Sumamigren

Package Leaflet: Information for the Patient

Sumamigren, 50 mg, Film-Coated Tablets

Sumamigren, 100 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.

Contents of the Package Leaflet

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

1. What Sumamigren is and what it is used for

Sumamigren is indicated for the acute treatment of migraine attacks.
Sumamigren contains sumatriptan as the active substance, which belongs to a group of medicines called triptans. Sumatriptan works by constricting blood vessels in the area of the carotid artery. The dilation of these vessels is likely to be the cause of migraine. Sumatriptan relieves headache and other symptoms associated with migraine, including nausea, sensitivity to light and sound.
The effect of the medicine starts about 30 minutes after administration.

2. Important information before taking Sumamigren

When not to take Sumamigren:

if you are allergic to sumatriptan or any of the other ingredients of this medicine (listed in section 6)
do not take prophylactically - Sumamigren should be taken only after the onset of migraine symptoms
in patients under 18 or over 65 years of age
if you have heart disease, including heart failure, previous myocardial infarction, ischemic heart disease, or related symptoms, angina pectoris (chest pain), coronary artery spasm (so-called Prinzmetal's angina)
if you have ever had a stroke or transient ischemic attack
if you have mild, moderate, or severe hypertension
if you have severe liver function disorders
if you have circulatory disorders, leg cramps while walking, or if your doctor has diagnosed peripheral vascular disease
in case of taking monoamine oxidase inhibitors used, among other things, in the treatment of depression (such as phenelzine, isocarboxazid, tranylcypromine). Sumamigren can be taken after at least 14 days from the end of treatment with monoamine oxidase inhibitors.
in case of taking other anti-migraine medicines, including other triptans (containing sumatriptan or zolmitriptan, rizatriptan, or naratriptan), or medicines containing ergotamine or its derivatives, such as methysergide.

Warnings and precautions

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

• you have had seizures or are exposed to factors that lower the seizure threshold (e.g., taking antidepressant, antipsychotic medications)
• you have risk factors for cardiovascular disease, such as:
• men over 40 years of age
• women after menopause
• smoking or using nicotine substitutes
• obesity
• you have a migraine headache, but it has not been previously diagnosed, and if you have migraines with atypical headache, as it may be caused by a neurological disorder
• you have previously been diagnosed with hemiplegic, basilar, or ophthalmoplegic migraine
• you have liver or kidney disease
• you are allergic to sulfonamides. In patients allergic to sulfonamides, after taking Sumamigren, allergic reactions of varying severity may occur, from skin changes to anaphylactic shock (its symptoms include: shortness of breath, swelling of the throat and larynx, itching of the skin and its redness, headache, feeling of "pressure", dizziness, significant weakness, up to loss of consciousness; in severe cases, it can be life-threatening).
• you are taking antidepressant medications containing selective serotonin reuptake inhibitors or selective serotonin and norepinephrine reuptake inhibitors (SSRIs and SNRIs) (see "Sumamigren and other medicines" below)
• you have mild controlled hypertension, as transient increases in blood pressure and peripheral vascular resistance may occur.
• you have intolerance to some sugars (see "Sumamigren contains lactose" below)
• you have acute or chronic pain or other conditions treated with buprenorphine. Taking this medicine with Sumamigren may lead to serotonin syndrome, a life-threatening condition (see section "Sumamigren and other medicines").

Stop taking the medicine and seek medical advice if you experience:

• atypical headache, as it may be a symptom of a stroke, transient ischemic attack, or intracranial hemorrhage. In patients with migraines, there is an increased risk of these diseases.
• after taking Sumamigren, transient pain and feeling of pressure in the chest and throat. Usually, these symptoms occur within 30 minutes of taking the medicine and last up to 2 hours. These symptoms may indicate ischemic heart disease, so you should see a doctor immediately.
• frequent or daily headaches despite (or due to) regular use of Sumamigren.

