Pays: Malaisie
Langue: anglais
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
SIMVASTATIN
PHARMANIAGA MANUFACTURING BERHAD
SIMVASTATIN
10 Tablets; 30 Tablets; 100 Tablets; 120 Tablets; 500 Tablets
PHARMANIAGA MANUFACTURING BERHAD
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ _ _ PHARMANIAGA SIMVASTATIN TABLET Simvastatin 10 mg/20 mg/ 40 mg WHAT IS IN THIS LEAFLET 1. What Pharmaniaga Simvastatin Tablet is used for 2. How Pharmaniaga Simvastatin Tablet works 3. Before you use Pharmaniaga Simvastatin Tablet 4. How to use Pharmaniaga Simvastatin Tablet 5. While you are using Pharmaniaga Simvastatin Tablet 6. Side effects 7. Storage and Disposal of Pharmaniaga Simvastatin Tablet 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT PHARMANIAGA SIMVASTATIN TABLET IS USED FOR Pharmaniaga Simvastatin Tablet helps to lower cholesterol and triglyceride levels in hyperlipidemia. Pharmaniaga Simvastatin Tablet is used in people who have coronaryheart disease (CHD) or who are at high risk of CHD (for example, if they have diabetes, a history of stroke, or other blood vessel disease). HOW PHARMANIAGA SIMVASTATIN TABLETS WORKS Pharmaniaga Simvastatin Tablet works by reducing the amount of cholesterol made by the liver. In terms of good and bad cholesterol, Pharmaniaga Simvastatin Tablet reduces the bad cholesterol and raises the good cholesterol. Pharmaniaga Simvastatin Tablet does not reduce the cholesterol and triglycerides that come from fat in food. BEFORE YOU USE PHARMANIAGA SIMVASTATIN TABLET _When you must not take it _ Do not take Pharmaniaga Simvastatin Tablet if: • You have an allergy to Pharmaniaga Simvastatin Tablet or other brands of simvastatin, or to any of the ingredients listed at the end of this leaflet. • Symptoms of an allergic reaction may include skin rash, itchiness, shortness of breath, swelling of the tongue of face, or painful joints. • You are pregnant or breastfeeding • Your baby may absorb this medicine in the womb or from breast milk and therefore there is a possibility of harm to the baby • You have liver disease. • You have had muscle pain, tenderness or weakness from other medicines used to treat high cholesterol or triglycerides. • If you are not sure whether Lire le document complet
(L)250mm (W)200mm 01 05.02.14 - New artwork received. 02 18.02.14 - Amend wording. REVISION NO. DATE REASON FOR CHANGE ARTWORK LOG artwork prepared by: cynthia yap email: graphic@focusprint.info (Graphic Dept) customer PHARMANIAGA MANUFACTURING BERHAD description SIMVASTATIN LEAFLET (FRONT) size attn (L)250 X (W)200MM date 13.12.2021 FOCUSPRINT SDN BHD DATE: t: 603-8766 6030 f: 603-8766 6033 (Factory) website: www.focusprint.com.my 1 PLEASE CHOP & SIGN FOR APPROVAL colours process colours: BLACK IMPORTANT ! PLEASE NOTE THAT THIS COLOUR PRINT IS FOR VISUAL PURPOSE ONLY. OUTPUT COLOUR MIGHT DIFFER IN ACTUAL PRODUCTION. 03 05.09.14 - New artwork received. 04 24.09.14 - Amend PRP No. 05 09-10.14 - Amend wording. 08 09 26.12.14 - Amend wording. 07 23.12.14 - Amend wording. 06 26.11.14 - Amend wording. 10.02.15 - Amend PRP no and add in Date of revision. 10 25.02.15 - Amend wording. 11 27.03.15 - Amend wording. 12 08.11.17 - Amend wording & PRP no 13 28.05.2020 - Amend wording & PRP no 14 29.06.2020 - Amend wording. 15 20.08.2020 - Amend Logo, BE, Revision date and address. 16 21.08.2020 - Amend Revision date and address. 17 21.08.2020 - Non Italic for Product Registration 19 09.09.2021 - Amend wording from artwork dated 21.08.2020 21 13.12.2021 - Amend wording from “or” to “and”. 20 01.12.2021 - Amend wording from artwork dated 21.08.2020, amend wording, PRP and date of revision. 18 18.03.2021 - Add Bar for Simvastatin 20mg (PRP 0387.9/PRP 0388.9/PRP 0385.9 040417) material 60G SIMILI (L)250mm (W)200mm 01 05.02.14 - New artwork received. 02 18.02.14 - Amend wording. REVISION NO. DATE REASON FOR CHANGE ARTWORK LOG artwork prepared by: cynthia yap email: graphic@focusprint.info (Graphic Dept) customer PHARMANIAGA MANUFACTURING BERHAD description SIMVASTATIN LEAFLET (BACK) size attn (L)250 X (W)200MM date 13.12.2021 FOCUSPRINT SDN BHD DATE: t: 603-8766 6030 f: 603-8766 6033 (Factory) website: www.focusprint.com.my 1 PLEASE CHOP & SIGN FOR APPROVAL colours process colours: BLACK IMPORTANT ! PLEASE NOTE THAT THIS C Lire le document complet