Bifonen

Leaflet accompanying the packaging: patient information

Byfonen, 400 mg, coated tablets

Ibuprofen in the form of ibuprofen lysinate

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse after 3 days, the patient must contact a doctor (applies to adolescents).
• If there is no improvement or the patient feels worse after 3 days in the case of fever and/or migraine and 5 days in the case of pain treatment, the patient must contact a doctor (applies to adults).

Table of contents of the leaflet

• 1. What is Byfonen and what is it used for
• 2. Important information before taking Byfonen
• 3. How to take Byfonen
• 4. Possible side effects
• 5. How to store Byfonen
• 6. Package contents and other information

1. What is Byfonen and what is it used for

The active substance is ibuprofen. It belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). The action of NSAIDs is to change the way the body reacts to pain, swelling, and high temperature.
Byfonen is used for short-term symptomatic treatment of:

• mild or moderate pain, such as headache, migraine, toothache, menstrual cramps, muscle pain, back pain, rheumatic pain,
• fever,
• subfebrile state and symptoms of colds and flu.

Byfonen is indicated for use in adults and adolescents over 12 years of age and with a body weight of at least 40 kg.

2. Important information before taking Byfonen

When not to take Byfonen:

• If the patient is allergic to ibuprofen, aspirin (acetylsalicylic acid), or other painkillers, or any of the other ingredients of this medicine (listed in section 6),
• 6),
• If the patient has experienced shortness of breath, asthma, runny nose, swelling, or hives after taking aspirin (acetylsalicylic acid) or similar painkillers (from the NSAID group),
• If the patient currently has (or has had more than twice in the past) stomach or duodenal ulcers, or bleeding from the stomach or duodenum,
• If the patient has had bleeding from the gastrointestinal tract or perforation of the gastrointestinal tract in connection with the use of NSAIDs,
• If the patient has severe heart, liver, or kidney failure,
• If the patient has blood clotting disorders of unknown origin,
• If the patient is severely dehydrated (due to vomiting, diarrhea, or inadequate fluid intake),
• If the patient is in the last three months of pregnancy,
• In adolescents with a body weight below 40 kg or under 12 years of age.

Warnings and precautions

Before starting treatment with Byfonen, the patient should discuss it with their doctor or pharmacist if:

• the patient has or has had asthma or other allergic diseases, as shortness of breath may occur,
• the patient has hay fever, nasal polyps, or chronic obstructive respiratory diseases, as these patients are at increased risk of allergic reactions. These reactions can take the form of asthma attacks (so-called analgesic asthma), angioedema, or urticaria,
• the patient has kidney, heart, liver, or intestinal diseases,
• the patient has had gastrointestinal diseases (including ulcerative colitis or Crohn's disease),
• the patient has a certain congenital blood clotting disorder (e.g., acute intermittent porphyria),
• the patient has systemic lupus erythematosus or mixed connective tissue disease (these are autoimmune diseases that manifest with joint pain, skin changes, and disorders of other organs),
• the patient has chickenpox - it is not recommended to take Byfonen, as the symptoms of the disease may worsen,
• the patient has an infection - see below "Infections",
• the patient has recently undergone major surgery,
• the patient is dehydrated,
• the patient is taking other NSAIDs. It is recommended to avoid taking this medicine together with other NSAIDs, including selective cyclooxygenase-2 inhibitors,
• the patient is in the first six months of pregnancy.

Other warnings

• Taking anti-inflammatory or pain-relieving medications, such as ibuprofen, may be associated with a slight increase in the risk of heart attack or stroke, especially when taken in high doses. Do not exceed the recommended dose and duration of treatment.
• Before taking Byfonen, the patient should discuss treatment with their doctor or pharmacist if:
• the patient has heart diseases, such as heart failure, angina pectoris (chest pain), the patient has had a heart attack, bypass surgery, or has peripheral arterial disease (poor blood circulation in the legs or feet due to narrowing or blockage of arteries) or if the patient has had any stroke (including mini-stroke or transient ischemic attack - TIA),
• the patient has high blood pressure, diabetes, high cholesterol levels, or a family history of heart disease or stroke, or if the patient smokes.
• During the use of ibuprofen, symptoms of an allergic reaction to this medicine have been reported, including breathing problems, facial and throat swelling (angioedema), chest pain, and

