Naratriptan 2.5 mg film-coated tablets

• 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.

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

• 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 pain (angina) or have already had a heart attack.
• If you have circulatory 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 ischemic attack or TIA).
• If you have high blood pressure. You may be able to take Naratriptan 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 contains 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 Naratriptan tablets.

Talk to your doctor or pharmacist before taking Naratriptan 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.

In very rare cases people have developed serious heart conditions after taking Naratriptan 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 Naratriptan tablets are prescribed for you.

If you are allergic to antibiotics called sulphonamides

If so, you may also be allergic to Naratriptan tablets. 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 tablets.

If you take Naratriptan tablets frequently

Taking Naratriptan tablets too often may make your headaches worse.

Tell your doctor if this applies to you. He or she may recommend you stop taking Naratriptan tablets.

If you feel pain or tightness in your chest after you take Naratriptan 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.

Naratriptan tablets are not recommended for people aged over 65 or for children under the age of 18.

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 tablets, and others may cause side effects if they’re taken with Naratriptan tablets. You must tell your doctor if you are taking:

• any medicines for your migraine which contain any triptan/5-HT1 agonist (such as sumatriptan or zolmitriptan). Don’t take Naratriptan tablets at the same time as these medicines. Stop taking these medicines at least 24 hours before taking Naratriptan tablets.
• ergotamine also used to treat migraine or similar medicines such as methysergide. Don’t take Naratriptan tablets at the same time as these medicines. Stop taking these medicines at least 24 hours before taking Naratriptan 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 Naratriptan tablets may make side effects more likely.

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 Naratriptan 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 Naratriptan tablets while you are pregnant.

Do not breast-feed your baby for 24 hours after taking Naratriptan tablets. If you express any breast milk during this time, discard the milk and don’t give it to your baby.

Either the symptoms of migraine or your medicine may make you drowsy. If you are affected, don’t drive or operate machinery.

Naratriptan tablets contain a small amount of sugar called lactose. If you have an intolerance to lactose or any other sugars ask your doctor for advice about taking Naratriptan tablets.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

The usual dose for adults aged 18 to 65 is one Naratriptan 2.5 mg tablet, swallowed whole with water.

Naratriptan tablets are not recommended for children under 18 and adults over 65.

When to take Naratriptan tablets

It is best to take Naratriptan 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 Naratriptan 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 Naratriptan tablets don’t give you any relief ask your doctor or pharmacist for advice.

Taking too many Naratriptan tablets could make you ill. If you have taken more than two tablets in 24 hours contact your doctor for advice.

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 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.

• 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).

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.