Ország: Ausztrália
Nyelv: angol
Forrás: Department of Health (Therapeutic Goods Administration)
sumatriptan succinate
Apotex Pty Ltd
sumatriptan succinate
Registered
CHEMMART SUMATRIPTAN _Sumatriptan succinate_ CONSUMER MEDICINE INFORMATION FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 WHAT IS IN THIS LEAFLET This leaflet answers some common questions about sumatriptan. 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 this medicine 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 want to read it again. WHAT THIS MEDICINE IS USED FOR Sumatriptan is used to relieve a migraine attack. This medicine may be used for migraine headaches with or without what is known as 'aura'. Sumatriptan belongs to a group of drugs called serotonin agonists. _HOW IT WORKS_ It is thought that a migraine headache is due to widening of certain blood vessels in the head. Sumatriptan works by narrowing the affected vessels, to ease the symptoms of migraine. This medicine does not work in other types of headache which are not a migraine. It should not be used to prevent migraine attacks from occurring. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed this medicine for another reason. This medicine is available only with a doctor's prescription. This medicine is not addictive. The effectiveness of this medicine has not been established in adolescents between 12 and 17; and the safety and effectiveness of this medicine in children under the age of 12 years has not been established. Sumatriptan is not recommended for use in people aged over 65 years. BEFORE YOU TAKE THIS MEDICINE _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE THIS MEDICINE IF YOU HAVE AN ALLERGY TO: • sumatriptan succinate • any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezin Olvassa el a teljes dokumentumot
1 AUSTRALIAN PRODUCT INFORMATION –CHEMMART SUMATRIPTAN, (SUMATRIPTAN SUCCINATE) TABLETS 1 NAME OF THE MEDICINE Sumatriptan succinate. 2 AND 3 QUALITATIVE AND QUANTITATIVE COMPOSITION AND PHARMACEUTICAL FORM Each tablet contains 50 mg sumatriptan (as succinate), as the active ingredient. In addition, each tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, crospovidone, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate and Opadry 03B84755 Pink (50 mg) or Opadry 03B28796 White (100 mg) as coating material. The coating material contains hypromellose, titanium dioxide, polyethylene glycol, iron oxide red (50 mg only) and iron oxide black (50 mg only). Chemmart Sumatriptan tablets are intended for oral administration. Each tablet contains 50 mg or 100 mg sumatriptan (as succinate), as the active ingredient. 50 mg Tablets: Pink coloured, capsule shaped, biconvex film coated tablets, debossed with “50” on one side and plain on the other side. 100 mg Tablets: White coloured, capsule shaped, biconvex film coated tablets debossed with “100” on one side and plain on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Sumatriptan tablets are indicated for the acute relief of migraine attacks with or without aura. There is no information available on the use of Sumatriptan tablets in the treatment of basilar or hemiplegic migraine. 4.2 DOSE AND METHOD OF ADMINISTRATION Sumatriptan is indicated for the acute intermittent relief of both migraine and cluster headache. It should not be used prophylactically. Ergotamine or ergotamine derivatives and sumatriptan should not be administered concurrently (see SECTION 4.3 - CONTRAINDICATIONS). MIGRAINE It is recommended to start the treatment at the first sign of a migraine headache or associated symptoms such as nausea, vomiting or photophobia. The efficacy of sumatriptan is 2 independent of the duration of the attack when starting treatment. Administration during a migraine aura prior to oth Olvassa el a teljes dokumentumot