Land: Vereinigtes Königreich
Sprache: Englisch
Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)
Bromocriptine mesilate
Viatris UK Healthcare Ltd
N04BC01
Bromocriptine mesilate
5mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06070100; GTIN: 5013054160045
PATIENT INFORMATION LEAFLET PARLODEL 1 MG & 2.5 MG TABLETS PARLODEL 5MG & 10MG CAPSULES Bromocriptine mesilate 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 any further 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. • In this leaflet, Parlodel 1 mg & 2.5 mg Tablets will be called Parlodel Tablets and Parlodel 5mg & 10mg Capsules will be called Parlodel. IN THIS LEAFLET: 1. What Parlodel is for 2. Before you take Parlodel 3. How to take Parlodel 4. Possible side effects 5. How to store Parlodel 6. Further information 1. WHAT PARLODEL IS FOR Parlodel belongs to a group of medicines called dopamine agonists and prolactin inhibitors. It works by increasing the release of dopamine in the brain, which treats diseases where you need more of this substance. It also works by decreasing the release of prolactin and growth hormone in the body, which treats diseases where you need less of these substances. Parlodel may be used for: • For the 1 mg and 2.5 mg strengths. Stopping breast milk production for medical reasons only, and when you and your doctor have decided that it is necessary. Parlodel should not routinely be used to stop breast milk production. It should also not be used to relieve symptoms of painful breast engorgement after giving birth if these can be adequately treated with non-medical means (such as firm breast support, ice application) and/or a painkiller. • Treating fertility and period problems usually caused by not having the right amount of prolactin. This includes polycystic ovary syndrome (reduces prolactin levels) • Treating non-cancerous tumours in the brain called prolactinomas (reduces prolactin levels) • Treating diseases where too much growth hormone is made, which causes people to be very tall or to have large hands and feet. This is called acromegaly (red Lesen Sie das vollständige Dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Parlodel 5mg Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: Ergotaman-3`, 6`, 18-trione, 2-bromo-12`-hydroxy-2`- (1-methylethyl-5`-(2- methylpropyl)-, (5`alpha)-mono-methanesulphonate. Each capsule contains 11.47mg of bromocriptine mesilate Ph Eur equivalent to 10 mg of bromocriptine base. Excipients with known effect: Each tablet contains 0.5mg di-sodium edetate Each tablet contains 116.38 mg Lactose monohydrate For a full list of excipients see section 6.1 3 PHARMACEUTICAL FORM Light blue and white opaque hard gelatin capsules imprinted with ‘5 mg’ on the capsule body. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS HYPERPROLACTINAEMIA The treatment of hyperprolactinaemia in men and women with hypogonadism and/or galactorrhoea. MENSTRUAL CYCLE DISORDERS AND FEMALE INFERTILITY Amenorrhoea and oligomenorrhoea, with or without galactorrhoea. Drug-induced hyperprolactinaemic disorders. Polycystic ovary syndrome. Some infertile women with oligomenorrhoea or amenorrhoea and galactorrhoea may be unduly sensitive to prolactin. Parlodel has been used successfully in the treatment of a number of infertile women with galactorrhoea who do not have demonstrable hyperprolactinaemia. PROLACTINOMAS To reduce tumour size, particularly in those at risk of optic nerve compression. ACROMEGALY Parlodel has been used in a number of specialised units, as an adjunct to surgery and/or radiotherapy to reduce circulating growth hormone in the management of acromegalic patients. 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 to or are unable to tolerate Levodopa and those whose response to Levodopa is declining. PREMENSTRUAL SYMPTOMS AND BENIGN BREAST DISEASE (See section 4.4 Special Lesen Sie das vollständige Dokument