Sumatriptan Teva

PACKAGE LEAFLET: INFORMATION FOR THE USER

Sumatriptan Teva 50 mg film-coated tablets, 100 mg film-coated tablets

Generic medicine
Please read this leaflet carefully before 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. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this 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. How to store Sumatriptan Teva
6. Contents of the pack and other information

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

• Sumatriptan Teva belongs to the group of anti-migraine preparations. The active substance in Sumatriptan Teva film-coated tablets is sumatriptan, a 5-HT receptor agonist.
• Migraines are thought to be caused by the dilation of blood vessels. Sumatriptan causes the constriction of these blood vessels, thereby relieving the migraine attack.
• Sumatriptan is used to treat migraine attacks with or without aura (a sensation preceding the attacks, involving visual disturbances such as flashes of light, 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 to any of the other ingredients of this medicine (listed in section 6);
• if you have had a heart attack in the past;
• if you suffer from any heart disease;
• if you have symptoms that may indicate heart disease, such as temporary chest pain or a sensation of pressure in the chest;
• if you have previously had a stroke or a transient ischaemic attack (TIA, a milder form of stroke lasting less than 24 hours);
• if you have circulation problems in your legs causing cramp-like pain when walking (known as peripheral vascular disease);
• if you suffer from very high blood pressure or if your blood pressure remains high even after taking medication;
• if you have severe liver problems;
• if you are currently using or have recently used medicines containing ergotamine or ergotamine derivatives (including methysergide), another triptan, or a 5-HT1 receptor agonist (such as naratriptan or zolmitriptan);
• if you are currently using or have recently used medicines for treating depression belonging to the group of monoamine oxidase inhibitors (MAO inhibitors).

If you think you may have any of these conditions or if you have any doubts, contact your doctor before taking Sumatriptan Teva.

Warnings and precautions

• Before prescribing sumatriptan, your doctor will determine whether your headache is caused by migraine or by another condition.

Talk to your doctor or pharmacist before taking Sumatriptan 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 know you are allergic to antibacterial medicines belonging to the sulfonamide group;
• if you have high blood pressure under control, as in a small number of cases, sumatriptan has been shown 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 after concomitant use of SSRIs and sumatriptan;
• if you experience chest pain and/or tightness in the chest or throat. These side effects are usually short-lived. However, if they persist, if you are concerned, or if they worsen, contact your doctor immediately;
• if you have chronic daily headaches. Frequent use of sumatriptan may actually lead to chronic headache. In such cases, you should contact your doctor, as you may need to stop taking sumatriptan;
• if you are considered at risk of developing heart disease (for example, if you are diabetic, a heavy smoker, or undergoing nicotine replacement therapy), and particularly if you are a post-menopausal woman or a man over 40 years of age with these risk factors, your doctor should check your cardiac function before prescribing sumatriptan. Very rarely, serious heart problems have occurred after taking sumatriptan, even in the absence of signs indicating heart disease. If you have any doubts, consult your doctor.
• if you take herbal preparations containing St. John’s wort ( Hypericum perforatum ) together with sumatriptan, side effects may be more common.

Other medicines and Sumatriptan Teva
Some medicines may affect the effectiveness of sumatriptan, and sumatriptan may affect the effectiveness of other medicines. Contact your doctor if you are taking:

• other medicines for migraine, such as ergotamine or similar medicines, another triptan, or a 5-HT1 receptor agonist (such as naratriptan or zolmitriptan);
• medicines for the treatment of depression (MAO inhibitors, serotonin reuptake inhibitors) or serotonin-noradrenaline reuptake inhibitors (SNRIs).

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

Pregnancy, breastfeeding and fertility

Pregnancy:

• Ask your doctor or pharmacist for advice before taking this medicine.
• There is only limited data available on the safety of sumatriptan in human pregnancy. To date, these data do not indicate an increased risk of malformations. Use of sumatriptan during pregnancy is not recommended unless otherwise directed by your doctor.

Breastfeeding:

• If you are breastfeeding, consult your doctor or pharmacist before taking this medicine.
• Sumatriptan is excreted in breast milk. Exposure to the infant can be minimized by avoiding breastfeeding for 12 hours after taking sumatriptan and by discarding milk produced during this period.

Driving and using machines

• Migraine itself or its treatment with sumatriptan may cause drowsiness. Do not drive or operate machinery if you experience these symptoms.

