NARATRIPTAN 2.5 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

Naratriptan 2.5 mg film-coated tablets

Naratriptan

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 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.

Migraine symptoms are likely to be caused by the temporary swelling 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 and vomiting) and 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 to naratriptan or any of the other ingredients of this medicine (listed in section 6).

• – If you have a heart problem such 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 agonist, such as sumatriptan.

If any of these apply to you:

Tell your doctor and don’t take Naratriptan tablets.

Warning and precautions

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
• Ifyouareamano­ver40,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.

Children and Adolescents

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

Other medicines and Naratriptan tablets

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.

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 Naratriptan tablets for pregnant women, though up till now there is no evidence of any increased the 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.

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.

Naratriptan tablets contain Lactose

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.

3. how to take naratriptan tablets

Only take Naratriptan tablets after your migraine headache begins.

Don’t take Naratriptan 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 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 doesn’t give you any relief ask your doctor or pharmacist for advice.

If you take more Naratriptan tablets than you should

Taking too much Naratriptan 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 Naratriptan 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 occur due to the migraine itself.
• Tiredness, drowsiness or sleepness (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 occur due to the migraine attack itself).
• Slight increase in blood pressure, which may last up to 12 hours after taking Naratriptan 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 pain (angina) and heart attack.
• Poor blood circulation to the arms and legs, causing pain and discomfort.

If you get any of these effects tell your doctor or pharmacist.

Reporting of side 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: 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.

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 of the pack and other information

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).