Amignul 12.5 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Amignul 12.5 mg Film-coated tablets

Almotriptan

Read the entire 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 and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Amignul is and what it is used for
2. What you need to know before taking Amignul
3. How to take Amignul
4. Possible adverse effects
5. How to store Amignul
6. Contents of the pack and other information

1. What Amignul is and what it is used for

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

Amignul is used to relieve headaches 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 to any of the other ingredients of this medicine (listed in section 6)

• if you have or have ever had any condition that reduces blood flow to the heart, such as:

  • myocardial infarction
  • chest pain or discomfort that usually occurs during physical activity or stress
  • heart problems without pain
  • chest pain occurring at rest
  • severe hypertension (very high blood pressure)
  • uncontrolled mild or moderate hypertension

• if you have had a stroke or reduced blood flow to the brain

  • if you have had a blockage in the major arteries of the arms or legs (peripheral vascular disease)

• if you are taking other medicines for migraine, including ergotamine, dihydroergotamine, methysergide, or another selective serotonin agonist (e.g. sumatriptan)

• if you have severe liver disease.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Amignul:

• if your type of headache has not been diagnosed

• if you are allergic (hypersensitive) to antibacterial medicines used to treat urinary tract infections (sulfonamides)

• if your headache symptoms are different from your usual migraine attacks, for example, if you experience tinnitus or vertigo, brief paralysis of part of your body, paralysis of the muscles controlling eye movement, or any other new symptom

• if you are at risk of heart disease, including uncontrolled high blood pressure, high cholesterol, obesity, diabetes, if you smoke, have a family history of heart disease, if you are a postmenopausal woman, or a man over 40 years of age

• if you have mild or moderate liver disease

• if you have severe kidney disease

• if you are over 65 years of age, as you may be more likely to experience increases in blood pressure

• if you are taking SSRIs (selective serotonin reuptake inhibitors) or SNRIs (serotonin-noradrenaline reuptake inhibitors). See also below, Taking Amignul with other medicines.

It has been suggested that excessive use of anti-migraine medications may lead to chronic headache.

Children and adolescents

Children under 18 years of age should not take Amignul.

People over 65 years of age

If you are over 65, 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 need to take any other medicines.

Please inform your doctor:

• if you are taking any medicines for depression such as monoamine oxidase inhibitors (e.g. moclobemide), selective serotonin reuptake inhibitors (e.g. fluoxetine), or serotonin-noradrenaline reuptake inhibitors (e.g. venlafaxine), as these medicines may cause serotonin syndrome, a potentially serious reaction to treatment. Symptoms of serotonin syndrome include: confusion, agitation, fever, sweating, uncoordinated movements of limbs or eyes, uncontrollable muscle movements, or diarrhea.

• if you are taking herbal preparations containing St. John’s wort (Hypericum perforatum), as this may increase the likelihood of adverse effects.

Almotriptan should not be taken at the same time as other medicines containing ergotamine, which are also used to treat migraine. However, both medicines may be taken one after the other, provided a minimum interval has elapsed between doses:

• after taking almotriptan, wait at least 6 hours before taking ergotamine
• after taking ergotamine, wait at least 24 hours before taking almotriptan.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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 only after careful consideration of the benefit-risk balance.

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

Driving and use of machines

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

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

3. How to take Amignul

Amignul should only be used to treat an acute migraine attack once it has started, and not to prevent migraine attacks or headaches.

Always follow the administration instructions for this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Adults (18–65 years of age)

The recommended dose is one Amignul tablet (12.5 mg of almotriptan), 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 following 24 hours, a second tablet of 12.5 mg may be taken, provided that at least 2 hours have elapsed between the first and second tablet.

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

The tablets may be taken with liquid (for example, water) and may be taken with or without food.

Amignul should be taken as soon as possible after the onset of a migraine attack, although it may still be effective if taken somewhat later.

Severe renal impairment

If you have severe renal 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, contact your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, contact 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 missed doses.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Frequent (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, noises, or clicking sounds in the ears (tinnitus)
• strong heartbeats (palpitations)
• throat tightness
• diarrhea
• discomfort during digestion (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 blood vessels in the heart (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)
• spasm of the blood vessels in the intestine, which may cause reduced blood flow and damage to your intestine. You may experience abdominal pain and bloody diarrhea.

During treatment with Amignul, immediately inform your doctor:

• if you have chest pain, chest tightness, throat tightness, or any other symptom suggesting a heart attack. Please report this immediately to your doctor and do not take any further Amignul tablets.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 expiry date stated on the packaging, following "EXP". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This way, you will help protect the environment.

6. Package contents and other information

Composition of Amignul

The active substance is almotriptan 12.5 mg (as almotriptan D,L-malic acid salt).

The other components are:

Tablet core: mannitol (E-421), microcrystalline cellulose, povidone, sodium carboxymethylstarch, and stearic fumarate and sodium.

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

Appearance of the product and contents of the pack

Amignul is available as white, round, biconvex film-coated tablets for oral use, with the 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 medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the most recent review of this leaflet: January 2021

Up-to-date detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/