Table of Contents
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
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Zocor 10 mg, film-coated tablets.
Zocor 20 mg, film-coated tablets.
Zocor 40 mg, film-coated tablets.
Zocor 80 mg, film-coated tablets.
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Each tablet contains 10 mg of simvastatin.
Each tablet contains 20 mg of simvastatin.
Each tablet contains 40 mg of simvastatin.
Each tablet contains 80 mg of simvastatin.
Excipient(s):
For a full list of excipients, see section 6.1.
Each 10 mg tablet contains 70.7 mg of lactose monohydrate.
Each 20 mg tablet contains 141.5 mg of lactose monohydrate.
Each 40 mg tablet contains 283.0 mg of lactose monohydrate.
Each 80 mg tablet contains 565.8 mg of lactose monohydrate.
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Film-coated tablet.
The peach-coloured, oval-shaped tablets marked 'MSD 735' on one side contain 10 mg simvastatin. The tan-coloured, oval-shaped tablets marked 'MSD 740' on one side contain 20 mg simvastatin. The brick-red coloured, oval-shaped tablets marked 'MSD 749&# |
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