Leaflet: information for the user

Almotriptan cinfa 12.5 mg film-coated tablets

Read 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 questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse. See section 4.

1.Whatisalmotriptancinfaandwhatisitusedfor.

2.Whatyouneedtoknowbeforestartingtotakealmotriptancinfa.

3.Howtotakealmotriptancinfa.

4.Possiblesideeffects.

5.Storageofalmotriptancinfa.

6.Contentsofthepackandadditionalinformation.

Almotriptán cinfa is a migraine 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 the serotonin receptors of the cerebral (cranial) blood vessels, causing vasoconstriction.

Almotriptán cinfa is used to relieve the headaches associated with migraine attacks with or without aura.

Do not take almotriptán cinfa

• If you are allergic to almotriptán or any of the other ingredients of this medicine (listed in section 6).
• If you have or have had any disease that limits the blood supply to the heart, such as:

• Myocardial infarction.
• Chest pain or discomfort that occurs normally after physical activity or stress.
• Cardiac problems without pain.
• Chest pain that occurs at rest.
• Severe hypertension (very high blood pressure).
• Uncontrolled hypertension, mild or moderate.

• If you have had a stroke or a reduction in cerebral blood flow.
• If you have had a blockage of the large arteries of the arms or legs (peripheral vascular disease).
• If you are taking other medications for migraine, including ergotamine, dihydroergotamine, and methysergide or other selective serotonin receptor agonists (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 antibiotics used for the treatment of urinary tract infections (sulfonamides).
• If your headache symptoms are different from your usual migraine symptoms, for example, you hear ringing in your ears or have vertigo, have a brief paralysis of a part of your body or paralysis of the muscles that control your eye movement, or any other new symptom.
• If you are at risk of developing 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 a man 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 such as selective serotonin reuptake inhibitors (SSRIs) or serotonin and noradrenaline reuptake inhibitors (SNRIs). See also below, Taking almotriptán cinfa with other medicines.

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

Children and adolescents

Children under 18 years should not take this medicine.

Older patients

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

Other medicines and almotriptán cinfa

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

Please inform your doctor:

• If you are taking any medication for depression such as monoamine oxidase inhibitors (e.g. meclobemide), selective serotonin reuptake inhibitors (e.g. fluoxetine) or serotonin and noradrenaline reuptake inhibitors (e.g. venlafaxine), as these medications may cause serotonin syndrome, a potentially very serious treatment reaction. Symptoms of serotonin syndrome include: confusion, agitation, fever, sweating, uncoordinated movements of the limbs or eyes, uncontrollable muscle movements or diarrhea.
• If you are taking preparations based on St. John's Wort (Hypericum perforatum), as it may increase the likelihood of adverse effects.

Almotriptán 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 a minimum time has elapsed between the 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, or think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medicine.

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

Use of this medicine during breastfeeding should be approached with caution. You should avoid breastfeeding for 24 hours after treatment.

Driving and operating machinery

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

Almotriptán cinfa contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Almotriptan cinfa should only be used to treat an existing migraine attack and not to prevent migraine or headache attacks.

Adults (18-65 years)

The recommended dose is a 12.5 mg almotriptan tablet that should be taken as soon as possible after the onset of a migraine crisis. If the crisis does not subside, do not take more than one tablet.

If you experience a second crisis within the next 24 hours, you can take a second 12.5 mg tablet, but only after 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. Almotriptan cinfa should be taken as soon as possible after the onset of a migraine crisis, although it is also effective if taken a little 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, 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 almotriptan cinfa

Try to take this medication as prescribed. Do not take a double dose to compensate for missed doses.

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

Like all medicines,thismedicinecan 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)

• Sensation of tingling, itching, or numbness of the skin (paresthesia).
• Headache.
• Ringing, buzzing, or clicking sounds (tinnitus).
• Palpitations.
• Throat constriction.
• Diarrhea.
• Discomfort when digesting food (dyspepsia).
• Dry mouth.
• Muscle pain (myalgia).
• Bone pain.
• Chest pain.
• Sensation of weakness (asthenia).

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

• Coronary artery spasm.
• Heart attack (myocardial infarction).
• Tachycardia.

Unknown frequency(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 may also occur during a migraine attack itself).
• Intestinal vasospasm that may cause inadequate blood flow and damage to your intestine. You may experience abdominal pain and bloody diarrhea.

During treatment with almotriptan cinfa, inform your doctor immediately:

• If you experience chest pain, throat constriction, or any other symptom that suggests a heart attack. Please inform your doctor immediately and do not take any other almotriptan cinfa tablets.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthismedicationoutofsightandoutofreachofchildren.

Do not use this medication after the expiration date that appears on the packaging, after CAD.

Theexpirationdateisthelastdayofthemonththatisindicated.

Thismedicationdoesnotrequirespecialstorageconditions.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications that you no longer need at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications that you no longer need. By doing so, you will help protect the environment.

Composition of almotriptan cinfa

• Theactiveingredientisalmotriptan.Eachfilm-coatedtabletcontains12.5mgofalmotriptanasalmotriptanmalate.
• Theothercomponentsare:
• • Core of the tablet: mannitol, microcrystalline cellulose, povidone, sodium carboxymethylcellulose (type A) (from potato), and stearate and sodium fumarate.
  • Coatingofthetablet: hypromellose (E-464), titanium dioxide (E-171), and macrogol 400.

Appearance of the product and contents of the package

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

Itispresentedinaluminum-aluminum or PVC-aluminum blisters.

Eachpackagecontains3, 4, 6, or 9 film-coated tablets.

Itmayonlybecommercializedinsomepackagesizes.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Cinfa, S.A

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Responsible for manufacturing

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

Last review date of this leaflet:June2021

ThedetailedinformationaboutthismedicineisavailableonthewebsiteoftheSpanishAgencyforMedicinesandHealthProducts(AEMPS)http://www.aemps.gob.es/

YoucanaccessdetailedandupdatedinformationaboutthismedicinebyscanningtheQRcodeincludedintheleafletandthecarton.Alsoyoucanaccessthisinformationonthefollowinginternetaddress:https://cima.aemps.es/cima/dochtml/p/78686/P_78686.html

QRcodeto:https://cima.aemps.es/cima/dochtml/p/78686/P_78686.html