Product Information for the Patient

Sumatriptan Sandoz 50 mg Film-Coated Tablets

Read this entire product information carefully before starting to take this 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 you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this product information. See section 4.

6.Contents of the pack and additional information

Each Sumatriptán Sandoz tablet contains a doseof sumatriptan, which belongs to a group of medicines called triptans (also known as 5-HT1 receptor agonists).

Sumatriptan is used to treat migraine headachewith or without aura. Sumatriptan should only be used in cases of clear diagnosis of migraine.

The symptoms of migrainemay be caused by the temporary dilation of blood vessels in the head. It is believed that sumatriptan reduces the dilation of these blood vessels. This in turn helps to relieve headache pain and alleviate other symptoms of a migraine attack, such as a feeling of discomfort (nausea or vomiting) and sensitivity to light and sound.

Do not take Sumatriptán Sandoz

• if you are allergicto sumatriptan or any of the other ingredients of this medicine (listed in section 6),
• if you have had anyheart problemssuch as narrowing of the arteries (ischaemic heart disease) or chest pain (angina), or have had a heart attack,
• if you havecirculation problems in your legsthat cause cramp-like pains when you walk (peripheral vascular disease),
• if you have had astrokeor a mini-stroke (also known as transient ischaemic attack or TIA),
• if you havehigh blood pressure. You may be able to use sumatriptan if your high blood pressure is mild and you are being treated,
• if you have aserious liver disease,
• with othermigraine medicines, including those that contain ergotamine or similar medicines, such as methysergide, or any triptan or 5HT1 agonist (such as naratriptan or zolmitriptan),
• with any of the following medicines to treat, for example, depression or Parkinson's disease:
• MAOIs(monoamine oxidase inhibitors) or if you have taken these medicines (for example, moclobemide or selegiline) in the last 2 weeks.

If you are affected by any of these situations: consult your doctor, and do not take sumatriptan tablets.

Warnings and precautions

Consult your doctor or pharmacist before starting to take sumatriptan.

If you have any additional risk factors:

• if you are aheavy smokeror
• if you are undergoingnicotine replacement therapy, and especially
• if you are aman over 40 years oldor,
• if you are awoman who has passed the menopause.

In very rare cases, patients have developed serious heart disease after using sumatriptan, despite not having any signs of heart disease beforehand. If any of the above points affect you, you have a higher risk of developing heart disease, soinform your doctorso that they can check your heart function before prescribing sumatriptan.

If you have a history of seizures (convulsions)

Or any other situation that may make it more likely that you will have a seizure, for example, a head injury or alcoholism. Inform your doctor so that they can keep a close eye on you.

If you have liver or kidney disease

Inform your doctor so that they can keep a close eye on you.

If you are allergic to sulphonamide antibiotics

If you are, you may also be allergic to sumatriptan. If you know that you are allergic to an antibiotic but are not sure if it is a sulphonamide,inform your doctor or pharmacist before using sumatriptan.

If you take sumatriptan frequently

The use of sumatriptan too frequently may make your headache worse.

Inform your doctor if this happens.You may recommend that you stop using sumatriptan.

If you feel pain or tightness in your chest after using sumatriptan

These effects can be intense but usually pass quickly. If they do not pass quickly, or get worse,seek medical help immediately. In section 4 of this leaflet, you will find more information about these possible side effects.

Children and adolescents

Sumatriptán Sandoz is not recommended for children and adolescents under 18 years old because:

• sumatriptan has not been studied in children under 10 years,
• the efficacy of sumatriptan in children and adolescents from 10 to 17 years has not been demonstrated in clinical studies.

Taking Sumatriptán Sandoz with other medicines

Inform your doctor or pharmacist if you are using or have recently used other medicines, including those bought without a prescription. This includes herbal medicines, dietary supplements such as vitamins, iron or calcium, or medicines bought without a prescription.

Some medicines should not be taken with sumatriptan and others may cause side effects if taken with sumatriptan.

