Frimig neo

Package leaflet: Information for the user

Frimig Neo, 50 mg, film-coated tablets
Frimig Neo, 100 mg, film-coated tablets
Sumatriptanum
Please read all of this leaflet carefully before taking this medicine, because 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 them 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.

Leaflet contents:

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

1. What is Frimig Neo and what is it used for
Frimig Neo contains sumatriptan, which belongs to a group of medicines known as triptans [also known as selective serotonin receptor (5HT) agonists].
Frimig Neo is used in adults for the acute treatment of 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 of blood vessels, thereby helping to relieve headache pain and reduce other symptoms of a migraine attack, such as nausea, vomiting, and sensitivity to light and sound.

2. Important information before taking Frimig Neo

When not to take Frimig Neo:

• if the patient is allergic to sumatriptan or to any of the other ingredients of this medicine (listed in section 6)
• if the patient has heart disease, such as coronary artery narrowing (ischaemic heart disease) or chest pain (angina), or has had a heart attack
• if the patient has circulatory disorders 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. Patients with adequately treated, mild hypertension may take sumatriptan.
• if the patient has severe liver disease
• if the patient is taking other migraine medicines, including those containing ergotamine or ergot-like medicines such as methysergide, other triptans, or medicines known as 5HT receptor agonists (such as naratriptan or zolmitriptan)
• if the patient is taking MAOIs (monoamine oxidase inhibitors) used to treat depression, or has taken MAOIs within the last 2 weeks.

Warnings and precautions
Before prescribing Frimig Neo, the doctor will determine whether the patient's headache is due to migraine and not another condition.
Before starting Frimig Neo, consult a doctor or pharmacist if any of the following apply to the patient:

• the patient is a regular smoker or uses nicotine replacement therapy, particularly if the patient is:
  • a man over 40 years of age, or
  • a woman who has gone through menopause.
    In very rare cases, serious heart problems have developed in some patients after taking 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 their doctor, who may need to check heart function before prescribing sumatriptan.
• the patient has a history of seizures (fits) or other conditions that may increase the risk of seizures, such as head injury or alcoholism
• the patient has liver or kidney disease
• the patient is allergic to medicines known as 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, they should inform their doctor or pharmacist before taking this medicine
• the patient frequently uses sumatriptan. Excessive use of sumatriptan may lead to worsening of headaches. The doctor may advise stopping the use of sumatriptan.
• the patient experiences chest pain or tightness in the chest after taking sumatriptan. These symptoms may be intense but usually resolve quickly. However, if symptoms do not resolve quickly or become severe, immediate medical help must be sought. See also section 4.

Children and adolescents
The safety and efficacy of Frimig Neo in children and adolescents (under 18 years of age) have not been established, and therefore it should not be used in this age group.

Frimig Neo and other medicines
Some medicines must not be taken with Frimig Neo, while others may cause adverse effects when taken together.
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including herbal products and over-the-counter medicines.
Inform the doctor if the patient is taking:

• Ergotamine, also used to treat migraine, or ergot-like medicines such as methysergide. Frimig Neo must not be taken at the same time as these medicines. The patient must stop taking these medicines at least 24 hours before starting Frimig Neo. The patient should also not take them again until at least 6 hours after the last dose of Frimig Neo.

• Other triptans or medicines known as 5HT receptor agonists (such as naratriptan or zolmitriptan). Frimig Neo must not be taken at the same time as these medicines. The patient must stop taking these medicines at least 24 hours before starting Frimig Neo. The patient should also not take them again until at least 24 hours after the last dose of Frimig Neo.

• Monoamine oxidase inhibitors (MAOIs), used to treat depression. Frimig Neo must not be taken if the patient has taken such medicines within the last 2 weeks.

• Selective serotonin reuptake inhibitors (Selective Serotonin Reuptake Inhibitors, SSRIs, including citalopram, fluoxetine, fluvoxamine, paroxetine and sertraline) and serotonin-noradrenaline reuptake inhibitors (Serotonin Noradrenaline Reuptake Inhibitors, SNRIs, including venlafaxine and duloxetine), used to treat depression. Taking Frimig Neo with these medicines may cause serotonin syndrome (a group of symptoms which may include restlessness, confusion, excessive sweating, hallucinations, increased reflexes, muscle stiffness, shivering, rapid heart rate and tremor). If such symptoms occur, the doctor must be informed immediately.

• St. John's wort (Hypericum perforatum). Unwanted effects may occur more frequently when Frimig Neo is taken together with herbal medicines containing St. John's wort.

• Lithium, a medicine used to treat bipolar disorder (manic depression). Taking sumatriptan together with lithium may cause serotonin syndrome.

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
There is limited information on the safety of sumatriptan use in pregnant women, but so far there is no evidence of an increased risk of congenital malformations. The doctor will discuss with the patient whether she can use Frimig Neo during pregnancy.

Breastfeeding
Breastfeeding must be avoided for 12 hours after taking Frimig Neo. Breast milk expressed during this time must be discarded and not used for feeding the infant.
Some breastfeeding women have reported breast and/or nipple pain after taking sumatriptan. This pain is usually transient and resolves within 3 to 12 hours.

