Almotriptan Kern Pharma 12.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

AlmotriptanKern Pharma 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Almotriptán Kern Pharma is and what it is used for

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

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

2. What you need to know before taking Almotriptán Kern Pharma

Do not take Almotriptán Kern Pharma

• 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 any condition that impairs blood flow to the heart, such as:

  • myocardial infarction,
  • chest pain or discomfort that usually occurs during physical activity or stress,
  • silent cardiac problems,
  • chest pain occurring at rest,
  • severe hypertension (very high blood pressure),
  • uncontrolled mild or moderate hypertension.

• if you have had a stroke or reduced cerebral blood flow,

• if you have had blockage of the large arteries in the arms or legs (peripheral vascular disease),

• if you are taking other migraine medications, including ergotamine, dihydroergotamine, 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 Kern Pharma:

• 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 tinnitus or vertigo, brief paralysis of part of your body, paralysis of the 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 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-noradrenaline reuptake inhibitors). See also below, Taking Almotriptán Kern Pharma with other medicines.

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

Children and adolescents

Children under 18 years of age should not take Almotriptán Kern Pharma.

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 Kern Pharma with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

Please tell 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-noradrenaline reuptake inhibitors (e.g., venlafaxine), as these medicines may cause serotonin syndrome, a potentially serious reaction. Symptoms of serotonin syndrome include: confusion, agitation, fever, sweating, uncoordinated movements of limbs or eyes, involuntary muscle contractions, or diarrhea,
• if you are taking herbal 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 sequentially, provided a minimum interval has elapsed between doses:

• after taking almotriptan, wait at least 6 hours before taking ergotamine,
• after taking ergotamine, wait at least 24 hours before taking Almotriptán.

Almotriptán Kern Pharma with food and drinks

Almotriptán Kern Pharma can be taken regardless of meals.

Pregnancy and breastfeeding

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

There is very limited information on the use of almotriptan during pregnancy. Almotriptán Kern Pharma 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 following treatment.

Driving and using machines

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

3. How to take Almotriptán Kern Pharma

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Almotriptán Kern Pharma 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 Kern Pharma (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 elapsed 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 (e.g., water) and may be taken with or without food.

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

Severe renal impairment

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

If you take more Almotriptán Kern Pharma than you should

If you accidentally take too many Almotriptán Kern Pharma 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. Telephone 915 620 420, indicating the medicine and the amount ingested.

If you forget to take Almotriptán Kern Pharma

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

If you have any questions about the use of Almotriptán Kern Pharma, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences 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, noises, or clicking sounds in the ears (tinnitus)
• strong heartbeats (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 Kern Pharma, immediately inform your doctor:

If you experience chest pain, chest or throat tightness, or any other symptom suggesting a heart attack. Please report this immediately to your doctor and do not take any further Almotriptán Kern Pharma 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 may 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 Kern Pharma

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 is the last day of the month indicated.

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

6. Contents of the pack and other information

Composition of Almotriptán Kern Pharma 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:
  Tablet core: mannitol (E-421), microcrystalline cellulose, povidone, sodium starch glycolate from potato, and stearic acid and sodium fumarate.
  Tablet coating: hypromellose, titanium dioxide (E-171), macrogol 400 and talc.

Appearance of the medicinal product and contents of the pack

Almotriptán Kern Pharma 12.5 mg film-coated tablets are supplied in packs containing 4 and 6 tablets.

White, circular, biconvex film-coated tablets.

Marketing Authorisation Holder

Kern Pharma, S.L.
Polígono Ind. Colón II. Venus 72
08228 Terrassa (Barcelona)

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 and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/