Ország: Svédország
Nyelv: svéd
Forrás: Läkemedelsverket (Medical Products Agency)
midodrinhydroklorid
Evolan Pharma AB
C01CA17
midodrinhydroklorid
2,5 mg
Tablett
midodrinhydroklorid 2,5 mg Aktiv substans
Receptbelagt
Förpacknings: Blister, 20 tabletter; Blister, 30 tabletter; Blister, 50 tabletter; Blister, 90 tabletter; Blister, 100 tabletter; Blister, 10 tabletter; Blister, 40 tabletter; Blister, 60 tabletter; Blister, 70 tabletter; Blister, 80 tabletter; Blister, 500 tabletter
Godkänd
2017-05-12
PACKAGE LEAFLET: INFORMATION FOR THE USER MIDODRIN EVOLAN 2.5 MG TABLETS MIDODRIN EVOLAN 5 MG TABLETS midodrine hydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE 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 or nurse. - 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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. Whatis and what it is used for 2. What you need to know before you take Olvassa el a teljes dokumentumot3. How to take 4. Possible side effects 5. How to store 6. Content of the pack and other information 1. WHAT IS AND WHAT IT IS USED FOR The name of your medicine is . It contains the substance midodrine hydrochloride. This belongs to a group of medicines called adrenergic and dopaminergic agents. Midodrine hydrochloride is a medicine that raises your blood pressure and is used to treat certain severe forms of low blood pressure in adults when other treatments have not worked. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DO NOT TAKE : • if you are allergic to midodrine hydrochloride or any of the other ingredients of this medicine (listed in section 6) • if you have high blood pressure • if you have a slow pulse • if you have difficulty urinating • if you have certain forms of cardiovascular disease (ask your doctor if this applies to you) • if you have elevated pressure in the eye (glaucoma) or poor vision as a result of diabetes • if you have an overactive thyroid gland • if you have hormonal disorders caused by a tumour in the adrenal medulla (pheochromocytoma) • if you have acute kidney disease or se
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Midodrin Evolan 2.5 mg tablets Midodrin Evolan 5 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2.5 mg of midodrine hydrochloride Each tablet contains 5 mg of midodrine hydrochloride For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Tablet. White, flat, round tablets embossed with “2.5” 7 mm in diameter. White, flat, round tablets embossed with “5” 10 mm in diameter. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONSis indicated in adults for the treatment of severe orthostatic hypotension due to autonomic dysfunction when other forms of treatment and corrective factors are inadequate. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Posology Initial dose: 2.5 mg three times a day. Depending on the individual response, the dose may be increased weekly up to a maximum dose of 10 mg three times a day. The blood pressure should repeatedly be measured at the start of the treatment and monitored closely after each dose increase. An ambulatory 24 h blood pressure measurement can be considered to optimize the dosage schedule. The last daily dose can be lower and should be taken at least 4 hours before bedtime in order to prevent supine hypertension (see also section 4.4). Olvassa el a teljes dokumentumotmay be taken with or without 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 on a possible dose reduction in the elderly population. Cautious dose titration is recommended. _Patients with renal impairment_ There are no specific studies that have focused on a possible dose reduction in patients with renal impairment. A careful dose titration is recommended. Typically, midodrine is contraindicated in patients with acute renal impairment or severe renal impairment (see section 4.3). _Pati