Frimig

Package leaflet: Information for the user

Frimig, 50 mg, coated tablets
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, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It 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, they should inform their doctor or pharmacist. See section 4.

Table of contents:

1. What Frimig is and what it is used for
2. What you should know 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 dilation of blood vessels
in the head. Sumatriptan is thought to reduce this dilation. This helps
relieve headache pain and reduce 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 while 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. Patients with mild high blood pressure who are 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 action 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 the group called monoamine oxidase inhibitors (MAOI) or has taken MAOI within the last 2 weeks;
• selective serotonin reuptake inhibitors (SSRI) including: citalopram, fluoxetine, fluvoxamine, paroxetine or sertraline;
• serotonin and noradrenaline reuptake inhibitors (SNRI) 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 illness.
Before starting to take 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 already gone through menopause.
  In very rare cases, serious heart problems have developed in some patients after using sumatriptan, even if they previously had no symptoms of heart disease. If any of the above points apply, this may mean the patient is in a higher-risk group for 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, e.g. 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 cases, 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 and other medicines;
• the patient frequently takes sumatriptan. Overuse of sumatriptan may lead to worsening of headache. The doctor may advise stopping the use of sumatriptan;
• the patient experiences chest pain or tightness after using sumatriptan. These symptoms may be intense but usually resolve quickly. However, if these symptoms do not resolve quickly or become severe, immediate medical help should be sought.

Frimig and 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 if taken together with Frimig. Inform the doctor if the patient is taking:

• Ergotamine, also used in the treatment of migraine, or medicines with similar action such as methysergide maleate. Frimig must not be used at the same time as these medicines. The patient should stop taking these medicines at least 24 hours before starting Frimig. The patient should also not take them again for 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 at the same time as these medicines. The patient should stop taking these medicines at least 24 hours before starting Frimig. The patient should also not take them again for at least 24 hours after stopping Frimig.

• Monoamine oxidase inhibitors (MAOI), 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 (SSRI) and serotonin and noradrenaline reuptake inhibitors (SNRI), used in the treatment of depression. Using Frimig with these medicines may cause serotonin syndrome (a group of symptoms which may include restlessness, confusion, sweating, hallucinations, increased reflexes, muscle spasms, 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 a doctor or pharmacist before using this medicine.
Pregnancy:
If the patient is pregnant or suspects pregnancy, she should inform her doctor before taking Frimig. Experience with the safety of Frimig during pregnancy is limited. To date, available data 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.
Some breastfeeding women have reported breast pain and/or nipple pain after using sumatriptan. The pain is usually transient and resolves within 3 to 12 hours.
Driving and using machines
Migraine symptoms or the medicine itself 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 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, meaning 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
your doctor or pharmacist.
These tablets are best 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 for the prevention of migraine attacks – 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 your 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 symptom recurrence
A patient may take another Frimig tablet only if at least 2 hours have passed since the previous tablet was taken.
Do not take more than a total of 300 mg within 24 hours.

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 your 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 24 hours.
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 anyone else takes too many tablets, contact a doctor, hospital,
or Poison Information Centre 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 can cause adverse reactions, although not everyone will experience them.

Allergic reactions
Frequency unknown (frequency cannot be determined from 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 eyelid, facial or lip swelling, and sudden wheezing, irregular heartbeat, chest tightness or collapse).
If any allergic reactions occur, Frimig should be discontinued immediately. In the event of severe allergic reactions, medical advice should be sought immediately.

Other possible adverse reactions
Common (may occur in less than 1 in 10 patients):

• tinnitus, dizziness, drowsiness, sensory disturbances;
• transient increase in blood pressure (occurring shortly after administration of the medicine), sudden flushing;
• difficulty in breathing;
• nausea or vomiting;
• feeling 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.

Rare (may occur in less than 1 in 1,000 patients):

• chest pain.

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

• minor abnormalities in liver function tests observed in isolated cases.

Frequency unknown (frequency cannot be determined from available data):

• anxiety;
• seizures (epileptic), involuntary movements, tremors, nystagmus;
• visual disturbances such as blurred vision, restricted vision, or loss of vision (these may also be caused by the 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 pallor and numbness of fingers and toes);
• inflammation of the large intestine (symptoms include pain in the lower left part of the 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 in swallowing.

If any adverse reactions occur, including any possible reactions not listed in this leaflet, consult a doctor or pharmacist.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions enables further information on the safety of the medicine to be collected.

5. How to store Frimig

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box.
The expiry date refers to the last day of the stated month.
Do not store above 25°C. Keep the blister 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 in use. 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.
• Other components of the medicine 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
50 mg coated tablet:
Round, white coated tablets with the imprints “RDY” on one side and “292” on the other side.
100 mg coated tablet:
White, capsule-shaped coated tablets with the imprints “RDY” on one side and “293” on the other side.
Products in both strengths are packed in blisters within cardboard boxes containing 2, 3, 4, 6, 12, and 18 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Orion Pharma Poland Sp. z o.o.
[email protected]

This medicinal product is authorised for marketing in the European Economic Area under the following names:
Finland, Sweden: Oriptan
Poland, Czech Republic: Frimig
Hungary: Sumatriptan Orion