Algofen 200mg Ibuprofen Analgesic 12 Coated Tablets

NAME
ALGOFEN 200 MG COATED TABLETS

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

ACTIVE PRINCIPLES
One coated tablet contains: ibuprofen 200 mg.

EXCIPIENTS
Corn starch, stearic acid, croscarmellose sodium, colloidal anhydrous silica, povidone, carmellose sodium, shellac, gum arabic, titanium dioxide, calcium sulphate, sucrose, carnauba wax.

INDICATIONS
Pain of various origins and nature (headache, toothache, neuralgia, osteoarticular and muscle pain, menstrual pain).

CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity 'to the active substance or to other pain relievers (acetylsalicylic acid, etc.) or to any of the excipients. Do not administer under the age of 12. History of gastrointestinal haemorrhage or perforation related to previous active treatments or history of recurrent peptic haemorrhage / ulcer (two or more distinct episodes of demonstrated ulceration or bleeding). Third trimester of pregnancy. Severe heart failure (NYHA class IV).

DOSAGE
Adults and children over 12 years: 1-2 coated tablets 2-3 times a day. Do not exceed the dose of 6 coated tablets per day. Do not exceed the recommended doses: in particular elderly patients should follow the minimum dosages indicated above. Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms. Method of administration: it is advisable to take the drug on a full stomach. If the use of the drug is necessary for more 'than 3 days in adolescents, or in the case of worsening of symptoms, the doctor should be consulted.

STORAGE
This medicine does not require any special storage conditions.

WARNINGS
After three days of treatment without appreciable results, consult your doctor. In asthmatic patients the product should be used with caution consulting your doctor before taking the product. The concomitant use of NSAIDs including selective COX-2 inhibitors should be avoided. Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment that is needed to control symptoms (see paragraphs below on gastrointestinal and cardiovascular risks). Cardiovascular and cerebrovascular effects 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). In general, epidemiological studies do not suggest that low doses of ibuprofen (e.g. <= 1200 mg / day) are associated with an increased risk of arterial thrombotic events. Patients with uncontrolled hypertension, congestive heart failure (NYHA class II-III), established ischemic 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, hyperlipidemia, diabetes mellitus, smoking habits), especially if high doses (2400 mg / day) are required. ) of ibuprofen. Gastrointestinal Effects Elderly: Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal. Gastrointestinal haemorrhage, ulceration and perforation: Gastrointestinal haemorrhage, ulceration and perforation, which can be fatal, have been reported during treatment with all NSAIDs, at any time, with no warning symptoms or a previous history of serious gastrointestinal events. In the elderly and in patients with a history of ulcer, especially if complicated by haemorrhage or perforation, the risk of gastrointestinal haemorrhage, ulceration or perforation is higher with increased doses of NSAIDs. These patients should start treatment with the lowest available dose. Concomitant use of protective agents (misoprostol or proton pump inhibitors) should be considered for these patients and also for patients taking low doses of aspirin or other drugs that may increase the risk of gastrointestinal events. Patients with a history of gastrointestinal toxicity, particularly the elderly, should report any unusual gastrointestinal symptoms (especially gastrointestinal bleeding) particularly in the initial stages of treatment. Caution should be exercised in 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 aspirin. When gastrointestinal bleeding or ulceration occurs in patients taking the drug, 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 may be exacerbated. Skin Effects: Serious skin reactions, some of them fatal, including 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 appear to be at higher risk: the onset of the reaction occurs in most cases within the first month of treatment. The drug should be discontinued at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity '. The use is not recommended in women who intend to become pregnant. Administration should be discontinued in women who have fertility problems 'or who are undergoing investigation of fertility'. Caution is required (discuss with your doctor or pharmacist) before starting treatment in patients with a history of hypertension and / or heart failure as fluid retention, hypertension and edema have been reported in association with NSAID treatment. In dehydrated adolescents there is a risk of impaired renal function. Contains sucrose Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not take this medicinal product.

INTERACTIONS
Anticoagulants: NSAIDs can increase the effects of anticoagulants, such as warfarin. Any interactions with coumarin-type anticoagulants should be kept in mind and therefore patients undergoing treatment with such drugs must consult their doctor before taking the product. Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal haemorrhage. Corticosteroids: increased risk of gastrointestinal ulceration or bleeding. Acetylsalicylic acid: Concomitant administration of ibuprofen and acetylsalicylic acid is generally not recommended due to the potential for increased side effects. Experimental data suggest that ibuprofen can competitively inhibit the effect of low-dose acetylsalicylic acid on platelet aggregation when the two drugs are administered simultaneously. Although there are uncertainties regarding the extrapolation of these data to the clinical situation, the possibility cannot be excluded that regular, long-term use of ibuprofen may reduce the cardioprotective effect of low dose acetylsalicylic acid. No relevant clinical effects are considered likely following occasional use of ibuprofen. Diuretics, ACE inhibitors and angiotensin II antagonists: NSAIDs may reduce the effect of diuretics and other antihypertensive drugs. In some patients impaired renal function (e.g. dehydrated patients or elderly patients with impaired renal function) the co-administration of an ACE inhibitor or angiotensin II antagonist and agents that inhibit the cyclo-oxygenase system may lead to further deterioration of renal function, including possible acute renal failure, usually reversible. These interactions should be considered in patients taking the drug concomitantly with ACE inhibitors or angiotensin II antagonists. 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. Experimental data indicate that ibuprofen can inhibit the effects of low dose acetylsalicylic acid on platelet aggregation when drugs are administered concomitantly. However, the limited data and the uncertainties relating to their application to the clinical situation do not allow definitive conclusions to be drawn for the continued use of ibuprofen; there appears to be no clinically relevant effect from the occasional use of ibuprofen.

SIDE EFFECTS
The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, gastrointestinal perforation or bleeding, sometimes fatal, may occur, particularly in the elderly. These phenomena quickly regress with the suspension of the treatment. Following administration, nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported. Gastritis has been observed less frequently. Edema, hypertension and heart failure have been reported in association with NSAID treatment. Bullous reactions including Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis (very rarely). Clinical studies suggest that the use of ibuprofen, especially at high doses (2400mg / day), may be associated with a modest increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke). Report any suspected adverse reactions via the national reporting system.

PREGNANCY AND BREASTFEEDING
Inhibition of prostaglandin synthesis can negatively 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 has been considered to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to cause an increase in pre- and post-implantation loss and embryo-fetal mortality. Furthermore, an increased incidence of various malformations, including cardiovascular, has been reported in animals administered prostaglandin synthesis inhibitors during the organogenetic period. During the first and second trimester of pregnancy, it should not be administered except in strictly necessary cases. If the drug is used by a woman expecting conception, 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 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 resulting in delayed or prolonged labor. Consequently, it is contraindicated during the third trimester of pregnancy.