Naratriptan 2.5mg Film-Coated Tablets
Read all of this leaflet carefully before you
start taking this medicine because it
contains important information foryou.
• 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 Naratriptan tablets are and what they are used for
2. What you need to know before you take Naratriptan tablets
3. How to take Naratriptan tablets
4. Possible side effects
5. How to store Naratriptan tablets
6. Contents of the pack and other information
1. What Naratriptan tablets are and what they are used for
Naratriptan tablets contain naratriptan (as hydrochloride), which belongs to a group of medicines called triptans (also known as 5-HT1 receptor agonists).
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.
2. What you need to know before you take Naratriptan tablets
Do not take Naratriptan tablets:
• If you are allergic (hypersensitive) to naratriptan or any of the other ingredients of this medicine (listed in 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 liverdisease.
• 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.
If any of the above apply to you please tell your doctor and do not take Naratriptan tablets.
Warning and precautions
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.
Ifany ofthe 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;
• Are a man over 40 years of age.
• Are a post-menopausal woman.
Also tell your doctor: sulphonamides.
may also be allergic to Naratriptan tablets.
antibiotics but are not sure if it is a sulphonamide.
•
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.
Ifyou 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.
Other medicines and Naratriptan tablets
Please tell your doctor or pharmacist ifyou are taking or have recently taken or might take 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 your doctor, ifyou are taking:
•
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.
•
contain ergotamine orsimilar 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.
•
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.
•
Taking herbal remedies containing St John's Wort together with Naratriptan tablets may increase the likelihood ofsuffering side effects.
Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. 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 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.
Naratriptan tablets contain Lactose
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.
3. How to 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 this medicine exactly as your doctor has told you. 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 forchildren 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 voursvmptoms 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.
Ifyou 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.
Ifyou forget to take Naratriptan tablets
Do not take a double dose to make up for a forgotten dose.
Ifyou stop taking Naratriptan tablets
Do not stop taking this medicine without first talking to your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
• 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:
• 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 upto 12 hours after taking Naratriptan tablets.
Rare:
(may affect up to1in 1,000 people)
• Lower left-side abdominal pain and bloody diarrhoea (ischemic colitis).
Very rare:
(may affect up to 1 in 10,000 people)
• Heart problems, including chest pain (angina) and heart attack.
• Poor blood circulation in hands and legs, causing pain and discomfort.
Reporting ofside effects
If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Naratriptan tablets
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date that is stated on the carton after EXP. The expiry date refers to the last day of that month. This medicinal product does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents ofthe pack and other information
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Allergic reaction:
(may affect up to1in 1,000 people)
Ifyou experience any ofthe below side effects immediately contact your doctor:
•
eyelids, face or lips, unconsciousness. Common:
(may affect uptol in10 people)
occur due to the migraine attack itself.
•
Uncommon:
(may affect up to 1 in 100 people)
•
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.
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; film-coating of the tablet: hypromellose, titanium oxide (E171), triacetin, iron oxide yellow (E172) and indigo carmine (E132).
What Naratriptan tablets look like and contents of the pack
The tablet is Green 'D' shaped biconvex coated tablet debossed with 'U54' on one side and plain on the other side. They are available in blister packs of2, 3,4,6, 12or18 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 LE3 0PA, UK
Manufacturer
Accord Healthcare Limited Sage house, 319 Pinner Road North Harrow, Middlesex HA1 4HF, UK
This leafletwas last revised in November 2016.