Frimig

Package Leaflet: Information for the User

Frimig, 50 mg, coated tablets

Frimig, 100 mg, 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 Frimig is and what it is used for
• 2. Important information before taking Frimig
• 3. How to take Frimig
• 4. Possible side effects
• 5. How to store Frimig
• 6. Contents of the pack and other information

1. What Frimig is and what it is used for

Each Frimig tablet contains a single dose of sumatriptan, which belongs to a group of medicines called triptans (also known as 5HT receptor agonists).
Frimig is used to treat migraine attacks with or without aura.
Migraine symptoms may be caused by temporary blood vessel dilation in the head. Sumatriptan is thought to reduce this dilation. This 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 Frimig

When not to take Frimig:

• if you are allergic to sumatriptan or any of the other ingredients of this medicine (listed in section 6);
• if you have heart disease, such as coronary artery narrowing (ischemic heart disease) or chest pain (angina), or if you have had a heart attack;
• if you have circulatory problems in your legs, which cause pain when walking, similar to cramps (peripheral vascular disease);
• if you have had a stroke or a transient ischaemic attack (TIA);
• if you have high blood pressure. Patients with mild high blood pressure, which is being treated, may take sumatriptan;
• if you have severe liver function disorders;
• if you are taking other anti-migraine medicines, including those containing ergotamine or similar-acting medicines such as methysergide or other triptans or 5HT receptor agonists (such as naratriptan or zolmitriptan);
• if you are taking any antidepressant medicines:
• monoamine oxidase inhibitors (MAOIs) or if you have 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 Frimig to a patient, the doctor will determine whether the patient's headache is caused by a migraine and not another condition.
Before taking Frimig, tell your doctor if any of the following apply to you:

• you are a heavy smoker or use nicotine replacement therapy, especially if you are a man over 40 or a woman who has had the 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 applies to you, this may mean that you are at increased risk of heart disease. Tell your doctor, who will check your heart before prescribing sumatriptan;
• you have had seizures or other conditions that may increase the risk of seizures - such as head injury or alcoholism;
• you have liver or kidney disease;
• you are intolerant to some sugars;
• you are allergic to medicines called sulfonamides. You may also be allergic to sumatriptan. If you are allergic to an antibiotic and do not know if it belongs to the sulfonamide group, tell your doctor or pharmacist before taking this medicine;
• you are taking SSRI or SNRI antidepressants. See also the section below, "Frimig and other medicines";
• you take sumatriptan frequently. Taking sumatriptan too often may make your headaches worse. Your doctor may advise you to stop taking sumatriptan;
• you experience pain or pressure in your chest after taking sumatriptan. These symptoms can be intense but usually pass quickly. However, if they do not pass quickly or become severe, seek medical help immediately.

Frimig 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. This includes any herbal preparations, dietary supplements such as vitamins, iron, or calcium, and medicines you have bought without a prescription.
Some medicines must not be taken with Frimig, and others may cause side effects if taken with Frimig. Tell your doctor if you are taking:

• Ergotamineused to treat migraineor similar-acting medicines such as methysergide. Do not take Frimig with these medicines. Stop taking these medicines at least 24 hours before starting Frimig. Do not take them again for at least 6 hours after stopping Frimig.

Stop taking these medicines at least 24 hours before starting Frimig. Do not take them again for at least 6 hours after stopping Frimig.

• Other triptansor 5HT receptor agonists (such as naratriptan or zolmitriptan). Do not take Frimig with these medicines. Stop taking these medicines at least 24 hours before starting Frimig. Do not take them again for at least 24 hours after stopping Frimig.
• Monoamine oxidase inhibitors (MAOIs)used to treat depression. Do not take Frimig if you have taken MAOIs in the last 2 weeks.
• Selective serotonin reuptake inhibitors (SSRIs)and serotonin and noradrenaline reuptake inhibitors (SNRIs)used to treat depression. Taking Frimig with these medicines may cause serotonin syndrome (a condition that can include restlessness, confusion, sweating, hallucinations, increased reflexes, muscle stiffness, shivering, fast heart rate, and trembling). Tell your doctor immediately if you experience any of these symptoms.
• St. John's Wort (Hypericum perforatum). When taking Frimig and 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 you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy:
If you are pregnant or think you may be pregnant, tell your doctor before taking Frimig. Experience with the use of Frimig during pregnancy is limited. So far, available data do not indicate an increased risk of birth defects. Discuss with your doctor whether you can take Frimig during pregnancy.
Breastfeeding:
Do not breastfeed your baby for 12 hours after taking Frimig. Express milk during this time and discard it. Do not give it to your baby.

