SUMATRIPTAN TEVA 50 mg FILM-COATED TABLETS

Introduction

Patient Information Leaflet

Sumatriptan Teva 50 mg film-coated tablets EFG

Read the entire leaflet carefully before starting to take the medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.

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

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

Contents of the leaflet:

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 side effects
5. Storage of Sumatriptan Teva
6. Package contents and additional information

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

• Sumatriptan belongs to the group of anti-migraine preparations. The active ingredient of Sumatriptan Teva is sumatriptan, a 5-HT1 receptor agonist (serotoninergic

receptor)

• It is thought that the headaches that occur in migraine are the result of the dilation of blood vessels. Sumatriptan constricts these blood vessels, thereby relieving migraine headache.
• Sumatriptan is used to treat migraine attacks with or without aura (a warning sensation that usually involves visual distortions, such as flashes, zig-zag lines, stars, or waves).

2. What you need to know before taking Sumatriptan Teva

Do not take Sumatriptan Teva

• if you are allergic(hypersensitive) to sumatriptan or any of the other ingredients 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 temporary chest pain or a feeling of pressure in your chest;
• if you have a history of strokeor transient ischemic attack
• (TIA, a mild form of stroke that lasts less than 24 hours);
• if you have circulation problems in your legs that cause pain when walking (called peripheral vascular disease),
• if you have high blood pressureto a significant degree, or if your blood pressure is high despite
• medication;
• if you have severe liver problems;
• if you are using or have recently used medicines that contain ergotamineor
• ergotamine derivatives (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 depressionthat belong to the group known as monoamine oxidase inhibitors (MAOIs);
• if you think you may have any of these problems, or if you have any doubts, consult your doctor before taking sumatriptan.

Warnings and precautions

Before prescribing Sumatriptan, your doctor will determine if your headache is caused by migraine and not by any other disease.

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

• if you know you have liver or kidney problems

• if you have been diagnosed with epilepsyor any other disease that lowers the threshold

for epileptic seizures;

• if you know you are allergic to antibacterial medicinesthat belong to the group

of sulfonamides;

• if you have controlled high blood pressure, as sumatriptan has been shown to increase blood pressure in a small number of cases;

• if you are taking Selective Serotonin Reuptake Inhibitors (SSRIs) or Serotonin and Noradrenaline Reuptake Inhibitors (SNRIs). Hyperreflexia and lack of coordination have been observed after concomitant use of Selective Serotonin Reuptake Inhibitors and sumatriptan;

• if you experience chest or throat pain and/or pressure. These effects are usually short-lived. However, if they persist and concern you, or worsen, contact your doctor immediately for advice;

• if you experience daily chronic headaches. Taking Sumatriptan too frequently can lead to the development of chronic headache. In these cases, you should contact your doctor as you may need to stop taking Sumatriptan;

• if you are considered to be at risk of developing heart disease (e.g., diabetics, heavy smokers, or undergoing nicotine replacement therapy), and in particular, if you are a postmenopausal woman or a man over 40 years old with these risk factors, your doctor should check your heart function before prescribing Sumatriptan. In very rare cases, serious heart disease has occurred after taking Sumatriptan, even without signs of heart disease. Consult your doctor if you have doubts;

• if you are taking herbal preparations that contain St. John's Wort (Hypericum perforatum) with sumatriptan, adverse effects may be more frequent.

Other medicines and Sumatriptan Teva

Certain medicines may affect the efficacy of Sumatriptan, and Sumatriptan may affect the efficacy of other medicines. Contact your doctor if you use:

• 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, 24 hours must pass before you can take sumatriptan. On the other hand, do not take ergotamine, ergotamine derivatives, or medicines in the same group as sumatriptan until 6 hours after taking sumatriptan.
• medicines to treat depression(MAOIs or serotonin reuptake inhibitors or serotonin and noradrenaline reuptake inhibitors);

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

Pregnancy and breastfeeding

Pregnancy:

Consult your doctor or pharmacist before using any medicine.

Only limited information is available on the safety of Sumatriptan in human pregnancy. So far, these data do not indicate a higher risk of malformations. It is recommended that you do not take Sumatriptan Teva during pregnancy, unless your doctor advises 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 can minimize your baby's exposure by avoiding breastfeeding for 12 hours after administration of Sumatriptan Teva, during which time the expressed milk should be discarded.

Driving and using machines

Migraine itself or its treatment with Sumatriptan Teva may cause drowsiness. Do not drive or operate machines if you are affected.

Sumatriptan Teva contains lactose

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

Sumatriptan 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 the administration instructions of this medicine exactly as indicated by your doctor or pharmacist. Consult your doctor or pharmacist if you have doubts.

Sumatriptan Teva should not be taken to prevent migraine attacks, as it is intended to treat migraine attacks. Sumatriptan Teva should be taken as soon as migraine pain appears; however, it is equally effective when taken in an advanced state of the attack.

