Frimig

Leaflet attached to the packaging: information for the user

Frimig, 50 mg, coated tablets

Frimig, 100 mg, coated tablets

Sumatriptan

Please read carefully the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• Please keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, please consult a doctor or pharmacist.
• This medicine has been prescribed specifically for one person. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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.
The symptoms of migraine can be caused by temporary blood vessel dilation in the head. It is thought that sumatriptan reduces the dilation of these blood vessels. This in turn helps to eliminate 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 allergicto sumatriptan or any of the other ingredients of this medicine (listed in section 6);
• if the patient has heart diseasesuch as coronary artery narrowing (ischemic heart disease) or chest pain (angina), or if the patient has had a heart attack;
• if the patient has circulatory problemsin the legs that cause pain when walking similar to cramps (peripheral vascular disease);
• if the patient has had a strokeor a mini-stroke (also known as transient ischemic attack, TIA);
• if the patient has high blood pressure. A patient with mild high blood pressure that is being treated appropriately may take sumatriptan;
• if the patient has severe liver function disorders;
• if the patient is taking other migraine medicines, including those containing ergotamine or medicines that work in a similar way, such as methysergide maleate or other triptans or medicines known as 5HT receptor agonists (such as naratriptan or zolmitriptan);
• if the patient is taking any antidepressant medicines:
• medicines belonging to the group known as monoamine oxidase inhibitors (MAOIs)or if the patient has taken an MAOI in 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 to a patient, the doctor will determine whether the patient's headache is caused by migraine and not by another disease.
Before taking Frimig, the patient should consult a doctor if any of the following apply:

• the patient is a heavy smoker or uses nicotine replacement therapy, especially if:
• the patient is a man over 40 years old or
• the patient is a woman who has already gone through 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 points apply to the patient, it may mean that the patient is at increased risk of heart disease. The patient should inform their doctor, who should check their heart function before prescribing sumatriptan;
• the patient has a history of seizuresor other conditions that may increase the risk of seizures - such as head injury or alcoholism;
• the patient has liver or kidney disease;
• the patient has intolerance to some sugars;
• the patient is allergic to medicinesknown as sulfonamides. In such a case, the patient may also be allergic to sumatriptan. If the patient is allergic to an antibiotic but does not know if it belongs to the group of sulfonamides, they should tell their doctor or pharmacist before taking this medicine;
• the patient is taking antidepressant medicinesknown as SSRIs (selective serotonin reuptake inhibitors) or SNRIs (serotonin and noradrenaline reuptake inhibitors). See also the subsection below Frimig and other medicines;
• the patient often takes sumatriptan. Taking sumatriptan too frequently may cause worsening of headache. The doctor may advise the patient to stop taking sumatriptan;
• the patient experiences chest pain or pressureafter taking sumatriptan. Such symptoms may be intense but usually pass quickly. However, if they do not pass quickly or become severe, the patient should seek medical help immediately.

Frimig and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take, including:

• Ergotamineused to treat migraineor medicines that work in a similar way, such as methysergide maleate. The patient should not take Frimig at the same time as these medicines. The patient should stop taking these medicines at least 24 hours before starting to take Frimig. The patient should not take them again for at least 6 hours after stopping Frimig.
• Other triptansor medicines known as 5HT receptor agonists(such as naratriptan or zolmitriptan). The patient should not take Frimig at the same time as these medicines. The patient should stop taking these medicines at least 24 hours before starting to take Frimig. The patient should not take them again for at least 24 hours after stopping Frimig.
• Monoamine oxidase inhibitors (MAOIs)used to treat depression. The patient should not take Frimig if they have taken such medicines 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 characterized by symptoms such as restlessness, confusion, sweating, hallucinations, increased reflexes, muscle stiffness, shivering, rapid heartbeat, and trembling). The patient should immediately inform their doctor if such symptoms occur.
• St. John's Wort (Hypericum perforatum). When taking Frimig and herbal medicines containing St. John's Wort, side effects may occur more frequently.
• Lithium, a medicine used to treat manic-depressive disorders(bipolar disorder).

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy:
If the patient is pregnant or suspects they are pregnant, they should inform their doctor before taking Frimig. Experience with the safety of Frimig during pregnancy is limited. So far, available data do not indicate an increased risk of congenital anomalies. The patient should discuss with their doctor whether they can take Frimig during pregnancy.
Breastfeeding:
The patient should not breastfeed their baby within 12 hours of taking Frimig. Milk expressed during this time should be discarded and not given to the baby.

Driving and using machines

Migraine symptoms or the medicine may cause drowsiness. If this symptom occurs, the patient should 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 the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicine.

Other excipients

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

3. How to take Frimig

This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
The tablets are best taken as soon as the patient feels that a migraine attack is about to start, although they can also be taken at any time during a migraine attack.
The patient should not take Frimig to prevent a migraine attack - the medicine should only be taken after the symptoms of migraine have appeared.
Adults
The recommended dose is one 50 mg tablet, swallowed whole with water.
Some patients may need a dose of 100 mg - the patient should 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.

In case of recurrence of symptoms

The patient can take another Frimig tablet only if at least 2 hours have passed since the previous tablet was taken. The patient should not take more than 300 mg in total in 24 hours.

In case of no improvement after taking one tablet

The patient should not take a second tablet or any other medicines containing sumatriptan during the same migraine attack. If there is no improvement after taking one tablet, the patient can take other pain-relieving medicines such as paracetamol, acetylsalicylic acid, or non-steroidal anti-inflammatory drugs. Frimig can be taken again during the next migraine attack. If Frimig does not provide relief, the patient should consult their doctor for advice.

Overdose of Frimig

The patient should not take more than six 50 mg tablets or three 100 mg tablets (which is 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 the patient or anyone else has taken too many tablets, they should contact a doctor, hospital, or the Poison Information Centre.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

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, for example in the form of red spots or hives.
Anaphylaxis (severe allergic reactions, such as swelling of the eyelids, face, or lips and sudden onset of wheezing, irregular heartbeat, chest pressure, or collapse).
If any allergic reactions occur, the patient should stop taking Frimig. In case of severe allergic reactions, the patient should seek medical help immediately.

Other possible side effects

Common (may occur in less than 1 in 10 patients):

• ringing in the ears, dizziness, drowsiness, sensory disturbances;
• transient increase in blood pressure (occurring shortly 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 transient (temporary) and may affect any part of the body, including the chest and throat. Feeling of weakness, fatigue.

Very rare (may occur in less than 1 in 10,000 patients):

• mild liver function test abnormalities have been observed in single cases.

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

• anxiety;
• seizures (epileptic), 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 disorders, in which the heart may beat faster, slower, or change rhythm, chest pain (angina), or heart attack;
• low blood pressure, Raynaud's phenomenon (a condition characterized by paleness and numbness of the fingers and toes);
• colitis (inflammation of the colon), bloody diarrhea;
• increased sweating;
• stiffness of the neck, joint pain;
• in a patient who has recently had an injury or has an inflammatory condition (such as rheumatism or colitis), pain or worsening of pain may occur at the site of injury or inflammation;
• difficulty swallowing.

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should consult their doctor or pharmacist.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: 22 49-21-301, fax: 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 this medicine.

5. How to store Frimig

The medicine should be stored out of sight and reach of children.
The patient should not use this medicine after the expiry date stated on the carton.
The expiry date refers to the last day of the month.
The patient should not store the medicine at temperatures above 25°C. The patient should store the blister in the outer packaging.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 Frimig contains

• The active substance of the medicine is sumatriptan 50 mg or 100 mg in the form of sumatriptan succinate.
• The other ingredients of the medicine are: tablet core: lactose monohydrate, sodium croscarmellose, 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 engraved "RDY" on one side and "292" on the other side.
100 mg coated tablet:
White coated capsules with engraved "RDY" on one side and "293" on the other side.
Products in both strengths are packaged in blisters in cardboard boxes containing 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 about this medicine, the patient should contact the local representative of the marketing authorization holder:
Orion Pharma Poland Sp. z o. o.
[email protected]

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