Naratriptan 2.5mg Film-Coated Tablets
Out of date information, search anotherRead all of this leaflet carefully before you start taking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 foryou. 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 get serious (see section 4), or it you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet
1. What Naratriptan tablets are and what they are used for
2. Before you take Naratriptan tablets
3. How to take Naratriptan tablets
4. Possible side effects
5. How to store Naratriptan tablets
6. Further information
Naratriptan tablets contain naratriptan (as hydrochloride), which belongs to a group of medicines called triptans (also known as 5-HT1 receptoragonists).
Naratriptan tablets are used to treat migraine headaches.
Migraine symptoms are likely to be caused by the temporary swelling of blood vessels in the head.
Naratriptan 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.
Do not take Naratriptan tablets:
• if you are allergic (hypersensitive) to naratriptan or any of the other ingredients of Naratriptan 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 Naratriptan 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, nor with ergotamine containing drugs orsimilardrugs, 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 Naratriptan tablets.
Take special care with Naratriptan tablets
Before taking Naratriptan tablets, your doctor should know certain things.
In some rare cases patients have developed severe heart disease after taking Naratriptan tablets, even if they have not previously had signs of symptoms of heart disease.
If any of the below 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 Naratriptan tablets ifyou:
• smoke a lot or you are using nicotine replacement therapy, especially ifyou;
. areamanover40yearsofage . are a post-menopausal woman
Also tell yourdoctor if:
• Ifyou are allergic to antibiotics known as sulphonamides
• If you are allergic to sulphonamides, you may also be allergic to Naratriptan tablets.
• If you know you are allergic to some antibiotics but are not sure if it is a sulphonamide.
• 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 inhibitors).
Taking Naratriptan tablets too often can worsen your headaches.
Tell your doctor if this applies to you. Your doctor may recommend that you stop taking Naratriptan tablets.
If you experience pain or pressing sensation in your chest after taking Naratriptan 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 ifyou are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Some medicines should not be taken simultaneously with Naratriptan tablets, and some may cause side effects if taken together with Naratriptan tablets.
Tell yourdoctor, ifyou are taking:
• any triptan, e.g. 5-HT1-receptoragonist, which are used to treat migraine. Do not take Naratriptan tablets with these medicines. Do not take these medicines again until at least 24 hours after taking Naratriptan tablets.
• any medicines for your migraine which contain ergotamine or similar medicines, such as methysergide. Do not take Naratriptan tablets with these medicines. You should stop taking them at least 24 hours before taking Naratriptan tablets. Do not take them again for at least 24 hours after taking Naratriptan tablets.
• medications for depression that belong to the SSRI (Serotonin reuptake Inhibitors) or SNRI (serotonin norepinephrine reuptake inhibitor) groups. Taking Naratriptan 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 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 tablets. There is little information available on the safety of Naratriptan tablets in pregnant women, although there is no indication that it would increase the risk of malformations. Your doctor may recommend that you do not take Naratriptan tablets during pregnancy.
• Do not breast feed for 24 hours after taking Naratriptan tablets. If any milk is excreted during this time period, discard the milk and do notgive it toyourchild.
Driving and using machines
Either the symptoms of migraine or the medicines for it may make you feel tired. If you feel tired, do not drive or operate machinery.
Important information about some ofthe ingredients of Naratriptan tablets
Naratriptan tablets contain a small amount of lactose. If you are lactose-intolerant or are intolerant to other sugars ask your doctor if you can take Naratriptan tablets.
Only take Naratriptan tablets when the migraine headache has already started.
Do not take Naratriptan tablets to try to prevent a migraine attack.
Always take Naratriptan 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 2.5 mg tablet of Naratriptan tablets swallowed whole with water. Naratriptan tablets are not recommended for children under 18 years of age or adults over 65 years of age.
When to take Naratriptan tablets
It is best to take Naratriptan tablets at the first sign of a migraine attack, although it can be taken at any stage of the attack.
If your symptoms begin to come back
You may take a second Naratriptan 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 Naratriptan tablets do not help at all contact your doctor or pharmacist.
If you take more Naratriptan tablets than you should
Do not take more than two Naratriptan tablets in any 24-hour period.
Taking too many Naratriptan 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, askyour doctor or pharmacist.
Uncommon side effects
(happens to no more than 1 patient out of 100)
• 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 forverylong.
• If these symptoms persist or become severe (especially chest pain) immediately contactyour doctor. 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 Naratriptan tablets.
Rare side effects
(happens to no more than 1 patient out of 1000)
• Lower left-side abdominal pain and bloody diarrhoea (ischemic colitis)
Very rare side effects
(happens to no more than 1 patient out of 10000)
• 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 get 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 Naratriptan tablets after the expiry date that is stated 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.
Like all medicines, Naratriptan tablets can cause side effects, although not everybody gets them.
Allergic reaction (happens to no more than 1 patient out of 1000): if you experience any of the below side effects immediately contactyour doctor:
• rash, wheeziness of lungs, swelling of eyelids, face or lips, unconsciousness.
Common side effects
(happens to no more than 1 patient out of 10)
• Nausea or vomiting, although these may occur due to the migraine attack itself.
• Fatigue, drowsiness or general malaise.
• Dizziness, tingling sensation or hot flashes.
What Naratriptan tablets contain
• The active substance is naratriptan hydrochloride corresponding to 2.5 mg naratriptan.
• The other ingredients are: core of the tablet: Microcrystalline Cellulose, Lactose Anhydrous, Croscarmellose Sodium and Magnesium Stearate; filmcoating of the tablet: Hypromellose, Titanium oxide (E171), Triacetin, Iron Oxide Yellow (E172), Indigo Carmine (E132).
What Naratriptan tablets look like and contents of the pack
The tablet is Green 'D' shaped biconvex coated tablets debossed with 'U54' on one side and plain on the other side. They are available in blister packs of 2, 3, 4, 6, 12 or 18 tablets and HDPE containers of 30 tablets and 500 tablets, although not all pack sizes may be marketed
Marketing Authorisation Holder
Morningside Healthcare Ltd 115 Narborough Road. Leicester,
LE30PA,UK.
Manufacturer
Accord Healthcare Limited,
Sage house, 319 Pinner Road,
North Harrow, Middlesex HA1 4HF, UK.