Ratiopharm Ibuprofen 400mg 12 Coated Tablets

NAME
IBUPROFENE FARMAPRO 400 MG TABLETS COATED WITH FILM

PHARMACOTHERAPEUTIC CATEGORY
Non-steroidal anti-inflammatory and antirheumatic drugs.

ACTIVE PRINCIPLES
Ibuprofen.

EXCIPIENTS
Tablet core: modified corn starch; croscarmellose sodium; hypromellose; stearic acid; anhydrous colloidal silica. Coating: hypromellose; macrogol 8000; titanium dioxide.

INDICATIONS
Short-term symptomatic treatment of: mild to moderate pain.

CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity to the active substance or to any of the listed excipients; known reactions of bronchospasm, asthma, rhinitis, angioedema or urticaria following previous intake of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs); unspecified disturbances of blood formation; peptic ulcer / active haemorrhage or history of peptic ulcer / recurrent haemorrhage (two or more distinct episodes of proven ulceration or bleeding); history of gastrointestinal bleeding or perforation related to previous NSAID treatment; cerebrovascular haemorrhage or other types of active haemorrhage; severely impaired liver or kidney function; severe heart failure; severe dehydration (caused by vomiting, diarrhea or insufficient fluid intake); last trimester of pregnancy; the drug is contraindicated in children and adolescents under 15 years of age, as this dosage is not suitable due to the high quantity of active ingredient.

DOSAGE
The lowest effective dose should be used for the minimum time necessary to relieve symptoms. The dose of ibuprofen is based on the patient's body weight and age. The intervals between administrations depend on the symptoms and the maximum total daily dose. A minimum interval of at least 6 hours must be applied. The recommended dose must not be exceeded. >> Film-coated tablets 400 mg. Over 15 years: 1 tablet (equivalent to 400 mg of ibuprofen) as a single dose; 3 tablets (equivalent to 1200 mg of ibuprofen) maximum daily dose. For short-term use: if the use of the medicine is necessary for more 'than 3 days in adolescents, or in the case of worsening of symptoms. If the use of the medicine is necessary for more 'than 4 days in adults, or if symptoms worsen, a doctor should be consulted. Elderly: No specific dose adjustment required. Due to the possible side effect profile, elderly patients should be monitored with particular care. Renal impairment: No dose reduction is expected in patients with mild to moderate renal impairment. Hepatic impairment: No dose reduction is expected in patients with mild to moderate hepatic impairment. Method of administration: for oral use. The film-coated tablets should be swallowed whole with water. In patients with gastric sensitivity it is recommended to take ibuprofen with meals.

STORAGE
This medicinal product does not require any special storage conditions.

