Antalgil 200 mg - analgesic and anti-inflammatory 30 tablets

Product Description

Antalgil contains the active ingredient ibuprofen and belongs to the category of nonsteroidal anti-inflammatory antirheumatic drugs.

Indications

Antalgil is used for the symptomatic treatment of pain of various origins and nature (headache, toothache, neuralgia, menstrual pain, osteoarticular and muscle pain).

Contact your doctor if you do not feel better or if you feel worse after 3 days.

Composition

Active ingredients

Each tablet contains: active ingredient ibuprofen 200 mg. For a full list of excipients, see the following:

Excipients

Maize 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.

Directions for use and dosage

Adults and children over 12 years: Take 1-2 tablets 2-3 times a day. Do not exceed a dose of 6 tablets per day. Use the lowest effective dose for the shortest period necessary to relieve symptoms. This medicine is intended for short-term use only and should not exceed 3 days of treatment. If symptoms persist or worsen, consult a doctor.

Elderly: NSAIDs should be used with particular caution in elderly patients, who are more prone to adverse events and are at increased risk of potentially fatal gastrointestinal bleeding, ulceration, or perforation. If treatment is considered necessary, the lowest dose should be used for the shortest duration necessary to control symptoms.

Children: ANTALGIL is contraindicated in children under 12 years of age.

Renal impairment: In patients with mild or moderate reduction in renal function, the dosage should be kept as low as possible for the shortest duration necessary to control symptoms, and renal function should be monitored. ANTALGIL is contraindicated in patients with severe renal impairment.

Hepatic impairment: In patients with mild or moderate reduction in liver function, the dosage should be kept as low as possible for the shortest duration necessary to control symptoms, and liver function should be monitored. ANTALGIL is contraindicated in patients with severe hepatic impairment.

Method of administration: The tablet should be swallowed with a glass of water during or after a meal.

Warnings

Minimization of Side Effects
Use the lowest effective dose for the shortest duration possible to control symptoms. It is advisable to take the drug on a full stomach.

Precautions for Asthmatic Patients
In asthmatic patients, Antalgil should be used with caution, consulting your doctor before taking it.

Interactions with Other NSAIDs
The use of Antalgil should be avoided in conjunction with other NSAIDs, including selective COX-2 inhibitors.

Masking of Symptoms of Infections
Antalgil can mask the symptoms of infection, which could delay the initiation of adequate treatment and worsen the outcome of the infection. Monitoring for infection is recommended.

Precautions for the Elderly
Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal.

Gastrointestinal Risks
Gastrointestinal bleeding, ulceration, and perforation may occur during treatment with NSAIDs. Patients with a history of ulcers, particularly if complicated with haemorrhage or perforation, should start treatment on the lowest available dose.

Cardiovascular and Cerebrovascular Effects
Caution should be exercised in patients with a history of hypertension and/or heart failure. NSAIDs may reduce the effect of diuretics and other antihypertensive drugs.

Severe Skin Reactions
Serious skin reactions, some of them fatal, have been reported very rarely in association with the use of NSAIDs. Antalgil should be discontinued at the first appearance of skin rash or other signs of hypersensitivity.

Renal Effects
Ibuprofen may cause sodium, potassium, and water retention in patients who have never suffered from renal disorders due to its effects on renal perfusion.

Contraindications

Children under 12 years. Hypersensitivity to the active substance or to other closely related substances from a chemical point of view 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). Active gastroduodenal ulcer or other gastropathies. Severe heart failure (NYHA class IV). Last trimester of pregnancy and breastfeeding. Severe renal or hepatic impairment.

Undesirable effects

Classification of adverse events by frequency:

• Very common (>1/10)
• Common (>1/100, < 1/10)
• Uncommon (> 1/1,000, < 1/100)
• Rare (>1/10,000, < 1/1,000)
• Very rare (<1/10,000), including isolated reports
• Not known (frequency cannot be estimated from the available data)

Undesirable effects are largely dose-dependent, in particular the risk of gastrointestinal bleeding. For other risk factors. The use of ibuprofen, especially at high doses (2400 mg/day), may increase the risk of arterial thrombotic events such as myocardial infarction or stroke.

