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 is and what it is 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 IS AND WHAT IT IS USED FOR
Naratriptan Film-coated tablets contain naratriptan (as hydrochloride), which belongs to a group of medicines called triptans (also known as 5-HT1 receptor agonists).
Naratriptan Film-coated tablets are used to treat migraine.
Migraine symptoms are likely to be caused by the temporary swelling of blood vessels in the head. Naratriptan Film-coated 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.
Naratriptan Film-coated 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 Naratriptan Film-coated 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 Film-coated 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 or similar drugs, such as methysergide, or with other triptans or another 5-HT1-receptor agonist.
Take special care with Naratriptan Film-coated tablets
Before taking Naratriptan Film-coated tablets, your doctor should know certain things.
In some rare cases patients have developed severe heart disease after taking Naratriptan Film-coated 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 Film-coated 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 Naratriptan Film-coated 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 Naratriptan Film-coated 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 simultaneously with Naratriptan Film-coated tablets, and some may cause side effects if taken together with Naratriptan Film-coated tablets.
Tell your doctor, if you are taking:
- any triptan, e.g. 5-HT1-receptor agonist, which are 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 takingNaratriptan 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 takingNaratriptan Film-coated tablets. Do not take
- 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 takingNaratriptan Film-coated tablets. There is little information available on the safety of Naratriptan Film-coated 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 Film-coated tablets during pregnancy
- Do not breast feed for 24 hours after taking Naratriptan Film-coated tablets. If any milk is excreted during this time period, discard the milk and do not give it to your child.
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 of the ingredients of Naratriptan Film-coated tablets
Naratriptan Film-coated tablets contains 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 Naratriptan Film-coated tablets when the migraine headache has already started.
Do not take Naratriptan Film-coated tablets to try to prevent a migraine attack.
Always take Naratriptan Film-coated 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 Film-coated tablets.
Naratriptan Film-coated tablets is not recommended for children under 18 years of age or adults over 65 years of age.
Method of administration:
Oral use.
Naratriptan Film-coated tablets should be swallowed whole with water, without chewing.
When to take Naratriptan Film-coated tablets
It is best to take Naratriptan Film-coated 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 second Naratriptan Film-coated tablets 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-hours period.
If the first tablet is not effective
Do not take another tablet to treat the same attack
If Naratriptan Film-coated tablets does 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 Naratriptan Film-coated tablets in any 24-hour period.
Taking too much Naratriptan Film-coated 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
4. POSSIBLE SIDE EFFECTS
Like all medicines, Naratriptan Film-coated tablets can cause side effects, although not everybody gets them.
Allergic reaction (affects 1 to 10 user in 10,000): if you experience any of the below side effects immediately contact your doctor:
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) immediately contact your 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
(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.
5. HOW TO STORE Naratriptan Film-coated tablets
Keep out of the reach and sight of children.
Do not use Naratriptan Film-coated 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 contains
- The active substance is naratriptan
Each film-coated tablet contains 2.5 mg 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 looks like and contents of the pack
The tablet is Green ‘D’ shaped, biconvex, film-coated tablets debossed with ‘U54’ on one side and plain on the other side. They are available in
Blister of 2, 3, 4, 6, 12 and 18 film-coated tablets and HDPE bottle of 30 and 500 film-coated tablets. Not all pack sizes may be marketed.
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
This leaflet was last approved in 10/2011
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