Sumatriptan Viatri 50 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Sumatriptán Viatris 50 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 other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

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

This medicine contains the active substance sumatriptan succinate. Sumatriptan succinate belongs to a group of medicines called 5-HT1 receptor agonists, which are used to treat migraine attacks. Migraine causes episodes of headache, sometimes with vomiting, or other symptoms such as, for example, sensitivity to light or sound in some people. Migraine symptoms may be caused by temporary dilation of blood vessels in the brain. Sumatriptan is believed to reduce this dilation of blood vessels.

Sumatriptan should not be used if you have not been diagnosed with migraine, and it is not effective in preventing a migraine attack.

2. What you need to know before taking Sumatriptan Viatris

Do not take Sumatriptan Viatris:

• If you are allergic to sumatriptan or to 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 muscles with signs of chest pain, including myocardial infarction (ischaemic heart disease) or chest pain due to arterial wall constriction (Prinzmetal's angina), or if you suffer from hardened arteries, or have circulation problems in your legs causing 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 experienced symptoms of a stroke that occurred over a short period of time and from which you have fully recovered (transient ischaemic attack).

• If you have severe liver problems.

• If your blood pressure is uncontrolled or if you are receiving treatment for moderately or severely high blood pressure (hypertension).

• If you are taking or have taken within the last 24 hours, medicines used to treat migraine containing 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, within the past two weeks, medicines used to treat depression or Parkinson’s disease called Monoamine Oxidase Inhibitors (MAOIs).

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

Warnings and precautions

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

Consult your doctor or pharmacist before taking Sumatriptan Viatris:

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

  • A family history of heart problems.
  • Diabetes.
  • High cholesterol levels in the blood.
  • Being overweight.
  • Being a regular smoker or using any form of Nicotine Replacement Therapy (NRT).
  • Being a man over 40 years of age or a postmenopausal woman.

• If you are being treated for mildly high blood pressure (hypertension) and are under monitoring.

• If you have previously suffered seizures or epilepsy.

• If you have kidney problems.

• If you have liver problems.

• If you are allergic to antibiotics known as sulfonamides (such as cotrimoxazole).

• If you use sumatriptan together with medicines used to treat depression (see “Other medicines and Sumatriptan Viatris” for more information), as this may cause increased heart rate, chills, sweating, fever, high blood pressure, agitation, confusion, hallucinations, tremors, which are signs of serotonin syndrome.

If you take Sumatriptan Viatris regularly

Taking sumatriptan too frequently may cause or worsen headaches. This may also occur if you feel the need to regularly use other medicines such as painkillers for migraine. Speak with your doctor or pharmacist if this happens to you.

Sumatriptan Viatris may cause chest and throat tightness

You may feel pain or tightness in your chest and throat after taking sumatriptan. If these symptoms do not resolve quickly, contact your doctor immediately.

Other medicines and Sumatriptan Viatris

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine. In particular, you must inform your doctor if you are taking:

• Antidepressant medicines called SSRIs (e.g., citalopram, fluoxetine, fluvoxamine, paroxetine, or sertraline), or SNRIs (such as venlafaxine or duloxetine (which may also be used for urinary disorders)). If you are taking SSRIs and SNRIs and take sumatriptan, this may increase the risk of developing a potentially serious adverse effect known as serotonin syndrome (see “Warnings and precautions”). Your doctor may need to monitor you closely.

• 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 within the last two weeks.

• Herbal remedies containing St. John’s wort.

If you are taking or have taken other migraine medicines

If you have taken other migraine medicines 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 its 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, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.

There is limited information on the safety of sumatriptan in pregnant women, although to date there is no evidence that it increases the risk of congenital malformations. Your doctor will discuss with you whether or not you should use sumatriptan during pregnancy.

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

Some women have reported breast and/or nipple pain after using sumatriptan. The pain is usually temporary and resolves within 3 to 12 hours.

Driving and using machines

This medicine, like migraine itself, may cause drowsiness, dizziness, or nausea. If this occurs, it may affect your ability to drive or operate machinery. Caution is advised if engaging in such activities.

