ALMOTRIPTAN NORMON 12.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Almotriptan Normon 12.5 mg Film-Coated Tablets EFG

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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

1. What Almotriptan Normon is and what it is used for

Almotriptan Normon is an antimigraine medication that belongs to a class of compounds known as selective serotonin receptor agonists. It is believed that Almotriptan Normon reduces the inflammatory response associated with migraines by binding to serotonin receptors in cerebral blood vessels (cranial), causing vasoconstriction.

Almotriptan Normon is used to relieve headache pain associated with migraine attacks with or without aura.

2. What you need to know before you take Almotriptan Normon

Do not take Almotriptan Normon

• if you are allergic to almotriptan or any of the other ingredients of this medicine (listed in section 6),
• if you have or have ever had any disease that limits blood flow to the heart, such as:
• • myocardial infarction,
  • chest pain or discomfort that occurs normally after physical activity or stress,
  • painless cardiac problems,
  • chest pain that occurs at rest,
  • severe hypertension (very high blood pressure),
  • uncontrolled, mild or moderate hypertension.
• if you have had a stroke or a reduction in cerebral blood flow,
• if you have had an obstruction of the large arteries of the arms or legs (peripheral vascular disease),
• if you are taking other medications for migraine, including ergotamine, dihydroergotamine, and methysergide or other selective serotonin receptor agonists (e.g., sumatriptan),
• if you have severe liver disease.

Warnings and Precautions

Consult your doctor or pharmacist before taking Almotriptan Normon:

• if your type of migraine has not been diagnosed,
• if you are allergic to antibacterial medications used to treat urinary tract infections (sulfonamides),
• if the symptoms of your headache are different from those of your usual migraine attacks, for example, you hear noise in your ears or feel dizzy, you have brief paralysis of a part of your body or paralysis of the muscles that control your eye movements, or any other new symptoms,
• if you are at risk of having heart disease, including high blood pressure and uncontrolled high blood pressure, high cholesterol, obesity, diabetes, if you are a smoker, have a family history of heart disease, are a postmenopausal woman, or are a man over 40 years old,
• if you have mild or moderate liver disease,
• if you have severe kidney disease,
• if you are over 65 years old, as you are more likely to experience increases in blood pressure,
• if you are taking antidepressants, SSRIs (selective serotonin reuptake inhibitors) or SNRIs (serotonin and norepinephrine reuptake inhibitors). See also below, Taking Almotriptan Normon with other medicines.

It has been suggested that excessive use of antimigraine medications may lead to chronic headache.

Children and Adolescents

Children under 18 years old should not take Almotriptan Normon.

Over 65 years of age

If you are over 65 years old, you should consult your doctor before taking this medicine.

Taking Almotriptan Normon with other medicines

Tell your doctor or pharmacist if you are using or have recently used or may need to use any other medicines.

Please inform your doctor:

• if you are taking any medication for depression, such as monoamine oxidase inhibitors (e.g., moclobemide), selective serotonin reuptake inhibitors (e.g., fluoxetine), or serotonin and norepinephrine reuptake inhibitors (e.g., venlafaxine), as these medications can cause serotonin syndrome, a potentially very serious treatment reaction. The symptoms of serotonin syndrome include: confusion, agitation, fever, sweating, uncoordinated movements of the limbs or eyes, uncontrolled muscle movements, or diarrhea,
• if you are taking St. John's Wort (Hypericum perforatum) preparations, as they may increase the likelihood of adverse effects.

Almotriptan should not be taken at the same time as other medications that contain ergotamine, which are also used to treat migraines. However, both medications can be taken one after the other, provided that a minimum amount of time has passed between doses:

• after taking almotriptan, it is recommended to wait at least 6 hours before taking ergotamine,
• after taking ergotamine, it is recommended to wait at least 24 hours before taking almotriptan.

Almotriptan Normon with food and drinks

Almotriptan Normon can be taken with or without food.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, 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 only limited information available on the use of almotriptan during pregnancy. Almotriptan Normon should only be used during pregnancy if prescribed by your doctor and only after carefully considering the balance of benefits and risks.

Cautions should be exercised when using this medicine during breastfeeding. You should avoid breastfeeding during the 24 hours following treatment.

Driving and using machines

This medicine, like migraines, can cause drowsiness. If you experience these effects, avoid driving or using machines, as it can be dangerous.

Almotriptan Normon contains sodium

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

3. How to take Almotriptan Normon

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

Almotriptan Normon should only be used to treat a migraine attack that has already started and not to prevent migraine attacks or headaches.

Adults (18-65 years)

The recommended dose is one Almotriptan Normon tablet (12.5 mg of almotriptan) that should be taken as soon as possible after the onset of a migraine attack. If the attack does not subside, do not take more than one tablet.

If you experience a second attack within the next 24 hours, you can take a second 12.5 mg tablet, but always provided that at least 2 hours have passed between the first and second tablets.

The maximum daily dose is two 12.5 mg tablets in 24 hours.

The tablets can be taken with liquid (e.g., water) and can be taken with or without food.

Almotriptan Normon should be taken as soon as possible after the onset of a migraine attack, although it is also effective if taken later.

Severe Kidney Disease

If you have severe kidney disease, do not take more than one 12.5 mg tablet in 24 hours.

If you take more Almotriptan Normon than you should

If you accidentally take too many Almotriptan Normon tablets, or if someone else or a child takes this medicine, consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Phone 915 620 420, indicating the medicine and the amount taken.

If you forget to take Almotriptan Normon

Try to take Almotriptan Normon as prescribed. Do not take a double dose to make up for forgotten doses.

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.

Common(may affect up to 1 in 10 people)

• dizziness,
• drowsiness,
• nausea,
• vomiting,
• fatigue.

Uncommon(may affect up to 1 in 100 people)

• tingling, itching, or numbness of the skin (paresthesia),
• headache,
• ringing, noise, or clicking (tinnitus),
• strong heartbeats (palpitations),
• throat tightness,
• diarrhea,
• indigestion (dyspepsia),
• dry mouth,
• muscle pain (myalgia),
• bone pain,
• chest pain,
• feeling of weakness (asthenia).

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

• coronary artery spasm (coronary vasospasm),
• heart attack (myocardial infarction),
• increased heart rate (tachycardia).

Frequency not known(cannot be estimated from the available data)

• seizures.

Tell your doctor immediately:

If you have chest pain, tightness in the chest or throat, or any other symptoms that may indicate a heart attack. Please inform your doctor immediately and do not take any more Almotriptan Normon tablets.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Health Products Agency (Website: www.notificaRAM.es).

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Almotriptan Normon

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

No special storage conditions are required.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month shown.

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

Composition of Almotriptan Normon 12.5 mg film-coated tablets

• The active substance is almotriptan. Each film-coated tablet contains 12.5 mg of almotriptan (as almotriptan malate).
• The other ingredients of the tablet are: Tablet core: mannitol (E-421), microcrystalline cellulose, povidone, sodium starch glycolate, and sodium stearyl fumarate. Tablet coating: hypromellose, titanium dioxide (E-171), macrogol 400, and talc.

Appearance and packaging of the product

White, circular, biconvex film-coated tablets.

Almotriptan Normon 12.5 mg film-coated tablets are available in packs of 4, 6, and 9 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of last revision of this leaflet:June 2013

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/