Package leaflet: Information for the user

Warning! Keep this leaflet. Information on the immediate packaging in a foreign language.
Sumatriptan Actavis, 50 mg, coated tablets
Sumatriptanum
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 further questions, ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet:

What Sumatriptan Actavis is and what it is used for
What you need to know before taking Sumatriptan Actavis
How to take Sumatriptan Actavis
Possible side effects
How to store Sumatriptan Actavis
Contents of the pack and other information

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

Each Sumatriptan Actavis tablet contains a single dose of sumatriptan, which belongs to a group of medicines known as triptans (also called 5HT receptor agonists).
Sumatriptan Actavis is used to treat migraine attacks with or without aura.
Migraine symptoms may be caused by temporary dilation of blood vessels in the head. Sumatriptan is believed to reduce this dilation. This helps relieve headache and other symptoms of migraine, such as nausea or vomiting, and sensitivity to light and sound.

2. Important information before taking Sumatriptan Actavis

When not to take Sumatriptan Actavis:

if the patient is allergic to sumatriptan or any of the other ingredients of this medicine (listed in section 6);
if the patient has heart diseases such as coronary artery narrowing (ischaemic heart disease) or chest pain (angina), or if the patient has had a heart attack;
if the patient has circulatory problems in the legs causing pain when walking similar to cramps (peripheral vascular disease);
if the patient has had a stroke or mini-stroke [also called transient ischaemic attack (TIA)];
if the patient has high blood pressure. A patient with mild high blood pressure adequately treated may use sumatriptan;
if the patient has severe liver function disorders;
if the patient is taking other anti-migraine medicines, including those containing ergotamine or medicines acting similarly such as methysergide maleate or other triptans, or medicines called 5HT receptor agonists (such as naratriptan or zolmitriptan);

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if the patient is taking any antidepressant medicines:
medicines belonging to a group called monoamine oxidase inhibitors (MAOI) or has taken MAOIs within the last 2 weeks,
selective serotonin reuptake inhibitors (SSRI) including: citalopram, fluoxetine, fluvoxamine, paroxetine or sertraline,
serotonin and noradrenaline reuptake inhibitors (SNRI) including: venlafaxine and duloxetine;
in children under 18 years of age.

Warnings and precautions
Before prescribing Sumatriptan Actavis to a patient, the doctor should determine whether the patient's headache is caused by migraine and not by another condition.
Before starting to take Sumatriptan Actavis, consult a doctor if any of the following apply to the patient:

the patient is a regular smoker or uses nicotine replacement therapy, particularly if:
the patient is a man over 40 years of age, or
the patient is a woman who has gone through menopause. In very rare cases, some patients have developed serious heart problems after using sumatriptan, even if they previously had no symptoms of heart disease. If any of the above points apply, this may mean the patient is at increased risk of heart disease. The doctor should be informed and may need to check heart function before prescribing sumatriptan;
the patient has a history of seizures or other conditions that may increase the likelihood of seizure attacks – e.g. head injury or alcoholism;
the patient has liver or kidney disease;
the patient has intolerance to certain sugars;
the patient is allergic to medicines called sulphonamides. In such cases, the patient may also be allergic to sumatriptan. If the patient is allergic to an antibiotic but does not know whether it belongs to the sulphonamide group, the patient should inform the doctor or pharmacist before taking this medicine;
the patient is taking antidepressant medicines called SSRIs (selective serotonin reuptake inhibitors) or SNRIs (serotonin and noradrenaline reuptake inhibitors). See also section below Sumatriptan Actavis and other medicines;
the patient frequently takes sumatriptan. Excessive use of sumatriptan may worsen headache. The doctor may advise stopping sumatriptan;
the patient experiences chest pain or tightness after using sumatriptan. These symptoms may be intense but usually resolve quickly. However, if these symptoms do not resolve quickly or become severe, immediate medical help should be sought.

