Antalgil 200 mg - analgesic and anti-inflammatory 10 tablets

Product Description

Ibuprofen 10 Tablets

Composition

Each 350 mg tablet contains: Active ingredient: ibuprofen 200 mg.

Excipients

Corn starch, pregelatinized starch, hypromellose, microcrystalline cellulose, sodium starch glycolate, precipitated silica, sodium lauryl sulfate, E 104 aluminum lake, E 110 aluminum lake, titanium dioxide, propylene glycol, carnauba wax.

Therapeutic indications

Symptomatic treatment of pain of various origins and nature (headache, toothache, neuralgia, menstrual pain, osteoarticular and muscular pain).

Contraindications

Children under 12 years (see section 4.2) Hypersensitivity to the active substance or to other chemically closely related substances and/or to any of the excipients. 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). Severe heart failure. Pregnancy and breastfeeding (see section 4.6). Severe renal or hepatic insufficiency (see section 4.2). Active gastroduodenal ulcer or other gastropathies.

Dosage

Adults and children over 12 years: 1-2 tablets 2-3 times a day. Do not exceed the dose of 6 tablets per day. Do not exceed the recommended doses. Elderly: In particular, elderly patients should adhere to the minimum dosages indicated above. The elderly should start treatment with the lowest possible dosage. low available dose (see section 4.4) Children: ANTALGIL is contraindicated in children under 12 years of age (see section 4.3). Renal impairment: ANTALGIL is contraindicated in patients with severe renal impairment (see section 4.3). Hepatic impairment: ANTALGIL is contraindicated in patients with severe hepatic impairment (see section 4.3).

Warnings and precautions

Undesirable effects can be minimised by using the lowest effective dose for the lowest effective dose. short duration as necessary to control symptoms (see section 4.2 and the sections below Gastrointestinal and cardiovascular risks. It is advisable to take the medicine on a full stomach. 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 use of Antalgil should be avoided in conjunction with NSAIDs including selective COX-2 inhibitors. Elderly: Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal. (see section 4.2). Gastrointestinal bleeding, ulceration and perforation: gastrointestinal bleeding, ulceration and perforation, which can be fatal, have been reported with all NSAIDs at anytime during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events. In the elderly and in patients with a history of ulcer, especially if complicated with haemorrhage or perforation (see section 4.3), the risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing doses of NSAIDs. 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 also for patients taking low-dose aspirin or other drugs likely to increase the risk of gastrointestinal events (see below and section 4.5). Patients with a history of gastrointestinal toxicity, particularly when elderly, should report any unusual gastrointestinal symptoms (especially gastrointestinal bleeding) particularly in the initial stages of treatment. Caution should be advised in patients taking concomitant medications which could 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 (see section 4.5). When If gastrointestinal bleeding or ulceration occurs in patients taking Antalgil, 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 (see section 4.8 – Undesirable effects). Caution is required in patients with a history of hypertension and/or heart failure as fluid retention and edema have been reported in association with NSAID therapy. NSAIDs may reduce the effect of diuretics and other antihypertensive drugs. (see interactions) Clinical trial and epidemiological data suggest that the use of ibuprofen, particularly at high doses (2,400 mg/day) and in long-term treatment, may be associated with a small increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke). In general, epidemiological studies do not suggest that low doses (2,400 mg/day) and long-term treatment are associated with a small increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke). In general, epidemiological studies do not suggest that low doses (2,400 mg/day) and long-term treatment are associated with a small increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke). Doses of ibuprofen (e.g., <1,200 mg/day) are associated with an increased risk of myocardial infarction. 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 (see section 4.8). Patients appear to be at higher risk early in the course of therapy: the onset of the reaction occurs in the majority of cases within the first month of treatment. Antalgil should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. The use of Antalgil, as with any drug inhibiting the synthesis of prostaglandins and cyclooxygenase, is not recommended in women attempting to conceive. Antalgil should be discontinued in women who have fertility problems or who are undergoing investigation of infertility.

