Χώρα: Κύπρος
Γλώσσα: Ελληνικά
Πηγή: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας
DESMOPRESSIN ACETATE
FERRING HELLAS MEPE (0000010966) 2 KARAGIORGI SERVIAS STR., ATHENS, 10562
H01BA02
DESMOPRESSIN
0.1MG
TABLETS
DESMOPRESSIN ACETATE (0062357862) 0,1MG
ORAL USE
Εθνική Διαδικασία
DESMOPRESSIN
Νομικό καθεστώς: Με Ιατρική Συνταγή
PATIENT INFORMATION LEAFLET READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING MINIRIN. - Keep this leaflet, you may need to read it again - If you have further questions, please ask your doctor or pharmacist. - This medicine has been prescribed for you personally and you should not pass it on to others, even if their symptoms are the same as yours it may harm them. IN THIS LEAFLET YOU WILL FIND THE FOLLOWING INFORMATION: 1. What Minirin is and what it is used for 2. Before you use Minirin 3. How to use Minirin 4. Possible side effects 5. Storing Minirin MINIRIN TABLETS 0.1 AND 0.2 MG - The active substance is desmopressin - The other ingredients are lactose monohydrate, potato starch, povidone and magnesium stearate. MARKETING AUTHORISATION HOLDER Ferring GmbH Wittland 11, 24109 Kiel, Germany LOCAL REPRESENTATIVE A. Potamitis Medicare Ltd 62, Arch. Kyprianou Avenue, 2059 Strovolos, Nicosia, Cyprus Tel.: +357 22583333 MANUFACTURER Ferring International Center SA St. Prex, Switzerland 1. WHAT MINIRIN IS AND WHAT IT IS USED FOR The active substance in Minirin acts as the natural hormone vasopressin as it regulates the kidneys ability to concentrate urine. Minirin is used for the treatment of: - Central diabetes insipidus (pituitary disorder which leads to extreme thirst and a large urine volume). - Primary nocturnal enuresis (bedwetting) in children from 6 years of age with normal ability to concentrate urine. - Nocturia in adults. 2. BEFORE YOU USE MINIRIN When used for primary nocturnal enuresis and nocturia the fluid intake to quench thirst must be limited to a minimum from 1 hour before until 8 hours after the intake of Minirin. Minirin should be used with caution when the fluid balance is disturbed. DO NOT USE MINIRIN: - if you are hypersensitive (allergic) to the active substance or any of the other ingredients in Minirin. - if you suffer from polydipsia (abnormal large fluid intake), weak heart and other states of diseases which need treatment with diuretics, impaired renal function or low serum sodium Διαβάστε το πλήρες έγγραφο
SUMMARY OF THE PRODUCT CHARACTERISTICS 1 N AME OF THE MEDICINAL PRODUCT MINIRIN tablets 0.1 mg and 0.2 mg 2 Q UALITATIVE AND Q UANTITATIVE C OMPOSITION _per tablet 0.1 mg_ _per tablet 0.2 mg_ Desmopressin acetate 0.1 mg 0.2 mg Resp. desmopressin 0.089 mg 0.178 mg Re. other excipients see 6.1 3 P HARMACEUTICAL F ORM Tablet 4 C LINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Central diabetes insipidus. Primary nocturnal enuresis (from 6 years of age) when the enuresis alarm has not had the desired effect in patients with normal ability to concentrate urine. Symptomatic treatment of nocturia in adults associated with nocturnal polyuria, i.e. nocturnal urine production exceeding bladder capacity. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The dosage of MINIRIN tablets is individually titrated. Desmopressin should always be taken at the same time in relation to food intake, since food intake causes decreased absorption and by that also might influence the effect of desmopressin, see section 4.5. _Central diabetes insipidus: _A suitable initial dose for children and adults is 0.1 mg 3 times daily. The dosage is then titrated according to the patient's response. According to present clinical experience the daily dose has varied between 0.2 and 1.2 mg. For most patients 0.1- 0.2 mg 3 times a day is an optimal dosage regimen. In the event of signs of water retention/hyponatraemia the treatment should be interrupted and the dosage should be adjusted. _Primary nocturnal enuresis: _A suitable initial dose is 0.2 mg at bedtime. The dose may be increased up to 0.4 mg if the lower dose is not sufficiently effective. Fluid restriction shall be enforced. In the event of signs or symptoms of water retention and/or hyponatraemia - 1 - (headache, nausea/vomiting, weight gain, and in serious cases convulsions) the treatment should be interrupted until the patient has completely recovered. When the treatment is resumed strict fluid restriction is necessary, see section 4.4. Evaluation of continued need of treatment should be carried ou Διαβάστε το πλήρες έγγραφο