Zimybe 10/80 TM
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Active ingredients: ezetimibe + simvastatin
Brand name
(ARTG)
: ZIMYBE 10/80 ezetimibe 10 mg and simvastatin 80 mg tablet blister packConsumer Medicine Information (CMI)
Read the CMI leaflet for facts you need to know before, during and after taking your medicine.
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What this medicine is used for
(ARTG)
Adults (greater than or equal to 18 years) Prevention of Cardiovascular Disease ZIMYBE is indicated in patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS) taking their maximum tolerated dose of simvastatin and 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 Section 5.1 Pharmacodynamic Properties, Clinical trials).,Primary Hypercholesterolaemia ZIMYBE is indicated as adjunctive therapy to diet in patients 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 or ezetimibe alone. · Patients already treated with a statin and ezetimibe.,Homozygous Familial Hypercholesterolaemia (HoFH) ZIMYBE is indicated in patients with HoFH. Patients may also receive adjunctive treatments (e.g., LDL apheresis).,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) ZIMYBE is indicated as 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) ZIMYBE 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
- Oral
- A white to off-white, oval, biconvex tablet debossed with M on one side of the tablet and ES4 on the other side.
Images
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Storage conditions
(ARTG)
- Store below 25 degrees Celsius
- 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
- 30 pack
- 5 pack
- 10 pack
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient ezetimibe + simvastatin
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
