Prospect: information for the patient

Sumatriptan Viatris 50 mg film-coated tablets EFG

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

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

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

-This medicine has been prescribed only to you, and you must not give it to other people, 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 is Sumatriptan Viatris and what it is used for

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

3.How to take Sumatriptan Viatris

4.Possible adverse effects

5.Storage of Sumatriptan Viatris

6.Contents of the pack and additional information

This medication contains the active ingredient sumatriptán succinato. Sumatriptán succinato belongs to a group of medications called 5-HT1 receptor agonists that are used to treat migraine attacks.5-HT11. Migraine causes headache attacks, sometimes with vomiting, or other symptoms such as, for example, in some people, sensitivity to light or noise. The symptoms of migraine may be caused by the temporary dilation of the blood vessels in the skull. It is believed thatsumatriptán reduces the dilation of these blood vessels.

Sumatriptán should not be used if you have not been diagnosed with migraine and it does not serve to prevent a migraine attack.

Sumatriptán should not be used for rare forms of migraine caused by brain or eye problems (for example, hemiplegic, basilar, or ophthalmoplegic migraine).

Do not take Sumatriptán Viatris:

-If you are allergic to sumatriptan or any of the other components of this medication (listed in section 6).

-If you are allergic to sulfonamide antibiotics (such as cotrimoxazol).

-If you have heart problems, such as reduced blood flow to your heart muscles with chest pain, including myocardial infarction (cardiac ischemic disorder) or chest pain due to contraction of arterial walls (Prinzmetal's angina) or suffer from hardened arteries, peripheral vascular disorders that cause leg cramps when walking.

-If you have had a heart attack (myocardial infarction).

-If you have had a stroke (cerebral hemorrhage) in the past or if you have experienced symptoms of a stroke that occurred for a short period of time and have fully recovered (transient ischemic attack).

-If you have severe liver problems.

-If your blood pressure is not controlled or if you are receiving treatment for moderately high or very high blood pressure (hypertension).

-If you are taking or have taken within the last 24 hours, medications used to treat migraines that contain ergotamine or methysergide or any triptan or 5-HT1 agonist such as naratriptan or zolmitriptan (see “Other medications and Sumatriptán Viatris” for more information).

-If you are taking or have taken recently, within the last two weeks, medications for depression or Parkinson's disease called Monoamine Oxidase Inhibitors (MAOIs).

-If you are taking lithium (usually used to treat mental disorders such as severe depression, mania, or types of severe headaches known as cluster headaches).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Sumatriptán Viatris:

-If you have risk factors for heart disease, such as:

• A family history of heart disorders.
• Diabetes.
• High levels of cholesterol in the blood.
• Obesity.
• Regular smoker or using some form of Nicotine Replacement Therapy (NRT).
• Male over 40 years or postmenopausal woman.

-If you are receiving treatment for mildly high blood pressure (hypertension) and it is being controlled.

-If you have had seizures or epilepsy in the past.

-If you have kidney problems.

-If you have liver problems.

-If you use sumatriptan with medications used to treat depression (see “Other medications and Sumatriptán Viatris” for more information), as this may cause an increase in heart rate, chills, sweating, fever, high blood pressure, agitation, confusion, hallucinations, tremors, which are signs of the serotonin syndrome.

If you take Sumatriptán Viatris regularly

The frequent use of sumatriptan may cause or worsen headaches. This can also occur if you need to use other medications, such as analgesics, regularly for migraines. Talk to your doctor or pharmacist if this happens.

Sumatriptán Viatris may cause chest and throat tightness

You may experience chest and throat tightness after taking sumatriptan.If these symptoms do not subside soon, contact your doctor immediately.

Other medications and Sumatriptán Viatris

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication.Especially, you must inform your doctor if you are taking:

• Antidepressant medications called SSRIs (for example citalopram, fluoxetine, fluvoxamine, paroxetine, or sertraline), SNRIs (such as venlafaxine or duloxetine (also used for urinary disorders)). If you are taking SSRIs and SNRIs and take sumatriptan, this may increase the risk of a potentially serious adverse effect known as Serotonin Syndrome (see "Warnings and precautions”). Your doctor may want to monitor you.
• Lithium (for more information see “Do not take Sumatriptán Viatris”).
• Medications used to treat depression or Parkinson's disease called Monoamine Oxidase Inhibitors (MAOIs). Do not take sumatriptan if you have taken an MAOI in the last two weeks.
• Herbal plants containing St. John's Wort.

If you are taking or have taken other medications for migraines

If you have taken other medications for migraines such as ergotamine or ergotamine derivatives (such as methysergide), or a triptan/5-HT1 agonist (such as naratriptan or zolmitriptan), you must wait at least 24 hours before taking sumatriptan.

If you have taken sumatriptan, you must wait at least 6 hours before taking ergotamine or derivatives (such as methysergide) and wait at least 24 hours before taking a triptan/5-HT1 agonist.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before taking this medication.

If you are breastfeeding, you must be aware that sumatriptan is excreted in breast milk. Suspend breastfeeding for 12 hours after taking sumatriptan.Breast milk must be expressed and discarded during this time.

Driving and operating machinery

This medication, like migraines, may cause drowsiness. If you experience these effects, avoid driving or operating machinery as it may be hazardous.

Sumatriptán Viatris contains lactose and sodium

If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

This medication contains less than 1 mmol 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 again with your doctor or pharmacist.

