Sumatriptan Actavis

Leaflet attached to the packaging: information for the user

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Sumatriptan Actavis, 50 mg, effervescent tablets

Sumatriptanum

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be read again if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed specifically for one person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Sumatriptan Actavis and what is it used for
• 2. Important information before taking Sumatriptan Actavis
• 3. How to take Sumatriptan Actavis
• 4. Possible side effects
• 5. How to store Sumatriptan Actavis
• 6. Contents of the packaging and other information

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

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

2. Important information before taking Sumatriptan Actavis

When not to take Sumatriptan Actavis:

allergicto sumatriptan or any of the other ingredients of this medicine (listed in section 6);heart diseasesuch as coronary artery narrowing (ischemic heart disease) or chest pain (angina), or if the patient has had a heart attack;circulatory problemsin the legs that cause pain when walking, similar to cramps (peripheral vascular disease);strokeor mini-stroke (also known as transient ischemic attack, TIA);high blood pressure. A patient with mild high blood pressure that is being treated may take sumatriptan;severe liver function disorders;migraine medicines, including those containing ergotamine or medicines that work in a similar way, such as methysergide maleate or other triptans or 5HT receptor agonists;

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antidepressant medicines;
• medicines belonging to the group called monoamine oxidase inhibitors (MAOIs)or if the patient has taken an MAOI in the last 2 weeks,
• selective serotonin reuptake inhibitors (SSRIs)such as citalopram, fluoxetine, fluvoxamine, paroxetine, or sertraline,
• serotonin and noradrenaline reuptake inhibitors (SNRIs)such as venlafaxine and duloxetine;
• in children under 18 years of age.

Warnings and precautions

Before prescribing Sumatriptan Actavis to the patient, the doctor will determine if the patient's headache is caused by migraine and not another condition. Before taking Sumatriptan Actavis, the patient should consult their doctor if any of the following apply:

• the patient is a heavy smoker or uses nicotine replacement therapy, especially if:
• the patient is a man over 40 years old, or
• the patient is a woman who has already gone through menopause. In very rare cases, some patients have developed severe heart problems after taking sumatriptan, even if they had no previous symptoms of heart disease. If any of the above points apply to the patient, it may mean that the patient is at increased risk of heart disease. The doctor should be informed;
• the patient has a history of seizuresor other conditions that may increase the risk of seizures - such as head injury or alcoholism;
• the patient has liver or kidney disease;
• the patient has an intolerance to some sugars;
• the patient is allergic to sulfa medicines. In this case, the patient may also be allergic to sumatriptan. If the patient is allergic to an antibiotic but does not know if it belongs to the sulfa group, they should tell their doctor or pharmacist before taking this medicine;
• the patient is taking SSRI or SNRI antidepressant medicines. See also the section below Sumatriptan Actavis and other medicines;
• the patient often takes sumatriptan. Taking sumatriptan too frequently may cause worsening of headache. The doctor may advise stopping sumatriptan;
• the patient experiences chest pain or pressureafter taking sumatriptan. Such symptoms may be intense but usually pass quickly. However, if they do not pass quickly or become severe, medical help should be sought immediately.

Sumatriptan Actavis and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take, including herbal preparations, dietary supplements such as vitamins, iron, or calcium, and medicines that have been purchased without a prescription. Some medicines should not be taken with Sumatriptan Actavis, and others may cause side effects if taken with Sumatriptan Actavis. The patient should inform their doctor if they are taking:

• ergotamineused to treat migraineor medicines that work in a similar way, such as methysergide maleate. Sumatriptan Actavis should not be taken at the same time as these medicines. The patient should stop taking these medicines at least 24 hours before starting Sumatriptan Actavis and should not take them again for at least 6 hours after stopping Sumatriptan Actavis;

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• other triptansor medicines called 5HT receptor agonists (such as naratriptan or zolmitriptan). Sumatriptan Actavis should not be taken at the same time as these medicines. The patient should stop taking these medicines at least 24 hours before starting Sumatriptan Actavis and should not take them again for at least 24 hours after stopping Sumatriptan Actavis;
• monoamine oxidase inhibitors (MAOIs)used to treat depression. Sumatriptan Actavis should not be taken if the patient has taken MAOIs in the last 2 weeks.
• selective serotonin reuptake inhibitors (SSRIs)and serotonin and noradrenaline reuptake inhibitors (SNRIs)used to treat depression. Taking Sumatriptan Actavis with these medicines may cause serotonin syndrome (a condition characterized by symptoms such as restlessness, confusion, sweating, hallucinations, increased reflexes, muscle stiffness, shivering, and rapid heart rate). The patient should immediately inform their doctor if such symptoms occur;
• St. John's Wort (Hypericum perforatum). When taking Sumatriptan Actavis and herbal medicines containing St. John's Wort, side effects may occur more frequently;
• lithium, a medicine used to treat manic-depressive illness (bipolar disorder).

