Contraindications : התוויות נגד

4.3 Contraindications
Minirin tablets are contra-indicated in cases of:
-Habitual or psychogenic polydipsia (resulting in a urine production exceeding 40 ml/kg/24 hours);
- Syndrome of inappropriate ADH secretion;
- Known hyponatraemia;
- A history of known or suspected cardiac insufficiency and other conditions requiring treatment with diuretics;
- Moderate and severe renal insufficiency (creatinine clearance below 50 ml/min) ; - Hypersensitivity to desmopressin or to any of the excipients;
- Patients over the age of 65 for the treatment of primary nocturnal enuresis.
- Patients over the age of 65 for the treatment of nocturia.
Before prescribing Minirin tablets the diagnosis of psychogenic polydipsia and alcohol abuse should be excluded.
4.4 Special Warnings and Special Precautions for use
Special warnings:
When used for primary nocturnal enuresis and nocturia indications, the fluid intake must be limited to a minimum from 1 hour before until the next morning (at least 8 hours) after administration. Treatment without concomitant reduction of fluid intake may lead to water retention and/or hyponatraemia with or without accompanying warning signs and symptoms (headache, nausea/vomiting, weight gain, and, in severe cases, convulsions). All patients and, when applicable, their guardians should be carefully instructed to adhere to the fluid restrictions.
This product contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption should not take this medicine.
Use of the product should be under specialist supervision with appropriate facilities available for monitoring and interpretation of response.
All patients on desmopressin therapy should be observed for the signs of symptoms associated with hyponatraemia (headache, nausea/vomiting, weight increased and, in severe cases, convulsions).
Care should be taken with patients who have reduced renal function (see section 4.2) and/or cardiovascular disease or cystic fibrosis (see section 4.3).
Patients being treated for primary nocturnal enuresis or nocturia should discontinue Minirin Tablets during an episode of vomiting and/or diarrhoea until their fluid balance is once again normal.