Ülke: Yeni Zelanda
Dil: İngilizce
Kaynak: Medsafe (Medicines Safety Authority)
Norethisterone 5mg;
Bayer New Zealand Limited
Norethisterone 5 mg
5 mg
Tablet
Active: Norethisterone 5mg Excipient: Lactose monohydrate Magnesium stearate Maize starch
Blister pack, PVC/Al, 30 tablets
Prescription
Prescription
Bayer AG
Package - Contents - Shelf Life: Blister pack, PVC/Al - 30 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, PVC/Al - 100 tablets - 36 months from date of manufacture stored at or below 30°C
1969-12-31
1904 PRIMOLUT N ® CMI 1 PRIMOLUT ® N (PREE·MOE·LOOT) _Norethisterone _ _CONSUMER MEDICINE INFORMATION _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Primolut N. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Primolut N against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST FOR MORE ADVICE. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT PRIMOLUT N IS USED FOR Primolut N contains a hormone, norethisterone. This type of hormone is similar to the natural female hormone progesterone. Some of the information in this leaflet is based on experience with estrogen containing oral contraceptives as some of the active ingredient in Primolut N is converted to estrogen in the body. However, Primolut N is not to be used as a contraceptive Primolut N is used to treat • irregular menstrual periods • abnormally heavy and prolonged menstrual bleeding • premenstrual complaints (premenstrual syndrome) • endometriosis (a disease caused by womb-lining tissue growing outside the womb) ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. BEFORE YOU TAKE PRIMOLUT N _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE PRIMOLUT N IF YOU HAVE AN ALLERGY TO: • norethisterone, the active ingredient in Primolut N • any of the ingredients listed at the end of this leaflet. SOME OF THE SYMPTOMS OF AN ALLERGIC REACTION MAY INCLUDE: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin. DO NOT TAKE THIS MEDICINE IF YOU ARE PREGNANT OR THINK YOU MIGHT BE PREGNANT. It may affect your developing baby if you take it during pregnancy. DO NOT BREASTFEED I Belgenin tamamını okuyun
1902 Primolut N- Data Sheet Page 1 of 13 NEW ZEALAND DATA SHEET 1 PRIMOLUT N® PRIMOLUT N ® 5 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet of PRIMOLUT N contains 5 mg of norethisterone. Excipients with known effect: Lactose monohydrate For the full list of excipients, see Section 6.1 List of excipients 3 PHARMACEUTICAL FORM Each round, white, flat, 7 mm tablet is impressed with an “AN” in a regular hexagon on one side and quarter-scored on the other and contains 5 mg norethisterone. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications Dysfunctional bleeding, premenstrual syndrome, cyclical mastopathy, timing of menstruation, endometriosis, menorrhagia. 4.2 Dose and method of administration The tablets are to be swallowed whole with some liquid. The efficacy of PRIMOLUT N could be reduced if the user forgets to take a tablet as directed. The woman should take only the last missed tablet as soon as she remembers and then continue tablet intake at her usual time on the next day. If contraceptive protection is required, additional non-hormonal contraceptive methods should be used. The following dosages are recommended: _Dysfunctional uterine bleeding _ The administration of one tablet PRIMOLUT N three times daily over 10 days, in the majority of cases, leads to the arrest of uterine bleeding that is not associated with organic lesions within 1 to 3 days. Nevertheless, to ensure treatment success, PRIMOLUT N must be taken for the full 10 days. About 2 to 4 days after completion of the treatment, withdrawal bleeding will occur with the intensity and duration of normal menstruation. _Slight bleeding during tablet-taking _ Occasionally, slight bleeding may occur after the initial arrest of bleeding. In these cases tablet- taking must not be interrupted or stopped. _Missing arrest of haemorrhage, heavy break-through bleeding _ If the vaginal bleeding does not stop, despite correct tablet intake, an organic cause or an extra- genital factor (e.g. polyps, carcinoma of the cervix uteri or endometrium, Belgenin tamamını okuyun