WARNINGS
Undesirable effects can be minimized by using the lowest effective dose for the minimum time necessary to achieve symptom control. Gastrointestinal safety: Concomitant use of ibuprofen and other NSAIDs, including selective cyclooxygenase-2 inhibitors should be avoided. Elderly: Elderly patients are subject to an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal. Gastrointestinal bleeding, ulceration and perforation: GI bleeding, ulceration or perforation, which can be fatal, has been reported during treatment with all NSAIDs, at any time during therapy, with or without warning symptoms or a previous history of serious gastrointestinal events. In patients with a history of ulcer, particularly if complicated with haemorrhage or perforation, and in the elderly, the risk of gastrointestinal bleeding, ulceration or perforation is greater with increasing NSAID doses. These patients should start treatment with the lowest available dose. Concomitant use of protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for both these patients and for patients taking concomitantly low doses of acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal events. Patients with a history of gastrointestinal toxicity, particularly if elderly, should report any symptoms of an unusual gastrointestinal nature (especially gastrointestinal haemorrhage) particularly in the initial stages of treatment. Caution is needed when treating patients taking concomitant medications that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as acetylsalicylic acid. When gastrointestinal bleeding or ulceration occurs in patients taking ibuprofen, the treatment should be discontinued. NSAIDs should be administered with caution to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease), as these conditions can be exacerbated. Cardiovascular and cerebrovascular effects: particular caution is required before starting treatment in patients with a history of hypertension and / or heart failure, because fluid retention, hypertension and edema have been reported in association with NSAID therapy. Clinical studies and epidemiological data suggest that the use of ibuprofen, especially at high doses (2400 mg per day) and for long-term treatments, may be associated with a slightly increased risk of arterial thrombotic events. In general, epidemiological studies do not indicate that low doses of ibuprofen (e.g. <= 1200 mg per day) are associated with an increased risk of myocardial infarction. 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. In the early stages of therapy, patients seem to be at a higher risk of these reactions: in fact, the onset of the reaction occurs in most cases within the first month of treatment. The use of ibuprofen should be discontinued at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity '. Exceptionally, chickenpox can be the cause of severe skin and soft tissue infectious complications. So far, it has not been possible to exclude that NSAIDs contribute to the worsening of these infections. It is therefore recommended not to use the medicine in case of chickenpox. Particular caution is required in patients presenting with: systemic lupus erythematosus (SLE) and mixed connective tissue disease; congenital disorders of porphyrin metabolism (eg acute intermittent porphyria); chronic inflammatory gastrointestinal disorders or bowel disease (ulcerative colitis, Crohn's disease); hypertension and / or heart failure; impaired renal function (as acute deterioration of renal function may occur in patients with pre-existing renal disease); dehydration; impaired liver function; hay fever, nasal polyps or chronic obstructive respiratory diseases as there is an increased risk of allergic reactions for them. These can manifest as asthma attacks (so-called analgesic asthma), Quincke's edema or urticaria; allergies to other substances, as there is an increased risk of hypersensitivity reactions for them even with the use of the drug; directly after major surgery. Additional information: Ibuprofen, can 'temporarily inhibit the function of platelets (platelet aggregation). Patients with coagulation disorders should therefore be carefully monitored. If prolonged therapy with ibuprofen is considered necessary, regular checks of liver values, renal function and blood cell counts should be performed. Adequate water supply must be ensured during treatment to prevent dehydration and the possible increase in renal toxicity associated with the use of ibuprofen. Prolonged use of any pain reliever for headache can make it worse. If this occurs or is suspected, medical advice should be sought and treatment discontinued. The diagnosis of drug overuse headache (MOH) should be suspected in patients who have frequent or daily headaches despite (or due to) regular use of headache medications. In general, the habitual intake of analgesics, in particular a combination of different analgesic substances, can cause permanent renal damage with the risk of renal failure (analgesic nephropathy). Following concomitant alcohol consumption, undesirable effects related to the active substance, especially those affecting the gastrointestinal tract or the central nervous system, may increase during the use of NSAIDs. In very rare cases, severe acute hypersensitivity reactions (eg anaphylactic shock) have been observed. Therapy should be discontinued at the first signs of a hypersensitivity reaction after taking / administering ibuprofen. Medical procedures appropriate to the symptoms must be performed by specialized personnel. NSAIDs can mask the symptoms of infections and fever. There is a risk of renal impairment in dehydrated adolescents.

