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ENTRESTO Film-coated tablet (2023)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Entresto 24 mg/26 mg film-coated tablets. Entresto 49 mg/51 mg film-coated tablets. Entresto 97 mg/103 mg film-coated tablets.

2. Qualitative and quantitative composition

<u>Entresto 24 mg/26 mg film-coated tablets:</u> Each film-coated tablet contains 24.3 mg sacubitril and 25.7 mg valsartan (as sacubitril valsartan sodium salt complex). <u>Entresto 49 mg/51 mg film-coated ...

3. Pharmaceutical form

Film-coated tablet (tablet). <u>Entresto 24 mg/26 mg film-coated tablets:</u> Violet white ovaloid biconvex film-coated tablet with bevelled edges, unscored, debossed with NVR on one side and LZ on the ...

4.1. Therapeutic indications

Adult heart failure Entresto is indicated in adult patients for treatment of symptomatic chronic heart failure with reduced ejection fraction (see section 5.1). Paediatric heart failure Entresto is indicated ...

4.2. Posology and method of administration

Posology General considerations Entresto should not be co-administered with an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB). Due to the potential risk of angioedema ...

4.3. Contraindications

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. Concomitant use with ACE inhibitors (see sections 4.4 and 4.5). Entresto must not be administered until 36 hours ...

4.4. Special warnings and precautions for use

Dual blockade of the renin-angiotensin-aldosterone system (RAAS) The combination of sacubitril/valsartan with an ACE inhibitor is contraindicated due to the increased risk of angioedema (see section 4.3). ...

4.5. Interaction with other medicinal products and other forms of interaction

Interactions resulting in a contraindication ACE inhibitors The concomitant use of sacubitril/valsartan with ACE inhibitors is contraindicated, as the concomitant inhibition of neprilysin (NEP) and ACE ...

4.6. Fertility, pregnancy and lactation

Pregnancy The use of sacubitril/valsartan is not recommended during the first trimester of pregnancy and is contraindicated during the second and third trimesters of pregnancy (see section 4.3). Valsartan ...

4.7. Effects on ability to drive and use machines

Sacubitril/valsartan has a minor influence on the ability to drive and use machines. When driving vehicles or operating machines it should be taken into account that occasionally dizziness or fatigue may ...

4.8. Undesirable effects

Summary of the safety profile The most commonly reported adverse reactions in adults during treatment with sacubitril/valsartan were hypotension (17.6%), hyperkalaemia (11.6%) and renal impairment (10.1%) ...

4.9. Overdose

Limited data are available with regard to overdose in humans. A single dose of 583 mg sacubitril/617 mg valsartan and multiple doses of 437 mg sacubitril/463 mg valsartan (14 days) were studied in healthy ...

5.1. Pharmacodynamic properties

<b>Pharmacotherapeutic group:</b> Agents acting on the renin-angiotensin system; angiotensin II receptor blockers (ARBs), other combinations <b>ATC code:</b> C09DX04 Mechanism of action Sacubitril/valsartan ...

5.2. Pharmacokinetic properties

The valsartan contained within sacubitril/valsartan is more bioavailable than the valsartan in other marketed tablet formulations; 26 mg, 51 mg, and 103 mg of valsartan in sacubitril/valsartan is equivalent ...

5.3. Preclinical safety data

Non-clinical data (including studies with sacubitril and valsartan components and/or sacubitril/valsartan) reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated ...

6.1. List of excipients

<u>Tablet core:</u> Microcrystalline cellulose Low-substituted hydroxypropylcellulose Crospovidone, type A Magnesium stearate Talc Silica colloidal anhydrous <u>Film coat:</u> <em>Entresto 24 mg/26 mg ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

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

6.5. Nature and contents of container

PVC/PVDC/Aluminium blisters. <u>Entresto 24 mg/26 mg film-coated tablets:</u> Pack sizes: 14, 20, 28, 56 or 196 film-coated tablets and multipacks containing 196 (7 packs of 28) film-coated tablets. <u> ...

6.6. Special precautions for disposal and other handling

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

7. Marketing authorization holder

Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

8. Marketing authorization number(s)

<u>Entresto 24 mg/26 mg film-coated tablets:</u> EU/1/15/1058/001 EU/1/15/1058/008-010 EU/1/15/1058/017-018 <u>Entresto 49 mg/51 mg film-coated tablets:</u> EU/1/15/1058/002-004 EU/1/15/1058/011-013 EU/1/15/1058/019-020 ...

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 19 November 2015 Date of latest renewal: 25 June 2020

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