BUSCOFEN*12 SOFTGELS 200MG

BUSCOFEN 200 mg soft capsules
Ibuprofen

What it is and what it is used for
Buscofen contains ibuprofen, a medicine belonging to the class of analgesic anti-inflammatories, i.e., medicines that fight pain and inflammation.
Buscofen is used, in adults and adolescents aged 12 years and older, for:
- treatment of pain of various origins and natures (menstrual pain, headache, toothache, neuralgia, musculoskeletal pain);
- reduction of feverish and flu-like symptoms.
Consult your doctor if you do not feel better or if you feel worse after three days of treatment.

What you need to know before taking the medicine
Do not take Buscofen
• If you are allergic to ibuprofen and/or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to other anti-rheumatic medicines (e.g., acetylsalicylic acid, etc.), medicines used for the treatment of joint or muscle pain (see section "Other medicines and Buscofen").
• If you have a history of bleeding or perforation of the stomach or intestines after taking other medicines.
• If you suffer from stomach and intestinal diseases (e.g., active or severe gastrointestinal ulcer).
• If you have had two or more distinct episodes of stomach ulcer or bleeding in the past.
• If you suffer from severe liver or kidney disease.
• If you suffer from severe heart disease (severe heart failure).
• If you suffer from blood composition disorders (blood dyscrasias).
• If you are in the third trimester (7th - 9th month) of pregnancy or are breastfeeding (see section "Pregnancy, breastfeeding and fertility").
• If the patient is a child under 12 years of age.
• If you are severely dehydrated (due to vomiting, diarrhea, or insufficient fluid intake).

Warnings and precautions
Consult your doctor or pharmacist before taking Buscofen:

• If you have had episodes of difficulty breathing (bronchospasm) after using acetylsalicylic acid (aspirin) or other anti-inflammatory drugs.
• If you suffer from asthma, runny nose (chronic rhinitis), nasal polyps (nasal polyposis) or inflammation of the paranasal sinus mucosa (sinusitis) or suffer/have suffered from allergies because you could experience difficulty breathing (bronchospasm), skin redness with itching (urticaria) or swelling of the skin and throat (angioedema), especially if you have already had allergic reactions after using other medicines used for the treatment of joint or muscle pain, fever, or for the treatment of inflammation (NSAIDs).
• If you are taking other anti-inflammatory medicines, including selective COX-2 inhibitors (an enzyme involved in inflammatory processes), as in these cases the risk of ulcers and bleeding may increase (see section "Other medicines and Buscofen").
• If you are elderly or have suffered from ulcers, especially if the ulcer also involved bleeding or perforation (see section "Do not take Buscofen"), as the risk of bleeding, ulcer, or perforation is higher, especially with higher doses of anti-inflammatory drugs. In these cases, you should start treatment with the lowest available dose, and possibly consult your doctor to prescribe a medicine that protects the stomach (misoprostol or proton pump inhibitors). This possibility should also be considered if you are taking low doses of acetylsalicylic acid or drugs that may increase the risk of stomach and/or intestinal diseases (see section "Other medicines and Buscofen").
• If you have suffered from stomach or intestinal diseases related to the use of drugs, and particularly if you are elderly, you must report any unusual symptoms in the stomach and intestine (especially bleeding) to your doctor, particularly in the initial stages of treatment.
• If you are taking other medicines that increase the risk of ulcer or bleeding of the stomach and/or intestine, such as oral corticosteroids (e.g., cortisone), anticoagulants (e.g., warfarin), antidepressants (selective serotonin reuptake inhibitors), or antiplatelet drugs (e.g., acetylsalicylic acid). See also section "Other medicines and Buscofen". If gastrointestinal bleeding or ulceration occurs in patients taking Buscofen, treatment should be discontinued.
• If you have suffered or suffer from chronic bowel diseases such as ulcerative colitis or Crohn's disease, as they may worsen (see section 4 "Possible side effects").
• If you suffer from high blood pressure and/or heart disease, as fluid retention, increased blood pressure, and swelling have been found in association with NSAID treatment. NSAIDs can reduce the action of medicines taken to lower blood pressure (see section "Other medicines and Buscofen"). Your doctor will prescribe Buscofen only after carefully evaluating your condition.
• If you have high blood pressure and the medicines you are taking cannot lower it and/or you have heart disease or circulatory problems in the brain or other parts of the body, or you think you may be at risk for these diseases (for example, if you suffer from high blood pressure, diabetes, or high cholesterol, or if you smoke).
• If you have lost a considerable amount of fluid or experience swelling, heart problems, or high blood pressure.
• If you have decreased kidney function, heart or liver malfunction, or if you are elderly or on treatment for high blood pressure, as you may be more prone to kidney problems. Furthermore, the habitual concomitant use of several painkillers can further increase this risk.
• If you suffer from a coagulation disorder or are taking medicines that slow down blood clotting (anticoagulants) (see section "Other medicines and Buscofen").
• If you suffer from an autoimmune disease that can affect various organs and tissues of the body (systemic lupus erythematosus), or a connective tissue disease, present in many parts of the body, such as bones and cartilage, since in rare occasions in patients treated with ibuprofen, symptoms of "aseptic meningitis" have been observed. Although this is more likely to occur in patients with systemic lupus erythematosus and related connective tissue diseases, it has also been observed in patients who did not have concomitant chronic diseases.
• If you are taking medicines to treat pain, heart disease, or high blood pressure (see section "Other medicines and Buscofen").
• If you intend to become pregnant (see section "Pregnancy, breastfeeding and fertility").
• If you have difficulty conceiving or are undergoing fertility investigations (see section "Pregnancy, breastfeeding and fertility").
• If you have an infection - see section "Infections" below.

