Страна: Великобритания
Язык: английский
Источник: MHRA (Medicines & Healthcare Products Regulatory Agency)
Frovatriptan succinate monohydrate
Viatris UK Healthcare Ltd
N02CC07
Frovatriptan succinate monohydrate
2.5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04070401; GTIN: 5016695006789
1 PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT MYLATRIP 2.5 MG FILM-COATED TABLETS frovatriptan READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Mylatrip is and what it is used for 2. What you need to know before you take Mylatrip 3. How to take Mylatrip 4. Possible side effects 5. How to store Mylatrip 6. Contents of the pack and other information 1. WHAT MYLATRIP IS AND WHAT IT IS USED FOR Mylatrip contains the active ingredient frovatriptan which belongs to a group of medicines called triptans. Mylatrip is used to treat migraine headache in adults. Migraine symptoms may be caused by the widening of blood vessels in the head. Mylatrip is thought to reduce the widening of these blood vessels. This helps to take away the headache and other symptoms of a migraine attack, such as feeling or being sick (nausea or vomiting) and being sensitive to light and sound. Mylatrip works only when a migraine headache has started. You should not take Mylatrip to prevent migraines occuring. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MYLATRIP DO NOT TAKE MYLATRIP - if you are allergic to frovatriptan or any of the other ingredients of this medicine (listed in section 6). - if you have moderately high or very high blood pressure or mild high blood pressure that is not being treated. - if you have or have had heart disease, a heart attack, angina (chest pain as a result of lack of oxygen in the heart muscle) or other signs of coronary heart disease such as breathlessness, extreme tiredness or Прочитать полный документ
OBJECT 1 MYLATRIP 2.5 MG FILM-COATED TABLETS Summary of Product Characteristics Updated 25-Sep-2017 | Generics UK T/A Mylan 1. Name of the medicinal product Mylatrip 2.5 mg film-coated tablets 2. Qualitative and quantitative composition Each film-coated tablet contains 2.5 mg frovatriptan as frovatriptan succinate monohydrate. Excipient with known effect: Each film-coated tablet contains 107.09 mg lactose. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Film-coated tablet White to off white, film-coated, round, biconvex tablet debossed with “M” on one side of the tablet “FR” over “2.5” on the other side. 4. Clinical particulars 4.1 Therapeutic indications Acute treatment of the headache phase of migraine attacks with or without aura. Frovatriptan is indicated in adults. 4.2 Posology and method of administration Posology Frovatriptan should be taken as early as possible after the onset of a migraine attack but it is also effective when taken at a later stage. Frovatriptan should not be used prophylactically. If a patient does not respond to the first dose of frovatriptan, a second dose should not be taken for the same attack, since no benefit has been shown. Frovatriptan may be used for subsequent migraine attacks. _Adults (18 to 65 years of age)_ The recommended dose of frovatriptan is 2.5 mg. If the migraine recurs after initial relief, a second dose may be taken, providing there is an interval of at least 2 hours between the two doses. The total daily dose should not exceed 5 mg per day. _Paediatric population_ (under 18 years) The safety and efficacy of frovatriptan in children and adolescents below the age of 18 years have not been established. Therefore, its use in this age group is not recommended. No data are available. _Older people (over 65 years)_ Frovatriptan data in patients over 65 years remain limited. Therefore, its use in this category of patients is not recommended. _Renal impairment_ No dosage adjustment is required in patients with renal impairment (see sect Прочитать полный документ