SUMATRIPTAN VIATRIS 50 mg FILM-COATED TABLETS

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

Do not take Sumatriptan Viatris:

• If you are allergic to sumatriptan or any of the other ingredients of this medicine (listed in section 6).

• If you have heart problems, such as reduced blood flow to your heart muscle with signs of chest pain, including heart attack (ischemic heart disease) or chest pain due to contraction of the arterial walls (Prinzmetal's angina) or if you have hardened arteries, circulation problems in your legs that cause cramps when walking (peripheral vascular disorder).
• If you have had a heart attack (myocardial infarction).
• If you have had a stroke (cerebrovascular accident) in the past or if you have suffered from symptoms of a stroke that occurred for a short period and from which you have fully recovered (transient ischemic attack).
• If you have severe liver problems.
• If your blood pressure is not controlled or if you are being treated for moderately or very high blood pressure (hypertension).
• If you are taking or have taken in the last 24 hours, medicines used to treat migraine that contain ergotamine or methysergide or any triptan or 5-HT1 agonist such as naratriptan or zolmitriptan (see "Other medicines and Sumatriptan Viatris" for more information).
• If you are taking or have recently taken, in the last two weeks, medicines for treating 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

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

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

• If you have risk factors for heart disease, such as:
  • A family history of heart disorders.
  • Diabetes.
  • High cholesterol levels in the blood.
  • Overweight.
  • You are a habitual smoker or are using some form of Nicotine Replacement Therapy (NRT).
  • Male over 40 years old or postmenopausal woman.

• If you are being treated for slightly 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 are allergic to antibiotics called sulfonamides (such as cotrimoxazole).
• If you use sumatriptan with medicines used to treat depression (see "Other medicines and Sumatriptan Viatris" for more information), as this may cause an increase in heart rate, chills, sweating, fever, high blood pressure, agitation, confusion, hallucinations, tremors that are signs of serotonin syndrome.

If you take Sumatriptan Viatris regularly

Taking sumatriptan too frequently can cause or worsen headaches. This can also happen if you need to use other medicines, such as painkillers, regularly for migraine. Talk to your doctor or pharmacist if this happens to you.

Sumatriptan Viatris may cause chest and throat tightness

You may notice pain or tightness in the chest and throat after taking sumatriptan. If these symptoms do not go away soon, contact your doctor immediately.

Other medicines and Sumatriptan Viatris

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In particular, you should tell your doctor if you are taking:

• Antidepressant medicines called SSRIs (e.g., 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 side effect known as serotonin syndrome (see "Warnings and precautions"). Your doctor may want to monitor you.
• Lithium (for more information, see "Do not take Sumatriptan Viatris").
• Medicines 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 2 weeks.
• Herbal remedies that contain St. John's Wort.

If you are taking or have taken other medicines for migraine

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

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

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 safety of sumatriptan for pregnant women, although so far there is no evidence that it increases the risk of congenital malformations. Your doctor will discuss with you whether you should use sumatriptan during pregnancy.

If you are breastfeeding, you should be aware that sumatriptan is excreted in breast milk. Suspend breastfeeding for the 12 hours following administration of sumatriptan. Breast milk should be expressed and discarded during this time.

Driving and using machines

This medicine, like migraine, can cause drowsiness, dizziness, or nausea. If this happens, it may affect your ability to drive or operate machinery. Caution is recommended if you perform such activities.

Sumatriptan Viatris contains lactose and sodium

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

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

3. How to take Sumatriptan Viatris

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

• Take this medicine as soon as you feel the first symptoms of a migraine attack. However, it can be taken at any time during a migraine attack.
• Do not take this medicine to prevent a migraine attack.

Adults

The recommended dose is one 50 mg tablet. In some cases, a dose of 25 mg or 100 mg may be necessary. Since the tablet cannot be divided into two equal doses, if necessary, your doctor should prescribe another medicine with the same active substance, dose, and pharmaceutical form available in a divisible tablet.

If you experience some improvement but the headache comes back, you can take a second dose within 24 hours, provided that there is a minimum interval of 2 hours between the two doses. The maximum dose is 300 mg of sumatriptan every 24 hours. Swallow the tablet whole with the help of a glass of water.

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

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.

Patient with liver problems

If you have mild or moderate liver problems, your doctor may recommend that you take 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 (telephone 91 562 04 20), indicating the medicine and the amount taken. It is recommended to take the package and the leaflet of the medicine to the healthcare professional.

4. Possible side effects

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

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

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

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

• Severe and sudden allergic 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 (anaphylactic reactions).
• Seizures or convulsions (more likely in patients prone to epilepsy).
• Heart attack (myocardial infarction), with chest pain, shortness of breath, indigestion, nausea, vomiting, lack of energy, or discomfort in the upper body.
• Chest pain (angina pectoris) or reduced blood flow to your heart muscle with signs of chest pain (ischemic heart disease).
• Inflammation of the colon (which can appear as pain in the left side of the stomach with 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 of 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 can affect any part of the body, including the throat and chest.
• Flushing (sudden reddening of the face, often the cheeks, neck, and upper chest).
• Dizziness or drowsiness.
• Fatigue, weakness, although these effects are transient.
• Increased blood pressure.
• Feeling of nausea (nausea) or being sick (vomiting).
• Shortness of breath (dyspnea).
• Muscle pain, sensitivity, or weakness, not caused by exercise (myalgia).

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

• Changes in the results of your liver tests (this may appear in blood tests).

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

• Eyelid or vision problems such as blinking, double vision, reduced vision, blind spot with reduced vision (visual field defect), loss of vision, which could be permanent. You may also experience repeated, involuntary, back-and-forth eye movements (nystagmus).
• Twisting and repetitive movements or abnormal postures (dystonia).
• Tremors.
• Anxiety.
• Irregular heartbeat such as slow or fast, changes in heartbeat or rhythm (this may appear on the ECG used to record the electrical activity of the heart), palpitations.
• Spasms in the blood vessels that supply the heart, which can cause chest pain.
• Low blood pressure.
• Diarrhea.
• Raynaud's phenomenon, which causes paleness in the skin and numbness or pain in the fingers of the hands and feet 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 if you have inflammation (such as rheumatism or colon inflammation), you may experience pain or worsening of pain at the site of the injury or inflammation.

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 through 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 Sumatriptan Viatris

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the carton or blister after EXP. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Sumatriptan Viatris

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

The other ingredients 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, red iron oxide (E-172), and yellow iron oxide (E-172). (See section 2 "Sumatriptan contains lactose and sodium").

Appearance of the product and pack contents

Round, pink tablets, engraved on one side 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.

Not all pack sizes may be marketed.

The blister may contain empty triangular pockets that do not contain tablets. Only the round pockets of the blister contain tablets.

Marketing authorization holder:

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer

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

You can request more information about this medicine by contacting 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 and in the United Kingdom (Northern Ireland) under the following names:

Spain: Sumatriptan Viatris 50 mg film-coated tablets EFG

Italy: Sumatriptan Mylan 50 mg film-coated tablets

United Kingdom (Northern Ireland): Sumatriptan 50 mg film-coated tablets

Date of last revision of this leaflet:February 2025

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