shortness of breath. If the patient notices any of these symptoms, they should stop taking Byfonen immediately and contact their doctor or emergency services.
Severe skin reactions
In connection with the use of ibuprofen, severe skin reactions have been reported, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). The patient should stop taking Byfonen and seek medical attention immediately if any of the symptoms associated with severe skin reactions described in section 4 occur.
Side effects can be reduced by using the smallest effective dose for the shortest possible time. Elderly people are more likely to experience side effects.
Ibuprofen may temporarily inhibit platelet function (platelet aggregation). Patients with bleeding disorders should be closely monitored.
The patient should consult their doctor or dentist before taking Byfonen before surgical procedures.
Regular use of several different types of painkillers may lead to permanent kidney damage and increase the risk of kidney failure. This risk may be increased by physical exertion associated with electrolyte loss and dehydration. Therefore, regular use of painkillers should be avoided.
Long-term use of any painkillers for headache may paradoxically increase its severity. If this situation is suspected or confirmed, the patient should seek medical advice and stop treatment. Headache caused by medication overuse (medication-overuse headache) should be suspected in patients who frequently or daily experience headaches, despite (or due to) regular use of headache medications.
In the case of long-term use of Byfonen, regular monitoring of liver and kidney function parameters and blood morphology is necessary.
NSAIDs may mask symptoms of infection and fever.
Infections
Byfonen may hide objective symptoms of infection, such as fever and pain. Therefore, Byfonen may delay the use of appropriate infection treatment, which can lead to increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If the patient takes this medicine while an infection is present, and the symptoms of the infection persist or worsen, they should consult their doctor immediately.

Children and adolescents

Do not use in adolescents with a body weight below 40 kg or in children under 12 years of age.
In dehydrated adolescents, there is a risk of kidney function disorder.

Byfonen 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.

• blood-thinning medicines (i.e., blood thinners or anticoagulants, such as aspirin (acetylsalicylic acid), warfarin, ticlopidine),
• medicines that lower blood pressure (ACE inhibitors, such as captopril, beta blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan),
• aspirin (acetylsalicylic acid) or other NSAIDs, as they may increase the risk of gastrointestinal ulcers or bleeding,
• digoxin (used in heart failure), as it may increase the effect of digoxin,
• corticosteroids (containing cortisone or substances similar to cortisone), as they may increase the risk of gastrointestinal ulcers or bleeding,
• antiplatelet agents, as they may increase the risk of gastrointestinal bleeding,
• phenytoin (used in epilepsy), as it may increase the effect of phenytoin,
• selective serotonin reuptake inhibitors (antidepressants), as they may increase the risk of gastrointestinal bleeding,
• lithium salts (used in manic-depressive illness and depression), as they may increase the effect of lithium salts,
• probenecid and sulfinpyrazone derivatives (used in gout), as they may slow down the excretion of ibuprofen,
• potassium-sparing diuretics, as they may increase the level of potassium in the blood,
• methotrexate (used in the treatment of cancer and rheumatic diseases), as it may increase the effect of methotrexate,
• tacrolimus and cyclosporin (immunosuppressive agents), as they may cause kidney damage,
• mifepristone (a drug used to induce abortion), as it may reduce the effect of mifepristone,
• zidovudine (a drug used to treat HIV and AIDS), as the use of ibuprofen may increase the risk of bleeding into the joint or bleeding leading to swelling in HIV-infected patients with hemophilia,
• sulfonylurea derivatives (a group of antidiabetic drugs), as an interaction is possible,
• quinolones (a group of antibiotics), as they may increase the risk of seizures,
• drugs that inhibit the CYP2C9 enzyme, such as the antifungal agents voriconazole or fluconazole, as they may increase the exposure to ibuprofen,
• the herbal medicine Ginkgo biloba, as there is a risk of increased bleeding tendency when ibuprofen and Ginkgo biloba are used together.
• do not take Byfonen while taking aspirin (acetylsalicylic acid) at doses above 75 mg per day. When taking low doses of aspirin (acetylsalicylic acid) (up to 75 mg per day), consult a doctor or pharmacist before taking Byfonen.

Some other medicines may also affect the action of Byfonen or their action may change under the influence of this medicine. Therefore, before taking Byfonen with other medicines, the patient should always consult their doctor or pharmacist.

Byfonen and alcohol

Some side effects, such as gastrointestinal or central nervous system disorders, are more likely to occur when Byfonen is taken with alcohol.