Driving and operating machinery
Migraine symptoms or the medicine itself may cause drowsiness. If drowsiness occurs, the patient must not drive or operate machinery.

Frimig Neo contains lactose.
Frimig Neo, 50 mg: This medicine contains 44 mg of lactose (monohydrate form).
Frimig Neo, 100 mg: This medicine contains 88 mg of lactose (monohydrate form).
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

Other excipients
This 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 Neo

This medicine should always be taken according to the instructions given by your doctor or pharmacist. If in
doubt, consult your doctor or pharmacist.
When to take Frimig Neo
Frimig Neo should be taken as soon as the patient feels that a migraine attack is about to occur,
although it may also be taken at any time during a migraine attack.
Do not take Frimig Neo for the prevention of migraine attacks. The medicine should be taken
only after migraine symptoms have started.
What dose to take
The recommended dose for adults is one 50 mg tablet. Some patients may require a dose of 100 mg.
Follow your doctor's instructions.
If symptoms recur
A second tablet of Frimig Neo may be taken only if at least 2 hours have passed since the first tablet was taken.
Do not take more than 300 mg (six 50 mg tablets or three 100 mg tablets) in total within 24 hours.
If there is no improvement after taking one tablet
Do not take a second tablet of Frimig Neo or any other medicine containing a triptan during the same migraine attack.
Frimig Neo may be used again during the next attack. If Frimig Neo does not provide relief, consult your doctor.
Elderly patients (over 65 years of age)
Frimig Neo is not recommended for use in patients over 65 years of age.
Method of administration
The tablets do not have a score line, so they should be swallowed whole with water.
Taking more Frimig Neo than recommended
Taking too much Frimig Neo may cause illness. Symptoms of overdose are the same as those listed in section 4.
If you have taken too many tablets, consult a doctor for advice.
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 they do not occur in every patient.
Severe 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 welts).
• Anaphylaxis (severe allergic reactions, such as swelling of the eyelids, face or lips, and suddenly occurring wheezing, irregular heartbeat, chest tightness or collapse). If any of these symptoms occur shortly after taking Frimig Neo, stop taking the medicine Frimig Neo immediately and seek medical advice without delay.

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

• Pain, sensation of heaviness, pressure or tightness in the chest, throat or other parts of the body, or unusual sensations including numbness, tingling, and feelings of warmth or cold. These adverse symptoms may be very intense but usually pass quickly. If these symptoms persist or become severe (especially chest pain), immediate medical help should be sought. In a small number of people, these symptoms may be due to a heart attack.

Other possible adverse reactions
Common (may occur in up to 1 in 10 people):

• Dizziness, drowsiness
• Transient increase in blood pressure (occurring shortly after administration), sudden flushing of the face
• Breathing difficulties
• Nausea or vomiting
• Muscle pain
• Feeling of weakness, fatigue.

Uncommon (may occur in up to 1 in 1,000 people):

• Chest pain.

Rare (may occur in up to 1 in 10,000 people):

• Liver function disorders. If the patient is to undergo blood tests to check liver function, the doctor should be informed about the use of Frimig Neo.

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

• Anxiety
• Seizures (epileptic fits), involuntary movements (dystonia), tremors, nystagmus
• Visual disturbances such as blurred vision, restricted vision, or loss of vision (these may also be due to 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 paleness and numbness of fingers and toes)
• Inflammation of the large intestine (symptoms include pain in the lower left abdomen and bloody diarrhoea), diarrhoea, difficulty swallowing
• Increased sweating
• Stiff neck, joint pain
• In patients who have recently had an injury or who have an inflammatory condition (such as rheumatism or inflammation of the large intestine), pain or worsening of pain at the site of injury or inflammation may occur.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Frimig Neo

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date (EXP) stated on the cardboard box or blister pack.
The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Frimig Neo contains

• The active substance is sumatriptan. One tablet contains 50 mg or 100 mg of sumatriptan (as sumatriptan succinate).
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, magnesium stearate, titanium dioxide (E 171), polydextrose, hypromellose, triacetin, polyethylene glycol 8000, iron oxide red (E 172) (only in 100 mg tablets), iron oxide yellow (E 172) (only in 100 mg tablets).

What Frimig Neo looks like and contents of the pack
Film-coated tablet (tablet)
Frimig Neo, 50 mg: White, triangular, biconvex tablet, embossed with "SUM" on one side and "50" on the other. The tablet measures 8 mm in length and width.
Frimig Neo, 100 mg: Pink, triangular, biconvex tablet, embossed with "SUM" on one side and "100" on the other. The tablet measures 10 mm in length and width.

Pack sizes
Frimig Neo, 50 mg is available in blister packs containing 2, 6 or 12 tablets in a cardboard box.
Frimig Neo, 100 mg is available in blister packs containing 2, 6 or 18 tablets in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Orion Corporation
Orionintie 1
02200 Espoo
Finland

Manufacturer
Orion Corporation Orion Pharma
Orionintie 1
02200 Espoo
Finland
Orion Corporation Orion Pharma
Joensuunkatu 7
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]