Frimig

Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Frimig, 100 mg, coated tablets
Sumatriptanum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet to be able to read it again if necessary.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents of the leaflet:

1. What is Frimig and what is it 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 is Frimig and what is it 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 dilation of blood vessels in the
head. Sumatriptan is believed to reduce this dilation. This helps relieve headache and alleviate other symptoms of a migraine attack, such as nausea or vomiting and sensitivity to light and sound.

2. Important information before taking Frimig

When not to take Frimig:

• if the patient is allergic to sumatriptan or any of the other ingredients of this medicine (listed in section 6);
• if the patient has heart diseases such as coronary artery narrowing (ischaemic heart disease) or chest pain (angina), or if the patient has had a heart attack;
• if the patient has circulatory problems in the legs causing pain when walking, similar to cramps (peripheral vascular disease);
• if the patient has had a stroke or mini-stroke [also known as transient ischaemic attack (TIA)];
• if the patient has high blood pressure. A patient with mild high blood pressure adequately treated may use sumatriptan;
• if the patient has severe liver function disorders;
• if the patient is taking other anti-migraine medicines, including those containing ergotamine or medicines with similar effects such as methysergide maleate or other triptans, or medicines called 5HT receptor agonists (such as naratriptan or zolmitriptan);
• if the patient is taking any antidepressant medicines:
• medicines belonging to a group called monoamine oxidase inhibitors (MAOIs) or has taken MAOIs within the last 2 weeks;
• selective serotonin reuptake inhibitors (SSRIs) including: citalopram, fluoxetine, fluvoxamine, paroxetine or sertraline;
• serotonin and noradrenaline reuptake inhibitors (SNRIs) including: venlafaxine and duloxetine;
• in children under 18 years of age.

Warnings and precautions
Before prescribing Frimig, the doctor should confirm that the patient's headache is caused by migraine and not by another illness.
Before starting Frimig, consult a doctor if any of the following apply to the patient:

• the patient is a regular smoker or uses nicotine replacement therapy, especially if:
• the patient is a man over 40 years of age, or
• the patient is a woman who has undergone menopause. In very rare cases, serious heart problems have developed in some patients after using sumatriptan, even if they had no previous symptoms of heart disease. If any of the above points apply, this may mean the patient is at increased risk of heart disease. The patient should inform the doctor, who should check heart function before prescribing sumatriptan;
• the patient has a history of seizures or other conditions that may increase the likelihood of a seizure, such as head injury or alcoholism;
• the patient has liver or kidney disease;
• the patient has intolerance to certain sugars;
• the patient is allergic to medicines called sulphonamides. In such a case, the patient may also be allergic to sumatriptan. If the patient is allergic to an antibiotic but does not know whether it belongs to the sulphonamide group, the patient should inform the doctor or pharmacist before taking this medicine;
• the patient is taking antidepressant medicines called SSRIs (selective serotonin reuptake inhibitors) or SNRIs (serotonin and noradrenaline reuptake inhibitors). See also the section below “Frimig with other medicines”;
• the patient frequently uses sumatriptan. Overuse of sumatriptan may worsen headache. The doctor may advise stopping sumatriptan;
• the patient experiences chest pain or tightness after taking sumatriptan. These symptoms may be intense but usually resolve quickly. However, if these symptoms do not resolve quickly or become severe, medical help should be sought immediately.

Frimig with other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use. This includes herbal preparations, dietary supplements such as vitamins, iron or calcium, and medicines purchased without a prescription.
Some medicines must not be used with Frimig, while others may cause adverse effects when used together with Frimig. Inform the doctor if the patient is taking:

• Ergotamine, also used in the treatment of migraine, or medicines with similar effects such as methysergide maleate. Frimig must not be used together with these medicines. The patient should stop taking these medicines at least 24 hours before starting Frimig. These medicines should not be taken again until at least 6 hours after stopping Frimig;
• Other triptans or medicines called 5HT receptor agonists (such as naratriptan or zolmitriptan). Frimig must not be used together with these medicines. The patient should stop taking these medicines at least 24 hours before starting Frimig. These medicines should not be taken again until at least 24 hours after stopping Frimig;
• Monoamine oxidase inhibitors (MAOIs), used in the treatment of depression. Frimig must not be taken if the patient has taken such medicines within the last two weeks;
• Selective serotonin reuptake inhibitors (SSRIs) and serotonin and noradrenaline reuptake inhibitors (SNRIs), used in the treatment of depression. Using Frimig with these medicines may cause serotonin syndrome (a set of symptoms which may include restlessness, confusion, sweating, hallucinations, increased reflexes, muscle stiffness, shivering, rapid heart rate and tremor). The doctor should be informed immediately if such symptoms occur;
• St John's wort (Hypericum perforatum). When taking Frimig and herbal medicines containing St John's wort, adverse effects may occur more frequently;
• Lithium, a medicine used in the treatment of bipolar disorder (manic depression).

