Frimig Duo

Leaflet attached to the packaging: patient information

Frimig Duo, 85 mg + 500 mg, coated tablets

Sumatriptan + Naproxen sodium

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

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given 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 Duo and what is it used for
• 2. Important information before taking Frimig Duo
• 3. How to take Frimig Duo
• 4. Possible side effects
• 5. How to store Frimig Duo
• 6. Contents of the pack and other information

1. What is Frimig Duo and what is it used for

Frimig Duo contains two active substances, sumatriptan and naproxen sodium. Sumatriptan belongs to a group of medicines called triptans (also known as 5HT receptor agonists), and naproxen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Frimig Duo is used to treat migraine attacks in adults when treatment with a single active substance has been insufficient. Frimig Duo may be used to treat migraine attacks with or without aura (aura is a warning sign that usually includes flashing lights, zigzag lines, stars, or waves). It is thought that migraine headaches may be caused by the dilation of blood vessels in the head. Sumatriptan causes the constriction of blood vessels and thereby relieves migraine headaches, and naproxen also reduces this pain.

2. Important information before taking Frimig Duo

When not to take Frimig Duo:

• if the patient is allergic to sumatriptan or naproxen or any of the other ingredients of this medicine (listed in section 6)
• if the patient is allergic or has ever had allergic reactions (itching or skin rash) or asthma symptoms (wheezing breath) after taking acetylsalicylic acid or other NSAIDs, such as ibuprofen, diclofenac, or meloxicam
• if the patient currently has or has had heart disease, such as severe heart failure, coronary artery narrowing (ischemic heart disease), or chest pain (angina pectoris) or myocardial infarction
• if the patient has high blood pressure. If hypertension is mild and properly treated, the doctor will decide whether it is possible to use Frimig Duo in the patient
• if the patient has had a stroke or mini-stroke [also called transient ischemic attack (TIA)], as the risk of stroke may be higher in the patient
• if the patient has circulatory disorders in the legs that cause pain when walking similar to cramps (peripheral vascular disease)
• if the patient currently has or has had stomach or duodenal ulcers
• if the patient currently has or has ever had gastrointestinal bleeding or perforation of the gastrointestinal tract while taking NSAIDs
• if the patient has severe kidney impairment
• if the patient has moderate or severe liver impairment
• if the patient is taking other anti-migraine medicines, including those containing ergotamine or triptans or medicines known as 5HT receptor agonists (such as naratriptan or zolmitriptan);
• if the patient is taking or has taken within the last 2 weeks medicines belonging to a group called monoamine oxidase inhibitors (MAOIs) (e.g., moclobemide used to treat depression or selegiline used to treat Parkinson's disease)
• if the patient is in the last three months of pregnancy

Warnings and precautions

Frimig Duo should only be used when the headache is definitely caused by migraine. If the headache is different from the usual headaches, Frimig Duo should not be taken without first discussing it with a doctor. Before starting treatment with Frimig Duo, the patient should consult a doctor if any of the following situations apply to them:

• circulatory disorders in the hands and feet or in the brain
• chest pain and a feeling of pressure in the chest shortly after taking Frimig Duo. These symptoms may be intense and may radiate towards the throat. In very rare cases, they are due to the effect of the medicine on the heart. Therefore, if the symptoms do not disappear, the patient should contact a doctor.
• the patient is at increased risk of heart disease; the patient is a heavy smoker or uses nicotine replacement therapy and especially if the patient: is a woman who has already gone through menopause or is a man over 40 years old. In very rare cases, some patients have experienced severe heart disorders after taking Frimig Duo, even if they had no previous symptoms of heart disease. In case of doubt, the patient should consult a doctor for advice.
• ischemic heart disease
• unexplained abdominal pain or anemia (low hemoglobin level in the blood) or if there is blood in the stool or black stools
• gastrointestinal disease, such as ulcerative colitis or Crohn's disease
• asthma or allergies or facial swelling, lip swelling, eye swelling, or tongue swelling in the medical history
• rhinitis or nasal polyps in the medical history
• bleeding or blood clotting disorders
• epilepsy or any other disease that reduces the seizure threshold
• hypersensitivity to certain antibiotics (sulfonamides)
• reduced heart, kidney, or liver function
• the patient is elderly
• autoimmune disease, such as systemic lupus erythematosus (SLE).

