Buscofen Granules For Oral Solution 400mg Ibuprofen Analgesic 10 Sachets

Ibuprofen-based granules for oral suspension.

Therapeutic indications

Buscofen Granulate is used in the treatment of pain of various origins and nature (menstrual pain, headache, toothache, neuralgia, osteoarticular and muscle pain).

Dosage and Posology

The drug should be taken according to the following doses and methods:

• Adults and adolescents over 12 years: 1 sachet 2 - 3 times a day. Do not exceed the dose of 1200 mg (3 sachets) in 24 hours. If the use of the medicine is necessary for more than 3 days in adolescents, or in the case of worsening of symptoms, the doctor should be consulted.
• Elderly: Elderly patients should adhere to the minimum doses indicated.
• Patients with renal insufficiency: in the presence of renal insufficiency the elimination can be reduced and the dosage should be adjusted accordingly. Buscofen should not be used for more than 7 days.

Dissolve the contents of the sachet in a glass of water, stirring with a teaspoon until completely dissolved and immediately drink the solution.
Take this medicine on a full stomach.

Overdose

The signs and symptoms of toxicity were generally not observed at doses below 100 mg / kg in children or adults. However, supportive treatment may be required in some cases. Children have been observed to exhibit signs and symptoms of toxicity after ingestion of ibuprofen at doses of 400 mg / kg or greater.

Most people who have ingested significant amounts of ibuprofen will experience symptoms within 4-6 hours. The most commonly reported symptoms of overdose include nausea, vomiting, abdominal pain, lethargy and sleepiness. Effects on the central nervous system (CNS) include headache, tinnitus, dizziness, convulsions, and loss of consciousness. Nystagmus, metabolic acidosis, hypothermia, renal effects, gastrointestinal bleeding, coma, apnea, diarrhea, and CNS and respiratory depression have also been reported rarely. Disorientation, arousal state and cardiovascular toxicity including hypotension, bradycardia and tachycardia have been reported. In cases of significant overdose, renal failure and liver damage are possible.

There is no specific antidote for ibuprofen overdose. In the event of an overdose, symptomatic and supportive treatment is therefore indicated. Particular attention is paid to the control of blood pressure, acid-base balance and any gastrointestinal bleeding. Within 1 hour of ingestion of a potentially toxic amount, administration of activated charcoal should be considered. Alternatively, gastric lavage should be considered within 1 hour of ingestion of a potentially life-threatening overdose in adults. Adequate diuresis must be ensured and renal and hepatic functions closely monitored. The patient should remain under observation for at least four hours following ingestion of a potentially toxic amount of drug. Any occurrence of frequent or prolonged seizures should be treated with intravenous diazepam. Depending on the clinical condition of the patient, other supportive measures may be necessary. For more information, contact your local poison control center.

Contraindications

• Hypersensitivity to the active substance or to any of the excipients.
• Subjects with hypersensitivity to acetylsalicylic acid or to other analgesics, antipyretics, non-steroidal anti-inflammatory drugs (NSAIDs), particularly when hypersensitivity is associated with nasal polyposis, angioedema and / or asthma.
• Severe hepatic insufficiency.
• Severe renal insufficiency (glomerural filtration less than 30ml / min)
• Severe heart failure (NYHA class IV)
• Subjects suffering from blood dyscrasias of unknown origin, from porphyria, from hypertension, from severe uncontrolled coronary insufficiency
• Severe or active peptic ulcer.
• History of gastrointestinal bleeding or perforation related to previous active treatments or history of recurrent peptic ulcer / haemorrhage (two or more distinct episodes of proven ulceration or bleeding)
• Subjects with clinical conditions that lead to an increased tendency to bleed
• In conjunction with surgery (including dental operations)
• Subjects who have suffered significant fluid losses (due to vomiting, diarrhea or low fluid ingestion)
• During the third trimester of pregnancy
• Children under 12 years old.

Side effects

The side effects seen with ibuprofen are generally common to other analgesics, antipyretics, non-steroidal anti-inflammatory drugs.

