ALMOTRIPTAN VIATRIS 12.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Almotriptan Viatris 12.5 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

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

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

Almotriptan Viatris contains almotriptan, an antimigraine 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 in cerebral blood vessels (cranial), causing vasoconstriction.

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

2. What you need to know before you take Almotriptan Viatris

Do not take Almotriptan Viatris

• If you are allergic to the active substance or any of the other ingredients 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 (angina).
  • Painless cardiac problems.
  • Chest pain that occurs at rest (Prinzmetal's angina).
  • Severe hypertension (very high blood pressure).
  • Uncontrolled, mild, or moderate hypertension.
• If you have had a stroke, a mini-stroke (also known as "TIA"), or a reduction in blood flow to the brain.
• If you have had an obstruction of the large arteries in the arms or legs (peripheral vascular disease).
• If you are taking other medications for migraine, such as ergotamine, dihydroergotamine, and methysergide, or another selective serotonin agonist (e.g., sumatriptan). See "Using Almotriptan Viatris with other medicines" for more information.
• If you have severe liver disease.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Almotriptan Viatris if:

• Your type of migraine has not been diagnosed.
• You are allergic to sulfonamide medications used to treat infections and diuretic tablets.
• 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, you have brief paralysis of a part of your body or paralysis of the muscles that control your eye movements, or any other new symptoms.
• You are at risk of having heart disease, including high blood pressure and uncontrolled high blood pressure, high cholesterol levels, obesity, diabetes, smoking, family history of heart disease, postmenopausal women, or men over 40 years old.
• You have mild or moderate liver disease.
• If you have severe kidney disease.
• You are over 65 years old (as you are more likely to experience increases in blood pressure).
• You are taking antidepressant ISRS (selective serotonin reuptake inhibitors) or IRSN (serotonin and norepinephrine reuptake inhibitors). Or if you are taking opioid-like painkillers. See also "Using Almotriptan Viatris with other medicines" below.

During treatment

It has been suggested that excessive use of antimigraine medications may lead to chronic headache.

Children and adolescents

Children under 18 years old should not take almotriptan.

Elderly patients (over 65 years old)

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

Using Almotriptan Viatris with other medicines

Tell your doctor or pharmacist that you are taking, have recently taken, or might take any other medicines.

Tell your doctor:

• If you are taking any medication for 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). Or if you are taking opioid-like painkillers (e.g., buprenorphine). As these medications may cause serotonin syndrome, a potentially life-threatening treatment reaction. The symptoms of serotonin syndrome are: confusion, agitation, fever, sweating, uncoordinated limb or eye movements, or uncontrolled muscle movements or diarrhea.
• If you are taking St. John's Wort (Hypericum perforatum) preparations, as they may increase the likelihood of adverse effects.
• Almotriptan should not be taken at the same time as other medications containing ergotamine, which are also used to treat migraines. However, both medications 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 (a medication for treating migraine attacks).

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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Only limited information is available on the use of almotriptan during pregnancy.

Pregnancy: Almotriptan should only be used during pregnancy if prescribed by your doctor and only after carefully considering the risks and benefits.

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

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

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

Almotriptan Viatris contains sodium

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

3. How to take Almotriptan Viatris

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again. Almotriptan should only be used to treat an ongoing migraine attack and not to prevent migraine attacks or headaches.

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

Adults (18 - 65 years old)

• 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 next 24 hours, you can take a second 12.5 mg tablet, but only if at least 2 hours have passed since you took the first tablet.
• The maximum daily dose is two 12.5 mg tablets in 24 hours.
• You should take Almotriptan Viatris as soon as possible after the onset of a migraine attack, although it is also effective if taken later.

Patient 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 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 forgotten doses.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

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

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

• Chest pain, feeling of pressure in the chest that can affect the lower jaw, neck, and arm, discomfort, dizziness, and irregular heartbeat. These can be signs of a heart attack or reduced blood flow to the heart muscle.

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

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

Tell your doctor immediately if you experience:

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

Other possible side effects

Common (may affect up to 1 in 10 people):

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

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

• Feeling of tingling, pricking, or numbness of the skin (paresthesia).
• Headache.
• Ringing, buzzing, or whistling in the ears (tinnitus).
• Strong heartbeat (palpitations).
• Diarrhea.
• Indigestion (dyspepsia).
• Dry mouth.
• Muscle pain (myalgia).
• Bone pain.
• Feeling of weakness (asthenia).

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

• Increased heart rate (tachycardia).

Not known (cannot be estimated from the available data):

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

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via 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 Almotriptan Viatris

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister and the carton after EXP. The expiry date is the last day of the month shown.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Return the blisters and any unused medicine to a pharmacy for disposal. If you are unsure, ask your pharmacist how to dispose of blisters and any unused medicine. This will help protect the environment.

6. Contents of the pack and further 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 ingredients are:

• Core of the tablet: mannitol (E421), microcrystalline cellulose, povidone, sodium starch glycolate, and sodium stearyl fumarate. 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 packaged in blisters of 3, 4, 6, 9, and 12.

Almotriptan Viatris tablets are packaged in single-dose perforated blisters of 4 and 6.

Not all pack sizes may be marketed.

Marketing authorisation 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

You can request more information about this medicine by contacting the local representative of the marketing authorisation holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicine is authorised 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 last revision of this leaflet:November 2020

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