You must inform your doctor if you are taking:

• ergotamineused also for the treatment ofmigraine, or similar medicines such as methysergide. Do not take sumatriptan at the same time as these medicines. Stop taking these medicines at least 24 hours before taking sumatriptan. Do not take medicines that contain ergotamine or similar medicines for at least 6 hours after taking sumatriptan,
• other triptans/5-HT1 agonists(such as naratriptan, rizatriptan, zolmitriptan), also used to treatmigraine, (see the section "Do not take Sumatriptán Sandoz") above. Do not use sumatriptan at the same time as these medicines. Stop taking these medicines at least 24 hours before using sumatriptan. Do not take another 5-HT1 agonist triptan/agonist for at least 24 hours after using sumatriptan.
• MAOIs(monoamine oxidase inhibitors) used to treatdepression or Parkinson's disease. Do not take sumatriptan if you have taken these medicines in the last two weeks,
• SSRIs(selective serotonin reuptake inhibitors) andSNRIs(serotonin and noradrenaline reuptake inhibitors) used to treatdepression. The use of sumatriptan with these medicines may cause serotonin syndrome (a series of symptoms that may include restlessness, confusion, sweating, hallucinations, increased reflexes, muscle spasms, chills, increased heart rate, and tremors). Inform your doctor immediately if you have the following symptoms.
• St. John's Wort(Hypericum perforatum). Taking medicines based on plants that contain St. John's Wort with sumatriptan may cause side effects more likely.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

• The information about the safety of sumatriptan in pregnant women is limited, although there is currently no evidence that it increases the risk of malformations. Your doctor will assess with you whether you should use or not sumatriptan during pregnancy.
• Stop breastfeeding for 12 hours after taking sumatriptan. If you breastfeed during this time, discard the milk and do not give it to your baby.

Driving and operating machines

This medicine, like migraine, can cause drowsiness.If you notice these effects, avoid driving or operating machines as it may be dangerous.

Sumatriptán Sandoz contains lactose.

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

Sumatriptán Sandoz contains aspartame as a sweetener, a source of phenylalanine.

This medicine contains 0.09 mg of aspartame in each film-coated tablet.

Aspartame contains a source of phenylalanine that may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

This medicine contains sodium

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

Follow exactly the administration instructions for Sumatriptán Sandoz as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

When to take Sumatriptán Sandoz

• It is best to take sumatriptan as soon as you feel a migraine, although it can be taken at any time during an attack.
• Do not use sumatriptan to try to prevent an attack; it should only be used after the onset of migraine symptoms.

Recommended dose is:

Adults between 18 and 65 years

• The recommended dose for adults between 18 and 65 years is a Sumatriptán Sandoz tablet of 50 mg. Some patients may need 100 mg. You should follow your doctor's advice.

Older adults (over 65 years)

• Sumatriptan is not recommended for patients over 65 years.

If your symptoms start again

• You can take a second sumatriptan tablet in the following 24 hours if at least 2 hours have passed since the first tablet. Do not take more than a total of 300 mg in 24 hours.

If the first tablet does not work

• Do not take a second tabletor any other medication containing sumatriptan for the same attack. In these cases, the attack can be treated with pain medications such as paracetamol, acetylsalicylic acid, or ibuprofen. You can take sumatriptan for the next attack.

If you have mild to moderate liver insufficiency

• If you have mild to moderate liver insufficiency, consider doses of 25-50 mg. Follow your doctor's advice.

If sumatriptan does not provide relief, consult your doctor or pharmacist.

Administration form

Swallow the film-coated tablets or half a tablet whole with water.

The 50 mg tablet can be divided into equal doses.

If you take more Sumatriptán Sandoz than you should

Do nottake more than 6 tablets of 50 mg or 3 of 100 mg(300 mg total) in 24 hours. Taking too much sumatriptan can make you feel unwell.

If you have taken more than 300 mg in 24 hours,contact your doctor.

If you have any questions about this product, consult your doctor or pharmacist.

If you have taken more Sumatriptán Sandoz than you should, consult your doctor or go to the nearest hospital immediately, or call the Toxicological Information Service.Phone: 91 562 04 20 indicating the medication and the amount ingested.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Some of these symptoms may be caused by the migraine itself.

Allergic reactions: seek medical help immediately.

The following side effects have occurred, but their exact frequency is unknown.

• Allergic signs include rash, hives (itching and rash); wheezing; swollen eyelids, face, or lips, complete collapse.

If you notice any of these symptoms shortly after using sumatriptan:

Do not use sumatriptan again. Contact your doctor immediately.