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. Pregnancy:If the patient is pregnant or suspects they are pregnant, they should inform their doctor before taking Sumatriptan Actavis. Experience with the safety of Sumatriptan Actavis during pregnancy is limited. So far, available data do not indicate an increased risk of congenital anomalies. The patient should discuss with their doctor whether they can take Sumatriptan Actavis during pregnancy. Breastfeeding:The patient should not breastfeed their child within 12 hours of taking Sumatriptan Actavis. Milk expressed during this time should be discarded and not given to the child.

Driving and using machines

Migraine symptoms or the medicine may cause drowsiness. If this symptom occurs, the patient should not drive or operate machinery.

Sumatriptan Actavis contains lactose

This medicine contains 176 mg of lactose in the form of lactose monohydrate and anhydrous lactose in a 50 mg tablet. If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

Other excipients

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Sumatriptan Actavis

This medicine should always be taken as directed by the doctor. In case of doubts, the doctor or pharmacist should be consulted. The tablets are best taken as soon as the patient feels a migraine attack is coming, although they can also be taken at any time during a migraine attack. Sumatriptan Actavis should not be taken to prevent a migraine attack - it should only be taken after migraine symptoms have appeared. AdultsThe recommended dose is one 50 mg tablet, swallowed whole with water. Some patients may require a 100 mg dose - the doctor's instructions should be followed. Children and adolescents under 18 years of ageSumatriptan 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.

In case of recurrence of symptoms

The patient may take another Sumatriptan Actavis tablet only if at least 2 hours have passed since the previous tablet was taken. No more than 300 mg should be taken in total in 24 hours.

If there is no improvement after taking one tablet

The patient should not take a second tablet or any other sumatriptan-containing medicine during the same migraine 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 can be used again during the next migraine attack. If Sumatriptan Actavis does not provide relief, the patient should consult their doctor for advice.

Using more Sumatriptan Actavis than recommended

The patient should not take more than six 50 mg tablets or three 100 mg tablets (which is a total of 300 mg) in 24 hours. Taking too much Sumatriptan Actavis may cause illness. The symptoms of overdose are the same as those listed in section 4, "Possible side effects". If the patient or someone else has taken too many tablets, they should contact a doctor, hospital, or Poison Information Center. In case of any further doubts about the use of this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Sumatriptan Actavis can cause side effects, although not everybody gets them.

Allergic reactions

Frequency not known (frequency cannot be estimated from the available data):Skin allergic reactions: skin rashes, such as red spots or hives. Anaphylaxis (severe allergic reactions, such as swelling of the eyelids, face, or lips, and sudden onset of wheezing, irregular heartbeat, chest pressure, or collapse). If any allergic reactions occur, the patient should stop taking Sumatriptan Actavis. In case of severe allergic reactions, medical help should be sought immediately.

Other possible side effects

Common (may affect up to 1 in 10 people):

• ringing in the ears, dizziness, drowsiness, sensation disturbances;
• transient increase in blood pressure (occurring shortly after administration), sudden flushing;
• breathing difficulties;

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• nausea or vomiting;
• feeling of heaviness, muscle pain;
• pain, feeling of heat or cold, squeezing or pressure. These symptoms are usually transient (temporary) and may affect any part of the body, including the chest and throat. Feeling of weakness, fatigue.

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

• mild liver function test abnormalities have been observed in individual cases.

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

• anxiety;
• seizures (epileptic), involuntary movements, tremors, nystagmus;
• vision disturbances such as blurred vision, limited vision, loss of vision (which may also be a symptom of the migraine itself);
• heart disorders, which may cause the heart to beat faster, slower, or irregularly, chest pain (angina), or heart attack;
• low blood pressure, Raynaud's phenomenon (a condition characterized by paleness and numbness of the fingers and toes);
• inflammation of the large intestine (symptoms include abdominal pain and bloody diarrhea), diarrhea;
• increased sweating;
• stiffness of the neck, joint pain;
• in a patient who has recently had an injury or has an inflammatory condition (such as rheumatism or inflammatory bowel disease), pain or worsening of pain may occur at the site of the injury or inflammation;
• difficulty swallowing.

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should consult their doctor or pharmacist.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Sumatriptan Actavis

The medicine should be stored out of sight and reach of children. This medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated. The medicine should not be stored at temperatures above 25°C. The blister should be stored in the outer packaging. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment. Page 5 of 6

6. Contents of the packaging and other information

What Sumatriptan Actavis contains

• The active substance of the medicine is sumatriptan 50 mg in the form of sumatriptan succinate.
• The other ingredients of the medicine are: Core:lactose monohydrate, sodium croscarmellose, lactose, microcrystalline cellulose, magnesium stearate; Coating:lactose monohydrate, mannitol, titanium dioxide (E 171), triacetin, talc.

What Sumatriptan Actavis looks like and contents of the pack

White, elongated, biconvex tablets with a dividing line on both sides, with the inscription "SN" on one side and the number "50" on the other side. The product is packaged in blisters in cardboard boxes containing 3, 6, 12, and 18 effervescent tablets.

Marketing authorization holder in the Czech Republic, the 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 by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź Authorization number in the Czech Republic, the country of export: 33/390/07-C

Parallel import authorization number: 300/24

Date of leaflet approval: 24.07.2024

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