País: Malásia
Língua: inglês
Origem: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
FELODIPINE
ASTRAZENECA SDN. BHD.
FELODIPINE
30 Tablet Tablets
AstraZeneca Pharmaceutical Co. Ltd.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ PLENDIL ® _ _ TABLET FELODIPINE (2.5MG, 5MG & 10MG) 1 WHAT IS IN THIS LEAFLET 1. What Plendil is used for 2. How Plendil works 3. Before you use Plendil 4. How to use Plendil 5. While you are using it 6. Side effects 7. Storage and disposal of Plendil 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT PLENDIL IS USED FOR Plendil is used for the treatment of high blood pressure and vascular cramp in the heart (angina pectoris). HOW PLENDIL WORKS Plendil lowers the blood pressure by dilating the blood vessels. This results in the blood passing more easily through the vessels, and the blood pressure falls. Plendil affects neither the ability of the heart to contract, nor the pulse. High blood pressure often occurs as a result of the blood having difficulty in passing through the blood vessels. In cases of vascular cramps in the heart, the work of the heart is facilitated as a result of the blood vessels being widened. BEFORE YOU USE PLENDIL - _When you must not use it _ _ _ Plendil must not be used: • in cases of untreated heart failure • in cases of acute myocardial infarction (heart attack) • in cases of unstable angina pectoris • during pregnancy • if you are hypersensitive (allergic) to any of the ingredients contained in the tablet - _Before you start to take it_ Talk to your doctor before starting to take Plendil if you have any of the following conditions: • narrowing of the aortic valve in the heart (aortic stenosis) • impaired liver function • heart failure • low blood pressure • Plendil contains lactose. If you are allergic to some sugars, consult your doctor before taking this medicine. - _Taking other medicines_ Tell your doctor if you are taking ther medicines at the same time as you are taking Plendil. Some medicines can affect or be affected by the treatment with Plendil. Grapefruit juice can potentiate the effect of Plendil, and should therefore be avoided. HOW TO TAKE PLENDIL - _How m Leia o documento completo
PLENDIL ® 2.5 MG, 5 MG AND 10 MG _felodipine _ TABLETS COMPOSITION Felodipine 2.5 mg, 5 mg and 10 mg PHARMACEUTICAL FORM Film-coated extended-release tablets based on the hydrophilic gel matrix principle. The Plendil 2.5 mg tablet is yellow, circular, biconvex, engraved A/FL on one side and 2.5 on the other side, with a diameter of 8.5 mm. The Plendil 5 mg tablet is pink, circular, biconvex, engraved A/Fm on one side and 5 on the other side, with a diameter of 9 mm. The Plendil 10 mg tablet is reddish-brown, circular, biconvex, engraved A/FE on one side and 10 on the other side, with a diameter of 9 mm. THERAPEUTIC INDICATIONS Hypertension Stable angina pectoris POSOLOGY AND METHOD OF ADMINISTRATION The tablets should be taken in the morning, be swallowed with water and must not be divided, crushed or chewed. The tablets can be administered without food or following a light meal not rich in fat or carbohydrate. _ _ _Hypertension _ The dose should be adjusted individually. Treatment should be started with 5 mg once daily. If necessary the dose may be further increased or another antihypertensive agent added. The usual maintenance doses are 5 mg to 10 mg once daily. In elderly patients initial treatment with 2.5 mg daily should be considered. _Stable angina pectoris_ The dose should be adjusted individually. Treatment should be started with 5 mg once daily, increasing to 10 mg once daily if needed. _ELDERLY PATIENTS _ Initial treatment with 2.5mg daily dose should be considered. _IMPAIRED RENAL FUNCTION _ Impaired renal function does not affect plasma concentrations of felodipine. No dose adjustment is required. However, Plendil should be used with caution in patients with severely impaired renal function (see Pharmacokinetic Properties) _ _ _IMPAIRED HEPATIC FUNCTION_ _ _ Patients with impaired hepatic function may have elevated plasma concentrations of felodipine and may respond to treatment at lower doses (see Special Warnings & Precautions for Use). _ _ _PAEDIATRIC PATIENTS _ Due to limited clinical experience Leia o documento completo