Land: Israel
Sprache: Englisch
Quelle: Ministry of Health
QUINAGOLIDE AS HYDROCHLORIDE
FERRING PHARMACEUTICALS LTD
G02CB04
TABLETS
QUINAGOLIDE AS HYDROCHLORIDE 0.025 MG
PER OS
Required
FERRING GmbH ,GERMANY
QUINAGOLIDE
QUINAGOLIDE
Second line treatment of hyperprolactinaemia (idiopathic or due to prolactin secreting micro- or macroadenoma) and its clinical manifestation (galactorrhoea, oligomenorrhea, infertility, reduced libido).
2010-09-30
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed with a doctor’s prescription only NORPROLAC ® NORPROLAC ® 25 MCG 50 MCG TABLETS TABLETS COMPOSITION: COMPOSITION: Each tablet contains: Each tablet contains: Quinagolide 25 mcg Quinagolide 50 mcg Lactose 90 mg Lactose 90 mg NORPROLAC ® NORPROLAC ® 75 MCG 150 MCG TABLETS TABLETS COMPOSITION: COMPOSITION: Each tablet contains: Each tablet contains: Quinagolide 75 mcg Quinagolide 150 mcg Lactose 87 mg Lactose 174 mg INACTIVE INGREDIENTS – see section 6 “Further Information”. READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed for the treatment of your ailment. Do not pass it on to others. It may harm them, even if it seems to you that their ailment is similar. 1. WHAT IS THE MEDICINE INTENDED FOR? The medicine inhibits prolactin secretion. THERAPEUTIC GROUP: Dopamine D 2 -receptor agonist. 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: - Do not breastfeed while taking the medicine. - Do not use this medicine if there is a known sensitivity to any of the medicine’s ingredients. - Do not use this medicine in cases of impaired liver or kidney function. SPECIAL WARNINGS REGARDING USE OF THE MEDICINE - Consult with the doctor before beginning treatment if you are pregnant. - Consult with the doctor before beginning treatment if you suffer or have suffered in the past from: low blood pressure, psychotic disturbances. - During treatment with this medicine, blood pressure tests should be performed. - If you are sensitive to any type of food, inform your doctor before taking the medicine. - Inform your doctor if you or any of your family members notice that you are developing urges or cravings to behave in ways that are unusual for you, or if you cannot resist the impulse or temptation to carry out cert Lesen Sie das vollständige Dokument
SUMMARY OF PRODUCT CHARACTERISTICS 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 micrograms contains: 25 micrograms of quinagolide as quinagolide hydrochloride. 1 tablet 50 micrograms contains: 50 micrograms of quinagolide as quinagolide hydrochloride. 1 tablet 75 micrograms contains: 75 micrograms of quinagolide as quinagolide hydrochloride. 1 tablet 150 micrograms contains: 150 micrograms of quinagolide as quinagolide hydrochloride. For excipients, see 6.1. 3. PHARMACEUTICAL FORM Tablet 25 micrograms: 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. Tablet 50 micrograms: 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. Tablet 75 micrograms: White, circular, flat, bevelled edge, 7 mm in diameter. Inscriptions: “NORPROLAC” circular on one side and “75” linear on the other side. Tablet 150 micrograms: 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 Second line treatment of hyperprolactinaemia (idiopathic or due to prolactin-secreting micro- or macroadenoma) and its clinical manifestation (galactorrhoea, oligomenorrhoea, infertility, reduced libido). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION 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 b Lesen Sie das vollständige Dokument