Almotriptan Normon 12.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Almotriptan Normon 12.5 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as 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 should not give it to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if these effects are not listed in this leaflet. See section 4.

Leaflet contents

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

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

Almotriptán Normon is an antimigraine medicinal product belonging to a class of compounds known as selective serotonin receptor agonists. Almotriptán Normon is believed to reduce the inflammatory response associated with migraines by binding to serotonin receptors on cerebral (cranial) blood vessels, causing vasoconstriction.

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

2. What you need to know before taking Almotriptán Normon

Do not take Almotriptán Normon

• if you are allergic to almotriptan or to any of the other ingredients of this medicine (listed in section 6)
• if you have or have ever had a condition that reduces blood flow to the heart, such as:
  • myocardial infarction,
  • chest pain or discomfort that usually occurs during physical activity or stress,
  • heart problems without chest pain,
  • chest pain occurring at rest,
  • severe hypertension (very high blood pressure),
  • uncontrolled mild or moderate hypertension.
• if you have had a stroke or reduced blood flow to the brain,
• if you have had blockage of the major arteries in the arms or legs (peripheral vascular disease),
• if you are taking other migraine medications, including ergotamine, dihydroergotamine, and methysergide, or another selective serotonin agonist (e.g., sumatriptan),
• if you have severe hepatic disease.

Warnings and precautions

Consult your doctor or pharmacist before taking Almotriptán Normon:

• if your type of migraine has not been diagnosed,
• if you are allergic to antibacterial medicines used to treat urinary tract infections (sulfonamides),
• if your headache symptoms differ from your usual migraine attacks, for example, if you experience ringing in the ears or vertigo, brief paralysis of part of your body, paralysis of muscles controlling eye movement, or any other new symptom,
• if you are at risk of heart disease, including uncontrolled high blood pressure, high cholesterol, obesity, diabetes, if you smoke, have a family history of heart disease, are a postmenopausal woman, or are a man over 40 years of age,
• if you have mild or moderate liver disease,
• if you have severe renal disease,
• if you are over 65 years of age, as you may be more likely to experience increases in blood pressure,
• if you are taking SSRIs (selective serotonin reuptake inhibitors) or SNRIs (serotonin-norepinephrine reuptake inhibitors). See also below, Taking Almotriptán Normon with other medicines.

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

Children and adolescents

Children under 18 years of age should not take Almotriptán Normon.

Patients over 65 years of age

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

Taking Almotriptán Normon with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Please inform your doctor:

• if you are taking any medicines for depression, such as monoamine oxidase inhibitors (e.g., moclobemide), selective serotonin reuptake inhibitors (e.g., fluoxetine), or serotonin-norepinephrine reuptake inhibitors (e.g., venlafaxine), as these medicines may cause serotonin syndrome, a potentially serious reaction to treatment. Symptoms of serotonin syndrome include: confusion, agitation, fever, sweating, uncoordinated movements of limbs or eyes, uncontrollable muscle movements, or diarrhea,
• if you are taking preparations containing St. John's Wort (Hypericum perforatum), as this may increase the likelihood of adverse effects.

Almotriptan should not be taken at the same time as other medicines containing ergotamine, which are also used to treat migraine. However, both medicines may be taken one after the other, provided a minimum time interval 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.

Almotriptán Normon with food and drink

Almotriptán Normon can be taken regardless of meals.

Pregnancy and breastfeeding

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

Information on the use of almotriptan during pregnancy is very limited. Almotriptán Normon should only be used during pregnancy if prescribed by your doctor and only after careful consideration of the benefit-risk balance.

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

Driving and using machines

This medicine, like migraine itself, may cause drowsiness. If you experience these effects, avoid driving or using machinery, as it could be dangerous.

Almotriptán Normon contains sodium

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

3. How to take Almotriptán Normon

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

Almotriptán 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 of age)

The recommended dose is one tablet of Almotriptán Normon (12.5 mg of almotriptan), which 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 following 24 hours, a second 12.5 mg tablet may be taken, provided that at least 2 hours have passed between the first and second tablet.

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

The tablets can be taken with liquid (for example, water) and may 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 still effective if taken somewhat later.

Severe renal impairment

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

If you take more Almotriptán Normon than you should

If you accidentally take too many Almotriptán 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 at telephone number 915 620 420, indicating the name of the medicine and the amount ingested.

If you forget to take Almotriptán Normon

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

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

4. Possible adverse effects

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

Frequent (may affect up to 1 in 10 patients)

• dizziness,
• somnolence,
• nausea,
• vomiting,
• fatigue.

Uncommon (may affect up to 1 in 100 patients)

• tingling, itching, or numbness of the skin (paresthesia),
• headache,
• ringing or other noises in the ears (tinnitus),
• strong or irregular heartbeat (palpitations),
• throat tightness,
• diarrhea,
• discomfort during digestion (dyspepsia),
• dry mouth,
• muscle pain (myalgia),
• bone pain,
• chest pain,
• feeling of weakness (asthenia).

Very rare (may affect up to 1 in 10,000 patients)

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

Frequency not known (cannot be estimated from available data)

• seizures.

During treatment with Almotriptán Normon, immediately inform your doctor:

If you experience chest pain, tightness in the chest or throat, or any other symptom suggestive of a heart attack. Please report this immediately to your doctor and do not take any further Almotriptán Normon tablets.

Reporting of adverse effects

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

By reporting adverse 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 stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Almotriptán Normon 12.5 mg film-coated tablets

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

Appearance of the product and contents of the pack

White, round, biconvex film-coated tablets.

Almotriptán Normon 12.5 mg film-coated tablets are available in packs containing 4, 6, or 9 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the most recent revision of this leaflet: June 2013

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) at http://www.aemps.gob.es/

You can access detailed information about this medicine by scanning the QR code included in the package leaflet and carton with your mobile phone (smartphone). You may also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/77646/P_77646.html