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RASILEZ Film-coated tablet (2017)

Αναφορές

Βιβλιογραφική αναφορά

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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Περιεχόμενα

Name of the medicinal product

Rasilez 150 mg film-coated tablets. Rasilez 300 mg film-coated tablets.

Qualitative and quantitative composition

Rasilez 150 mg film-coated tablets: Each film-coated tablet contains 150 mg aliskiren (as hemifumarate). Rasilez 300 mg film-coated tablets: Each film-coated tablet contains 300 mg aliskiren (as hemifumarate). ...

Pharmaceutical form

Film-coated tablet. Rasilez 150 mg film-coated tablets: Light-pink, biconvex, round tablet, imprinted IL on one side and NVR on the other side. Rasilez 300 mg film-coated tablets: Light-red, biconvex, ...

Therapeutic indications

Treatment of essential hypertension in adults.

Posology and method of administration

Posology The recommended dose of Rasilez is 150 mg once daily. In patients whose blood pressure is not adequately controlled, the dose may be increased to 300 mg once daily. The antihypertensive effect ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. History of angioedema with aliskiren. Hereditary or idiopathic angioedema. Second and third trimesters of pregnancy ...

Special warnings and precautions for use

General In the event of severe and persistent diarrhoea, Rasilez therapy should be stopped (see section 4.8). Aliskiren should be used with caution in patients with serious congestive heart failure (New ...

Interaction with other medicinal products and other forms of interaction

Contraindicated (see section 4.3) P-gp potent inhibitors A single dose interaction study in healthy subjects has shown that ciclosporin (200 and 600 mg) increases C<sub>max</sub> of aliskiren 75 mg approximately ...

Fertility, pregnancy and lactation

Pregnancy There are no data on the use of aliskiren in pregnant women. Aliskiren was not teratogenic in rats or rabbits (see section 5.3). Other substances that act directly on the RAAS have been associated ...

Effects on ability to drive and use machines

Aliskiren has minor influence on the ability to drive and use machines. However, when driving vehicles or operating machines it must be borne in mind that dizziness or weariness may occasionally occur ...

Undesirable effects

Summary of the safety profile Serious adverse reactions include anaphylactic reaction and angioedema which have been reported in post-marketing experience and may occur rarely (less than 1 case per 1,000 ...

Overdose

Symptoms Limited data are available related to overdose in humans. The most likely manifestations of overdosage would be hypotension, related to the antihypertensive effect of aliskiren. Treatment If symptomatic ...

Pharmacodynamic properties

Pharmacotherapeutic group: Agents acting on the renin-angiotensin system; renin inhibitor ATC code: C09XA02 Mechanism of action Aliskiren is an orally active, non-peptide, potent and selective direct inhibitor ...

Pharmacokinetic properties

Absorption Following oral absorption, peak plasma concentrations of aliskiren are reached after 1-3 hours. The absolute bioavailability of aliskiren is approximately 2-3%. Meals with a high fat content ...

Preclinical safety data

Safety pharmacology studies did not reveal any adverse effects on central nervous, respiratory or cardiovascular function. Findings during repeat-dose toxicity studies in animals were consistent with the ...

List of excipients

Crospovidone Magnesium stearate Microcrystalline cellulose Povidone Colloidal anhydrous silica Hypromellose Macrogol Talc Black iron oxide (E172) Red iron oxide (E172) Titanium dioxide (E171)

Incompatibilities

Not applicable.

Shelf life

Shelf life: 2 years.

Special precautions for storage

Do not store above 30°C. Store in the original package in order to protect from moisture.

Nature and contents of container

Rasilez 150 mg film-coated tablets PA/Alu/PVC – Alu blisters: Unit packs containing 7, 14, 28, 30, 50, 56 or 90 tablets. Multipacks containing 84 (3x28), 98 (2x49) or 280 (20x14) tablets. PVC/polychlorotrifluoroethylene ...

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

Novartis Europharm Limited, Frimley Business Park, Camberley GU16 7SR, United Kingdom

Marketing authorization number(s)

Rasilez 150 mg film-coated tablets: EU/1/07/405/001-010 EU/1/07/405/021-030 Rasilez 300 mg film-coated tablets: EU/1/07/405/011-020 EU/1/07/405/031-040

Date of first authorization / renewal of the authorization

Date of first authorisation: 22 August 2007 Date of latest renewal: 24 August 2012

Πηγαίο έγγραφο

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