Frimig duo

Package leaflet: Information for the patient

Frimig Duo, 85 mg + 500 mg, film-coated tablets
Sumatriptan + Sodium naproxen
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 questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

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

Frimig Duo contains two active substances: sumatriptan and sodium naproxen. 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 for the treatment of migraine attacks in adults when treatment with a single
active substance has proven insufficient. Frimig Duo may be used to treat migraine attacks
with or without aura (aura refers to warning symptoms that typically include flashes of light,
zigzag lines, stars, or waves).
Migraine headaches are thought to result from the dilation of blood vessels in the head.
Sumatriptan causes constriction of these blood vessels, thereby relieving migraine headache,
while naproxen additionally 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 has had an allergy or allergic reactions (itching or skin rash) or asthma symptoms (wheezing) after taking acetylsalicylic acid or other NSAIDs such as ibuprofen, diclofenac or meloxicam
• if the patient currently has or has previously had heart disease, such as severe heart failure, coronary artery narrowing (ischaemic heart disease), chest pain (angina pectoris) or heart attack
• if the patient has high blood pressure. If hypertension is mild and adequately treated, the doctor will decide whether Frimig Duo can be used
• if the patient has had a stroke or mini-stroke [also known as transient ischaemic attack (TIA)], because the risk of stroke may be higher
• if the patient has circulation disorders in the legs causing pain during walking similar to cramps (peripheral vascular disease)
• if the patient currently has or has previously had stomach or duodenal ulcers
• if the patient currently has or has ever previously had gastrointestinal bleeding or perforation while taking NSAIDs
• if the patient has severe kidney function impairment
• if the patient has moderate or severe liver function impairment
• if the patient is taking other migraine medications, including those containing ergotamine or similar-acting drugs such as methysergide maleate or other triptans, or drugs 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 headache is definitely caused by migraine. If the headache differs from usual migraine headaches, do not take Frimig Duo without first discussing it with a doctor.
Before starting Frimig Duo, consult a doctor if any of the following apply to the patient:

• circulatory disorders in hands and feet or in the brain
• pain and 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 may result from the drug's effect on the heart. Therefore, if symptoms do not subside, contact a doctor.
• the patient is in a group at increased risk of heart disease; the patient is a smoker or uses nicotine replacement therapy, especially if the patient:
  • is a woman who has already undergone menopause
  • is a man over 40 years of age
    In very rare cases, serious heart problems have occurred in some patients after taking Frimig Duo, even if no prior symptoms of heart disease were previously diagnosed. If in doubt, consult a doctor.
• ischaemic heart disease
• unexplained abdominal pain or anaemia (low haemoglobin levels in 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, lip, eye or tongue swelling in medical history
• history of rhinitis or nasal polyps
• blood clotting disorders or bleeding
• epilepsy or any other condition lowering the seizure threshold
• hypersensitivity to certain antibiotics (sulphonamides)
• reduced heart, kidney or liver function
• the patient is elderly
• autoimmune disease such as systemic lupus erythematosus (SLE)

Serious skin reactions (including Stevens-Johnson syndrome, toxic epidermal necrolysis and drug reaction with eosinophilia and systemic symptoms (DRESS)) have been reported with the use of naproxen. The use of Frimig Duo should be discontinued and immediate medical help sought if any symptoms associated with serious skin reactions described in section 4 occur.

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 have not been established in this age group.

Frimig Duo and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines planned for use. This includes over-the-counter medicines and herbal remedies. In particular, inform the doctor if the patient is taking:

