EZETAST Film-coated tablet (2021)

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Περιεχόμενα

1. Name of the medicinal product

Ezetimibe. Atorvastatin (as calcium trihydrate).

2. Qualitative and quantitative composition

EZETAST is a film-coated tablet containing ezetimibe 10 mg and atorvastatin 10, 20, 40 or 80 mg. EZETAST 10/10: Each tablet contains 10 mg of ezetimibe and atorvastatin calcium trihydrate equivalent ...

3. Pharmaceutical form

EZETAST 10/10: White to off-white, capsule-shaped, biconvex, film-coated tablet debossed with AE on one side and 1 on the other side. EZETAST 10/20: White to off-white, capsule-shaped, biconvex, ...

4.1. Therapeutic indications

Prevention of Cardiovascular Disease EZETAST is indicated in patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS) taking their maximum tolerated dose of atorvastatin ...

4.2. Posology and method of administration

This combination product is not indicated for first-line use. Patient should be on an appropriate lipid‐lowering diet and should continue on this diet during treatment with EZETAST. Dosage in Patients ...

4.3. Contraindications

Hypersensitivity to any component of this medication. Myopathy secondary to other lipid lowering agents. Active liver disease or unexplained persistent elevations of serum transaminases (see Section 4.4 ...

4.4. Special warnings and precautions for use

Identified Precautions Liver Enzymes As with other lipid-lowering agents of the same class, moderate (>3 x upper limit of normal [ULN]) elevations of serum transaminases have been reported following therapy ...

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

No clinically significant pharmacokinetic interaction was seen when ezetimibe was co- administered with atorvastatin. Multiple mechanisms may contribute to potential interactions with HMG-CoA reductase ...

4.6. Fertility, Pregnancy and Lactation

Effects on Fertility Ezetimibe Ezetimibe had no effects on fertility in male and female rats at doses up to 1000 mg/kg/day by oral gavage, corresponding to exposures of approximately 1 and 7 times the ...

4.7. Effects on ability to drive and use machines

No studies of the effects on the ability to drive and use of machines have been performed. However, certain side effects that have been reported with ezetimibe and atorvastatin tablets may affect some ...

4.8. Undesirable effects

Co-administration of ezetimibe and atorvastatin has been evaluated for safety in more than 2,400 patients in 7 clinical trials. Co-administration of ezetimibe and atorvastatin was generally well-tolerated. ...

4.9. Overdose

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia). No specific treatment of overdosage with EZETAST can be recommended. In the event of an overdose, ...

5.1. Pharmacodynamic properties

Mechanism of Action Ezetimibe and atorvastatin tablet is a lipid-lowering product that selectively inhibits the intestinal absorption of cholesterol and related plant sterols and inhibits the endogenous ...

5.2. Pharmacokinetic properties

Ezetimibe/atorvastatin has been shown to be bioequivalent at the high and low end of dosage to co-administration of corresponding doses of ezetimibe and atorvastatin tablets. Bioequivalence at the mid ...

5.3. Preclinical safety data

Genotoxicity Ezetimibe Ezetimibe alone or in combination with a statin (simvastatin, lovastatin, pravastatin or atorvastatin) or fenofibrate did not cause gene mutation in bacteria or chromosomal damage ...

6.1. List of excipients

Each film-coated tablet of EZETAST contains the following inactive ingredients: Povidone, sodium lauryl sulfate, lactose monohydrate, crospovidone, colloidal anhydrous silica, sodium stearylfumarate, microcrystalline ...

6.2. Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3. Shelf life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4. Special precautions for storage

Store below 25°C in a dry place.

6.5. Nature and contents of container

EZETAST tablets are packed in blisters of Cold form Alu-Alu as forming (base) material and 0.025 hard tampered heat-sealed lacquer coated plain Aluminium foil as the lidding material. Available as 30 tablet ...

6.6. Special precautions for disposal and other handling

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

7. Marketing authorization holder

Lupin Australia Pty Ltd, Suite 2, Level 2, 19-23 Prospect Street, Box Hill, VIC, 3128 Distributor: Arrotex Pharmaceuticals Pty Ltd, 15-17 Chapel Street, Cremorne, VIC, 3121, Australia

8. Marketing authorization number(s)

Australian Registration Numbers: EZETAST 10/10: AUST R 306963 EZETAST 10/20: AUST R 306966 EZETAST 10/40: AUST R 306958 EZETAST 10/80: AUST R 306956

9. Date of first authorization / renewal of the authorization

Date of first approval: 01 November 2019

10. Date of revision of the text

30 July 2021

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