AMIGNUL 12.5 mg FILM-COATED TABLETS

Introduction

Leaflet: Information for the user

Amignul 12.5 mg Film-coated tablets

Almotriptan

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

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed to 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 side effects, consult your doctor, pharmacist, or nurse, even if they are not mentioned in this leaflet. See section 4.

Contents of the leaflet

1. What is Amignul and what is it used for
2. What you need to know before taking Amignul
3. How to take Amignul
4. Possible side effects
5. Storage of Amignul
6. Package contents and additional information

1. What is Amignul and what is it used for

Amignul is an antimigraine drug 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 serotonin receptors in cerebral blood vessels (cranial), causing vasoconstriction.

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

2. What you need to know before taking Amignul

Do not take Amignul

• if you are allergic to almotriptan or any of the other components of this medicine (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 in the arms or legs (peripheral vascular disease)

• if you are taking other medicines to combat migraines, including ergotamine, dihydroergotamine, and methysergide or another selective serotonin agonist (e.g., sumatriptan)
• if you have severe liver disease.

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 are allergic (hypersensitive) to antibacterial medicines 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, have 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, are a smoker, have a family history of heart disease, are a postmenopausal woman, or are a man over 40 years old
• if you have mild or moderate liver disease
• if you have severe kidney disease
• if you are over 65 years old, as you are more likely to experience increased blood pressure
• if you are taking antidepressants (SSRIs or SNRIs). See also below, Taking Amignul with other medicines.

It has been suggested that excessive use of antimigraine 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

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other type of medicine.

Please inform your doctor:

• if you are taking any medicine for the treatment of 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 medicines may cause serotonin syndrome, a potentially very serious reaction to treatment. 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.

Almotriptan should not be taken at the same time as other medicines that contain ergotamine, which are also used to treat migraines. However, both medicines can be taken one after the other, provided that a minimum amount of time has passed between 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, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

There is very limited information on the use of almotriptan during pregnancy. Amignul should only be used during pregnancy if prescribed by your doctor and after carefully considering the balance of benefits and risks.

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

Driving and using machines

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; it is essentially "sodium-free".

3. How to take Amignul

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

Follow the administration instructions of this medicine exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Adults (18-65 years)

The recommended dose is one Amignul tablet (12.5 mg of almotriptan) that should be taken as soon as possible after the start 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 always provided that 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.

Amignul should be taken as soon as possible after the start of a migraine attack, although it is also effective if taken later.

Severe kidney disease

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

If you take more Amignul than you should

If you accidentally take too many Amignul tablets, or if someone else or a child takes this medicine, consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Telephone 915 620 420.

If you forget to take Amignul

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

If you have any other doubts about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Common(may affect up to 1 in 10 people)

• dizziness
• drowsiness
• nausea
• vomiting
• fatigue

Uncommon(may affect up to 1 in 100 people)

• tingling, itching, or numbness of the skin (paresthesia)
• headache
• ringing, noise, or clicking (tinnitus)
• strong heartbeats (palpitations)
• throat tightness
• diarrhea
• indigestion (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 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)
• intestinal vasospasm that can cause lack of blood flow and damage your intestine. You may experience abdominal pain and bloody diarrhea.

During treatment with Amignul, inform your doctor immediately:

• if you have chest pain, tightness in the chest or throat, or any other symptoms that may suggest a heart attack. Please inform your doctor immediately and do not take any more Amignul tablets.

Reporting side effects

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

5. Storage of Amignul

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

Do not use this medicine after the expiration date stated on the packaging, after "EXP". The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

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

6. Package contents and additional information

Composition of Amignul

The active ingredient is almotriptan 12.5 mg (as almotriptan D,L-malate acid).

The other ingredients are:

Core of the tablet: mannitol (E-421), microcrystalline cellulose, povidone, sodium carboxymethyl starch, and sodium stearyl fumarate.

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

Appearance of the product and package contents

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

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

Marketing authorization holder and manufacturer

Marketing authorization holder

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

Manufacturer

Industrias Farmacéuticas Almirall, S.A. Ctra. de Martorell, 41-61 08740 Sant Andreu de la Barca - Barcelona (Spain).

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this leaflet: January 2021

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