Patient Information Leaflet

Binofenum 400 mg film-coated tablets

Ibuprofen
Generic medicine
Please read all of this leaflet carefully before taking this medicine, as it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Binofenum is and what it is used for
What you need to know before taking Binofenum
How to take Binofenum
Possible side effects
How to store Binofenum
Contents of the pack and other information

1. What Binofenum is and what it is used for

Binofenum belongs to a class of medicines called NSAIDs (non-steroidal anti-inflammatory drugs) which work by reducing fever (antipyretic), relieving pain (analgesic), and providing anti-inflammatory effects.
Binofenum is used for the short-term symptomatic treatment of mild to moderate pain, such as headache including migraine, backache, toothache, menstrual pain, postoperative pain, and muscle and joint pain associated with influenza, for the symptomatic treatment of soft tissue injuries such as sprains and muscle strains, and for the treatment of fever.
Binofenum is indicated for use in adults and adolescents with a body weight of 40 kg or more (aged over 12 years).
Consult your doctor if you do not feel better or feel worse after 3 days in adolescents and after 3 days in adults for fever, and after 5 days for pain.

2. What you need to know before taking Binofenum

Do not take Binofenum

if you are allergic to ibuprofen or to any of the other ingredients of this medicine (listed in section 6).
if you have had allergic reactions such as asthma, runny nose, hives, or swelling of the lips, face, tongue, or throat after taking medicines containing acetylsalicylic acid or other pain and anti-inflammatory medicines (NSAIDs),
if you have previously experienced stomach or small intestine (duodenum) perforation or bleeding related to prior use of pain and anti-inflammatory medicines (NSAIDs),
if you currently suffer from stomach or duodenal ulcer or bleeding, or if you have had two or more episodes in the past,
if you suffer from severe liver, kidney, or heart problems,
if you are in the last 3 months of pregnancy,
if you suffer from severe dehydration (caused by vomiting, diarrhea, or insufficient fluid intake),
if you have any active bleeding (including cerebral bleeding).

Warnings and precautions
Talk to your doctor before taking Binofenum:

if you suffer from chronic inflammatory bowel diseases such as ulcerative colitis (inflammation of the colon with ulcers), or inflammatory disorders affecting the digestive tract (Crohn's disease), as these conditions may worsen. If you have gastrointestinal disorders, you should use this medicine cautiously, as it may increase the risk of bleeding and other gastrointestinal complications. Patients who have previously had a stomach or duodenal ulcer are at higher risk of gastrointestinal bleeding.
if you suffer from asthma, the risk of developing bronchospasm (a spasmodic constriction of the bronchi) may increase.
if you are taking medicines that affect blood clotting mechanisms, Binofenum or other medicines in this group may prolong bleeding time or cause ulcers.
if you suffer from hay fever, nasal polyps, or chronic respiratory diseases, the risk of an allergic reaction may increase.
if you suffer from kidney disease, Binofenum should be used only with caution and always at the lowest effective dose, as medicines in this group may impair kidney function. The same warnings apply if you suffer from liver disease.
if you have an infection – see the section “Infections” below.

The risk of side effects increases with higher doses and in elderly patients. Therefore, treatment should be started with the lowest possible dose and continued for the shortest duration necessary to relieve symptoms.
Gastrointestinal ulcers, perforation, and bleeding
Occasionally, gastrointestinal bleeding, ulceration, or perforation may occur during treatment. If you notice unusual gastrointestinal symptoms, speak to your doctor immediately.
Skin reactions
Serious skin reactions including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and generalized acute exanthematous pustulosis (GEP) have been reported in association with ibuprofen treatment. Stop using Binofenum and consult your doctor immediately if you notice any symptoms related to these serious skin reactions described in section 4.
Cardiovascular and cerebrovascular effects
Anti-inflammatory/pain-relieving medicines such as ibuprofen may be associated with a slight increase in the risk of heart attack or stroke, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment.
You should discuss treatment with your doctor or pharmacist before taking Binofenum if:

you have heart problems including heart failure, angina pectoris (chest pain), or if you have had a heart attack, bypass surgery, peripheral arterial disease (poor circulation in the legs or feet due to narrowed or blocked arteries), or any type of stroke (including "mini-stroke" or transient ischemic attack "TIA").
you have high blood pressure, diabetes, high cholesterol, or a family history of heart disease or stroke, or if you are a smoker.

