País: Austrália
Língua: inglês
Origem: Department of Health (Therapeutic Goods Administration)
sumatriptan succinate, Quantity: 140 mg
Medis Pharma Pty Ltd
sumatriptan succinate
Tablet
Excipient Ingredients: lactose; croscarmellose sodium; colloidal anhydrous silica; microcrystalline cellulose; crospovidone; magnesium stearate; titanium dioxide; hypromellose; macrogol 400
Oral
2 tablets
(S4) Prescription Only Medicine
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.
Visual Identification: White coloured, capsule shaped, biconvex film-coated tablets debossed with"100" one side and plain on the other side which contain Sumatriptan (as succinate) 100 mg.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius
Licence status A
2010-06-18
SUMATRIPTAN-GA Sumatriptan succinate _CONSUMER MEDICINE INFORMATION _ 110113 Sumatriptan-GA CMI v1 Page 1 of 4 WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start taking Sumatriptan-GA tablets. This leaflet answers some common questions about Sumatriptan-GA tablets. It does not contain all of 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 expected benefits of you taking Sumatriptan-GA tablets against the risks this medicine could 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 SUMATRIPTAN-GA IS USED FOR Sumatriptan-GA tablets contain the active ingredient sumatriptan succinate. This medicine belongs to a group of drugs called serotonin agonists. Sumatriptan-GA tablets are used to relieve a migraine attack. They should not be used to prevent migraine attacks from occurring. Sumatriptan-GA tablets may be used for migraine headaches with or without what is known as 'aura'. It is thought that migraine headache is due to widening of certain blood vessels in the head. Sumatriptan-GA tablets work by making those vessels normal again and ease the symptoms of migraine. Your Sumatriptan-GA tablets do not work in other types of headache which are not a migraine. Sumatriptan-GA tablets are not addictive. BEFORE YOU TAKE SUMATRIPTAN-GA _WHEN YOU MUST NOT TAKE IT _ _ _ DO NOT TAKE SUMATRIPTAN-GA TABLETS IF: • YOU HAVE EVER HAD AN ALLERGIC REACTION TO SUMATRIPTAN SUCCINATE (SEE "SIDE-EFFECTS") OR ANY OF THE INGREDIENTS LISTED TOWARD THE END OF THIS LEAFLET. (SEE "INGREDIENTS"). • YOU HAVE OR HAVE HAD: - heart disease or heart attack - shortness of breath, pain or tightness in the chest, jaw or upper arm - peripheral vascular disease (pain in the back of the legs) or are prone to cold, tingling or numb hands and feet - Prinzmetal's angina (an uncommon form of angina w Leia o documento completo
SUMATRIPTAN-WT _PRODUCT INFORMATION _ Sumatriptan-WT PI v1.doc Page 1 of 11 NAME OF THE MEDICINE PROPRIETARY NAME: SUMATRIPTAN-WT TABLETS NON-PROPRIETARY NAME: Sumatriptan succinate CHEMICAL NAME: 3-[2-(dimethylamino) ethyl]-N-methyl-1H-indole-5-methane sulphonamide, butane-1,4-dioate (1:1). MOLECULAR FORMULA: C 14 H 21 N 3 O 2 SC 4 H 6 O 4 MOLECULAR WEIGHT: 413.5 CAS NUMBER: 103628-48-4 STRUCTURE: Sumatriptan succinate DESCRIPTION Sumatriptan succinate takes the form of a white to off-white powder. Sumatriptan-WT tablets contain the active sumatriptan succinate. The inactive ingredients are lactose, croscarmellose sodium, cellulose-microcrystalline, crospovidone, colloidal silicon dioxide, magnesium stearate, and Opadry White or Pink (depending on the colour contain - hypromellose, titanium dioxide, macrogol 400 , Iron oxide red CI77491, Iron oxide black CI77499). PHARMACOLOGY Sumatriptan has been demonstrated to be a specific vascular 5-hydroxytryptamine-1 (5HT 1 ) receptor agonist with no effect at other 5HT receptor (5HT 2 -5HT 7 ) subtypes. The vascular 5HT 1 receptor is found predominantly in cranial blood vessels and mediates vasoconstriction. In animals, sumatriptan selectively constricts the carotid arterial circulation, but does not alter cerebral blood flow. The carotid arterial circulation supplies blood to the extracranial and intracranial tissues such as the meninges, and dilatation and/or oedema formation in these vessels is thought to be the underlying mechanism of migraine in man. In addition, experimental evidence suggests that sumatriptan inhibits trigeminal nerve activity. Both these actions may contribute to the anti-migraine action of sumatriptan in humans. PHARMACOKINETICS: Population pharmacokinetic modelling indicated that clearance and volume of distribution both increase with body size in the adolescent population resulting in higher exposure in lower bodyweight adolescents. The model predicted that a subject with a body weight of 40 kg would have an apparent clearance of 222 L/h and a Leia o documento completo