Active ingredients

Each coated tablet contains: Active ingredient: ibuprofen 200 mg. For a full list of excipients, see section 6.1.

Excipients

Corn starch, sodium starch glycolate, povidone, colloidal anhydrous silica, talc, hydroxypropylcellulose, gum arabic, sucrose, Macrogol 6000, light magnesium carbonate, titanium dioxide.

Therapeutic indications

Pain of various origins and natures (headache, toothache, neuralgia, osteoarticular and muscular pain, menstrual pain). Adjuvant in the symptomatic treatment of fever and flu.

Contraindications/Side effects

• Do not administer to children 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 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 hepatic or renal insufficiency. • Severe cardiac insufficiency.

Dosage

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

Conservation

This medicine does not require any special storage temperatures.

Warnings

• In asthmatic patients the product should be used with caution, after consulting your doctor. • The use of Moment, as with any drug that inhibits the synthesis of prostaglandins and cyclooxygenase, is not recommended in women intending to become pregnant. • Administration of Moment should be suspended in women who have fertility problems or who are undergoing investigation of fertility. • The use of Moment should be avoided in conjunction with NSAIDs, including selective COX-2 inhibitors. • Undesirable effects can be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see paragraphs below on gastrointestinal and cardiovascular risks). • Cardiovascular and cerebrovascular effects: Clinical trial and epidemiological data suggest that use of ibuprofen, particularly at high doses (2400 mg/day) and in long-term treatment, may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). Overall, epidemiological studies do not suggest that low doses of ibuprofen (e.g. ≤ 1200 mg/day) are associated with an increased risk of myocardial infarction. • In dehydrated adolescents there is a risk of altered renal function. • 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 any time 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, particularly if complicated with haemorrhage or perforation (see section 4.3), the risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing NSAID doses. These patients should start treatment on 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-dose aspirin or other drugs likely to increase gastrointestinal risk (see below and section 4.5). • 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. • Carefully monitor patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or anti-platelet agents such as aspirin (see section 4.5). • If gastrointestinal bleeding or ulceration occurs in patients taking Moment, the treatment should be withdrawn. • 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). • Caution is advised before initiating treatment in patients with a history of hypertension and/or heart failure as fluid retention, hypertension and oedema have been reported in association with NSAID therapy. • 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 highest risk early in the course of therapy: the onset of the reaction occurs in the majority of cases within the first month of treatment. Moment should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. • Moment contains: – sucrose: patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not take this medicine.

Interactions

• Possible interactions with coumarin-type anticoagulants should be taken into account: patients undergoing treatment with these 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 (see section 4.4). • Anticoagulants: NSAIDs may increase the effects of anticoagulants, such as warfarin (see section 4.4). • Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding (see section 4.4). • 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 cyclooxygenase system may lead to further deterioration of renal function, including possible acute renal failure, which is 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 initiating concomitant therapy. • 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).

Side effects

Skin effects Allergic skin rashes (erythema, pruritus, urticaria) may occasionally occur. Bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis (very rare). Gastrointestinal effects The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation, or gastrointestinal haemorrhage, sometimes fatal, particularly in the elderly, may occur (see section 4.4). Following administration of Moment, the following have been reported: feeling of heaviness in the stomach, nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see section 4.4). Less frequently, gastritis has been observed. Cardiovascular effects Oedema, hypertension, and cardiac failure have been reported in association with treatment with NSAIDs. Clinical trials and epidemiological data suggest that the use of ibuprofen (particularly at high doses (2400 mg/day) and in long-term treatment may be associated with a modest increased risk of arterial thrombotic events (e.g., myocardial infarction or stroke) (see Section 4.4). These phenomena regress rapidly upon discontinuation of treatment.

Overdose

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

Pregnancy and breastfeeding

Pregnancy: Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryo/fetal development. 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. Additionally, an increased incidence of various malformations, including cardiovascular, has been reported in animals administered prostaglandin synthesis inhibitors during the organogenetic period. 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 newborn, at the end of pregnancy, to: – possible prolongation of bleeding time, and an anti-aggregating effect which may occur even at very low doses; – inhibition of uterine contractions resulting in delayed or prolonged labor.