Leaflet: information for the user

Naramig 2.5 mg film-coated tablets

Naratriptan

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

The 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 for the treatment of headache that occurs in migraine.

The symptoms of migraine may be due to temporary dilation of blood vessels inlthe head. It is believed that Naramig reduces the dilation of these blood vessels, which helps to eliminate the headache andalleviate other symptoms of migraine, such as nausea and vomiting and sensitivity to light andal sound.

Do not take Naramig:

• If you are allergicto naratriptán or to any of the other components of this medication (listed in section 6).
• If you have any heart problems, such as narrowing of the arteries (ischemic cardiopathy) or chest pain (angina), or have had a previous heart attack.
• If you have circulatory problems in your legsthat cause cramp-like pains when walking (peripheral vascular disease).
• If you have had a strokeor a mini-stroke (also known asischemic transient attackorITA).
• If you have high blood pressure.Naramig may be taken if you have mild hypertension and are being treated.
• If you have severe kidney or liver problems.
• If you are taking other migraine medications, including those containing ergotamine, or similar medications such as metisergida, or with triptans or 5-HT1receptor agonists.

If you are in any of these situations:

→Inform your doctor and do not take Naramig.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Naramig.

If you have any risk factors:

• If you area smokeror are usingnicotine replacement therapy, and especially
• In the case ofmen over 40 years old,or
• In the case ofpostmenopausal women.

In very rare cases, people have experienced severe cardiac alterations after taking Naramig, although they had no history of heart disease.

If you are in any of the above situations, you may be at a higher risk of heart disease. Therefore:

→Inform your doctor so that your cardiac function can be reviewedbefore starting treatment with Naramig.

If you are allergic to sulfonamide antibiotics

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

→Inform your doctor or pharmacist before starting to take Naramig.

If you take Naramig frequently

Taking Naramig too frequently may worsen your headaches.

→Inform your doctorif you are in this situation.Your doctor may recommend that you stop taking Naramig.

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

These effects can be intense but are generally transient. If they do not disappear quickly or become more severe:

→Go to your doctor immediately. Section 4 of this leaflet has more information about this side effect.

If you are taking antidepressants called SSRIs (

Selective serotonin reuptake inhibitors) orSNRIs (

serotonin and noradrenaline reuptake inhibitors), used to treat depression

→Inform your doctor or pharmacist before starting to take Naramig.

Use of Naramig with other medications

Inform your doctor or pharmacist if you are taking,have taken recently or may need to take any other medication, including herbal remedies or over-the-counter medications.

Some medications should not be taken with Naramig and others may cause side effects if taken together with Naramig.Inform your doctor if you are taking:

• Anytriptanor5-HT1receptor agonist used for the treatment ofmigraine. Do not take Naramig together with these medications. Do not take them again for at least 24 hours after taking Naramig.
• Ergotamine, also used to treatmigraineor similar medications, such as metisergida. Do not take Naramig together with these medications. Stop taking these medications for 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) orSNRIs(serotonin and noradrenaline reuptake inhibitors), used to treatdepression. The use of Naramig with these medications may cause confusion, weakness, and/or lack of coordination. Inform your doctor immediately if you are in this situation.
• St. John's Wort(Hypericum perforatum). The use of herbal remedies containing St. John's Wort while taking Naramig may increase the risk of side effects.

Pregnancy and breastfeeding

• If you are pregnant, think you may be pregnant, or plan to become pregnant,consult your doctor or pharmacist before using this medication. There is limited information available on the safety of Naramig during pregnancy, although there is currently no evidence of an increased risk of birth defects. Your doctor may recommend that you do not take Naramig while pregnant.
• Do not breastfeed your child for 24 hours after taking Naramig.Discard any breast milk produced during that time.

Driving and operating machinery

• The symptoms of migraine and the medication maymake you feel drowsy.Do not drive or operate machinery if affected.

Naramig contains lactose

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance:

→Consult with them beforetaking this medication.

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

Take Naramig only after your migraine has started

Do not take Naramig to prevent an attack

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

What is the dose you should take

• The normal dose for adults between 18 and 65 yearsis a 2.5 mg Naramig tablet, swallowed whole with a little water.

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

When to take your dose

• It is best to take Naramig as soon as the migraine headache appears.However, they can be taken at any time during an attack.

When symptoms start to appear again

• You can take a second Naramig tablet after 4 hours, unless you have any kidney or liver damage.
• If you have any kidney or liver alteration, do not take more than one tablet in 24 hours.
• Do not take more than two tablets in 24 hours.

When the first dose does not provide relief

• Do not take another tablet for that same attack.

If Naramig does not provide any relief:

?Ask your doctor or pharmacist.

When taking 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 become ill. If you have taken more than 2 tablets in 24 hours:

?Inform your doctor or call the Toxicological Information Service, phone 91.562.04.20, indicating the medication and the amount taken.

If you have any other doubtabout the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Allergic reaction: seek medical attention immediately(may affect up to1 in 1,000 people)

• The signs of an allergic reaction include: skin rash, wheezing, eyelid, face, or lip inflammation, complete collapse.

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

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

Common side effects(may affect up to1 in 10 people)

• Feeling sick (nausea) or being sick (vomiting), although it may be due to the migraine itself.
• Tiredness, drowsiness, or general discomfort.
• Dizziness, tingling sensation, or hot flushes.

If you experience any of these side effects:

→Inform your doctor or pharmacist.

Less common side effects(may affect up to1 in 100 people)

• Pressure, heaviness, 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 worsen, especially chest pain:

→Seek urgent medical attention.In a small number of people, these symptoms may be caused by a heart attack.

Other less common side effects include:

• Visual disturbances (although they may be due to the migraine itself).
• The heartbeats may be faster, slower, or irregular.
• A slight increase in blood pressure that may last up to 12 hours after taking Naramig.

If you experience these side effects:

→Inform your doctor or pharmacist.

Rare side effects(may affect up to1 in 1,000 people)

• Drowsiness (somnolence).
• Pain in the lower left part of the stomach and bloody diarrhea (ischemic colitis).

If you experience these side effects:

→Inform your doctor or pharmacist.

Very rare side effects(may affect up to1 in 10,000 people)

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

If you experience these side effects:

→Inform your doctor or pharmacist.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use,www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date shown on the packaging (EXP). The expiration date is the last day of the month indicated.

Do not store above 86°F (30°C).

Dispose of unused medications and packaging through the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused medications and packaging. By doing so, you will help protect the environment.

Composition of Naramig

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

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

Appearance of the product and contents of the package

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

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holderGlaxo, S.A.

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

28760 Tres Cantos (Madrid)

Tel: +34 900 202 700

[email protected]

Responsible manufacturerDelpharm Poznan Spólka Akcyjna
ul. Grunwaldzka 189
60-322 Poznan
Poland

This medicine is authorized in the member states of the European Economic Area with the following names:

BelgiumNaramig

FinlandNaramig

FranceNaramig

GermanyNaramig

GreeceNaramig

LuxembourgNaramig

NetherlandsNaramig

PortugalNaramig

SpainNaramig

SwedenNaramig

Last review date of this leaflet:June 2020.

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/