BUSCOFENPOCKET 400 MG ORAL POWDER IN SACHET 10 SINGLE-DOSE SACHETS IN PAP/AL/MEEA

Name
BUSCOFENPOCKET 400 mg oral powder in sachet
Ibuprofen


What is it and what is it for?
Ibuprofen belongs to a group of medications known as nonsteroidal anti-inflammatory drugs (NSAIDs). These medications work by altering the body's response to pain, inflammation, and high body temperature.

BUSCOFENPOCKET is used for the short-term symptomatic treatment of mild to moderate pain such as headache, toothache, menstrual pain and/or fever.

BUSCOFENPOCKET 400 mg is recommended for adults and adolescents with a body weight of 40 kg or more (aged 12 years and over).


What you need to know before taking the medicine
Do not take BUSCOFENPOCKET
- if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6);
- if you have experienced shortness of breath, asthma, runny nose, hives or angioedema (severe allergic reaction causing swelling of the face or throat) after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs);
- if you have ever had bleeding or perforation of the stomach or intestine related to previous NSAID therapy;
- if you have an active or recurrent ulcer (peptic ulcers) or bleeding in your stomach or duodenum or if you have had this problem repeatedly (two or more episodes of proven ulceration or bleeding) in the past;
- if you suffer from severe liver, kidney or heart failure;
- if you have bleeding in the brain (cerebrovascular haemorrhage) or other active bleeding;
- if you suffer from a blood formation disorder of unknown origin, e.g. thrombocytopenia;
- if you are severely dehydrated (due to vomiting, diarrhoea or insufficient fluid intake);
- in the last three months of pregnancy (see "Pregnancy and breastfeeding").


Warnings and precautions
Talk to your doctor or pharmacist before taking BUSCOFENPOCKET if:
- suffer from certain hereditary blood formation diseases (e.g. acute intermittent porphyria);
- suffer from certain skin diseases (systemic lupus erythematosus (SLE) or mixed connective tissue disease);
- you suffer or have suffered from intestinal diseases (ulcerative colitis or Crohn's disease), as they may worsen (see section 4 "Possible side effects");
- has reduced kidney function;
- has liver problems;
- are taking other medicines that may increase the risk of ulceration or bleeding, such as oral corticosteroids (e.g. prednisolone), blood-thinning medicines (e.g. warfarin), selective serotonin reuptake inhibitors (medicines used for depression) or antiplatelet agents (e.g. acetylsalicylic acid);
- are taking other NSAIDs (including COX-2 inhibitors such as celecoxib or etoricoxib), as taking them at the same time should be avoided;
- have heart problems, including heart failure, angina (chest pain), or 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 a "mini-stroke" or transient ischemic attack, "TIA");
- have high blood pressure, diabetes, high cholesterol, or a family history of heart disease or stroke, or if you are a smoker;
- suffer from allergies (e.g. skin reactions to other substances, asthma, hay fever), nasal polyps, chronic swelling of the nasal mucosa or chronic obstructive pulmonary disease, as in this case you are at greater risk of allergic reactions;
- he just underwent major surgery;
- have problems with blood clotting (thickening);
- if you have a chickenpox infection it is advisable to avoid using BUSCOFENPOCKET;
- have an infection – see section “Infections” below;
- have ever developed a fixed drug eruption (round or oval patches of redness and swelling of the skin, blisters, hives and itching) after taking ibuprofen (see section 4).

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 BUSCOFENPOCKET immediately and contact your doctor or emergency services immediately if you notice any of these signs.

Undesirable effects can be limited by using the lowest effective dose for the shortest duration necessary to control symptoms.

In general, the habitual use of (different types of) painkillers can cause serious and permanent kidney problems. This risk may be increased by physical exertion associated with salt loss and dehydration. Therefore, it should be avoided.

During prolonged use of BUSCOFENPOCKET, regular monitoring of liver values, renal function, and blood counts is necessary.

Prolonged use of any type of painkiller for headaches can worsen these values. If this occurs, consult your doctor for advice and discontinue treatment with BUSCOFENPOCKET.

If you suffer or have suffered from asthma or allergic diseases, shortness of breath may occur.

Take special care with BUSCOFENPOCKET:

Severe 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 BUSCOFENPOCKET and contact your doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

Infections
BUSCOFENPOCKET may hide the symptoms of infections, such as fever and pain. Therefore, BUSCOFENPOCKET may delay adequate treatment of the infection, which could increase the risk of complications. This has been observed in pneumonia caused by bacteria and 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, contact your doctor immediately.

The use of anti-inflammatory/analgesic drugs such as ibuprofen may be associated with a modest increased risk of heart attack or stroke, especially when taken in high doses. Do not exceed the recommended dose or maximum duration of treatment.

Gastrointestinal bleeding (bleeding into the stomach or intestines), ulceration, or perforation, which can be life-threatening, has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events. If gastrointestinal bleeding or ulceration occurs, discontinue use of this medicine immediately. The risk of gastrointestinal bleeding, ulceration, or perforation is greater with increasing NSAID doses, in patients with a history of ulcers, particularly if complicated with haemorrhage or perforation (see section 2 "Do not take BUSCOFENPOCKET"), and in the elderly. These patients should start treatment on the lowest available dose. For these patients, as well as for patients who require concomitant use of low-dose aspirin or other drugs that may increase gastrointestinal risk, combination therapy with protective agents (e.g., misoprostol or proton pump inhibitors) should be considered. If gastrointestinal bleeding or ulceration occurs during treatment with ibuprofen, treatment should be discontinued and a doctor should be consulted.