Laboratory tests: Rare: increased blood urea nitrogen, serum transaminases, alkaline phosphatase; decreased hemoglobin, hematocrit; inhibition of platelet aggregation; prolonged bleeding time; decreased serum calcium; increased serum uric acid.

Cardiac disorders: Very rare: palpitations, cardiac failure, myocardial infarction, acute pulmonary oedema, oedema.

Blood and lymphatic system disorders: Very rare: haematopoietic disorders such as anaemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis.

Nervous system disorders: Common: headache, somnolence, dizziness, tiredness, agitation, insomnia, irritability; very rare: aseptic meningitis.

Eye disorders: Uncommon: visual disturbances; rare: toxic amblyopia.

Ear and labyrinth disorders: Very rare: tinnitus.

Respiratory, thoracic and mediastinal disorders: Uncommon: rhinitis, bronchospasm.

Gastrointestinal disorders: Very common: gastrointestinal disorders such as heartburn, dyspepsia, abdominal pain, nausea, vomiting, flatulence, diarrhoea, constipation; common: gastrointestinal ulcers, sometimes with haemorrhage and perforation; uncommon: gastritis; very rare: oesophagitis, pancreatitis, intestinal stenosis.

Renal and urinary disorders: Uncommon: development of oedema, nephrotic syndrome, interstitial nephritis; very rare: renal papillary necrosis.

Skin and subcutaneous tissue disorders: Uncommon: photosensitivity; very rare: serious skin reactions such as erythema multiforme, exfoliative dermatitis, bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis.

Immune system disorders: Uncommon: hypersensitivity reactions such as urticaria, pruritus, purpura, exanthema, asthma attacks; rare: lupus erythematosus syndrome; very rare: serious hypersensitivity reactions.

Hepatobiliary disorders: Very rare: liver dysfunction, liver damage, liver failure, acute hepatitis, jaundice.

Psychiatric disorders: Rare: depression, confusion, hallucinations.

Reporting suspected adverse reactions is important for the continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are invited to report any suspected adverse reactions via the Italian Medicines Agency.

Pregnancy and breastfeeding

Pregnancy and Embryo/Fetal Development
Inhibition of prostaglandin synthesis may negatively affect pregnancy and/or embryo/fetal development. Epidemiological studies indicate an increased risk of miscarriage and malformations after the use of prostaglandin synthesis inhibitors in early pregnancy.

Effects in Animals
In animals, the use of prostaglandin synthesis inhibitors has caused an increase in pre- and post-implantation loss and embryo-fetal mortality, as well as an increased incidence of malformations.

Use of ANTALGIL during Pregnancy
From the 20th week of pregnancy, the use of ANTALGIL may cause oligohydramnios due to fetal renal dysfunction and constriction of the ductus arteriosus. During the first and second trimesters, ANTALGIL should not be administered unless strictly necessary and with the dose and duration of treatment most recommended. low possible.

Third Trimester of Pregnancy
During the third trimester, the use of ANTALGIL is contraindicated due to possible negative effects on the fetus and mother, including cardiopulmonary toxicity and renal dysfunction.

Breastfeeding
Ibuprofen is excreted in breast milk, but at therapeutic doses during short-term treatment, the risk of influences on the newborn seems unlikely. For long-term treatment, early weaning should be considered.

Female Fertility
Medicines that inhibit cyclooxygenase/prostaglandin synthesis may impair female fertility by affecting ovulation. This effect is reversible upon discontinuation of treatment.