Due to the use of naproxen, severe skin reactions (including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS)) have been reported. The patient should stop taking Frimig Duo and seek immediate medical attention if they experience any symptoms associated with severe skin reactions, as described in section 4.

Children and adolescents

This medicine should not be given to children and adolescents under 18 years of age, as the efficacy and safety of Frimig Duo in this age group have not been established.

Frimig Duo and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. This includes medicines that are available without a prescription and herbal medicines. In particular, the patient should tell their doctor if they are taking:

• other medicines used to treat migraine, containing ergotamine or triptans or medicines known as 5HT receptor agonists. Frimig Duo should not be taken at the same time as these medicines (see "When not to take Frimig Duo"). These medicines and Frimig Duo should not be taken within 24 hours of taking any of these medicines.
• MAOIs (e.g., moclobemide used to treat depression or selegiline used to treat Parkinson's disease). Frimig Duo should not be taken for 2 weeks after stopping treatment with MAOIs.
• selective serotonin reuptake inhibitors (SSRIs) and serotonin-noradrenaline reuptake inhibitors (SNRIs) used to treat depression. The use of Frimig Duo with these medicines may cause serotonin syndrome (a syndrome of symptoms that may include restlessness, confusion, sweating, hallucinations, increased reflexes, muscle spasms, shivering, and rapid heart rate). The patient should immediately inform their doctor if they experience such symptoms.
• acetylsalicylic acid (aspirin) or other anti-inflammatory painkillers.
• medicines that prevent blood clotting and the formation of blood clots (e.g., warfarin, heparin, or clopidogrel), as the concurrent use of these medicines may increase the risk of bleeding. The patient should avoid taking these medicines at the same time.
• methotrexate (a medicine used to treat psoriasis and cancer)
• digoxin (used to treat heart conditions)
• lithium (a medicine used to treat bipolar disorder). The use of Frimig Duo with lithium may cause serotonin syndrome.
• certain immunosuppressive medicines (e.g., cyclosporine, tacrolimus)
• herbal medicines containing St. John's Wort (Hypericum perforatum). Side effects may occur more frequently.

Pregnancy, breastfeeding, and fertility

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. PregnancyFrimig Duo should not be taken if the patient is in the last three months of pregnancy, as it may harm the unborn baby or cause problems during delivery. It may cause kidney and heart problems in the unborn baby. It may increase the risk of bleeding in the patient and the baby and cause delayed or prolonged labor. Frimig Duo should not be used during the first six months of pregnancy, unless the doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible time. From the 20th week of pregnancy, the medicine may cause kidney problems in the unborn baby if taken for more than a few days. This may lead to a decrease in the amount of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the baby's heart. If treatment is necessary for a longer period, the doctor may recommend additional monitoring. BreastfeedingBoth sumatriptan and naproxen pass into breast milk, and therefore, Frimig Duo should not be taken during breastfeeding. The patient should not breastfeed their baby for at least 12 hours after taking Frimig Duo. The milk expressed during this time should be discarded and not given to the baby. FertilityFrimig Duo may cause difficulty in conceiving. The patient should inform their doctor if they plan to conceive or are having difficulty conceiving. It is not recommended to take Frimig Duo if the patient plans to have a baby.

Driving and using machines

Frimig Duo or migraine symptoms may cause drowsiness or dizziness. If the patient experiences such symptoms, they should not drive or operate machinery.

Frimig Duo contains sodium

The medicine contains 60 mg of sodium (the main component of common salt) in each tablet. This corresponds to 3% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to take Frimig Duo

This medicine should always be taken exactly as prescribed by the doctor. In case of doubt, the patient should consult their doctor or pharmacist. Frimig Duo should not be taken to prevent a migraine attack – the medicine should only be taken when migraine symptoms occur.

