Țară: Malaezia
Limbă: engleză
Sursă: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CABERGOLINE
PFIZER (MALAYSIA) SDN. BHD.
CABERGOLINE
2 Tablets; 8 Tablets
Pfizer Italia S.r.l.
Pfizer Confidential _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ DOSTINEX ® TABLET Cabergoline (0.5 mg) PLD Title : Dostinex Tablet PLD Date : 20 January 2020 Country : Malaysia Reference Document : Malaysia LPD dated 02 August 2018 Reason for Change : To align with current effective Malaysia LPD (dated 02 August 2018) : Revise as per new template : PfLEET Number: 2019-0052724, To update as per BOH comments : To update serial number and to remove phone number for reporting side effects Pfizer Confidential _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ DOSTINEX TABLET Cabergoline (0.5 mg) 2 WHAT IS IN THIS LEAFLET 1. What Dostinex is used for 2. How Dostinex works 3. Before you use Dostinex 4. How to use Dostinex 5. While you are using it 6. Side effects 7. Storage and Disposal of Dostinex 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT DOSTINEX IS USED FOR Dostinex is used to prevent the production of milk in women after child birth, if breast-feeding is to be prevented for medical reasons. Dostinex may be prescribed by your doctor to reduce your body's level of a hormone known as prolactin. Dostinex may be needed if your levels of prolactin are abnormally high (hyperprolactinaemia). HOW DOSTINEX WORKS Dostinex is an oral tablet that contains cabergoline and belongs to a class of medicines called ‘dopamine agonists’. Dopamine is produced naturally in the body and helps to transmit messages to the brain. Cabergoline mimics the action of dopamine to reduce the production of prolactin in the blood. Prolactin is the hormone which stimulates the breast to produce milk. BEFORE YOU USE DOSTINEX - _When you must not use it_ You are allergic to cabergoline, to other medicines called ergot alkaloids, or to any of the other ingredients in the tablet - You have heart valve disorder - You have had fibrotic reactions (scar tissue) affecting your abdomen, heart or lungs. _Pregnancy and lactation_ If you are pregnant or planning to get pregnant, discuss this with your Citiți documentul complet
Pfizer Confidential Page 1 of 9 LPD Title : Cabergoline LPD Date : 02 August 2018 Country : Malaysia Reference : CDS 05 February 2013 Reason for Change : To update Sections 4.4, 4.7 and 4.8 based on BOH recommendation. Update to storage condition & Nature and Contents of Container PFIZER DOSTINEX * Cabergoline 1. NAME OF THE MEDICINAL PRODUCT DOSTINEX 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Available as tablets each containing 0.5 mg Cabergoline. 3. PHARMACEUTICAL FORM Tablets 4. CLINICAL PARTICULARS 4.1. Therapeutic indications Inhibition/Suppression of Physiological Lactation: Cabergoline is indicated for 1) the inhibition of physiological lactation soon after parturition and 2) suppression of established lactation. Treatment of Hyperprolactinaemic Disorders: Cabergoline is indicated for the treatment of hyperprolactinemic disorders. 4.2. Posology and method of administration General: Cabergoline tablets are for oral administration. Since the tolerability of dopaminergic agents is improved when administered with food, it is recommended that cabergoline be taken with meals. In patients known to be intolerant to dopaminergic drugs, the likelihood of adverse events may b e lessened by starting therapy with cabergoline at reduced doses (e.g., 0.25 mg once a week) with subsequent gradual increase until the therapeutic dosage is reached. If persistent or severe adverse events occur, temporary reduction of dosage followed by a more gradual increase (e.g., increments of 0.25 mg per week every two weeks) may increase tolerability. Citiți documentul complet