Land: Malaysia
Språk: engelsk
Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DESOGESTREL; Ethinylestradiol
PAHANG PHARMACY SDN. BHD.
DESOGESTREL; Ethinylestradiol
21 Tablets; 63 Tablets
Gedeon Richter Plc.
_ _ _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ NOVYNETTE TABLET Ethinylestradiol/Desogestrel (0.02 mg/0.15 mg) 1 WHAT IS IN THIS LEAFLET 1. What Novynette is used for 2. How Novynette works 3. Before you use Novynette 4. How to use Novynette 5. While you are using it 6. Side effects 7. Storage and Disposal of Novynette 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT NOVYNETTE IS USED FOR Oral contraception. HOW NOVYNETTE WORKS _Novynette_ works by inhibition of ovulation and changes in the cervical secretion to prevent pregnancy. BEFORE YOU _USE NOVYNETTE_ - _When you must not use it_ Do not take Novynette if you have any of the conditions listed below: - if you have (or have ever had) a blood clot in a blood vessel of your legs, your lungs or other organs; - if you know you have a disorder affecting your blood clotting – for instance, protein C deficiency, protein S deficiency, antithrombin- III deficiency, Factor V Leiden or antiphospholipid antibodies; - if you need an operation and you are off your feet for a long time; - if you have ever had a heart attack or a stroke; - if you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be a first sign of a heart attack) or temporary stroke symptoms; - if you have any of the following diseases that may increase your risk of a clot in the arteries: - severe diabetes with blood vessel damage - very high blood pressure - a very high level of fat in the blood (cholesterol or triglycerides) - a condition known as hyperhomocysteinaemia; - if you have (or have ever had) ‘migraine with aura’; - if you have (or have ever had) or if you are suspected of having breast cancer or cancer of the genital organs; - if you have (or have ever had) a liver disease and your liver function is still not normal. - if you have (or have ever had) a tumour in the liver; - if you have unexplained bleeding from your vagina; - if you have a condition characterised by the overgrowth of the lining Les hele dokumentet
PACKAGE INSERT NOVYNETTE _FILM-COATED TABLETS_ COMPOSITION Ethinylestradiol 0.02 mg Desogestrel 0.15 mg per film-coated tablet DESCRIPTION Slightly yellow, round shaped, biconvex film-coated tablets of 6 mm diameter, with P9 sign on one side and RG sign on other side. CLINICAL PARTICULARS THERAPEUTIC INDICATIONS Oral contraception The decision to prescribe Novynette should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Novynette compares with other combined hormonal contraceptives (CHCs) (see Sections Contraindications and Special warnings and special precautions for use). POSOLOGY AND METHOD OF ADMINISTRATION Posology How to take Novynette The tablets must be taken in the order directed on the package every day at about the same time. One tablet is to be taken daily for 21 consecutive days. Each subsequent pack is started after a 7-day tablet-free interval; during which time a withdrawal bleed usually occurs. This usually starts on day 2-3 after the last tablet and may not have finished before the next pack is started. How to start Novynette _No preceding hormonal contraceptive use [in the past month] _ The tablet intake must be started on the first day of the woman’s natural cycle (i.e. on the first day which the woman has a menstrual bleeding). Tablet intake is also allowed to start on day 2-5, but during the first cycle concurrent use of a barrier method for the first 7 days of tablet intake is advisable. _Changing from a combined hormonal contraceptive (combined oral contraceptive (COC), _ _combined contraceptive vaginal ring or transdermal patch) _ The woman should start taking Novynette on the day after the last active tablet (the last tablet containing the active substance) of her previous COC, but at the latest on the day following the usual tablet-free interval or following the last placebo tablet (tablet containing no active substance) of her previous COC. In case a vaginal ring or a transdermal Les hele dokumentet