Adults

The recommended dose for adults is one tablet, taken as soon as possible after the onset of migraine symptoms. If the headache recurs or the patient only experiences slight relief from headache, a second dose can be taken after 2 hours from the first tablet. The patient should not take more than two doses of Frimig Duo in 24 hours. If the patient does not experience any relief after the first dose, they should not take a second dose. They should first talk to their doctor.

Patients with liver and kidney impairment

If the patient has mild liver or kidney impairment and it is necessary to take Frimig Duo, they should take only one tablet in 24 hours.

Use in elderly patients (over 65 years of age)

Frimig Duo is not recommended for use in patients over 65 years of age.

Use in children and adolescents

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

Method of administration

Oral administration. The tablets should be swallowed whole with water. The tablets should not be chewed or crushed, as this may affect the proper rate of absorption of the medicine. The tablets can be taken with or without food. Food does not have a significant effect on the action of Frimig Duo.

Overdose of Frimig Duo

The patient should not take more than two tablets in 24 hours. The symptoms of overdose are the same as those listed in section 4 "Possible side effects". If the patient has taken too many tablets or a child has accidentally taken the medicine, they should contact a doctor or hospital for information on the risk and advice on what to do. 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 Duo can cause side effects, although not everybody gets them. Some of the reported side effects may be caused by the migraine attack.

Important side effects to look out for:

The patient should stop taking Frimig Duo and immediately consult a doctor if they experience any of the following side effects. Urgent medical attention may be necessary. Severe stomach or intestinal disorders, symptoms include:

• Bleeding from the stomach, in the form of vomiting blood or coffee grounds.
• Bleeding from the lower part of the digestive tract (anus), in the form of black, tarry stools or bloody diarrhea.
• Ulcers or perforations of the stomach or intestinal lining. Symptoms include indigestion, abdominal pain, fever, nausea, vomiting.
• Worsening of ulcerative colitis or Crohn's disease, with symptoms such as pain, diarrhea, vomiting, and weight loss.

Allergic reactions, symptoms include:

• Severe allergic reaction with sudden onset, causing difficulty breathing or dizziness (anaphylactic reaction).
• Swelling of the face, tongue, or throat, difficulty swallowing, hives, and difficulty breathing (angioedema).

Liver disorders, symptoms include:

• Feeling tired, loss of appetite, nausea or vomiting, pain or swelling in the right upper abdomen, dark urine, pale stools, and yellowing of the skin or whites of the eyes (toxic hepatitis).

Severe skin reactions, symptoms include:

• Usually, flu-like symptoms (malaise, fever, headache, cough, and joint pain) occur first, followed by a rapidly spreading, red or purple rash with painful blisters and skin peeling, as well as possible blisters in the mouth, throat, eyes, and genitals (Stevens-Johnson syndrome and (or) toxic epidermal necrolysis). Unknown frequency (frequency cannot be estimated from the available data):
• Widespread rash, high body temperature, increased liver enzyme activity, blood disorders (eosinophilia), lymph node enlargement, and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS). See also section 2.
• A characteristic skin allergic reaction, known as fixed drug eruption, which usually recurs in the same location (locations) after re-administration of the medicine and may take the form of round or oval red patches and skin swelling, blisters (hives), itching.

Myocardial infarction, symptoms include:

• Chest pain that may radiate to the neck and arms and down the left arm.

Stroke, symptoms include:

• Weakness and numbness that may occur on one side of the body.
• Sudden disturbance of smell, taste, hearing, or vision, feeling disoriented.

Meningitis, symptoms include:

• Fever, nausea or vomiting, stiff neck, headache, sensitivity to light, and confusion (most likely in people with autoimmune disorders, such as systemic lupus erythematosus).

Other possible side effects:

Very common (may affect more than 1 in 10 people):

• Pain in the upper abdomen.
• Nausea, heartburn, constipation.

