Država: Velika Britanija
Jezik: engleski
Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)
Naratriptan hydrochloride
CST Pharma Ltd
N02CC02
Naratriptan hydrochloride
2.5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04070401; GTIN: 5055946800974
PATIENT INFORMATION LEAFLET NARAMIG® 2.5MG TABLETS (NARATRIPTAN HYDROCHLORIDE) Your tablets are available using the name Naramig 2.5mg tablets, but will be referred to as Naramig throughout this leaflet. 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 Naramig is and what it is used for 2. What you need to know before you take Naramig 3. How to take Naramig 4. Possible side effects 5. How to store Naramig 6. Contents of the pack and other information 1. WHAT NARAMIG IS AND WHAT IT IS USED FOR Naramig contains naratriptan (hydrochloride), which belongs to a group of medicines called triptans (_also known as 5-HT_ _1_ _ receptor _ _agonists_). NARAMIG IS USED TO TREAT MIGRAINE. Migraine symptoms may be caused by the temporary widening of blood vessels in the head. Naramig is believed to reduce the widening of these blood vessels. This in turn helps to take away the headache and relieve other symptoms of a migraine attack, such as feeling or being sick (nausea or vomiting) and sensitivity to light and sound. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NARAMIG DO NOT TAKE NARAMIG: IF YOU ARE ALLERGIC to naratriptan, or any of the other ingredients of this medicine (listed in section 6) IF YOU HAVE A HEART PROBLEM such as heart failure or chest pains (_angina_), or have already had a heart attack IF YOU HAVE CIRCULATION PROBLEMS IN YOUR LEGS that cause cramp- like pains when you walk (_peripheral vascular disease_) IF YOU HAVE HAD A STROKE or a mini-stroke (_also called a transient _ _ischaemic Pročitajte cijeli dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Naramig 2.5 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Tablets containing 2.5 mg of naratriptan as naratriptan hydrochloride. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablets 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Naramig Tablets are indicated for the acute treatment of migraine attacks with or without aura. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Naramig tablets should be taken as early as possible after the onset of a migraine headache but they are effective if taken at a later stage. Naramig Tablets are recommended as monotherapy for the acute treatment of a migraine attack. Naramig Tablets should not be used prophylactically. Posology Adults (18-65 years of age) The recommended dose of Naramig Tablets is a single 2.5mg tablet. The total dose should not exceed two 2.5mg tablets in any 24 hour period. If symptoms of migraine should recur, following an initial response, a second dose may be taken provided that there is a minimum interval of four hours between the two doses. If a patient does not respond to a first dose of Naramig Tablets a second dose should not be taken for the same attack, as it is unlikely to be of benefit. However Naramig Tablets may be used for subsequent migraine attacks. Adolescents (12-17 years of age) Efficacy of Naramig Tablets at single doses of 0.25, 1.0 and 2.5mg was not demonstrated to be greater than placebo in a placebo-controlled study in adolescents (12 to 17 years). Therefore, the use of Naramig Tablets in patients under 18 years of age is not recommended. Children (under 12 years of age) There are no data available on the use of naratriptan in children under 12 years of age therefore its use in this age group is not recommended. Elderly (over 65 years of age) The safety and effectiveness of naratriptan in individuals over age 65 have not been evaluated and therefore, its use in this age group can not be recommended. There is a moderate decreas Pročitajte cijeli dokument