Naramig 2.5mg Tablets
Rev. date: 19. 01 .2015 Leaflet reference: NAR2.5/UT
PACKAGE LEAFLET: INFORMATION FOR THE USER
NARAMIG® 2.5MG TABLETS
(Naratriptan hydrochloride)
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 Naramig® 2.5mg Tablets are and what they are used for
2. What you need to know before you take Naramig® 2.5mg Tablets
3. How to take Naramig® 2.5mg Tablets
4. Possible side effects
5. How to store Naramig® 2.5mg Tablets
6. Contents of the pack and other information
1. WHAT NARAMIG® 2.5MG TABLETS ARE AND WHAT THEY ARE USED FOR
Naramig® 2.5mg Tablets contain naratriptan (hydrochloride) which belongs to a group of medicines called triptans (also known as 5-HT1 receptor agonists).
Naramig® 2.5mg Tablets are used to treat migraine.
Migraine symptoms may be caused by the temporary widening of blood vessels in the head. Naramig® 2.5mg Tablets are believed to reduce the widening of these blood vessels. This in turn helps to take away the headache and relieve other symptoms of a migraine attack, such as feeling or being sick (nausea or vomiting) and sensitivity to light and sound.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NARAMIG® 2.5MG TABLETS
Do not take Naramig® 2.5mg Tablets:
• If you’re allergic to naratriptan, or any of the other ingredients of this medicine (listed in section 6)
• If you have a heart problem such as heart failure or chest pains (angina), or have already had a heart attack
• If you have circulation problems in your legs that cause cramplike pains when you walk (peripheral vascular disease)
• If you have had a stroke or a mini-stroke (also called a transient ischaemic attack or TIA)
• If you have high blood pressure. You may be able to take Naramig® 2.5mg Tablets if your high blood pressure is mild and is being treated.
• If you have kidney or liver disease
• With other migraine medicines, including those which contain ergotamine, or with similar medicines such as methysergide, or with other 5-HT1 receptor agonists, such as sumatriptan
If any of these apply to you:
^ Tell your doctor, and don't take Naramig® 2.5mg Tablets.
Warnings and precautions
Talk to your doctor or pharmacist before taking Naramig® 2.5mg Tablets.
If you have any extra risk factors
• If you are a heavy smoker or are using nicotine replacement therapy, and especially
• If you are a man over 40, or
• If you are a woman who has been through the menopause.
In very rare cases, people have developed serious heart conditions after taking Naramig® 2.5mg Tablets, even though they had no signs of heart disease before.
If any of the points in the list applies to you, it could mean you have a greater risk of developing heart disease - so:
^ Tell your doctor so that your heart function can be checked before Naramig® 2.5mg Tablets are prescribed for you.
If you are allergic to antibiotics called sulphonamides
If so, you may also be allergic to Naramig® 2.5mg T ablets. If you know you are allergic to an antibiotic but you are not sure whether it is a sulphonamide:
^ Tell your doctor or pharmacist before taking Naramig® 2.5mg Tablets.
If you take Naramig® 2.5mg Tablets frequently
Taking Naramig® 2.5mg Tablets too often may make your headaches worse.
^ Tell your doctor if this applies to you. He or she may recommend you stop taking Naramig® 2.5mg Tablets.
If you feel pain or tightness in your chest after you take Naramig® 2.5mg Tablets
These effects may be intense but they usually pass quickly. If they don't pass quickly, or they become severe:
^ Get medical help immediately. Section 4 of this leaflet has more information about these possible side effects.
Not for older people or children under 18
Naramig® 2.5mg Tablets are not recommended for people aged over 65 or for children under the age of 18.
Other medicines and Naramig® 2.5mg Tablets
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Some medicines must not be taken with Naramig® 2.5mg Tablets and others may cause adverse effects if they're taken with Naramig® 2.5mg Tablets. You must tell your doctor if you are taking:
• any medicines for your migraine which contain any triptan / 5-HTi agonist (such as sumatriptan or zolmitriptan). Don't take Naramig® 2.5mg Tablets at the same time as these medicines. Stop taking these medicines at least 24 hours before taking Naramig® 2.5mg Tablets.
• ergotamine also used to treat migraine or similar medicines such as methysergide. Don't take Naramig® 2.5mg Tablets at the same time as these medicines. Stop taking these medicines at least 24 hours before taking Naramig® 2.5mg Tablets.
• any antidepressants classed as selective serotonin reuptake inhibitors (SSRIs), such as citalopram, fluoxetine or paroxetine, or serotonin noradrenaline reuptake inhibitors (SNRIs) such as venlafaxine. If you are not sure, talk to your doctor or pharmacist.
• St John’s Wort (Hypericum perforatum). Using herbal remedies that contain St John's Wort while you are taking Naramig® 2.5mg Tablets may make side effects more likely.
Pregnancy and breast-feeding
• If you are pregnant, think you may be pregnant or are planning to have a baby ask your doctor for advice before taking this medicine. There is only limited information about the safety of Naramig® 2.5mg Tablets for pregnant women, though up till now there is no evidence of any increased risk of birth defects. Your doctor may recommend that you do not take Naramig® 2.5mg Tablets while you are pregnant.
• Don’t breast-feed your baby for 24 hours after taking Naramig® 2.5mg Tablets. If you express any breast milk during this time, discard the milk and don't give it to your baby.
Driving and using machines
• Either the symptoms of migraine or your medicine may make you drowsy. If you are affected, don’t drive or operate machinery.