Interactions

Corticosteroids: increased risk of gastrointestinal ulceration or bleeding (see section 4.4) Anticoagulants: NSAIDs may enhance the effects of anticoagulants, such as warfarin (see section 4.4). Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding. Diuretics, ACE inhibitors 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 or an angiotensin II antagonist and agents that inhibit the cyclo-oxygenase system may lead to a further deterioration of acute renal function, usually reversible. These interactions should be considered in patients taking Antalgil 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 renal function monitoring should be considered after initiation of concomitant therapy. (see section 4.4) Therefore, patients undergoing treatment with such drugs should consult their doctor before taking the product. Experimental data indicate that ibuprofen may inhibit the effects of low-dose acetylsalicylic acid on platelet aggregation when the drugs are administered concomitantly. However, the limited data and uncertainties regarding their application to the clinical situation do not allow definitive conclusions to be drawn for the continuous use of ibuprofen; there appears to be no clinically relevant effect from occasional use of ibuprofen (see section 5.1).

Undesirable effects

The following spontaneous adverse events have been reported with the use of ibuprofen tablets, and within each organ class or system, are classified by frequency, using the following convention: Very common (>1/10) Common (>1/100, < 1/100) Uncommon (> 1/ 1,000, < 1/100) Rare (>1/10,000, < 1/1,000) Very rare (<1/10,000), including isolated reports N.B.: The adverse reactions listed below are mainly dose-dependent and differ from individual to individual. Gastrointestinal disorders: The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation or gastrointestinal bleeding, sometimes fatal, particularly in the elderly, may occur (see section 4.4). The following have been reported after administration of ANTALGIL: stomach, nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see section 4.4 – special warnings and precautions for use). Gastritis has been observed less frequently. Common: gastrointestinal disorders such as epigastric pain, abdominal pain, nausea, flatulence, diarrhoea, constipation, dyspepsia. Uncommon: peptic ulcer, perforation or gastrointestinal haemorrhage, sometimes fatal, particularly in the elderly (see section 4.4), melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease. Very rare: Gastritis, vomiting. Respiratory, thoracic and mediastinal disorders. Uncommon: rhinitis. Blood and lymphatic system disorders: Rare: leukopenia, thrombocytopenia. Very rare: aplastic anaemia, agranulocytosis, haemolytic anaemia.) ANTALGIL may cause a prolongation of bleeding time by reversibly inhibiting platelet aggregation. Nervous system disorders: Common: dizziness, fatigue, headache. Uncommon: insomnia, visual and hearing disturbances. Rare: depression, aseptic meningitis (usually in patients with autoimmune disease). Very rare: confusion, hallucinations. Renal and urinary tract disorders: Rare: renal dysfunction including renal failure. Skin and subcutaneous tissue disorders: Common: rash. Uncommon: allergic skin eruptions (erythema, pruritus, urticaria), swelling. Very rare: severe allergic reactions such as erythema multiforme. Bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis (very rare). Cardiac and vascular disorders: Very rare: edema, hypertension, cardiac failure. Edema, hypertension, and cardiac failure have been reported in association with NSAID treatment. Clinical trial and epidemiological data suggest that use of ibuprofen, particularly at high doses (2,400 mg/day) and in long-term treatment, may be associated with a small increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke) (see section 4.4). Hepatobiliary disorders: Rare: liver function disorders, particularly with long-term therapy. Very rare: hepatitis, jaundice.

Pregnancy and breastfeeding

Pregnancy Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or embryo/foetal development. Results of epidemiological studies suggest an increased risk of miscarriage, 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 is believed to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to result in increased 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 trimesters of pregnancy, ANTALGIL should not be administered unless clearly necessary. If ANTALGIL is used by a woman attempting to conceive, or during the first and second trimesters 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 may expose the fetus to: - cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); - renal dysfunction, which may progress to renal failure with oligo-hydroamniosis; 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. - Consequently, ANTALGIL is contraindicated during the third trimester of pregnancy. Furthermore, use of the product during breastfeeding is not recommended.