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 taking Binofenum immediately and contact your doctor or emergency services if you notice any of these signs.
Aseptic meningitis (inflammation of the brain membranes without bacterial infection)
Aseptic meningitis has rarely been reported in patients treated with ibuprofen. However, this condition is more likely to occur in patients with connective tissue diseases, so-called "collagenoses", such as systemic lupus erythematosus.
Infections
Binofenum may mask symptoms of infections such as fever and pain. Therefore, Binofenum may delay appropriate treatment of the infection, 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 a doctor immediately.
It is advised not to take Binofenum in case of chickenpox.
Additional precautions
Prolonged use of painkillers for headaches may worsen them. If this occurs or is suspected, you must stop taking Binofenum and contact your doctor.
Ibuprofen may temporarily inhibit platelet function.
Children and adults
There is a risk of kidney failure in dehydrated children and adolescents.
Due to the high amount of active ingredient, Binofenum is not intended for children under 12 years of age or adolescents weighing less than 40 kg.
Other medicines and Binofenum
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Binofenum may affect or be affected by other medicines. For example:

acetylsalicylic acid – may increase the risk of side effects
other NSAIDs (including COX-2 inhibitors) – may increase the risk of gastrointestinal bleeding and ulcers
anticoagulants (e.g., warfarin): ibuprofen may enhance the effect of these medicines
methotrexate (used to treat cancer and autoimmune diseases): ibuprofen may affect its elimination
lithium (used to treat depression and mania) and phenytoin (used to prevent epileptic seizures) – ibuprofen may increase their plasma levels
cardiac glycosides (e.g., digoxin): ibuprofen may increase their blood levels and may worsen heart failure
diuretics (water tablets): may increase the side effects of ibuprofen; ibuprofen may reduce the effect of these medicines
medicines that lower blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan) – ibuprofen may reduce the effect of these medicines
cholestyramine (used to treat high cholesterol) – concomitant use with ibuprofen may reduce ibuprofen absorption in the gastrointestinal tract
aminoglycosides (medicines against certain types of bacteria): excretion of aminoglycosides may be prolonged, and ibuprofen may increase their toxicity
antiplatelet agents (used to prevent blood clotting, e.g., acetylsalicylic acid, ticlopidine) and SSRIs (medicines for depression) such as paroxetine, sertraline, citalopram – may increase the risk of gastrointestinal bleeding
cyclosporine and tacrolimus (for immunosuppression after organ transplantation) – ibuprofen may increase the risk of nephrotoxicity
zidovudine (used to treat HIV patients): ibuprofen may increase the risk of adverse effects
mifepristone (used to terminate pregnancy): ibuprofen may reduce its effectiveness
probenecid or sulfinpyrazone (for the treatment of gout) – ibuprofen may reduce the effect of these medicines
quinolone antibiotics (medicines against certain types of bacteria): may increase the risk of seizures
sulfonylureas (for the treatment of type 2 diabetes): ibuprofen may potentiate the effects of these medicines. Rare cases of hypoglycemia (low blood sugar levels) have been reported with simultaneous use of these drugs.
corticosteroids (used against inflammation) – may increase the risk of gastrointestinal side effects (gastrointestinal ulceration or bleeding)
voriconazole or fluconazole (a type of antifungal medicine): concomitant use may increase exposure to ibuprofen
herbal medicine containing ginkgo biloba – may enhance the risk of bleeding

Other medicines may also affect or be affected by Binofenum treatment.
Therefore, always consult your doctor or pharmacist before using Binofenum with other medicines.
Binofenum and alcohol
You should not drink alcohol while taking Binofenum, as it may increase the side effects of Binofenum, especially those affecting the gastrointestinal tract or the central nervous system.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take Binofenum 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 your and your baby's tendency to bleed and may cause delayed or prolonged labor.
You should not take Binofenum during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor. If treatment is needed during this period or while trying to conceive, the lowest possible dose for the shortest possible time should be used. If taken for more than a few days from the 20th week of pregnancy onwards, Binofenum may cause kidney problems in the fetus, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If longer-term treatment is needed, your doctor may recommend additional monitoring.
Breastfeeding
Long-term treatment is not recommended for breastfeeding women. Ibuprofen and its metabolites pass into breast milk in very small amounts, and breastfeeding usually does not need to be interrupted if ibuprofen is used at the recommended dose and for the shortest possible duration.
Fertility
Binofenum belongs to a group of medicines (NSAIDs) that may impair fertility in women. This effect is reversible upon discontinuation of the medicine.
Driving and using machines
Binofenum does not alter or alters only negligibly the ability to drive and use machines. However, if you experience dizziness, drowsiness, fatigue, visual disturbances, or other symptoms affecting the central nervous system while taking this medicine, you should not drive or operate machinery. This is especially important when combined with alcohol.
Binofenum contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
Binofenum contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., it is essentially "sodium-free".

