Country: Իռլանդիա
language: անգլերեն
source: HPRA (Health Products Regulatory Authority)
DESMOPRESSIN ACETATE
Ferring Ireland Ltd
H01BA; H01BA02
DESMOPRESSIN ACETATE
0.1 milligram(s)
Tablet
Product subject to prescription which may be renewed (B)
Vasopressin and analogues; desmopressin
Not marketed
1994-02-10
PACKAGE LEAFLET: INFORMATION FOR THE USER DDAVP ® /DESMOPRESSIN 0.1MG TABLETS Desmopressin Acetate 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 use 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). IN THIS LEAFLET: 1. What DDAVP/Desmopressin Tablets are and what they are used for 2. What you need to know before you take DDAVP/Desmopressin Tablets 3. How to take DDAVP/Desmopressin Tablets 4. Possible side effects 5. How to store DDAVP/Desmopressin Tablets 6. Contents of the pack and other information 1. WHAT ARE DDAVP/DESMOPRESSIN TABLETS ARE AND WHAT THEY ARE USED FOR DDAVP/Desmopressin Tablets are for oral use only. They are available in one strength, 0.1mg. They contain desmopressin acetate, an antidiuretic that reduces urine production. DDAVP/Desmopressin Tablets are used to treat: - DIABETES INSIPIDUS (extreme thirst and the continuous production of large volumes of dilute urine). IMPORTANT: this should not be confused with diabetes mellitus (sugar diabetes). - PRIMARY NOCTURNAL ENURESIS (bed wetting from the age of five). - NOCTURIA IN ADULTS UP TO 65 YRS (night time urine production exceeding bladder capacity). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DDAVP/DESMOPRESSIN TABLETS DO NOT TAKE DDAVP/DESMOPRESSIN TABLETS: - if you are allergic to desmopressin or any of the other ingredients of this medicine (listed in section 6) - if you have a serious heart or kidney disease - if you are taking diuretics (water tablets) - if you drink unusually large quantities of fluids, including alcohol - for Primary Nocturnal Enuresis and Nocturia: these tablets should not be used read_full_document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT DDAVP/Desmopressin 0.1mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains desmopressin acetate 0.1 mg equivalent to desmopressin (free base) 89 micrograms. Also contains lactose monohydrate, 123.7 mg per tablet. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet White, oval convex tablet, with a score line on one face and “0.1” on the reverse. 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 4.2 POSOLOGY AND METHOD OF ADMINISTRATION GENERAL Effect of food: Food intake may reduce the intensity and duration of the antidiuretic effect at low doses of desmopressin (see section 4.5). In the event of signs or symptoms of water retention and/or hyponatraemia (headache, nausea/vomiting, weight gain, and, in severe cases, convulsions) treatment should be interrupted until the patient has fully recovered. When restarting treatment strict fluid restriction should be enforced (see section 4.4). If adequate clinical effect is not achieved within 4 weeks following appropriate dose titration the medication should be discontinued. INDICATION SPECIFIC _Central Diabetes Insipidus:_ Dosage is individual in diabetes insipidus but clinical experience has shown that the total daily dose normally lies in the range of 0.2 to 1.2 mg. A suitable starting dose in adults and children is 0.1 mg three times daily. This dosage regimen should then be adjusted in accordance with the patient’s response. For the majority of patients, the maintenance dose is 0.1 mg to 0.2 mg three times daily. _Primary nocturnal enuresis:_ The recommended initial dose is 0.2 mg at bedtime. If this dose is not sufficiently effective, the dose may be increased up to 0.4 mg. Fluid restriction should be observed. 1. For the diagnosis and treatment of cranial diabetes insipidus including post-hypophysectomy polyuria/polydipsia and for the treatm read_full_document