Kraj: Nowa Zelandia
Język: angielski
Źródło: Medsafe (Medicines Safety Authority)
Domperidone maleate 12.72mg equivalent to domperidone 10 mg
PSM Healthcare Ltd trading as API Consumer Brands
10 mg
Tablet
Active: Domperidone maleate 12.72mg equivalent to domperidone 10 mg Excipient: Colloidal silicon dioxide Lactose monohydrate Magnesium stearate Maize starch Microcrystalline cellulose Povidone Purified water Sodium laurilsulfate
Prescription
Treatment of acute symptoms of nausea and vomiting.
Package - Contents - Shelf Life: Blister pack, PVC/Al - 25 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Al - 30 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Al - 100 tablets - 36 months from date of manufacture stored at or below 25°C
2017-08-17
Domperidone (Pharmacy Health) 10 mg tablets Consumer Medicine Information NZ - V2 February 2018 1 DOMPERIDONE (PHARMACY HEALTH) Domperidone (as maleate) 10 mg CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Domperidone. It does not contain all the available information. 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 Domperidone the benefits this medicine is expected to have for you. If you have any concerns about taking Domperidone ask your doctor or pharmacist. Keep this leaflet with your medicine. You may need to read it again. WHAT DOMPERIDONE IS USED FOR Domperidone is used to treat the following conditions in adults: • nausea and vomiting • discomfort caused by a slow moving stomach known as gastroparesis. Symptoms include not being able to finish a meal, a feeling of being “too full” or bloated after a meal, a loss of appetite, feeling sick and maybe vomiting, or belching without relief. Domperidone is an antiemetic and a prokinetic medicine. It works by blocking the action of a chemical messenger in the brain which causes the feeling of nausea and vomiting, as well as increasing the movement or contractions of the stomach and intestines, allowing food to move more easily through the stomach. There is insufficient evidence to support use of Domperidone in children reflux disease. Domperidone may not be suitable for chemotherapy or radiotherapy induced nausea and vomiting or vomiting after an operation. Your doctor may have prescribed Domperidone for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. BEFORE YOU TAKE DOMPERIDONE WHEN YOU MUST NOT TAKE IT Do not take Domperidone if: • you have an allergy to domperidone, or any of the ingredients. See Product Description at the end of this leaflet for a list of ingredients. • you have a tumour of the pituitary gland called prolact Przeczytaj cały dokument
NEW ZEALAND DATA SHEET New Zealand Data Sheet Page 1 of 13 DOMPERIDONE (PHARMACY HEALTH) 1. PRODUCT NAME Domperidone (Pharmacy Health) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Name and strength of the active substance domperidone maleate Ph. Eur (equivalent to 10 mg of domperidone) Excipient(s) with known effect For the full list of excipients, see section 6.1. Contains: Lactose. 3. PHARMACEUTICAL FORM Oral – tablet, uncoated Presentation Domperidone (Pharmacy Health) are: White round, biconvex, uncoated tablet with inscription “Dm 10’ on one side. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Adults and children aged 12 years and over (weighing ≥ 35 kg) Symptomatic treatment of the dyspeptic symptom complex that may be associated with delayed gastric emptying such as epigastric sense of fullness, abdominal distension or swelling, or epigastric pain or discomfort. Treatment of acute symptoms of nausea and vomiting. There is insufficient evidence to support the use of domperidone in childhood gastro‐ oesophageal reflux disease. Domperidone may not be suitable for chemotherapy‐ or radiotherapy‐induced nausea and vomiting or post‐operative nausea and vomiting . 4.2 Dose and method of administration General Domperidone (Pharmacy Health) should be taken 15‐30 minutes before meals and, if necessary, before going to bed at night. If taken after meals, absorption is somewhat delayed. NEW ZEALAND DATA SHEET New Zealand Data Sheet Page 2 of 13 DOMPERIDONE (PHARMACY HEALTH) Adults and children aged 12 years and older (weighing ≥ 35 kg) 1 tablet three to four times daily. The dose of domperidone should be the lowest effective dose for the individual situation (typically 30 mg/day). The dose may be increased, if necessary, to a maximum daily oral dose of 40 mg (1 tablet four times daily). Usually, the maximum treatment duration should not exceed one week for the treatment of acute nausea and vomiting. For other indications, the initial duration of treatment is up to four weeks. If treatment exceed Przeczytaj cały dokument