Land: Verenigd Koninkrijk
Taal: Engels
Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)
Bromocriptine mesilate
Meda Pharmaceuticals Ltd
G02CB01
Bromocriptine mesilate
2.5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06070100; GTIN: 5013054160021 5013054160038
Page 1 of 2 PACKAGE INFORMATION LEAFLET PARLODEL ® 2.5MG TABLETS (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 2.5mg Tablets 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: 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 (reduces growth hormone levels) Treating Parkinson’s Disease (increases dopamine levels). 2. BEFORE YOU TAKE PARLODEL DO NOT Lees het volledige document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Parlodel 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 “2.5MG” on the upper side. 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). Parlodel 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. 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 combinati Lees het volledige document