SUMAMIGREN 50 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Sumamigren Control, 50 mg, Film-Coated Tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
3. What Sumamigren Control is and what it is used for
4. Important information before taking Sumamigren Control
   1. When not to take Sumamigren Control
   2. Warnings and precautions
   3. Children and adolescents
   4. Elderly patients
   5. Sumamigren Control and other medicines
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Sumamigren Control contains lactose
   9. Sumamigren Control contains E 124 (red cochineal lake)
   10. Sumamigren Control contains sodium
5. How to take Sumamigren Control
   1. Overdose of Sumamigren Control
6. Possible side effects
   1. Common (affecting less than 1 in 10 people):
   2. Very rare (affecting less than 1 in 10,000 people):
   3. Frequency not known (cannot be estimated from the available data):
   4. Reporting side effects
7. How to store Sumamigren Control
8. Contents of the pack and other information
   1. What Sumamigren Control contains:
   2. What Sumamigren Control looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Date of last revision of the leaflet:

Package Leaflet: Information for the User

Sumamigren Control, 50 mg, Film-Coated Tablets

Sumatriptan

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

• 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What Sumamigren Control is and what it is used for

Sumamigren Control is used for the acute treatment of migraine attacks with or without aura.
Sumamigren Control should only be used after the onset of migraine symptoms. It should not be used prophylactically.

2. Important information before taking Sumamigren Control

When not to take Sumamigren Control

• if you are allergic to sumatriptan or any of the other ingredients of this medicine (listed in section 6)
• if you have been diagnosed with: symptoms of coronary heart disease, Prinzmetal's angina (a type of coronary heart disease), peripheral vascular disease, previous myocardial infarction, stroke or transient cerebral ischaemia
• if you have been diagnosed with severe liver impairment
• if you have been diagnosed with moderate or severe hypertension or uncontrolled mild hypertension
• if you are taking ergotamine or its derivatives, including methysergide (vasoconstrictor medicines used to treat migraine) or any other triptan or 5-HT receptor agonist (medicines used to treat migraine)
• if you are taking or have taken in the last 2 weeks monoamine oxidase inhibitors (MAOIs) (medicines used to treat depression)

Warnings and precautions

Before taking Sumamigren Control, discuss it with your doctor or pharmacist.
Tell your doctor if you have:

• headache, but migraine has not been diagnosed before
• headache that is different from the usual migraine headache
• shortness of breath, pain or feeling of pressure in the chest (which may radiate to the jaw or arms) for no apparent reason
• heart disease risk factors (men over 40 years old, postmenopausal women, overweight people, diabetes, high cholesterol, smokers, family history of heart disease)
• liver or kidney function disorders
• history of seizures or predisposition to seizures
• allergy to sulfonamide medicines, as there is a possibility of allergic reactions to sumatriptan, ranging from skin changes to anaphylactic shock
• mild controlled hypertension, as a transient increase in blood pressure and peripheral vascular resistance may occur
• acute or chronic pain or other conditions treated with buprenorphine. Taking this medicine with Sumamigren Control may lead to serotonin syndrome, a potentially life-threatening condition (see "Sumamigren Control and other medicines").

When taking sumatriptan and selective serotonin reuptake inhibitors (SSRIs) (medicines used to treat depression) rarely reported serotonin syndrome, including changes in mental status, autonomic dysfunction (disorders related to the part of the nervous system responsible for involuntary functions, e.g. gastrointestinal and cardiovascular disorders, excessive sweating) and neuromuscular dysfunction. Serotonin syndrome has also been reported during concomitant use of triptans and SSRIs or serotonin-norepinephrine reuptake inhibitors (SNRIs) as well as buprenorphine.
If concomitant treatment with sumatriptan and an SSRI or SNRI or buprenorphine is clinically justified, the patient should be closely monitored by the doctor.
When taking sumatriptan and St. John's Wort (Hypericum perforatum) products, side effects may occur more frequently.
Overuse of medicines for the acute treatment of migraine attacks, including triptans and painkillers, may be associated with worsening of headaches in susceptible patients (medication overuse headache, MOH). In each patient who experiences an increase in frequency or severity of migraine during treatment, the doctor should consider the diagnosis of medication overuse headache. In these patients, it may be necessary to discontinue treatment.

Children and adolescents

Sumamigren Control is not recommended for use in children and adolescents.

Elderly patients

Sumamigren Control is not recommended for use in elderly patients (over 65 years old).

Sumamigren Control and other medicines

Tell your doctor about all medicines you are taking now or have taken recently, as well as any medicines you plan to take.
After taking Sumamigren Control, do not take any ergotamine or its derivatives for 6 hours, and do not take any triptans or 5-HT receptor agonists for 24 hours. After taking any ergotamine or other triptan or 5-HT receptor agonist, do not take Sumamigren Control for at least 24 hours.
Do not take Sumamigren Control with MAOIs or for 2 weeks after stopping treatment with MAOIs.
When taking sumatriptan and St. John's Wort (Hypericum perforatum) products, side effects may occur more frequently.
When taking sumatriptan with SSRIs, rarely reported serotonin syndrome (including changes in mental status, autonomic dysfunction, and neuromuscular dysfunction). Serotonin syndrome has also been reported during concomitant use of triptans and SNRIs (see "Warnings and precautions").
Do not take Sumamigren Control with buprenorphine without prior consultation with your doctor. This medicine may interact with Sumamigren Control and cause symptoms such as involuntary, rhythmic muscle contractions, including eye movements, agitation, hallucinations, coma, excessive sweating, tremors, increased reflexes, muscle tension, and body temperature above 38°C. If you experience such symptoms, contact your doctor.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Sumatriptan passes into breast milk. Therefore, during the 12 hours after taking Sumamigren Control, breastfeeding is not recommended.

