Prospect: information for the user

Almotriptán Viatris 12.5 mg film-coated tablets

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

-Keep this prospect, as you may need to read it again.

-If you have any questions, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you should not give it 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 or pharmacist, even if they are not listed in this prospect. See section 4.

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

2.What you need to know before starting to take Almotriptán Viatris

3.How to take Almotriptán Viatris

4.Possible adverse effects

5.Storage of Almotriptán Viatris

6.Contents of the package and additional information

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

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

Do not take Almotriptán Viatris

• If you are allergic to the active ingredient or to any of the other components of this medication (listed in section 6).
• If you have or have 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).
  • Cardiac problems without pain.
  • 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 a blockage of the large arteries of the arms or legs (peripheral vascular disease).
• If you are taking other medications to combat migraine, such as ergotamine, dihydroergotamine, and methysergide or another selective serotonin agonist (e.g. sumatriptan). See "Use of Almotriptán Viatris with other medications" for more information.
• If you have severe liver disease.

Warnings and precautions

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

• Your type of migraine has not been diagnosed.
• You are allergic to sulfonamide medications used to treat infections and diuretic tablets.
• 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.
• You are at risk of developing heart disease, including high and uncontrolled blood pressure, high cholesterol, obesity, diabetes, are a smoker, have a family history of heart disease, are a postmenopausal woman or are a male over 40 years old.
• You have mild or moderate liver disease.
• You have severe kidney disease.
• You are over 65 years old (since you are more likely to experience increased blood pressure).
• You are taking selective serotonin reuptake inhibitors (SSRIs) or serotonin and noradrenaline reuptake inhibitors (SNRIs) or opioid analgesics. See also "Use of Almotriptán Viatris with other medications" 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.

Older adults (over 65 years)

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

Use of Almotriptán Viatris with other medications

Inform your doctor or pharmacist that you are taking, have taken recently, or may need to take any other medication.

Inform your doctor:

• If you are taking any medication 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). Or if you are taking opioid analgesics (e.g. buprenorphine). As these medications may cause serotonin syndrome, a potentially fatal treatment reaction. The symptoms of serotonin syndrome are as follows: confusion, agitation, fever, sweating, uncoordinated movements of the limbs or eyes, uncontrollable 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.
• Almotriptán should not be taken at the same time as other medications that contain ergotamine, which are also used to treat migraine. However, both medications can be taken one after the other, provided there is a minimum time interval between the doses.

After taking almotriptan, it is recommended to wait at least 6 hours before taking ergotamine (migraine medication).

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 medication.

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 careful consideration of the risks and benefits.

Breastfeeding: You should exercise caution when using this medication during breastfeeding. You should avoid breastfeeding for 24 hours after treatment.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

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

Almotriptán Viatris contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. Almotriptán should only be used to treat an ongoing migraine attack and not to prevent migraine attacks or headaches.

The tablets should be swallowed with a liquid (e.g., water) and can 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 crisis does not subside, do not take more than one tablet for the same crisis.
• If you experience a second crisis within the next 24 hours, you can take a second 12.5 mg tablet but only after 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 Almotriptán Viatris as soon as possible after the onset of a migraine attack, although it is also effective if taken a bit 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 Almotriptán Viatris than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Almotriptán Viatris

Try to take Almotriptán Viatris as prescribed. Do not take a double dose to make up for the missed doses.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may cause side effects, although not everyone will experience them.

If you notice any of the following side effects, stop taking this medication 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, a feeling of oppression in the chest that may affect the lower jaw, neck, and arm, discomfort, dizziness, and an irregular heart rhythm. 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, chest oppression, wheezing.
• Seizures (convulsions).
• Reduced blood flow to the intestine, which may cause intestinal damage (intestinal ischemia). You may experience abdominal pain and bloody diarrhea.

During treatment with Almotriptán Viatris, inform your doctor immediately:

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

Other possible side effects

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

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

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

• Sensation of tingling, pins and needles, or numbness of the skin (paresthesia).
• Headache.
• Ringing, buzzing, or hissing in the ears (tinnitus).
• Strong heartbeats (palpitations).
• Diarrhea.
• Discomfort during digestion (dyspepsia).
• Dry mouth.
• Muscle pain (myalgia).
• Bone pain.
• Sensation of weakness (asthenia).

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

• Increased heart rate (tachycardia).

Unknown(cannot be estimated from available data):

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

Reporting of 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 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 medication.

Keep out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the blister pack and the container after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of Almotriptan Viatris

• The active ingredient is malate of almotriptan. Each film-coated tablet contains malate of almotriptan equivalent to 12.5 mg of almotriptan.
• The other components are:

• Tablet core: mannitol (E421), microcrystalline cellulose, povidone, sodium starch glycolate, and stearic acid fumarate. See section 2 “Almotriptan Viatris contains sodium”.
• Coating material: Hypromellose, titanium dioxide (E171), and macrogol.

Appearance of Almotriptan Viatris and contents of the container

Almotriptan Viatris are white or off-white, round, biconvex tablets marked with “M” on one face 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.

Only some sizes of packaging may be commercially available.

Marketing Authorization Holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible Person(s) for Manufacturing

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 medicine, please contact the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

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

Spain- Almotriptan Viatris 12.5 mg film-coated tablets EFG

France- ALMOTRIPTAN VIATRIS 12.5 mg, coated tablet

Italy- Almotriptan MYLAN

Last review date of this leaflet: November 2020

For detailed information about this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/