SUMAMIGREN 100 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Sumamigren, 50 mg, Film-Coated Tablets
3. Sumamigren, 100 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
4. What is Sumamigren and what is it used for
5. Important information before taking Sumamigren
   1. When not to take Sumamigren:
   2. Warnings and precautions
   3. Sumamigren and other medicines
   4. Sumamigren with food and drink
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Sumamigren 50 mg contains 123.5 mg of lactose monohydrate, red iron oxide, and sodium
   8. Sumamigren 100 mg contains 247 mg of lactose monohydrate and sodium
   9. Lactose
   10. Red iron oxide (E172)
   11. Sodium
6. How to take Sumamigren
   1. Sumamigren must not be taken prophylactically.
   2. Adults from 18 to 65 years of age
   3. If taking a single dose of the medicine leads to the disappearance of symptoms, but the migraine attack
   4. Children and adolescents (under 18 years of age)
   5. Elderly patients (over 65 years of age)
   6. Taking a higher dose of Sumamigren than recommended
7. Possible side effects
   1. Other side effects that may occur after taking Sumamigren
   2. Very rare:
   3. Unknown frequency:
   4. Reporting side effects
8. How to store Sumamigren
9. Contents of the pack and other information
   1. What Sumamigren contains
   2. What Sumamigren looks like and what the pack contains
   3. Marketing authorization holder and manufacturer
   4. Date of the last update of the leaflet:

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, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, 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 is Sumamigren and what is it 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 is Sumamigren and what is it 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 has an anti-migraine effect by constricting the blood vessels in the area of the carotid artery. The expansion of these vessels is likely to be the cause of migraine. Sumatriptan relieves headache and other symptoms associated with migraine, including nausea, hypersensitivity 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 have passed since 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), medicines containing ergotamine or its derivatives, such as methysergide.

Warnings and precautions

Before starting to take Sumamigren, discuss it with your doctor or pharmacist.
Tell your doctor if:

• you have had seizure attacks or are exposed to factors that lower the seizure threshold (e.g., taking antidepressant or antipsychotic medications)
• you have risk factors for cardiovascular diseases, 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 an unusual headache, as it may be caused by a neurological disorder
• you have been previously diagnosed with hemiplegic, basilar, or ophthalmoplegic migraine
• you have liver or kidney disease
• you are allergic (hypersensitive) 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 simultaneously with Sumamigren may lead to serotonin syndrome, a life-threatening condition (see "Sumamigren and other medicines").

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

• unusual 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 a 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 simultaneously 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 the medicines you are taking now or have taken recently, as well as the 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.
Sumamigren must notbe taken with:

• medicines containing ergotamine and its derivatives (e.g., methysergide), used in the treatment of migraines. Before taking Sumamigren, you should 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 have passed since 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 simultaneous 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 simultaneous 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 independently of meals.
Tablets should be swallowed whole with water.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Sumamigren should not be taken during pregnancy or breastfeeding (unless your doctor advises otherwise).

Driving and using machines

During the use of Sumamigren, drowsiness may occur. If drowsiness occurs, do not drive or operate any machines.

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 previously been diagnosed with intolerance to some sugars, you should consult 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 the medicine is considered "sodium-free".

3. How to take Sumamigren

This medicine should always be taken according to the doctor's recommendations. In case of doubts, consult your doctor or pharmacist.
The dose of the medicine is determined individually by the doctor, depending on the patient's condition.

Sumamigren must not be taken prophylactically.

Sumamigren is recommended for the acute treatment of migraine attacks and must not be taken simultaneously with other medicines containing sumatriptan or other triptans (zolmitriptan, rizatriptan, or naratriptan) and medicines containing ergotamine or ergotamine derivatives (including methysergide).
Do not take a higher dose than recommended.

Adults from 18 to 65 years of age

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 is required.
Tablets should be swallowed whole with water.
If taking 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 nonsteroidal anti-inflammatory drugs. The next tablet can be taken during the next migraine attack.

If taking 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 take a higher dose 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 of age)

The medicine must not be taken in children and adolescents.

Elderly patients (over 65 years of age)

The medicine must not be taken in this group of patients.

Taking a higher dose of Sumamigren than recommended

In case of taking a higher dose of the medicine than recommended, contact your doctor immediately, who will provide appropriate treatment.
In case of any further doubts related to the use of this medicine, consult 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
Unknown: frequency cannot be estimated from the available data.
You should immediatelyconsult a 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;
• Seizure attacks;
• 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 consult a 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 in the case of driving vehicles or operating machines).
• Nausea or vomiting - if they are 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.

Unknown frequency:

• 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 can lead to fainting, especially when standing up.
• Slow or rapid heartbeat, palpitations, arrhythmias, chest pain.
• Tremors or uncontrolled movements.
• Diarrhea.
• Excessive sweating.
• Joint pain.
• Stiffness of the neck.
• Anxiety.
• In a patient who has recently had an injury or has 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, during the use of the medicine, other side effects may occur.

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 Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. 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 gather more information on the safety of the medicine.

5. How to store Sumamigren

The medicine should be stored in a place invisible and inaccessible to children.
There are no special recommendations for storing the medicine.
Do not take this medicine after the expiry date stated on the carton and blister after: EXP.
The expiry date stated on the packaging indicates the last day of the given 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 containers. Ask your pharmacist how to dispose of medicines that are no longer used. 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.
• 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 (E171), triethyl citrate, and (only for 50 mg tablets) red iron oxide (E172).

What Sumamigren looks like and what the pack contains

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 the last update of the leaflet: