Binofenact

Package leaflet: Information for the user

Binofenact

400 mg soft capsules
Ibuprofen
Equivalent medicine
Read this entire leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
• Adults: consult your doctor if you do not notice improvement or if you notice worsening of symptoms after 4 days when treating pain, or after 3 days when treating fever or migraine headache.
• Adolescents (12–18 years): consult your doctor if you do not notice improvement or if you notice worsening of symptoms after 3 days. Contents of this leaflet
  1. What Binofenact is and what it is used for
  2. What you need to know before taking Binofenact
  3. How to take Binofenact
  4. Possible side effects
  5. How to store Binofenact
  6. Contents of the pack and other information

1. What Binofenact is and what it is used for

Binofenact contains the active substance ibuprofen, which belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs provide relief by altering the body's response to pain and fever.
Binofenact is used for the short-term symptomatic treatment of mild to moderate pain, such as headache, acute headache due to migraine with or without aura, toothache, pain from soft tissue injuries, menstrual pain, fever and sore throat associated with the common cold.
In case of inflammatory and degenerative diseases of joints, spine and soft tissues of the musculoskeletal system accompanied by pain, redness, swelling and muscle stiffness, and neuralgia (nerve pain), the product may be used only upon medical advice.
For adults and adolescents with a body weight of at least 40 kg (from 12 years of age onwards).

2. What you should know before taking Binofenact

Do not take Binofenact:

• if you are allergic to ibuprofen or to any of the other ingredients of this medicine (listed in section 6).
• if you have had an allergic reaction to acetylsalicylic acid or other NSAIDs such as asthma, difficulty breathing, swelling of the face, tongue or throat, hives, or runny nose.
• if you currently have (or have had two or more episodes of) duodenal or gastric ulcer or stomach bleeding.
• if you have experienced gastrointestinal perforation or gastrointestinal bleeding after taking NSAIDs.
• if you suffer from cerebrovascular bleeding or any other active bleeding.
• if you suffer from unclear disorders in blood formation.
• if you are severely dehydrated (due to vomiting, diarrhoea, or insufficient fluid intake).
• if you suffer from severe renal, cardiac, or hepatic failure.
• if you are in the last 3 months of pregnancy.

Warnings and precautions
Talk to your doctor or pharmacist before taking Binofenact:

• if you have recently undergone major surgery
• if you have or have suffered from asthma or allergic diseases, as you may experience difficulty breathing
• if you suffer from or have fever, nasal polyps, or chronic obstructive respiratory disorders, as there is an increased risk of allergic reactions. Allergic reactions may present as asthma attacks (so-called analgesic-induced asthma), Quincke's edema, or urticaria
• if you have heart problems
• if you have gastrointestinal ulcers (see section “Do not take Binofenact”)
• if you have a history of gastrointestinal diseases (such as ulcerative colitis, Crohn’s disease)
• if you have systemic lupus erythematosus (SLE) or mixed connective tissue disease (a disease affecting the skin, joints, and kidneys)
• if you have an inherited blood formation disorder (acute intermittent porphyria)
• if you have a blood coagulation disorder
• if you are taking other NSAIDs. Concomitant use with NSAIDs, including specific cyclooxygenase-2 inhibitors, increases the risk of adverse reactions (see section “Other medicines and Binofenact” below) and should be avoided
• if you have chickenpox, it is advisable to avoid using Binofenact
• if you are elderly
• if you have an infection – see section «Infections» below.

Start treatment with the lowest available dose if you have had gastrointestinal ulcers, are elderly, or require concomitant administration of low-dose acetylsalicylic acid or other medicines that may increase gastrointestinal risk (see “Other medicines and Binofenact”). Your doctor may also add therapy with medicines that protect the gastrointestinal mucosa (e.g. misoprostol or proton pump inhibitors). Inform your doctor if you experience any unusual stomach symptoms, especially signs of bleeding such as blood in vomit or dark stools (see also section 4 “Possible side effects”). Patients with kidney or liver problems should consult a doctor before taking ibuprofen capsules.