• other migraine treatments containing ergotamine or triptans or drugs known as 5HT receptor agonists. Frimig Duo must not be used simultaneously with these medicines (see section "When not to use Frimig Duo"). These medicines and Frimig Duo should not be taken within 24 hours of each other.
• MAO inhibitors (e.g. moclobemide used to treat depression or selegiline used to treat Parkinson's disease). Frimig Duo must not be taken within 2 weeks after stopping treatment with MAO inhibitors.
• selective serotonin reuptake inhibitors (SSRIs) and serotonin-noradrenaline reuptake inhibitors (SNRIs), used to treat depression. Taking Frimig Duo with these medicines may cause serotonin syndrome (a group of symptoms that may include restlessness, confusion, excessive sweating, hallucinations, increased reflexes, muscle stiffness, shivering, rapid heart rate and tremor). Contact a doctor immediately if such symptoms occur.
• acetylsalicylic acid (aspirin) or other anti-inflammatory painkillers.
• medicines preventing blood clotting and thrombus formation (e.g. warfarin, heparin or clopidogrel), as concomitant use may increase the risk of bleeding. Concomitant use of these medicines should be avoided.
• methotrexate (a medicine used to treat psoriasis and cancer)
• digoxin (used to treat heart conditions)
• lithium (used to treat bipolar disorder). Taking Frimig Duo with lithium may cause serotonin syndrome.
• certain immunosuppressive medicines (e.g. cyclosporine, tacrolimus)
• herbal remedies containing St. John's wort (Hypericum perforatum). Adverse reactions may occur more frequently.

Pregnancy, breastfeeding and fertility

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
Frimig Duo should not be taken during the last three months of pregnancy, as it may harm the unborn child or cause problems during delivery. It may cause kidney and heart problems in the unborn child. It may increase the tendency to bleeding in both mother and child and may delay or prolong labour.

Frimig Duo should not be used during the first 6 months of pregnancy unless the doctor considers its use absolutely necessary. If treatment is required during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible time. From week 20 of pregnancy, the medicine may cause kidney problems in the unborn child if taken for longer than a few days. This may lead to reduced amniotic fluid volume surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is required for longer than a few days, the doctor may recommend additional monitoring.

Breastfeeding
Both sumatriptan and naproxen pass into breast milk, therefore Frimig Duo should not be used during breastfeeding.
Do not breastfeed for at least 12 hours after taking Frimig Duo. Breast milk expressed during this time should be discarded and not used to feed the baby.

Effect on fertility
Frimig Duo may cause difficulty becoming pregnant. Inform the doctor if the patient plans to become pregnant or has difficulty conceiving. Frimig Duo is not recommended if the patient is planning to have a child.

Driving and using machines
Frimig Duo or migraine symptoms may cause drowsiness or dizziness. If such symptoms occur, do not drive or operate machinery.

Frimig Duo contains sodium
This medicine contains 60 mg of sodium (the main component of table salt) per tablet. This corresponds to 3% of the maximum recommended daily dietary sodium intake for adults.

3. How to take Frimig Duo

This medicine should always be taken as directed by the physician. In case of doubts, consult a doctor or pharmacist. Do not use Frimig Duo to prevent migraine attacks – this medicine should only be taken after migraine symptoms have started.

Adults
The recommended dose for adults is one tablet, taken as soon as possible after the onset of migraine symptoms.

If headache recurs or if the patient experiences only slight relief, a second dose may be taken two hours after the first tablet. Do not take more than two doses of Frimig Duo within 24 hours.

If the patient experiences no relief after the first dose, do not take a second dose. Consult your doctor first.

Patients with hepatic or renal impairment
If the patient has mild impairment of liver or kidney function and treatment with Frimig Duo is necessary, only one tablet should be taken within 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. Tablets should be swallowed whole with water. Do not chew or crush the tablets, as this may affect the proper rate of drug absorption. Tablets may be taken with or without food. Food does not have a significant effect on the action of Frimig Duo.

Taking more than the recommended dose of Frimig Duo
Do not take more than two tablets within 24 hours. Symptoms of overdose are the same as those listed in section 4 "Possible side effects". If too many tablets have been taken or if a child accidentally ingests the medicine, contact a doctor or hospital immediately for advice on the risks and necessary actions.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Some of the reported adverse effects may be caused by a migraine attack.
Important adverse effects to be aware of:
Stop taking Frimig Duo and contact your doctor immediately if any of the following adverse effects occur.
Urgent medical attention may be required.

Severe stomach or intestinal problems, symptoms include:
Uncommon ( may affect up to 1 in 100 people ):

• Bleeding from the stomach, presenting as vomiting blood or material resembling coffee grounds.
• Bleeding from the lower gastrointestinal tract (rectum), presenting as tarry, sticky stools or bloody diarrhoea.
• Ulceration or defects in the mucous lining of the stomach or intestines. Symptoms include indigestion, abdominal pain, fever, nausea, vomiting.
• Worsening of symptoms of ulcerative colitis or Crohn's disease, manifesting as pain, diarrhoea, vomiting and weight loss.

