Product Information for the Patient

Sumatriptan Teva 50 mg Film-Coated Tablets

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

• Keep this product information, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to others

who may 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 product information. See section 4.

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

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

3. How to take Sumatriptan Teva

4. Possible adverse effects

5. Storage of Sumatriptan Teva

6. Contents of the pack and additional information

• Sumatriptán belongs to the group of antimigraine preparations. The active ingredient of Sumatriptán Teva is sumatriptan, a 5-HT1 receptor agonist (serotoninergic receptor)

serotoninérgico)

• It is thought that the headaches that appear in migraine are the result of the dilation of blood vessels. Sumatriptán constricts these blood vessels, thereby alleviating migraine-type headache.
• Sumatriptán 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).

Do not take Sumatriptán Teva

• if you areallergic(hypersensitive) to sumatriptan or any of the other components of this medication (listed in section 6)
• if you have hadany heart attack;
• if you have any heart disease;
• if you havesymptoms that may indicate heart disease, such as chest pain or a sensation of pressure in your chest;
• if you havehistory of strokeor transient ischemic attack (TIA, a mild form of stroke that lasts less than 24 hours);
• if you have problems with blood circulation in your legs that cause
• cramping pain when walking (called peripheral vascular disease),
• if you havehigh blood pressurethat is significant, or if your blood pressure is high despite medication;
• if you havesevere liver problems;
• if you are using or have recently used medications that containergotamineor ergotamine derivatives (including metisergide) or any triptan/5-HT1 receptor agonist (such as naratriptan or zolmitriptan)
• if you are using or have recently usedmedications 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 are unsure, consult your doctor before taking sumatriptan.

Warnings and precautions

Your doctor will determine if your headache is caused by a migraine and not by any other disease before prescribing Sumatriptán.

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 withepilepsyor any other disease that lowers your seizure threshold;

of seizures;

• if you know you areallergic to antibacterial medicationsthat belong to the sulfonamide group;

group;

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

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

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

• if you experience chronic daily headaches. Taking Sumatriptán too frequently may lead to developing a chronic headache. In these cases, you should contact your doctor as you may need to stop taking Sumatriptán;

• if you are considered to be at risk of developing heart disease (e.g. diabetics, heavy smokers or those 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 cardiac function before prescribing Sumatriptán. In very rare cases, severe heart disease has occurred after taking Sumatriptán, even without 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, the adverse effects may be more frequent.

Other medications and Sumatriptán Teva

Certain medications may affect the efficacy of Sumatriptán and Sumatriptán may affect the efficacy of other medications. Contact your doctor if you use:

• other migraine medications, such as ergotamine, ergotamine derivatives or any other medication in the same group as sumatriptan (such as naratriptan, zolmitriptan, rizatriptan, almotriptan and eletriptan). If you have taken these medications, you should wait 24 hours before taking sumatriptan. On the other hand, do not take ergotamine, ergotamine derivatives or medications in the same group as sumatriptan until 6 hours after taking sumatriptan.
• medications to treat depression(MAOIs or SSRIs or SNRIs);

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

Pregnancy and lactation

Pregnancy:

Consult your doctor or pharmacist before using any medication.

There is limited information available on the safety of Sumatriptán in human pregnancy. So far, 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 tells you to.

Lactation:

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

Sumatriptán is excreted in breast milk. You can minimize your baby's exposure by avoiding breastfeeding for 12 hours after administering Sumatriptán Teva, during which time the expressed milk should be discarded.

Driving and operating machinery

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

Sumatriptán Teva contains lactose

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

Sumatriptán Teva contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per coated tablet; this is, essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your

doctor or pharmacist. Consult your doctor or pharmacist if you have any doubts.

Sumatriptán Teva should not be taken to prevent migraine attacks, as it is intended to

treat migraine attacks. Sumatriptán Teva should be taken as soon as the migraine pain

appears; however, it is equally effective when taken in an advanced stage of the attack.

The recommended dose for adults is 50 mg. For some patients, 100 mg may be necessary.