3. How to take Binofenum

Take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
For short-term use only.
The lowest effective dose for the shortest duration necessary to relieve symptoms should be used. If you have an infection, consult your doctor immediately if symptoms (such as fever and
pain) persist or worsen (see section 2).
Adults and adolescents with body weight equal to or greater than 40 kg (over 12 years of age)
The recommended dose for the treatment of acute pain or fever is 1 tablet (400 mg) taken as a single dose or up to 3 times daily, if needed, with an interval of 4–6 hours between doses.
The maximum daily dose must not exceed 3 tablets (1,200 mg).
No dose adjustment is required for elderly patients (over 65 years of age).
If in adults this medicine is required for more than 3 days for fever or 5 days for pain, or if symptoms worsen, a doctor should be consulted.
If in adolescents this medicine is required for more than 3 days or if symptoms worsen, a doctor should be consulted.
Use in children and adolescents
Binofenum is not indicated for children under 12 years of age and adolescents weighing less than 40 kg. Other formulations and dosage strengths of ibuprofen are available for this group.
Method of administration
The Binofenum tablet should be swallowed whole with plenty of water. Do not chew, split, or crush the tablets to avoid mouth discomfort or throat irritation.
A faster effect may be achieved by taking the dose on an empty stomach. Patients with gastric sensitivity should take Binofenum with food.
If you take more Binofenum than you should
If you have taken more Binofenum than you should, or if a child has taken this medicine by mistake, contact your doctor or the nearest hospital immediately for advice on the risk and actions to take.
Symptoms of overdose may include nausea, stomach ache, vomiting (possibly with traces of blood), headache, tinnitus, confusion, and oscillating eye movements.
At high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness, dizziness, blood in the urine, low blood potassium levels, feeling cold, and breathing difficulties have been reported. Other symptoms of overdose include lethargy or dry mouth. In cases of severe overdose, renal failure and liver damage may occur.
If you forget to take Binofenum
Do not take a double dose to make up for the forgotten dose.
If you have 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 experiences them.
The side effects reported with Binofenum are the same as those associated with other non-steroidal anti-inflammatory drugs.
Stop using Binofenum if you develop any of these symptoms and consult your doctor immediately (see also section 2):

flat, reddish spots, target-shaped or circular rashes on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital, and 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, red, scaly rash with pustules under the skin and blisters mainly located in skin folds, trunk, and upper extremities, accompanied by fever at the beginning of treatment (generalized pustular eruption), not known (frequency cannot be estimated from the available data),
a serious skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: skin rash, fever, swollen lymph nodes, and increased eosinophils (a type of white blood cells), frequency not known (frequency cannot be estimated from the available data).

The following side effects may occur with ibuprofen, listed in order of frequency:
Common (may affect up to 1 in 10 people):

feeling unwell, vomiting, diarrhoea, constipation, flatulence, indigestion, abdominal pain, gastrointestinal bleeding (black stools or vomiting blood)
dizziness or tiredness
headache
skin rash

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

various kidney disorders, such as kidney inflammation, nephrotic syndrome (a group of symptoms indicating kidney disease), and kidney failure
runny nose (rhinitis)
stomach inflammation
stomach or intestinal ulcer, perforation of the wall of the digestive tract
mouth ulcers
hepatitis, jaundice, liver failure
shortness of breath, bronchial asthma, bronchoconstriction
tingling sensation or "pins and needles"
difficulty sleeping
drowsiness
feeling anxious
urticaria, itching, purpura (bleeding under the skin causing spots)
angioedema (swelling occurring in various body parts such as subcutaneous facial tissue, respiratory and digestive mucosa, causing problems in the affected area)
skin sensitivity to light
blurred or disturbed vision (visual impairment)
hearing disorders, ringing in the ears (tinnitus)
balance disorders

