Angelini Moment 200mg Ibuprofen 24 Coated Tablets

Composition:

Each coated tablet contains: Active ingredient: ibuprofen 200 mg.
Excipients: Maize starch, sodium carboxymethyl starch sodium, povidone, colloidal anhydrous silica, talc, hydroxypropylcellulose, gum arabic, sucrose, Macrogol 6000, light magnesium carbonate, titanium dioxide.

PHARMACEUTICAL FORM : White, glossy, round coated tablet.

Therapeutic indications : Pain of various origins and nature (headache, toothache, neuralgia, osteo-articular and muscular pain, menstrual pain). Adjuvant in the symptomatic treatment of fever and flu.

Contraindications

—Do not administer under 12 years of age

-Pregnancy and breastfeeding.

- Hypersensitivity to the active substance, to other antirheumatics (acetylsalicylic acid, etc.) or to any of the excipients.

-Active or severe gastroduodenal ulcer or other gastropathies.

- History of gastrointestinal haemorrhage or perforation related to previous active treatments or history of recurrent peptic haemorrhage / ulcer (two or more distinct episodes of proven ulceration or bleeding).

- Severe hepatic or renal insufficiency.

-Several heart failure.

Special warnings and precautions for use

In asthmatic patients the product should be used with caution, after consulting your doctor. The use of Moment, as with any prostaglandin synthesis and cyclooxygenase inhibitor drug, is not recommended in women intending to become pregnant.

Moment should be discontinued in women who have fertility problems or who are undergoing fertility investigations.

- The use of Moment should be avoided concomitantly with NSAIDs, including selective COX-2 inhibitors.

-Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see paragraphs below on gastrointestinal and cardiovascular risks).

Cardiovascular and cerebrovascular effects: clinical studies and epidemiological data suggest that the use of ibuprofen, especially at high doses (2400 mg / day) and for long-term treatments, 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 myocardial infarction. There is a risk of impaired renal function in dehydrated adolescents

- Elderly: Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal. Gastrointestinal bleeding, ulceration and perforation: Gastrointestinal bleeding, ulceration and perforation, which can be fatal, have been reported during treatment with all NSAIDs, at any time, with or without warning symptoms or a previous history of serious gastrointestinal events.

- In the elderly and in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3), the risk of gastrointestinal bleeding, 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.

- Closely monitor 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 Moment 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 may be exacerbated.

- Caution is required 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 treatment with NSAIDs.

- 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). 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. Moment should be discontinued at the first appearance of skin rash, mucosal lesions or any other signs of hypersensitivity.

Moment contains:
sucrose: patients with rare hereditary problems - fructose intolerance, glucose-galactose malabsorption, or sucrase isomaltase insufficiency, should not take this medicine.

Interactions

■ Any interactions with coumarin-type anticoagulants should be kept in mind: patients undergoing treatment with such drugs should consult their doctor before taking the product. It is also advisable to seek medical advice in case of any concomitant therapy before administering the product.

• 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.

• Diuretics, ACE inhibitors 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 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 Moment 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 may inhibit the effects of low dose acetylsalicylic acid on platelet aggregation when drugs are administered concomitantly. However, the paucity of the 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

Pregnancy and breastfeeding

Pregnancy

Inhibition of prostaglandin synthesis can adversely 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 was believed to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to cause increased pre- and post-implantation loss and embryo-fetal mortality.

Furthermore, an increased incidence of various malformations, including cardiovascular, has been reported in animals given prostaglandin synthesis inhibitors during the organogenetic period.

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 oligo-hydroamnios; the mother and the newborn, at the end of pregnancy,

- 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.

Effects on ability to drive and use machines

Normally, the use of ibuprofen does not affect the ability to drive or the use of other machines. However, those patients whose activity requires vigilance should use caution in case they notice drowsiness, dizziness or depression while taking ibuprofen.

Side effects

Skin effects

Sometimes allergic skin rashes (erythema, itching, urticaria) can occur.

Bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis (very rarely).

Gastrointestinal 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.

After administration of Moment the following have been reported: feeling of stomach weight, nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease.

Gastritis has been observed less frequently.

Cardiovascular effects

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 2400 mg / day) and for long-term treatment, may be associated with a modest increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke).

These phenomena quickly regress with the suspension of the treatment.

Overdose

In case of overdose, gastric lavage, correction of blood electrolytes is indicated. There is no specific antidote to ibuprofen.

Pharmacokinetic properties

Ibuprofen is well absorbed following oral administration and rapidly reaches optimal blood levels.

Ibuprofen is rapidly and completely excreted in the urine, in fact more than 90% of the administered dose is eliminated in 24 hours in the form of metabolites or other conjugated compounds.

How to use : Adults and adolescents over 12 years: 1-2 tablets, 2-3 times a day. Do not exceed the dose of 6 tablets per day. If the use of the medicine is necessary for more than 3 days in adolescents, or in the case of worsening of symptoms, the doctor should be consulted. Do not exceed the recommended dose; in particular elderly patients should follow the minimum dosages indicated above. Take the product on a full stomach.