NARAMIG 2.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Naramig 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.

Contents of the Package Leaflet

1. What is Naramig and what is it used for
2. What you need to know before you take Naramig
3. How to take Naramig
4. Possible side effects
5. Storage of Naramig
6. Contents of the pack and other information

1. What is Naramig and what is it used for

Naramig tablets contain naratriptan (hydrochloride), which belongs to a group of medicines called triptans (also known as 5-HT1 receptor agonists).

Naramig tablets are used to treat migraine headaches.

Migraine symptoms may be caused by temporary widening of blood vessels in the head. It is thought that Naramig works by reversing this widening, which helps to relieve the headache and other symptoms of migraine, such as nausea and vomiting and sensitivity to light and sound.

2. What you need to know before you take Naramig

Do not take Naramig:

• If you are allergicto naratriptan or any of the other ingredients of this medicine (listed in section 6).
• If you have heart problems, such as narrowing of the arteries (ischaemic heart disease) or chest pain (angina), or have had a heart attack in the past.
• If you have circulatory problems in your legsthat cause cramp-like pains when you walk (peripheral vascular disease).
• If you have had a stroke or a mini-stroke (also known as a transient ischaemic attack or TIA).
• If you have high blood pressure.You may take Naramig if you have mild high blood pressure and are being treated.
• If you have severe kidney or liver disease.
• If you are taking other medicines for migraine, including those that contain ergotamine, or similar medicines such as methysergide, or triptans or 5-HT1 receptor agonists.

If you are in any of these situations:

→Tell your doctor and do not take Naramig.

Warnings and precautions

Consult your doctor or pharmacist before taking Naramig.

If you have any risk factors:

• If you are a smokeror are using nicotine replacement therapy, and especially
• In the case of men over 40 years old, or
• In the case of postmenopausal women.

On very rare occasions, people have had serious heart problems after taking Naramig, even though they had no history of heart disease.

If you are in any of the above situations, you may have a greater risk of heart disease. Therefore:

→Tell your doctor so that your heart function can be checkedbefore starting treatment with Naramig.

If you are allergic to antibiotics called sulphonamides

If so, you may also be allergic to Naramig. If you are allergic to an antibiotic but are not sure if it is a sulphonamide:

→Tell your doctor or pharmacist before taking Naramig.

If you take Naramig frequently

Taking Naramig too frequently can make your headaches worse.

→Tell your doctorif you are in this situation. They may advise you to stop taking Naramig.

If you feel pain or tightness in your chest after taking Naramig

These effects can be intense but are usually temporary. If they do not go away quickly or get worse:

→See a doctor immediately. Section 4 of this leaflet has more information on this side effect.

If you are taking antidepressants called SSRIs (Selective Serotonin Reuptake Inhibitors) or SNRIs (Serotonin and Noradrenaline Reuptake Inhibitors)

→Tell your doctor or pharmacist before taking Naramig.

Using Naramig with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including herbal remedies or medicines bought without a prescription.

Some medicines must not be taken with Naramig and others may cause side effects if taken with Naramig. Tell your doctor if you are taking:

• Any triptan or 5-HT1 receptor agonist used to treat migraine. Do not take Naramig with these medicines. Do not take them again for at least 24 hours after taking Naramig.
• Ergotamine, also used to treat migraineor similar medicines, such as methysergide. Do not take Naramig with these medicines. Stop taking these medicines at least 24 hours before taking Naramig and do not take them again for at least 24 hours after taking Naramig.
• SSRIs(Selective Serotonin Reuptake Inhibitors) or SNRIs(Serotonin and Noradrenaline Reuptake Inhibitors) used to treat depression. Taking Naramig with these medicines can cause confusion, weakness and/or lack of coordination. Tell your doctor immediately if you are in this situation.
• St John's Wort (Hypericum perforatum). Taking herbal remedies that contain St John's Wort while taking Naramig may make you more likely to experience side effects.

Pregnancy and Breast-feeding

• If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advicebefore taking this medicine. There is only limited information about the safety of Naramig in pregnancy, although there is no evidence of an increased risk of birth defects at present. Your doctor may advise you not to take Naramig while you are pregnant.
• Do not breast-feed your baby for 24 hours after taking Naramig.Discard any breast milk produced during this time.