Sumatriptan Teva contains a sugar called lactose. If your doctor has told you that you have an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take Sumatriptan Teva

Always take this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Sumatriptan Teva should not be taken to prevent migraine attacks, as it is intended solely for their
treatment. Sumatriptan Teva should be taken as soon as possible after the onset of a migraine attack;
however, it remains effective even if taken later during the attack.
The recommended dose for adults is 50 mg. Some patients may require 100 mg. If
Sumatriptan Teva does not provide immediate relief, taking additional tablets for the same
attack will not provide further benefit. Sumatriptan Teva may be used for a subsequent
attack. If the migraine disappears after the first dose but returns later, you may take
another tablet, provided that at least 2 hours have passed since the first tablet was taken.
Do not take more than 300 mg ( 6 tablets of 50 mg or 3 tablets of 100 mg ) within 24 hours.
Use in children and adolescents
The use of Sumatriptan Teva in children, adolescents, and patients over 65 years of age is not
recommended.
For patients with mild to moderate hepatic impairment, lower doses of 25–50 mg should be considered.
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 described in section 4, “Possible side effects”. If you have
taken too many tablets, contact a doctor or go to a hospital.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you wish to discuss this, contact your doctor.

The following side effects may occur with the following frequencies:

Common: may affect up to 1 in 10 people

• Drowsiness, dizziness, tingling.
• Temporary increase in blood pressure (occurring shortly after taking the medicine), flushing.
• Nausea or vomiting.
• Sensation of tightness. This is generally a transient (temporary) symptom, but it may be intense and may occur in any part of 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 in any part of the body, including the chest and throat.
• Shortness of breath.
• Feeling of weakness and fatigue.

Very rare: may affect up to 1 in 10,000 people

• If you undergo a blood test to check liver function, Sumatriptan Teva may interfere with the results.

Some patients may experience the following side effects, but the frequency with which they occur is unknown (the frequency cannot be estimated from the available data):

• Allergic skin reactions. A skin rash such as red spots or urticaria (swellings on the skin). Anaphylaxis (severe allergic reactions such as swelling of the eyelids, face, lips, or shortness of breath, palpitations, or sudden chest tightness). If any severe allergic reaction occurs, stop taking Sumatriptan and contact your doctor immediately.
• Nystagmus (involuntary back-and-forth eye movements), scotoma (dark spots in the visual field), tremor, and dystonia (involuntary muscle contractions). Seizures, usually in people with a history of epilepsy.
• Visual disturbances (twitching, diplopia, reduced vision, vision loss, including permanent visual defects), although these may also be caused by the migraine attack itself.
• Fast or slow heartbeat, palpitations, irregular heartbeat, and serious coronary complications, myocardial infarction, transient ischemic changes on ECG.
• Low blood pressure, i.e. a disorder characterized by signs of pallor or bluish discoloration of the skin and/or pain in the fingers of hands and feet, ears, nose, or jaw in response to cold or stress (Raynaud's syndrome).
• Inflammation of the colon (a part of the intestine), which may present as pain in the lower left part of the abdomen and bloody diarrhoea (ischaemic colitis).
• Diarrhoea.
• Joint pain.
• Feeling of anxiety.
• Neck stiffness.
• Excessive sweating.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. Side effects can also be reported directly via the national reporting system at: http://www.agenziafarmaco.gov.it/it/responsabili. Reporting side effects helps provide more information on the safety of this medicine.

5. How to store 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. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Sumatriptan Teva contains

• The active substance is sumatriptan. Each tablet contains 50 mg/100 mg of sumatriptan (succinate).
• The other components are:
• Tablet core: monohydrate lactose, croscarmellose sodium, anhydrous colloidal silica, microcrystalline cellulose and magnesium stearate
• Tablet coating: hypromellose, monohydrate lactose, titanium dioxide (E171), macrogol 3000 and glycerol triacetate. The 50 mg tablets also contain red, yellow and black iron oxide (E172).

Description of the appearance of Sumatriptan Teva and package contents

• Sumatriptan Teva 50 mg film-coated tablets are pinkish-peach coloured, oblong, film-coated tablets marked with the numbers “5” and “0” on one side, with a score line on each side. The tablet can be divided into two equal doses.
• Sumatriptan Teva 100 mg film-coated tablets are white to off-white, oblong, film-coated tablets marked with the number “100” on one side and smooth on the other.

The product is available in packs of 2, 3, 4, 6, 12, 18, 30 and 50 tablets. The 50 mg formulation is also available in packs of 24 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Teva Italia S.r.l. – Via Messina 38 – 20154 Milan, Italy

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

TEVA UK Limited
Brampton Road, Hampden Park, Eastbourne
BN22 9AG
United Kingdom

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

Teva Santé
Rue Bellocier, Sens 89107
France