Land: Sydafrika
Sprog: engelsk
Kilde: South African Health Products Regulatory Authority (SAHPRA)
Novagen Pharma (Pty) Ltd
Not Indicated
#N/A
None
Registered
Page 1 of 9 SCHEDULING STATUS: S4 NOVABE, 10 MG TABLETS EZETIMIBE CONTAINS SUGAR READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING NOVABE • Keep this leaflet. You may need to read it again. • If you have further questions, please ask your doctor, pharmacist, nurse or other healthcare provider. • NOVABE has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours. WHAT IS IN THIS LEAFLET 1. What NOVABE is and what it is used for 2. What you need to know before you take NOVABE 3. How to take NOVABE 4. Possible side effects 5. How to store NOVABE 6. Contents of the pack and other information 1. WHAT NOVABE IS AND WHAT IT IS USED FOR NOVABE contains the active substance ezetimibe 10 mg per tablet and belongs to a group of medicines called serum-cholesterol reducers. NOVABE is a medicine used to lower increased cholesterol levels. NOVABE lowers total cholesterol, as well as LDL or “bad” cholesterol. NOVABE works by reducing the cholesterol absorbed from your digestive tract. Page 2 of 9 NOVABE adds to the cholesterol-lowering effect of statins, a group of medicines that reduce the cholesterol your body makes by itself. NOVABE is used in conjunction with diet, either alone, or with another cholesterol lowering medicine (statin). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NOVABE DO NOT TAKE NOVABE: • if you are hypersensitive (allergic) to ezetimibe or to any other ingredients of NOVABE • if you are pregnant or breastfeeding • if you have moderate or severe liver problems • if you are a child below the age of 10 years Do not take NOVABE together with a statin if you have active liver disease or unexplained persistent elevations in liver enzymes. WARNINGS AND PRECAUTIONS Tell your doctor or healthcare professional before taking NOVABE: Take special care with NOVABE: • if you are taking NOVABE with a statin, please refer to the Patient Information Leaflet for that particular medicine • if you are Læs hele dokumentet
Page 1 of 15 SCHEDULING STATUS: S4 1. NAME OF THE MEDICINE NOVABE (10 mg tablets) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg ezetimibe. _Excipient with known effect: _ NOVABE contains sugar, lactose monohydrate 62 mg per tablet. _ _ For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablets. White to off-white, uncoated, capsule shaped, bevelled edge tablets debossed with “E Z” on one side and “10” on the other side. The size is 8,1 mm x 4,1 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS PRIMARY HYPERCHOLESTEROLAEMIA: NOVABE administered with an HMG-CoA reductase inhibitor (statin) or alone, is indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol (total-C) and low-density lipoprotein cholesterol (LDL-C), in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia. HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLAEMIA (HOFH) NOVABE administered with a statin is indicated for the reduction of elevated total-C and LDL-C levels in patients with HoFH. Page 2 of 15 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The patient should be on an appropriate lipid-lowering diet and weight loss programme where indicated and should continue on this diet during treatment with NOVABE. The recommended dose of NOVABE is 10 mg once daily, used alone, with a statin, or with fenofibrate. ELDERLY PATIENTS No dosage adjustment is required for elderly patients (see section 5.2). PAEDIATRIC PATIENTS Children 10 years of age or older: No dosage adjustment is required (see section 5.2). Children under 10 years of age: No clinical data on safety and efficacy are available; therefore, treatment with NOVABE is contraindicated. HEPATIC IMPAIRMENT No dosage adjustment is required in patients with mild hepatic insufficiency (Child Pugh A). Treatment with NOVABE is contraindicated in patients with moderate (Child Pugh B) or severe (Child Pugh C) liver dysfunction due to unknown effects (see section 4.3 and 5.2). CO-ADMINISTRATION WITH BI Læs hele dokumentet