Do not take Sumamigren with preparations containing St. John's Wort (Hypericum perforatum), as side effects may occur more frequently.

Sumamigren and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take. The medicines listed below may occur under several different trade names. They will not be listed in this section, only the active substances or their groups. Therefore, you should carefully check the packaging and the leaflet of the medicine you are taking for the name of its active substance.
Do not takeSumamigren with:

• medicines containing ergotamine and its derivatives (e.g., methysergide), used in the treatment of migraines. Before taking Sumamigren, wait at least 24 hours after taking any medicine containing ergotamine or other triptans (zolmitriptan, rizatriptan, or naratriptan). On the other hand, medicines containing ergotamine can be taken at least 6 hours after taking Sumamigren. Other triptans can be taken at least 24 hours after taking Sumamigren. medicines containing monoamine oxidase inhibitors (used, among other things, in the treatment of depression). Sumamigren can be taken after at least 14 days from the end of treatment with monoamine oxidase inhibitors. medicines containing selective serotonin reuptake inhibitors (used in the treatment of certain mental illnesses, including depression), such as citalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, medicines containing selective serotonin and norepinephrine reuptake inhibitors, such as venlafaxine, and buprenorphine. During concomitant use of sumatriptan and these medicines, serotonin syndrome has been reported, which is characterized by the occurrence of the following symptoms: muscle stiffness, involuntary, rhythmic muscle contractions, including those that control eye movements, dilated pupils, seizures, tremors, increased reflexes, hallucinations, anxiety, agitation, coma, excessive sweating, increased body temperature (above 38°C) and blood pressure, vomiting, diarrhea. If you experience any of these symptoms, you should contact your doctor immediately. If concomitant use of these medicines is necessary, the patient should be under close medical supervision. preparations containing St. John's Wort (Hypericum perforatum), as side effects may occur more frequently.

Sumamigren with food and drink

Sumamigren can be taken with or without food.
Swallow the tablets whole with water.

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.
Do not take Sumamigren during pregnancy or breastfeeding (unless your doctor advises otherwise).

Driving and using machines

During treatment with Sumamigren, drowsiness may occur. If drowsiness occurs, do not drive or operate any machinery.

Sumamigren 50 mg contains 123.5 mg of lactose monohydrate, red iron oxide, and sodium

Sumamigren 100 mg contains 247 mg of lactose monohydrate and sodium

Lactose

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

Red iron oxide (E172)

Red iron oxide may cause allergic reactions.

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

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The dose of the medicine is determined individually by the doctor, depending on the patient's condition.

Do not take Sumamigren prophylactically.

Sumamigren is recommended for the acute treatment of migraine attacks and should not be taken concomitantly with other medicines containing sumatriptan or other triptans (zolmitriptan, rizatriptan, or naratriptan) or medicines containing ergotamine or ergotamine derivatives (including methysergide).
Do not exceed the recommended dose.

Adults (18-65 years)

The recommended single dose of the medicine is 50 mg, taken as soon as possible after the onset of a migraine attack (the medicine is also effective during the attack). In some patients, a dose of 100 mg may be required.
Swallow the tablets whole with water.
If the use of a single dose of the medicine (1 tablet) does not lead to the disappearance of symptoms, do not take a second Sumamigren tablet during the same migraine attack. In such a situation, during the attack, you can take paracetamol, acetylsalicylic acid, or non-steroidal anti-inflammatory drugs. The next tablet can be taken during the next migraine attack.

If the use of a single dose of the medicine leads to the disappearance of symptoms, but the migraine attack returns,

you can take another dose (1 tablet)within the next 24 hours, provided that there is at least a 2-hour interval between the two doses. Do not exceed a dose of more than 300 mg per day, and in patients with mild and moderate liver function disorders, the maximum daily dose is 50 mg.

Children and adolescents (under 18 years)

Do not take Sumamigren in children and adolescents.

Elderly patients (over 65 years)

Do not take Sumamigren in this patient group.