Driving and using machines

Migraine symptoms or the medicine may cause drowsiness. If this occurs, do not drive or operate machinery.
Frimig contains lactose.
This medicine contains 176.3 mg of lactose in a 50 mg tablet and 352.6 mg of lactose in a 100 mg tablet.
If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Other excipients

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

3. How to take Frimig

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Take these tablets as soon as you feel that a migraine attack is coming, although you can take them at any time during an attack.
Do not take Frimig to prevent a migraine attack - only take it after migraine symptoms appear.
Adults
The recommended dose is one 50 mg tablet, swallowed whole with water.
Some patients may need a 100 mg dose - follow your doctor's instructions.
Children and adolescents under 18 years
Frimig is not recommended for children under 18 years.
Elderly patients (over 65 years)
Frimig is not recommended for patients over 65 years.

If symptoms return

You can take another Frimig tablet only if it has been at least 2 hours since you took the previous tablet. Do not take more than 300 mg in total in 24 hours.

If there is no improvement after taking one tablet

Do not take a second tablet or any other sumatriptan-containing medicine during the same attack. If there is no improvement after taking one tablet, you can take other painkillers such as paracetamol, acetylsalicylic acid, or non-steroidal anti-inflammatory drugs. You can take Frimig again during the next attack. If Frimig does not relieve your symptoms, ask your doctor for advice.

Overdose of Frimig

Do not take more than six 50 mg tablets or three 100 mg tablets (a total of 300 mg) in 24 hours. Taking too much Frimig may cause illness. The symptoms of overdose are the same as those listed in section 4 "Possible side effects". If you or someone else has taken too many tablets, contact a doctor, hospital, or the Poison Information Centre.

4. Possible side effects

Like all medicines, Frimig 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 wheezing, uneven heartbeat, chest pressure, or collapse).
If you experience any allergic reactions, stop taking Frimigand seek medical help immediatelyif the reactions are severe.

Other possible side effects

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

• ringing in the ears, dizziness, drowsiness, sensation disturbances;
• temporary increase in blood pressure (occurring soon after administration), sudden flushing;
• breathing difficulties;
• nausea or vomiting;
• feeling of heaviness, muscle pain;
• pain, feeling of heat or cold, squeezing or pressure. These symptoms are usually temporary (transient) 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 single cases.

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

• anxiety;
• seizures (convulsions), 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 problems, 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 that causes the fingers and toes to become pale and cold);
• inflammation of the colon (symptoms include abdominal pain and bloody diarrhea), diarrhea;
• increased sweating;
• stiffness of the neck, joint pain;
• in patients who have recently had an injury or have 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 you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. You can also report side effects directly to the Pharmacovigilance Department, 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
You can also report side effects 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 Frimig

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton.
The expiry date refers to the last day of the month.
Do not store above 25°C. Store in the original package.
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 Frimig contains

• The active substance is sumatriptan 50 mg or 100 mg as sumatriptan succinate.
• The other ingredients are: tablet core: lactose monohydrate, croscarmellose sodium, lactose, microcrystalline cellulose, magnesium stearate; coating: lactose monohydrate, mannitol, titanium dioxide (E 171), triacetin, talc.

What Frimig looks like and contents of the pack

50 mg coated tablet:
Round, white, coated tablets with "RDY" engraved on one side and "292" on the other.
100 mg coated tablet:
White, capsule-shaped, coated tablets with "RDY" engraved on one side and "293" on the other.
Both strengths are available in blisters in cartons of 2, 3, 4, 6, 12, and 18 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland

Manufacturer

Orion Corporation, Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland
Orion Corporation, Orion Pharma
Joensuunkatu 7
FI-24100 Salo
Finland
To obtain more detailed information on this medicine, contact the local representative of the marketing authorization holder:
Orion Pharma Poland Sp. z o.o.
kontakt@orionpharma.info.pl

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Finland, Sweden:
Oriptan
Poland, Czech Republic:
Frimig
Hungary:
Sumatriptan Orion
Date of last revision of the leaflet:01.02.2022