Sumatriptan Viatris contains lactose and sodium

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

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

3. How to take Sumatriptan 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.

• Take this medicine as soon as the first symptoms of a migraine attack appear. However, it may 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 required. 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 as a divisible tablet.

If some improvement occurs but the headache returns, a second dose may be taken within 24 hours, provided that at least 2 hours have elapsed between doses. The maximum dose is 300 mg of sumatriptan every 24 hours. Swallow the tablet whole with a glass of water.

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

Use in children and adolescents (under 18 years of age)

The use of sumatriptan is not recommended in children and adolescents.

Use in elderly patients (over 65 years of age)

The use of sumatriptan is not recommended.

Patients 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service (telephone 91 562 04 20), stating the medicine and the amount ingested. It is recommended to take the medicine packaging and leaflet to the healthcare professional.

4. Possible adverse effects

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

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

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

Frequency not known (cannot be estimated from available data)

• Severe and sudden allergic reaction with signs such as skin rash, itching or hives, swelling of the face, lips, tongue or other parts of the body, difficulty breathing, wheezing or trouble breathing (anaphylactic reactions).
• Seizures or convulsions (more likely in patients prone to epilepsy).
• Heart attack (myocardial infarction), with symptoms such as chest pain, shortness of breath, indigestion, nausea, vomiting, fatigue or discomfort in the upper body.
• Chest pain (angina pectoris) or reduced blood flow to your coronary muscles, with symptoms of chest pain (ischaemic heart disease).
• Inflammation of the colon (which may present as pain on the left side of the stomach, presence of blood in stools and diarrhoea).

Other adverse effects:

Frequent (may affect up to 1 in 10 people)

• Sensations such as tingling, itching, and numbness in hands or feet (paraesthesia), reduced 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.
• Feeling of flushing (sudden redness of the face (often cheeks), neck, and upper chest).
• Dizziness or drowsiness.
• Fatigue, weakness, although these effects are transient.
• Increase in blood pressure.
• Feeling of nausea or being nauseous (nausea), or feeling dizzy (vomiting).
• Shortness of breath (dyspnoea).
• Muscle pain, tenderness, or muscle weakness not caused by exercise (myalgia).

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

• Breast pain

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

• Changes in the results of your liver function tests (this may be seen in blood tests).

Frequency not known (cannot be estimated from available data)

• Eye or vision problems such as blinking, double vision, reduced vision, blind spot with reduced vision (visual field defect), or loss of vision, which could be permanent. You may also experience involuntary, repetitive back-and-forth eye movements (nystagmus).
• Twisting movements and repetitive movements or abnormal postures (dystonia).
• Tremors.
• Anxiety.
• Irregular heartbeat such as slow or fast heartbeat, changes in heartbeat or heart rhythm (this may be seen on the ECG used to record the heart's electrical activity), palpitations.
• Spasms in the blood vessels supplying the heart, which may cause chest pain.
• Low blood pressure.
• Diarrhoea.
• Raynaud's phenomenon causing paleness of the skin and numbness or pain in the fingers and toes when exposed to cold.
• Neck stiffness.
• Pain, swelling in the joints (arthralgia).
• Excessive sweating (hyperhidrosis).
• Difficulty swallowing.
• If you have recently had an injury or have inflammation (such as rheumatism or inflammation of the colon), you may experience pain or worsening of pain at the site of injury or inflammation.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 stated on the carton or blister pack after EXP or CAD. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This 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 components are: monohydrate lactose, 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”).

Nature of the product and contents of the pack

Round, pink film-coated tablets, engraved on one side with “SU50” and “G” on the other.

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

Only certain pack sizes may be marketed.

The blister may contain empty triangular-shaped pockets that do not contain tablets. Tablets are only located in the round pockets of the blister.

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

For further 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 and in the United Kingdom (Northern Ireland) under the following names:

Spain: Sumatriptán Viatris 50 mg film-coated tablets EFG
Italy: Sumatriptan Mylan 50 mg compresse rivestite con film
United Kingdom (Northern Ireland): Sumatriptan 50 mg Film-coated Tablets

Date of the most recent revision of this leaflet: September 2025

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