Almotriptan Cinfa 12.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

almotriptan cinfa 12.5 mg film-coated tablets EFG

Read the entire 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, ask your doctor, pharmacist or nurse.
• 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, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What almotriptan cinfa is and what it is used for

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

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

2. What you need to know before taking almotriptan cinfa

Do not take almotriptan cinfa

• 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 restricts blood flow to the heart, such as:

  • Myocardial infarction.
  • Chest pain or discomfort that usually occurs during physical activity or stress.
  • Heart problems without pain.
  • Chest pain that occurs at rest.
  • Severe hypertension (very high blood pressure).
  • Mild or moderate uncontrolled hypertension.

• If you have had a stroke or reduced blood flow to the brain.

• If you have had a blockage in the large arteries of the arms or legs (peripheral vascular disease).

• If you are taking other medicines for migraine, including ergotamine, dihydroergotamine, methysergide, or another selective serotonin agonist (e.g., sumatriptan).

• If you have severe liver problems.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking almotriptan cinfa:

• If your type of headache has not been diagnosed.
• If you have an allergy (hypersensitivity) to antibacterial medicines used to treat urinary tract infections (sulfonamides).
• If your headache symptoms are different 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 a man over 40 years of age.
• If you have mild or moderate liver problems.
• If you have severe kidney problems.
• 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 almotriptan cinfa 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 this medicine.

Elderly patients (over 65 years of age)

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

Other medicines and almotriptan cinfa

Tell 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 medicine 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 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, wait at least 6 hours before taking ergotamine.
• After taking ergotamine, wait at least 24 hours before taking almotriptan.

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. Almotriptan cinfa 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 use of machines

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

almotriptan cinfa 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 cinfa

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

Almotriptan cinfa 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 12.5 mg almotriptan tablet, 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 may be taken with liquid (e.g., water) and may be taken with or without food. Almotriptan cinfa should be taken as soon as possible after the onset of a migraine attack, although it is still effective if taken somewhat later.

Severe kidney problems

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

If you take more almotriptan cinfa than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take almotriptan cinfa

Try to take this medicine 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, pharmacist, or nurse.

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 people)

• Dizziness
• Somnolence
• Nausea
• Vomiting
• Fatigue

Uncommon (may affect up to 1 in 100 people)

• Tingling, itching, or numbness of the skin (paresthesia)
• Headache
• Ringing, noises, or clicking sounds in the ears (tinnitus)
• Strong or rapid 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 people)

• 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)

• Allergic reactions (hypersensitivity reactions), including swelling of the mouth, neck, or hands (angioedema)
• Severe allergic reactions (anaphylactic reactions)
• Seizures
• Visual disturbances, blurred vision (visual disorders may also occur during a migraine attack itself)
• Spasm of the intestinal blood vessels, which may lead to reduced blood flow and damage to the intestine. You may experience abdominal pain and bloody diarrhea.

During treatment with almotriptan cinfa, immediately inform your doctor:

• If you experience chest pain, chest tightness, throat tightness, or any other symptoms suggestive of a heart attack. Please report this immediately to your doctor and do not take any further almotriptan cinfa tablets.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, 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: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of almotriptan cinfa

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

Do not use this medicine after the expiry date stated on the packaging, following EXP.

The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater drains or household waste. Unused medicines and their containers should be taken to the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of any unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and other information

Composition of almotriptan cinfa

• The active substance is almotriptan. Each film-coated tablet contains 12.5 mg of almotriptan as almotriptan malate.
• The other components are:
  • Tablet core: mannitol, microcrystalline cellulose, povidone, sodium carboxymethyl starch (type A) (from potato), and stearic fumarate and sodium.
  • Tablet coating: hypromellose (E-464), titanium dioxide (E-171), and macrogol 400.

Appearance of the product and contents of the container

Almotriptan cinfa are white, round, biconvex film-coated tablets.

They are presented in ALU/ALU or PVC/ALU blisters.

Each pack contains 3, 4, 6, or 9 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial Areta
31620 Huarte (Navarra) - Spain

Manufacturer

Galenicum Health S.L.U.
Sant Gabriel, 50, Esplugues de Llobregat,
08950, Barcelona (Spain)

or

Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial Areta
31620 Huarte (Navarra) - Spain

Date of the most recent review of this leaflet: June 2021

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

You can access detailed and up-to-date information on this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/78686/P_78686.html

QR code to: https://cima.aemps.es/cima/dochtml/p/78686/P_78686.html