Almotriptan Viatris 12.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Almotriptan Viatris 12.5 mg film-coated tablets EFG

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 or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Almotriptán Viatris is and what it is used for

Almotriptán Viatris contains almotriptan, a migraine medication belonging to a class of compounds known as selective serotonin receptor agonists (also known as "triptans"). Almotriptan is believed to reduce the inflammatory response associated with migraines by binding to serotonin receptors on cerebral (cranial) blood vessels, causing vasoconstriction.

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

2. What you need to know before taking Almotriptan Viatris

Do not take Almotriptan Viatris

• If you are allergic to the active substance 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 occurring typically during physical activity or stress (angina).
  • Silent heart problems.
  • Chest pain occurring at rest (Prinzmetal's angina).
  • Severe hypertension (very high blood pressure).
  • Uncontrolled mild or moderate hypertension.
• If you have had a stroke, a transient ischaemic attack (also known as "TIA") or reduced blood supply 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, such as ergotamine, dihydroergotamine and methysergide, or another selective serotonin agonist (e.g. sumatriptan). See "Use of Almotriptan Viatris with other medicines" for more information.
• If you have severe liver disease.

Warnings and precautions

Talk to your doctor or pharmacist before taking Almotriptan Viatris if:

• Your type of migraine has not been diagnosed.
• You are allergic to sulphonamide medicines used to treat infections or diuretic tablets.
• 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.
• 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, are a postmenopausal woman, or are a man over 40 years of age.
• You have mild or moderate liver disease.
• You have severe kidney disease.
• You are over 65 years of age (as you are more likely to experience increases in blood pressure).
• You are taking SSRIs (selective serotonin reuptake inhibitors) or SNRIs (serotonin-noradrenaline reuptake inhibitors), or opioid-type painkillers. See also "Use of Almotriptan Viatris with other medicines" below.

During treatment

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

Children and adolescents

Almotriptan must not be used in children and adolescents under 18 years of age.

Elderly patients (over 65 years of age)

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

Use of Almotriptan Viatris with other medicines

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

Tell 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), or if you are taking opioid-type painkillers (e.g., buprenorphine). These medicines may cause serotonin syndrome, a potentially life-threatening reaction. Symptoms of serotonin syndrome include: confusion, agitation, fever, sweating, uncoordinated movements of limbs or eyes, involuntary muscle contractions, or diarrhea.
• If you are taking preparations containing St John’s wort (Hypericum perforatum), as this may increase the likelihood of adverse effects.
• Almotriptan must 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 time interval has elapsed between doses.

After taking almotriptan, wait at least 6 hours before taking ergotamine (a medicine used to treat migraine attacks).

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 only very limited information available on the use of almotriptan during pregnancy.

Pregnancy: Almotriptan should only be used during pregnancy if prescribed by your doctor and only after careful consideration of risks and benefits.

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

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Almotriptan or migraine may cause drowsiness. If you experience drowsiness, you should not drive or operate machinery or tools.

Almotriptan Viatris contains sodium

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

3. How to take Almotriptan Viatris

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Almotriptan should only be used to treat an ongoing migraine attack and not to prevent migraine attacks or other types of headache.

The tablets should be swallowed with liquid (e.g., water) and may be taken with or without food.

Adults (18 - 65 years)

• The recommended dose is one 12.5 mg tablet, 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 for the same attack.
• If you experience a second attack within the following 24 hours, a second 12.5 mg tablet may be taken, provided that at least 2 hours have passed since the first tablet was taken.
• The maximum daily dose is two 12.5 mg tablets within 24 hours.
• You should take Almotriptan Viatris as soon as possible after the onset of a migraine attack, although it remains effective if taken somewhat later.

Patients with severe renal impairment

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

If you take more Almotriptan Viatris than you should

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Poison Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Almotriptan Viatris

Try to take Almotriptan Viatris 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, ask your doctor or pharmacist.

4. Possible adverse effects

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

If you notice any of the following side effects, stop taking this medicine and consult your doctor or go to the nearest hospital emergency department immediately:

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

• Chest pain, sensation of tightness in the chest that may extend to the lower jaw, neck, and arm, discomfort, dizziness, and irregular heartbeat. These may be signs of a heart attack or reduced blood flow to the heart muscle.

Frequency not known (cannot be estimated from available data):

• Severe and sudden allergic reaction such as skin rash, itching, swelling of the face, lips, tongue, or other parts of the body, tightness in the chest, wheezing.
• Seizures (fits).
• Reduced blood flow to the intestine, which may cause intestinal damage (intestinal ischemia). You may experience abdominal pain and bloody diarrhea.

During treatment with Almotriptan Viatris, inform your doctor immediately:

• This medicine may cause short-term chest pain or tightness in the chest and throat, which may be intense. If these effects last a long time, or if you notice them when you are not taking this medicine, inform your doctor immediately and do not take any more Almotriptan Viatris tablets. These effects may be signs of problems with blood flow to the heart.

Other possible adverse effects

Frequent (may affect up to 1 in 10 patients):

• Dizziness.
• Drowsiness.
• Nausea.
• Vomiting.
• Fatigue.

Uncommon (may affect up to 1 in 100 patients):

• Tingling, pricking, or numbness of the skin (paraesthesia).
• Headache.
• Ringing, buzzing, or hissing sounds in the ears (tinnitus).
• Strong heartbeats (palpitations).
• Diarrhea.
• Digestive discomfort (dyspepsia).
• Dry mouth.
• Muscle pain (myalgia).
• Bone pain.
• Feeling of weakness (asthenia).

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

• Increased heart rate (tachycardia).

Not known (cannot be estimated from available data):

• Visual impairment, blurred vision (visual disturbances may also occur during a migraine attack itself).

Reporting of adverse effects:

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Almotriptan Viatris

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the blister and outer packaging following CAD. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater drains or household waste. Unused medicines and their packaging should be returned to the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment.

6. Contents of the pack and other information

Composition of Almotriptan Viatris

• The active substance is almotriptan malate. Each film-coated tablet contains almotriptan malate equivalent to 12.5 mg of almotriptan.

• The other components are:

• Tablet core: mannitol (E421), microcrystalline cellulose, povidone, sodium starch glycolate from potato, and stearic fumarate and sodium. See section 2 “Almotriptan Viatris contains sodium”.

• Coating material: hypromellose, titanium dioxide (E171), macrogol.

Appearance of Almotriptan Viatris and contents of the pack

Almotriptan Viatris are white or almost white, round, biconvex tablets, marked with “M” on one side and “AL2” on the other.

Almotriptan Viatris tablets are packed in blisters of 3, 4, 6, 9 and 12.

Almotriptan Viatris tablets are also packed in perforated unit-dose blisters of 4 and 6.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer(s)

McDermott Laboratories Ltd t/a Gerard Laboratories
35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13
Ireland

Or

Mylan Hungary Kft.
Mylan utca 1., Komárom, 2900
Hungary

For more information about this medicinal product, contact the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.
C/ General Aranaz, 86
28027 - Madrid
Spain

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

Spain – Almotriptan Viatris 12.5 mg film-coated tablets EFG
France – ALMOTRIPTAN VIATRIS 12.5 mg, film-coated tablet
Italy – Almotriptan MYLAN

Date of the most recent revision of this leaflet: November 2020

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (Agencia Española de Medicamentos y Productos Sanitarios - AEMPS): http://www.aemps.gob.es/