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

• Dizziness, tingling, drowsiness, sensation disorders, headache, feeling empty-headed
• Visual disturbances
• Ringing in the ears, hearing disorders
• Worsening of heart failure (edema, shortness of breath), transient increase in blood pressure (occurring soon after administration), sudden flushing
• Breathing difficulties
• Vomiting (nausea, vomiting), digestive disorders, diarrhea, inflammation of the mouth
• Skin symptoms (e.g., itching, rash, red spots), bruising, increased sweating
• Muscle pain
• Pain, feeling hot or cold, pressure, squeezing, or feeling heavy, feeling weak, fatigue.

Uncommon (may affect up to 1 in 100 people):

• Increased potassium levels, fluid retention (edema)
• Mood changes, depression, decreased ability to concentrate, memory problems, sleep disorders, or changes in sleep patterns
• Seizures and (or) convulsions
• Irregular heartbeat (palpitations)
• Increased liver enzyme activity and bilirubin levels (jaundice)
• Menstrual disorders
• Thirst.

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

• Hearing loss
• Fluid accumulation in the lungs
• Worsening of asthma
• Hair loss
• Increased sensitivity of the skin to sunlight, blistering, and skin changes (pseudoporphyria)
• Muscle weakness, muscle pain.

Very rare (may affect up to 1 in 10,000 people):

• Blood disorders, such as anemia, changes in white blood cell count, low platelet count, blood abnormalities
• Worsening of Parkinson's disease
• Vasculitis
• Pneumonia
• Salivary gland swelling
• Mild liver function test abnormalities
• Skin disorders with red, itchy patches, usually on the palms, soles, and face (erythema multiforme), exacerbation of skin diseases (e.g., psoriasis, lichen planus, systemic lupus erythematosus (SLE)).
• Blood or protein in the urine, kidney function disorders, kidney inflammation, other kidney diseases.

Unknown frequency (frequency cannot be estimated from the available data):

• Anxiety
• Involuntary movements (dystonia), tremors, oculogyric crisis
• Heart disorders that may cause rapid, slow, or irregular heartbeat, chest pain (angina pectoris)
• Low blood pressure, Raynaud's phenomenon (a condition characterized by pale and cold fingers and toes)
• Difficulty swallowing
• Increased sweating
• Stiff neck, joint pain
• Pain or worsening of pain at the site of injury or inflammation, fever.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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 Side effects can also be reported to the marketing authorization holder. By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Frimig Duo

The medicine should be stored out of sight and reach of children. This medicine should not be taken after the expiry date (EXP) stated on the label and carton. The expiry date refers to the last day of the month. There are no special precautions for storing the medicine. 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 Duo contains

• The active substances of the medicine are sumatriptan (in the form of sumatriptan succinate) and naproxen sodium. Each tablet contains 119 mg of sumatriptan succinate, which corresponds to 85 mg of sumatriptan, and 500 mg of naproxen sodium, which corresponds to 457 mg of naproxen.
• The other ingredients of the medicine are: calcium hydrogen phosphate, microcrystalline cellulose, sodium croscarmellose, sodium hydrogen carbonate, povidone, magnesium stearate, talc, and coating ingredients (hypromellose, titanium dioxide (E 171), triacetin, indigo carmine, aluminum lake (E 132)).

What Frimig Duo looks like and contents of the pack

Frimig Duo is a blue, capsule-shaped, coated tablet, 19 mm x 10 mm x 7 mm in size, with the imprint "85/500" on one side and smooth on the other. Pack sizes: Blister: 3 and 9 tablets

Marketing authorization 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 more 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:

Austria, Italy: Sumanet Denmark, Finland, Norway, Sweden, Hungary: Nomigrin Belgium, Estonia, Ireland, Lithuania, Latvia: Migsun Germany, Greece, France, Spain, Netherlands, Portugal: Suvexx Poland, Czech Republic, Slovakia: Frimig Duo Date of last revision of the leaflet:12.2024