SUMATRIPTAN SANDOZ 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Sumatriptan Sandoz 50 mg Film-Coated Tablets EFG

Read all of this 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only.Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist.This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Sumatriptan Sandoz is and what it is used for
2. What you need to know before you take Sumatriptan Sandoz
3. How to take Sumatriptan Sandoz
4. Possible side effects
5. Storage of Sumatriptan Sandoz

1. Contents of the pack and further information

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

Each Sumatriptan 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 headacheswith or without aura. Sumatriptan should only be used for a clear diagnosis of migraine.

Migraine symptomscan be caused by the temporary widening of blood vessels in the head. It is thought that sumatriptan works by reversing this widening of blood vessels. This helps to relieve the headache and other symptoms of a migraine attack, such as feeling sick (nausea or vomiting) and being sensitive to light and sound.

2. What you need to know before you take Sumatriptan Sandoz

Do not take Sumatriptan Sandoz

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

If any of these apply to you, consult your doctor and do not take sumatriptan tablets.

Warnings and precautions

Talk to your doctor or pharmacist before taking sumatriptan.

If you have any extra risk factors:

• if you are a heavy smokeror
• if you are on nicotine replacement therapy, and especially
• if you are a man over 40 years oldor,
• if you are a woman who has passed the menopause.

In rare cases, patients have developed serious heart conditions after taking sumatriptan, even though they had no signs of heart disease before.If any of the above points apply to you, you have a higher risk of developing heart disease. Tell your doctor so that they can check your heart function before prescribing sumatriptan.

If you have a history of fits (seizures)

or any other condition that may make you more likely to have a fit, such as a head injury or alcoholism.Tell your doctor so that they can keep a close check on you.

If you have liver or kidney disease

Tell your doctor so that they can keep a close check on you.

If you are allergic to antibiotics called sulfonamides

If so, you may also be allergic to sumatriptan.If you know you are allergic to an antibiotic but are not sure if it is a sulfonamide, tell your doctor or pharmacist before taking sumatriptan.

If you take sumatriptan frequently

Taking sumatriptan too often may make your headaches worse.Tell your doctor if this happens.They may advise you to stop taking sumatriptan.

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

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

Children and adolescents

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

• sumatriptan has not been studied in children under 10 years old,
• the effectiveness of sumatriptan in children and adolescents aged 10-17 years has not been demonstrated in clinical studies.

Taking Sumatriptan Sandoz with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those you can buy without a prescription.This includes herbal medicines, dietary supplements such as vitamins, iron or calcium, or medicines you can buy at the pharmacy.

Some medicines must not be taken with sumatriptan and others may cause side effects when taken with sumatriptan.

You must tell your doctor if you are taking:

• ergotamine, used to treat migraine, 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 receptor agonists(such as naratriptan, rizatriptan, zolmitriptan), also used to treat migraine, (see the section "Do not take Sumatriptan 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 triptan/5-HT1 receptor agonist for at least 24 hours after using sumatriptan.
• MAOIs(monoamine oxidase inhibitors) used to treat depression or Parkinson’s disease. Do not take sumatriptan if you have taken these medicines in the last 2 weeks,
• SSRIs(selective serotonin reuptake inhibitors) and SNRIs(serotonin and noradrenaline reuptake inhibitors) used to treat depression. Taking sumatriptan with these medicines can cause serotonin syndrome (a set of symptoms that can include restlessness, confusion, sweating, hallucinations, increased reflexes, muscle spasms, shivering, increased heart rate, and trembling). Tell your doctor immediately if you have any of these symptoms.
• St John’s Wort (Hypericum perforatum). Taking herbal medicines that contain St John’s Wort with sumatriptan may increase the risk of side effects.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

• Information on the safety of sumatriptan in pregnant women is limited.Although there is no evidence that it increases the risk of malformations, your doctor will assess whether you should use sumatriptan during pregnancy.
• Stop breastfeeding for 12 hours after taking sumatriptan.If you express breast milk during this time, discard the milk and do not give it to your baby.

Driving and using machines

This medicine, like migraine itself, may cause drowsiness.If you experience these effects, do not drive or use machines as it may be dangerous.

Sumatriptan Sandoz contains lactose.

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

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

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

Aspartame contains a source of phenylalanine that may be harmful if you have phenylketonuria (a rare, inherited disorder in which phenylalanine builds up because the body cannot remove it properly).

This medicine contains sodium.

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

3. How to take Sumatriptan Sandoz

Take Sumatriptan Sandoz exactly as your doctor has told you.If you are not sure, check with your doctor or pharmacist.

When to take Sumatriptan Sandoz

• It is best to take sumatriptan as soon as you feel a migraine coming on, although you can take it at any time during an attack.
• Do not use sumatriptan to try to prevent an attack - only use it after your migraine symptoms start.

