BUSCOFENACT*20 SOFTGELS 400MG

BuscofenAct 400 mg soft capsules
Ibuprofen

What it is and what it is used for
BuscofenAct contains the active ingredient ibuprofen, which belongs to a class of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs relieve disorders by modifying 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 pain;
- fever and pain associated with the common cold.

BuscofenAct is indicated for adults and adolescents weighing over 40 kg (12 years and older).

Consult 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 pain treatment 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, diarrhoea or insufficient fluid intake);
- if you are in the last trimester of pregnancy.

Do not use BuscofenAct in adolescents weighing <40 kg and in children under 12 years of age due to the high active ingredient content.

Warnings and precautions
You should discuss therapy 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 disorders;
- 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 to the legs or feet due to narrowing or obstruction of the arteries) or any type of stroke (including mini-stroke or TIA, transient ischemic 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 conditions (Systemic Lupus Erythematosus (SLE) or mixed connective tissue disease);
- if you have any hereditary diseases related to blood cell production (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 respiratory diseases, as in such cases there is an increased risk of allergic reactions. Allergic reactions can manifest as asthma attacks (the so-called analgesic asthma), Quincke's oedema or urticaria;
- if you have a chickenpox infection, it is advisable to avoid the use of BuscofenAct;
- if you suffer from coagulation 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 section 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 must immediately stop taking ibuprofen, consult a doctor immediately and inform the 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
Severe skin reactions, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), 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 severe skin reactions described in section 4.

Infections
BuscofenAct can mask symptoms of infections such as fever and pain. Therefore, it is possible that BuscofenAct may delay adequate treatment of the infection, which could increase the risk of complications. This has been observed in pneumonia caused by bacteria and in bacterial skin infections related to chickenpox. If you take this medicine while you have an infection and the symptoms of the infection persist or worsen, consult your doctor immediately.

Such undesirable effects can be minimised by using the lowest effective dose for the shortest treatment period. Elderly patients are at higher risk of undesirable effects. In general, habitual use of analgesics can lead to severe permanent kidney problems. This risk may be increased under physical exertion associated with salt loss and dehydration. Therefore, this should be avoided.
Prolonged use of any type of painkiller for headache can lead to a worsening of the headache. If this situation occurs or is suspected, you should inform 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) regular use of headache medications.

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

Signs of an allergic reaction to this medicine, including breathing problems, swelling of the face and neck (angioedema) and chest pain, have been reported with ibuprofen. Stop BuscofenAct immediately and contact your doctor or emergency medical service 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 weighing <40 kg and in children under 12 years of age due to the high active ingredient content.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the following known NSAID side effects occur, or if you have any doubts, stop taking this medicine and consult your doctor as soon as possible. Elderly patients are at higher 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 similar to 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;
- fatigue associated with loss of appetite;
- sore throat, associated with mouth ulcers, fatigue and fever;
- abundant nosebleeds and skin bleeding;
- unusual fatigue associated with reduced urine output;
- swelling of the face, feet or legs;
- chest pain;
- visual disturbances;
- non-raised reddish spots, target-shaped or circular on the trunk, often with central blisters, skin peeling, ulcers of the mouth, throat, nose, genitals and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis);
- widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome);
- widespread, red and scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalised exanthematous pustulosis).

Tell your doctor if you experience any of the following side effects, if they worsen 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, diarrhoea, constipation, and slight blood loss in the stomach and/or intestines which can cause anaemia in exceptional cases.

Uncommon frequency (may affect up to 1 in 100 people)
- gastrointestinal ulcers, sometimes with haemorrhage and perforation, inflammation of the oral mucosa 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 fatigue;
- visual disturbances;
- various skin rashes;
- allergic reactions such as skin rashes, itching and asthma attacks (with possible drop in blood pressure). Stop treatment with BuscofenAct and inform your doctor immediately.

Rare frequency (may affect up to 1 in 1,000 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 (oedema), high blood pressure (hypertension) and heart failure have been reported in association with NSAID treatment;
- inflammation of the oesophagus or pancreas, formation of narrowing in the small and large intestine (in the form of diaphragmatic and intestinal stricture);
- severe skin infections and soft tissue complications have occurred during chickenpox infection;
- urine output lower than normal and swelling (especially in patients with high blood pressure or reduced kidney function), swelling (oedema) and cloudy urine (nephrotic syndrome), inflammatory kidney diseases (interstitial nephritis) which can lead to acute renal failure. If any of the above-mentioned symptoms occur or if you have a general feeling of unwellness, stop taking BuscofenAct and consult your doctor immediately, as these could be the first signs of kidney damage or kidney failure;
- disorders in blood cell production. The first signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nose and skin bleeding. In these cases, you must immediately stop treatment and consult your doctor. No treatment with painkillers or antipyretics should be undertaken on your own initiative;
- psychotic reactions and depression;
- a worsening of inflammation associated with infections (e.g. necrotising fasciitis) has been observed in conjunction with the use of certain painkillers (NSAIDs). If signs of an infection occur or worsen during the use of BuscofenAct, you must consult your doctor immediately. It must be assessed whether antibiotic therapy is necessary;
- hypertension (high blood pressure), vasculitis, palpitations, heart failure, heart attack;
- liver dysfunction (a first sign could 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 with neck stiffness, headache, nausea, vomiting, fever, clouded consciousness have been observed with the use of ibuprofen. Patients with autoimmune diseases (SLE, mixed connective tissue disease) may be more predisposed. Contact your doctor immediately if these symptoms occur;
- severe forms of skin reactions, such as skin rash with redness and blistering (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, Lyell's syndrome), hair loss (alopecia);
- severe generalised hypersensitivity reactions.

Frequency not known (cannot be estimated from the available data)
- a widespread, red and scaly rash, with pustules forming under the skin and blisters located mainly on the skin folds, trunk and upper limbs, accompanied by fever at the beginning of treatment (acute generalised exanthematous pustulosis). Stop using BuscofenAct if you develop these symptoms and contact your doctor immediately. See also section 2;
- a severe 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);
- skin becomes sensitive to light;
- fixed drug eruption (manifesting as round or oval patchy redness and swelling of the skin, possibly associated with itching);
- chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome.
Medicines such as BuscofenAct may be associated with a modest increased risk of heart attack (myocardial infarction) or stroke.

Reporting side effects
If you get 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-averse.
By reporting side effects you can help provide more information on the safety of this medicine.