Driving and using machines

Due to a migraine attack or after taking Sumamigren Control, drowsiness may occur.
In such cases, do not drive or operate machinery.

Sumamigren Control contains lactose

If you have been diagnosed with intolerance to some sugars, contact your doctor before taking the medicine.

Sumamigren Control contains E 124 (red cochineal lake)

The medicine may cause allergic reactions.

Sumamigren Control contains sodium

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

3. How to take Sumamigren Control

Always take this medicine exactly as your doctor or pharmacist has told you.
If you are not sure, ask your doctor or pharmacist.
Sumamigren Control should only be used after the onset of migraine symptoms, it should not be used prophylactically. Swallow the tablets whole with water. The line on the tablet is not intended for breaking the tablet.
Do not take more than the recommended dose.
The recommended dose of Sumamigren Control for adults is 50 mg, taken as soon as possible after the first symptoms of migraine appear, but the medicine is equally effective when taken at any stage of the headache. Some patients may require a dose of 100 mg - follow the doctor's instructions.
If the symptoms of the migraine attack do not improve after taking the first dose, taking a second dose during the same attack is not recommended. In such cases, treatment with paracetamol, acetylsalicylic acid, or another non-steroidal anti-inflammatory medicine may be used.
If the symptoms of the migraine attack recur, further doses of Sumamigren Control may be taken, but not earlier than 2 hours after the first dose.
Do not take more than 300 mg in 24 hours.
Sumamigren Control is not recommended for use in children, adolescents, and elderly patients (over 65 years old).

Overdose of Sumamigren Control

In case of overdose, contact your doctor or pharmacist immediately.

4. Possible side effects

Like all medicines, Sumamigren Control can cause side effects, although not everybody gets them.
Side effects have been reported with the following frequencies:

Common (affecting less than 1 in 10 people):

• pain, numbness, tingling, heat or cold sensation, heaviness, tension in various parts of the body, including the chest and throat.

These symptoms may be severe but are usually transient and short-lived. If the symptoms persist and worsen, contact your doctor immediately. Do not take further doses of Sumamigren Control before consulting your doctor.
Other common side effects:

• dizziness
• fatigue
• drowsiness
• weakness
• transient increase in blood pressure shortly after administration
• flushing
• shortness of breath
• nausea and vomiting
• muscle pain.

Very rare (affecting less than 1 in 10,000 people):

• liver function changes (if liver function tests are performed, inform your doctor that you are taking Sumamigren Control, as it may affect the results).

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

In case of any of the following symptoms, stop taking the medicine and contact your doctor immediately:

• very severe chest pain radiating to the jaw and arms
• sudden wheezing or feeling of pressure in the chest
• swelling of the eyelids, face, or lips
• anaphylactic shock (drop in blood pressure, weakness, fainting)
• seizures
• rash with red spots or hives
• abdominal pain and (or) intense rectal bleeding.

Other side effects with unknown frequency:

• tremors
• dystonia (muscle tone disorder)
• visual disturbances such as nystagmus, blurred vision, flickering lights, double vision, changes in the visual field, loss of vision, including permanent vision loss (visual disturbances may be part of a migraine attack)
• slow or rapid heart rate or feeling of irregular or strong heartbeat
• hypotension (excessive decrease in blood pressure)
• change in normal finger or toe color
• joint pain
• neck stiffness
• excessive sweating
• diarrhea
• feeling of anxiety
• in patients who have recently had trauma or have an inflammatory condition (such as rheumatism or colitis), pain or worsening of pain at the site of trauma or inflammation may occur
• difficulty swallowing.

In case of the above symptoms, there is no need to stop taking the medicine, but inform your doctor about them during the next visit.
In case of persistent blue discoloration of the fingers or toes, stop taking the medicine and contact your doctor immediately.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181 C
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sumamigren Control

Keep the medicine out of the sight and reach of children.
There are no special storage precautions.
Do not use this medicine after the expiry date stated on the carton and blister after EXP.
The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Sumamigren Control contains:

• The active substance is sumatriptan in the form of sumatriptan succinate. Each film-coated tablet contains 50 mg of sumatriptan.
• The other ingredients are: tablet core: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, magnesium stearate, talc, anhydrous colloidal silica. tablet coating: hypromellose, macrogol 6000, talc, titanium dioxide (E 171), triethyl citrate, and red cochineal lake (E 124).

What Sumamigren Control looks like and contents of the pack

Film-coated tablets, oblong, biconvex, pink, with a line on one side.
The line on the tablet is not intended for breaking the tablet.
Each pack contains 2 film-coated tablets packed in a cardboard box.

Marketing authorization holder and manufacturer

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański
tel. +48 22 364 61 01

Date of last revision of the leaflet: