ATOZET Film-coated tablet (2023)

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Περιεχόμενα

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 of ezetimibe and 10, 20, 40 or 80 mg of atorvastatin (as atorvastatin calcium trihydrate). Excipient(s) with known effect: Each 10 mg/10 mg film-coated tablet ...

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, ...

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 ...

4.2. Posology and method of administration

Posology Hypercholesterolaemia and/or Coronary Heart Disease (with ACS History) The patient should be on an appropriate lipid-lowering diet and should continue on this diet during treatment with ATOZET. ...

4.3. Contraindications

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. Therapy with ATOZET is contraindicated during pregnancy and breast-feeding, and in women of child-bearing potential ...

4.4. Special warnings and precautions for use

Myopathy/Rhabdomyolysis In post-marketing experience with ezetimibe, cases of myopathy and rhabdomyolysis have been reported. Most patients who developed rhabdomyolysis were taking a statin concomitantly ...

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

Multiple mechanisms may contribute to potential interactions with HMG CoA reductase inhibitors. Drugs or herbal products that inhibit certain enzymes (e.g. CYP3A4) and/or transporter (e.g. OATP1B) pathways ...

4.6. Pregnancy and lactation

Women of childbearing potential Women of childbearing potential should use appropriate contraceptive measures during treatment (see section 4.3). Pregnancy Atherosclerosis is a chronic process, and ordinarily ...

4.7. Effects on ability to drive and use machines

ATOZET has 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.

4.8. Undesirable effects

Summary of the safety profile ATOZET (or co-administration of ezetimibe and atorvastatin equivalent to ATOZET) has been evaluated for safety in more than 2,400 patients in 7 clinical trials. Tabulated ...

4.9. Overdose

ATOZET In the event of an overdose, symptomatic and supportive measures should be employed. Liver function tests should be performed and serum CPK levels should be monitored. Ezetimibe In clinical studies, ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Lipid modifying agents, HMG-CoA reductase inhibitors in combination with other lipid modifying agents ATC code: C10BA05 ATOZET (ezetimibe/atorvastatin) is a lipid-lowering ...

5.2. Pharmacokinetic properties

ATOZET ATOZET has been shown to be bioequivalent to co-administration of corresponding doses of ezetimibe and atorvastatin tablets. Absorption ATOZET The effects of a high-fat meal on the pharmacokinetics ...

5.3. Preclinical safety data

ATOZET In three-month co-administration studies in rats and dogs with ezetimibe and atorvastatin, the toxic effects observed were essentially those typically associated with statins. The statin-like histopathologic ...

6.1. List of excipients

Tablet core: Ezetimibe Layer: Croscarmellose sodium Lactose monohydrate Magnesium stearate Cellulose, microcrystalline Povidone Sodium laurilsulphate Atorvastatin Layer: Cellulose, ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

2 years.

6.4. Special precautions for storage

Store in the original package in order to protect from oxygen.

6.5. Nature and contents of container

ATOZET 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 mg: Packs of 10, 30, 90, and 100 film-coated tablets in nitrogen-purged aluminium/aluminium (oPA-AlPVC cavity with Al lidding) blisters. ...

6.6. Special precautions for disposal and other handling

No special requirements.

7. Marketing authorization holder

N.V. Organon, Kloosterstraat 6, NL-5349 AB Oss, The Netherlands

8. Marketing authorization number(s)

ATOZET 10 mg/10 mg MA031/02401 ATOZET 10 mg/20 mg MA031/02402 ATOZET 10 mg/40 mg MA031/02403 ATOZET 10 mg/80 mg MA031/02404

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 17 October 2014 Date of latest renewal: 22 March 2019

10. Date of revision of the text

July 2023

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