Medicines such as Binofenact may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. Any risk is more likely with high doses or prolonged treatment. Do not exceed the recommended dose or duration of treatment (see section 3). If you have had heart problems such as heart failure, angina pectoris (chest pain), or if you have had a heart attack, coronary bypass surgery, peripheral vascular disease (poor blood circulation in the legs and feet due to narrowed or blocked arteries), or if you have had any form of stroke (including mini-stroke or transient ischemic attack “TIA”), or if you think you may be at risk of these conditions (e.g. if you have

high blood pressure, diabetes, high cholesterol, a family history of cardiovascular disease, or are a smoker),
discuss your treatment with your doctor or pharmacist before taking this medicine.
Signs of an allergic reaction to this medicine, including breathing difficulties, swelling of the face and neck (angioedema), and chest pain, have been reported with ibuprofen. Stop Binofenact immediately and contact your doctor or emergency medical services immediately if you notice any of these signs.
Serious skin reactions have been reported in association with ibuprofen treatment, 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). Stop using Binofenact and contact your doctor immediately if you notice any symptoms related to these serious skin reactions described in section 4.
To minimize the risk of side effects, always use the lowest effective dose for the shortest possible duration. Elderly patients have a higher risk of developing adverse effects.
In general, habitual use of (various types of) painkillers may lead to serious and long-lasting kidney problems. This risk may be increased during physical exertion associated with loss of salts and dehydration. Therefore, it should be avoided.
Prolonged use of any type of painkiller for headache may worsen it. If this occurs or is suspected, seek medical advice and discontinue treatment. The diagnosis of medication-overuse headache (MOH) should be suspected in patients who have frequent or daily headaches despite (or due to) regular use of headache medicines.
Regular monitoring of liver values, renal function, and blood counts is necessary during prolonged administration of Binofenact. Your doctor may ask you to undergo these tests during treatment.

Infections
Binofenact may mask symptoms of infections such as fever and pain. Therefore, Binofenact may delay appropriate treatment of the infection, potentially increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine while having an infection and infection symptoms persist or worsen, consult your doctor immediately.

Children and adolescents
In dehydrated children and adolescents, there is a risk of kidney impairment.
The use of Binofenact is not recommended in adolescents weighing less than 40 kg or in children under 12 years of age.

Other medicines and Binofenact
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Binofenact may affect or be affected by other medicines, for example:

• anticoagulant medicines (to prevent blood clotting) (e.g. acetylsalicylic acid, warfarin, ticlopidine)
• medicines for high blood pressure (ACE inhibitors, e.g. captopril, beta-blockers, e.g. atenolol, angiotensin II antagonists, e.g. losartan). Some other medicines may affect or be affected by treatment with Binofenact. Therefore, always seek advice from a doctor or pharmacist before using Binofenact with other medicines. In particular, inform your doctor or pharmacist if you are taking any of the following medicines:
• Acetylsalicylic acid or other NSAIDs (anti-inflammatory and pain-relieving medicines): this may increase the risk of gastrointestinal ulcers or gastrointestinal bleeding.
• Digoxin (for heart failure): because the effect of digoxin may be increased.
• Glucocorticoids (medicines containing cortisone or cortisone-like substances): this may increase the risk of gastrointestinal ulcers or gastrointestinal bleeding.
• Antiplatelet agents: this may increase the risk of bleeding.
• Phenytoin (for epilepsy): because the effect of phenytoin may be increased.
• Selective serotonin reuptake inhibitors (medicines used for depression): because these may increase the risk of gastrointestinal bleeding.
• Lithium (a medicine for manic-depressive illness and depression): because the effect of lithium may be increased.
• Probenecid and sulfinpyrazone (medicines for gout): because excretion of ibuprofen may be delayed.
• Medicines for high blood pressure and diuretics: because ibuprofen may reduce the effects of these medicines and there may be an increased risk to the kidneys.
• Potassium-sparing diuretics: this may lead to hyperkalaemia (elevated potassium levels in the blood).
• Methotrexate (a medicine for cancer or rheumatic diseases): because the effect of methotrexate may be increased.
• Tacrolimus and cyclosporine (immunosuppressive medicines): because kidney damage may occur.
• Zidovudine (a medicine for treating HIV/AIDS): because taking ibuprofen capsules may increase the risk of bleeding into a joint or bleeding leading to swelling in HIV-positive haemophiliacs.
• Sulphonamides (antidiabetic medicines): possible interactions may occur.
• Quinolone antibiotics: because the risk of seizures may be increased.
• Mifepristone (a medicine prescribed to terminate pregnancy): because ibuprofen may reduce the effect of this medicine.
• Bisphosphonates (medicines prescribed for treating osteoporosis): because these may increase the risk of gastrointestinal ulcer or bleeding.
• Oxpentifylline (pentoxifylline) (a medicine prescribed to improve blood flow to arms and legs): this may increase the risk of gastrointestinal bleeding.
• Baclofen, a muscle relaxant: because the toxicity of baclofen may be increased.
• Voriconazole or fluconazole (medicines prescribed for treating fungal infections): because sensitivity to ibuprofen may be increased.

Concomitant use of Binofenact with products containing ginkgo biloba may increase the risk of bleeding.

Low-dose acetylsalicylic acid
Do not take this medicine if you are taking acetylsalicylic acid at doses exceeding 75 mg per day. If you are on low-dose acetylsalicylic acid (up to 75 mg per day), inform your doctor or pharmacist before taking Binofenact.

Binofenact and alcohol
Alcohol consumption should be avoided during treatment with Binofenact, as it may worsen side effects.

Pregnancy, breastfeeding, and fertility

If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Do not take ibuprofen during the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in the fetus. It may affect the tendency of both you and your baby to bleed and may delay or prolong labour beyond the expected time.

You should not take ibuprofen during the first 6 months of pregnancy unless absolutely necessary and under medical advice. If treatment is required during this period or during attempts to conceive, the lowest possible dose should be used for the shortest possible duration. From week 20 of pregnancy, ibuprofen may cause kidney problems in the fetus if taken for more than a few days, reducing the levels of amniotic fluid surrounding the baby (oligohydramnios) or causing narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If treatment for more than a few days is required, your doctor may recommend additional monitoring.

Breastfeeding
Ibuprofen appears in breast milk in very small amounts and usually it is not necessary to stop breastfeeding during short-term treatment. However, if it is prescribed for longer-term treatment, early weaning should be considered.

Fertility
Binofenact belongs to a group of medicines (NSAIDs) that may impair female fertility. This effect is reversible upon discontinuation of the medicine. It is unlikely that occasional use of Binofenact will affect your chances of becoming pregnant, but inform your doctor before taking this medicine if you have difficulty becoming pregnant.

Driving and using machines
For short-term treatment and at normal dosage, this medicine does not affect or affects negligibly the ability to drive and use machines. If fatigue, dizziness, drowsiness, or visual disturbances occur, do not drive or operate machinery. Alcohol consumption increases the risk of these side effects.

Binofenact contains sorbitol
This medicine contains 50 mg of sorbitol per capsule.

3. How to take Binofenact

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The lowest effective dose for the shortest necessary duration should be used to relieve symptoms. If you have an infection, contact your doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).

Adults and adolescents weighing at least 40 kg (12 years of age and older)
The recommended dose is 400 mg (1 capsule), up to 3 times daily as needed. Allow at least 6 hours between doses of 400 mg (1 capsule). Do not take more than 1200 mg (3 capsules) within 24 hours.

For the treatment of migraine-related headache, the recommended dose is a single dose of 1 capsule of 400 mg. If needed, take a further 400 mg dose (1 capsule) at intervals of 4–6 hours. Do not take more than 1200 mg (3 capsules) within 24 hours.

If, in adults, this medicine is required for more than 3 days for migraine-related headache or fever, or for more than 4 days for pain treatment, or if symptoms worsen, you should consult your doctor.
If, in adolescents (12 years and older), this medicine is required for more than 3 days or if symptoms worsen, you should consult your doctor.

Use in children and adolescents
The use of Binofenact is not recommended in adolescents weighing less than 40 kg or in children under 12 years of age.

Method of administration
Binofenact capsules must be swallowed whole with plenty of water. Do not chew the capsules.
Patients with a sensitive stomach should take ibuprofen during meals. Taking the capsules after meals may delay the onset of pain or fever relief. Do not exceed the recommended dose or take it more frequently than advised.

If you take more Binofenact than you should
If you have taken more Binofenact than you should, or if children have accidentally taken this medicine, always contact a doctor or go to the nearest hospital emergency department for advice on the risk and what actions to take. Symptoms of overdose may include nausea, stomach ache, vomiting (which may contain blood), headache, ringing in the ears, confusion, and jerky eye movements. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness, blood in the urine, low blood potassium levels, feeling cold in the body, and breathing problems have been reported.

In severe poisoning, prolonged bleeding time, acute kidney failure, liver damage, and worsening of asthma in asthmatic patients may occur.

If you forget to take Binofenact
Simply follow the instructions above regarding how to take the medicine and do not take more than recommended.
Do not take a double dose to make up for a forgotten dose.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Side effects can be minimized by taking the lowest effective dose for the shortest time needed to relieve symptoms. Elderly people using this product have an increased risk of developing problems associated with these side effects.
Medicines such as Binofenact may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke.
Some of the side effects listed below occur less frequently when the maximum daily dose is 1200 mg compared to higher-dose therapy in patients with rheumatic diseases.
If you think you are experiencing any of the following serious side effects or symptoms, stop taking this medicine and seek immediate medical help:

• Stomach and intestinal ulcers, sometimes with bleeding and perforation, blood in vomit or dark stools (common: may affect up to 1 in 10 people).
• Kidney disease with blood in the urine, which may be associated with kidney failure (uncommon: may affect up to 1 in 100 people).
• Severe allergic reactions (very rare: may affect up to 1 in 10,000 people), such as:
• difficulty breathing or unexplained shortness of breath
• dizziness or faster heartbeat
• drop in blood pressure leading to shock
• swelling of the face, tongue, or throat.
• flat, non-elevated red spots, target-shaped or circular rashes on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital, or eye ulcers. These severe skin reactions may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis]. (very rare: may affect up to 1 in 10,000 people).
• Widespread rash with redness and scaling, with subcutaneous nodules and blisters mainly in skin folds, on the trunk, and upper limbs, accompanied by fever at the beginning of treatment (generalized pustular eruption). See also section 2 (not known: frequency cannot be estimated from available data).
• A serious skin condition that may affect the mouth or other parts of the body, with symptoms including: red spots, often itchy, resembling chickenpox rash, starting on the limbs and sometimes on the face and rest of the body. The spots may turn into blisters or progress into raised red lesions with a lighter center. Affected individuals may have fever, sore throat, headache, and/or diarrhea (very rare: may affect up to 1 in 10,000 people).
• Severe skin peeling or desquamation (very rare: may affect up to 1 in 10,000 people).
• Inflammation of the pancreas with severe upper abdominal pain, often with nausea and vomiting (very rare: may affect up to 1 in 10,000 people).
• Nausea, vomiting, loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes, pale-coloured stools, dark urine – these may be signs of hepatitis or liver failure (very rare: may affect up to 1 in 10,000 people).
• Heart disease with shortness of breath and swelling of the feet or legs due to fluid accumulation (heart failure) (very rare: may affect up to 1 in 10,000 people).
• Aseptic meningitis (infection around the brain or spinal cord with symptoms including fever, nausea, vomiting, headache, stiff neck, extreme sensitivity to bright light, and mental confusion, leading to reduced awareness of surroundings) (very rare: may affect up to 1 in 10,000 people).
• Heart attack ("myocardial infarction", very rare: may affect up to 1 in 10,000 people) or stroke (not known: frequency cannot be estimated from available data).
• Severe kidney damage (papillary necrosis), particularly with long-term use (rare: may affect up to 1 in 1,000 people).
• Worsening of inflammation related to infection (e.g., development of a syndrome with bacteria consuming skin tissue), especially when other NSAIDs are used (very rare: may affect up to 1 in 10,000 people).
• Problems in blood cell production – early signs include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, nosebleeds, and skin bleeding (very rare: may affect up to 1 in 10,000 people).
• A severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: rash, fever, swollen lymph nodes, and increased eosinophils (a type of white blood cell) (not known: frequency cannot be estimated from available data).