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
If the patient is pregnant or suspects she is pregnant, she should inform her doctor before taking Frimig. Experience with the safety of Frimig during pregnancy is limited. Available data so far do not indicate an increased risk of congenital malformations. The patient should discuss with her doctor whether she can use Frimig during pregnancy.

Breastfeeding
Breastfeeding should be avoided for 12 hours after taking Frimig. Breast milk expressed during this time should be discarded and not used for feeding the baby.

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

Frimig contains lactose.
This medicine contains 352.6 mg of lactose per 100 mg tablet.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the doctor before taking this medicine.

Other excipients
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

3. How to take Frimig

This medicine should always be taken as directed by the doctor. If in doubt, consult a doctor or pharmacist.
Frimig is available in the following doses: 50 mg, 100 mg.
These tablets should be taken as soon as the patient feels that a migraine attack is about to occur, although they may also be taken at any time during a migraine attack.
Do not take Frimig to prevent a migraine attack – this medicine should only be taken after migraine symptoms have started.

Adults
The usual recommended dose is one 50 mg tablet, swallowed whole with water.
Some patients may require a 100 mg dose – follow the doctor's instructions.

Children and adolescents under 18 years of age
Frimig is not recommended for use in children under 18 years of age.

Elderly patients (over 65 years of age)
Frimig is not recommended for use in patients over 65 years of age.

If symptoms recur
Another tablet of Frimig may be taken only if at least 2 hours have passed since the previous tablet was taken. Do not exceed a total of 300 mg in any 24-hour period.

If there is no improvement after taking one tablet
Do not take a second tablet or any other medicine containing sumatriptan during the same 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. Frimig may be used again during the next attack. If Frimig does not provide relief, consult a doctor for advice.

Taking more than the recommended dose of Frimig
Do not take more than six 50 mg tablets or three 100 mg tablets (totaling 300 mg) in any 24-hour period. Taking too much Frimig may cause illness. Symptoms of overdose are the same as those listed in section 4, "Possible side effects". If a patient or another person takes too many tablets, contact a doctor, hospital, or Poison Information Center immediately.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine may cause adverse reactions, although they do not occur in every patient.

Allergic reactions
Frequency unknown (frequency cannot be estimated from the available data):
Skin allergic reactions: skin rashes, for example in the form of red spots or hives (skin wheals).
Anaphylaxis (severe allergic reactions, such as swelling of the eyelids, face or lips, and sudden wheezing, irregular heartbeat, chest tightness or collapse).
If any allergic reactions occur, treatment with Frimig should be discontinued. In the event of severe allergic reactions, seek immediate medical advice.

Other possible adverse reactions
Common (may affect up to 1 in 10 patients):

• Tinnitus, dizziness, drowsiness, sensory disturbances;
• Transient increase in blood pressure (occurring shortly after administration), sudden flushing;
• Difficulty breathing;
• Nausea or vomiting;
• Sensation of heaviness, muscle pain;
• Pain, sensation of heat or cold, tightness or pressure. These symptoms are usually 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 patients):

• Minor disturbances in liver function tests observed in isolated cases.

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

• Anxiety;
• Seizures (epileptic), involuntary movements, tremors, nystagmus;
• Visual disturbances such as blurred vision, restricted vision, vision loss (these may also be caused by migraine attack itself);
• Heart disorders, in which the heart may beat faster, slower or change rhythm, chest pain (angina) or myocardial infarction;
• Low blood pressure, Raynaud's phenomenon (a condition characterized by paleness and numbness of fingers and toes);
• Inflammation of the large intestine (symptoms include pain in the lower left abdomen and bloody diarrhoea), diarrhoea;
• Increased sweating;
• Neck stiffness, joint pain;
• In a patient who has recently suffered trauma or who has an inflammatory condition (such as rheumatism or inflammation of the large intestine), pain or worsening of pain may occur at the site of trauma or inflammation;
• Difficulty swallowing.

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions enables further collection of information on the safety of the medicine.

5. How to store the medicine Frimig

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Store below 25°C. Keep blister packs in the outer packaging.
Medicines must 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 packaging and other information

What Frimig contains

• The active substance is sumatriptan 100 mg in the form of sumatriptan succinate.
• The other components are: Tablet core: monohydrate lactose, sodium croscarmellose, lactose, microcrystalline cellulose, magnesium stearate; Coating: monohydrate lactose, mannitol, titanium dioxide (E 171), triacetin, talc.

What Frimig looks like and contents of the pack
White film-coated tablets, capsule-shaped, with the imprints “RDY” on one side and “293” on the other side.
The medicine is packed in blisters in cardboard boxes containing 6, 12 or 18 tablets.
For further information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in the Czech Republic, country of export:
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
Parallel importer:
InPharm Sp. z o.o., ul. Strumykowa 28/11, 03-138 Warsaw, Poland
Repackaged by:
InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warsaw, Poland
Marketing Authorisation number in the Czech Republic, country of export: 33/626/08-C
Parallel import authorisation number: 383/25
This medicinal product is authorised for sale in the European Economic Area under the following names:
Finland, Sweden: Oriptan
Poland, Czech Republic: Frimig
Hungary: Sumatriptan Orion