Country: Ástralía
Tungumál: enska
Heimild: Department of Health (Therapeutic Goods Administration)
eletriptan hydrobromide, Quantity: 48.485 mg (Equivalent: eletriptan, Qty 40 mg)
Viatris Pty Ltd
Tablet, film coated
Excipient Ingredients: lactose monohydrate; magnesium stearate; microcrystalline cellulose; croscarmellose sodium; titanium dioxide; hypromellose; sunset yellow FCF; triacetin
Oral
2 tablets
(S3) Pharmacist Only Medicine
For the acute relief of migraine in patients who have a stable, well-established pattern of symptoms.
Visual Identification: Orange, round, convex, film-coated tablet, engraved with "VLE" on one side and "REP40" on the other.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2020-12-16
RELPAX ® MIGRAINE R e l p a x ® M i g r a i n e CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your pharmacist or doctor. 1. WHY AM I USING RELPAX ® MIGRAINE? Relpax ® Migraine contains the active ingredient eletriptan hydrobromide. Relpax ® Migraine is used to treat migraine attacks. For more information, see Section 1. Why am I using Relpax® Migraine? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE RELPAX ® MIGRAINE? Do not use if you have ever had an allergic reaction to eletriptan hydrobromide or any of the ingredients listed at the end of the CMI. TALK TO YOUR PHARMACIST OR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use Relpax® Migraine? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Relpax ® Migraine and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE RELPAX ® MIGRAINE? • Always take as directed by your pharmacist or doctor • One tablet of Relpax ® Migraine should be taken as soon as possible after the start of a migraine attack. It will also provide relief later during the migraine; if required, a second dose may be taken. More instructions can be found in Section 4. How do I use Relpax® Migraine? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING RELPAX ® MIGRAINE? THINGS YOU SHOULD DO • Remind any pharmacist, doctor or dentist you visit that you are using Relpax ® Migraine. • Call your doctor straight away if o you become pregnant o your migraine headache lasts for longer than 24 hours. o your pattern of symptoms has changed. o you feel this headache is different or worse than your usual migraine e.g. more frequent, more persistent, more severe, or you don’t recover between attacks. THINGS YO Lestu allt skjalið
Version: ujprelmi10722 Supersedes: ujprelmi10221 Page 1 of 19 AUSTRALIAN PRODUCT INFORMATION - RELPAX ® MIGRAINE (ELETRIPTAN HYDROBROMIDE) 1. NAME OF THE MEDICINE Eletriptan hydrobromide 2. QUALITATIVE AND QUANTITATIVE COMPOSITION RELPAX MIGRAINE 40 mg tablets contain eletriptan hydrobromide equivalent to 40 mg eletriptan. _ _ EXCIPIENT(S) WITH KNOWN EFFECT Each RELPAX MIGRAINE tablet contains sugars as lactose (monohydrate). For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM RELPAX MIGRAINE 40 mg tablets are orange, round, convex, film-coated tablets, with “Pfizer” on one side and “REP40” on the other side. _ _ 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the acute relief of migraine in patients who have a stable, well-established pattern of symptoms. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE _ADULTS (18-65 YEARS OF AGE) _ In controlled clinical trials, single doses of 20 mg, 40 mg and 80 mg were effective for the acute treatment of migraine in adults. A greater proportion of patients had a response following a 40 mg or 80 mg dose than following a 20 mg dose. The recommended initial dose is 40 mg. The maximum single dose is 40 mg. If the initial dose of RELPAX MIGRAINE 40 mg is ineffective, controlled clinical trials have not shown a benefit of a second dose to treat the same attack. However, if the headache returns following initial improvement, there is evidence to suggest that a repeat dose of 40 mg may be beneficial. If a second dose is required, it should not be taken within 2 hours of the initial dose. Version: ujprelmi10722 Supersedes: ujprelmi10221 Page 2 of 19 The maximum daily dose should not exceed 80 mg. METHOD OF ADMINISTRATION Oral administration. RELPAX MIGRAINE 40 mg tablet should be taken as early as possible after the onset of migraine headache, but they are also effective if taken at a later stage. RELPAX MIGRAINE tablets should not be used prophylactically. The tablets should be swallowed whole with water. DOSAGE ADJUSTMENT _HEPA Lestu allt skjalið