Naratriptan 2.5 Mg Film-Coated Tablets
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Naratriptan 2.5 mg film-coated tablets
naratriptan
Read all of this leaflet carefully before you start taking this medicine
■ 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours
■ If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet
1 .What Naratriptan film-coated tablets are and what they are used for
2. Before you take Naratriptan film-coated tablets
3. How to take Naratriptan film-coated tablets
4. Possible side effects
5. How to store Naratriptan film-coated tablets
6. Further information
1. WHAT NARATRIPTAN FILM-COATED TABLETS ARE AND WHAT THEY ARE USED FOR
These tablets contain naratriptan (as hydrochloride), which belongs to a group of medicines called triptans (also known as 5-HT1 receptor agonists).
These tablets are used to treat migraine.
Migraine symptoms are likely to be caused by the temporary swelling of blood vessels in the head.
These tablets are believed to work by reducing the size of these blood vessels. This in turn will help to relieve headache and other symptoms of a migraine attack, such as nausea and vomiting or sensitivity to light and sound.
These tablets should not be used prophylactically.
2. BEFORE YOU TAKE NARATRIPTAN FILM-COATED TABLETS
Do not take Naratriptan film-coated tablets:
■ if you are allergic (hypersensitive) to naratriptan or any of the other ingredients of these tablets (for a full list see section 6)
■ if you have heart problems, such as obstruction of blood vessels (ischemic heart disease) or chest pain (angina) or have had a heart attack
■ if you have circulatory problems in the legs that cause cramp-like symptoms when you walk (peripheral blood circulation problem)
■ if you have had a stroke or transient ischemic attack (TIA)
■ if you have high blood pressure. You may be able to take these tablets if your blood pressure is only slightly elevated and you receive medication for it
■ if you have severe kidney disease or severe liver disease
■ with other migraine medications, ergotamine containing drugs or similar drugs, such as methysergide, or with other triptans or another 5-HT1 -receptor agonist.
If any of the above apply to you please tell your doctor and do not take these tablets.
Take special care with Naratriptan film-coated tablets
Before taking these tablets, your doctor should know certain things.
In some rare cases patients have developed severe heart disease after taking these tablets, even if they have not previously had any symptoms of heart disease.
If any of the following applies to you, you might have a higher risk of a heart disease. Tell your doctor, so that your heart condition may be evaluated before you are prescribed these tablets if you:
■ smoke a lot or you are using nicotine replacement therapy, especially if you
■ are a man over 40 years of age
■ are a post-menopausal woman Also tell your doctor:
■ If you are allergic to antibiotics known as sulfonamides. If you are allergic to sulfonamides, you may also be allergic to these tablets.
■ If you know you are allergic to some antibiotic but are not sure if it is a sulfonamide
■ If you are taking a medication for depression that belongs to the medicinal groups called SSRI (selective serotonin reuptake inhibitors) or SNRI (serotonin norepinephrine reuptake inhibitor).
Taking Naratriptan film-coated tablets too often can worsen your headaches.
Tell your doctor if this applies to you. Your doctor may recommend that you stop taking these tablets. If you experience pain or pressing sensation in your chest after taking Naratriptan film-coated tablets
These effects can be severe, but usually resolve quickly. If they do not go away quickly or if the symptoms become serious, contact your doctor immediately. For more information on possible side effects, see section 4.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Some medicines should not be taken at the same time as these tablets, and some may cause side effects if taken together with these tablets.
Tell your doctor, if you are taking:
■ any triptan, e.g. 5-HT1-receptor agonist, which is used to treat migraine. Do not take Naratriptan film-coated tablets with these medicines. Do not take these medicines again until at least 24 hours after taking Naratriptan film-coated tablets.
■ any medicines for your migraine which contain ergotamine or similar medicines, such as methysergide. Do not take Naratriptan film-coated tablets with these medicines.You should stop taking them at least 24 hours before taking Naratriptan film-coated tablets. Do not take them again for at least 24 hours after taking Naratriptan film-coated tablets.
■ medications for depression that belong to the SSRI (Serotonin reuptake Inhibitors) or SNRI (serotonin norepinephrine reuptake inhibitor) groups. Taking Naratriptan film-coated tablets with these medicines can cause dizziness, weakness and/or problems with coordination.
Tell your doctor immediately if you experience these symptoms.
■ St John’s Wort (hypericum perforatum).
Taking herbal remedies containing St John's Wort together with Naratriptan film-coated tablets may increase the likelihood of suffering side effects.
