Land: Nieuw-Zeeland
Taal: Engels
Bron: Medsafe (Medicines Safety Authority)
Caffeine 100mg (anhydrous); Ergotamine tartrate 1mg; ;
AFT Pharmaceuticals Ltd
Caffeine 100 mg (anhydrous)
100 mg/1 mg
Tablet
Active: Caffeine 100mg (anhydrous) Ergotamine tartrate 1mg Excipient: Iron oxide yellow Magnesium stearate Microcrystalline cellulose Purified talc Starch Tartaric acid
Bottle, glass, 100-tablet amber glass, 100 tablets
Prescription
Prescription
Siegfried PharmaChemikalien Minden GmbH
Treatment of acute attacks of migraine with or without aura in adults.
Package - Contents - Shelf Life: Bottle, glass, Amber glass - 100 tablets - 24 months from date of manufacture stored at or below 25°C
1969-12-31
CAFERGOT ERGOTAMINE TARTRATE 1 MG AND CAFFEINE 100 MG TABLETS WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start taking Cafergot. This leaflet answers some common questions about Cafergot tablets 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 using Cafergot against the benefits it can provide. IF YOU HAVE ANY CONCERNS ABOUT CAFERGOT, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT CAFERGOT IS USED FOR CAFERGOT IS USED TO TREAT ATTACKS OF MIGRAINE WITH OR WITHOUT AURA. These headaches are thought to be caused by temporary changes in the size of small blood vessels in the brain. These blood vessels swell, causing the pain and visual disturbances that often happen during an attack. Cafergot stops the attack by causing the blood vessels to constrict (shrink) back to normal size. Cafergot is only taken to treat migraine attacks. It is not taken to prevent attacks from happening. There are some types of headaches which must not be treated with Cafergot. Your doctor will determine the best treatment for your headache. Cafergot tablets contain the active ingredients, ergotamine tartrate and caffeine. Ergotamine belongs to a group of medicines known as the "ergot alkaloids." Caffeine helps ergotamine work better and faster by increasing its absorption into the body. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY CAFERGOT HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed Cafergot for another reason. Cafergot is only available with a doctor's prescription. There is not enough information to recommend this medicine for children under 6 years of age. BEFORE YOU TAKE CAFERGOT _WHEN YOU MUST NOT TAKE CAFERGOT_ _ _ DO NOT TAKE CAFERGOT IF YOU HAVE EVER HAD AN ALLERGIC REACTION TO ANY OF THE FOLLOWING: • ergotamine or caffeine, the active ingredients in Cafergot tablets • any of th Lees het volledige document
NEW ZEALAND DATA SHEET 1 CAFERGOT (ERGOTAMINE TARTRATE 1 MG AND CAFFEINE 100 MG TABLET) CAFERGOT ergotamine tartrate 1 mg and caffeine 100 mg tablet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Ergotamine tartrate 1 mg and Caffeine 100 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cafergot tablets are round, flat with bevelled edge, 9 mm diameter, speckled yellow/white, inscribed with a breakline and XL on one side and plain on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of acute attacks of migraine with or without aura in adults. 4.2 DOSE AND METHOD OF ADMINISTRATION Cafergot should be given at the first signs of a migraine attack. DOSE ADULTS _FIRST ATTACK_ : The first time Cafergot is taken, an initial dose of 2 Cafergot tablets orally, is recommended. If relief is not obtained within half an hour, a further tablet should be administered; this may be repeated at half-hourly intervals, but the maximum daily dose of 6 tablets should not be exceeded. _ _ _SUBSEQUENT ATTACKS:_ If the pain persists, take 1 tablet every half an hour up to the maximum daily dose of 6 tablets. The maximum weekly dose is 10 tablets. CHILDREN UNDER 18 YEARS Not recommended. MAXIMUM DOSE PER ATTACK OR PER DAY Adults: 6 mg ergotamine tartrate = 6 tablets. MAXIMUM WEEKLY DOSE Adults: 10 mg ergotamine tartrate = 10 tablets. SPECIAL POPULATIONS _Renal impairment_ Cafergot is contraindicated in patients with severe renal impairment (see Contraindications). _Hepatic impairment_ Cafergot is contraindicated in patients with severe hepatic impairment (see Contraindications). Patients with mild to moderate hepatic impairment, especially patients with cholestasis, should be appropriately monitored (see Warnings and Precautions). _Pediatrics_ Cafergot is not recommended in children and adolescents under the age of 18 years. Safety and efficacy have not been established in pediatric patients. _Geriatrics_ Cafergot is not recommended for patients aged over 65 years. No studies have been perfo Lees het volledige document