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

aseptic meningitis (inflammation of the protective membrane surrounding the brain)
feeling depressed or confused
optic neuritis (inflammation of the optic nerve), toxic optic neuropathy (damage to the optic nerve)
swelling

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

pancreatitis (inflammation of the pancreas)
liver failure
heart failure
heart attack
hypertension
severe kidney damage (papillary necrosis), particularly with long-term use
severe forms of skin reaction
severe allergic reaction causing swelling of the face, tongue or throat, shortness of breath, rapid heartbeat, low blood pressure (anaphylaxis or severe shock)
blood count abnormalities – early signs include: fever, sore throat, mouth ulcers, flu-like symptoms, extreme fatigue, nosebleeds, and bruising

Not known (frequency cannot be estimated from the available data):

worsening of Crohn's disease or colitis
chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

If you experience more serious reactions such as facial swelling or difficulty breathing, visual disturbances, or black stools, stop taking the medicine and consult a doctor immediately.
Medicines such as Binofenum may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
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 following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Binofenum

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "Exp" or "EXP". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Binofenum contains

The active substance is ibuprofen. Each film-coated tablet contains 400 mg of ibuprofen.
The other ingredients are: Tablet core: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, anhydrous colloidal silica, povidone, maize starch, sodium lauryl sulfate, magnesium stearate (E 470)
Film coating: hydroxypropylcellulose (E 463), hypromellose 2910/3 (E 464), hypromellose 2910/6 (E 464), macrogol 400, titanium dioxide (E 171)

Description of the appearance of Binofenum and package contents
Film-coated tablets, white, capsule-shaped, smooth on both sides, approximately 16.7 x 7.8 mm in size.
Pack sizes: 24, 30, 36, 48, 50 and 100 film-coated tablets.
Not all pack sizes may be marketed.

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

Manufacturers:
Medis International a.s.
Průmyslová 961/16
747 23 Bolatice
Czech Republic

Dr. Max Pharma s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic

This medicinal product is authorized in the European Economic Area countries under the following names:
Italy: Binofenum
Poland: Ibuprofen Dr. Max Pharma
Czech Republic: Ibuprofen Dr. Max Pharma
Romania: Ibuprofen Dr. Max Pharma 400 mg film-coated tablets
Slovakia: Ibuprofen Dr. Max Pharma 400 mg filmom obalené tablety

Patient information leaflet

Binofenum 400 mg film-coated tablets

Ibuprofen
Please read this 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 of the side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice any improvement, or if your symptoms worsen after 3 days when treating fever or after 5 days for pain in adults, and in adolescents after 3 days of treatment.

Contents of this leaflet:

What Binofenum is and what it is used for
What you need to know before taking Binofenum
How to take Binofenum
Possible side effects
How to store Binofenum
Package contents and other information

1. What Binofenum is and what it is used for

Binofenum belongs to a class of medicines called NSAIDs (non-steroidal anti-inflammatory drugs),
which work by reducing fever (antipyretic), relieving pain (analgesic), and exerting an anti-inflammatory effect.
Binofenum is used for the short-term symptomatic treatment of mild to moderate pain, such as headache including migraine, back pain, toothache, menstrual pain, postoperative pain, and muscle and joint pain associated with influenza, for the symptomatic treatment of soft tissue injuries such as sprains and muscle strains, and for the treatment of fever.
Binofenum is indicated for use in adults and adolescents with a body weight of 40 kg or more (over 12 years of age).
Consult your doctor if you do not feel better or if you feel worse after 3 days in adolescents and after 3 days in adults for fever, and after 5 days for pain.

2. What you need to know before taking Binofenum

Do not take Binofenum

if you are allergic to ibuprofen or to any of the other ingredients of this medicine (listed in section 6).
if you have had allergic reactions such as asthma, runny nose, hives, or swelling of the lips, face, tongue, or throat after taking medicines containing acetylsalicylic acid or other pain and anti-inflammatory medicines (NSAIDs).
if you have previously experienced stomach or small intestine (duodenum) perforation or bleeding related to prior use of pain and anti-inflammatory medicines (NSAIDs).
if you currently have or have previously had two or more episodes of stomach or duodenum ulcers or bleeding.
if you suffer from severe liver, kidney, or heart problems.
if you are in the last 3 months of pregnancy.
if you have severe dehydration (caused by vomiting, diarrhoea, or insufficient fluid intake).
if you have any active bleeding (including cerebral bleeding).

