Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Bromocriptine mesilate
IVAX Pharmaceuticals UK Ltd
G02CB01
Bromocriptine mesilate
2.5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06070100
BROMOCRIPTINE 2.5 MG TABLETS PATIENT INFORMATION LEAFLET 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. Your medicine is called Bromocriptine 2.5mg Tablets but will be referred to as Bromocriptine throughout this leaflet. Please note that the leaflet also contains information about other strengths available, Bromocriptine 1mg Tablets, Bromocriptine 5mg Capsules and Bromocriptine 10mg Capsules. IN THIS LEAFLET: What Bromocriptine is for Before you take Bromocriptine How to take Bromocriptine Possible side effects How to store Bromocriptine Further information WHAT BROMOCRIPTINE IS FOR Bromocriptine 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. Bromocriptine may be used for: * Stopping breast milk production for medical reasons only, and when you and your doctor have decided that it is necessary. Bromocriptine 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 ta Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT BROMOCRIPTINE 2.5mg Tablets 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. Bromocriptine mesilate 2.87mg, equivalent to 2.5mg of bromocriptine base. For a full list of excipients see section 6.1 3 PHARMACEUTICAL FORM Tablet: Each tablet is round, white, flat, with a bevelled edge, angle-scored and coded with “2.5 MG” on the upper side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS INHIBITION OF LACTATION FOR MEDICAL REASONS Prevention or suppression of post-partum physiological lactation only where medically indicated (such as in case of intrapartum loss, neonatal death, HIV infection of the mother). Bromocriptine is not recommended for the routine suppression of lactation or for the relief of symptoms of post-partum pain and engorgement which can be adequately treated with non-pharmacological intervention (such as firm breast support, ice application) and/or simple analgesics. 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. Bromocriptine 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 Bromocriptine 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, Bromocr Read the complete document