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 Fertility, 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 excipient(s)
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
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1. NAME OF THE MEDICINAL PRODUCT
 ATOZET 10 mg/10 mg film-coated tablets
ATOZET 10 mg/20 mg film-coated tablets
ATOZET 10 mg/40 mg film-coated tablets
ATOZET 10 mg/80 mg film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
 Each film-coated tablet contains 10 mg ezetimibe and 10, 20, 40 or 80 mg of atorvastatin (as atorvastatin calcium trihydrate).
Excipients with known effect:
Each 10 mg/10 mg film-coated tablet contains 153 mg of lactose.
Each 10 mg/20 mg film-coated tablet contains 179 mg of lactose.
Each 10 mg/40 mg film-coated tablet contains 230 mg of lactose.
Each 10 mg/80 mg film-coated tablet contains 334 mg of lactose.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
 Film-coated tablet
10 mg/10 mg tablet: Capsule-shaped, biconvex, white to off-white, film-coated, size 12.74 mm x 5.10 mm, “257” debossed on one side
10 mg/20 mg tablet: Capsule-shaped, biconvex, white to off-white, film-coated, size 14.48 mm x 5.79 mm, “333” debossed on one side
10 mg/40 mg tablet: Capsule-shaped, biconvex, white to off-white, film-coated size 16.38 mm x 6.27 mm, “337” debossed on one side
10 mg/80 mg tablet: Capsule-shaped, biconvex, white to off-white, film-coated, size 19.05 mm x 7.94 mm, “357” debossed on one side
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
 Prevention of Cardiovascular Events
ATOZET is indicated to reduce the risk of cardiovascular events (see section 5.1) in patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS), either previously treated with a statin or not.
Hypercholesterolaemia
ATOZET is indicated as adjunctive therapy to diet for use in adults with primary (heterozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia where use of a combination product is appropriate
• patients not appropriately controlled with a statin alone
• patients already treated with a statin and ezetimibe
Homozygous Familial Hypercholesterolaemia (HoFH)
ATOZET is indicated as adjunctive therapy to diet for use in adults with HoFH. Patients may also receive adjunctive treatments (e.g., low-density lipoprotein [LDL] apheresis).
4.2 Po