SUMATRIPTAN ZENTIVA

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

Equivalent medicine
Read this leaflet carefully before you start using 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 other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Sumatriptan Zentiva is and what it is used for
2. What you need to know before taking Sumatriptan Zentiva
3. How to take Sumatriptan Zentiva
4. Possible side effects
5. How to store Sumatriptan Zentiva
6. Contents of the pack and other information

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

This medicinal product belongs to a class of medicines called anti-migraine preparations.
The symptoms of migraine may be caused by the temporary dilation of blood vessels in the brain.
Medicines such as Sumatriptan Zentiva are thought to work by reducing the swelling (or dilation) of these blood vessels.
Sumatriptan Zentiva is used to treat acute migraine attacks with or without aura (warning sensation, usually in the form of visual disturbances such as flashes of light, zigzag lines, stars or waves), including acute migraine attacks associated with the menstrual period.

2. What you need to know before taking Sumatriptan Zentiva

Do not take Sumatriptan Zentiva

• if you are allergic to sumatriptan (the active substance in Sumatriptan Zentiva) or to any of the other ingredients of this medicine (listed in section 6) or to sulfonamides;
• if you have had a heart attack or have any cardiovascular disease;
• if you have symptoms that could indicate heart disease, such as temporary chest pain or a sensation of chest tightness;
• if you suffer from high blood pressure;
• if you have a history of stroke or transient ischemic attacks (reduced oxygen supply to the brain);
• if you have circulation problems in the legs causing cramps or pain when walking (known as peripheral vascular disease);
• if you suffer from severe liver failure;
• if you are taking or have recently taken medicines containing ergotamine (anti-migraine medicines) or ergotamine derivatives (including methysergide) or any triptan or 5-HT receptor agonist (such as naratriptan, rizatriptan or zolmitriptan);
• if you are taking or have taken within the last 2 weeks so-called MAO inhibitors (e.g. moclobemide for depression or selegiline for Parkinson’s disease).

Warnings and precautions
Talk to your doctor or pharmacist before taking Sumatriptan Zentiva:

• if you experience symptoms of heart disease, such as transient chest pain that may be severe and radiate to the throat.

Sumatriptan Zentiva should only be used in cases of diagnosed migraine, and your doctor will decide whether this medicine is suitable for your type of migraine.
If you have controlled hypertension with transient increases in blood pressure values, inform your doctor before taking Sumatriptan Zentiva (see section “Do not take Sumatriptan Zentiva”).
If your headache appears different from usual, do not take Sumatriptan Zentiva without consulting your doctor.
Inform your doctor immediately and stop treatment with Sumatriptan Zentiva if you suddenly experience symptoms such as chest pain or chest tightness.
Inform your doctor if you are a heavy smoker, use nicotine replacement therapy, or are diabetic, particularly if you are a man over 40 years of age with the above-mentioned risk factors or if you are a postmenopausal woman, as you may be considered at increased risk of developing heart disease.
If you have reduced liver function or kidney problems, the effect of the medicine may be affected.
Inform your doctor if you have had seizures or epilepsy, or any other condition that lowers the seizure threshold.
If you have previously experienced hypersensitivity reactions to sulfonamides (medicines used for infections), especially skin reactions, you may also be hypersensitive to sumatriptan (the active substance in Sumatriptan Zentiva).
If you are taking selective serotonin reuptake inhibitors (SSRIs, such as fluoxetine, paroxetine, fluvoxamine or sertraline), serotonin-noradrenaline reuptake inhibitors (SNRIs, such as venlafaxine) or buprenorphine (a potent painkiller). The use of these medicines together with Sumatriptan Zentiva may lead to serotonin syndrome, a potentially life-threatening condition (see "Other medicines and Sumatriptan Zentiva").
Taking Sumatriptan Zentiva too frequently may lead to the development of chronic headache. In this case, you must contact your doctor, as you may need to stop taking Sumatriptan Zentiva.

Other medicines and Sumatriptan Zentiva
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.
The effect of certain medicines may be altered or the effect of Sumatriptan Zentiva may change if taken at the same time. This risk particularly exists with medicines containing:

• ergotamine (for migraine). If you use ergotamine or ergotamine derivatives, such as ergotamine tartrate or methysergide maleate, you must stop treatment at least 24 hours before taking Sumatriptan Zentiva. Conversely, do not take ergotamine for at least 6 hours after taking Sumatriptan Zentiva;
• any triptan or 5-HT receptor agonist (such as naratriptan, rizatriptan, zolmitriptan) also used to treat migraine. Do not use Sumatriptan Zentiva in combination with these medicines. Stop taking these medicines at least 24 hours before taking Sumatriptan Zentiva. Do not take any triptan or 5-HT receptor agonist for at least 24 hours after taking Sumatriptan Zentiva;
• so-called MAO inhibitors (e.g. moclobemide for depression or selegiline for Parkinson’s disease). If you are taking MAO inhibitors, you must stop therapy at least 14 days before taking Sumatriptan Zentiva;
• so-called selective serotonin reuptake inhibitors (e.g. sertraline, paroxetine, fluoxetine for depression or other psychiatric disorders) or serotonin-noradrenaline reuptake inhibitors (e.g. venlafaxine), or buprenorphine (a potent painkiller). The use of Sumatriptan Zentiva with these medicines may cause serotonin syndrome (a group of symptoms that may include restlessness, agitation, confusion, excessive sweating, body temperature above 38°C, hallucinations, coma, increased reflexes, muscle spasms, rhythmic, involuntary muscle contractions involving the muscles controlling eye movements, shivering, increased heart rate and tremor). Inform your doctor immediately if you experience any of these symptoms;
• lithium (for manic/depressive disorders);
• St. John’s wort (Hypericum perforatum, a herbal medicine).

