Država: Malta
Jezik: engleski
Izvor: Medicines Authority
NeoFarma Pharmaceuticals Limited 42-46, Mill Street, Qormi, QRM 3105, Malta
G03DC02
NORETHISTERONE ACETATE 5 mg/5ml
TABLET
NORETHISTERONE ACETATE 5 mg/5ml
POM
SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
Licence number in the source country: Spain - 39927, 724247
Authorised
2024-01-19
PACKAGE LEAFLET – INFORMATION FOR THE USER PRIMOLUT-NOR 5 MG TABLETS NORETHISTERONE Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have more questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Primolut-Nor is and what it is used for 2. Before you take Primolut-Nor 3. How you take Primolut-Nor 4. Possible side effects 5. How to store Primolut-Nor 6. Further information 1.WHAT PRIMOLUT-NOR IS AND WHAT IT IS USED FOR Primolut-Nor contains norethisterone, which belongs to a group of medicines called progestogens, which are female hormones. Primolut-Nor can be used: • to treat irregular, painful or heavy periods • to treat endometriosis (where tissue from the lining of the womb is present in places where it is not normally found) 2.BEFORE YOU TAKE PRIMOLUT-NOR Before you can begin taking Primolut-Nor, your doctor will ask you some questions about your personal health history and that of your close relatives. The doctor will also measure your blood pressure, and depending upon your personal situation, may also carry out some other tests. Do not take Primolut-Nor if you are: • allergic to norethisterone or any of the other ingredients. The ingredients are listed in section 6 • pregnant or if you think you might be pregnant • breastfeeding or if you have: • any unexplained bleeding from the vagina • (or are recovering from ) a liver disease and the blood tests show that your liver is not yet working normally. • (or have ever had) liver cancer. Do not take Primolut-Nor if you have: • (or ever have had) blood clots in the legs or lungs, a heart attack or stroke (see also “Other things you should know”) • (or ever have had) any m Pročitajte cijeli dokument
1 of 11 BP22036_REC30610 S UMMARY O F P RODUCT C HARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Primolut-Nor 5 mg Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet of Primolut-Nor 5 mg contains 5 mg of norethisterone acetate. Excipient with known effect: 67,375 mg lactose monohydrate. For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Compressed. Primolut-Nor 5 mg: white tablet with a cross groove on one side and engraved on the other side with the letters "AP" enclosed in a regular hexagon. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Dysfunctional bleeding, endometriosis 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Posology The tablets are to be swallowed whole with some liquid. The efficacy of Primolut-Nor 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, barrier contraceptive methods should be used. _Dysfunctional bleeding _ Primolut-Nor 1 tablet is to be taken 3 times daily for 10 days. In the majority of cases this will arrest uterine bleeding that is not associated with organic lesions within 1 to 3 days, nevertheless to ensure treatment success Primolut-Nor 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 suspension of bleeding. Also in these cases tablet intake should not be interrupted or stopped. • Missing arrest of haemorrhage, heavy breakthrough bleeding If 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, myoma, residua of abortion, extra-uterine pregnancy or coagulation disorders) must be considered Pročitajte cijeli dokument