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

• Pancreatic dysfunction. Symptoms include severe abdominal pain radiating to the back.

Allergic reactions, symptoms include:
Rare ( may affect up to 1 in 1,000 people ):

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

Liver function disorders, symptoms include:
Rare ( may affect up to 1 in 1,000 people ):

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

Severe skin rashes, symptoms include:
Very rare ( may affect up to 1 in 10,000 people ):

• Initially, flu-like symptoms (malaise, fever, headache, cough and joint pain) usually occur, followed by rapidly spreading red or purple rash with painful blisters and skin peeling, as well as possible blisters in the mouth, throat, eyes and genital organs (Stevens-Johnson syndrome and/or toxic epidermal necrolysis).

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

• Widespread rash, high fever, increased liver enzyme activity, blood disorders (eosinophilia), enlarged lymph nodes and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS syndrome). See also section 2.
• A characteristic allergic skin reaction known as fixed drug eruption, which typically recurs in the same location(s) upon re-exposure to the medicine and may present as round or oval red patches, swelling of the skin, blisters (urticaria) and itching.

Heart attack, symptoms include:
Frequency not known ( frequency cannot be estimated from available data ):

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

Stroke, symptoms include:
Frequency not known ( frequency cannot be estimated from available data ):

• Muscle weakness and numbness, which may occur on one side of the body.
• Sudden disturbances in the sense of smell, taste, hearing or vision, and a feeling of disorientation.

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

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

Other possible adverse effects:
Very common ( may affect more than 1 in 10 people ):

• Upper abdominal pain.
• Nausea, heartburn, constipation.

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

• Dizziness, tingling, drowsiness, sensory disturbances, headache, feeling of emptiness in the head.
• Vision disturbances.
• Ringing in the ears, hearing disturbances.
• Worsening of heart failure (swelling, shortness of breath), transient increase in blood pressure (occurring shortly after taking the medicine), sudden flushing.
• Breathing difficulties.
• Vomiting (nausea, vomiting), digestive disturbances, diarrhoea, inflammation of the mucous membrane of the mouth.
• Skin reactions (e.g. itching, rash, red spots), bruising, increased sweating.
• Muscle pain.
• Pain, feeling of heat or cold, pressure, tightness or heaviness, feeling of weakness, fatigue.

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

• Increased potassium levels, fluid retention (oedema).
• Mood changes, depression, reduced concentration, memory problems, difficulty falling asleep or changes in sleep patterns.
• Attacks and/or epileptic seizures (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.
• Accumulation of fluid in the lungs.
• Worsening of asthma.
• Hair loss.
• Increased skin sensitivity to sunlight, formation of blisters and skin lesions (pseudoporphyria).
• Muscle weakness, muscle pain.
• Chest pain.

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

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

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

• Anxiety.
• Involuntary movements (dystonia), tremor, nystagmus.
• Heart disorders that may cause increased heart rate, slowed heart rate or changes in heart rhythm, chest pain (angina pectoris).
• Low blood pressure, Raynaud's phenomenon (a condition characterised by paleness and numbness of fingers and toes).
• Difficulty swallowing.
• Increased sweating.
• Neck stiffness, joint pain.
• Pain or worsening of pain at the site of injury or inflammation, fever.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist.
Adverse effects can be reported directly to the Department of Monitoring of 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 effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Frimig Duo

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date (EXP) stated on the label and the carton. The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
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 Duo contains

• The active substances in this medicinal product are sumatriptan (in the form of sumatriptan succinate) and naproxen sodium. Each tablet contains 119 mg of sumatriptan succinate, equivalent to 85 mg of sumatriptan, and 500 mg of naproxen sodium, equivalent to 457 mg of naproxen.
• Other components 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, aluminium lake of indigo carmine (E 132)).

What Frimig Duo looks like and contents of the pack
Frimig Duo is a film-coated tablet in a capsule-shaped, medium blue colour,
measuring 19 mm x 10 mm x 7 mm in length, width, and thickness, with the imprint “ 85/500 ”
engraved on one side and smooth on the other.
Pack sizes:
Blister packs: 3 and 9 tablets

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]

This medicinal product is authorised in 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