Naramig

Package Leaflet: Information for the User

Naramig, 2.5 mg, Film-Coated Tablets

Naratriptan

Read all of this leaflet carefully before 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 Pack

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

1. What Naramig is and what it is used for

Naramig contains naratriptan (as hydrochloride), which belongs to a group of medicines called triptans (also known as 5-HT1 receptor agonists).
Naramig is used to treat migraine attacks.

2. Before you take Naramig

Do not take Naramig

• If you are allergic to 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 (Prinzmetal's angina - coronary artery spasm) or have had a heart attack.
• If you have circulation problems in your legs, which cause pain when you walk (peripheral vascular disease).
• If you have had a stroke or a transient ischaemic attack (TIA).
• If you have high blood pressure. You may be able to take Naramig if your high blood pressure is mild and is being treated.
• If you have severe kidney or liver disease.
• Do not take Naramig with other migraine medicines, including those containing ergotamine or similar medicines such as methysergide, or with other triptans or 5-HT1 receptor agonists. If any of the above apply to you, tell your doctor and do not take Naramig.

Warnings and precautions

Before you start taking Naramig, tell your doctor or pharmacist:

If you have any of the following risk factors:

• if you are a heavy smoker or are using nicotine replacement therapy, and in particular
• if you are a man over 40 years old or
• if you are a woman who has passed the menopause.

In very rare cases, patients have had serious heart problems after taking Naramig, even though they had no signs of heart disease before.
If any of the above apply to you, it may mean you have an increased risk of heart problems.
Tell your doctor. Your doctor will carry out a heart examination before prescribing Naramig.

If you are allergic to sulphonamide antibiotics

You may also be allergic to Naramig.
If you know 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 get a headache which is unusual for you or if you get a headache which is severe

Patients who get migraines may be more likely to have strokes or other problems with their blood vessels.
Naramig should only be used for migraines that have been diagnosed by a doctor.
Tell your doctor if you get a headache which is unusual for you before taking Naramig. Your doctor may want to examine you to make sure that the headache is not caused by another illness.

If you take Naramig for a long time

Taking Naramig for a long time may make your headaches worse.
Tell your doctor if this happens to you. Your doctor may want you to stop taking Naramig.

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

These symptoms may be severe but are usually short-lived.
If they do not go away quickly or get worse, do not take any more Naramig and tell your doctor straight away (see also section 4).

If you are taking antidepressants called selective serotonin reuptake inhibitors (SSRIs) or selective serotonin/noradrenaline reuptake inhibitors (SNRIs) or St John's Wort (Hypericum perforatum)

Tell your doctor before taking Naramig (see also section “Naramig with other medicines”).

Naramig with other medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, including those you have bought without a prescription, including herbal medicines.
Some medicines cannot be taken with Naramig and some may cause side effects when taken with Naramig.

Tell your doctor if you are taking:

• a triptan or 5-HT1 receptor agonist (for migraine). Do not take Naramig at the same time as these medicines. Do not take these medicines within 24 hours of taking Naramig.
• ergotamine, also used for migraine, or similar medicines such as methysergide. Do not take Naramig at the same time as these medicines. Stop taking these medicines at least 24 hours before taking Naramig. Do not take these medicines within 24 hours of taking Naramig.
• selective serotonin reuptake inhibitors (SSRIs) or serotonin/noradrenaline reuptake inhibitors (SNRIs) for depression. Taking Naramig with these medicines can cause serotonin syndrome, a serious condition (see section 4). Symptoms may include: fever, hallucinations, confusion, loss of coordination, abdominal cramps, and changes in blood pressure.
• St John's Wort (Hypericum perforatum). Taking this herbal remedy with Naramig may increase the chance of you getting side effects.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
There is limited information on the use of Naramig in pregnancy. Your doctor may advise you not to take Naramig if you are pregnant.
Do not breast-feed for 24 hours after taking Naramig. Any breast milk produced during this time should be discarded.