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.
Do not take Byfonen in the last three months of pregnancy, as it may harm the unborn baby or cause problems during delivery. This medicine may cause kidney and heart problems in the unborn baby. It may also increase the risk of bleeding in the mother and baby and cause delayed or prolonged labor.
Do not take Byfonen 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 smallest dose should be used for the shortest possible time. From the 20th week of pregnancy, Byfonen may cause kidney function disorders in the unborn baby if taken for more than a few days. This may lead to a low level of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of the arterial duct (ductal constriction) in the baby's heart. If treatment is required for a longer period, the doctor may recommend additional monitoring.
Only a small amount of ibuprofen and its breakdown products pass into breast milk. This medicine can be taken during breastfeeding if used in the recommended dose for the shortest possible time.
Byfonen belongs to a group of medicines that may impair female fertility. This effect is reversible after stopping the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Byfonen

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.
This medicine is intended for short-term use only.
Use the smallest effective dose for the shortest possible time necessary to relieve symptoms. If the symptoms of an infection (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).
Use in adults and adolescents with a body weight of at least 40 kg (from 12 years of age):

• Take 1 tablet with water, up to three times a day, as needed.
• Maintain an interval of at least six hours between doses.
• Do not take more than three tablets (1200 mg of ibuprofen) in 24 hours.

Use in children and adolescents:
Do not use in children under 12 years of age and adolescents with a body weight below 40 kg.
Byfonen coated tablets have a dividing line on one side. The dividing line on the tablet only facilitates its breaking, for easier swallowing.
Treatment duration
If this medicine needs to be used in children and adolescents from 12 to 18 years of age for more than 3 days or if symptoms worsen, consult a doctor.
Adult patients should consult a doctor if symptoms persist or worsen or if this medicine needs to be used for more than 5 days for pain treatment or more than 3 days for migraine or fever treatment.

Taking a higher dose of Byfonen than recommended

If the patient has taken a higher dose of Byfonen than recommended or if a child has accidentally taken the medicine, they should always consult a doctor or go to the nearest hospital to get an opinion on possible health risks and advice on what to do in such a case.
Symptoms of overdose may include nausea, abdominal pain, diarrhea, tinnitus, headache, vomiting (which may contain blood), blood in the stool, disorientation, and nystagmus. After taking a large dose, drowsiness, excitement, disorientation, chest pain, palpitations, low blood pressure, kidney failure, liver damage, blue discoloration of the skin and mucous membranes (cyanosis), loss of consciousness, coma, seizures (mainly in children), increased bleeding tendency, weakness, and dizziness, blood in the urine, low potassium levels in the blood, feeling cold, and breathing problems have been reported. Additionally, the prothrombin time/INR may be prolonged, probably due to disorders of circulating clotting factors in the blood. Acute kidney failure and liver damage may occur. In patients with asthma, asthma may worsen.

Missing a dose of Byfonen

Do not take a double dose to make up for a missed dose.
In case of any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects can be minimized by using the smallest effective dose for the shortest possible time necessary to relieve symptoms. In elderly people taking this medicine, there is an increased risk of side effects.
Taking medicines like Byfonen may be associated with a slightly increased risk of heart attack (myocardial infarction) or stroke (see section 2, "Other warnings").

Stop taking the medicine and seek medical help immediately if the patient experiences:

• abdominal pain, fresh blood in the stool, black or tarry stools, vomiting blood or dark particles resembling coffee grounds [symptoms of gastrointestinal bleeding] (uncommon).
• swelling of the face, tongue, or throat, difficulty breathing, rapid heartbeat, low blood pressure leading to shock. These symptoms may occur after the first use of this medicine [symptoms of severe allergic reaction] (rare).
• asthma attacks (which may be accompanied by a drop in blood pressure), worsening of asthma symptoms, wheezing, or shortness of breath for unknown reasons [symptoms of severe allergic reaction] (uncommon).
• red, non-raised, plate-like, or round patches on the torso, often with blisters in the center, peeling of the skin, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis] (rare).
• widespread rash, high body temperature, swollen lymph nodes, and an increased number of eosinophils (a type of white blood cell) [DRESS syndrome] (frequency cannot be estimated from the available data).
• widespread, red, scaly, generalized rash with bumps under the skin and blisters, mainly in skin folds, on the torso, and upper limbs, with fever at the beginning of treatment [acute generalized exanthematous pustulosis] (frequency cannot be estimated from the available data).
• severe abdominal pain, often with nausea and vomiting [pancreatitis] (rare).
• fever, sore throat, superficial mouth ulcers, flu-like symptoms, increased fatigue, nosebleeds, and bruising [blood disorders] (rare).
• meningitis, characterized by stiffness of the neck, headache, nausea, vomiting, fever, or changes in consciousness (aseptic meningitis). Patients with autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease) may be particularly at risk (rare).
• chest pain, which may be a symptom of a potentially severe allergic reaction called Kounis syndrome (frequency cannot be estimated from the available data).

