BUSCOFENPOCKET*ORAL SOL 10SACH 400MG

BUSCOFENPOCKET 400 mg oral powder in sachet
ibuprofen

What it is and what it is used for
Ibuprofen belongs to a group of medicines known as Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). These medicines work by modifying 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 weighing 40 kg or more (aged 12 years or older).

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 stomach or intestinal bleeding or perforation related to previous NSAID therapy;
- if you have active or recurrent ulcers (peptic ulcers) or bleeding in the stomach or duodenum, or if you have repeatedly had this problem (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:
- you suffer from certain hereditary blood formation diseases (e.g. acute intermittent porphyria);
- you 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 these may worsen (see section 4 Possible side effects);
- you have reduced kidney function;
- you have liver problems;
- you are taking other medicines that may increase the risk of ulceration or bleeding, such as oral corticosteroids (e.g. prednisolone), blood thinners (e.g. warfarin), selective serotonin reuptake inhibitors (medicines used for depression) or antiplatelet agents (e.g. acetylsalicylic acid);
- you are taking other NSAIDs (including COX-2 inhibitors such as celecoxib or etoricoxib), as co-administration should be avoided;
- you have heart problems, including heart failure, angina pectoris (chest pain), or a history of heart attack, 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 transient ischaemic attack, TIA);
- you have high blood pressure, diabetes, high cholesterol or a family history of heart disease or stroke or if you are a smoker;
- you suffer from allergies (e.g. skin reactions to other substances, asthma, hay fever), nasal polyps, chronic swelling of the nasal mucosa or chronic obstructive respiratory diseases, as you are then at a higher risk of allergic reactions;
- you have recently undergone major surgery;
- you have blood clotting problems (thickening);
- if you have a chickenpox infection, it is advisable to avoid using BUSCOFENPOCKET;
- you have an infection - see section Infections below.

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

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

With prolonged use of BUSCOFENPOCKET, regular monitoring of liver values, kidney function, and blood count is necessary.

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

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

Be especially careful with BUSCOFENPOCKET:
Severe 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 generalised 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 severe skin reactions described in section 4.

Infections
BUSCOFENPOCKET can mask 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 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.

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

Gastrointestinal bleeding (bleeding in the stomach or intestines), potentially fatal ulceration or perforation have 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, stop taking this medicine immediately. The risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing doses of NSAIDs, in patients with a history of ulcers, especially if complicated by haemorrhage or perforation (see section 2 Do not take BUSCOFENPOCKET), and in the elderly. These patients should start treatment with the lowest available dose. For these patients, as well as for patients requiring concomitant use of low doses of acetylsalicylic acid or other drugs that may increase gastrointestinal risk, combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered. When gastrointestinal bleeding or ulceration occurs during ibuprofen treatment, treatment should be stopped and the doctor should be consulted.

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

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

Elderly
Elderly people taking NSAIDs are at a higher risk of side effects, particularly those related to the stomach and intestines. For more information, see section 4 Possible side effects.
If you have a history of gastrointestinal toxicity, especially 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 kidney impairment in dehydrated adolescents.
BUSCOFENPOCKET 400 mg is not suitable for children under 12 years of age and adolescents weighing 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 minimum dose for the minimum time necessary to relieve symptoms. You may experience one of the known side effects of NSAIDs. If this occurs, or if you have any doubts, stop taking this medicine and consult your doctor as soon as possible.

Elderly people using this medicine are at a higher risk of developing problems associated with side effects.

Stop taking this medicine and seek immediate medical attention if you experience:
- signs of intestinal bleeding such as: severe abdominal pain, dark, tar-like stools, vomiting blood or dark particles resembling coffee grounds;
- signs of rare but severe allergic reactions, such as worsening of asthma, wheezing or shortness of breath of unknown origin, swelling of the face, tongue or throat, difficulty breathing, accelerated heartbeat, drop in blood pressure with consequent shock. These can also occur upon first use of this medicine. If any of these symptoms occur, call your doctor immediately;
- non-raised, target-shaped or circular reddish patches 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).

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

Common (may affect up to 1 in 10 people):
- dizziness or fatigue, headache;
- stomach ache, indigestion, diarrhoea, heartburn, nausea, vomiting, flatulence, constipation;
- various skin rashes.

Uncommon (may affect up to 1 in 100 people):
- sneezing, blocked or runny nose or itchy nose (rhinitis);
- hypersensitivity reactions with skin rashes and itching, as well as asthma attacks (possibly with a drop in blood pressure). In this case, the doctor must be informed immediately and ibuprofen intake must be stopped;
- tingling or prickling sensation, drowsiness, agitation, irritability;
- difficulty sleeping, feeling anxious;
- hives, itching, small bruises on the skin or inside the mouth, nose or ears, skin sensitisation to light;
- visual disturbance. In this case, the doctor must be informed immediately and ibuprofen intake must be stopped;
- hearing problems, dizziness or spinning sensation (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 (oedema) and protein accumulation in the urine); kidney inflammation (interstitial nephritis), which may be accompanied by acute kidney dysfunction. Reduced urine output, fluid accumulation within the body (oedema) and generally feeling unwell can be signs of kidney disease and even kidney failure. If any of the above symptoms occur, stop administering BUSCOFENPOCKET and consult your doctor immediately.

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

Very rare (may affect up to 1 in 10,000 people)
- a worsening of infection-related inflammations (e.g. necrotising fasciitis) associated with the use of some painkillers (NSAIDs) has been described. If signs of an infection occur or worsen during the use of BUSCOFENPOCKET, consult a doctor immediately. It should be examined whether there is an indication for anti-infective/antibiotic therapy;
- changes in blood count - pancytopenia, anaemia, leucopenia, thrombocytopenia, neutropenia, agranulocytosis, aplastic anaemia, haemolytic anaemia (the first symptoms are fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, bleeding from the nose and skin, unusual or unexplained bruises). In these cases, therapy must be stopped immediately and a doctor consulted. No treatment with painkillers or medicines that reduce fever (antipyretic drugs) should be undertaken;
- psychotic reactions;
- high blood pressure, heart failure, heart attack;
- inflammation of blood vessels;
- inflammation of the pancreas and oesophagus;
- diaphragm-like intestinal strictures;
- liver failure or damage, particularly with long-term use, manifesting as yellowing of the skin and eyes or pale stools and dark urine;
- in exceptional cases, severe skin infections and soft tissue complications have occurred during chickenpox infection;
- hair loss (alopecia);
- reduced urine excretion and increased tissue fluid formation (oedema), particularly in patients with high blood pressure or impaired kidney function.

Not known (frequency cannot be estimated from the available data)
- a widespread, red and scaly rash, with the formation of pustules under the skin and blisters located mainly on skin folds, trunk and upper limbs accompanied by fever at the beginning of treatment (acute generalised exanthematous pustulosis). Stop using BUSCOFENPOCKET 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 increased eosinophils (a type of white blood cell).

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

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.