INTERACTIONS
Caution is needed if ibuprofen is taken concomitantly with the following medicines. Acetylsalicylic acid or other non-steroidal anti-inflammatory drugs / analgesics: increased risk of gastrointestinal ulcer and bleeding. Digoxin, phenytoin, lithium: the concomitant use of the drug and preparations based on digoxin, phenytoin or lithium can increase the serum levels of these drugs. Correct use of the drugs mentioned does not normally require monitoring of serum levels of lithium, digoxin and phenytoin. Diuretics, ACE inhibitors, beta-blockers and angiotensin II antagonists: NSAIDs may reduce the effect of diuretics and other antihypertensive drugs. In some patients with impaired renal function (e.g. dehydrated patients or elderly patients with impaired renal function) the co-administration of an ACE inhibitor, a beta-blocker or an angiotensin II antagonist and agents that inhibit the cyclooxygenase, may result in further deterioration of renal function, including acute renal failure, which is generally reversible. Therefore, the combination should be administered with caution, especially in elderly patients. Patients should be adequately hydrated and monitoring of renal function should be considered after initiation of concomitant therapy and regularly thereafter. Concomitant administration of the drug and potassium-sparing diuretics can lead to hyperkalaemia. Corticosteroids: increased risk of gastrointestinal ulceration or bleeding. Anticoagulants: NSAIDs can increase the effects of anticoagulants, such as warfarin. Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding. Methotrexate: Administration of the drug within 24 hours before or after the administration of methotrexate can lead to elevated concentrations of methotrexate and an increase in its toxic effects. Zidovudine: There are indications of an increased risk of haemarthrosis and hematoma in HIV positive patients with haemophilia receiving concomitant treatment with zidovudine and ibuprofen. Ciclosporin: there are indications of a possible interaction involving an increased risk of renal toxicity. Sulfonylureas: Clinical studies have shown interactions between non-steroidal anti-inflammatory drugs and antidiabetic drugs (sulfonylureas). Although interactions between ibuprofen and sulphonylurea have not been described so far, a check of blood glucose values is recommended as a precautionary measure during concomitant intake. Tacrolimus: the risk of renal toxicity increases if the two drugs are co-administered. Probenecid and sulfinpyrazone: Medicines that contain probenecide sulfinpyrazone may delay the excretion of ibuprofen. Quinolone antibiotics: Data from animal studies indicate that NSAIDs may increase the risk of seizures associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing seizures. CYP2C9 inhibitors: Concomitant administration of ibuprofen and CYP2C9 inhibitors may increase exposure to ibuprofen (CYP2C9 substrate). In a study with voriconazole and fluconazole (CYP2C9 inhibitors), an increased exposure to S (+) - ibuprofen from approximately 80% to 100% was observed. Dose reduction of ibuprofen should be considered when co-administered strong CYP2C9 inhibitors, particularly when high doses of ibuprofen are administered with voriconazole or fluconazole. Experimental data suggest that ibuprofen may inhibit the effect of low dose acetylsalicylic acid on platelet aggregation when the two drugs are administered simultaneously. However, the limitations of these data and the uncertainties regarding extrapolation of ex vivo data to the clinical situation do not allow firm conclusions to be drawn for the regular use of ibuprofen, and no relevant clinical effects are considered likely following occasional ibuprofen use. .

SIDE EFFECTS
The list of undesirable effects below includes all known undesirable effects associated with ibuprofen treatment, including those reported by patients with rheumatism on prolonged high dose treatment. Frequency data, except very rare reports, are based on short-term drug administration with maximum daily doses of 1200 mg ibuprofen for oral formulations, and maximum doses of 1800 mg for suppositories. The following frequencies were used in the evaluation of undesirable effects: very common (> = 1/10); common (> = 1/100, <1/10); uncommon (> = 1/1000, <1/100); rare (> = 1 / 10,000, <1/1000); very rare (<1 / 10,000); not known. It should be considered that the following adverse reactions are predominantly dose-dependent and patient-patient variable. Adverse events commonly observed are gastrointestinal in nature. Peptic ulcers, gastrointestinal perforation or bleeding, sometimes fatal, may occur, especially in the elderly. Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported following administration of ibuprofen. Gastritis was observed less frequently. In particular, the risk of gastrointestinal bleeding depends on the dose and duration of treatment. Edema, hypertension and heart failure have been reported in association with NSAID treatment. Clinical studies and epidemiological data suggest that the use of ibuprofen, especially at high doses (2400mg per day) and for long-term treatments, may be associated with a slightly increased risk of arterial thrombotic events (for example myocardial infarction or stroke). Infections and infestations: Exacerbation of inflammation associated with infection (e.g. development of necrotizing fasciitis) has been reported very rarely in conjunction with the use of non-steroidal anti-inflammatory drugs. This is probably related to the mechanism of action of nonsteroidal anti-inflammatory drugs. Therefore, if signs of an infection appear or an infection worsening during treatment with the drug, it is recommended that the patient seek medical attention without delay. Sid will therefore have to evaluate if there is a need for anti-infective / antibiotic therapy. Symptoms of aseptic meningitis, with neck stiffness, headache, nausea, vomiting, fever or clouding of consciousness have been observed very rarely during treatment with ibuprofen. Patients with autoimmune disorders (SLE, mixed connective tissue disease) appear to be predisposed. Disorders of the blood and lymphatic system. Very rare: haematopoietic disorders (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). The first signs may be the following: fever, sore throat, superficial oral lesions, flu-like symptoms, severe physical exhaustion, nosebleed and skin. In such cases, the patient should be advised to stop taking the medicinal product immediately, to avoid self-medication with analgesics or antipyretics and to seek medical attention. Immune system disorders. Uncommon: hypersensitivity reactions', with skin rash and itching, or asthma attacks (possibly with drop in blood pressure). The patient must be warned to inform a doctor immediately and not to take the drug anymore, in this case; very rare: severe general hypersensitivity reactions. This can present as face edema, swelling of the tongue, swelling of the internal larynx with consequent constriction of the respiratory tract, respiratory distress, rapid heartbeat, drop in blood pressure up to shock dangerous for the patient's survival. If one of these symptoms occurs, which can also occur during the first use of the drug, immediate medical assistance is required. Psychiatric disorders. Very rare: psychotic reactions, depression. Nervous system disorders. Uncommon: central nervous system disorders such as headache, dizziness, insomnia, excitement, irritability or fatigue. Eye disorders. Uncommon: visual disturbances. In this case, the patient should be advised to inform the doctor immediately and to stop taking ibuprofen. Ear and labyrinth disorders. Rare: tinnitus. Cardiac pathologies. Very rare: palpitations, heart failure, myocardial infarction. Vascular pathologies. Very rare: arterial hypertension, vasculitis. Gastrointestinal disorders. Common: gastrointestinal disturbances such as heartburn, abdominal pain, nausea, vomiting, flatulence, diarrhea, constipation and slight gastrointestinal blood loss which can cause anemia in exceptional cases; uncommon: gastrointestinal ulcers, potentially with haemorrhage and perforation. Ulcerative stomatitis, exacerbation of colitis and Crohn's disease, gastritis; very rare: esophagitis, pancreatitis, formation of diaphragmatic intestinal strictures. The patient should be advised to stop taking the medicinal product and to see a doctor immediately if relatively severe upper abdominal pain or melaena or haematemesis occurs. Hepatobiliary disorders. Very rare: hepatic dysfunction, liver damage, particularly in long-term therapy, hepatic failure, acute hepatitis. Skin and subcutaneous tissue disorders. Uncommon: various skin rashes; very rare: bullous reactions including Stevens Johnson syndrome and Toxic Epidermal Necrolysis (Lyell's syndrome); alopecia; in isolated cases, severe skin infections with soft tissue complications may arise during a chickenpox infection. Renal and urinary disorders. Rare: kidney tissue damage (papillary necrosis); increase in serum concentration of uric acid; very rare: edema formation, particularly in patients with arterial hypertension or renal insufficiency, nephrotic syndrome, interstitial nephritis which may be accompanied by acute renal insufficiency; reduced urinary excretion and edema may be indicative of renal disease, which may sometimes include renal failure. If such symptoms appear or worsen, the patient should be advised to stop taking ibuprofen. The reporting of suspected adverse reactions that occur after the authorization of the drug is important, as it allows continuous monitoring of the benefit / risk ratio of the drug.

PREGNANCY AND BREASTFEEDING
Inhibition of prostaglandin synthesis can negatively affect pregnancy and / or embryo / fetal development. Data from epidemiological studies show an increased risk of abortion and 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, the administration of prostaglandin synthesis inhibitors has induced an increase in 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 organogenesis period. During the first and second trimester of pregnancy, ibuprofen should not be administered unless strictly necessary. If ibuprofen 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 (premature closure of the arterial duct and pulmonary hypertension); renal dysfunction, which can progress to renal failure with oligohydramnios; the mother and the newborn, at the end of pregnancy, to: possible prolongation of the bleeding time and antiplatelet effect which can occur even at very low doses; inhibition of uterine contractions with consequent delay or prolongation of labor Consequently, the use of ibuprofen is contraindicated during the third trimester of pregnancy. Only small amounts of ibuprofen and its metabolic products are excreted in breast milk. As there are no known undesirable effects in the infant, it is generally not necessary to discontinue breastfeeding during short-term use and at recommended doses for the treatment of mild to moderate pain. However, when prescribing the drug for prolonged or high dose treatment, early weaning should be considered. There is evidence showing that drugs that inhibit cyclooxygenase / prostaglandin synthesis may cause impairment of female fertility following an effect on ovulation. However, this event is reversible with the suspension of the treatment.