BUSCOFENACT "400 MG SOFT CAPSULES"12 CAPSULES IN BLISTER PVC/PE/PVDC-AL"

Name
BuscofenAct 400 mg soft capsules
Ibuprofen


What is it and what is it for?
BuscofenAct contains the active ingredient ibuprofen, which belongs to a class of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs relieve symptoms by altering the body's response to pain and fever.

BuscofenAct is indicated for the short-term symptomatic treatment of:
- mild to moderate pain such as headache, toothache, and menstrual cramps;
- fever and pain associated with the common cold.

BuscofenAct is indicated in adults and adolescents with a body weight greater than 40 kg (12 years and older).

Talk to your doctor if you do not feel better or if you feel worse:
- after 3 days in adolescents;
- after 3 days in case of fever, or after 4 days for the treatment of pain in adults.


What you need to know before taking the medicine
Do not take BuscofenAct
- if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6);
- if you have ever suffered from shortness of breath, asthma, runny nose, swelling or hives after using acetylsalicylic acid or other NSAIDs;
- if you have or have had a history of recurrent stomach/duodenal ulcer (peptic ulcer) or bleeding (two or more distinct episodes of proven ulceration or bleeding);
- if you have had a history of gastrointestinal bleeding or perforation related to previous NSAID therapy;
- if you suffer from severe heart failure;
- if you suffer from severe liver failure or severe kidney failure;
- if you suffer from cerebrovascular haemorrhages, or other haemorrhages;
- if you suffer from haematological disorders of unknown origin;
- if you are severely dehydrated (due to vomiting, diarrhea or poor fluid intake);
- if you are in your last trimester of pregnancy.
Do not use BuscofenAct in adolescents with body weight <40 kg and in children under 12 years of age due to the high content of the active ingredient.


Warnings and precautions
You should discuss your treatment with your doctor or pharmacist before taking BuscofenAct:
- if you suffer or have suffered from asthma or allergic diseases as shortness of breath may occur;
- if you have liver problems;
- if you have reduced kidney function;
- if you have or have ever had intestinal diseases (ulcerative colitis or Crohn's disease);
- if you have heart problems including heart attack, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral arterial disease (poor circulation in the legs or feet due to narrowing or blockage of the arteries), or any type of stroke (including a "mini stroke" or "TIA" - transient ischaemic attack);
- if you have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker;
- if you suffer from certain skin diseases (Systemic Lupus Erythematosus (SLE) or a mixed connective tissue disease);
- if you have any hereditary disease related to the production of blood cells (acute intermittent porphyria);
- if you have had high blood pressure and/or heart failure;
- if you have undergone major surgery. In this case, medical supervision is particularly required;
- if you suffer from hay fever, nasal polyps, or chronic obstructive pulmonary disease, as these conditions increase the risk of allergic reactions. Allergic reactions may manifest as asthma attacks (so-called "pain-induced asthma"), Quincke's edema, or urticaria;
- if you have a chickenpox infection it is advisable to avoid using BuscofenAct;
- if you suffer from blood clotting disorders;
- in cases of prolonged administration of BuscofenAct, periodic monitoring of liver function, kidney function and blood count is necessary;
- concomitant use of NSAIDs, including specific cyclooxygenase-2 inhibitors, increases the risk of adverse reactions (see paragraph "Taking BuscofenAct with other medicines") and should be avoided;
- if you have an infection – see section “Infections” below;
- if you develop a rash or skin symptoms, you should stop taking ibuprofen immediately, seek medical advice immediately, and tell your doctor that you are taking this medicine;
- if you develop symptoms or signs of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) which include rash, fever, swollen lymph nodes and an increase in a type of white blood cell (eosinophilia).

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 acute generalized exanthematous pustulosis (AGEP), have been reported in association with ibuprofen treatment. Stop using BuscofenAct and contact your doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

Infections
BuscofenAct may mask the symptoms of infections, such as fever and pain. Therefore, BuscofenAct may delay adequate treatment of the infection, which could increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If you take this medicine while you have an infection and the symptoms persist or worsen, contact your doctor immediately.
These side effects can be minimized by using the lowest effective dose for the shortest duration of treatment. Elderly people are at higher risk of side effects.
In general, the habitual use of painkillers can lead to serious, permanent kidney problems. This risk may be increased by physical exertion associated with salt loss and dehydration. Therefore, this should be avoided.
Prolonged use of any type of painkiller for headaches can lead to worsening of the headache. If this occurs or is suspected, you should notify your doctor and discontinue treatment.
The diagnosis of medication-overuse headache (MOH) should be suspected in patients with frequent or daily headaches despite (or because of) the regular use of headache medications.

Anti-inflammatory/painkiller medications such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when taken in high doses. Do not exceed the recommended dose or duration of treatment.

Signs of an allergic reaction to ibuprofen, including breathing problems, swelling of the face and neck area (angioedema), and chest pain, have been reported with ibuprofen.
Stop taking BuscofenAct immediately and contact your doctor or emergency services immediately if you notice any of these signs.