Sumatriptan Actavis and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. This includes all herbal preparations, dietary supplements such as vitamins, iron or calcium, and medicines purchased without a prescription.
Some medicines must not be used with Sumatriptan Actavis, and others may cause adverse effects if taken at the same time. The doctor should be informed if the patient is taking:

ergotamine, also used to treat migraine, or medicines acting similarly such as methysergide maleate. Sumatriptan Actavis must not be used at the same time as these medicines. These medicines should be discontinued at least 24 hours before starting Sumatriptan Actavis. They should not be taken again until at least 6 hours after stopping Sumatriptan Actavis;

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other triptans or medicines called 5HT receptor agonists (such as naratriptan or zolmitriptan). Sumatriptan Actavis must not be used at the same time as these medicines. These medicines should be discontinued at least 24 hours before starting Sumatriptan Actavis. They should not be taken again until at least 24 hours after stopping Sumatriptan Actavis;
monoamine oxidase inhibitors (MAOI), used to treat depression. Sumatriptan Actavis must not be taken if the patient has taken such medicines within the last two weeks.
selective serotonin reuptake inhibitors (SSRI) and serotonin and noradrenaline reuptake inhibitors (SNRI), used to treat depression. Using Sumatriptan Actavis with these medicines may cause serotonin syndrome (a group of symptoms which may include restlessness, confusion, sweating, hallucinations, overactive reflexes, muscle spasms, shivering, rapid heart rate and tremor). The doctor should be informed immediately if such symptoms occur;
St John's wort (Hypericum perforatum). When taking Sumatriptan Actavis and herbal medicines containing St John's wort, adverse effects may occur more frequently;
lithium, a medicine used to treat bipolar disorder (manic depression).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before taking this medicine.
Pregnancy:
If the patient is pregnant or suspects pregnancy, she should inform her doctor before taking Sumatriptan Actavis. Experience with the safety of Sumatriptan Actavis during pregnancy is limited. Available data so far do not indicate an increased risk of congenital malformations. The patient should discuss with her doctor whether she can use Sumatriptan Actavis during pregnancy.
Breastfeeding:
Breastfeeding should be avoided for 12 hours after taking Sumatriptan Actavis. Breast milk expressed during this time should be discarded and not used for feeding the baby.

Driving and operating machinery
Migraine symptoms or the medicine used may cause drowsiness. If this occurs, the patient should not drive or operate machinery.

Sumatriptan Actavis contains lactose
This medicine contains 176 mg lactose as lactose monohydrate and lactose in the 50 mg tablet.
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should contact the doctor before taking this medicine.

Other excipients
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Sumatriptan Actavis

This medicine should always be taken as prescribed by a doctor. If in doubt, consult a doctor or pharmacist.
These tablets should ideally be taken as soon as the patient feels a migraine attack is imminent, although they may also be taken at any time during a migraine attack.
Do not take Sumatriptan Actavis to prevent a migraine attack – the medicine should only be taken after migraine symptoms have started.
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Adults
The usual recommended dose is one 50 mg tablet, swallowed whole with water.
Some patients may require a 100 mg dose – follow the doctor's instructions.

Children and adolescents under 18 years of age
Sumatriptan Actavis is not recommended for use in children under 18 years of age.

Elderly patients (over 65 years of age)
Sumatriptan Actavis is not recommended for use in patients over 65 years of age.

If symptoms recur
The patient may take another tablet of Sumatriptan Actavis only if at least 2 hours have passed since the previous tablet was taken. Do not exceed a total of 300 mg within 24 hours.

If there is no improvement after taking one tablet
Do not take a second tablet or any other medicine containing sumatriptan during the same attack. If there is no improvement after taking one tablet, the patient may take other pain-relieving medicines such as: paracetamol, acetylsalicylic acid, or non-steroidal anti-inflammatory drugs. Sumatriptan Actavis may be used again during the next attack. If Sumatriptan Actavis does not provide relief, consult a doctor for advice.