Anti-inflammatory/pain relief medications such as ibuprofen may be associated with a modest increased risk of heart attack (“myocardial infarction”) or stroke (lack of blood flow to the brain), especially if administered in high doses. Do not exceed the recommended dose or duration of treatment.

You should discuss your therapy with your doctor or pharmacist before taking Buscofen if you have:
• heart problems including heart attack, angina (chest pain) or if you have a history of heart attack, coronary artery bypass surgery, peripheral arterial disease (poor circulation in 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);
• high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker.

Medicines like Buscofen can:
• be associated with the occurrence of severe kidney diseases (such as renal papillary necrosis, analgesic nephropathy and kidney failure), therefore your doctor will monitor your kidney function;
• cause eye disorders, therefore, in case of prolonged treatments, periodic eye check-ups are recommended. If visual disturbances occur, discontinue treatment with Buscofen.

Pay particular attention with Buscofen:
Skin reactions
Severe skin reactions have been reported in association with Buscofen treatment. Stop taking Buscofen and consult your doctor immediately if you develop a rash, mucosal lesions, blisters, or other signs of allergy, as these may be the first signs of a very severe skin reaction. See section 4.

Infections
Buscofen can mask the symptoms of infections such as fever and pain. It is therefore possible that Buscofen could 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 infection symptoms persist or worsen, consult your doctor immediately.

Adolescents
In dehydrated adolescents, there is a risk of kidney disease.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects of the drug can be minimized if you use the lowest recommended dose and if you use the drug only for the period necessary to control your symptoms.
If you develop an ulcer or experience stomach and/or intestinal bleeding or skin and/or mucosal lesions, you must stop treatment with Buscofen and contact your doctor.
These side effects are usually more frequent in the elderly.
The use of Buscofen can cause side effects that are generally mild or moderate, or more severe reactions, including allergic reactions, although rarely.
If you experience any of the following symptoms, IMMEDIATELY STOP using Buscofen and contact your doctor or the nearest hospital where you will undergo appropriate and specific treatment:
• skin rashes or lesions,
• mucosal lesions,
• signs of an allergic reaction, even severe (erythema, itching, urticaria, asthma, swelling of the skin and mucous membranes, anaphylactic shock),
• peeling skin,
• severe skin rash or peeling skin (toxic epidermal necrolysis, Stevens-Johnson syndrome),
• visual disturbances,
• liver disease (liver dysfunction),
• bleeding, ulcer and perforation of the stomach and intestine, which can be fatal, particularly in the elderly.