• Gastrointestinal disorders: the most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, gastrointestinal perforation or haemorrhage, sometimes fatal, may occur, particularly in the elderly. Gastrointestinal perforation with the use of ibuprofen has been rarely observed. Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, epigastric pain, heartburn, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported following administration of Buscofen. Gastritis was observed less frequently. Pancreatitis has also been observed very rarely
• Immune system disorders: Hypersensitivity reactions have been reported following treatment with NSAIDs. These may consist of a) non-specific allergic reaction and anaphylaxis, b) respiratory tract reactions including asthma, even severe, bronchospasm or dyspnoea or c) skin disorders, including various types of rash, itchy urticaria, purpura , angioedema and, more rarely, exfoliative and bullous dermatitis (including Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme.
• Cardiac and vascular disorders: Edema and fatigue, hypertension and heart failure have been reported in association with NSAID treatment. Clinical studies suggest that the use of ibuprofen, especially at high doses (2400 mg / day), may be associated with a modest increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke).

Other less frequently reported adverse events for which causality has not necessarily been established include:

• Blood and lymphatic system disorders: leukopenia, thrombocytopenia, neutropenia, agranulocytosis, aplastic anemia and haemolytic anemia. Psychiatric disorders: insomnia, anxiety, depression, confusional state, hallucinations.
• Nervous system disorders: headache, paraesthesia, dizziness, somnolence, optic neuritis. Infections and infestations: aseptic rhinitis and meningitis (especially in patients with pre-existing autoimmune disorders, such as systemic lupus erythematosus and mixed connective tissue disease) with symptoms of neck stiffness, headache, nausea, vomiting, fever or disorientation
• Respiratory, thoracic and mediastinal disorders: bronchospasm, dyspnoea, apnea.
• Eye disorders: rare cases of ocular alteration with consequent visual disturbances, toxic optic neuropathy.
• Ear and labyrinth disorders: impaired hearing, tinnitus, dizziness.
• Hepatobiliary disorders: impaired liver function, liver failure, hepatitis and jaundice.
• Skin and subcutaneous tissue disorders: Bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis (very rare), and photosensitivity reactions.
• Renal and urinary disorders: impairment of renal function and toxic nephropathy in various forms, including interstitial nephritis, nephrotic syndrome and renal failure.
• General disorders and administration site conditions: malaise, fatigue.

Pregnancy and breastfeeding

Inhibition of prostaglandin synthesis can adversely affect pregnancy and / or embryo / fetal development. Results of epidemiological studies suggest an increased risk of miscarriage and cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiac malformations increased from less than 1% to approximately 1.5%. The risk was considered to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to cause increased pre- and post-implantation loss and embryo-fetal mortality. In addition, an increased incidence of various malformations, including cardiovascular, has been reported in animals given prostaglandin synthesis inhibitors during the organogenetic period. During the first and second trimester of pregnancy, Ibuprofen Carlo Erba should not be administered except in strictly necessary cases. If Ibuprofen Carlo Erba is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose and duration of treatment should be kept as low as possible. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose

- the fetus to:

• cardiopulmonary toxicity (with premature closure of the arterial duct and pulmonary hypertension);
• renal dysfunction, which can progress to renal failure with oligo-hydroamnios;

- the mother and the newborn, at the end of pregnancy, to:

• possible prolongation of bleeding time, and antiplatelet effect which may occur even at very low doses;
• inhibition of uterine contractions resulting in delayed or prolonged labor.

Special warnings

The concomitant use of Buscofen with other NSAIDs, including selective cyclooxygenase-2 (COX-2) inhibitors, should be avoided due to an increased risk of ulceration or bleeding. Undesirable effects can be minimized by using the lowest effective dose for the shortest duration of treatment needed to control symptoms (see paragraphs below on gastrointestinal and cardiovascular risks). Like other NSAIDs, ibuprofen can mask signs of infection.

Expiry and retention

Check the expiration date indicated on the package. The expiry date indicated on the package refers to the product in intact packaging, correctly stored. No storage conditions.

Warning : do not use the medicine after the expiry date indicated on the package.

Composition

One sachet of Buscofen Granules contains:

Active principle

Ibuprofen sodium dihydrate 512 mg, equivalent to ibuprofen 400 mg.

Excipients

Sucrose, potassium bicarbonate, orange flavor, acesulfame potassium, aspartame.