Sumatriptan Zentiva with food and drink
You may take Sumatriptan Zentiva with or without food. The tablets should be swallowed with water.
Pregnancy, breast-feeding and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breast-feeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
There are insufficient data on the use of sumatriptan in pregnant women. Do not take Sumatriptan Zentiva if you are pregnant unless your doctor considers the benefit to outweigh the possible risks.
Breast-feeding
Sumatriptan is excreted in breast milk. Breast-feeding should be avoided for 12 hours after treatment; during this time, breast milk should be discarded. Consult your doctor for advice.
Driving and using machines
The use of Sumatriptan Zentiva may cause side effects that could impair your ability to work safely or to move safely in traffic.
The migraine itself or its treatment with Sumatriptan Zentiva may cause dizziness.
Sumatriptan Zentiva contains lactose and sodium
This medicine contains lactose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially “sodium-free”.

3. How to take Sumatriptan Zentiva

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The tablets should be swallowed with water. Sumatriptan Zentiva must not be used to prevent migraine attacks.
Sumatriptan Zentiva should be taken at the first signs of a migraine attack, although it remains effective even if taken at a later stage of the attack.

The usual dose is:
Adults:
The recommended dose is one 50 mg tablet at the onset of a migraine attack. Some patients may require 100 mg.
If this tablet does not relieve your migraine, do not take additional tablets for the same attack, as it is unlikely that a further dose will be beneficial. Sumatriptan Zentiva may be taken during the next 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 one additional dose within 24 hours; the total dose must not exceed 300 mg.

Children and adolescents (under 18 years of age)
Sumatriptan Zentiva must not be used in children and adolescents under 18 years of age.

Elderly (over 65 years of age)
Data are not available. Sumatriptan Zentiva is not recommended in the elderly.

Patients with impaired liver function
If you have impaired liver function (mild to moderate impairment), a lower dose of 25–50 mg should be considered. Follow your doctor's instructions.

If you take more Sumatriptan Zentiva than you should
Contact your doctor, emergency services, or pharmacist if you have taken more Sumatriptan Zentiva than indicated in this leaflet or prescribed by your doctor.
Symptoms of overdose are the same as those listed in section 4, “Possible side effects”.
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 everyone gets them.
Common (may affect up to 1 in 10 people)
Tingling, dizziness, drowsiness; transient increase in blood pressure (shortly after treatment), flushing; shortness of breath; nausea, vomiting; feeling of heaviness, pressure or tightness (usually transient but may be intense and may affect any part of the body, including chest and throat); muscle pain; pain, sensation of heat or cold, feeling of weakness, fatigue (both side effects are usually transient and of mild to moderate intensity).
Very rare (may affect up to 1 in 10,000 people)
Minor disturbances in liver function tests.
Frequency not known (frequency cannot be estimated from the available data)
Hypersensitivity reactions ranging from skin allergic reactions (rash) to rare cases of severe allergic symptoms (anaphylaxis).
If you experience severe allergic reactions (such as swelling of the eyelids, face or lips, sudden shortness of breath, tremors or chest tightness), stop taking Sumatriptan Zentiva and contact your doctor immediately.
Nystagmus (involuntary back-and-forth movement of the eyeball); scotoma (localized area of blindness or reduced visual field); tremor and dystonia (involuntary muscle contractions), seizures (usually in people with a history of epilepsy), visual disturbances (blurred vision, diplopia, reduced vision, vision loss including some reports of permanent damage); although these may be caused by the migraine attack itself; slow or fast pulse and heartbeat, heart rhythm disturbances, reduced oxygen supply to the myocardium, coronary artery spasms, myocardial infarction, chest pain; low blood pressure, Raynaud's syndrome (reduced blood circulation to hands and feet), inflammation of the colon (due to reduced blood supply) which may present as pain in the lower left side of the abdomen and bloody diarrhoea (ischaemic colitis), diarrhoea, difficulty in swallowing, neck stiffness, joint pain; excessive sweating; feeling of anxiety; if you have recently sustained an injury or have an inflammation (such as rheumatism or inflammation of the colon), you may experience pain or worsening of pain at the site of injury or inflammation.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sumatriptan Zentiva

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the pack after "Exp".
The expiry date refers to the last day of that month.
Do not dispose of any medicine 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 Zentiva contains

• The active substance is sumatriptan.
• The other ingredients are: Core of the tablet: lactose monohydrate; anhydrous lactose; microcrystalline cellulose; sodium croscarmellose; magnesium stearate. Tablet coating: lactose monohydrate; mannitol; talc; glycerol triacetate; titanium dioxide (E171).

Description of the appearance of Sumatriptan Zentiva and package contents
50 mg tablet: white, oval, biconvex tablet, scored on both sides and on the edge, with "SN" engraved on one side and "50" on the other.
The tablet can be divided into two equal doses.
100 mg tablet: white, oval, biconvex tablet with "SN" engraved on one side and "100" on the other.
Packaging:
1, 2, 3, 4, 6, 12, 18 and 24 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Zentiva Italia S.r.l.
Viale L. Bodio 37/b
20158 Milan, Italy

Manufacturer
Specifar S.A.
1,28 Octovriou str.
Agia Varvara
12351 Athens, Greece