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

• Nausea, heartburn, gas (flatulence), diarrhea, constipation, vomiting, abdominal pain

Common (may affect up to 1 in 10 people)

• Headache, drowsiness, dizziness, spinning sensation, fatigue, restlessness, insomnia, irritability
• Occult blood loss that may lead to a condition with reduced red blood cell count (symptoms include fatigue, headache, shortness of breath during exercise, dizziness, and pallor),
  mouth ulcers and sores, inflammation of the colon (symptoms include diarrhea, usually with blood and mucus, stomach pain, fever), worsening of inflammatory bowel disease, inflammation of the intestinal wall

Uncommon (may affect up to 1 in 100 people)

• Hives, itching, unusual bleeding or bruising under the skin, rash, asthma attacks (sometimes with hypotension)
• Stuffy or runny nose, sneezing, facial pressure or pain, difficulty breathing
• Inflammation of the stomach (symptoms include pain, nausea, vomiting, blood in vomit, blood in bowel movements)
• Increased sensitivity of the skin to sunlight
• Fluid accumulation in body tissues, especially in patients with high blood pressure or kidney problems
• Visual disturbances

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

• A disease affecting the skin, joints, and kidneys (systemic lupus erythematosus)
• Depression, confusion, hallucinations, mental illness with strange or disturbing thoughts or moods
• Ringing, buzzing, hissing, or other persistent sounds in the ears
• Increased blood urea nitrogen, serum transaminases, and alkaline phosphatase; decreased hemoglobin and hematocrit values; inhibition of platelet aggregation; prolonged bleeding time; reduced serum calcium; increased serum uric acid – all observed in blood tests
• Loss of vision

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

• Fast or irregular heartbeat (palpitations)
• Fluid accumulation in body tissues
• High blood pressure
• Inflammation of the feeding tube (esophagus), intestinal narrowing
• Unusual hair loss or thinning
• If you have chickenpox, severe skin infections with soft tissue complications may occur
• Menstrual cycle disturbances

Not known (cannot be estimated from available data):

• Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the website https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you help provide more information on the safety of this medicine.

5. How to store Binofenact

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after SCAD or EXP. The
expiry date refers to the last day of that month.
Do not store above 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer used. This will help protect the environment.

6. Package contents and other information

What Binofenact contains

• The active substance is ibuprofen. Each capsule contains 400 mg of ibuprofen.
• The other components are: macrogol 400 (E1521), sorbitan oleate (E494), povidone K-30, potassium hydroxide (E525). Capsule shell: gelatine (E441), macrogol 400 (E1521), sorbitol solution (E420), medium-chain triglycerides. Capsule polishing: isopropyl alcohol.

Description of the appearance of Binofenact and contents of the pack
Oval, transparent soft gelatin capsules containing a colourless to pale yellow, transparent viscous liquid, packed in transparent PVC/PVDC/aluminium blisters. Size: 15.25 x 10 mm. Packs: 10, 12, 20, 24, 30, 48 and 50 capsules. Not all pack sizes may be marketed.

Marketing Authorization Holder:
Medreg s.r.o.
Na Florenci 2116/15
Nové Město, 110 00 Prague 1
Czech Republic

Manufacturer:
Medis International a.s.
Výrobní závod Bolatice
Průmyslová 961/16, 747 23 Bolatice
Czech Republic

This medicinal product is authorised in the European Economic Area countries under the following names:
CZ: Ibuprofen Dr. Max
SK: Ibuprofen Dr. Max 400 mg mäkké kapsuly
PL: Ibuprofen Dr. Max
RO: Ibuprofen Dr. Max 400 mg capsule moi
IT: Binofenact