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Document: leaflet MAH GENERIC_PL 04569-1037 change

• leaflet CHANELLE MEDICAL (UK) LIMITED_PL 35507-0112
• leaflet MAH GENERIC_PL 04569-1037
• leaflet MAH GENERIC_PL 13931-0051
• leaflet MAH GENERIC_PL 35507-0112
• leaflet ZENTIVA_PL 13931-0051

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Package Leaflet: Information for the patient

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 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

This medicine contains the active substance naratriptan (hydrochloride). Naratriptan 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.    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).

•    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

Talk to your doctor or pharmacist before taking Naratriptan if:

•    you have extra risk factors for heart

disease, such as being a heavy smoker, using nicotine replacement, being a male over 40 years old or a woman who has been through the menopause.    ■

•    you are allergic to other medicines called ¹ sulfonamides (which may include some ; antibiotics and water tablets (diuretics)).

Naratriptan should not be used for unusual forms of migraine caused by brain or eye problems (e.g. hemiplegic, basilar or ophthalmoplegic).

During treatment

•    This medicine may cause pain or a feeling of tightness in your chest or throat after taking. If these symptoms don't pass quickly, tell your doctor immediately. In very rare cases, people have developed serious heart conditions after taking naratriptan, even though they had no signs of heart disease before

•    If you need to use Naratriptan too often talk to your doctor, as this may make your headaches worse.

Other medicines and Naratriptan

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines bought without a prescription, or 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 (e.g. methysergide). Don't take Naratriptan at the same time as these medicines. Stop taking these medicines at least 24 hours before taking naratriptan.

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

•    herbal medicines containing St John's Wort.

Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant or are planning to have a baby talk to your doctor before you take Naratriptan. 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 using naratriptan. The breast milk should be expressed and discarded during this period.

Ask your doctor or pharmacist for advice before taking any medicine.

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 medicine.

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3.    How to take Naratriptan

Always take this medicine exactly as your doctor or pharmacist 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 problems. 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.

Use in children and adolescents (under 18 years)

Naratriptan is not recommended for children and adolescents.

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 than 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 medicine, ask your doctor or pharmacist.

4.    Possible side effects

Like all 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 reactions such as rash, itching, hives, wheezing, swollen eyelids, face or lips, complete collapse

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

•    Chest pain which may move into the shoulder, arm and jaw with shortness of breath and feeling sweaty - these may be signs of a heart attack

•    Chest pain and feeling breathless, especially after exercise, which may be caused by narrowing of the blood vessels to the heart (angina)

•    Heartbeat may go faster, slower or change rhythm (which may be seen in electrical activity tests of the heart)

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

Other possible side effects

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, sleepiness, or generally feeling unwell.

•    Dizziness, tingling feelings, or getting hot flushes.

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 last for up to 12 hours after taking naratriptan.

Very rare (may affect up to 1 in 10,000 people):

•    Poor blood circulation to the arms and legs, causing pain and discomfort.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. 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 Naratriptan

•    Keep this medicine out of the sight and reach of children.

•    Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. 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. 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 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 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 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 blister packs of 2, 3, 4, 6, 12, or 18 film-coated tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

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 08/2015.

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LC7082