Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Pitavastatin Calcium (as Hydrate)
DKSH MALAYSIA SDN. BHD.
Pitavastatin Calcium (as Hydrate)
30 Tablets
Kowa Company, Ltd, Nagoya Factory
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ _ _ LIVALO FILM-COATED TABLETS 2MG LIVALO FILM-COATED TABLETS 4MG _ _ Pitavastatin Calcium (as hydrate) (2.0 mg or 4.0mg of pitavastatin calcium) 1 WHAT IS IN THIS LEAFLET 1. What LIVALO is used for 2. How LIVALO works 3. Before you use LIVALO 4. How to use LIVALO 5. While you are using it 6. Side effects 7. Storage and Disposal of LIVALO 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT LIVALO IS USED FOR LIVALO contains a medicine called pitavastatin. This belongs to a group of medicines called ‘statins’. LIVALO is used to correct the levels of fat (lipid) in your blood and can be taken by children from the age of 6 years, as well as by adults. An imbalance of fats particularly cholesterol can sometimes lead to a heart attack or stroke. You have been given LIVALO because you have an imbalance of fats and changing your diet and making lifestyle changes have not been enough to correct this. You should continue with your cholesterol-lowering diet and lifestyle changes while you are taking LIVALO. HOW LIVALO WORKS LIVALO inhibits synthesis of cholesterol in the liver by its inhibitory effect on HMG-CoA reductase, and consequently lowers plasma cholesterol. LIVALO is usually used in the treatment of primary hyperlipidemia including familial hypercholesterolaemia or mixed dyslipidemia. BEFORE YOU USE LIVALO _- When you must not use it _ Do not take LIVALO: - if you are allergic (hypersensitive) to pitavastatin, any other statin or the other ingredients of LIVALO (listed in ‘8. Product Description’). - if you are pregnant or breast- feeding. - if you are a woman able to have children and you are not using a reliable contraceptive method (see ‘Pregnancy, breast-feeding and fertility’). - if you currently have liver problems. - if you take ciclosporin – used after an organ transplant. - if you have repeated or unexplained muscle aches or pains. If you are not sure, talk to your doctor or pharmacist before takin Baca dokumen lengkap
200.0 表 天 296.3 色 調 ジキスミ トラップ ( ) 角度 tdw31 APP.TB 品 名 リバロ添付文書MYS 制作日 MC 2022.10.3 C 本コード 0582-0966-20 校 作業者印 AC 仮コード 初校 永 森 KOWA COMPANY, LTD. LIVALO FILM-COATED TABLETS 2MG/ LIVALO FILM-COATED TABLETS 4MG 1. NAME OF THE MEDICINAL PRODUCT 2mg: LIVALO Film-coated Tablets 2mg. 4mg: LIVALO Film-coated Tablets 4mg. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 2.0mg (for LIVALO Tablets 2mg) or 4.0mg (for LIVALO Tablets 4mg) of pitavastatin calcium (as hydrate). For a full list of excipients see section 6.1. 3. PHARMACEUTICAL FORM 2mg: Slightly light-colored yellow-red, scored film-coated tablets embossed “Kowa 202” on one face and scored on the reverse. The tablet can be divided into equal halves. 4mg: Light yellow, scored film-coated tablets embossed “Kowa 203” on one face and scored on the reverse. The tablet can be divided into equal halves. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS LIVALO is indicated for the reduction of elevated total cholesterol (TC) and LDL-C, in adults, adolescents and children aged 6 years or older with primary hypercholesterolaemia, including heterozygous familial hypercholesterolaemia, and combined (mixed) dyslipidaemia, when response to diet and other non- pharmacological measures is inadequate. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Patients should be on a cholesterol lowering diet before treatment. It is important that all patients continue dietary control during treatment. The usual starting dose is 1mg or 2mg once daily. Adjustment of dose should be made at intervals of 4 weeks or more. Doses should be individualized according to LDL-C levels, the goal of therapy and patient response. The maximum daily dose is 4mg. Elderly No dose adjustment necessary in patients older than 70 years (see section 5.1 and section 5.2). Paediatric population Children and adolescents aged 6 years and over: LIVALO use in children should only be carried Baca dokumen lengkap