SIMVASTATIN Film-coated tablet (2023)

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Simvastatin 20 mg film-coated tablets.

Qualitative and quantitative composition

Each film-coated tablet contains 20 mg of simvastatin. Excipient with known effect: Each film-coated tablets contains 58.2 mg of lactose (as monohydrate). For the full list of excipients, see section ...

Pharmaceutical form

Film-coated tablet. Orange coated, oval, biconvex tablet with score line on both sides, coded 20 on one side. The tablet can be divided into equal doses.

Therapeutic indications

Hypercholesterolaemia Treatment of primary hypercholesterolaemia or mixed dyslipidaemia, as an adjunct to diet, when response to diet and other non-pharmacological treatments (e.g. exercise, weight reduction) ...

Posology and method of administration

Posology The dose range is 5-80 mg/day of simvastatin given orally as a single dose in the evening. Adjustments of dose, if required, should be made at intervals of not less than 4 weeks, to a maximum ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Active liver disease or unexplained persistent elevations of serum transaminases. Pregnancy and lactation (see ...

Special warnings and precautions for use

Myopathy / Rhabdomyolysis Simvastatin, like other inhibitors of HMG-CoA reductase, occasionally causes myopathy manifested as muscle pain, tenderness or weakness with creatine kinase (CK) above ten times ...

Interaction with other medicinal products and other forms of interaction

Multiple mechanisms may contribute to potential interactions with HMG Co-A reductase inhibitors. Medicinal products or herbal products that inhibit certain enzymes (e.g. CYP3A4) and/or transporter (e.g. ...

Fertility, pregnancy and lactation

Pregnancy Simvastatin is contraindicated during pregnancy (see section 4.3). Safety in pregnant women has not been established. No controlled clinical trials with simvastatin have been conducted in pregnant ...

Effects on ability to drive and use machines

Simvastatin has no or negligible influence on the ability to drive and use machines. However, when driving vehicles or operating machines, it should be taken into account that dizziness has been reported ...

Undesirable effects

The frequencies of the following adverse events, which have been reported during clinical studies and/or post-marketing use, are categorized based on an assessment of their incidence rates in large, long-term, ...

Overdose

To date, a few cases of overdose have been reported; the maximum dose taken was 3.6 g. All patients recovered without sequelae. There is no specific treatment in the event of overdose. In this case, symptomatic ...

Pharmacodynamic properties

Pharmacotherapeutic group: Lipid modifiying agents, plain, HMG-CoA reductase inhibitors ATC-Code: C10AA01 Mechanism of action After oral ingestion, simvastatin, which is an inactive lactone, ...

Pharmacokinetic properties

Simvastatin is an inactive lactone which is readily hydrolyzed in vivo to the corresponding beta-hydroxyacid, a potent inhibitor of HMG-CoA reductase. Hydrolysis takes place mainly in the liver; the rate ...

Preclinical safety data

Based on conventional animal studies regarding pharmacodynamics, repeated dose toxicity, genotoxicity and carcinogenicity, there are no other risks for the patient than may be expected on account of the ...

List of excipients

Tablet core: Pregelatinized starch Lactose monohydrate Cellulose, microcrystalline Butylhydroxyanisole (E320) Citric acid monohydrate (E330) Magnesium stearate Film-coating: Hypromellose ...

Incompatibilities

Not applicable.

Shelf life

Blisters: 3 years. Tablet containers: 3 years.

Special precautions for storage

Blister: Do not store above 30°C. Keep the blisters in the outer carton, in order to protect from light. Tablet container: Do not store above 30°C. Store in the original container, in order ...

Nature and contents of container

Blister (Al/PVC). Pack sizes: 10, 20, 28, 30, 40, 49, 50, 50 1, 60, 84, 90, 98 and 100 film-coated tablets. Polyethylene tablet container with screw cap. Pack sizes: 10, 20, 28, 30, 40, 50, 84, 90, 100, ...

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

Sandoz Limited, Park View, Riverside Way, Watchmoor Park, Camberley, Surrey, GU15 3YL, United Kingdom

Marketing authorization number(s)

PL 04416/0679

Date of first authorization / renewal of the authorization

Date of first authorisation: 21 July 2006

Date of revision of the text

22/06/2023

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