Nchi: Nyuzilandi
Lugha: Kiingereza
Chanzo: Medsafe (Medicines Safety Authority)
Melatonin 2mg;
Arrotex Pharmaceuticals (NZ) Limited
2 mg
Modified release tablet
Active: Melatonin 2mg Excipient: Calcium hydrogen phosphate dihydrate Colloidal silicon dioxide Lactose monohydrate Magnesium stearate Methacrylic acid copolymer Purified talc
Prescription
Indicated as a monotherapy for the short-term treatment of primary insomnia characterised by poor quality of sleep in patients aged 55 years and over.
Package - Contents - Shelf Life: Blister pack, Al/Al or PVC/PVDC/Al in outer cardboard carton - 7 tablets - 36 months from date of manufacture stored at or below 25°C protect from light - Blister pack, Al/Al in outer cardboard carton - 15 tablets - 36 months from date of manufacture stored at or below 25°C protect from light - Blister pack, Al/Al or PVC/PVDC/Al in outer cardboard carton - 21 tablets - 36 months from date of manufacture stored at or below 25°C protect from light - Blister pack, Al/Al or PVC/PVDC/Al in outer cardboard carton - 30 tablets - 36 months from date of manufacture stored at or below 25°C protect from light - Blister pack, Al/Al in outer cardboard carton - 42 tablets - 36 months from date of manufacture stored at or below 25°C protect from light - Blister pack, Al/Al in outer cardboard carton - 60 tablets - 36 months from date of manufacture stored at or below 25°C protect from light - Blister pack, Al/Al in outer cardboard carton - 90 tablets - 36 months from date of manufacture stored at or below 25°C protect from light
2018-11-26
MELOTIN PROLONGED RELEASE TABLET _Melatonin _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet contains answers to some common questions about MELATONIN. IT IS PARTICULARLY IMPORTANT THAT YOU READ THE SECTIONS "WHEN TO TAKE IT" AND "HOW TO TAKE IT" BEFORE YOU TAKE THIS MEDICINE. The leaflet does not contain all the information that is known about MELATONIN. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking MELATONIN against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT MELATONIN IS USED FOR MELATONIN is used to improve sleep quality and morning alertness in patients over 55 years of age with poor quality of sleep. The active substance of MELATONIN, melatonin (not of plant or animal origin), belongs to a group of naturally occurring hormones produced in the body._ _ Melatonin works by controlling the circadian rhythms and increasing the propensity to sleep. Your doctor, however, may prescribe MELATONIN for another purpose. ASK YOUR DOCTOR OR PHARMACIST IF YOU HAVE ANY QUESTIONS ABOUT WHY IT HAS BEEN PRESCRIBED FOR YOU. This medicine is only available with a doctor’s prescription. MELATONIN is not addictive. BEFORE YOU USE MELATONIN _WHEN YOU MUST NOT USE IT _ Do not take MELATONIN if you are allergic to it or any of the ingredients listed at the end of this leaflet. Symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing, swelling of the face, lips, tongue or other parts of the body, or rash, itching or hives on the skin. Do not take MELATONIN if you have been drinking alcohol or intend to drink alcohol or believe that you may have alcohol, in your blood stream. Do not take MELATONIN if you are pregnant or breast-feeding. MELATONIN has not been studied in pregnant or breast-feeding women. DO NO Soma hati kamili
1 NEW ZEALAND DATA SHEET 1 PRODUCT NAME Melotin 2mg Prolonged Release Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2mg of melatonin. Melotin contains lactose monohydrate. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Melotin 2 mg prolonged release tablets: White to off-white, round, biconvex tablets 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Monotherapy for the short-term treatment of primary insomnia characterized by poor quality of sleep in patients who are aged 55 or over. 4.2 D OSE AND METHOD OF ADMINISTRATION Oral use. Tablets should be swallowed whole. The recommended dose is 2 mg once daily, 1 - 2 hours before bedtime and after food. This dosage may be continued for up to thirteen weeks. PAEDIATRIC USE Melatonin is not recommended for use in children and adolescents below 18 years of age due to insufficient data on safety and efficacy. RENAL INSUFFICIENCY The effect of any stage of renal insufficiency on melatonin pharmacokinetics has not been studied. Caution should be used when melatonin is administered to such patients. HEPATIC IMPAIRMENT There is no experience of the use of Melatonin in patients with liver impairment. Published data demonstrates markedly elevated endogenous melatonin levels during daytime hours due to decreased clearance in patients with hepatic impairment. Therefore, Melatonin is not recommended for use in patients with hepatic impairment. 4.3 C ONTRAINDICATIONS Melatonin prolonged release tablets are contraindicated in patients with a known hypersensitivity to any ingredient of the product (see section 6.1 List of Excipients). 2 4.4 S PECIAL WARNINGS AND PRECAUTIONS FOR USE DROWSINESS Melatonin may cause drowsiness. Therefore, the product should be used with caution if the effects of drowsiness are likely to be associated with a risk to safety. AUTOIMMUNE DISEASES No clinical data exist concerning the use of Melatonin in individuals with autoimmune diseases. Therefore, Melatonin is not recommended for us Soma hati kamili