Država: Avstralija
Jezik: angleščina
Source: Department of Health (Therapeutic Goods Administration)
sumatriptan succinate, Quantity: 139.98 mg
Accord Healthcare Pty Ltd
sumatriptan succinate
Tablet, film coated
Excipient Ingredients: croscarmellose sodium; hypromellose; microcrystalline cellulose; lactose monohydrate; magnesium stearate; titanium dioxide
Oral
2 tablets
(S4) Prescription Only Medicine
SUMATRIP Tablets are indicated for the acute relief of migraine attacks with or without aura.
Visual Identification: White to off-white, capsule shaped, biconvex, film coated tablet plain on both sides.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2012-05-11
SUMATRIPTAN SANDOZ ® 1 Sumatriptan Sandoz ® Sumatriptan Succinate Film-Coated Tablets Consumer Medicine Information What Is In This Leaflet Please read this leaflet carefully before you start taking Sumatriptan Sandoz tablets. This leaflet answers some common questions about Sumatriptan Sandoz 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 Sandoz 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 are Sumatriptan Sandoz tablets used for? Sumatriptan Sandoz tablets contain the active ingredient sumatriptan succinate. This medicine belongs to a group of drugs called serotonin agonists. Sumatriptan Sandoz tablets are used to relieve a migraine attack. They should not be used to prevent migraine attacks from occurring. Sumatriptan Sandoz 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 Sandoz tablets work by making those vessels normal again and ease the symptoms of migraine. Your Sumatriptan Sandoz tablets do not work in other types of headache which are not a migraine. Sumatriptan Sandoz tablets are not addictive. Before you take Sumatriptan Sandoz tablets Do not take if: You must not take Sumatriptan Sandoz 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 n Preberite celoten dokument
1 AUSTRALIAN PRODUCT INFORMATION – SUMATRIPTAN SANDOZ 50 & 100 MG (SUMATRIPTAN SUCCINATE) FILM-COATED TABLETS 1 NAME OF THE MEDICINE Sumatriptan succinate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Sumatriptan Sandoz is available in two strengths, 50mg and 100mg" List of excipients with known effects: sugars as lactose. For the full list of excipients, see section _6.1 LIST OF EXCIPIENTS_. 3 PHARMACEUTICAL FORM Sumatriptan Sandoz _50 MG (AUST R 187214) _ Each film-coated tablet contains Sumatriptan succinate equivalent to 50 mg Sumatriptan. Pink coloured, capsule shaped biconvex film coated tablets, plain on both sides. Sumatriptan Sandoz _100 MG (AUST R 187215) _ Each film-coated tablet contains Sumatriptan succinate equivalent to 100 mg Sumatriptan. White to off-white coloured, capsule shaped biconvex film coated tablets, plain on both sides. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Sumatriptan Sandoz is indicated for the acute relief of migraine attacks with or without aura. 4.2 D OSE AND METHOD OF ADMINISTRATION Sumatriptan is indicated for the acute intermittent relief of both migraine and cluster headache. It should not be used prophylactically. MIGRAINE It is recommended that treatment be started at the first sign of a migraine headache or associated symptoms such as nausea, vomiting or photophobia. The efficacy of Sumatriptan is independent of the duration of the attack when starting treatment. Administration during a migraine aura prior to other symptoms occurring may not prevent the development of a headache. If a patient does not respond to the first dose of Sumatriptan, a second dose should not be taken for the same attack. Sumatriptan may be used for subsequent attacks. The initial recommended adult dose of Sumatriptan is 50 mg. Some patients may require 100 mg. The dose should be adjusted according to the individual's response. If symptoms recur further doses may be given in the next 24 hours provided not more than 300 mg are taken in any 24 hour period. The tablet should be swallowed w Preberite celoten dokument