Amignul 12,5 mg comprimidos recubiertos con pelicula

Prospecto: Information for the User

Amignul 12.5 mg Film-Coated Tablets

Almotriptan

Read this prospectus carefully before starting to take the medicine, as it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not mentioned in this prospectus. See section 4

1.What Amignul is and for what it is used

2.What you need to know before starting to take Amignul

3.How to take Amignul

4.Possible adverse effects

5.Storage of Amignul

6. Contents of the pack and additional information

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

Amignul is used to relieve headaches associated with migraine attacks with or without aura.

Do not take Amignul

-if you are allergic to almotriptan 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, mild, or moderate hypertension

-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 medicines for migraine, including ergotamine, dihydroergotamine, and methysergideor another selective serotonin receptor agonist (e.g. sumatriptan)

-if you have liver diseasesevere.

Warnings and precautions

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

• if your type of migraine has not been diagnosed
• if you have an allergy (hypersensitivity) 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 feel dizzy, 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 have a 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 womanor are amanover 40 years old

-if you have mild or moderate liver disease

-if you have kidney diseasesevere

-if you are over 65 years old, as you are more likely to experience increased blood pressure

-if you are taking selective serotonin reuptake inhibitors (SSRIs) or serotonin and noradrenaline reuptake inhibitors (SNRIs). See also below, Taking Amignul 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 old should not take Amignul.

Over 65 years old

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

Taking Amignul with other medicines

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

Please inform your doctor:

• if you are taking any medicine 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 medicines may causeserotonin syndrome, a potentially very serious treatment reaction. The symptoms of serotonin syndrome include: confusion, agitation, fever, sweating, uncoordinated movements of the limbs or eyes, involuntary 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.

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 a minimum time has elapsed between the 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.

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 almotriptan during pregnancy. Amignul should only be used during pregnancy if prescribed by your doctor and only after careful consideration of the balance of benefits and risks.

Caution should be exercised when using this medicine duringbreastfeeding. You should avoid breastfeeding for 24 hours after treatment.

Driving and operating machinery

Amignul may cause drowsiness. If you experience it, you should not drive or operate machinery.

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

Amignul should only be used to treat a migraine attack that has already occurred and not to prevent migraine or headache attacks.

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

Adults (18-65 years)

The recommended dose is a tablet ofAmignul(12.5 mg of almotriptan) 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 tablet of 12.5 mg, but only if at least2 hours have passed between the first and second tablets.

The maximum daily dose is two tablets of 12.5 mg in 24 hours.

The tablets can be taken with a liquid (e.g., water) and can be taken with or without food.

Amignul 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 disease

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

If you take moreAmignulthan you should

If you accidentally take too many tablets ofAmignul, or if another person or child takes this medication, consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, contact the Toxicological Information Service. Phone 915 620 420.

If you forgot to takeAmignul

Try to takeAmignulas prescribed. Do not take a double dose to compensate for the missed doses.

If you have anyotherdoubtsaboutthe use ofthis medication, consult your doctor,pharmacistor nurse.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Frequent(may affect up to 1 in 10 people)

• dizziness
• drowsiness
• nausea
• vomiting
• fatigue

Less frequent(may affect up to 1 in 100 people)

• tingling, itching, or numbness of the skin (paresthesia)
• headache
• ringing, buzzing, or clicking in the ears (tinnitus)
• palpitations
• throat constriction
• diarrhea
• indigestion when eating (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)

• coronary artery spasm
• heart attack (myocardial infarction)
• increased heart rate (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 blood vessel spasm that may cause inadequate blood flow and damage to your intestine. You may experience abdominal pain and bloody diarrhea.

During treatment with Amignul, 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 Amignul tablets.

Reporting 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 the 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.

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

Do not use this medication after the expiration date that appears on thecontainer, after “CAD”. 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 drains or in the trash.Dispose of containers and medications you no longer need at the SIGREcollection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Amignul

The active ingredient is almotriptan 12.5 mg (in the form of almotriptan D,L-malate acid).

The other components are:

Core of the tablet: mannitol (E-421), microcrystalline cellulose, povidone, sodium carboxymethylcellulose, and stearate and sodium fumarate.

Coating material: hypromellose, titanium dioxide (E-171), macrogol 400, and carnauba wax.

Appearance of the product and content of the container

Amignul is available in film-coated tablets, white, circular, and biconvex, for oral use, with a letter A engraved on one of the faces.

Amignul is available in boxes containing 2, 3, 4, 6, 7, 9, 12, 14, or 18 tablets. In Spain, boxes of 4 and 6 tablets are marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Almirall, S.A. General Mitre, 151 08022 - Barcelona (Spain).

Responsible for manufacturing

Industrias Farmacéuticas Almirall, S.A. Ctra.de Martorell, 41-6108740 Sant Andreu de la Barca - Barcelona (Spain).

This medicine is authorized in the member states of the European Economic Area with the following names:

Date of the last review of this leaflet: January 2021

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/