দেশ: মাল্যাশিয়া
ভাষা: ইংরেজি
সূত্র: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ATORVASTATIN CALCIUM
NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.
ATORVASTATIN CALCIUM
30Tablet Tablets
LEK PHARMACEUTICALS D.D.
ROTAQOR ® FILM-COATED TABLETS Atorvastatin (10mg, 20mg) _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ 1 WHAT IS IN THIS LEAFLET 1. What is Rotaqor used for 2. How Rotaqor works 3. Before you use Rotaqor 4. How to use Rotaqor 5. While you are using it 6. Side effects 7. Storage and disposal of Rotaqor 8. Product description 9. Manufacturer & Product Registration Holder 10. Date of revision WHAT IS ROTAQOR USED FOR You have been prescribed Rotaqor because either: (a) You have a high cholesterol level. This means you are at risk of getting a heart attack or stroke. You have been advised to take a statin, because changing your diet and taking more exercise were not enough to correct your cholesterol levels. You should continue with your cholesterol-lowering diet and exercise while you are taking Rotaqor. Or (b) You have other factors that increase your risk of getting a heart attack, stroke or related health problems. HOW ROTAQOR WORKS Rotaqor belongs to a group of medicines called statins. There are different types of cholesterol found in the blood, including – ‘bad’ cholesterol (LDL- C) and ‘good’ cholesterol (HDL-C). • Rotaqor can reduce the ‘bad’ cholesterol and increase the ‘good’ cholesterol. • It works by helping to block your body’s production of ‘bad’ cholesterol in the liver. It also improves your body’s ability to remove it from your blood. For most people, high cholesterol does not affect the way they feel because it does not produce any symptoms. However, if it is left untreated, fatty deposits can build up in the walls of your blood vessels causing them to narrow. Sometimes, these narrowed blood vessels can get blocked which can cut off the blood supply to the heart or brain leading to a heart attack or a stroke. By lowering your cholesterol levels, you can reduce your risk of getting a heart attack, a stroke or related health problems BEFORE YOU USE ROTAQOR - _When you must not use it _ • If you are allergic (hypersensitive) to atorvastatin, or to any of the ingred সম্পূর্ণ নথি পড়ুন
1. NAME OF THE MEDICINAL PRODUCT Rotaqor 10 mg Film-coated Tablets Rotaqor 20 mg Film-coated Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 10 mg film-coated tablet contains 10 mg of atorvastatin in the form of calcium salt. Each 20 mg film-coated tablet contains 20 mg of atorvastatin in the form of calcium salt. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. _Appearance: _ 10 mg tablets are white to almost white, round, biconvex film-coated tablets, debossed with “HLA 10” on one side. 20 mg tablets are light yellow, round, biconvex film-coated tablets, debossed with “HLA 20” on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Atorvastatin is indicated as an adjunct to diet for the treatment of patients with elevated total cholesterol, LDL-cholesterol, apolipoprotein B, and triglycerides and to increase HDL-cholesterol in patients with primary hypercholesterolemia (heterozygous familial and non-familial hypercholesterolemia), combined (mixed) hyperlipidemia (_Fredrickson _Types IIa and IIb), elevated serum triglyceride levels (_Fredrickson _ Type IV), and for patients with dysbetalipoproteinemia (_Fredrickson_ Type III) who do not respond adequately to diet. Atorvastatin is also indicated for the reduction of total cholesterol and LDL-cholesterol in patients with homozygous familial hypercholesterolemia when response to diet and other non-pharmacological measures are inadequate. _ _ _Prevention of Cardiovascular Disease _ In adult patients without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as age, smoking, hypertension, low HDL-C, or a family history of early coronary heart disease, atorvastatin is indicated to: • Reduce the risk of myocardial infarction • Reduce the risk of stroke • Reduce the risk for revascularization procedures and angina In patients with type 2 diabetes, and without clinically evident coronary heart disease, but with multiple risk factors for coronar সম্পূর্ণ নথি পড়ুন