BUSCOFEN*24 SOFT CAPS 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 combat 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, osteoarticular and muscular pain);
- reduction of fever and flu 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 paragraph 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 paragraph "Other medicines and Buscofen").
• If you have previously suffered from bleeding or perforation of the stomach or intestine after taking other drugs.
• If you suffer from stomach and intestinal diseases (for example, 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 if you are breastfeeding (see paragraph "Pregnancy, breastfeeding and fertility").
• If the patient is a child under 12 years of age.
• If you are severely dehydrated (due to vomiting, diarrhoea, 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), presence of polyps in the nose (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 paragraph "Other medicines and Buscofen").
• If you are elderly or if you have suffered from an ulcer, especially if the ulcer also manifested with bleeding or perforation (see paragraph "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 paragraph "Other medicines and Buscofen").
• If you have suffered from stomach or intestinal diseases related to the use of drugs, and in particular if you are elderly, you must report any unusual symptoms in the stomach and intestine to your doctor (especially bleeding), particularly in the initial stages of treatment.
• If you are taking other medicines that increase the risk of stomach and/or intestinal ulcer or bleeding, such as oral corticosteroids (e.g. cortisone), anticoagulants (e.g. warfarin), antidepressants (selective serotonin reuptake inhibitors), or antiplatelet agents (e.g. acetylsalicylic acid). See also paragraph "Other medicines and Buscofen". If gastrointestinal haemorrhage or ulceration occurs in patients taking Buscofen, treatment should be discontinued.
• If you have suffered or suffer from chronic intestinal diseases such as ulcerative colitis, or Crohn's disease, as they may worsen (see paragraph 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 paragraph "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 are not able to lower it and/or you have heart or circulatory diseases in the brain or other body districts 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 you experience swelling, heart problems or high blood pressure.
• If you have decreased kidney function, heart or liver malfunction, or if you are elderly or being treated with high blood pressure medications, as you may be more prone to kidney problems. Furthermore, the usual concomitant use of several painkillers can further increase this risk.
• If you suffer from a clotting disorder or are taking medicines that slow blood clotting (anticoagulants) (see paragraph "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, as in rare occasions symptoms of "aseptic meningitis" have been observed in patients treated with ibuprofen. 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 paragraph "Other medicines and Buscofen").
• If you intend to become pregnant (see paragraph "Pregnancy, breastfeeding and fertility").
• If you have problems getting pregnant or are undergoing fertility investigations (see paragraph "Pregnancy, breastfeeding and fertility").
• If you have an infection - see paragraph "Infections" below.

Anti-inflammatory/painkilling drugs like 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 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, family history of heart disease or stroke, or if you are a smoker.

Medicines like Buscofen can:
• be associated with the appearance of even serious kidney diseases (such as renal papillary necrosis, analgesic nephropathy and kidney failure), therefore your doctor will monitor your kidney function;
• cause eye disorders, therefore, for prolonged treatments, periodic eye check-ups are recommended. If you experience visual disturbances, stop treatment with Buscofen.

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

Infections
Buscofen can mask symptoms of infections such as fever and pain. It is therefore possible that Buscofen 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.

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 minimised 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 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 generally mild or moderate side effects or more serious reactions, even of an allergic type, 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 skin exfoliation (toxic epidermal necrolysis, Stevens-Johnson syndrome),
• visual disturbances,
• liver disease (hepatic dysfunction),
• bleeding, ulcer and perforation of the stomach and intestine, which can be fatal, particularly in the elderly.

In the event of an allergic reaction among those listed above, go to the hospital as immediate availability of appropriate equipment, medicines and personnel for emergency treatment is necessary, as in rare cases, following the use of ibuprofen, serious side effects, sometimes fatal, have been reported, 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.

In addition, you may experience further side effects that have also been reported with other medicines similar to Buscofen and which 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)
• inflammation of the stomach (gastritis)
• insomnia, anxiety
• numbness of the limbs or other body parts (paresthesia), drowsiness
• inflammation of the nasal mucosa (rhinitis)
• difficulty breathing (bronchospasm, dyspnoea)
• temporary cessation of breathing (apnea)
• visual disturbances
• hearing impairment
• ringing in the ears (tinnitus)
• vertigo
• liver disorders (altered liver function)
• liver inflammation (hepatitis)
• yellowing of the skin and eyes (jaundice)
• kidney diseases (renal function damage and toxic nephropathy in various forms, including interstitial nephritis, nephrotic syndrome and kidney failure)
• hypersensitivity reactions such as skin rash, urticaria, itching, formation of red spots on the skin (purpura), swelling of the skin and mucous membranes (angioedema), difficulty breathing (bronchospasm or dyspnoea), 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, confusional state, 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 paragraph "Warnings and precautions"), with symptoms of neck stiffness, 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 (systemic lupus erythematosus syndrome)
• aggravation of inflammations caused by an existing infection (e.g. development of necrotizing fasciitis)
• high nitrogen levels in the blood
• 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 your own 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, fast heartbeat, severe rapidly developing allergic reaction that can cause death (anaphylaxis), severe skin rash or skin exfoliation (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
• diarrhoea
• flatulence
• constipation
• indigestion
• abdominal pain
• heartburn
• blood in stools
• blood in vomit
• lesions inside the mouth
• worsening of inflammatory bowel diseases (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, 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 start of treatment (acute generalised exanthematous pustulosis). Stop using Buscofen if you develop these symptoms and contact your doctor immediately. See also paragraph 2.

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