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SPC, UK: VALSARTAN Film-coated tablets (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Valsartan 40mg Film-coated Tablets. Valsartan 80mg Film-coated Tablets. Valsartan 160mg Film-coated Tablets. Valsartan 320mg Film-coated Tablets.

Qualitative and quantitative composition

Each film-coated tablet contains 40 mg of valsartan. Each film-coated tablet contains 80 mg of valsartan. Each film-coated tablet contains 160 mg of valsartan. Each film-coated tablet contains 320 mg of ...

Pharmaceutical form

Film-coated tablet. Yellow, oval-shaped, biconvex, film-coated tablets (9.2 3.7 mm) debossed with V and 1' on either side of the score line on one side and M on the other side. The tablet can be divided ...

Therapeutic indications

Hypertension (40 mg only) Treatment of hypertension in children and adolescents 6 to 18 years of age. Hypertension (80 mg, 160 mg and 320 mg only) Treatment of essential hypertension in adults, and hypertension ...

Posology and method of administration

Posology Hypertension (only 80 mg, 160 mg and 320 mg) The recommended starting dose of Valsartan is 80 mg once daily. The antihypertensive effect is substantially present within 2 weeks, and maximal effects ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Severe hepatic impairment, biliary cirrhosis and cholestasis. Second and third trimester of pregnancy (see sections ...

Special warnings and precautions for use

Hyperkalaemia Concomitant use with potassium supplements, potassium-sparing diuretics, salt substitutes containing potassium, or other agents that may increase potassium levels (heparin, etc.) is not recommended. ...

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 Angiotensin II Receptor Antagonists (AIIRAs) is not recommended during the first trimester of pregnancy (see section 4.4). The use of AIIRAs is contra-indicated during the second and ...

Effects on ability to drive and use machines

No studies on the effects on the ability to drive have been performed. When driving vehicles or operating machines it should be taken into account that occasionally dizziness or weariness may occur when ...

Undesirable effects

In controlled clinical studies in adult patients with hypertension, the overall incidence of adverse reactions (ADRs) was comparable with placebo and is consistent with the pharmacology of valsartan. The ...

Overdose

Symptoms Overdose with Valsartan may result in marked hypotension, which could lead to depressed level of consciousness, circulatory collapse and/or shock. Treatment The therapeutic measures depend on ...

Pharmacodynamic properties

Pharmacotherapeutic group: Angiotensin II Antagonists, plain ATC code: C09CA03 Mechanism of action Valsartan is an orally active, potent, and specific angiotensin II (Ang II) receptor antagonist. It acts ...

Pharmacokinetic properties

Absorption Following oral administration of valsartan alone, peak plasma concentrations of valsartan are reached in 2–4 hours. Mean absolute bioavailability is 23%. Food decreases exposure (as measured ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential. In rats, maternally toxic doses ...

List of excipients

Tablet core: Microcrystalline cellulose Crospovidone Povidone Croscarmellose sodium Silica, colloidal anhydrous Magnesium stearate Tablet coating: Hypromellose E464 Titanium dioxide E171 Macrogol/PEG 8000 ...

Incompatibilities

Not applicable.

Shelf life

Shelf life: 3 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

Valsartan film-coated tablets are presented in the following pack types. HDPE bottle pack (marketable pack) comprises of white HDPE bottle with white opaque polypropylene closure with induction sealing ...

Special precautions for disposal and other handling

No special requirements for disposal.

Marketing authorization holder

Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

Marketing authorization number(s)

PL 04569/1175 PL 04569/1176 PL 04569/1177 PL 04569/1178

Date of first authorization / renewal of the authorization

05/08/2011

Date of revision of the text

February 2018

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