देश: मलेशिया
भाषा: अंग्रेज़ी
स्रोत: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DESMOPRESSIN
Ferring Sdn. Bhd.
DESMOPRESSIN
30 Tablets
Catalent UK Swindon Zydis Limited
NOCDURNA ® Oral Lyophilisate for sublingual 25mcg and 50mcg Desmopressin Acetate 25mcg and 50mcg Consumer Medication Information Leaflet (RiMUP) WHAT IS IN THIS LEAFLET 1. What NOCDURNA ® is used for 2. How NOCDURNA ® works 3. Before you use NOCDURNA ® 4. How to use NOCDURNA ® 5. While you are using it 6. Side effects 7. Storage and Disposal of NOCDURNA ® 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT NOCDURNA ® IS USED FOR NOCDURNA ® is provided as oral lyophilisate in sublingual tablet. It is used for the treatment of nocturia (frequent need to get up to urinate at night) due to nocturnal polyuria (overproduction of urine during night) in adults. HOW NOCDURNA ® WORKS NOCRUDNA contains active ingredient desmopressin which is an antidiuretic, which reduces urine production. BEFORE YOU USE NOCDURNA ® _When you must not use it _ DO NOT USE NOCDURNA ® if you: - are allergic to desmopressin or any of the other ingredients in this medicine - suffer from polydipsia (excessive thirst and increased fluid intake) or psychogenic polydipsia (psychologically caused increased thirst and increased fluid intake) - have known or suspected cardiac insufficiency (heart failure in which the heart is not able to pump enough blood throughout the body) - have any disease requiring treatment with diuretics - have moderately or severely reduced kidney function - have or have had hyponatraemia (low sodium level in the blood) - have SIADH (hormone secretion disorder) _ _ _Before you start to use it _ Check with your doctor before taking NOCDURNA ® . It is especially important that you talk to your doctor before taking NOCDURNA ® if: - you have severe bladder dysfunction and problems urinating - you are 65 years or older since your doctor will have to monitor the level of sodium in your blood (see the section 3 “How to take NOCDURNA ® ” below) - you have low levels of sodium in your blood - you have a medical condition(s) causing fluid and/or electrolyte imbalance - you ha पूरा दस्तावेज़ पढ़ें
PROPOSED PACKAGING MATERIAL Code NOCD25,50-I-MY-01.03 Size Submission ☒ NDA ☐ Renewal ☐ Variation change detail no.: _ _ Code of previous version NOCD25,50-I-MY-01.02 Changes Requested by NPRA to change name to “oral Lyophilisate for sublingual”, updated updated Qualitative and Quantitative Composition and Pharmaceutical form sections. ☒ CCDS version:1 ☐ Core PIL version: ☐ SPC country/version/date: ☐ LAC no.: Name & Date JIWO, 22-Oct-2020 1 NOCDURNA ® 25 MCG & 50 MCG Oral lyophilisate for sublingual QUALITATIVE AND QUANTITATIVE COMPOSITION Each oral lyophilisate for sublingual contains desmopressin acetate equivalent to 25 or 50 mcg desmopressin. Excipients: Gelatin, Mannitol (E 421), Citric acid, anhydrous PHARMACEUTICAL FORM Oral lyophilisate for sublingual. NOCDURNA ® 25 mcg: White, round, oral lyophilisate of approximately 12 mm marked with 25 on one side. NOCDURNA ® 50 mcg: White, round, oral lyophilisate of approximately 12 mm marked with 50 on one side_. _ THERAPEUTIC INDICATIONS NOCDURNA ® is indicated for symptomatic treatment of nocturia due to idiopathic nocturnal polyuria in adults. POSOLOGY AND METHOD OF ADMINISTRATION Posology • Women: 25 mcg daily, one hour before bedtime, administered sublingually without water. • Men: 50 mcg daily, one hour before bedtime, administered sublingually without water. A dose increase with this product is not recommended in elderly patients ≥ 65 years. If higher doses are considered for patients under the age of 65 years in case of an insufficient response to NOCDURNA ® , other desmopressin oral lyophilisate products should be used (see Special Warnings and Precautions for Use, Undesirable Effects and Pharmacodynamic Properties) In the event of signs or symptoms of water retention and/or hyponatremia (headache, nausea/vomiting, weight gain, and, in severe cases, convulsions) treatment should be interrupted and reassessed. When restarting treatment strict fluid restriction should be enforced and serum sodium levels monitored (see Special Wa पूरा दस्तावेज़ पढ़ें