Tell the doctor if the patient experiencesany of the following side effects:
Common(may affect up to 1 in 10 people):

• gastrointestinal symptoms, such as heartburn, abdominal pain, nausea, vomiting, bloating, diarrhea, constipation, and minor gastrointestinal bleeding, which may lead to anemia in exceptional cases.

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

• stomach or intestinal ulcers, which may lead to bleeding and perforation.
• mouth ulcers with ulcers, gastritis, worsening of ulcerative colitis, and Crohn's disease.
• central nervous system disorders, such as headache, dizziness, insomnia, restlessness, irritability, or fatigue.
• vision disorders.
• allergic reactions, such as skin rashes and itching.
• various skin changes.

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

• tinnitus.
• kidney damage (renal papillary necrosis) and increased uric acid levels in the blood.

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

• esophagitis, intestinal narrowing.
• severe skin and soft tissue infections and complications in patients with chickenpox.
• fluid accumulation in tissues, especially in patients with high blood pressure or kidney disease, edema, and foamy urine (nephrotic syndrome), interstitial nephritis, which may lead to acute kidney failure.
• psychotic reactions, depression.
• in connection with the use of non-steroidal anti-inflammatory drugs (NSAIDs), cases of worsening of infectious diseases (e.g., development of necrotizing fasciitis) have been reported. If symptoms of infection worsen or appear while taking ibuprofen, the patient should immediately consult a doctor. It should be determined whether there are indications for infection treatment or antibiotic therapy.
• high blood pressure, vasculitis, palpitations, heart failure, heart attack.
• liver function disorders, liver damage (especially with long-term use), liver failure, acute hepatitis.
• hair loss.

Frequency not known

• skin becomes sensitive to light

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor or pharmacist. 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
PL-02 222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 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 Byfonen

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month.
Store below 30°C.
Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Byfonen contains

• The active substance is ibuprofen. Each coated tablet contains 400 mg of ibuprofen (in the form of 684 mg of ibuprofen lysinate).
• Other ingredients are: Tablet core: microcrystalline cellulose, copovidone, sodium carboxymethylcellulose (type A), magnesium stearate. Tablet coating (Opadry 200 White 200F280000): polyvinyl alcohol, partially hydrolyzed, titanium dioxide (E171), talc, macrogol 4000, methacrylic acid, and ethyl acrylate copolymer (1:1) and sodium hydroxide.

What Byfonen looks like and what the pack contains

Byfonen is a white or cream-colored, oblong, biconvex, coated tablet with a dividing line on one side. The tablet dimensions are approximately 20 mm x 8 mm.
The dividing line on the tablet only facilitates its breaking, for easier swallowing, and not for dividing into equal doses.
The coated tablets are packaged in hard white blister packs made of PVC/PVDC/Aluminum foil or, alternatively, in white blister packs made of PVC/PVDC/Aluminum foil reinforced with a PET layer, with a child-resistant closure.
Byfonen is available in blister packs containing 10, 12, 20, or 24 tablets.

Marketing authorization holder

ALKALOID-INT d.o.o., Šlandrova ulica 4, 1231 Ljubljana – Črnuče, Slovenia
Phone: 386 1 300 42 90
Fax: 386 1 300 42 91
email: [email protected]

Manufacturer/Importer

ALKALOID-INT d.o.o., Šlandrova ulica 4, 1231 Ljubljana – Črnuče, Slovenia
Phone: 386 1 300 42 90
Fax: 386 1 300 42 91
email: [email protected]
Terapia SA, Str. Fabricii, nr. 124, Cluj-Napoca, 400632, Romania
Phone: +40 (264) 501 500
Fax: +40 (264) 415 097
e-mail: [email protected]

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Bulgaria
BlokMAX Rapid 400 mg film-coated tablets/
БлокМАКС Рапид 400 mg филмирани таблетки
Croatia
BlokMAX Rapid 400 mg film-coated tablets
Republic of Czech
Dolirief
Hungary
Dolowill Rapid Forte 684 mg film tablet
Italy
VEGEDOL
Poland
Byfonen
Romania
PADUDEN Rapid Forte 400 mg film-coated tablets
Slovakia
Dolirief 400 mg, film-coated tablets
Slovenia
Dolirief 400 mg, film-coated tablets
Date of last revision of the leaflet:11.2024