Država: Velika Britanija
Jezik: engleski
Izvor: myHealthbox
midodrine hydrochloride
Brancaster Pharma Limited
C01CA17
midodrine hydrochloride
2.5mg
Tablets
Oral use
100 tablets.
POM - Prescription Only Medicine
Cross Vetpharm Group UK Limited
Cardiac Therapy, Adrenergic and dopaminergic agents
indicated in adults for the treatment of severe orthostatic hypotension due to autonomic dysfunction when corrective factors have been ruled out and other forms of treatment are inadequate
Authorised
2015-03-18
210 mm 35 mm 280 mm By keeping your head elevated at night the potential risk of your blood pressure rising when you lie down is reduced. You should be monitored by your doctor for possible secondary effects of high blood pressure. ALSO TALK TO YOUR DOCTOR IF YOU: • have a serious disorder of the nervous system (autonomic nervous system disorders), since taking this medicine may lead to a further drop in blood pressure when you stand up. If this occurs, further treatment with this medicine should be stopped. • suffer from problems with your circulation. • suffer from a disease of the prostate, as you may find passing urine is difficult when taking this medicine. You should have your kidney function and blood pressure checked by your doctor before you start using this medicine. During treatment with this medicine, your blood pressure will be checked from time to time, and if necessary your dose adjusted. It is important that you immediately report symptoms related to high blood pressure, such as elevated heart rate, headache and blurred vision. Your doctor will then decide whether to adjust dosage or discontinue your treatment with Bramox tablets. If any of the warnings apply to you, or have in the past, talk to your doctor. CHILDREN AND ADOLESCENTS Do not give this medicine to children and adolescents under the age 18 because the safety and efficacy of Bramox tablets in this age group have not been established. OTHER MEDICINES AND BRAMOX TABLETS Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. IN PARTICULAR, TELL YOUR DOCTOR OR PHARMACIST IF YOU ARE TAKING ANY OF THE FOLLOWING: • Reserpine and guanethidine (medicines used to reduce high blood pressure), antihistamines (used to treat allergies), hormones for the thyroid (used when the thyroid is not working properly), tricyclic antidepressants and MAO-inhibitors (both used to treat depression) and other Pročitajte cijeli dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bramox 2.5 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2.5 mg of midodrine hydrochloride. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White, round tablet of diameter 6 mm. Plain on one side with “MID” debossed above the score line and “2.5” debossed below the score line on the other side. The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Bramox 2.5 mg tablets are indicated in adults for the treatment of severe orthostatic hypotension due to autonomic dysfunction when corrective factors have been ruled out and other forms of treatment are inadequate. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Initial dose: 2.5 mg three times a day. Depending on the results of supine and standing blood pressure recordings, this dose may be increased weekly up to a dose of 10 mg three times a day (Bramox 5 mg tablets are also available). This is the usual maintenance dosage. A careful evaluation of the response to treatment and of the overall balance of the expected benefits and risks needs to be undertaken before any dose increase and advice to continue therapy for long periods. The last daily dose should be taken at least 4 hours before bedtime in order to prevent supine hypertension (see also section 4.4). Bramox 2.5 mg tablets may be taken with food (see section 5.2). _Paediatric population _ The safety and efficacy of midodrine in children have not been established. No data are available. _Elderly population _ _ _ There is limited data on dosing in the elderly and there are no specific studies which have focused Pročitajte cijeli dokument