Naramig® 2.5mg Tablets contain lactose
Naramig® 2.5mg Tablets contain a small amount of a sugar called lactose. If you have an intolerance to lactose or any other sugars:
^ Ask your doctor for advice about taking Naramig® 2.5mg Tablets.
3. HOW TO TAKE NARAMIG® 2.5MG TABLETS
Only take Naramig® 2.5mg Tablets after your migraine headache begins.
Don’t take Naramig® 2.5mg Tablets to try to prevent an attack.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
How much to take
• The usual dose for adults aged 18 to 65 is one Naramig® 2.5mg tablet, swallowed whole with water.
Naramig® 2.5mg T ablets are not recommended for children under 18 and adults over 65.
When to take Naramig® 2.5mg Tablets
• It’s best to take Naramig® 2.5mg Tablets as soon as you feel a migraine coming on, although it can be taken at any time during an attack.
If your symptoms start to come back
• You can take a second Naramig® 2.5mg tablet after 4 hours, unless you have kidney or liver damage.
• If you have kidney or liver damage don't take more than one tablet in 24 hours.
• No one should take more than two tablets in 24 hours.
If the first tablet has no effect
• Don’t take a second tablet for the same attack.
If Naramig® 2.5mg Tablets don't give you any relief:
^ Ask your doctor or pharmacist for advice.
If you take more Naramig® 2.5mg Tablets than you should
• Don’t take more than two Naramig® 2.5mg tablets in 24 hours.
Taking too much Naramig® 2.5mg Tablets could make you ill. If you have taken more than two tablets in 24 hours:
^ Contact your doctor for advice.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor straight away if you notice any of the following serious side effects - you may need urgent medical treatment:
• Heartbeat may go faster, slower or change rhythm (affects up to 1 in 100 people).
• Pain in the lower left side of the stomach and bloody diarrhoea (ischaemic colitis - affects up to 1 in 1,000 people).
• Allergic reaction (affects up to 1 in 1,000 people). The signs of allergy include rash; hives; itching; wheezing; swollen eyelids, face or lips; complete collapse.
If you get any of these symptoms soon after taking Naramig® 2.5mg Tablets:
^ Don’t take any more. Contact a doctor straight away.
• Heaviness, pressure, tightness or pain in the chest, throat or other parts of the body (affects up to 1 in 100 people). These effects may be intense but generally pass quickly.
If these effects continue or become severe (especially the chest pain): ^ Get medical help urgently. In a very small number of people these symptoms can be caused by a heart attack.
Common:
may affect up to 1 in 10 people
• Feeling sick (nausea) or being sick (vomiting), although this may be due to the migraine itself.
• Tiredness, drowsiness, or sleepiness (somnolence), or generally feeling unwell.
• Dizziness, tingling feelings, or getting hot flushes.
If you get any of these effects:
^ Tell your doctor or pharmacist.
Uncommon:
may affect up to 1 in 100 people
• Visual disturbances (although these may be due to the migraine attack itself).
• Slight increase in blood pressure which may occur up to 12 hours after taking Naramig® 2.5mg Tablets.
If you get any of these effects:
^ Tell your doctor or pharmacist.
Very rare:
may affect up to 1 in 10,000 people
• Heart problems, including chest pains (angina) and heart attack.
• Poor blood circulation to the arms and legs, causing pain and discomfort.
If you get these symptoms:
^ Tell your doctor or pharmacist.
If you get side effects
If you notice any unwanted effects, even ones not listed in this leaflet, or if any of the side effects becomes troublesome:
^ Tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor, 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 NARAMIG® 2.5MG TABLETS
• Store below 30°C.
• Keep out of the sight and reach of children.
• Do not use this medicine after the expiry date which is printed on the carton label. The expiry date refers to the last day of the month.
• If your doctor stops treatment return any unused medicine to your pharmacist for safe disposal. Only keep this medicine, if your doctor tells you to.
• If your tablets show signs of deterioration or discolouration, you should seek the advice of your pharmacist who will tell you what to do.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
Your medicine is called Naramig® 2.5mg Tablets. Each green, D-shaped tablet is marked ‘GX CE5' on one side, plain on the reverse.
Each pack contains a blister strip of 6 tablets.
What is in your medicine
Each tablet contains 2.5mg Naratriptan (as the hydrochloride).
Each tablet also contains microcrystalline cellulose, anhydrous lactose, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide E171, triacetin, yellow iron oxide E172 and indigo carmine aluminium lake E132.
Who manufactured your medicine
Naramig® 2.5mg Tablets are manufactured by GlaxoSmithKline Pharmaceuticals S.A., ul. Grunwaldzka 189, 60-322 Poznan, Poland and is procured from within the EU and repackaged by the Product Licence Holder: Beachcourse Limited, 20 Alliance, Alliance Road, London W3 0RB.
PL 16378/0168 |POM|
Additional information
This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist who have the information you need, and will advise you.
Pharmaceutical Companies are not allowed to answer questions from patients about their diseases. There are two national organisations and a patient information service, which offer both help and advice on migraine:
Migraine Action Association Unit 6
Oakley Hay Lodge Business Park Great Folds Road Great Oakley Northants NN18 9AS Tel: 01536 461333
The Migraine Trust 55-56 Russell Square London WC1B 4HP Tel: 020 7436 1336
You may be able to find out more about prescribed medicines from books in public libraries.
Revision date: 19. 01 .2015 Leaflet reference: NAR2.5/UT
Naramig® is a registered trademark of the GlaxoSmithKline group of companies
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