NARATRIPTAN AL

NARATRIPTAN AL akut 2,5 mg Filmtabletten

Important notes (mandatory information)

Naratriptan AL akut 2.5 mg film-coated tablets Areas of application: for the treatment of migraines.

For risks and side effects, read the package leaflet and consult your doctor or pharmacist.


Patient information: Information for users
Naratriptan AL akut 2.5 mg film-coated tablets
Active ingredient: Naratriptan

Read the entire package leaflet carefully before you start taking this medicine, because it contains important information. Always take this medicine exactly as described in this package leaflet or exactly as your doctor or pharmacist has told you.
o Keep the package leaflet. You may want to read it again later.
o Ask your pharmacist if you need more information or advice.
o If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
o If you do not feel better or if you feel worse, contact your doctor.

What is in this package leaflet
1. WHAT IS NARATRIPTAN AL AKUT AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING NARATRIPTAN AL AKUT?
3. HOW TO TAKE NARATRIPTAN AL AKUT?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE NARATRIPTAN AL AKUT?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS NARATRIPTAN AL AKUT AND WHAT IS IT USED FOR?
Naratriptan AL akut contains naratriptan (as naratriptan hydrochloride), which belongs to the group of medicines known as triptans (also known as 5-HT1 receptor agonists).
Naratriptan AL akut is used to treat migraines. Migraine symptoms can be caused by a temporary widening of the blood vessels in the head. It is thought that naratriptan reduces this widening of the blood vessels. This helps to relieve the headache and other symptoms of migraine, such as a general feeling of being unwell (nausea or vomiting), as well as sensitivity to light and noise.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING NARATRIPTAN AL AKUT?

Naratriptan AL akut must not be taken

o if you are allergic to naratriptan, soya, peanuts or any of the other ingredients of this medicine (listed in section 6)
o if you have heart problems, such as narrowing of the coronary arteries (ischemic heart disease) or chest pain (angina pectoris), or if you have already had a heart attack
o if you have circulatory problems in your legs that cause cramp-like pain when walking (peripheral vascular disease)
o if you have had a stroke or transient episodes of reduced blood flow to the brain (also known as a transient ischemic attack or TIA)
o if you have high blood pressure. You can take Naratriptan AL akut if your high blood pressure is mild and well controlled
o if you have severe kidney or liver disease
o together with other medicines for migraines, including those containing ergotamine, or with similar medicines such as methysergide, or with other triptans or 5-HT1 receptor agonists.
If any of the above applies to you, tell your doctor and do not take Naratriptan AL akut.

Warnings and precautions
Please talk to your doctor or pharmacist before taking Naratriptan AL akut. Your doctor needs certain information before you take Naratriptan AL akut.

If you have certain other risk factors

o if you are a heavy smoker or if you are undergoing nicotine replacement therapy, and especially
o if you are a man over 40 years of age, or
o if you are a woman after the menopause.

In very rare cases, serious heart problems have occurred in patients after taking Naratriptan AL akut, even if there were no previous signs of heart disease. If any of the above applies to you, it could mean that you have an increased risk of developing heart disease, so tell your doctor so that your heart function can be checked before you are prescribed Naratriptan AL akut.

If you are hypersensitive to so-called sulfonamide antibiotics

If this is the case, you could also be hypersensitive to Naratriptan AL akut. If you know that you are hypersensitive to an antibiotic, but are not sure whether it is a sulfonamide, tell your doctor or pharmacist before taking Naratriptan AL akut.

If you take Naratriptan AL akut frequently

Taking Naratriptan AL akut too often can make your headaches worse. Tell your doctor if this applies to you. He/she may recommend that you stop taking Naratriptan AL akut.

If you experience pain or tightness in the chest after taking Naratriptan AL akut

This can be severe, but usually passes quickly. If it does not pass quickly or if it gets worse, see a doctor immediately. You will find more information about these possible side effects in section 4 of this package leaflet.

If you are taking medicines for depression, so-called SSRIs (selective serotonin reuptake inhibitors) or SNRIs (serotonin-noradrenaline reuptake inhibitors), tell your doctor or pharmacist before taking Naratriptan AL akut.

Taking Naratriptan AL akut with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or intend to take any other medicines. Some medicines must not be taken together with Naratriptan AL akut. Other medicines can cause side effects if they are taken together with Naratriptan AL akut. You must tell your doctor if you are taking the following medicines

o another triptan or a 5-HT1 receptor agonist for the treatment of migraines. Do not take Naratriptan AL akut at the same time as these medicines. Do not take this medicine again until at least 24 hours after taking Naratriptan AL akut.
o ergotamine, which is also used to treat migraines, or similar medicines, such as methysergide. Do not take Naratriptan AL akut at the same time as these medicines. Stop taking these medicines at least 24 hours before taking Naratriptan AL akut. Do not take these medicines again until at least 24 hours after taking Naratriptan AL akut.
o selective serotonin reuptake inhibitors (SSRIs, e.g. fluoxetine, sertraline) or serotonin-noradrenaline reuptake inhibitors (SNRIs, e.g. venlafaxine, duloxetine) for the treatment of depression. Taking these medicines together with Naratriptan AL akut can lead to confusion, weakness and/or impaired coordination. Tell your doctor immediately if you are affected in this way.
o St. John's wort (Hypericum perforatum). Side effects are more likely to occur if Naratriptan AL akut is taken together with herbal preparations containing St. John's wort.