Driving and using machines

• Both migraine symptoms and the medicine can make you feel sleepy. If you are affected, do not drive or use machines.

Naramig contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars:

→Consult your doctor beforetaking this medicine.

This medicine contains less than 23 mg of sodium (1mmol) per tablet; this is, essentially “sodium-free”.

3. How to take Naramig

Take Naramig only after your migraine headache has started

Do not take Naramig to prevent an attack

Follow the instructions for administration of this medicine exactly as told by your doctor. If you are not sure, ask your doctor or pharmacist again.

What dose should you take

• The usual dose for adults between 18 and 65 years oldis one 2.5 mg Naramig tablet, swallowed whole with a little water.

Naramig is not recommended for children under 18 years old or adults over 65 years old.

When to take your dose

• It is best to take Naramig as soon as your migraine headache starts.However, you can take it at any time during an attack.

If your symptoms come back

• You can take a second Naramig 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.
• Do not take more than two tablets in 24 hours.

If you do not get relief with the first dose

• Do not take another tablet for the same attack.

If Naramig does not provide you with any relief:

?Ask your doctor or pharmacist.

If you take more Naramig than you should

• Do not take more than 2 Naramig tablets in 24 hours.

If you take more Naramig than you should, you may feel unwell. If you have taken more than 2 tablets in 24 hours:

?Tell your doctor or call the Toxicology Information Service, telephone 91.562.04.20, stating the medicine and the amount taken.

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

4. Possible side effects

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

Allergic reaction: see a doctor immediately(may affect up to 1 in 1,000 people)

• Signs of an allergic reaction include: skin rash, wheezing, swelling of the eyelids, face or lips, collapse.

If you experience any of these symptoms soon after taking Naramig:

→Do not take any more tablets and contact a doctor immediately.

Common side effects(may affect up to 1 in 10 people)

• Feeling sick (nausea) or being sick (vomiting), although these may be due to the migraine itself.
• Feeling tired, sleepy or generally unwell.
• Dizziness, feeling of tingling or flushing.

If you experience any of these side effects:

→Tell your doctor or pharmacist.

Uncommon side effects(may affect up to 1 in 100 people)

• Heaviness, pressure, tightness or pain in the chest, throat or other parts of the body. These effects can be intense but are usually temporary.

If these side effects continue or get worse, especially chest pain:

→Seek medical attention immediately. In a 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 itself).
• Heartbeats may be faster, slower or irregular.
• Mild increase in blood pressure that can last up to 12 hours after taking Naramig.

If you experience these side effects:

→Tell your doctor or pharmacist.

Rare side effects(may affect up to 1 in 1,000 people)

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

If you experience these side effects:

→Tell your doctor or pharmacist.

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

• Heart problems, including chest pain (angina) and heart attack.
• Poor circulation in arms and legs, causing pain and discomfort.

If you experience these side effects:

→Tell your doctor or pharmacist.

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 Spanish Medicines Vigilance System for Human Use, www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Naramig

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 (EXP). The expiry date refers to the last day of the month shown.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Naramig contains

The active substanceis naratriptan (2.5 mg), as hydrochloride.

The other ingredientsof the tablet core are: microcrystalline cellulose, anhydrous lactose, sodium croscarmellose and magnesium stearate. The other ingredients of the tablet coating are: hypromellose, titanium dioxide (E171), triacetin, yellow iron oxide (E172), indigo carmine (indigo carmine, E132).

Appearance and packaging

Naramig tablets are green, film-coated, D-shaped and engraved with GX CE5 on one side. They are available in child-resistant blister packs containing 2, 4, 6 or 12 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holderGlaxo, S.A.

P.T.M. C/ Severo Ochoa, 2

28760 Tres Cantos (Madrid)

Tel: +34 900 202 700

[email protected]

ManufacturerDelpharm Poznan Spólka Akcyjna ul. Grunwaldzka 189 60-322 Poznan Poland

This medicine is authorised in the Member States of the European Economic Area under the following names:

Belgium Naramig

Finland Naramig

France Naramig

Germany Naramig

Greece Naramig

Luxembourg Naramig

Netherlands Naramig

Portugal Naramig

Spain Naramig

Sweden Naramig

Date of last revision of this leaflet:June 2020.

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/