Byfonen

Package leaflet: Information for the patient

Byfonen, 400 mg, coated tablets
Ibuprofen as ibuprofen lysinate
Please read all of this leaflet carefully before taking this medicine, because 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 that you can read it again if necessary.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days, or if your condition worsens, you must consult a doctor (applies to adolescents).
• If there is no improvement after 3 days in the case of fever and (or) migraine, or after 5 days in the case of pain treatment, or if your condition worsens, you must consult a doctor (applies to adults).

Contents of the leaflet

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

1. What Byfonen is and what it is used for

The active substance is ibuprofen. It belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs work by altering the body's response to pain, inflammation, and high temperature.
Byfonen is used for short-term symptomatic treatment of:

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

Byfonen is indicated for use in adults and adolescents aged over 12 years and weighing at least 40 kg.

2. Important information before using Byfonen

When not to take Byfonen:

• If the patient is allergic to ibuprofen, aspirin (acetylsalicylic acid), or other pain-relieving medicines, or to any of the other ingredients of this medicine (listed in section 6),
• If the patient has previously experienced asthma, bronchospasm, rhinitis, angioedema or urticaria after taking aspirin (acetylsalicylic acid) or similar pain-relieving medicines (NSAIDs),
• If the patient currently has (or has had more than twice in the past) gastric or duodenal ulceration and/or bleeding,
• If the patient has previously experienced gastrointestinal bleeding or perforation related to the use of NSAIDs,
• If the patient has severe heart, liver or kidney failure,
• If the patient has blood disorders of unknown origin,
• If the patient is severely dehydrated (due to vomiting, diarrhoea or insufficient fluid intake),
• If the patient is in the last 3 months of pregnancy,
• In adolescents with body weight below 40 kg or under 12 years of age.

Warnings and precautions
Before starting treatment with Byfonen, consult a doctor or pharmacist if:

• The patient has or has ever had asthma or other allergic conditions, as bronchospasm may occur,
• The patient has hay fever, nasal polyps or chronic obstructive respiratory diseases, as these patients have an increased risk of allergic reactions. These reactions may include asthma attacks (so-called analgesic-induced asthma), angioedema (Quincke's oedema) or urticaria,
• The patient has kidney, heart, liver or intestinal diseases,
• The patient has had gastrointestinal disorders (including ulcerative colitis or Crohn's disease),
• The patient has certain inherited blood disorders (e.g. acute intermittent porphyria),
• The patient has systemic lupus erythematosus or mixed connective tissue disease (these are autoimmune diseases causing joint pain, skin changes and organ dysfunction),
• The patient has chickenpox – taking Byfonen is not recommended, as symptoms may worsen,
• The patient has an infection – see section below "Infections",
• The patient has recently undergone major surgery,
• The patient is dehydrated,
• The patient is taking other NSAIDs. Concomitant use of this medicine with other NSAIDs, including selective COX-2 inhibitors, should be avoided,
• The patient is in the first six months of pregnancy.

Additional warnings

• Taking anti-inflammatory or pain-relieving medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used at high doses. Do not exceed the recommended dose or duration of treatment.
• Before using Byfonen, the patient should discuss treatment with a doctor or pharmacist if:
  • The patient has heart diseases such as heart failure, angina pectoris (chest pain), history of myocardial infarction, coronary bypass surgery, peripheral arterial disease (poor blood circulation in legs or feet due to narrowed or blocked arteries), or has had any stroke (including mini-stroke or transient ischaemic attack - TIA),
  • The patient has hypertension, diabetes, high cholesterol levels, family history of heart disease or stroke, or is a smoker.
• Allergic reactions to ibuprofen, including breathing difficulties, facial and neck swelling (angioedema), and chest pain, have been reported during treatment. If the patient experiences any of these symptoms, they should immediately stop taking Byfonen and contact a doctor or emergency services.
• Severe skin reactions
  Serious skin reactions have been reported with ibuprofen use, 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). Treatment with Byfonen should be discontinued and immediate medical attention sought if any symptoms of severe skin reactions described in section 4 occur.
• The risk of adverse effects can be reduced by using the lowest effective dose for the shortest possible duration. Elderly patients are more susceptible to adverse effects.
• Ibuprofen may temporarily inhibit platelet function (platelet aggregation). Patients with coagulation disorders should therefore be closely monitored.
• Consult a doctor or dentist before surgical procedures if taking Byfonen.
• Habitual use of multiple types of painkillers may lead to permanent kidney damage and increase the risk of kidney failure. This risk may be exacerbated by physical exertion associated with electrolyte loss and dehydration. Therefore, habitual use of painkillers should be avoided.
• Long-term use of any painkillers for headache may paradoxically increase headache severity. If such a condition is suspected or confirmed, medical advice should be sought and treatment discontinued. Medication-overuse headache should be suspected in patients who experience frequent or daily headaches despite (or because of) regular use of headache medications.
• Regular monitoring of liver and kidney function tests and blood counts is necessary during prolonged treatment with Byfonen.
• NSAIDs may mask signs of infection and fever.
• Infections
  Byfonen may conceal objective signs of infection such as fever and pain. Therefore, Byfonen may delay appropriate treatment of infection and consequently increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If the patient takes this medicine during an ongoing infection and infection symptoms persist or worsen, immediate medical consultation is required.