If you think any of the above conditions apply to you, consult your doctor before using BuscofenAct.

Children and adolescents
In dehydrated adolescents there is a risk of impaired kidney function.
Do not use BuscofenAct in adolescents with body weight <40 kg and in children under 12 years of age due to the high content of the active ingredient.


Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following known side effects of NSAIDs, or if you have any concerns, stop taking this medicine and consult your doctor as soon as possible. Elderly patients are at greater risk of developing problems associated with side effects.

Stop taking BuscofenAct immediately and inform your doctor if any of the following conditions occur, which may be a sign of serious adverse events:
- severe stomach problems, heartburn or abdominal pain;
- vomit containing blood that looks like coffee grounds;
- black stools or blood in the urine;
- skin reactions, such as itchy rashes;
- difficulty breathing and/or swelling in the face or throat;
- tiredness associated with loss of appetite;
- sore throat, associated with mouth ulcers, tiredness and fever;
- heavy nosebleeds and skin bleeding;
- abnormal fatigue associated with reduced urine output;
- swelling of the face, feet or legs;
- chest pain;
- vision problems;
- flat, reddish, target-shaped or circular spots on the trunk, often with central blisters, peeling skin, and ulcers of the mouth, throat, nose, genitals, and eyes. These severe rashes may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis);
- widespread skin rash, high body temperature and swollen lymph nodes (DRESS syndrome);
- widespread, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).

Tell your doctor if you experience any of the following side effects, if they get worse, or if you notice any side effects not listed.

Common frequency (may affect up to 1 in 10 people)
- gastrointestinal disorders such as heartburn, abdominal pain, nausea and indigestion, vomiting, flatulence, diarrhea, constipation, and slight bleeding in the stomach and/or intestines which may cause anemia in exceptional cases.

Uncommon frequency (may affect up to 1 in 100 people)
- gastrointestinal ulcers, sometimes with bleeding and perforation, inflammation of the mucosa of the mouth with ulcers (ulcerative stomatitis), inflammation of the stomach (gastritis), worsening of colitis and Crohn's disease;
- central nervous system disorders such as headache, dizziness, insomnia, agitation, irritability or tiredness;
- vision problems;
- various skin rashes;
- allergic reactions such as skin rashes, itching, and asthma attacks (with possible drop in blood pressure). Stop taking BuscofenAct and inform your doctor immediately.

Rare frequency (may affect up to 1 in 1000 people)
- tinnitus (ringing in the ears);
- kidney damage (papillary necrosis) and high concentrations of uric acid in the blood.

Very rare frequency (may affect up to 1 in 10,000 people)
- swelling (edema), high blood pressure (hypertension) and heart failure have been reported in association with NSAID treatment;
- inflammation of the esophagus or pancreas, formation of narrowing in the small and large intestine (in the form of diaphragmatic and intestinal stenosis);
- serious skin infections and soft tissue complications have occurred during chickenpox infection;
- decreased urine output and swelling (especially in patients with high blood pressure or impaired kidney function), swelling (edema) and cloudy urine (nephrotic syndrome), inflammatory kidney disease (interstitial nephritis), which can lead to acute kidney failure. If any of the above symptoms occur or if you feel generally unwell, stop taking BuscofenAct and consult your doctor immediately, as these may be the first signs of kidney damage or kidney failure;
- Disturbances in blood cell production. The first signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe tiredness, nosebleeds, and skin bleeding. In these cases, you should stop treatment immediately and consult your doctor. You should not self-medicate with painkillers or antipyretics;
- psychotic reactions and depression;
- worsening of inflammation associated with infections (e.g., necrotizing fasciitis) has been observed in association with the use of certain painkillers (NSAIDs). If signs of infection develop or worsen while using BuscofenAct, consult your doctor immediately. Antibiotic therapy should be considered;
- hypertension (high blood pressure), vasculitis, palpitations, heart failure, heart attack;
- liver dysfunction (an early sign may be yellowing of the skin), liver damage, especially during long-term treatment, liver failure, acute inflammation of the liver (acute hepatitis);
- Symptoms of aseptic meningitis, including neck stiffness, headache, nausea, vomiting, fever, and blurred consciousness, have been observed with ibuprofen use. Patients with autoimmune diseases (SLE, mixed connective tissue disease) may be more susceptible.
Contact your doctor immediately if these symptoms occur;
- severe forms of skin reactions, such as rash with redness and blistering (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis, Lyell's syndrome), hair loss (alopecia);
- severe generalized hypersensitivity reactions.

Frequency not known (cannot be estimated from the available data)
- a widespread, red, scaly rash with pustules under the skin and vesicles located mainly in the skin folds, trunk and upper limbs accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis).
Stop using BuscofenAct if you develop these symptoms and contact your doctor immediately.
See also section 2; - a serious skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: rash, fever, swollen lymph nodes, and an increase in eosinophils (a type of white blood cell);
- the skin becomes sensitive to light;
- fixed drug eruption (which manifests itself as redness in round or oval patches and swelling of the skin, possibly associated with itching);
- chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

Medicines such as BuscofenAct may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke.

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