Sumatriptan Teva 50 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Sumatriptan Teva 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. 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 must not be given to other

people, even if they have the same symptoms as you, because it could harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Sumatriptán Teva is and what it is used for

• Sumatriptán belongs to the group of anti-migraine preparations. The active substance in Sumatriptán Teva is sumatriptán, a 5-HT1 receptor agonist (serotonin receptor).

• It is thought that the headaches occurring in migraine result from the dilation of blood vessels. Sumatriptán constricts these blood vessels, thereby relieving migraine-type headache pain.

• Sumatriptán is used to treat migraine attacks with or without aura (a warning sensation that typically involves visual disturbances such as flashes of light, zig-zag lines, stars, or waves).

2. What you need to know before starting to take Sumatriptán Teva.

Do not take Sumatriptán Teva

• if you are allergic (hypersensitive) to sumatriptan or to any of the other components of this medicine (listed in section 6);
• if you have had a heart attack;
• if you have any heart disease;
• if you have symptoms that may indicate heart disease, such as chest pain or a sensation of pressure in your chest;
• if you have a history of stroke or transient ischaemic attack (TIA, a mild form of stroke lasting less than 24 hours);
• if you have circulation problems in your legs causing painful cramps when walking (called peripheral vascular disease);
• if you have significantly elevated blood pressure, or if your blood pressure is high despite medication;
• if you have severe liver problems;
• if you are using or have recently used medicines containing ergotamine or derivatives of ergotamine (including methysergide) or any triptan/5-HT1 receptor agonist (such as naratriptan or zolmitriptan);
• if you are using or have recently used medicines to treat depression belonging to the group known as monoamine oxidase inhibitors (MAOIs);
• if you think you may have any of these conditions, or if you have any doubts, consult your doctor before taking sumatriptan.

Warnings and precautions

Before prescribing Sumatriptán, your doctor will determine whether your headache is due to migraine and not caused by another condition.

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

• if you know you have liver or kidney problems;
• if you have been diagnosed with epilepsy or any other condition that lowers the seizure threshold;
• if you are known to be allergic to antibacterial medicines belonging to the sulfonamide group;
• if you have controlled high blood pressure, as sumatriptan has been shown in a small number of cases to increase blood pressure;
• if you are taking selective serotonin reuptake inhibitors (SSRIs) or serotonin-noradrenaline reuptake inhibitors (SNRIs). Hyperreflexia and lack of coordination have been observed following concomitant use of SSRIs and sumatriptan;
• if you experience chest and/or throat pain or tightness. These effects are usually short-lived. However, if they persist, worsen, or concern you, contact your doctor immediately for advice;
• if you experience chronic daily headaches. Taking Sumatriptán too frequently may lead to the development of chronic headache. In such cases, you should contact your doctor, as you may need to stop taking Sumatriptán;
• if you are considered at risk of developing heart disease (e.g. diabetics, heavy smokers, or undergoing nicotine replacement therapy), and particularly if you are a postmenopausal woman or a man over 40 years of age with these risk factors, your doctor should check your cardiac function before prescribing Sumatriptán. In very rare cases, serious heart conditions have occurred after taking Sumatriptán, even in the absence of signs of heart disease. Consult your doctor if you have any doubts;
• if you are taking herbal preparations containing St. John’s wort (Hypericum perforatum) with sumatriptan, adverse effects may occur more frequently.

Other medicines and Sumatriptán Teva

Certain medicines may affect the effectiveness of Sumatriptán, and Sumatriptán may affect the effectiveness of other medicines. Contact your doctor if you are using:

• other migraine medicines, such as ergotamine, ergotamine derivatives, or any other medicine in the same group as sumatriptan (such as naratriptan, zolmitriptan, rizatriptan, almotriptan, and eletriptan). If you have taken these medicines, you must wait 24 hours before taking sumatriptan. Conversely, do not take ergotamine, ergotamine derivatives, or medicines in the same group as sumatriptan until 6 hours after taking sumatriptan.
• medicines to treat depression (MAO inhibitors, serotonin reuptake inhibitors, or serotonin-noradrenaline reuptake inhibitors).

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Pregnancy and breastfeeding

Pregnancy:

Consult your doctor or pharmacist before using any medicine.

There is only limited information available on the safety of Sumatriptán in human pregnancy. To date, these data do not indicate an increased risk of malformations. It is recommended that you do not take Sumatriptán Teva during pregnancy unless your doctor specifically instructs you to do so.

Breastfeeding:

Consult your doctor or pharmacist for advice on using this medicine during breastfeeding.

Sumatriptan is excreted in breast milk. You should not breastfeed your baby until 12 hours after taking sumatriptan. If you express breast milk during this time, discard the milk and do not give it to your baby.

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

Driving and using machines

Migraine itself or treatment with Sumatriptán Teva may cause drowsiness. Do not drive or operate machinery if affected.

Sumatriptán Teva contains lactose

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

Sumatriptán Teva contains sodium

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

3. How to take Sumatriptan Teva

Follow exactly the instructions for use of this medicine given by your
doctor or pharmacist. Consult your doctor or pharmacist if you have any doubts.

Sumatriptan Teva must not be used to prevent migraine attacks, as it is intended to treat migraine attacks. Sumatriptan Teva should be taken as soon as migraine pain starts; however, it is equally effective when taken at a later stage of the attack.

The recommended dose for adults is 50 mg. In some patients, a dose of 100 mg may be required. If Sumatriptan Teva does not provide immediate relief, it is not beneficial to take additional tablets for the same attack. Sumatriptan Teva may be used for your next attack. If, after your first dose, your migraine disappears but then returns, you may take another tablet, provided that at least two hours have passed since you took the first tablet.

