ALMOTRIPTAN KERN PHARMA 12.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

AlmotriptanKern Pharma12.5 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, as 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 pack

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

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

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

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

2. What you need to know before you take Almotriptan Kern Pharma

Do not take AlmotriptanKernPharma

• 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 medicines for migraine, including ergotamine, dihydroergotamine and methysergide or another selective serotonin agonist (e.g. sumatriptan),
• if you have severeliver disease

Warnings and precautions

Consult your doctor or pharmacist before starting to take Almotriptan 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 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 a brief paralysis of a part of your body or paralysis of the muscles that control your eye movements, or any other new symptom,
• if you are at risk of having 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 are a man over 40 years old,
• if you have mild or moderate liver disease,
• if you have severekidney disease,
• if you are over 65 years old, as you are more likely to experience increases in blood pressure,
• if you are taking antidepressant ISRS (selective serotonin reuptake inhibitors) or IRSN (serotonin and norepinephrine reuptake inhibitors). See also below, Taking Almotriptan Kern Pharma with other medicines.

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

Children and adolescents

Children under 18 years old should not take Almotriptan Kern Pharma.

Over 65 years of age

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

Taking AlmotriptanKernPharmawith other medicines

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

Please inform your doctor:

• if you are taking any medicine 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 medicines may cause serotonin syndrome, a potentially very serious reaction to treatment. 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 preparations (Hypericum perforatum), as it may increase the likelihood of experiencing side effects.

Almotriptan should not be taken at the same time as other medicines that contain ergotamine, which are also used to treat migraine. However, both medicines 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.

AlmotriptanKern Pharmawith food and drink

Almotriptan Kern Pharma 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 Kern Pharma should only be used during pregnancy if prescribed by your doctor and only after carefully considering the balance of benefits and risks.

Cautious use is required when using this medicine during breastfeeding. You should avoid breastfeeding during the 24 hours following treatment.

Driving and using machines

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

3. How to take Almotriptan Kern Pharma

Follow exactly the administration instructions of this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist again.

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

Adults (18-65 years)

The recommended dose is one Almotriptan Kern Pharma 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 tablet.

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 Kern Pharma 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 AlmotriptanKernPharmathan you should

If you accidentally take too many Almotriptan 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, consult the Toxicology Information Service. Telephone 915 620 420, indicating the medicine and the amount ingested.

If you forget to take AlmotriptanKernPharma

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Frequent(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, clicking (tinnitus)
• strong heartbeat (palpitations)
• throat tightness
• diarrhea
• indigestion
• dry mouth
• muscle pain (myalgia)
• bone pain
• chest pain
• feeling of weakness (asthenia)

Very 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 experience:

Chest pain, tightness in the chest or throat, or any other symptom that may suggest a heart attack. Please inform your doctor immediately and do not take any further Almotriptan Kern Pharma tablets.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines (Website: www.notificaRAM.es).

By reporting side 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 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 further information

Composition of AlmotriptanKern Pharma12.5 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

Almotriptan Kern Pharma 12.5 mg film-coated tablets are available in packs of 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 last revision of this leaflet:June 2013

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