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Ezetimibe (MA) TM

You should seek medical advice in relation to medicines and use only as directed by a healthcare professional. Always read the label. If symptoms persist see your healthcare professional.

Active ingredients: ezetimibe

Brand name

(ARTG)

: ARX-EZETIMIBE ezetimibe 10 mg tablet blister pack

What this medicine is used for

(ARTG)

Adults ( greater than or equal to 18 Years),Primary Hypercholesterolaemia,Ezetimibe administered alone, or with an HMG-CoA reductase inhibitor (statin), is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia.,Homozygous Familial Hypercholesterolaemia (HoFH),Ezetimibe, administered with a statin, is indicated for patients with HoFH. Patients may also receive adjunctive treatments (e.g., LDL apheresis).,Homozygous Sitosterolaemia (Phytosterolaemia),Ezetimibe is indicated for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolaemia.,Prevention of Cardiovascular Disease,Ezetimibe, is indicated for administration in combination with the maximum tolerated dose of a statin with proven cardiovascular benefit in patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS) in need of additional lowering of LDL-C in the expectation of a modest further reduction in the risk of cardiovascular events following at least one year of therapy (see Clinical Trials).,Children and Adolescents 10-17 Years,(pubertal status: boys Tanner Stage II and above and girls who are at least one year post-menarche),,Heterozygous Familial Hypercholesterolaemia (HeFH) Ezetimibe co-administered with simvastatin (doses up to 40 mg) is indicated as an adjunctive therapy to diet in adolescent patients (10-17 years old) with heterozygous familial hypercholesterolaemia where use of a combination product is appropriate:,- Patients not appropriately controlled with a statin or ezetimibe alone,- Patients already treated with a statin and ezetimibe,,Homozygous Familial Hypercholesterolaemia (HoFH),Ezetimibe co-administered with simvastatin (doses up to 40 mg) is indicated in adolescent patients (10-17 years old) with HoFH. Patients may also receive adjunctive treatments (e.g. LDL apheresis).

How to use this medicine

(ARTG)

This medicine contains one component only.

Component :

  • Tablet, uncoated
  • Oral
  • White to off-white, capsule shaped tablet, plain on both sides

Storage conditions

(ARTG)

  • Store below 25 degrees Celsius
  • Store in Original Container
  • Shelf lifetime is 36 Months.
  • Store below 25 degrees Celsius
  • Store in Original Container
  • Shelf lifetime is 36 Months.

Do I need a prescription ?

(ARTG)

These medicine packs are available from a pharmacist and requires a prescription. It is Schedule 4 : Prescription Only Medicine.

  • 10 tablets pack
  • 30 tablets pack

Pregnant or planning a pregnancy ?

(AHT)

For the active ingredient ezetimibe

You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.

Reporting side effects

You can help ensure medicines are safe by reporting the side effects you experience.

You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems

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