ALMOTRIPTAN CINFA 12.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

almotriptán cinfa 12.5 mg film-coated tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not mentioned in this package leaflet. See section 4.

Contents of the Package Leaflet:

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

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

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

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

2. What you need to know before taking almotriptán cinfa

Do not take almotriptán cinfa

• If you are allergic to almotriptán or any of the other ingredients of this medication (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 medications to combat migraines, including ergotamine, dihydroergotamine, and methysergide or another selective serotonin agonist (e.g., sumatriptan).
• If you have severe liver problems.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take almotriptán cinfa:

• If your type of migraine has not been diagnosed.
• If you are allergic (hypersensitive) to antibacterial medications 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 symptoms.
• If you are at risk of having heart disease, including high blood pressure and uncontrolled cholesterol, obesity, diabetes, smoking, family history of heart disease, postmenopausal women, or men over 40 years old.
• If you have mild or moderate liver problems.
• If you have severe kidney problems.
• If you are over 65 years old, as you are more likely to experience increased blood pressure.
• If you are taking antidepressants (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs). See also below, Taking almotriptán cinfa with other medications.

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

Children and adolescents

Children under 18 years old should not take this medication.

Patientsof advanced age (over 65 years old)

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

Other medications and almotriptán cinfa

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

Please inform your doctor:

• If you are taking any medication 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 medications may cause serotonin syndrome, a potentially very serious treatment reaction. 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 (Hypericum perforatum) preparations, as they may increase the likelihood of side effects.

Almotriptán should not be taken at the same time as other medications that contain ergotamine, which are also used to treat migraines. However, both medications can be taken one after the other, provided that a minimum amount of time has passed between doses:

• After taking almotriptán, 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 almotriptán.

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 medication.

There is only limited information available on the use of almotriptán during pregnancy. Almotriptán cinfa should only be used during pregnancy if prescribed by your doctor and after carefully considering the balance of benefits and risks.

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

Driving and using machines

This medication, like migraines, can cause drowsiness. If you notice these effects, avoid driving or using machines, as it may be dangerous.

almotriptán cinfa contains sodium

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

3. How to take almotriptán cinfa

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Almotriptán cinfa 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 old)

The recommended dose is one 12.5 mg tablet of almotriptán, 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 next 24 hours, you can take a second 12.5 mg tablet, but only if at least 2 hours have passed between the first and second tablets.

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. Almotriptán cinfa should be taken as soon as possible after the onset of a migraine attack, although it is also effective if taken 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 almotriptán cinfa than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take almotriptán cinfa

Try to take this medication as prescribed. Do not take a double dose to make up for forgotten doses.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Common (may affect up to 1 in 10 people)

• Dizziness.
• Drowsiness.
• Nausea.
• Vomiting.
• Fatigue.

Uncommon (may affect up to 1 in 100 people)

• Feeling of tingling, itching, or numbness of the skin (paresthesia).
• Headache.
• Ringing, noises, clicking (tinnitus).
• Strong heartbeat (palpitations).
• Throat tightness.
• Diarrhea.
• Discomfort when digesting food (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 coronary blood vessels (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 disturbances can also occur during a migraine attack itself).
• Spasm of the blood vessels of the intestine, which can cause lack of blood flow and damage to the intestine. You may experience abdominal pain and bloody diarrhea.

During treatment with almotriptán cinfa, inform your doctor immediately:

• If you experience chest pain, tightness in the chest or throat, or any other symptoms that may indicate a heart attack. Please inform your doctor immediately and do not take any more almotriptán cinfa tablets.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not mentioned in this package leaflet. You can also report them directly through the Spanish Medicines Monitoring System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of almotriptán cinfa

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date stated on the packaging, after EXP.

The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Dispose of packaging and unused medications at the pharmacy's SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of packaging and unused medications. This will help protect the environment.

6. Contents of the pack and further information

Composition of almotriptán cinfa

• The active ingredient is almotriptán. Each film-coated tablet contains 12.5 mg of almotriptán as almotriptán malate.
• The other ingredients are:
• • Core of the tablet: mannitol, microcrystalline cellulose, povidone, sodium carboxymethyl starch (type A) (potato), and sodium stearyl fumarate.
  • Coating of the tablet: hypromellose (E-464), titanium dioxide (E-171), and macrogol 400.

Appearance of the product and contents of the pack

Almotriptán cinfa are film-coated tablets, white, circular, and biconvex.

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

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

Not all 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 last revision of this package leaflet:June 20, 2021

Detailed information about this medication 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 updated information about this medication by scanning the QR code included in the package leaflet and carton with your smartphone. 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