Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
BROMOCRIPTINE MESILATE
Mylan IRE Healthcare Limited
G02CB; G02CB01
BROMOCRIPTINE MESILATE
5 mg milligram(s)
Capsule, hard
Product subject to prescription which may be renewed (B)
Prolactine inhibitors; bromocriptine
Not marketed
2007-02-16
Package leaflet: Information for the user PARLODEL 5 MG HARD CAPSULES Bromocriptine mesilate 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. The name of your medicine is Parlodel 5 mg hard capsules, which will be called Parlodel capsules throughout this leaflet. WHAT IS IN THIS LEAFLET: 1. What Parlodel capsules are and what it is used for 2. What you need to know before you take Parlodel capsules 3. How to take Parlodel capsules 4. Possible side effects 5. How to store Parlodel capsules 6. Contents of the pack and other information 1. WHAT PARLODEL CAPSULES ARE AND WHAT IT IS USED FOR Parlodel capsules contain the active ingredient bromocriptine, which belongs to a group of medicines called dopamine agonists and prolactin inhibitors. Parlodel capsules are used for: Treatment of Parkinson’s disease Treatment of prolactinomas (a non-cancerous tumour of the pituitary gland in the brain) Co-treatment of acromegaly with surgery or radiotherapy. Acromegaly is abnormal growth caused by high levels of growth hormone. Treatment of hyperprolactinaemia (abnormally high levels of prolactin causing unexplained milk secretion and irregular periods in women and lack of sex drive in men). Treatment of menstrual cycle disorders and female infertility caused by hyperprolactinaemia (see above). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARLODEL CAPSULES DO NOT TAKE PARLODEL CAPSULES: - If you are allergic to bromocriptine, other similar drugs, or any of the other ingredients of this medicine (listed in section 6). An allerg Citiți documentul complet
Health Products Regulatory Authority 30 November 2020 CRN00C1YK Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT PARLODEL 5mg Hard Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains Bromocriptine Mesilate equivalent to bromocriptine 5 mg. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard Hard gelatin capsules with light blue cap and white opaque body printed “5mg” in ink on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS PARKINSON’S DISEASE: In the treatment of idiopathic Parkinson's disease. PARLODEL has been used both alone and in combination with levodopa in the management of previously untreated patients and those disabled by “on/off” phenomena. PARLODEL has been used with occasional benefit in patients who do not respond or are unable to tolerate levodopa and those whose response to levodopa is declining. PROLACTINOMAS: In a number of specialised units, patients who have been shown to have prolactin secreting adenomas have been treated successfully with PARLODEL. In particular PARLODEL can be considered as a first choice of treatment in patients with macroadenomas and as an alternative to the surgical procedure transsphenoidal hypophysectomy in patients with microadenomas. ACROLMEGALY: PARLODEL has been used in a number of specialized units as an adjunct to surgery and/or radiotherapy to reduce circulating growth hormone levels in the management of acromegalic patients. HYPERPROLACTINAEMIA: For the treatment of hyperprolactinaemia in patients with hypogonadism and/or galactorrhoea. MENSTRUAL CYCLE DISORDERS, FEMALE INFERTILITY: In the treatment of female infertility associated with normal basal gonadotrophin levels and hyperprolactinaemia (Absolute or relative). OTHER: There is insufficient evidence of efficacy of Parlodel in the treatment of premenstrual symptoms and benign breast disease. The use of Parlodel in patients with these conditions is therefore not recommended. 4.2 POSOLOGY AND METHOD OF Citiți documentul complet