Frequent side effects(may affect up to1 in 10people)

• dizziness, drowsiness,
• sensory disturbances such as tingling and reduced sensitivity,
• transient sudden increase in blood pressure after treatment,
• headaches,
• difficulty breathing (dyspnea),
• nausea or feeling of discomfort, which has occurred in some patients, but it is unclear if this is related to sumatriptan or the underlying disease,
• sensations of heaviness (usually transient, can be intense and can affect any part of the body, including the chest and throat),
• muscle pain in one or more muscles,
• pain, feeling of heat or cold, pressure, or tension (usually transient and can be intense and can affect any part of the body, including the chest and throat),
• feelings of weakness, fatigue (both side effects are mostly mild to moderate in intensity and duration).

Rare side effects(may affect up to1 in 10,000people)

• minor changes in liver function tests.

Unknown frequency(cannot be estimated from available data)

• allergic reactions of all degrees of severity, ranging from skin hypersensitivity (such as urticaria) to cases of anaphylaxis,
• seizures, although some have occurred in patients with a history of seizures or concurrent conditions that predispose to seizures. They have also been observed in patients with no apparent predisposing factors.
• tremors, muscle spasms that lead to abnormal posture and poor movement control,
• eye tremors, loss of visual field, blinking, double vision, reduced vision, loss of vision, including cases of permanent changes. However, visual disturbances can also occur during a migraine attack itself,
• slowing of heart rate (bradycardia), rapid heartbeat (tachycardia), palpitations, cardiac arrhythmias, coronary artery vasospasm, chest pressure, myocardial infarction,
• decreased blood pressure, circulatory disturbances in the extremities, e.g., in the finger (Raynaud's syndrome),
• inflammation of a part of the colon due to circulatory changes,
• diarrhea,
• difficulty swallowing
• neck stiffness,
• pain in one or more joints,
• abnormal feeling of fear often with psychological signs (such as sweating, tension, and rapid pulse),
• excessive sweating
• If you have had a recent injury or 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 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 the 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 this medication after the expiration date that appears on the strip, blister, packaging, and carton after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications.This will help protect the environment.

Composition of Sumatriptan Sandoz

• The active ingredient is sumatriptan (as succinate).

Each film-coated tablet contains 50 mg of sumatriptan (as succinate).

• The other components are:

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

Coating of the tablet: lactose monohydrate, maize starch, soluble starch, mannitol, aspartame, polisorbate 80, titanium dioxide (E171), iron oxide red (E172) and talc.

Appearance of the product and contents of the package

Sumatriptan Sandoz is presented in the form of film-coated tablets, pink, in capsule shape, convex on one side and scored on the other.

The film-coated tablets are packaged in ALU/ALU strips or PVC/PE/PVDC/Al blisters inserted in a cardboard box or packaged in a PP bottle with a LDPE cap.

ALU/ALU strips: 1, 2, 4, 6, 12 film-coated tablets.

PVC/PE/PVDC/Al blisters: 1, 2, 4, 6, 12, 18 film-coated tablets.

PP bottle with LDPE cap: 12 film-coated tablets.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing

Lek Pharmaceuticals d.d

Verovskova 57

1526 Ljubljana

Slovenia

or

Sandoz GmbH

Biochemiestrasse 10

A-6250 Kundl

Austria

or

Salutas Pharma GmbH

Otto-von-Guericke Allee 1

39179 Barleben

Germany

or

S.C. Sandoz, S.R.L.

Str. Livezeni nr. 7A

RO-540472 Targu-Mures

Romania

or

Lek Pharmaceuticals d.d,

Trimlini 2 D,

9220 Lendava

Slovenia

This medicine is authorized in the member states of the European Economic Area with the following names:

Austria:Sumatriptan Sandoz 50 mg - Filmtabletten

Czech Republic:SUMIGRA 50 MG

Denmark:Sumatriptan “Sandoz”

Finland:Sumatriptan Sandoztabletti, kalvopäällysteinen

Germany:Sumatriptan Sandoz 50 mg Filmtabletten

Italy:SUMATRIPTAN SANDOZ

Netherlands:Sumatriptan Sandoz 50, filmomhulde tabletten 50 mg

Norway:Sumatriptan Sandoz 50 mg tabletter, filmdrasjerte

Poland:SUMIGRA 50MG, TABLETKI POWLEKANE

Slovenia:Sumigra 50 mg filmsko obložene tablete

Switzerland:Sumatriptan Sandoz 50 mg filmdragerad tablett

Last review date of this leaflet:September 2020

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/