Taking more than the recommended dose of Sumamigren

If you have taken more than the recommended dose of the medicine, contact your doctor immediately, who will provide appropriate treatment.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Sumamigren can cause side effects, although not everybody gets them.
The frequency of side effects is defined as follows:
Common: in less than 1 in 10 patients
Very rare: in less than 1 in 10,000 patients
Not known: frequency cannot be estimated from the available data.
You should immediatelycontact your doctor if you experience the following side effects (if not specified otherwise, they occur with an unknown frequency):

• Wheezing, difficulty breathing, feeling of "pressure", swelling of the face, eyelids, lips, tongue, throat, and larynx, usually accompanied by itching skin rash (hives), dizziness, disorientation, and fainting, which may be symptoms of severe allergic reactions, including anaphylactic shock;
• Seizures;
• Raynaud's syndrome, which may manifest as pallor or cyanosis of the skin and (or) pain in the fingers of the hands or feet, ears, nose, or jaw due to cold or stress;
• Ischemic colitis (part of the intestine), which may manifest as pain in the left lower abdomen and (or) bloody diarrhea;
• Increasing or prolonged feeling of heaviness, increased blood pressure, pain, and pressure in the chest, throat, or other parts of the body, feeling of stabbing, tingling, burning (frequent side effects). These symptoms may occur within 30 minutes of taking the medicine and are usually not persistent. However, if they last more than 2 hours or worsen (especially chest pain), you should contact your doctor immediately, as they may be symptoms of a myocardial infarction (see warnings in section 2).

Other side effects that may occur after taking Sumamigren

Common:

• Sudden, short-term flushing of the face, dizziness, feeling of weakness, fatigue, and drowsiness (important when driving or operating machinery).
• Nausea or vomiting - if not part of the migraine.
• Muscle pain.
• Disorders of sensation, including numbness (loss of sensation).
• Pain, feeling of heat or cold, tension.
• Shortness of breath.

Very rare:

• Changes in laboratory test results assessing liver function.

Frequency not known:

• Visual disturbances, including flickering lights, double vision, changes in the field of vision, nystagmus. Cases of vision loss, including permanent vision loss, have also been observed.
• Low blood pressure, which may lead to fainting, especially when standing up.
• Slow or fast heart rate, palpitations, arrhythmias, chest pain.
• Tremors or uncontrolled movements.
• Diarrhea.
• Excessive sweating.
• Joint pain.
• Stiffness of the neck.
• Anxiety.
• In patients who have recently had an injury or have an inflammatory condition (such as rheumatism or colitis), pain or worsening of pain at the site of injury or inflammation may occur.
• Difficulty swallowing.

In some patients, other side effects may occur during treatment with Sumamigren.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Aleje Jerozolimskie 181C
02-222 Warsaw
Phone: +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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Sumamigren

Keep the medicine out of the sight and reach of children.
There are no special precautions for storing the medicine.
Do not take 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 indicates the expiry date, and after the abbreviation Lot/LOT, it indicates the batch number.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Sumamigren contains

• The active substance of the medicine is sumatriptan in the form of succinate. Each tablet contains 50 mg or 100 mg of sumatriptan.
• The other ingredients are: tablet core: lactose monohydrate, microcrystalline cellulose, sodium carboxymethylcellulose, magnesium stearate, talc, colloidal silica anhydrous. tablet coating: hypromellose, macrogol 6000, talc, titanium dioxide (E171), triethyl citrate, and (only for 50 mg tablets) red iron oxide (E172).

What Sumamigren looks like and contents of the pack

The 50 mg film-coated tablets are oblong, biconvex, pink, with a line. The line on the tablet is not intended for breaking the tablet.
The 100 mg film-coated tablets are oblong, biconvex, white.
The pack contains:
2, 6, 9, 12, or 18 film-coated tablets in aluminum/aluminum blisters in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

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

Date of last revision of the leaflet: