Brufen 400 mg 12 coated tablets

Brufen 400 mg 12 coated tablets is a nonsteroidal anti-inflammatory drug (NSAID) based on ibuprofen , indicated for the symptomatic treatment of mild to moderate pain . Thanks to its formulation in film-coated tablets , Brufen 400 mg guarantees a rapid analgesic and antipyretic action , proving particularly effective against headaches, toothaches, menstrual pain, muscle pain and fever associated with colds or flu.

Each tablet contains 400 mg of ibuprofen , an active ingredient known for its ability to relieve pain and reduce inflammation. Brufen 400 mg is ideal for adults and adolescents (from 12 years or 40 kg in weight), offering a practical and fast solution for the control of acute pain and fever. The 12-tablet pack is designed to ensure maximum convenience of use, both at home and on the go.

Ibuprofen works by blocking the production of prostaglandins, substances responsible for pain and inflammation, thus ensuring effective relief from the most common symptoms such as migraines, joint pain, muscle pain and pain associated with the menstrual cycle . The film-coated tablets are easy to swallow and guarantee a controlled release of the active ingredient , optimising the effectiveness of the treatment.

Choose Brufen 400 mg coated tablets for a pain reliever and anti-inflammatory of proven efficacy , suitable for those looking for a reliable solution for the rapid treatment of pain and fever . The product is available in blister packs of 12 tablets , practical to always carry with you for any eventuality.

ACTIVE INGREDIENTS

Active ingredients contained in Brufen 400 mg 12 coated tablets - What is the active ingredient in Brufen 400 mg 12 coated tablets?

Each tablet contains 200 mg ibuprofen (as lysine salt) Each tablet contains 400 mg ibuprofen (as lysine salt) For the full list of excipients, see section 6.1.

EXCIPIENTS

Composition of Brufen 400 mg 12 coated tablets - What does Brufen 400 mg 12 coated tablets contain?

Tablet core : Cellulose, microcrystalline (E460), Silica, colloidal anhydrous (E551), Crospovidone (E1202), Povidone (E1201), Magnesium stearate (E572), Talc (E553b). Tablet coating : Polyvinyl alcohol hydrolysate (E1203), Titanium dioxide (E171), Macrogol (E1521), Talc (E553b). Printing ink : Shellac (E904), Iron oxide black (E172), Ammonium hydroxide (E527).

DIRECTIONS

Therapeutic indications Brufen 400 mg 12 coated tablets - Why is Brufen 400 mg 12 coated tablets used? What is it used for?

For the symptomatic treatment of mild to moderate pain, such as headache, dental pain, menstrual pain and fever and pain in the common cold.

CONTRAINDICATIONS AND SIDE EFFECTS

Contraindications Brufen 400 mg 12 coated tablets - When should Brufen 400 mg 12 coated tablets not be used?

Ibuprofen is contraindicated in patients: - with hypersensitivity to the active substance or to any of the excipients listed in section 6.1, - with previous hypersensitivity reactions (e.g. bronchospasm, angioedema, rhinitis, urticaria or asthma) in response to acetylsalicylic acid (ASA) or other nonsteroidal anti-inflammatory drugs (NSAIDs), - with presence or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding), - with history of gastrointestinal bleeding or perforation related to previous NSAID therapy, - with severe hepatic insufficiency, severe renal insufficiency or severe heart failure (NYHA Class IV) (see section 4.4), - (200 mg only) children under 20 kg (approximately 6 years of age) - (400 mg only) adolescents under 40 kg or children under 18 years of age. 12 years of age - with cerebrovascular haemorrhage or other types of active bleeding, - with unexplained blood formation disorders, - with severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake), - during the last trimester of pregnancy (see section 4.6).

DOSAGE

Quantity and method of taking Brufen 400 mg 12 coated tablets - How to take Brufen 400 mg 12 coated tablets?

Adults and adolescents ≥ 40 kg body weight (12 years of age and over): (200 mg only) Initial dose: 200 mg or 400 mg. An additional dose of 1 or 2 tablets (200 mg to 400 mg) may be taken if necessary. The corresponding dosing interval should be chosen based on symptoms and the maximum recommended daily dose. It should not be less than 6 hours for a 400 mg dose and not less than 4 hours for a 200 mg dose. Do not exceed 1200 mg in any 24-hour period. (400 mg only) Initial dose: 400 mg. An additional dose of 400 mg may be taken if necessary. The corresponding dosing interval should be chosen based on symptoms and the maximum recommended daily dose. It should not be less than 6 hours for a 400 mg dose. Do not exceed 1200 mg in any 24-hour period. Paediatric population (200 mg only) Children over 6 years (20 kg - 40 kg body weight): Ibuprofen should only be used in children with a body weight of at least 20 kg. The maximum daily dose of ibuprofen is 20 - 30 mg ibuprofen per kg body weight, divided into 3 or 4 individual doses with an interval between doses of 6 to 8 hours. The maximum recommended daily dose should not be exceeded. A maximum dosage of 30 mg/kg ibuprofen in any 24-hour period should not be exceeded. The following dosage information applies:

Body weight	Single dose	Maximum daily dose
20kg - 29kg	1 tablet (200 mg ibuprofen)	3 tablets (equivalent to 600 mg of ibuprofen)
30kg - 39kg	1 tablet (200 mg ibuprofen)	4 tablets (equivalent to 800 mg of ibuprofen)

If this medicine is required for more than 3 days in children over 6 years of age and in adolescents or if symptoms worsen, a doctor should be consulted. Children under 6 years of age BRUFEN ANALGESICO is contraindicated in children under 6 years of age. (Only 400 mg) BRUFEN ANALGESICO is contraindicated in adolescents under 40 kg of body weight or in children under 12 years of age. If this medicine is required for more than 3 days in children over 12 years of age and in adolescents or if symptoms worsen, a doctor should be consulted. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). For short-term use only. If the medicine is required for more than 3 days in case of fever or for more than 4 days for the treatment of pain or if symptoms worsen, the patient should be advised to consult a doctor. Elderly patients No dose adjustment is necessary. Elderly patients should be monitored particularly carefully because of the possible adverse effect profile (see section 4.4). Patients with gastric sensitivity Patients with a sensitive stomach should take BRUFEN ANALGESICO during a meal. Taking ibuprofen after a meal may delay the onset of its action. If this occurs, additional ibuprofen should not be taken beyond that specified in section 4.2 (Posology) or until the corresponding dosing interval has elapsed. Patients with renal impairment No dose reduction is required in patients with mild to moderate renal impairment. For patients with severe renal dysfunction, see section 4.3. Patients with hepatic impairment No dose reduction is required in patients with mild to moderate hepatic impairment. For patients with severe hepatic dysfunction, see section 4.3. Method of administration For oral administration and short-term use only. Ibuprofen tablets should be swallowed whole with plenty of water. Do not chew the tablets.

CONSERVATION

Storage Brufen 400 mg 12 coated tablets - How to store Brufen 400 mg 12 coated tablets?

This medicinal product does not require any special storage conditions.

WARNINGS

Warnings Brufen 400 mg 12 coated tablets - About Brufen 400 mg 12 coated tablets it is important to know that:

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see effects on the gastrointestinal and cardiovascular systems). Caution should be exercised when administering ibuprofen to patients suffering from the following conditions, which may be exacerbated: - inborn errors of porphyrin metabolism (e.g. acute intermittent porphyria), - bleeding disorders (ibuprofen may prolong the duration of coagulation), - directly after major surgery, - systemic lupus erythematosus and mixed connective tissue disease (e.g. increased risk of aseptic meningitis) (see section 4.8), - hypertension and/or cardiac insufficiency, as renal function may deteriorate (see sections 4.3 and 4.8), - in patients suffering from hay fever, nasal polyps or chronic obstructive respiratory disorders, as they are at increased risk of allergic reactions. These may present with an asthma attack (so-called analgesic asthma), Quincke's edema or urticaria, - in patients who react allergically to other substances, since there is also an increased risk of hypersensitivity reactions during the use of ibuprofen. Elderly Elderly have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal (see section 4.2). Respiratory reactions Bronchospasm may be precipitated in patients suffering from bronchial asthma or allergic diseases or with a history of such diseases. Other NSAIDs The use of ibuprofen with other NSAIDs, including cyclooxygenase-2 selective inhibitors, increases the risk of adverse reactions and should be avoided (see section 4.5). Renal effects Renal impairment, since renal function may further deteriorate (see sections 4.3 and 4.8). In general, the habitual intake of analgesics, especially the combination of several analgesic substances, may lead to permanent kidney damage with risk of renal failure (analgesic nephropathy). This risk may increase under physical exertion associated with salt loss and dehydration. Therefore it should be avoided. There is a risk of renal impairment in dehydrated children and adolescents. Hepatic effects Hepatic dysfunction (see sections 4.3 and 4.8). It is appropriate to discontinue ibuprofen therapy when deterioration of liver function occurs concomitantly with its administration. After discontinuation of treatment, the state of health usually normalizes. Occasional monitoring of blood glucose is also appropriate. Cardiovascular and cerebrovascular effects Particular caution is required (discuss with your doctor or pharmacist) before starting treatment in patients with a history of hypertension and/or heart failure, because fluid retention, hypertension and oedema have been reported in association with NSAID therapy. Patients with uncontrolled hypertension (NYHA II-III), congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with ibuprofen after careful consideration and high doses (2400 mg/day) should be avoided. Careful consideration should also be exercised before initiating long-term treatment in patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus or smoking), particularly if high doses of ibuprofen (2400 mg/day) are required. Clinical trials suggest that use of ibuprofen, particularly at a high dose (2400 mg/day) and in long-term treatment, may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). In general, epidemiological studies do not indicate that low dose ibuprofen (e.g. ≤1200 mg/day) is associated with an increased risk of arterial thrombotic events. Impaired female fertility There is some evidence that drugs which inhibit cyclooxygenase/prostaglandin synthesis may cause impairment of female fertility by an effect on ovulation. This is reversible upon discontinuation of treatment (see section 4.6). Gastrointestinal safety NSAIDs should be given with caution to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated (see section 4.8). GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious GI events. In patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3), and in the elderly, the risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses. These patients should start treatment on the lowest dose available. Concomitant use of protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients and for patients taking concomitant low dose acetylsalicylic acid or other drugs likely to increase GI risk (see below and section 4.5). Patients with a history of GI toxicity, particularly when elderly, should report any unusual GI symptoms (especially GI bleeding) particularly in the initial stages of treatment. Caution should be advised in treating patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or anti-platelet agents such as acetylsalicylic acid (see section 4.5). When gastrointestinal bleeding or ulceration occurs in patients receiving ibuprofen, the treatment should be withdrawn. Severe skin reactions Serious skin reactions, some of them fatal, such as exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see section 4.8). Patients appear to be at highest risk of these reactions early in the course of therapy: the onset of the reaction occurring in the majority of cases within the first month of treatment. Acute generalised exanthematous pustulosis (AGEP) has been reported in association with medicinal products containing ibuprofen. The use of ibuprofen should be discontinued at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity. Exceptionally, chickenpox may cause severe skin reactions and infectious complications of the soft tissues. So far, the contributory role of NSAIDs in the worsening of these infections cannot be excluded. Therefore, it is recommended to avoid the use of ibuprofen in case of chickenpox. Masking of symptoms of underlying infections BRUFEN ANALGESICO may mask the symptoms of infection, which may delay the initiation of adequate treatment and therefore worsen the outcome of the infection. This has been observed in community-acquired bacterial pneumonia and in bacterial complications of chickenpox. When BRUFEN ANALGESICO is administered for the relief of fever or pain related to infection, monitoring of the infection is recommended. In non-hospital settings, the patient should seek medical attention if symptoms persist or worsen. Other observations In rare cases, severe acute hypersensitivity reactions (e.g. anaphylactic shock) have been observed. Therapy should be discontinued at the first signs of a hypersensitivity reaction after intake/administration of ibuprofen. Medical procedures appropriate to the symptoms should be performed by specialist personnel. Ibuprofen may temporarily inhibit platelet function (thrombocyte aggregation). Therefore, it is recommended to carefully monitor patients with coagulation disorders. In prolonged administration of ibuprofen, regular monitoring of liver parameters, renal function and blood cell counts is recommended. Prolonged use of any type of headache analgesic may cause worsening of headache. If such a situation occurs or is suspected, medical advice should be obtained and treatment should be discontinued. The diagnosis of medication-overuse headache should be suspected in patients who have frequent or daily headaches despite (or because of) the regular use of headache medications. Medication overuse headache should not be treated by increasing the dosage of the medicine. During treatment with ibuprofen, some cases with symptoms of aseptic meningitis, such as stiff neck, headache, nausea, vomiting, fever or disorientation, have been observed in patients with pre-existing autoimmune disorders (such as systemic lupus erythematosus, mixed connective tissue disease). Alcohol consumption should be avoided as it may intensify the side effects of NSAIDs, especially those related to the gastrointestinal tract or the central nervous system. Patients treated with ibuprofen should report to their doctor any signs or symptoms of gastrointestinal ulcer or bleeding, blurred vision or other ocular symptoms, skin rash, weight gain or oedema. If vision problems, blurred vision, scotoma or malfunction of color perception occur, treatment should be discontinued.

INTERACTIONS

Interactions Brufen 400 mg 12 coated tablets - Which medicines or foods can modify the effect of Brufen 400 mg 12 coated tablets?

The use of ibuprofen should be avoided in combination with: Acetylsalicylic acid Concomitant administration of ibuprofen and acetylsalicylic acid is generally not recommended due to the potential for increased adverse effects. Experimental data suggest that ibuprofen may competitively inhibit the effect of low dose acetylsalicylic acid on platelet aggregation when the two drugs are administered concomitantly. Although there are uncertainties regarding extrapolation of these data to the clinical situation, the possibility that regular, long-term use of ibuprofen may reduce the cardioprotective effect of low dose acetylsalicylic acid cannot be excluded. No clinically relevant effect is considered likely following occasional use of ibuprofen (see section 5.1). Other NSAIDs including salicylates and selective cyclooxygenase-2 inhibitors : Avoid concomitant use of two or more NSAIDs, as this may increase the risk of gastrointestinal ulcers and bleeding due to a synergistic effect (see section 4.4). Anticoagulants: NSAIDs may enhance the effects of anticoagulants, such as warfarin (see section 4.4). Diuretics, ACE inhibitors, beta blockers and angiotensin II antagonists: NSAIDs may reduce the effect of diuretics and other antihypertensive drugs. In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal function) the co-administration of an ACE inhibitor, a beta blocker or an angiotensin II antagonist and agents that inhibit the cyclooxygenase system may result in further deterioration of renal function, including acute renal failure, which is usually reversible. Therefore, the combination should be administered with caution, especially in elderly patients. Patients should be adequately hydrated and consideration should be given to monitoring renal function after initiation of concomitant therapy and regularly thereafter. Potassium-sparing diuretics : Concomitant administration of ibuprofen and potassium-sparing diuretics may lead to hyperkalaemia (monitoring of serum potassium is recommended). Corticosteroids: Increased risk of adverse reactions, especially of the gastrointestinal tract (gastrointestinal ulceration or bleeding) (see section 4.4). Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs): Increased risk of gastrointestinal bleeding (see section 4.4). Digoxin : NSAIDs may exacerbate cardiac failure, reduce glomerular filtration rate and increase plasma digoxin levels. A check of serum digoxin is not required, as a rule, in correct use (maximum 4 days). Phenytoin : Concomitant use of ibuprofen with phenytoin preparations may increase serum phenytoin levels. Monitoring of serum phenytoin is not required, as a rule, in correct use (maximum 4 days). Lithium : There is evidence of potential increases in plasma lithium levels. Monitoring of serum lithium is not required, as a rule, in correct use (maximum 4 days). Methotrexate: Administration of ibuprofen within 24 hours before administration of methotrexate may lead to an increase in the concentration of methotrexate and an increase in toxic effects. Ciclosporin : The risk of a damaging effect on the kidneys due to ciclosporin is increased by co-administration of certain NSAIDs. This effect cannot be excluded also for the association of ciclosporin with ibuprofen. Mifepristone. NSAIDs should not be used for 8-12 days after mifepristone administration, because NSAIDs may reduce the effect of mifepristone. Sulfinpyrazone : Medicines containing sulfinpyrazone may delay the excretion of ibuprofen. Probenecid: Medicines containing probenecid may reduce the excretion of NSAIDs and may increase their serum concentrations. Tacrolimus: Possible increased risk of nephrotoxicity when NSAIDs are co-administered with tacrolimus. Zidovudine: Increased risk of haematological toxicity when NSAIDs are co-administered with zidovudine. A blood count is recommended 1-2 weeks after initiation of co-administration. There are indications of an increased risk of haemarthrosis and haematoma in HIV-positive patients with haemophilia receiving concomitant treatment with zidovudine and ibuprofen. Sulfonylureas : NSAIDs may either increase or decrease the hypoglycaemic effect of sulfonylureas. Caution is advised in case of simultaneous treatment. Quinolone antibiotics : Animal data indicate that NSAIDs may increase the risk of convulsions associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may be at increased risk of developing convulsions. Alcohol, bisphosphonates, oxpentifylline (pentoxifylline) and sulfinpyrazone : may potentiate the gastrointestinal effects and the risk of bleeding or ulceration. Baclofen : increased toxicity of baclofen.

SIDE EFFECTS

Like all medicines, Brufen 400 mg 12 coated tablets can cause side effects - What are the side effects of Brufen 400 mg 12 coated tablets?

Possible side effects are those observed with ibuprofen acid. Undesirable effects are mostly dose-dependent and vary individually. In particular, the risk of gastrointestinal bleeding is dependent on the dose and duration of treatment. For other risk factors, see section 4.4. The following undesirable effects are related to the short-term use of low-dose ibuprofen (up to 1200 mg per day for mild to moderate pain and fever). Other undesirable effects may occur with treatments for other indications or prolonged use. Undesirable effects associated with ibuprofen are listed in the table below by system organ class and frequency. Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 and < 1/10), uncommon (≥ 1/1000 and < 1/100), rare (≥ 1/10,000 and < 1/1000), very rare (< 1/10,000) and not known (cannot be estimated from the available data). For each frequency, undesirable effects are listed in descending order of frequency.

Classification by systems and organs	Frequency	Side effects
Pathologies of the haemolymphopoietic system	Very rare	hematopoietic pathologies¹
Immune system disorders	Uncommon	hypersensitivity reactions with urticaria and pruritus²
	Very rare	severe hypersensitivity reactions. Symptoms may include: swelling of the face, tongue and larynx, edema, dyspnoea, tachycardia, hypotension (anaphylaxis, angioedema or severe shock)²
Psychiatric disorders	Rare	confusion, hallucinations
	Not known	psychotic disorders, depression
Nervous system disorders	Common	headache, drowsiness, dizziness, fatigue, agitation, vertigo, insomnia, irritability
	Very rare	aseptic meningitis
Eye pathologies	Not known	amblyopia 4 , blurred vision 4 , reduced vision 4
Ear and labyrinth pathologies	Rare	Tinnitus
Heart disease	Very rare	Palpitations, myocardial infarction, acute pulmonary edema
	Not known	heart failure, edema
Vascular pathologies	Not known	arterial hypertension
Respiratory, thoracic and mediastinal pathologies	Uncommon	Rhinitis
	Very rare	Asthma exacerbation
	Not known	Respiratory tract reactions such as bronchospasm, asthma or dyspnoea²
Gastrointestinal disorders	Very common	Heartburn, abdominal pain, nausea, dyspepsia, diarrhea, flatulence, constipation and vomiting 5
	Common	Peptic ulcer 6 , gastrointestinal perforation or bleeding 6 , melena, haematemesis, ulcerative stomatitis, colitis
	Uncommon	gastritis
	Very rare	esophagitis, pancreatitis, intestinal narrowing
	Not known	exacerbation of colitis and Crohn's disease 7
Hepatobiliary pathologies	Very rare	liver dysfunction, liver damage, especially in long-term use, liver failure, acute hepatitis and jaundice 8
Skin and subcutaneous tissue disorders	Uncommon	Photosensitivity, skin rash²
	Very rare	Severe forms of soft tissue skin reactions may occur during chickenpox infections, necrotizing fasciitis, exfoliative dermatitis, bullous reactions, including Stevens-Johnson syndrome, erythema multiforme and toxic epidermal necrolysis²
	Not known	Alopecia 9 , adverse reaction with eosinophilia and systemic symptoms (DRESS syndrome). Acute generalized exanthematous pustulosis (AGEP).
Kidney and urinary disorders	Uncommon	development of edema, especially in patients with arterial hypertension or renal insufficiency, nephrotic syndrome, interstitial nephritis which may be associated with renal insufficiency 10
	Rare	renal papillary necrosis 10
	Very rare	Acute renal failure 10 , dysuria
Reproductive system and breast disorders	Not known	menstrual disorders
Diagnostic tests	Rare	increased blood urea nitrogen, transaminases and alkaline phosphatase, decreased hemoglobin and hematocrit values, inhibition of platelet aggregation, decreased serum calcium, increased serum uric acid
	Not known	prolongation of bleeding time 11

Description of selected adverse reactions ¹ Examples include anaemia, leucopenia, thrombocytopenia, pancytopenia and agranulacytosis. Early signs: fever, sore throat, mouth ulcers, flu-like symptoms, symptoms of severe fatigue, nasal and skin bleeding. ² Hypersensitivity reactions: may include (a) non-specific allergic reactions and anaphylaxis, (b) respiratory tract reactions including asthma, exacerbation of asthma, bronchospasm and dyspnoea, or (c) various skin reactions including urticaria, exanthema and purpura, sometimes associated with pruritus. Angioedema and, in rare cases, exfoliative and bullous dermatitis including toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme have been reported. Some reactions including meningeal irritation and lethargy are considered to be associated with hypersensitivity reactions. Systemic lupus erythematosus and other collagen diseases are risk factors for severe cases of generalized hypersensitivity reactions. General hypersensitivity reactions are uncommon. Symptoms may include fever with rash, abdominal pain, headache, nausea and vomiting, signs of liver damage and even meningeal symptoms. In rare cases, ibuprofen may lead to bronchospasm in susceptible individuals. ³ The pathogenic mechanism of drug-induced aseptic meningitis is not fully understood. However, available data on NSAID-related aseptic meningitis suggest a hypersensitivity reaction (due to the temporal correlation between administration of the drug and the disappearance of symptoms after discontinuation of treatment). Isolated cases of aseptic meningitis symptoms such as stiff neck, headache, vomiting, fever and disorientation have been observed during treatment with ibuprofen in patients with pre-existing autoimmune diseases (systemic lupus erythematosus and mixed connective tissue diseases). ⁴ Reversible effects have been observed. ⁵ The most common adverse reactions are gastrointestinal adverse reactions. ⁶ Uncommonly fatal, especially in elderly patients. See Special warnings and precautions for use. ⁷ See section 4.4 ⁸ Hepatotoxic reactions may occur as part of generalised hypersensitivity reactions. ⁹ Reversible alopecia has been reported in black women. ¹⁰ Especially with prolonged use, associated with elevated serum urea concentrations, decreased urine output and oedema. Includes papillary necrosis. ¹¹ Ibuprofen may prolong bleeding time at doses exceeding 1000 mg daily. Clinical trial and epidemiological data suggest that use of ibuprofen, particularly at high doses (2400 mg daily) and in prolonged periods, may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see section 4.4). Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

OVERDOSE

Overdose Brufen 400 mg 12 coated tablets - What are the risks of Brufen 400 mg 12 coated tablets in case of overdose?

In children, ingestion of more than 400 mg/kg may cause symptoms. In adults, the dose-response effect is less clear. The half-life in overdose is 1.5-3 hours. Symptoms Significant overdoses are generally well tolerated provided no other medicinal products are involved. Most patients who have ingested significant quantities of NSAIDs will experience no more than nausea, vomiting, epigastric pain or, more rarely, diarrhoea. Tinnitus, headache and gastrointestinal bleeding are also possible. In more severe poisonings, central nervous system toxicity is observed, manifested by dizziness, drowsiness, occasionally excitement, disorientation, loss of consciousness (in children also myoclonic convulsions) or coma. Occasionally, patients experience convulsions. In severe poisoning, metabolic acidosis may occur and the prothrombin time/INR may be prolonged, probably due to interference with the actions of circulating coagulation factors. Acute renal failure and liver damage may occur. Exacerbation of asthma may occur in asthmatics. Hypotension, respiratory depression, and cyanosis may also occur. Treatment There is no specific antidote. Treatment should be symptomatic and supportive, including maintaining a clear airway and monitoring the heart and vital signs until stabilization occurs. Correction of serum electrolyte balance should be performed if necessary. Forced diuresis and hemodialysis are not helpful, as ibuprofen is extensively metabolized and almost entirely protein bound. Gastric emptying or oral administration of activated charcoal is indicated if the patient presents within 1 hour of ingesting a large amount. Activated charcoal may hinder endoscopy if gastrointestinal bleeding occurs. If frequent and prolonged, seizures should be treated with diazepam or lorazepam IV. Bronchodilators should be given for asthma.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Brufen 400 mg 12 coated tablets.

Pregnancy Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or embryo/foetal development. Data from epidemiological studies show an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The risk is believed to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has induced an increase in pre- and post-implantation loss and embryo-foetal mortality. In addition, an increased incidence of various malformations, including cardiovascular, has been reported in animals given prostaglandin synthesis inhibitors during the organogenesis period. From the 20th week of pregnancy onwards, the use of ibuprofen may cause oligohydramnios resulting from fetal renal dysfunction. This condition may occur soon after initiation of treatment and is usually reversible upon discontinuation of treatment. In addition, cases of constriction of the ductus arteriosus have been reported following treatment in the second trimester, most of which resolved upon discontinuation of treatment. Therefore, during the first and second trimester of pregnancy, ibuprofen should not be given unless clearly necessary. If ibuprofen is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low and duration of treatment as low as possible. Following exposure to ibuprofen for several days from the 20th week of gestation onwards, antenatal monitoring for oligohydramnios and constriction of the ductus arteriosus should be considered. If oligohydramnios or constriction of the ductus arteriosus occurs, ibuprofen should be discontinued. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the foetus to: - cardiopulmonary toxicity (premature constriction/closure of the ductus arteriosus and pulmonary hypertension); - renal dysfunction (see above) the mother and the neonate, at the end of pregnancy, to: - possible prolongation of bleeding time and anti-aggregating effect which may occur even at very low doses; - inhibition of uterine contractions resulting in delayed or prolonged labour. Consequently, the use of ibuprofen is contraindicated during the third trimester of pregnancy (see sections 4.3 and 5.3). Breast-feeding Only small amounts of ibuprofen and its metabolites are excreted in breast milk. To date, no harmful effects on the infant are known. Consequently, ibuprofen can be used during breast-feeding for the treatment of pain and fever in the short term and at the recommended doses. The safety for long-term use has not been established. Fertility There is evidence that drugs that inhibit cyclooxygenase/prostaglandin synthesis may cause impairment of female fertility due to an effect on ovulation. This event is reversible upon discontinuation of treatment.

DRIVING AND USE OF MACHINERY

Taking Brufen 400 mg 12 coated tablets before driving or using machines - Does Brufen 400 mg 12 coated tablets affect driving or using machines?

Ibuprofen has no or negligible influence on the ability to drive and use machines. However, since side effects such as fatigue, drowsiness, visual disturbances (reported as common) may occur at high doses, the ability to drive and use machines may be impaired in individual cases. This effect is enhanced by simultaneous consumption of alcohol.