Страна: Швеция
Язык: шведский
Источник: Läkemedelsverket (Medical Products Agency)
kinagolidhydroklorid
Orifarm AB
G02CB04
kinagolidhydroklorid
75 mikrogram
Tablett
laktosmonohydrat Hjälpämne; kinagolidhydroklorid 82 mikrog Aktiv substans
Apotek
Receptbelagt
Kinagolid
Förpacknings: Blister, 30 tabletter
Godkänd
2015-04-08
1 PACKAGE LEAFLET: INFORMATION FOR THE USER NORPROLAC 25 MICROGRAM + 50 MICROGRAM TABLETS NORPROLAC 75 MICROGRAM TABLETS NORPROLAC 150 MICROGRAM TABLETS Quinagolide READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again - If you have any further questions, ask your doctor or pharmacist - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Norprolac is and what it is used for 2. What you need to know before you take Norprolac 3. How to take Norprolac 4. Possible side effects 5. How to store Norprolac 6. Contents of the pack and other information 1. WHAT NORPROLAC IS AND WHAT IT IS USED FOR Norprolac contains quinagolide which belongs to a group of medicines known as prolactin inhibitors. Quinagolide reduces the secretion of the hormone prolactin. Norprolac is used to treat elevated levels of prolactin caused by prolactin-secreting tumours of the pituitary gland or by unknown causes. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NORPROLAC DO NOT TAKE NORPROLAC: - if you are allergic to quinagolide or any of the other ingredients of this medicine (listed in section 6). - if you have severely impaired kidney or liver function. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Norprolac - if you have a prolactin-related fertility disorder, as fertility may be restored by treatment with Norprolac. Women of child-bearing age who do not wish to become pregnant should use a reliable method of contraception during treatment with Norprolac. (See also section “Pregnancy, breast-feeding and fertility”.) - if you have any of the following diseases: psychiatric disorders or impaired liver or kidney function. - if yo Прочитать полный документ
1. NAME OF THE MEDICINAL PRODUCT NORPROLAC 25 microgram + 50 microgram tablets NORPROLAC 75 microgram tablets NORPROLAC 150 microgram tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 tablet 25 microgram contains: 25 microgram of quinagolide as quinagolide hydrochloride. 1 tablet 50 microgram contains: 50 microgram of quinagolide as quinagolide hydrochloride. 1 tablet 75 microgram contains: 75 microgram of quinagolide as quinagolide hydrochloride. 1 tablet 150 microgram contains:150 microgram of quinagolide as quinagolide hydrochloride. Excipient(s) with known effect: Lactose monohydrate For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet 25 microgram: Light pink with isolated pigment spots, circular, flat, bevelled edge, 7 mm in diameter. Inscriptions: “NORPROLAC” circular on one side and “25” linear on the other side. 50 microgram: Light blue with isolated pigment spots, circular, flat, bevelled edge, 7 mm in diameter. Inscriptions: “NORPROLAC” circular on one side and “50” linear on the other side. 75 microgram: White, circular, flat, bevelled edge, 7 mm in diameter. Inscriptions: “NORPROLAC” circular on one side and “75” linear on the other side. 150 microgram: White, circular, flat, bevelled edge, 9 mm in diameter. Inscriptions: “NORPROLAC” circular on one side and “150” linear on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hyperprolactinaemia (idiopathic or originating from a prolactin-secreting pituitary microadenoma or macroadenoma). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Since dopaminergic stimulation may lead to symptoms of orthostatic hypotension, the dosage of NORPROLAC should be initiated gradually with the aid of the titration pack, and given once daily in the evening with food. The optimal dose must be titrated individually on the basis of the prolactin-lowering effect and tolerability. _Adults_ With the titration pack treatment begins with 25 micrograms/day for the first 3 days, followed by 50 micro Прочитать полный документ