If Sumatriptán Teva does not provide immediate relief, it is not beneficial to take more

tablets for this attack. Sumatriptán Teva can be used for your next attack. If, after your

first dose, your migraine disappears but then returns, you can take another tablet, as

long as 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

It is not recommended to use Sumatriptán Teva 50 mg in children, adolescents, and patients

over 65 years old. For patients with mild to moderate liver problems, use low doses of

25-50 mg.

Method of administration

Swallow the tablet whole with water.

If you take more Sumatriptán 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 questions about the use of this medication, ask your doctor or

pharmacist.

Like all medicines, this medicine may cause side effects, although

not everyone will experience them.Contact your doctorif you need clarification on this.

The following side effects are possible with the following frequencies:

Frequent: may affect up to 1 in 10 people

• Drowsiness
• Dizziness
• Tickling
• Transient increase in blood pressure (which appears after treatment)
• Flushing
• Nausea or vomiting
• Sensation of tension. This is generally transient (temporary), but may be intense and can appear 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 can

appear anywhere in the body, including the chest and throat

• Sensation of weakness
• Fatigue
• Difficulty breathing

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

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

Unknown:the frequency cannot be estimated from the available data:

• Skin allergic reactions: a skin rash like red spots or hives (bumps on the skin).
• Anaphylaxis (intense allergic reactions such as sudden swelling of the eyelids, face or lips and difficulty breathing, rapid heartbeat or chest tightness).

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

• Nystagmus (involuntary 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.
• Heartaccelerated, slow heartbeat, palpitations, irregular heartbeat, and

serious complications of coronary artery, heart attack, transient ischemic changes on the ECG.

• Low blood pressure, which is a disease characterized by signs of paleness or a bluish tint on the skin and/or pain in the fingers of the hands, fingers of the feet, ears, nose or jaw in response to cold or stress (Raynaud's phenomenon).
• Colitis (inflammation of the colon), which may present as pain in the lower left part of the stomach and bloody diarrhea.
• Diarrhea.
• Joint pain.
• Anxiety.
• Neck stiffness.
• Excessive sweating
• If you had a recent injury or if you have inflammation (such as rheumatism or colitis) you may experience pain or worsening of pain at the site of the injury or inflammation.
• Difficulty swallowing.
• 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 of side effects

If you experience any type of side effect, consult your doctor, pharmacist or nurse, even if it is a possible side effect that does not appear in this leaflet. 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.

Do not use Sumatriptán 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 medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and

the medicines you no longer need at the SIGRE point of the pharmacy. If in doubt

ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Sumatriptan Teva

The active ingredient 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.

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

Appearance of Sumatriptan Teva and contents of the package

Sumatriptan Teva are film-coated tablets with a peach to pink color, oblong shape, engraved with “5” and “0” on one side, and with a notch on each side.

The tablet can be divided into equal doses.

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

Only some package sizes may be commercially available.

Holder of the Marketing Authorization

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1st floor,

Alcobendas, 28108 - Madrid

Responsible for Manufacturing

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 Member States of the EEA with the following names

names

Belgium:Sumatriptan TEVA 50 mg film-coated tablets

Denmark:Sumatriptan Teva

Spain:Sumatriptán TEVA 50 mg film-coated tablets EFG

Finland:Sumatriptan Teva 50 mg film-coated tablets

France:Sumatriptan TEVA 50 mg coated tablet

Hungary:Sumatriptan-Teva 50 mg tablet

Italy:Sumatriptan Teva 50 & 100 mg coated tablets

Luxembourg:Sumatriptan TEVA 50 mg coated tablets

Netherlands:Sumatriptan 50 mg PCH, film-coated tablets

Norway:Sumatriptan Teva 50 mg film-coated tablets

Sweden:Sumatriptan Teva 50 mg film-coated tablets

United Kingdom:Sumatriptan 50 mg Film-coated Tablets

Last review date of this leaflet:April 2024

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

http://www.aemps.gob.es

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