If you experience an allergic reaction among those listed above, go to the hospital as immediate availability of equipment, medicines, and personnel suitable for emergency treatment is necessary, since in rare cases, severe, sometimes fatal, side effects have been reported following the use of ibuprofen, even in the absence of known allergy.

The risk of experiencing such symptoms is higher in the early stages of therapy: in most cases, the reaction occurs within the first month of treatment.

Furthermore, you might experience additional side effects that have also been reported with other medicines similar to Buscofen and are listed below by frequency:

common (may affect up to 1 in 10 people)
• dizziness
• malaise
• fatigue

uncommon (may affect up to 1 in 100 people)
• stomach inflammation (gastritis)
• insomnia, anxiety
• numbness of the limbs or other parts of the body (paresthesia), drowsiness
• inflammation of the nasal mucosa (rhinitis)
• difficulty breathing (bronchospasm, dyspnea)
• temporary cessation of breathing (apnea)
• visual disturbances
• hearing impairment
• ringing in the ears (tinnitus)
• vertigo
• liver disorders (impaired liver function)
• liver inflammation (hepatitis)
• yellowing of skin and eyes (jaundice)
• kidney diseases (damage to kidney function and toxic nephropathy in various forms, including interstitial nephritis, nephrotic syndrome, and kidney failure)
• hypersensitivity reactions such as rash, urticaria, itching, formation of red spots on the skin (purpura), swelling of the skin and mucous membranes (angioedema), difficulty breathing (bronchospasm or dyspnea), asthma attacks with possible drop in blood pressure
• skin reactions to light (photosensitivity)

rare (may affect up to 1 in 1,000 people)
• reduction in the number of blood cells: reduction of white blood cells (leukopenia, neutropenia, agranulocytosis), red blood cells (hemolytic anemia, aplastic anemia), platelets (thrombocytopenia)
• reduced clotting ability
• depression, confusion, hallucinations
• inflammation of the optic nerve (optic neuritis)
• inflammation of the meninges, the membranes covering the brain (aseptic meningitis, especially in patients with pre-existing autoimmune disorders, see section "Warnings and precautions"), with symptoms of stiff neck, headache, nausea, vomiting, fever or disorientation
• eye disorders with visual disturbances and optic nerve disease (toxic optic neuropathy)
• swelling due to fluid accumulation in the tissues
• a disease that can affect various organs and tissues of the body (lupus erythematosus syndrome)
• worsening of inflammation caused by an existing infection (e.g., development of necrotizing fasciitis)
• high blood nitrogen levels
• altered liver function tests (increased transaminases, increased alkaline phosphatase)
• abnormal blood tests (reduced hemoglobin, reduced hematocrit, prolonged bleeding time, decreased blood calcium, increased blood uric acid)

very rare (may affect up to 1 in 10,000 people)
• inflammation of the pancreas, a gland involved in digestive processes (pancreatitis)
• sensation of feeling one's heartbeat (palpitations)
• heart disease (heart failure)
• heart attack (myocardial infarction)
• presence of fluid in the lungs (acute pulmonary edema)
• liver disease (liver failure)
• hypertension
• severe allergic reactions, which may include symptoms such as severe asthma, swelling of the face, tongue, and throat making it difficult to breathe, rapid heartbeat, severe and rapidly developing allergic reaction that can cause death (anaphylaxis), severe skin rash or peeling skin (toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme)
• severe skin infections and soft tissue disorders can occur during chickenpox infection

not known (frequency cannot be estimated from the available data)
• feeling of heaviness in the stomach
• nausea
• vomiting
• diarrhea
• flatulence
• constipation
• difficulty digesting
• abdominal pain
• heartburn
• blood in stools
• blood in vomit
• lesions inside the mouth
• worsening of inflammatory diseases of the colon and intestine (colitis, Crohn's disease)
• increased risk of sudden reduction of blood circulation in the brain (stroke)
• allergic reactions, anaphylaxis
• drug reaction with eosinophilia and systemic symptoms (DRESS syndrome): 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)
• a widespread, red, and scaly rash, with pustules under the skin and vesicles located mainly on skin folds, trunk, and upper limbs accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop using Buscofen if you develop these symptoms and contact your doctor immediately. See also section 2.

Reporting side effects
If you get any side effects, including any not listed in this leaflet, tell 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.