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.
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
Warnings and precautions
Consult your doctor, pharmacist, or nurse before starting to take almotriptán cinfa:
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:
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:
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)
Uncommon(may affect up to 1 in 100 people)
Very rare(may affect up to 1 in 10,000 people)
Unknown frequency(cannot be estimated from available data)
During treatment with almotriptan cinfa, inform your doctor immediately:
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
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
Have questions about this medication or your symptoms? Connect with a licensed doctor for guidance and personalized care.