Taking Naratriptan AL akut with food and drink
Swallow the tablet whole with a glass of water. You can take Naratriptan AL akut with and without food.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, or if you suspect you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. There is only limited information on the safety of Naratriptan AL akut in pregnant women, although there is no evidence of an increased risk of birth defects. Your doctor may recommend that you do not take Naratriptan AL akut during pregnancy. Do not breastfeed your baby for 24 hours after taking Naratriptan AL akut. If you express milk during this time, discard it and do not give it to your baby.

Driving and using machines
Both the migraine attack and taking Naratriptan AL akut can cause tiredness/drowsiness. If you are affected in this way, do not drive or operate machinery.

Naratriptan AL akut contains lactose
Therefore, please only take Naratriptan AL akut after consulting your doctor if you know that you suffer from an intolerance to certain sugars.

3. HOW TO TAKE NARATRIPTAN AL AKUT?
Do not take Naratriptan AL akut until a migraine headache has started. Do not take Naratriptan AL akut to prevent a migraine attack. Always take Naratriptan AL akut exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

How much should you take?
- Adults aged 18 to 65: The usual dose for adults aged 18 to 65 is 1 Naratriptan AL akut 2.5 mg film-coated tablet, taken whole with water.
- Naratriptan AL akut is not recommended for children under 18 years of age or adults over 65 years of age.

When should you take Naratriptan AL akut?
It is best to take Naratriptan AL akut as soon as you notice that a migraine headache is starting. However, it can also be taken at any later point during a migraine attack.

If your symptoms return

o You can take a second Naratriptan AL akut film-coated tablet after 4 hours, unless you have a kidney or liver disease.
o If you have a kidney or liver disease, do not take more than 1 film-coated tablet within 24 hours.
o No patient should take more than 2 film-coated tablets within 24 hours.

If the first tablet does not help

o Do not take another tablet for the same migraine attack.
o If Naratriptan AL akut does not provide any relief: Ask your doctor or pharmacist for advice.

Use in children, adolescents and the elderly
Naratriptan AL akut is not recommended for children under 18 years of age or adults over 65 years of age.

If you have taken more Naratriptan AL akut than you should
Do not take more than 2 Naratriptan AL akut film-coated tablets within 24 hours. Taking too much Naratriptan AL akut can make you feel sick. If you have taken more than 2 tablets within 24 hours: Ask your doctor for advice.

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?
Like all medicines, this medicine can cause side effects, although not everybody gets them.

Allergic reactions: seek medical attention immediately (can affect up to 1 in 1,000 people).
Signs of an allergy can include: rash, wheezing, swollen eyelids, face or lips, collapse. If you experience any of these symptoms shortly after taking Naratriptan AL akut, do not take Naratriptan AL akut again. Seek medical attention immediately.

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

o nausea and vomiting, which can also be caused by the migraine attack itself
o tiredness, drowsiness or a general feeling of being unwell
o dizziness, tingling sensations, hot flushes.
If you experience any of these symptoms, tell your doctor or pharmacist.

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

o a feeling of heaviness, pressure, tightness or pain in the chest, throat or other parts of the body. These symptoms can be severe, but usually pass quickly.
o If these symptoms persist or get worse (especially the chest pain), seek medical attention immediately. In very few patients, these symptoms may be caused by a heart attack.

Other uncommon side effects (can affect up to 1 in 100 people)

o visual disturbances (although these can also be caused by the migraine attack itself)
o the heartbeat may speed up, slow down or change rhythm
o a slight increase in blood pressure, which can last for up to 12 hours after taking Naratriptan AL akut.
If you experience any of these symptoms, tell your doctor or pharmacist.

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

o pain in the lower left abdomen and bloody diarrhoea (ischemic colitis). If you experience these symptoms, tell your doctor or pharmacist.

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

o heart problems, including chest pain (angina pectoris) and heart attack
o poor circulation in the arms and legs, causing pain and discomfort.
If you experience these symptoms, tell your doctor or pharmacist.

Naratriptan AL akut can cause allergic reactions in very rare cases due to the contained defatted soya lecithin.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly

Federal Institute for Drugs and Medical Devices
Dept. of Pharmacovigilance
Kurt-Georg-Kiesinger-Allee 3
D-53175 Bonn
Website: www.bfarm.de
By reporting side effects, you can help to provide more information on the safety of this medicine.

5. HOW TO STORE NARATRIPTAN AL AKUT?
Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton and the blister pack. The expiry date refers to the last day of the month indicated. This medicinal product does not require any special storage conditions.
Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you no longer use it. This helps to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Naratriptan AL akut contains

The active substance is naratriptan. 1 film-coated tablet contains 2.5 mg naratriptan as naratriptan hydrochloride. The other ingredients are: Tablet core: microcrystalline cellulose, hyprolose, lactose monohydrate, magnesium stearate (Ph. Eur.) [vegetable], maltodextrin, pregelatinized starch (maize), highly dispersed silicon dioxide, Film coating: Opadry II green, consisting of: macrogol 3350, poly(vinyl alcohol), defatted soya lecithin, talc, indigo carmine, aluminium salt (E 132), titanium dioxide (E 171), iron(III)-hydroxide-oxide × H2O (E 172).

What Naratriptan AL akut looks like and contents of the pack
Oval, biconvex, green film-coated tablets.
Naratriptan AL akut is available in packs of 2 film-coated tablets.

Pharmaceutical entrepreneur

ALIUD PHARMA GmbH
Gottlieb-Daimler-Straße 19
D-89150 Laichingen
info@aliud.de

Manufacturer

STADA Arzneimittel AG
Stadastraße 2 - 18
61118 Bad Vilbel

This package leaflet was last revised in May 2014.

Source: Information from the package leaflet
Status: 12/2014
Areas of application: for the treatment of migraines.