Država: Velika Britanija
Jezik: engleski
Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)
Quinagolide hydrochloride
Aspire Pharma Ltd
G02CB04
Quinagolide hydrochloride
75microgram
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06070100; GTIN: 5060209731421
PACKAGE LEAFLET QUINAGOLIDE TABLETS NORPROLAC® TABLETS PATIENT INFORMATION Read all of this leaflet carefully before you start TAKING THIS MEDICINE. • Keep this leaflet, you may need to use it again. • If you have further questions, please ask your doctor or pharmacist. • This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours. IN THIS LEAFLET: 1. What Quinagolide is and what it is used for 2. Before you take Quinagolide 3. How to take Quinagolide 4. Possible side effects 5. How to store Quinagolide 6. Further information 1. WHAT QUINAGOLIDE IS AND WHAT IT IS USED FOR Quinagolide is for oral use only. It is available in strengths of 25 micrograms, 50 micrograms and 75 micrograms. Quinagolide contains quinagolide which decreases the production of the hormone prolactin. Quinagolide is used to treat conditions resulting from high levels of prolactin in the blood (hyperprolactinaemia) including: • excess production of breast milk • changes in menstrual bleeding patterns • infertility • reduced sexual drive. 2. BEFORE YOU TAKE QUINAGOLIDE DO NOT TAKE QUINAGOLIDE: • if you have a medical condition affecting your liver or kidneys • if you are allergic to any of the ingredients listed in section 6 If you are pregnant or planning a pregnancy, please refer to the pregnancy section of this leaflet. BEFORE TAKING QUINAGOLIDE: • please consult your doctor if you have ever had any mental illness. • Quinagolide may cause your blood pressure to drop when you stand up, particularly for the first few days of treatment or following an increase in your dosage. This may result in reduced alertness or fainting. To avoid this, stand up slowly from a sitting or lying down position. Your doctor will normally check your blood pressure during the first few days of treatment and when increasing your dosage. • Inform your doctor if you or your family/carer notices that you are developing urges or cravings to behave in Pročitajte cijeli dokument
OBJECT 1 QUINAGOLIDE 75 MICROGRAMS TABLETS Summary of Product Characteristics Updated 11-Oct-2016 | Aspire Pharma Ltd 1. Name of the medicinal product NORPROLAC® 75 micrograms Tablets Quinagolide 75 micrograms Tablets 2. Qualitative and quantitative composition Quinagolide, as the hydrochloride, 75 micrograms 3. Pharmaceutical form Tablet for oral administration 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 Since dopaminergic stimulation may lead to symptoms of orthostatic hypotension, the dosage of NORPROLAC should be initiated gradually with the aid of the 'starter pack', and given only at bedtime. Adults The optimal dose must be titrated individually on the basis of the prolactin- lowering effect and tolerability. With the 'starter pack' treatment begins with 25 micrograms/day for the first 3 days, followed by 50 micrograms/day for a further 3 days. From day 7 onwards, the recommended dose is 75 micrograms/day. If necessary, the daily dose may then be increased stepwise until the optimal individual response is attained. The usual maintenance dosage is 75 to 150 micrograms/day. Daily doses of 300 micrograms or higher doses are required in less than one- third of the patients. In such cases, the daily dosage may be increased in steps of 75 to 150 micrograms at intervals not shorter than 4 weeks until satisfactory therapeutic effectiveness is achieved or reduced tolerability, requiring the discontinuation of treatment, occurs. Elderly Experience with the use of NORPROLAC in elderly patients is not available. Children Experience with the use of NORPROLAC in children is not available. Method of Administration NORPROLAC should be taken once a day with some food at bedtime. 4.3 Contraindications Hypersensitivity to the drug. Impaired hepatic or renal function For procedure during pregnancy, (see section 4.6 Pregnancy and lactation). 4.4 Special warnings an Pročitajte cijeli dokument