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156 mm

M

PACKAGE LEAFLET: INFORMATION FORTHE USER

NARATRIPTAN 2.5 mg

FILM-COATED

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, askyour 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.

What is in this leaflet:

1. What Naratriptan is and what it is used for.

2.    What you need to know before you take Naratriptan.

3.    How to take Naratriptan.

4.    Possible side effects.

5.    How to store Naratriptan.

6.    Contents of the pack and other information.

1.    WHAT NARATRIPTAN IS AND WHAT IT IS USED FOR

Naratriptan (hydrochloride) is one of a group of medicines called 5-HT1 receptor agonists (also known as triptans) that are used to treat migraine attacks. A migraine causes attacks of headache, sometimes with sickness or other symptoms e.g. some people become sensitive to light or noise. Migraine symptoms may be caused by the temporary widening of blood vessels in the head. Naratriptan is 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. Naratriptan Tablets should not be used where migraine has not been diagnosed.

2.    WHATYOU NEED TO KNOW BEFOREYOU 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)

•    you have heart problems such as narrowing of the arteries (ischaemic heart disease) or chest pains (angina)

•    you have ever had a heart attack

•    you have circulation problems in your legs that cause cramp-like pains when you walk (peripheral vascular disease)

•    you have had a stroke in the past or if you have had the symptoms of a stroke, which only lasted a short time and from which you made a complete recovery (transient ischaemic attack)

•    you have serious liver or serious kidney problems

•    you have high blood pressure (hypertension). You may be able to take Naratriptan if your high blood pressure is mild and is being treated.

•    you are already taking medicine containing ergotamine or similar medicines such as methysergide (to treat migraine), or any triptan or 5-HT agonist.

Warnings and precautions:

Talkto your doctor or pharmacist before taking Naratirptan if:

•    you notice pain or a feeling of tightness in your chest after taking Naratriptan. If these symptoms don't pass quickly, tell your doctor immediately.

•    you have extra risk factors for heart disease, such as being a heavy smoker, being a male over 40 years old or a woman who has been through the menopause

•    you use Naratriptan too often as this may make your headaches worse

•    you are allergic (hypersensitive) to antibiotics called sulphonamides.

Other medicines and Naratriptan:

Tell your doctor if you are taking or have recently taken any medicines, including medicines bought without a prescription. This includes any herbal products and dietary supplements such as vitamins, iron or calcium. In particular, inform your doctor if you are taking:

•    other migraine medicines - including any triptan or 5-HT1 receptor agonist (such as sumatriptan), any medicine containing ergotamine or ergotamine derivatives.

Don't take Naratriptan Tablets at the same time as these medicines. Don't take them again for at least 24 hours after taking Naratriptan Tablets.

•    antidepressants including SSRIs (for example citalopram, fluoxetine, fluvoxamine, paroxetine, or sertraline, reboxetine, venlafaxine)

•    herbal medicines containing St John's Wort.

Pregnancy and breast-feeding

If you are pregnant or could be pregnant, talk to your doctor before you take Naratriptan Tablets.There is only limited information about the safety of Naratriptan Tablets for pregnant women, though up till nowthere 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 using naratriptan. The breast milk should be expressed and discarded during this period.

Askyour doctor or pharmacist for advice before taking any medicinal product.

Driving and using machines

You may suffer drowsiness, dizziness or other related symptoms either due to the migraine itself or the use of these tablets. If affected do not operate machinery or drive.

Naratriptan contains lactose

These tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, such as lactose, contact your doctor before taking this medicinal product.

3. HOWTO TAKE NARATRIPTAN

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure:

•    Swallow the tablet whole with a glass of water.

•    Take this medicine as soon as possible after the start of the migraine attack. Although you can take it at any time during an attack.

•    This medicine should not be taken to prevent an attack.

Adults - Take one 2.5 mg tablet. If the first dose did help but the headache returned, you can take a second dose after four hours, unless you have kidney or liver damage. Do not take a second dose if the first dose had no effect.

The maximum dose is two 2.5 mg Naratriptan in 24 hours.

Always take Naratriptan exactly as your doctor has told you. Check with your doctor or pharmacist if you're not sure.

Children (under 18 years) - Naratriptan is not recommended for children.

Elderly patients (over 65 years) - Naratriptan is not recommended.

Patients with kidney or liver problems -

If you have mild to moderate kidney or liver problems, do not take more then one tablet in 24 hours.

If you take more Naratriptan tablets than you should:

Contact your doctor or local Accident and Emergency (casualty) department immediately if you have taken more than two tablets in 24 hours.

If you have any further questions on the use of this product, please askyour doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like most medicines, this medicine can cause side effects, although not everybody gets them.

If any of the following happen, stop taking Naratriptan and tell your doctor immediately or go to your nearest hospital emergency department:

Allergic reaction: get a doctor's help straight away (affects up to 1 in 1,000 people):

•    Allergic reactions such as rash, wheezing, swollen eyelids,face or lips, complete collapse

•    sensations such as heaviness, pressure or tightness or pain, which can affect any part of the body including the throat and chest.

These side effects are uncommon but serious. You may need medical attention.

Common side effects (affects 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 generally feeling unwell.

•    Dizziness, tingling feelings, or getting hot flushes.

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

Uncommon side effects (affects up to 1 in 100

people):

•    Heaviness, pressure, tightness or pain in the chest, throat or other parts of the body. 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.

Other uncommon side effects include:

•    Visual disturbances (although these may be due to the migraine attack itself).

•    Heartbeat may go faster, slower or change rhythm.

•    Slight increase in blood pressure, which may last for up to 12 hours after taking Naratriptan Tablets.

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

Rare side effects, (affects up to 1 in 1,000 people:

•    Pain in the lower left side of the stomach and bloody diarrhoea (ischaemic colitis).

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

Very rare side effects, (affects 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.

These side effects are rare but serious. You may need medical attention if you have these side effects. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5.    HOWTO STORE NARATRIPTAN

•    Keep Naratriptan out of the sight and reach of children.

•    Do not use Naratriptan after the expiry date that is stated on the carton.The expiry date refers to the last day of that month.

•    This medicine does not require any special storage conditions.

•    Do not throw away any medicines via wastewater or household waste. Askyour 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 Film-Coated Tablets contains:

•    The active substance is naratriptan. Each film coated tablet contains 2.5 mg of naratriptan (as naratriptan hydrochloride 2.78 mg).

•    The other ingredients are in the tablet core are: cellulose microcrystalline, lactose anhydrous, croscarmellose sodium, magnesium stearate. Other ingredients in the film coating are: hypromellose, titanium dioxide (E171), triacetin, iron oxide yellow (E172), indigo carmine aluminium lake (E132).

What Naratriptan Film-Coated Tablets looks like and contents of the pack

Naratriptan film-coated tablets are green, round, biconvex beveled edged film-coated tablets debossed with 'M' on one side and 'NN2' on the other side.

Naratriptan film-coated tablets are available in cold form blister pack comprising of aluminium foil laminated to oriented polyamide that is laminated to PVC on the side and plain aluminium foil on the other side with heat seal coating.

They are available in blister packs contain 2,3, 4,6,12, or 18 Naratriptan Film-Coated Tablets.

Marketing Authorisation Holder

Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.

Manufacturer

Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.

This leaflet was last revised in 03/2013.

348 mm