Warnings and precautions
Talk to your doctor before taking Binofenum:

if you suffer from chronic inflammatory bowel diseases such as ulcerative colitis (inflammation of the colon with ulcers) or Crohn’s disease (inflammation affecting the digestive tract), as these conditions may worsen. If you have gastrointestinal disorders, use this medicine with caution, as it may increase the risk of bleeding and other gastrointestinal complications. Patients who have previously had stomach or duodenal ulcers are at higher risk of gastrointestinal bleeding.
if you have asthma, as the risk of developing bronchospasm (a spastic constriction of the bronchi) may increase.
if you are taking medicines that affect blood clotting mechanisms, Binofenum or other medicines in this group may prolong bleeding time or cause ulcers.
if you suffer from hay fever, nasal polyps, or chronic respiratory diseases, the risk of an allergic reaction may increase.
if you have kidney disease, Binofenum should be used with caution and only at the lowest effective dose, as medicines in this group may impair kidney function. The same warnings apply if you have liver disease.
if you have an infection – see the section “Infections” below.

The risk of side effects increases with higher doses and in elderly patients. Therefore, treatment should be started with the lowest possible dose and continued for the shortest duration necessary to relieve symptoms.
Gastrointestinal ulcers, perforation, and bleeding
Gastrointestinal bleeding, ulceration, or perforation may occasionally occur during treatment. If you experience unusual gastrointestinal symptoms, speak to your doctor immediately.
Skin reactions
Serious skin reactions including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and generalized pustular eruption (acute generalized exanthematous pustulosis, AGEP) have been reported in association with ibuprofen treatment. Stop using Binofenum and consult your doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
Cardiovascular and cerebrovascular effects
Anti-inflammatory/pain-relieving medicines such as ibuprofen may be associated with a slight increase in the risk of heart attack or stroke, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment.
You should discuss treatment with your doctor or pharmacist before taking Binofenum if:

you have heart problems, including heart failure, angina pectoris (chest pain), or have had a heart attack, coronary bypass surgery, peripheral arterial disease (poor circulation in legs or feet due to narrowed or blocked arteries), or any type of stroke (including "mini-stroke" or transient ischaemic attack "TIA").
you have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker.

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 Binofenum immediately and contact your doctor or emergency services if you notice any of these signs.
Aseptic meningitis (inflammation of the brain membranes without bacterial infection)
Aseptic meningitis has been rarely reported in patients treated with ibuprofen. However, this condition is more likely to occur in patients with connective tissue diseases, so-called "collagenoses", such as systemic lupus erythematosus.
Infections
Binofenum may mask symptoms of infections such as fever and pain. Therefore, Binofenum may delay appropriate treatment of the infection, 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 a doctor immediately.
It is advised not to take Binofenum in case of chickenpox.
Additional precautions
Prolonged use of painkillers for headaches may worsen them. If this occurs or is suspected, you must stop taking Binofenum and contact your doctor.
Ibuprofen may temporarily inhibit platelet function.
Children and adults
There is a risk of kidney failure in dehydrated children and adolescents.
Due to the high amount of active ingredient, Binofenum is not intended for children under 12 years of age or adolescents weighing less than 40 kg.
Other medicines and Binofenum
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Binofenum may affect or be affected by other medicines. For example:

acetylsalicylic acid – may increase the risk of side effects
other NSAIDs (including COX-2 inhibitors) – may increase the risk of gastrointestinal bleeding and ulcers
anticoagulants (e.g., warfarin): ibuprofen may enhance the effect of these medicines
methotrexate (used to treat cancer and autoimmune diseases): ibuprofen may affect its elimination
lithium (used to treat depression and mania) and phenytoin (used to prevent epileptic seizures) – ibuprofen may increase their plasma levels
cardiac glycosides (e.g., digoxin): ibuprofen may increase their blood levels and may worsen heart failure
diuretics ("water tablets"): may increase ibuprofen's side effects; ibuprofen may reduce the effect of these medicines
blood pressure-lowering medicines (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan) – ibuprofen may reduce the effect of these medicines
cholestyramine (used to treat high cholesterol) – concomitant use with ibuprofen may reduce ibuprofen absorption in the gastrointestinal tract
aminoglycosides (medicines against certain types of bacteria): excretion of aminoglycosides may be prolonged, and ibuprofen may increase their toxicity
antiplatelet agents (used to prevent blood clotting, e.g., acetylsalicylic acid, ticlopidine) and SSRIs (antidepressants) such as paroxetine, sertraline, citalopram – may increase the risk of gastrointestinal bleeding
cyclosporine and tacrolimus (for immunosuppression after organ transplant) – ibuprofen may increase the risk of nephrotoxicity
zidovudine (used to treat HIV patients): ibuprofen may increase the risk of adverse effects
mifepristone (used to terminate pregnancy): ibuprofen may reduce its effectiveness
probenecid or sulfinpyrazone (for the treatment of gout) – ibuprofen may reduce the effect of these medicines
quinolone antibiotics (medicines against certain types of bacteria): may increase the risk of seizures
sulfonylureas (for the treatment of type 2 diabetes): ibuprofen may enhance the effects of these medicines. Rare cases of hypoglycaemia (low blood sugar levels) have been reported with simultaneous use.
corticosteroids (used against inflammation) – may increase the risk of gastrointestinal side effects (gastrointestinal ulceration or bleeding)
voriconazole or fluconazole (a type of antifungal medicine): concomitant use may increase exposure to ibuprofen
herbal medicine containing ginkgo biloba – may enhance the risk of bleeding

Other medicines may also affect or be affected by Binofenum treatment.
Therefore, always consult your doctor or pharmacist before using Binofenum with other medicines.
Binofenum and alcohol
You should not drink alcohol while taking Binofenum, as it may increase the side effects of Binofenum, especially those affecting the gastrointestinal tract or central nervous system.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not take Binofenum during the last 3 months of pregnancy, as it may harm the unborn baby or cause problems during delivery. It may cause kidney and heart problems in the unborn baby. It may affect your and your baby's tendency to bleed and may cause delayed or prolonged labour. You should not take Binofenum during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor. If treatment is needed during this period or while trying to conceive, the lowest possible dose should be used for the shortest possible time. If taken for more than a few days from the 20th week of pregnancy onwards, Binofenum may cause kidney problems in the unborn baby, leading 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 for more than a few days is needed, your doctor may recommend additional monitoring.
Breastfeeding
Long-term treatment is not recommended in breastfeeding women. Ibuprofen and its metabolites pass into breast milk in very small amounts, and it is usually not necessary to stop breastfeeding if ibuprofen is used at the recommended dose and for the shortest possible duration.
Fertility
Binofenum belongs to a group of medicines (NSAIDs) that may impair fertility in women. This effect is reversible upon discontinuation of the medicine.
Driving and using machines
Binofenum does not alter or alters negligibly the ability to drive and use machines.
However, if you experience dizziness, drowsiness, fatigue, vision disturbances, or other central nervous system symptoms while taking this medicine, you must not drive or operate machinery. This is especially important when combined with alcohol.
Binofenum contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
Binofenum contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., it is essentially "sodium-free".

3. How to take Binofenum

Take this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
For short-term use only.
The lowest effective dose for the shortest duration necessary to relieve symptoms should be used. If you have an infection, consult a doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).

Adults and adolescents with a body weight of 40 kg or more (over 12 years of age)
The recommended dose for the treatment of acute pain or fever is 1 tablet (400 mg) taken as a single dose or up to 3 times daily, if needed, with an interval of 4–6 hours between doses.
The maximum daily dose must not exceed 3 tablets (1 200 mg).
Dose adjustment is not required for elderly patients (over 65 years of age).
If this medicine is required for more than 3 days for fever or 5 days for pain in adults, or if symptoms worsen, a doctor should be consulted.
If this medicine is required for more than 3 days in adolescents, or if symptoms worsen, a doctor should be consulted.

Use in children and adolescents
Binofenum is not indicated for children under 12 years of age or adolescents weighing less than 40 kg. Other ibuprofen formulations and dosage strengths are available for this group.

Method of administration
The Binofenum tablet should be swallowed whole with plenty of water. Do not chew, split, or crush the tablets to avoid mouth discomfort or throat irritation.
A faster onset of action may be achieved by taking the dose on an empty stomach. Patients with gastric sensitivity should take Binofenum with food.

