Negara: Malaysia
Bahasa: Inggris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DESMOPRESSIN ACETATE
Ferring Sdn. Bhd.
DESMOPRESSIN ACETATE
30Tablet Tablets
Ferring International Center SA
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ MINIRIN ® TABLET Desmopressin Acetate (0.1mg, 0.2mg) 1 WHAT IS IN THIS LEAFLET : 1. What MINIRIN ® is used for 2. How MINIRIN ® works 3. Before you use MINIRIN ® 4. How to use MINIRIN ® 5. While you are using it 6. Side effects 7. Storage and Disposal of MINIRIN ® 8. Product Description 9. Product Registration Holder and Manufacturer 10. Date of revision WHAT MINIRIN ® IS USED FOR MINIRIN ® is used to treat: i. Central diabetes insipidus (disorder which leads to extreme thirst and large urine volumes). ii. Bedwetting in children from 5 years of age with normal ability to concentrate urine. iii. Nocturnal urgency (frequent urination during sleep) in adults. HOW MINIRIN ® WORKS Desmopressin acts as the natural hormone vasopressin and it regulates the kidneys ability to concentrate urine. BEFORE YOU USE MINIRIN ® _-When you must not use it _ Do not use MINIRIN ® if you have: • Urine production exceeding 40 ml/kg/24 hours; • Heart problems and other conditions that require treatment with diuretics (water pills); • Moderate and severe kidney problems; • Syndrome of inappropriate secretion of antidiuretics hormone (SIADH); • Low blood sodium level; • Hypersensitivity to Desmopressin or to any of the ingredients. _-Before you start to use it _ Before starting treatment with MINIRIN ® , you should check with your doctor, if you: - are 65 years or older, have low blood sodium levels or high 24-hour urine production. - have risk for increased pressure in the skull (e.g. systemic infections, fever, inflammation of the stomach and intestines). - have enlarged prostate. - have urinary tract infection. - have bladder stone/growth. - have excessive thirst. - have poorly controlled diabetes. When used for bedwetting and nocturnal urgency, the fluid intake to quench thirst must be limited to a minimum from 1 hour before until at least 8 hours after the intake of MINIRIN ® . MINIRIN ® should be used with caution when the fluid balance is disturbed. Consul Baca dokumen lengkapnya
(01 , 03 )-I-MY -01.0 1 according to SE SPC . Using SEA -01.01 template, over dosage -CCDS (MINTAB -10 -000 , MINTAB -13 -000 ), LAC : not required as confirmed by KTNI on 02 -Oct -2015 ; Drafted by JIWO 28 -Dec -16 MINIRIN ® Tablet 0.1 mg and 0.2 mg QUALITATIVE AND QUANTITATIVE COMPOSITION MINIRIN ® 0.1 m g: Each tablet contains desmopressin acetate 0.1 mg , corresponding to desmopressin (free base) 0.089 mg . MINIRIN ® 0.2 mg: Each tablet contains desmopressin acetate 0.2 mg , corresponding to desmopressin (free base) 0.178 mg. Excipients : Lactose monohydrate , p otato starch , p ovidone , m agnesium stearate . PHARMACEUTICAL FORM Tablet MINIRIN ® 0.1 mg : White, oval, convex tablet with a single score and marked “0.1 ” on one side . MINIRIN ® 0.2 mg: White, round, convex tablet with a single score and marked “0.2 ” on one side . The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. THERAPEUTIC INDICATIONS Central diabetes insip idus. The use of MINIRIN ® in patients with an established diagnosis will result in a reduction in urinary output with concomitant increase in urine osmolality and decrease in plasma osmolality. This will result in decreased urinary frequency and decreased nocturia. Primary nocturnal enuresis in children aged 5 years or more. Symptomatic treatment of nocturia in adults, associated with nocturnal polyuria, i.e. nocturnal urine production exceeding bladder capacity. POSOLOGY AND METHOD OF ADMINISTRATION Gen eral The dose of M INIRIN ® tablet s is individually adapted. Desmopressin should always be taken at the same time in relation to food intake , since f ood intake causes decreased absorption and by that also might influence the effect of desmopressin, see sect ion Interaction with other medicinal products and other forms of interaction . In the event of signs of water retention/hyponatraemia (headache, nausea/vomiting, weight gain, and in serious cases convulsions) the treatment should be temporarily interrupted until t Baca dokumen lengkapnya