Country: আয়ার্লণ্ড
ভাষা: ইংরেজি
সূত্র: HPRA (Health Products Regulatory Authority)
BROMOCRIPTINE MESILATE
Meda Health Sales Ireland Limited
G02CB01
BROMOCRIPTINE MESILATE
2.5 Milligram
Tablets
Product subject to prescription which may be renewed (B)
bromocriptine
Marketed
2007-02-16
Package leaflet: Information for the user PARLODEL 2.5 MG TABLETS Bromocriptine mesilate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINES 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. WHAT IS IN THIS LEAFLET: 1. What Parlodel tablets are and what it is used for 2. What you need to know before you take Parlodel tablets 3. How to take Parlodel tablets 4. Possible side effects 5. How to store Parlodel tablets 6. Contents of the pack and other information 1. WHAT PARLODEL TABLETS ARE AND WHAT IT IS USED FOR Parlodel tablets contain the active ingredient bromocriptine, which belongs to a group of medicines called dopamine agonists and prolactin inhibitors. Parlodel tablets 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). • To prevent lactation (milk production) for medical reasons. • Stopping breast milk production for medical reasons only, and when you and your doctor have decided that it is necessary. Bromocriptine should not be routinely used to stop breast milk production. It should also not be used to relieve symptoms of painful breast engorgement after giving birth i সম্পূর্ণ নথি পড়ুন
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Parlodel 2.5 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains bromocriptine mesilate equivalent to 2.5 mg of bromocriptine base. Excipients: Lactose monohydrate 116.38mg _For a full list of excipients see section 6.1._ 3 PHARMACEUTICAL FORM Tablet. Whitish, round tablet, flat with bevelled edges, angle-score and “2.5 MG” on upper side. The tablet can be divided into equal halves. 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). INHIBITION OF LACTATION FOR MEDICAL REASONS: Prevention or suppression of post-partum physiological lactation only where medically indicated (such as in the case of intrapartum loss, neonatal death, HIV infection of the mother). H E A L T H সম্পূর্ণ নথি পড়ুন