If you take more Binofenum than you should
If you have taken more Binofenum than you should, or if a child has taken this medicine by mistake, contact your doctor or the nearest hospital immediately for advice on the risk and actions to take.
Symptoms of overdose may include nausea, stomach ache, vomiting (possibly with blood), headache, tinnitus, confusion, and oscillating eye movements. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness, dizziness, blood in the urine, low blood potassium levels, feeling cold, and breathing difficulties have been reported. Other symptoms of overdose include lethargy or dry mouth. In cases of severe overdose, kidney failure and liver damage may occur.

If you forget to take Binofenum
Do not take a double dose to make up for the missed dose.
If you have 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 everybody gets them.
The side effects reported with Binofenum are the same as those associated with other
non-steroidal anti-inflammatory drugs.
Stop using Binofenum if you develop these symptoms and consult your doctor immediately (see
also section 2):

flat, reddish spots on the skin, target-shaped or circular rashes on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers. These serious 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 patients),
widespread, red, scaly rash with pustules under the skin and blisters mainly located in skin folds, trunk and upper limbs, accompanied by fever at the beginning of treatment (generalized pustular eruption), frequency not known (frequency cannot be estimated from the available data),
a serious skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: skin rash, fever, swollen lymph nodes and increased eosinophils (a type of white blood cells), frequency not known (frequency cannot be estimated from the available data).

The following side effects may occur with ibuprofen, listed in order of frequency:
Common (may affect up to 1 in 10 people):

feeling unwell, vomiting, diarrhoea, constipation, flatulence, indigestion, abdominal pain, gastrointestinal bleeding (black stools or vomiting blood)
dizziness or tiredness
headache
skin rash

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

various forms of kidney disorders, such as kidney inflammation, nephrotic syndrome (a group of symptoms of kidney disease) and kidney failure
runny nose (rhinitis)
stomach inflammation
stomach or intestinal ulcer, perforation in the wall of the digestive tract
mouth ulcers
hepatitis, jaundice, liver failure
shortness of breath, bronchial asthma, bronchoconstriction
tingling sensation or "pins and needles"
difficulty sleeping
drowsiness
anxiety
urticaria, itching, purpura (bleeding into the skin causing spots)
angioedema (swelling occurring in various parts of the body such as subcutaneous tissue of the face, mucous membranes of the respiratory and digestive tracts, causing problems in the affected area)
skin sensitivity to light
blurred or disturbed vision (visual impairment)
hearing disorders, ringing in the ears (tinnitus)
balance disorders

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

aseptic meningitis (inflammation of the protective membrane covering the brain)
feeling depressed or confused
optic neuritis (inflammation of the optic nerve), toxic optic neuropathy (damage to the optic nerve)
swelling

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

inflammation of the pancreas
liver failure
heart failure
heart attack
hypertension
severe kidney damage (papillary necrosis), particularly with long-term use
severe forms of skin reaction
severe allergic reaction causing swelling of the face, tongue or throat, shortness of breath, rapid heartbeat, low blood pressure (anaphylaxis or severe shock)
changes in blood count – early signs include: fever, sore throat, mouth ulcers, flu-like symptoms, extreme tiredness, nosebleeds and bruising

Not known (frequency cannot be estimated from the available data):

worsening of Crohn's disease or colitis
chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

If you experience more serious reactions such as facial swelling or difficulty breathing, visual disturbances or black stools, stop taking the medicine and consult a doctor immediately.
Medicines such as Binofenum may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
Reporting of side effects
If you get any side effects, including ones 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 following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Binofenum

6. Package contents and other information

What Binofenum contains

The active substance is ibuprofen. Each film-coated tablet contains 400 mg of ibuprofen.
The other ingredients are: Tablet core: microcrystalline cellulose, monohydrate lactose, sodium croscarmellose, anhydrous colloidal silica, povidone, maize starch, sodium lauryl sulfate, magnesium stearate (E 470) Film coating: hydroxypropylcellulose (E 463), hypromellose 2910/3 (E 464), hypromellose 2910/6 (E 464), macrogol 400, titanium dioxide (E 171)

Description of the appearance of Binofenum and package contents
Film-coated tablets, white, capsule-shaped, smooth on both sides, approximately 16.7 x 7.8 mm in size.
Pack sizes: 10, 12, and 20 film-coated tablets.
Not all pack sizes may be marketed.

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

Manufacturers:
Medis International a.s.
Průmyslová 961/16
747 23 Bolatice
Czech Republic
Dr. Max Pharma s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic