Land: Storbritannien
Sprog: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Zolmitriptan
Viatris UK Healthcare Ltd
N02CC03
Zolmitriptan
5mg
Orodispersible tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04070401; GTIN: 5016695004563
PAGE 1 OF 6 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ZOLMITRIPTAN 2.5 MG ORODISPERSIBLE TABLETS ZOLMITRIPTAN 5 MG ORODISPERSIBLE TABLETS 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 Zolmitriptan is and what it is used for 2. What you need to know before you take Zolmitriptan 3. How to take Zolmitriptan 4. Possible side effects 5. How to store Zolmitriptan 6. Contents of the pack and other information 1. WHAT ZOLMITRIPTAN IS AND WHAT IT IS USED FOR Zolmitriptan contains zolmitriptan, which belongs to a group of medicines called triptans. ZOLMITRIPTAN IS USED TO TREAT MIGRAINE HEADACHE. Migraine symptoms may be caused by the widening of blood vessels in the head. Zolmitriptan 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. Zolmitriptan works only when a migraine attack has started. You should not take Zolmitriptan to prevent migraines occuring. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZOLMITRIPTAN DO NOT TAKE ZOLMITRIPTAN: - if you are allergic to zolmitriptan 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 uncontrolled high blood pressure. - if you have or have had heart disease, a heart attack, or symptoms or signs of coronary heart disease, or angina (chest pain as a result of lack of oxygen in the heart muscle). - Læs hele dokumentet
OBJECT 1 ZOLMITRIPTAN 5 MG ORODISPERSIBLE TABLETS Summary of Product Characteristics Updated 06-Sep-2017 | Generics UK T/A Mylan 1. Name of the medicinal product Zolmitriptan 2.5 mg Orodispersible tablets Zolmitriptan 5 mg Orodispersible tablets 2. Qualitative and quantitative composition Each orodispersible tablet contains 2.5 mg zolmitriptan Each orodispersible tablet contains 5 mg zolmitriptan. Excipient with known effect: Each orodispersible tablet contains 5 mg aspartame. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Orodispersible Tablet White to off-white, round, flat faced bevelled edged orodispersible tablet of 6.5 mm diameter debossed with “M” on one side and “ZT1” on the other side. White to off-white, round, flat faced bevelled edged tablet of 6.5 mm diameter debossed with “M” on one side and “ZT3” on the other side. 4. Clinical particulars 4.1 Therapeutic indications Acute treatment of migraine headache with or without aura. Zolmitriptan is not indicated for prophylaxis of migraine. 4.2 Posology and method of administration Posology The recommended dose of Zolmitriptan to treat a migraine attack is 2.5 mg. It is advisable that zolmitriptan is taken as early as possible after the onset of migraine headache but it is also effective if taken at a later stage. If symptoms of migraine should recur within 24 hours following an initial response, a second dose may be taken. If a second dose is required, it should not be taken within 2 hours of the initial dose. If a patient does not respond to the first dose, it is unlikely that a second dose will be of benefit in the same attack. If a patient does not achieve satisfactory relief with 2.5 mg doses, for subsequent attacks 5 mg doses of zolmitriptan could be considered. Caution is advised due to an increased incidence of side effects. A controlled clinical study failed to demonstrate superiority of the 5 mg dose over the 2.5 mg dose. Nevertheless a 5 mg dose may be of benefit in some patients. The total daily intake s Læs hele dokumentet