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COVERSYL ARGININE Film-coated tablet (2021)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Coversyl Arginine 2.5 mg film-coated tablets. Coversyl Arginine 5 mg film-coated tablets. Coversyl Arginine 10 mg film-coated tablets.

Qualitative and quantitative composition

Perindopril arginine. <u>2.5mg:</u> One film-coated tablet contains 1.6975 mg perindopril corresponding to 2.5 mg perindopril arginine. Excipient with known effect: 36.29 mg lactose monohydrate. <u>5mg: ...

Pharmaceutical form

Film-coated tablet. <u>2.5mg:</u> White, round, convex, film-coated tablet. <u>5mg:</u> Light-green, rod-shaped film-coated tablet engraved with on one face and scored on both edges. The tablet can be ...

Therapeutic indications

Hypertension Treatment of hypertension. Heart failure Treatment of symptomatic heart failure. Stable coronary artery disease Reduction of risk of cardiac events in patients with a history of myocardial ...

Posology and method of administration

Posology The dose should be individualised according to the patient profile (see section 4.4) and blood pressure response. Hypertension Coversyl Arginine may be used in monotherapy or in combination with ...

Contraindications

Hypersensitivity to the active substance, to any of the excipients or to any other ACE inhibitor; History of angioedema associated with previous ACE inhibitor therapy (see section 4.4); Hereditary or idiopathic ...

Special warnings and precautions for use

Stable coronary artery disease If an episode of unstable angina pectoris (major or not) occurs during the first month of perindopril treatment, a careful appraisal of the benefit/risk should be performed ...

Interaction with other medicinal products and other forms of interaction

Clinical trial data has shown that dual blockade of the renin-angiotensin-aldosterone-system (RAAS) through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated ...

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 contra-indicated during the 2<sup>nd</sup> and 3<sup>rd</sup> ...

Effects on ability to drive and use machines

Coversyl Arginine has no direct influence on the ability to drive and use machines but individual reactions related to low blood pressure may occur in some patients, particularly at the start of treatment ...

Undesirable effects

a. Summary of safety profile The safety profile of perindopril is consistent with the safety profile of ACE inhibitors: The most frequent adverse events reported in clinical trials and observed with perindopril ...

Overdose

Limited data are available for overdosage in humans. Symptoms associated with overdosage of ACE inhibitors may include hypotension, circulatory shock, electrolyte disturbances, renal failure, hyperventilation, ...

Pharmacodynamic properties

<b>Pharmacotherapeutic group:</b> ACE inhibitor, plain <b>ATC code:</b> C09AA04 Mechanism of action Perindopril is an inhibitor of the enzyme that converts angiotensin I into angiotensin II (Angiotensin ...

Pharmacokinetic properties

Absorption After oral administration, the absorption of perindopril is rapid and the peak concentration is achieved within 1 hour. The plasma half-life of perindopril is equal to 1 hour. Perindopril is ...

Preclinical safety data

In the chronic oral toxicity studies (rats and monkeys), the target organ is the kidney, with reversible damage. No mutagenicity has been observed in <em>in vitro</em> or <em>in vivo</em> studies. Reproduction ...

List of excipients

<u>Core:</u> Lactose monohydrate Magnesium stearate Maltodextrin Hydrophobic colloidal silica Sodium starch glycolate (type A) <u>Film-coating:</u> Glycerol Hypromellose Copper chlorophyllin (not 2.5 mg) ...

Incompatibilities

Not applicable.

Shelf life

3 years.

Special precautions for storage

Keep the container tightly closed in order to protect from moisture.

Nature and contents of container

White polypropylene tablet container equipped with a polyethylene flow reducer and a white opaque stopper containing a desiccant gel. Box of 5, 10, 14, 20, 28, 30, 50, 60 (60 or 2 containers of 30), 84 ...

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Les Laboratoires Servier, 50, rue Carnot, 92284 Suresnes cedex, France

Marketing authorization number(s)

2.5mg: PL 05815/0035 5mg: PL 05815/0036 10mg: PL 05815/0037

Date of first authorization / renewal of the authorization

28/02/2007 – 10/12/2009

Date of revision of the text

10/2021

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