Interactions

Concomitant use of ibuprofen and the following substances should be avoided. 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 the 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. Other NSAIDs: As a result of synergistic effects, the concomitant use of multiple NSAIDs may increase the risk of gastrointestinal ulcers and bleeding. Concomitant administration of ibuprofen with other NSAIDs should therefore be avoided. Anticoagulants: NSAIDs may enhance the effects of anticoagulants, such as warfarin or heparin. In case of concomitant treatment, monitoring of coagulation status is recommended. Ticlopidine: NSAIDs should not be combined with ticlopidine due to the risk of an additive effect in inhibiting platelet function. Methotrexate: NSAIDs inhibit the tubular secretion of methotrexate, and some metabolic interactions may occur resulting in reduced clearance of methotrexate. Administration of ibuprofen within 24 hours before or after methotrexate administration may lead to elevated methotrexate concentrations and an increase in its toxic effects. Therefore, the concomitant use of NSAIDs and high doses of methotrexate should be avoided. Furthermore, the potential risk of interactions with low-dose methotrexate treatment should be considered, particularly in patients with impaired renal function. Renal function should be monitored in combination treatment. Ibuprofen (like other NSAIDs) should be used with caution in combination with the following substances: Moclobemide: Increases the effect of ibuprofen. Phenytoin, lithium: Concomitant administration of ibuprofen and phenytoin or lithium preparations may increase the serum levels of these drugs. Monitoring serum lithium levels is necessary, and monitoring serum phenytoin levels is recommended. Cardiac glycosides (e.g., digoxin): NSAIDs may exacerbate heart failure, reduce glomerular filtration rate, and increase plasma cardiac glycoside levels. Monitoring serum digoxin is recommended. Diuretics and antihypertensives: Diuretics and ACE inhibitors may increase the nephrotoxicity of NSAIDs. NSAIDs may reduce the effect of diuretics and antihypertensives, including ACE inhibitors and beta-blockers. In patients with reduced renal function (e.g., dehydrated patients or elderly patients with reduced renal function), the concomitant use of an ACE inhibitor and angiotensin II antagonist with a drug that inhibits cyclooxygenase may lead to further deterioration of renal function, including possible acute renal failure, which is usually reversible. This combination should therefore be used with caution, especially in elderly patients. Patients should be instructed to drink sufficient fluids, and periodic monitoring of renal values ​​should be considered shortly after initiating combination therapy. Concomitant administration of ibuprofen and potassium-sparing diuretics or ACE inhibitors may cause hyperkalemia. Careful monitoring of potassium levels is necessary. Captopril: Experimental studies indicate that ibuprofen counteracts the effect of captopril on increased sodium excretion. Aminoglycosides: NSAIDs may slow the elimination of aminoglycosides and increase their toxicity. Selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding. Cyclosporine: the risk of renal damage from ciclosporin is increased by concomitant administration of some NSAIDs. This effect cannot be ruled out for the combination of ciclosporin and ibuprofen. Cholestyramine: Concomitant treatment with cholestyramine and ibuprofen results in prolonged and reduced (25%) absorption of ibuprofen. The drugs should be administered with at least an hourly interval. Tacrolimus: high risk of nephrotoxicity. Zidovudine: there is evidence of an increased risk of haemarthrosis and haematoma in HIV-positive haemophiliac patients receiving concomitant treatment with zidovudine and ibuprofen. This may be due to a risk of haemarthrosis and haematoma in HIV-positive haemophiliac patients receiving concomitant treatment with zidovudine and ibuprofen. There may be an increased risk of hepatotoxicity during concomitant use of zidovudine and NSAIDs. A blood test is recommended 1-2 weeks after starting concomitant use. Ritonavir: may increase plasma concentrations of NSAIDs. Mifepristone: If NSAIDs are used within 8-12 days after mifepristone administration, they may reduce the effect of mifepristone. Probenecid or sulfinpyrazone: may cause a delay in the elimination of ibuprofen. The uricosuric effect of these substances is decreased. Quinolone antibiotics: Patients taking NSAIDs and quinolones may be at increased risk of developing seizures. Sulfonylureas: NSAIDs may enhance the hypoglycemic effect of sulfonylureas. In case of simultaneous treatment, monitoring of blood glucose levels is recommended. Corticosteroids: increased risk of gastrointestinal ulceration or bleeding. Antiplatelet agents (e.g., clopidogrel and ticlopidine): Increase the risk of gastrointestinal bleeding. Alcohol, bisphosphonates, and oxpentifylline (pentoxyfilline): May increase gastrointestinal side effects and the risk of bleeding and ulcers. Baclofen: High baclofen toxicity.

Format

Pack of 30 tablets.