Patient leaflet - NARATRIPTAN USV 2.5 MG FILM-COATED TABLETS
1. what naratriptan is and what it is used for
Naratriptan contains naratriptan (as hydrochloride), which belongs to a group of medicines called triptans (also known as 5-HT receptor agonists).
Naratriptan is used to treat migraine.
Migraine symptoms may be caused by the temporary widening of blood vessels in the head. Naratriptan 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 naratriptan
Do not take Naratriptan:
! If you are 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 cramp-like 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 Naratriptan 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 do not take Naratriptan.
Warnings and precautions
Talk to your doctor or pharmacist before taking Naratriptan.
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 Naratriptan, 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 Naratriptan is prescribed for you.
If you are allergic to antibiotics called sulphonamides
If so, you may also be allergic to Naratriptan. 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 Naratriptan.
If you take Naratriptan frequently
Taking Naratriptan too often may make your headaches worse.
mogen Healthcare
Tell your doctor if this applies to you. He or she may recommend you stop taking Naratriptan.
If you feel pain or tightness in your chest after you take Naratriptan
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 elderly or children and adolescents under 18 years of age
Naratriptan is not recommended for elderly aged over 65 years or for children and adolescents under 18 years of age
Other medicines and Naratriptan
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Some medicines must not be taken with Naratriptan and others may cause adverse effects if they are taken with Naratriptan.
You must tell your doctor if you are taking:
! any medicines for your migraine which contain any triptan/5-HT agonist (such as sumatriptan or zolmitriptan). Don't take Naratriptan at the same time as these medicines. Stop taking these medicines at least 24 hours before taking Naratriptan.
! ergotamine also used to treat migraine or similar medicines such as methysergide. Don't take Naratriptan at the same time as these medicines. Stop taking these medicines at least 24 hours before taking Naratriptan.
! 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 Naratriptan may make side effects more likely.
Pregnancy and breast-feeding
! If you are pregnant or breast-feeding, 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 Naratriptan 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 Naratriptan while you are pregnant.
! Do not breast-feed your baby for 24 hours after taking Naratriptan. 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, do not drive or operate machinery.
Naratriptan 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
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Only take Naratriptan after your migraine headache begins.
Do not take Naratriptan to try to prevent an attack.
How much to take
! The usual dose for adults aged 18 to 65 is one Naratriptan tablet, swallowed whole with water.
Children, adolescents and the elderly
Naratriptan is not recommended for children and adolescents under 18 years and adults over 65 years.
When to take Naratriptan
! It is the best to take Naratriptan 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 Naratriptan tablet after 4 hours, unless you have kidney or liver damage.
! If you have kidney or liver damage, do not 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
! Do not take a second tablet for the same attack. If Naratriptan does not give you any relief:
Ask your doctor or pharmacist for advice.
If you take more Naratriptan than you should
! Do not take more than two Naratriptan tablets in 24 hours. Taking too much Naratriptan could make you ill. If you have taken more than two tablets in 24 hours: Contact your doctor for advice.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
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:
! 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.
! 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 Naratriptan: Do not take any more. Contact a doctor straight away.
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 Naratriptan.
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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
5. how to store naratriptan
>. CONTENTS OF THE PACK AND OTHER INFORMATION
What Naratriptan looks like and contents of the pack
Naratriptan are green ‚D‘ shaped biconvex film coated tablets debossed with ‚U54‘ on one side and plain on the other side.
The tablets have dimension of approximately 13.5 × 7.4 mm.
They are available as Alu-alu blisters made up of Aluminium foil with PVC and plain aluminium foil.
The blisters contain 2, 4, 6, 10 or 12 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
USV UK Limited, Regus Woburn Place, 16 Upper Woburn Place, Euston, London, WC1H 0AF, United Kingdom.
Manufacturer responsible for batch release and distributor:
Ennogen Healthcare Limited, Unit G2-G4, Riverside Industrial Estate, Riverside Way, Dartford, DA1 5BS, UK.
This leaflet was last revised in October 2020.
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