The recommended dose for adults is 50 mg. For some patients, 100 mg may be necessary. If Sumatriptan Teva does not provide immediate relief, it is not beneficial to take more tablets for this attack. Sumatriptan Teva can be used for your next attack. If, after your first dose, your migraine disappears but then returns, you can take another tablet, provided that at least 2 hours have passed since you took the first tablet.

Do not take more than 300 mg (six50 mg tablets or three100 mg tablets) in 24 hours.

Use in children and adolescents

The use of Sumatriptan Teva 50 mg is not recommended in children, adolescents, and patients over 65 years old. For patients with mild to moderate liver problems, low 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, pharmacist, or call the Toxicology Information Service (tel.: 91 562 04 20), indicating the product and the amount ingested.

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

4. Possible side effects

Like all medicines, this medicine can have side effects, although not everyone gets them. Consult your doctorif you need to clarify this.

The following side effects are possible with the following frequencies:

Frequent: may affect up to 1 in 10 people

• Drowsiness
• Dizziness
• Tingling
• Transient increase in blood pressure (which appears after treatment)
• Flushing
• Nausea or vomiting
• Sensation of tension. This is usually transient (temporary), but can be intense and can appear in any part of the body, including the chest and throat
• Muscle pain
• Pain
• Sensation of heat or cold, pressure or tightness. These symptoms can be intense and can appear in any part of the body, including the chest and throat

• Sensation of weakness
• Fatigue
• Difficulty breathing

Very 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 results.

Unknown: frequency cannot be estimated from available data:

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

If a severe allergic reaction occurs, stop taking Sumatriptan Teva and contact your doctor immediately.

• Nystagmus (involuntary back-and-forth movement of the eyeball)
• Scotoma (dark spots in the field of vision)
• Tremor and dystonia (involuntary muscle contractions)
• Seizures - usually in people with a history of epilepsy
• Visual disturbances (blinking, double vision, reduced vision, loss of vision, including permanent defect), although this may be caused by the migraine attack itself.
• Fast heart rate, slow heartbeat, palpitations, irregular heartbeat, and serious coronary artery complications, heart attack, transient ischemic changes in the ECG.

• Decrease in blood pressure, which is a disease characterized by signs of paleness or a bluish tint to the skin and/or pain in the fingers of the hands, 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.
• Pain in the joints.
• Anxiety.
• Stiffness of the neck.
• Excessive sweating
• 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.
• Difficulty swallowing.
• There have been reports of serotonin syndrome (characterized by symptoms such as restlessness, hallucinations, coordination difficulties, rapid heartbeat, rapid changes in blood pressure, increased body temperature, hyperactive reflexes, nausea, vomiting, and diarrhea)

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System: https://www.notificaram.es. By reporting side 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 expiration date that appears on the carton/blister. The expiration date is the last day of the month indicated after CAD.

This medicine does not require special storage conditions.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Sumatriptan Teva

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

The other ingredients are:

• Core of the tablet: lactose monohydrate, sodium croscarmellose, anhydrous colloidal silica, microcrystalline cellulose, and magnesium stearate.

• Coating of the tablet: hypromellose, lactose monohydrate, titanium dioxide (E171), macrogol 3000, glycerol triacetate, red, yellow, and black iron oxide (E172).

Appearance of Sumatriptan Teva and package contents

Sumatriptan Teva are film-coated tablets of peach to pink color, oblong shape, engraved 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.

It may be that only some pack sizes are marketed.

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edifício Albatros B, 1ª planta,

Alcobendas, 28108 - Madrid

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 – Netherlands

This medicine is registered in the EEA Member States with the following names

Bélgica: Sumatriptan TEVA 50 mg filmomhulde tabletten

Dinamarca: Sumatriptan Teva

España: Sumatriptán TEVA 50 mg comprimidos recubiertos con película EFG

Finlandia: Sumatriptan Teva 50 mg tabletti kalvopäällysteinen

Francia: Sumatriptan TEVA 50 mg comprimé pelliculé

Hungría: Sumatriptan-Teva 50 mg tabletta

Italia: Sumatriptan Teva 50 & 100 mg compresse rivestite con filme

Luxemburgo: Sumatriptan TEVA 50 mg comprimés pelliculés

Países Bajos: Sumatriptan 50 mg PCH, filmomhulde tabletten

Noruega: Sumatriptan Teva 50 mg tabletter, filmdrasjerte

Suecia: Sumatriptan Teva 50 mg filmdragerade tabletter

Reino Unido: Sumatriptan 50 mg Film-coated Tablets

Date of the last revision of this leaflet:April 2024

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS)

http://www.aemps.gob.es

You can access detailed and updated information about this medicine by scanning the QR code included in the packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/68727/P_68727.html