Driving and using machines

Drowsiness may be a symptom of migraine or a side effect of Naramig. If this happens, do not drive or use machines.

Naramig contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Naramig contains sodium

Naramig contains less than 1 mmol sodium (23 mg) per tablet, which is essentially sodium-free.

3. How to take Naramig

Take Naramig only after your migraine headache starts.

The safety and effectiveness of naratriptan when given before the onset of a migraine aura have not been established.

Do not take Naramig to prevent an attack.

Always take Naramig exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Recommended dose

The usual dose for adults (aged 18-65 years) is one 2.5 mg tablet. Swallow the tablet whole with water.
Naramig is not recommended for children and adolescents under 18 years or adults over 65 years.

When to take Naramig

Naramig can be taken at any stage of a migraine attack but it is most effective when taken as soon as possible after the start of the attack.

If your symptoms come back

If you have no kidney or liver problems, you can take a second tablet after 4 hours.
Do not take more than 2 tablets in 24 hours.
If you have kidney or liver problems, do not take more than 1 tablet in 24 hours.

If your symptoms do not go away

Do not take another tablet during the same attack.
If Naramig does not relieve your migraine, tell your doctor or pharmacist.

If you take more Naramig than you should

Do not take more than 2 tablets in 24 hours.
Taking too much Naramig may cause side effects.
If you have taken more than 2 tablets in 24 hours, tell your doctor or pharmacist for advice.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Naramig can cause side effects, although not everybody gets them.
An allergic reaction (such as wheezing, swelling of the face, lips, tongue or throat, and difficulty breathing) occurs rarely (less than 1 in 1000 patients).
If you get any of these symptoms after taking Naramig, do not take any more and tell your doctor straight away.

Common side effects

(may affect up to 1 in 10 people)

• Nausea and vomiting, which may also be symptoms of migraine.
• Tiredness, drowsiness and general feeling of being unwell.
• Dizziness, tingling sensation, flushing.

Uncommon side effects

(may affect up to 1 in 100 people)

• Feeling of tightness, pressure or heaviness in the chest, throat or other parts of the body. These symptoms are usually severe but short-lived. If they do not go away or get worse, especially chest pain, you must tell your doctor straight away as they may be symptoms of a heart attack.

Other uncommon side effects include:

• Visual disturbances (which may also be symptoms of migraine).
• Fast, slow or irregular heart beats.
• Slightly increased blood pressure, which may last for up to 12 hours after taking Naramig.

Rare side effects

(may affect up to 1 in 1,000 people)

• Abdominal pain and bloody diarrhoea (ischaemic colitis).

Very rare side effects

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

• Heart problems, including heart attack.
• Problems with blood circulation in 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 national reporting system listed in the “Yellow Card Scheme” (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 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 after EXP.
The expiry date refers to the last day of that month.
Store in a cool, dry place, below 30°C.
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 Naramig contains

• The active substance is naratriptan (2.5 mg) as hydrochloride.
• The other ingredients are: Tablet core: microcrystalline cellulose, lactose anhydrous, sodium starch glycollate and magnesium stearate. Film-coating: Opadry Green OY-S-21027 (hypromellose, titanium dioxide (E171), triacetin, yellow iron oxide (E172), indigo carmine (E132)).

What Naramig looks like and contents of the pack

Naramig tablets are green, film-coated, D-shaped, with “GX CE5” engraved on one side. They are available in packs of 2, 4 and 6 tablets in blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder

GlaxoSmithKline (Ireland) Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
Ireland.

Manufacturer

Delpharm Poznań Spółka Akcyjna
ul. Grunwaldzka 189
60-322 Poznań
For further information, contact the Marketing Authorisation Holder:
GSK Services Sp. z o.o.
ul. Rzymowskiego 53
02-697 Warszawa
tel. (0-22) 576-90-00
Date of last revision of the leaflet: June 2022