypertensive patients on imidapril was 34% with 36% for placebo. Cough, dizziness, fatigue/somnolence, dyspepsia and vomiting occurred more ...

Overdose

Symptoms of overdosage are severe hypotension, shock, stupor, bradycardia, electrolyte disturbances and renal failure. After ingestion of an overdose, the patient should be kept under close supervision, ...

Pharmacodynamic properties

Pharmacotherapeutic group: ACE inhibitors ATC Code: C09AA16 Mechanism of action The hypotensive effect of imidapril in hypertension appears to result primarily from the suppression of the plasma renin-angiotensin-aldosterone ...

Pharmacokinetic properties

Absorption Following oral administration imidapril is rapidly absorbed from the gastrointestinal tract and reaches its maximum plasma concentration within 2 hours. Plasma concentrations decline monophasically ...

Preclinical safety data

There were no specific effects from either short studies (including mutagenicity studies) or long term toxicity studies (including carcinogenicity studies) which provide any additional relevant data to ...

List of excipients

Calcium hydrogen phosphate, anhydrous Maize starch, pregelatinised Lactose monohydrate Croscarmellose sodium Glycerol distearate

Incompatibilities

Not applicable.

Shelf life

3 years.

Special precautions for storage

Aluminium/aluminium blister. Do not store above 30°C. PVDC/aluminium blister. Do not store above 25°C.

Nature and contents of container

Aluminium/aluminium or PVDC/aluminium – Blister with 5, 7 and 10 tablets. Packs with 7, 10, 14, 15, 20, 28, 30, 50, 56, 84, 90, 100, and 1000 tablets Not all packaging material or pack sizes may be marketed. ...

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Mitsubishi Tanabe Pharma Europe Limited, 6<sup>th</sup> Floor, Dashwood House, 69 Old Broad Street, London, EC2M 1QS, United Kingdom

Marketing authorization number(s)

PL 20012/0004

Date of first authorization / renewal of the authorization

12/November/2007

Date of revision of the text

17 December 2014

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