Do not take more than 300 mg (six 50 mg tablets or three 100 mg tablets) in 24 hours.

Use in children and adolescents

The use of Sumatriptan Teva 50 mg is not recommended in children, adolescents, or patients over 65 years of age. In patients with mild to moderate liver problems, lower doses of 25–50 mg should be used.

Method of administration

Swallow the tablet whole with water.

If you take more Sumatriptan Teva than you should

The symptoms of overdose are the same as those listed in section 4, “Possible side effects”. If you have taken too many tablets, consult your doctor or pharmacist, or call the Toxicology Information Service (telephone: 91 562 04 20), indicating the product and the amount ingested.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. Contact your doctor if you need clarification on this.

The following adverse effects may occur with the following frequencies:

Common: may affect up to 1 in 10 people

• Drowsiness
• Dizziness
• Tingling
• Transient increase in blood pressure (occurring after treatment)
• Flushing
• Nausea or vomiting
• Sensation of tightness. This is usually transient (temporary), but may be intense and may occur anywhere in the body, including the chest and throat
• Muscle pain
• Pain
• Sensation of heat or cold, pressure, or tightness. These symptoms may be intense and may occur anywhere in the body, including the chest and throat
• Feeling of weakness
• Fatigue
• Difficulty breathing

Uncommon: may affect up to 1 in 1,000 people

• Breast pain

Rare: may affect up to 1 in 10,000 people

If you need to have a blood test to check your liver function, Sumatriptan Teva may affect your test results.

Not known: frequency cannot be estimated from available data:

• Allergic skin reactions: a skin rash such as red spots or hives (lumps on the skin).
• Anaphylaxis (severe allergic reactions such as swelling of the eyelids, face or lips, sudden difficulty breathing, palpitations, or chest tightness).

If you experience any severe allergic reaction, stop taking Sumatriptan Teva and contact your doctor immediately.

• Nystagmus (involuntary back-and-forth movement of the eyeball)

• Scotoma (dark spots in the visual field)

• Tremor and dystonia (involuntary muscle contractions)

• Seizures—usually in people with a history of epilepsy

• Visual disturbances (flickering, double vision, reduced vision, vision loss including permanent defects), although these may be caused by the migraine attack itself.

• Fast heartbeat, slow heartbeat, palpitations, irregular heartbeat, and serious coronary artery complications, heart attack, transient ischemic changes on ECG.

• Decreased blood pressure, a condition characterized by signs of paleness or a bluish tint to the skin and/or pain in the fingers, toes, ears, nose, or jaw in response to cold or stress (Raynaud's phenomenon).

• Inflammation of the colon (part of the intestine), which may present as pain in the lower left abdomen and bloody diarrhea (ischemic colitis).

• Diarrhea.

• Joint pain.

• Anxiety.

• Neck stiffness.

• Excessive sweating.

• 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.

• Difficulty swallowing.

• Cases of serotonin syndrome have been reported (characterized by symptoms such as restlessness, hallucinations, lack of coordination, rapid heartbeat, rapid changes in blood pressure, increased body temperature, hyperactive reflexes, nausea, vomiting, and diarrhea).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through 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 Teva.

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

Do not use Sumatriptan Teva after the expiry date stated on the carton/blister. The expiry date is the last day of the month indicated after EXP.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Sumatriptan Teva

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

The other components are:

• Tablet core: lactose monohydrate, sodium croscarmellose, colloidal anhydrous silica, microcrystalline cellulose, and magnesium stearate.

• Tablet coating: hypromellose, lactose monohydrate, titanium dioxide (E171), macrogol 3000, glycerol triacetate, red, yellow and black iron oxide (E172).

Appearance of Sumatriptan Teva and contents of the pack

Sumatriptan Teva are film-coated tablets, peach to pink in colour, oblong in shape, marked with “5” and “0” on one side and with a score line on each side.

The tablet can be divided into equal doses.

The product is available in pack sizes of 2, 3, 4, 6, 12, 18, 24, 30 and 50 tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder

Teva Pharma, S.L.U.
C/ Anabel Segura, 11, Edificio Albatros B, 1st floor,
Alcobendas, 28108 - Madrid, Spain

Manufacturer

Teva Pharmaceutical Works Private Limited Company
H-4042 Debrecen, Pallagi str. 13
Hungary

or

Pharmachemie B.V.
Swensweg 5
Postbus 552
2003 RN Haarlem – The Netherlands

This medicinal product is authorised in EEA Member States under the following names:

Belgium: Sumatriptan TEVA 50 mg filmomhulde tabletten
Denmark: Sumatriptan Teva
Spain: Sumatriptán TEVA 50 mg comprimidos recubiertos con película EFG
Finland: Sumatriptan Teva 50 mg tabletti kalvopäällysteinen
France: Sumatriptan TEVA 50 mg comprimé pelliculé
Hungary: Sumatriptan-Teva 50 mg tabletta
Italy: Sumatriptan Teva 50 & 100 mg compresse rivestite con filme
Luxembourg: Sumatriptan TEVA 50 mg comprimés pelliculés
The Netherlands: Sumatriptan 50 mg PCH, filmomhulde tabletten
Norway: Sumatriptan Teva 50 mg tabletter, filmdrasjerte
Sweden: Sumatriptan Teva 50 mg filmdragerade tabletter
United Kingdom: Sumatriptan 50 mg Film-coated Tablets

Date of the most recent review of this leaflet: October 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios, AEMPS):
http://www.aemps.gob.es

You can access detailed and up-to-date information about this medicinal product by scanning with your mobile phone (smartphone) the QR code included in the packaging. You can also access this information at the following internet address:
https://cima.aemps.es/cima/dochtml/p/68727/P_68727.html