The use of NSAIDs in association with alcohol may aggravate the adverse reactions caused by the active ingredient, especially those affecting the gastrointestinal tract or the central nervous system.

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

Elderly people
Elderly people taking NSAIDs are at increased risk of side effects, particularly those affecting the stomach and intestines. For more information, see section 4 "Possible side effects."
If you have a history of gastrointestinal toxicity, particularly if you are elderly, report any unusual abdominal symptoms (especially bleeding in the stomach or intestines), particularly in the early stages of treatment.

Children and adolescents
There is a risk of renal impairment in dehydrated adolescents.
BUSCOFENPOCKET 400 mg is not suitable for children under 12 years of age and adolescents with a body weight less than 40 kg.


Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects can be limited by using the lowest dose for the shortest time necessary to relieve symptoms. You may experience one of the known side effects of NSAIDs. If this occurs, or if you have any concerns, stop taking this medicine and consult your doctor as soon as possible.

Older people using this medicine are at greater risk of developing problems associated with side effects.

Stop taking this medicine and see a doctor immediately if you experience:
- signs of intestinal bleeding such as: severe abdominal pain, dark, tarry stools, vomiting blood or dark particles that look like coffee grounds;
- signs of rare but serious allergic reactions, such as worsening of asthma, wheezing or shortness of breath of unknown origin, swelling of the face, tongue, or throat, difficulty breathing, rapid heartbeat, or a drop in blood pressure resulting in shock. These may occur even when you first start taking this medicine. If you experience any of these symptoms, call your doctor immediately;
- flat, target-shaped or circular reddish 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).

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

Common (may affect up to 1 in 10 people): - feeling dizzy or tired, headache;
- stomach ache, digestive problems, diarrhea, heartburn, nausea, vomiting, flatulence, constipation;
- various skin rashes.

Uncommon (may affect up to 1 in 100 people):
- sneezing, stuffy or runny nose or itchy nose (rhinitis);
- hypersensitivity reactions with skin rashes and itching, as well as asthma attacks (possibly with low blood pressure). In this case, inform your doctor immediately and stop taking ibuprofen;
- sensation of tingling or prickling, drowsiness, agitation, irritability;
- difficulty sleeping, feeling anxious;
- hives, itching, small bruises on the skin or inside the mouth, nose, or ears, skin sensitivity to light;
- visual disturbance. In this case, inform your doctor immediately and stop taking ibuprofen;
- hearing problems, feeling dizzy or spinning (vertigo), ringing in the ears (tinnitus);
- difficulty breathing, wheezing or coughing, asthma or worsening of asthma;
- inflammation of the stomach lining, gastrointestinal ulcers, in some cases with bleeding and perforation, ulcerative stomatitis, exacerbation of colitis and Crohn's disease;
- hepatitis, yellowing of the skin or eyes, reduced liver function;
- nephrotic syndrome (fluid accumulation within the body (edema) and protein buildup in the urine); kidney inflammation (interstitial nephritis), which may be accompanied by acute kidney dysfunction. Reduced urine output, fluid accumulation within the body (edema), and a general feeling of malaise may be signs of kidney disease and even kidney failure. If any of the above symptoms occur, stop taking BUSCOFENPOCKET and consult your doctor immediately.

Rare (may affect up to 1 in 1,000 people):
- feeling depressed or confused;
- Symptoms of aseptic meningitis, including stiff neck, headache, nausea, vomiting, fever, or blurred consciousness, have been observed during treatment with ibuprofen. Patients with autoimmune disorders (SLE, mixed connective tissue disease) appear to be predisposed. If these symptoms occur, contact a doctor immediately.
- damage to the optic nerve;
- damage to kidney tissue (papillary necrosis), especially during long-term treatment, and increased uric acid and urea concentration in the blood;
- water retention (edema).

Very rare (may affect up to 1 in 10,000 people)
- worsening of infection-related inflammation (e.g., necrotizing fasciitis) has been reported with the use of some painkillers (NSAIDs). If signs of infection occur or worsen while using BUSCOFENPOCKET, consult a doctor immediately. The indication for anti-infective/antibiotic therapy should be examined;
- blood count changes - pancytopenia, anemia, leukopenia, thrombocytopenia, neutropenia, agranulocytosis, aplastic anemia, hemolytic anemia (early symptoms include fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nose and skin bleeding, unusual or unexplained bruising). In these cases, discontinue therapy immediately and consult a doctor. No painkillers or medications that reduce fever (antipyretics) should be used.
- psychotic reactions;
- high blood pressure, heart failure, heart attack;
- inflammation of the blood vessels;
- inflammation of the pancreas and esophagus;
- diaphragm-like intestinal stenosis;
- liver failure or damage, especially with long-term use, manifested by yellowing of the skin and eyes or pale stools and dark urine;
- in exceptional cases, serious skin infections and soft tissue complications have occurred during chickenpox infection;
- hair loss (alopecia);
- reduced urine output and increased tissue fluid formation (edema), particularly in patients with high blood pressure or impaired renal function.

Not known (frequency 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 BUSCOFENPOCKET 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).
- fixed drug eruption (such as round or oval patches of redness, swelling of the skin, blisters, hives, and itching);
- chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

Medicines like this 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.