Leaflet: information for the user

Almotriptán Normon 12.5 mg film-coated tablets

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, consult 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, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

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

Almotriptán Normon is used to relieve headaches associated with migraine attacks with or without aura.

Do not take Almotriptán Normon

• if you are allergic to almotriptan or any of the other components of this medication (listed in section 6)
• if you have or have 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,
  • cardiac problems without pain,
  • chest pain that occurs at rest,
  • severe hypertension (very high blood pressure),
  • uncontrolled hypertension, mild or moderate.
• if you have had a stroke or a reduction in cerebral blood flow,
• if you have had peripheral artery disease (obstruction of the large arteries of the arms or legs),
• 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 starting to take Almotriptán Normon:

• if your type of migraine has not been diagnosed,
• if you are allergic to antibiotics used to treat urinary tract infections (sulfonamides),
• if your headache symptoms are different from your usual migraine symptoms, for example, you hear ringing in your ears or feel vertigo, have a brief paralysis of a part of your body or paralysis of the muscles that control your eye movement, or any other new symptom,
• if you are at risk of developing heart disease, including high blood pressure and uncontrolled, high cholesterol, obesity, diabetes, are a smoker, have a family history of heart disease, are a postmenopausal woman or 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 increased blood pressure,
• if you are taking selective serotonin reuptake inhibitors (SSRIs) or serotonin and noradrenaline reuptake inhibitors (SNRIs). See also below, Taking Almotriptán Normon with other medications.

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

Children and adolescents

Children under 18 years old should not take Almotriptán Normon.

Over 65 years old

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

Taking Almotriptán Normon with other medications

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

Please inform your doctor:

• if you are taking any medication for depression, such as monoamine oxidase inhibitors (e.g. meclobemide), selective serotonin reuptake inhibitors (e.g. fluoxetine) or serotonin and noradrenaline reuptake inhibitors (e.g. venlafaxine), as these medications may causeserotonin syndrome, a potentially very serious treatment reaction. Symptoms of serotonin syndrome include: confusion, agitation, fever, sweating, uncoordinated movements of the limbs or eyes, involuntary muscle movements or diarrhea,
• if you are taking preparations based on St. John's Wort (Hypericum perforatum), as it 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 migraine. However, both medications can be taken one after the other, provided a minimum time has elapsed 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.

Almotriptán Normon with food and drinks

Almotriptán Normon can be taken regardless of meals.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.

There is very limited information available on the use of almotriptan during pregnancy. Almotriptán Normon should only be used during pregnancy if prescribed by your doctor and only after careful consideration of the balance of benefits and risks.

Caution should be exercised when using this medication during breastfeeding. You should avoid breastfeeding for 24 hours after treatment.

Driving and operating machinery

This medication, like migraine, can cause drowsiness. If you experience these effects, avoid driving or operating machinery as it may be hazardous.

Almotriptán Normon contains sodium

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

Followexactlytheadministration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Almotriptán Normon should only be used to treat a migraine attack that has already appeared and not to prevent migraine or headache attacks.

Adults (18-65 years)

The recommended dose is one Almotriptán Normontablet (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 tablet of 12.5 mg, but only if at least2 hours have passed between the first and second tablets.

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

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

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

Severe renal disease

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

If you take more AlmotriptánNormonthan you should

If you accidentally take too many Almotriptán Normon tablets, or if another person or child takes this medication, consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, contact the Toxicological Information Service. Phone 915 620 420,indicatingthemedicationandtheamountingested.

If you forgot to take AlmotriptánNormon

Try to take Almotriptán Normon as prescribed. Do not take a double dose to make up for the missed dose.

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

Frequent(may affect up to 1 in 10 patients)

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

Infrequent(may affect up to 1 in 100 patients)

• tingling, itching, or numbness of the skin (paresthesia),
• headache,
• ringing, buzzing, or clicking sounds (tinnitus),
• strong heartbeats (palpitations),
• throat constriction,
• diarrhea,
• discomfort when digesting food (dyspepsia),
• dry mouth,
• muscle pain (myalgia),
• bone pain,
• chest pain,
• sensation of weakness (asthenia).

Very Rare(may affect up to1 in 10,000 patients)

• spasm of the coronary blood vessels (coronary vasospasm),
• heart attack (myocardial infarction),
• increased heart rate (tachycardia).

Unknown Frequency(cannot be estimated from available data)

• seizures.

During treatment with Almotriptán Normon, inform your doctor immediately:

If you experience chest pain, throat constriction, or any other symptom that may indicate a heart attack. Please inform your doctor immediately and do not take any other Almotriptán Normon tablets.

Reporting Adverse Effects

If you experience any type of adverse effect, consulteyour doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use (Website:www.notificaRAM.es).

By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Almotriptán Normon 12.5 mg coated tablets

• The active ingredient is almotriptan. Each coated tablet contains 12.5 mg of almotriptan (in the form of almotriptan malate).
• The other components of the tablet are: Tablet core: mannitol(E-421), microcrystalline cellulose, povidone, sodium glycolate starch and stearate sodium fumarate.Coating of the tablet: hypromellose, titanium dioxide (E-171), macrogol 400 and talc.

Appearance of the product and contents of the packaging

White, circular, biconvex coated tablets.

Almotriptán Normon 12.5 mg coated tablets are presented in packs of 4, 6 and 9 tablets.

Only some pack sizes may be marketed.

Holder of the marketing authorization and responsible manufacturer

LABORATORIOS NORMON, S.A.

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

Date of the last review of this leaflet:June 2013

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