Children and adolescents
Do not use in adolescents with body weight below 40 kg or in children under 12 years of age.
Dehydrated adolescents are at risk of kidney function impairment.

Byfonen with other medicines
Inform the doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines planned for future use.

• Anticoagulant medicines (i.e. blood thinners or those preventing clot formation, such as aspirin (acetylsalicylic acid), warfarin, ticlopidine),
• Medicines lowering blood pressure (ACE inhibitors such as captopril, beta-blockers such as those containing 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 its effects may be potentiated,
• Glucocorticosteroids (medicines containing cortisone or cortisone-like substances), 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 its effects may be potentiated,
• Selective serotonin reuptake inhibitors (medicines for depression), as they may increase the risk of gastrointestinal bleeding,
• Lithium salts (medicines used in bipolar disorder and depression), as their effects may be potentiated,
• Probenecid and sulfinpyrazone derivatives (used in gout), as they may slow down ibuprofen elimination,
• Potassium-sparing diuretics, as they may lead to increased blood potassium levels,
• Methotrexate (used in cancer and rheumatic diseases), as its effects may be potentiated,
• Tacrolimus and cyclosporine (immunosuppressive medicines), as they may cause kidney damage,
• Mifepristone (used for medical abortion), as its effects may be reduced,
• Zidovudine (used in HIV and AIDS treatment), as ibuprofen use may increase the risk of joint bleeding or bleeding leading to swelling in HIV-infected patients with haemophilia,
• Sulfonylurea derivatives (antidiabetic medicines), as drug interactions are possible,
• Quinolones (antibiotics), as they may increase the risk of seizures,
• Medicines inhibiting the CYP2C9 enzyme, such as antifungal agents voriconazole or fluconazole, as they may increase exposure to ibuprofen,
• Herbal medicine St. John's wort (Hypericum perforatum), as there is a risk of increased bleeding tendency when used concomitantly with ibuprofen and St. John's wort.
• Do not take Byfonen while using aspirin (acetylsalicylic acid) at doses exceeding 75 mg per day. When undergoing low-dose aspirin (acetylsalicylic acid) treatment (up to 75 mg per day), consult a doctor or pharmacist before using Byfonen.

Some other medicines may also affect the action of Byfonen or their effects may be altered by this medicine. Therefore, always consult a doctor or pharmacist before combining Byfonen with other medicines.
Byfonen and alcohol
Some adverse effects, e.g. gastrointestinal or central nervous system effects, are more likely when alcohol is consumed together with Byfonen.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Do not take Byfonen during the last 3 months of pregnancy, as it may harm the unborn child or cause problems during delivery. This medicine 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.
Do not take Byfonen 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 the 20th week of pregnancy, Byfonen may cause kidney function disorders in the unborn child if taken for longer than a few days. This may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment longer than a few days is required, the doctor may recommend additional monitoring.
Only small amounts of ibuprofen and its metabolites pass into breast milk. This medicine may be used during breastfeeding if taken at the recommended dose for the shortest possible duration.
Byfonen belongs to a group of medicines that may impair female fertility. This effect is reversible upon discontinuation of the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine 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. If in doubt, consult a doctor or pharmacist.
This medicine is intended for short-term use only.
The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If, during an infection, symptoms (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).

Use in adults and adolescents with body weight of 40 kg or more (aged 12 years and older):

• Take 1 tablet with water, up to three times daily as needed.
• Leave at least a six-hour interval between doses.
• Do not exceed three tablets (1200 mg of ibuprofen) within 24 hours.

Use in children and adolescents:
Do not use in children under 12 years of age or in adolescents weighing less than 40 kg.
Byfonen coated tablets have a score line on one side. The score line is intended only to facilitate breaking the tablet for easier swallowing.

Duration of treatment:
If it is necessary to use this medicine in children and adolescents aged 12 to 18 years for longer than 3 days, or if symptoms worsen, consult a doctor.
Adult patients should consult a doctor if symptoms persist or worsen, or if it becomes necessary to use this medicine for longer than 5 days for pain relief, or longer than 3 days for migraine or fever treatment.

Overdose of Byfonen
If a patient has taken more than the recommended dose of Byfonen, or if a child has accidentally ingested the medicine, always consult a doctor or go to the nearest hospital for advice on possible health risks and on what actions should be taken.
Symptoms of overdose may include nausea, abdominal pain, diarrhoea, tinnitus, headache, vomiting (possibly with blood), blood in stool, disorientation, and nystagmus. After ingestion of a large dose, drowsiness, agitation, disorientation, chest pain, palpitations, hypotension, renal failure, liver damage, cyanosis (bluish discoloration of skin and mucous membranes), loss of consciousness, coma, convulsions (especially in children), increased tendency to bleed, weakness, dizziness, blood in urine, low blood potassium levels, feeling cold, and breathing difficulties have been reported. Additionally, prothrombin time/INR may be prolonged, likely due to disturbances in circulating coagulation factors. Acute renal failure and liver damage may occur. In patients with asthma, worsening of asthma is possible.