• Swallow the entire tablet with the help of a glass of water.
• Take this medication as soon as the first symptoms of a migraine attack appear. However, it can be taken at any time during a migraine attack.
• Do not take this medication to prevent a migraine attack.

Adults

The recommended dose is one 50 mg tablet. In some cases, a dose of 100 mg may be necessary.

If there is some improvement, but the headache returns, you can take a second dose within 24 hours, always with a minimum interval of 2 hours between the two doses. The maximum dose is 300 mg of sumatriptan per 24 hours.

Do not take a second dose if the first one has no effect. If sumatriptan has no effect after the first dose, you can take a pain reliever such as paracetamol, a nonsteroidal anti-inflammatory drug (NSAID), for example, aspirin (acetylsalicylic acid) or ibuprofen instead.

Use in children and adolescents (under 18 years)

Sumatriptan is not recommended for use in children and adolescents.

Use in elderly patients (over 65 years)

Sumatriptan is not recommended for use in elderly patients.

Patients with liver problems

If you have mild or moderate liver problems, your doctor may recommend a lower dose.

If you take more Sumatriptan Viatris than you should

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.

It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Some of the observed side effects may be associated with migraine.

If you experience any of the following side effects, stop taking this medicine immediately and seek medical advice urgently:

Unknown frequency (cannot be estimated from available data)

• Severe and sudden reaction with signs of allergy such as skin rash, itching, or hives on the skin, swelling of the face, lips, tongue, or other parts of the body, shortness of breath, wheezing, or difficulty breathing (anaphylaxis).
• Seizures or convulsions (more likely in patients prone to epilepsy).
• Heart attack (myocardial infarction), with presence of chest pain, shortness of breath, indigestion, nausea, vomiting, lack of energy, or discomfort in the upper part of the body.
• Chest pain (angina) or reduced blood flow to the coronary muscles with signs of chest pain (ischemic heart disease).
• Colon inflammation (which may appear as pain in the left side of the stomach with appearance of blood in the stool and diarrhea).

Other side effects:

Frequent (may affect up to 1 in 10 people)

• Sensations such as tingling, itching, and numbness in the hands or feet (paresthesia), decreased touch or sensitivity, especially of the skin (hypoesthesia), or sensation of heat or cold.
• Pain, heaviness, pressure, or tightness that may affect any part of the body, including the throat and chest.
• Sensation of flushing (sudden redness of the face, often the cheeks), neck, and upper chest).
• Dizziness or drowsiness.
• Fatigue, weakness. Although these effects are transient.
• Increased blood pressure.
• Sensation of dizziness (nausea) or being dizzy (vomiting).
• Shortness of breath (dyspnea).
• Muscle pain, sensitivity, or weakness, not caused by exercise (myalgia).

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

• Changes in liver test results (this may appear in blood tests).

Unknown frequency (cannot be estimated from available data)

• Eye or vision problems such as blinking, double vision, reduced vision, patchy vision with reduced vision (scotoma), loss of vision, which could be permanent. You may also experience repetitive, involuntary, back-and-forth eye movements (nystagmus).
• Torticollis and repetitive or abnormal postures (dystonia).
• Tremors.
• Anxiety.
• Irregular heart rhythm, such as slow or fast, changes in heartbeats or rhythm (this may appear in the ECG used to record the heart's electrical activity), palpitations.
• Spasms in blood vessels that supply the heart, which may cause chest pain.
• Low blood pressure.
• Diarrhea.
• Raynaud's phenomenon, which causes paleness in the skin and numbness or pain in the fingers and toes when cold.
• Stiffness in the neck.
• Pain, inflammation in the joints (arthralgia).
• Excessive sweating (hyperhidrosis).
• Difficulty swallowing.
• If you have had a recent injury or have inflammation (such as rheumatism or colon inflammation), you may experience pain or worsening of pain in the injured or inflamed area.

Reporting side effects

Ifyou experience any typeof side effect,consultyour doctor or pharmacist,even if it is a possible side effect that does not appear in this prospectus. 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 medicine.

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

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the packaging or blister after CAD or EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Sumatriptan Viatris

The active ingredient is sumatriptan(as succinate).Each film-coated tablet contains 50 mg of sumatriptan (as succinate).

The other components are: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose and magnesium stearate. The coating contains titanium dioxide (E-171), polydextrose (E-1200), hypromellose (E-454), triacetin (E-1518), macrogol, iron oxide red (E-172) and iron oxide yellow (E-172). (See section 2 “Sumatriptan contains lactose and sodium”).

Appearance of the product and contents of the pack

Round, pink tablets engraved on one face with“SU50” and “G” on the other.

Sumatriptan Viatris is available in blisters of 2, 3, 4, 5, 6, 10, 12, 18, 20 and 24 tablets or in single-dose blisters of 4 tablets.

Only some pack sizes may be marketed.

The blister may contain triangular-shaped empty cavities that do not contain tablets. Only the round cavities of the blister contain tablets.

Marketing Authorization Holder:

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible for manufacturing

McDermott Laboratories Ltd. t/a Gerard Laboratories

35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13

Ireland

or

Mylan Hungary Kft.

Mylan útca. 1

Komárom

2900

Hungary

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

Spain:Sumatriptan Viatris 50 mg film-coated tablets EFG

Italy:Sumatriptan Mylan50 mg film-coated tablets

United Kingdom:Sumatriptan 50 mg Film-coated Tablets

Further information on this medicinal product can be obtained by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

Date of the last review of this leaflet:January 2021

Further detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es/