Taking more than the recommended dose of Sumatriptan Actavis
Do not take more than six 50 mg tablets or three 100 mg tablets (which together constitute 300 mg) in 24 hours. Taking too much Sumatriptan Actavis may cause illness. Symptoms of overdose are the same as those listed in section 4, "Possible side effects". If too many tablets have been taken by the patient or another person, contact a doctor, hospital, or Poison Information Center immediately.

If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience
them.
Allergic reactions
Frequency unknown (frequency cannot be estimated from the available data):
Skin allergic reactions: skin rashes, for example in the form of red spots or hives (skin wheals).
Anaphylaxis (severe allergic reactions, such as swelling of the eyelids, face or lips, and sudden
wheezing, irregular heartbeat, chest tightness or collapse).
If any allergic reactions occur, treatment with Sumatriptan Actavis must be discontinued.
In the event of severe allergic reactions, immediate medical advice must be sought.
Other possible adverse reactions
Common (may occur in less than 1 in 10 patients):

tinnitus, dizziness, drowsiness, sensory disturbances;
transient increase in blood pressure (occurring shortly after administration of the medicine), sudden flushing;
difficulty breathing;
nausea or vomiting;
feeling of heaviness, muscle pain;
pain, sensation of heat or cold, tightness or pressure. These symptoms are usually transient and may affect any part of the body, including the chest and throat. Feeling of weakness, fatigue.

Very rare (may occur in less than 1 in 10,000 patients):

minor abnormalities in liver function tests observed in isolated cases.

Frequency unknown (frequency cannot be estimated from the available data):

anxiety;
seizures (epileptic fits), involuntary movements, tremors, nystagmus;
visual disturbances such as blurred vision, restricted vision, loss of vision (these may also be due to the migraine attack itself);
heart disorders, in which the heart may beat faster, slower or change rhythm, chest pain (angina) or myocardial infarction;
low blood pressure, Raynaud's phenomenon (a condition characterized by paleness and numbness of fingers and toes);
inflammation of the large intestine (symptoms include pain in the lower left abdomen and bloody diarrhoea), diarrhoea;
increased sweating;
neck stiffness, joint pain;
in a patient who has recently suffered trauma or who has an inflammatory condition (such as rheumatism or inflammation of the large intestine), pain or worsening of pain at the site of trauma or inflammation may occur;
difficulty swallowing.

If any adverse reactions occur, including any not listed in this leaflet,
you should consult a doctor or pharmacist.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, you should inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw,
tel.: 22 49-21-301, fax: 22 49-21-309, Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Sumatriptan Actavis

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Keep the blister in the outer packaging.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.
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6. Contents of the pack and other information

What Sumatriptan Actavis contains

The active substance is sumatriptan 50 mg as sumatriptan succinate.
Other components of the medicine are:
Tablet core: monohydrate lactose, sodium croscarmellose, lactose, microcrystalline cellulose, magnesium stearate;
Coating: monohydrate lactose, mannitol, titanium dioxide (E 171), triacetin, talc.

What Sumatriptan Actavis looks like and contents of the pack
White, elongated, biconvex coated tablets with a dividing line on both sides, embossed with the mark "SN" on one side and the number "50" on the other side.
The product is packed in blisters in cardboard boxes containing 3, 6, 12 and 18 coated tablets.
For more detailed information, please contact the responsible party or the parallel importer.
Responsible party in the Czech Republic, country of export:
Actavis Group PTC ehf, Dalshraun 1, IS-220 Hafnarfjördur, Iceland
Manufacturer:
Balkanpharma - Dupnitsa AD, 3, Samokovsko Shosse Str., 2600 Dupnitsa, Bulgaria
PharmaPath S.A., 28is Octovriou 1, Agia Varvara, 123 51, Greece
Parallel importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Authorisation number in the Czech Republic, country of export: 33/390/07-C
Parallel import authorisation number: 300/24
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