Missed dose of Byfonen
Do not take a double dose to make up for a missed dose.

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 adverse effects can be minimized by using the lowest effective dose for the shortest possible duration necessary to relieve symptoms. In elderly patients, there is an increased risk of experiencing adverse effects.
The use of medicines such as 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 immediate medical help if the patient experiences:

• abdominal pain, fresh blood in stool, black or tarry stools, vomiting blood or dark particles resembling coffee grounds [symptoms of gastrointestinal bleeding] (not common).
• swelling of the face, tongue or throat, difficulty breathing, rapid heartbeat, drop in blood pressure leading to shock. These symptoms may occur even after the first dose of this medicine [symptoms of severe allergic reaction] (very rare).
• asthma attacks (possibly accompanied by low blood pressure), worsening of asthma symptoms, wheezing or unexplained shortness of breath [symptoms of severe allergic reaction] (not common).
• red, flat, non-elevated circular or target-like skin lesions, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genital or eye ulcers. These severe skin rashes may be preceded by fever and flu-like symptoms [toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, exfoliative dermatitis] (very rare).
• widespread rash, high fever, swollen lymph nodes, and increased eosinophil count (a type of white blood cell) [DRESS syndrome] (frequency cannot be determined from available data).
• red, scaly, generalized rash with subcutaneous nodules and blisters, mainly located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment [acute generalized exanthematous pustulosis] (frequency cannot be determined from available data).
• severe upper abdominal pain, often with nausea and vomiting [pancreatitis] (very rare).
• fever, sore throat, superficial mouth ulcers, flu-like symptoms, profound fatigue, nosebleeds, and subcutaneous bleeding [blood cell production disorders] (very rare).
• inflammation of the membranes surrounding the brain, manifesting as neck stiffness, headache, nausea, vomiting, fever, or altered consciousness (aseptic meningitis). Patients with autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease) may be particularly predisposed (very rare).
• chest pain, which may indicate a potentially serious allergic reaction known as Kounis syndrome (frequency cannot be determined from available data).

Inform the doctor if the patient experiences any of the following adverse effects:
Common (may occur in less than 1 in 10 people):

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

Not common (may occur in less than 1 in 100 people):

• gastric or intestinal ulcers, which may lead to bleeding and perforation.
• oral mucositis with ulcers, gastritis, exacerbation of colitis, and Crohn's disease.
• central nervous system disorders, such as headache, dizziness, insomnia, psychomotor agitation, irritability, or fatigue.
• visual disturbances.
• allergic reactions, such as skin rashes and itching.
• various skin changes.

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

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

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

• esophagitis, intestinal stricture.
• severe skin infections and complications involving subcutaneous tissue in patients with chickenpox.
• fluid accumulation in tissues, especially in patients with hypertension or kidney disease, edema, and foamy urine (nephrotic syndrome), interstitial nephritis, which may lead to acute kidney failure.
• psychotic reactions, depression.
• with the use of non-steroidal anti-inflammatory drugs (NSAIDs), cases of worsening inflammatory conditions due to infections (e.g., necrotizing fasciitis) have been reported. If signs of infection appear or worsen during ibuprofen use, the patient should immediately consult a doctor. It should then be determined whether treatment of the infection or antibiotic therapy is indicated.
• hypertension, vasculitis, palpitations, heart failure, myocardial infarction.
• liver function disorders, liver damage (especially with long-term use), liver failure, acute hepatitis.
• hair loss.

Frequency unknown

• skin becomes sensitive to light

Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform a doctor or pharmacist. Adverse effects 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
PL-02 222 Warsaw
Phone: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store Byfonen

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton following: Expiry
(Exp). The expiry date refers to the last day of the stated month.
Store below 30°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 Byfonen contains

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

What Byfonen looks like and contents of the pack
Byfonen is an elongated, biconvex, white or cream-colored coated tablet with a score line on one side. The tablet measures approximately 20 mm × 8 mm.
The score line is intended only to facilitate tablet splitting for easier swallowing and does not ensure equal dosing.
The coated tablets are packed in hard white blister packs made of PVC/PVDC/Aluminum or alternatively, in white blister packs made of PVC/PVDC/Aluminum reinforced with a PET layer, with child-resistant packaging.
Byfonen is available in blister packs containing 10, 12, 20, or 24 tablets.

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

This medicinal product is authorised in the European Economic Area and 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 filmom obložene tablete
Czech Republic Dolirief
Hungary Dolowill Rapid Forte 684 mg filmtabletta
Italy VEGEDOL
Poland Byfonen
Romania PADUDEN Rapid Forte 400 mg comprimate filmate
Slovakia Dolirief 400 mg, filmom obalené tablety
Slovenia Dolirief 400 mg filmsko obložene tablete