The recommended dose is:

Adults aged 18-65 years

• The recommended dose for adults aged 18-65 years is one Sumatriptan Sandoz 50 mg tablet.For some patients, 100 mg may be needed. Follow your doctor’s advice.

Elderly patients (over 65 years)

• Sumatriptan is not recommended for patients over 65 years old.

If your symptoms come back

• You can take a second Sumatriptan Sandoz tablet in the next 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 tablet or any other medicine that contains sumatriptan for the same attack.In these cases, the attack can be treated with painkillers such as paracetamol, aspirin, or ibuprofen. You can take sumatriptan for the next attack.

If you have mild to moderate liver impairment

• If you have mild to moderate liver impairment, doses of 25-50 mg should be considered.Follow your doctor’s advice.

If sumatriptan does not give you relief

Talk to your doctor or pharmacist.

How to take the tablets

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

The 50 mg tablet can be divided into two equal doses.

If you take more Sumatriptan Sandoz than you should

Do not take more than 6 x 50 mg tablets or 3 x 100 mg tablets (300 mg in total) in 24 hours.Taking too much sumatriptan may 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, ask your doctor or pharmacist.

If you have taken more Sumatriptan Sandoz than you should, talk to your doctor or go to the nearest hospital immediately, or call the Toxicology Information Service.Telephone: 91 562 04 20, stating the medicine and the amount taken.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

Allergic reactions: get medical help immediately.

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

• Signs of allergy include rash, hives (itching and rash); wheezing; swelling of the eyelids, face or lips, collapse.

If you notice any of these symptoms soon after taking sumatriptan:

Do not take sumatriptan again. Contact your doctor immediately.

Common side effects(may affect up to 1 in 10 people)

• dizziness, drowsiness,
• sensory disturbances such as tingling and reduced sensitivity,
• temporary increase in blood pressure after treatment,
• flushing,
• difficulty breathing (dyspnoea),
• feeling sick (nausea) or being sick (vomiting), which has occurred in some patients but is not clear if it is related to sumatriptan or the disease itself,
• feelings of heaviness (usually transient, may be intense and may affect any part of the body, including the chest and throat),
• pain in one or more muscles,
• pain, feeling of heat or cold, pressure or tightness (usually transient and may be intense and may 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).

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

• minor changes in liver function tests.

Frequency not known(cannot be estimated from the available data)

• hypersensitivity reactions of all degrees of severity, from skin hypersensitivity (such as urticaria) to 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.
• tremor, muscle spasms leading to an abnormal posture and loss of movement control,
• eye twitching, loss of vision, blinking, double vision, reduced vision, loss of vision, including cases of permanent vision disturbances. However, visual disturbances can also occur during a migraine attack itself,
• slow heart rate (bradycardia), fast heart rate (tachycardia), palpitations, irregular heartbeat, coronary artery vasospasm, chest pressure, heart attack,
• decrease in blood pressure, circulatory disorders of the limbs, e.g. in the finger (Raynaud's syndrome),
• inflammation of a part of the colon due to circulatory disorders,
• diarrhoea,
• difficulty swallowing
• stiffness in the neck,
• pain in one or more joints,
• abnormal feeling of fear, often with psychological signs (such as sweating, tension, and rapid heartbeat),
• excessive sweating
• If you have had a recent injury or if you have inflammation (such as rheumatism or inflammation of the colon), you may experience pain or worsening of pain at the site of the injury or inflammation.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse.This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Agency’s website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Sumatriptan Sandoz

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

Do not use this medicine after the expiry date which is stated on the blister, packaging, and carton after EXP.The expiry date refers to the last day of the month shown.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste.Return any unused medicine to a pharmacy for disposal. If you are unsure, ask your pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Packaging Information Additional Content

Composition of Sumatriptan Sandoz

• The active ingredient is sumatriptan (as succinate).

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

• The other ingredients are:

Tablet core: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, and magnesium stearate.

Tablet coating: lactose monohydrate, corn starch, soluble starch, mannitol, aspartame, polysorbate 80, titanium dioxide (E171), red iron oxide (E172), and talc.

Appearance of the Product and Packaging Content

Sumatriptan Sandoz is presented in the form of film-coated tablets, pink, capsule-shaped, 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 an 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 pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

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 medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria: Sumatriptan Sandoz 50 mg - Filmtabletten

Czech Republic: SUMIGRA 50 MG

Denmark: Sumatriptan “Sandoz”

Finland: Sumatriptan Sandoz tabletti, 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 50 MG, TABLETKI POWLEKANE

Slovenia: Sumigra 50 mg filmsko obložene tablete

Switzerland: Sumatriptan Sandoz 50 mg filmdragerad tablett

Date of the last revision of this leaflet:September 2020

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/