Pregnancy and breast-feeding
■ If you are pregnant or may be pregnant, consult your doctor before taking Naratriptan film-coated tablets. Your doctor will decide if you should take these tablets during pregnancy
■ Do not breast-feed for 24 hours after taking Naratriptan film-coated tablets. If any milk is produced during this time period, discard the milk and do not give it to your child.
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE NARATRIPTAN FILM-COATED TABLETS
Driving and using machines
Either the symptoms of migraine or the medicines for it may make you feel tired or dizzy. If you feel tired or dizzy, do not drive or operate machinery.
Important information about some of the ingredients of Naratriptan film-coated tablets
These tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. HOW TO TAKE NARATRIPTAN FILM-COATED TABLETS
Only take these tablets when the migraine headache has already started.
Do not take these tablets to try to prevent a migraine attack.
Always take these tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Dosage
The usual dose for adults of 18 - 65 years of age is a single 2.5mg tablet.
These tablets are not recommended for children under 18 years of age or adults over 65 years of age.
Method of administration:
Oral use.
These tablets should be swallowed whole with water, without chewing.
When to take Naratriptan film-coated tablets
It is best to take these tablets at the first sign of a migraine attack, although they can be taken at any stage of the attack.
If your symptoms begin to come back
You may take a second tablet after four hours.
Do not take more than two tablets within 24 hours.
If you have kidney or liver disease, do not take more than one tablet in any 24-hour period.
If the first tablet is not effective
Do not take another tablet to treat the same attack. If these tablets do not help at all contact your doctor or pharmacist.
If you take more Naratriptan film-coated tablets than you should
Do not take more than two tablets in any 24-hour period.
Taking too many tablets could make you ill. If you have taken more than two tablets in any 24-hour period contact your doctor as soon as possible.
If you have any further questions on the use of this product, ask your doctor or pharmacist
Like all medicines, these tablets can cause side effects, although not everybody gets them.
Allergic reaction (affects 1 to 10 users in 10,000): if you experience any of the below side effects contact your doctor immediately:
rash, wheeziness of lungs, swelling of eyelids, face or lips, unconsciousness.
Common side effects
(affects 1 to 10 users in 100)
■ Nausea or vomiting, although these may occur due to the migraine attack itself.
■ Fatigue, drowsiness or general malaise.
■ Dizziness, tingling sensation or hot flashes. Uncommon side effects
(affects 1 to 10 users in 1,000)
■ Feeling of heaviness, pressure, tightness or pain in the chest or throat or anywhere else in the body. Although sometimes very strong, these effects usually do not last for very long
■ If these symptoms persist or become severe (especially chest pain) contact your doctor immediately. In a very small portion of people these may be symptoms of a heart attack.
Other uncommon side effects include:
■ Visual disturbances (although these may occur due to the migraine attack itself),
■ changes in heart rhythm or slight elevation of blood pressure, which may last up to 12 hours after taking these tablets.
Rare side effects
(affects 1 to 10 users in 10,000)
■ Lower left-side abdominal pain and bloody diarrhoea (ischemic colitis)
Very rare side effects (affects less than 1 user in 10,000)
■ heart problems, including chest pain (angina) and heart attack.
■ poor blood circulation in hands and legs, causing pain and discomfort
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Keep out of the reach and sight of children.
Do not use these tablets after the expiry date that is stated on the blister, on the bottle and on the carton. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Naratriptan film-coated tablets contain
■ The active substance is naratriptan
Each film-coated tablet contains 2.5mg naratriptan (as naratriptan hydrochloride)
The other ingredients are:
■ tablet core: Microcrystalline Cellulose, Lactose Anhydrous, Croscarmellose Sodium and Magnesium Stearate;
■ tablet coating: Hypromellose, Titanium oxide (E171), Triacetin, Iron Oxide Yellow (E172), Indigo Carmine aluminium lake (E132).
What Naratriptan film-coated tablets look like and contents of the pack
The tablets are Green ‘D’ shaped, biconvex, film-coated tablets debossed with ‘U54’ on one side and plain on the other side. They are available in blisters of 2, 3, 4, 6, 12 and 18 film-coated tablets and HDPE bottles of 30 and 500 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
USV Europe Limited
The Podium, 1 Eversholt Street, Euston
London NW1 2DN
United Kingdom
Manufacturer
Accord Healthcare Limited
Sage House, 319 Pinner Road, North Harlow
Middlesex HA1 4HF
United Kingdom
Distributed by:
Aspire Pharma Limited Antrobus House Business Centre 18 College Street, Petersfield Hampshire GU31 4AD United Kingdom
3009672 10/11
This leaflet was last approved in 01/2012 1010190/P1.7