ANALGESIC MOMENTCT 12BUST

ANALGESIC MOMENTCTORY 400 MG FREE FOR ORAL DEPARTMENT

active ingredients

A bag contains: active ingredient: ibuprofen sodium salt dihydrate 512 mg (corresponding to 400 mg of ibuprofen). For the full list of excipients, see section 6.1.

Excellent

Saccarosio, potassium bicarbonate, orange aroma, potassium acesulfame, aspartame.

Therapeutic indications

Pain from various origins and nature (headache, toothache, neuralgia, osteo-articolar and muscle pain, menstrual pain).

Contraindications

• Do not administer under 12 years. • Pregnancy and nursing. • Hypersensitivity to the active ingredient, to other antireumatics (acetylsalicylic acid, etc.) or to any of the excipients. • Active or severe gastroduodenal ulcer or other gastropathies. • History of gastrointestinal hemorrhage or perforation related to previous active treatments or history of hemorrhage/recurring peptic ulcer (two or more separate episodes of proven ulceration or bleeding). • Hepatic or severe kidney failure. • Severe heart failure. • Subjects with phenylketonuria (see section 4.4).

Population

Adults and teenagers over 12 years: 1 bag 2–3 times a day. Dissolve the contents of the sachet in a glass of water mixing with a teaspoon until dissolution and immediately drink the solution. Do not exceed the dose of 3 sachets per day. In case the use of the medicinal product is necessary for more than 3 days in adolescents, or in case of worsening of symptomatology, the doctor must be consulted. Do not exceed the recommended doses: especially older patients should comply with the above minimum dosages. Take the product on a full stomach.

Conservation

This medicine does not require any special storage temperature.

Warnings

• In asthmatic patients the product must be used with caution, after consulting the doctor. • The use of ANALGESICO MOMENTACT, as of any inhibitor drug of the synthesis of prostaglandins and cyclooxygenases is not recommended in women who intend to start a pregnancy. • The administration of ANALGESIC MOMENTACT should be suspended in women who have fertility problems or who are subject to fertility surveys. • The use of ANALGESIC MOMENTACT must be avoided in conjunction with NSAIDs, including selective COX–2 inhibitors. • Undesirable effects can be minimized with the use of the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see below paragraphs 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/die) and for long-term treatments, may be associated with a modest increase in the risk of arterial thrombotic events (p.es. infarction of myocardial or stroke). In general, epidemiological studies do not suggest that low doses of ibuprofen (e.g. ≤ 1200 mg/die) are associated with an increase in the risk of myocardial infarction. • In dehydrated adolescents there is a risk of alteration of kidney function. • Elders: elderly patients have an increase in the frequency of adverse reactions the NSAIDs, especially hemorrhages and gastrointestinal perforations, which can be fatal (see Section 4.2). • Gastrointestinal bleeding, ulceration and drilling: during treatment with all NSAIDs, at any time, with or without warning symptoms or previous history of serious gastrointestinal events, gastrointestinal hemorrhage, ulceration and perforation, which may be fatal. • In the elderly and patients with ulcer history, especially if complicated by hemorrhage or perforation (see section 4.3), the risk of gastrointestinal hemorrhage, ulceration or perforation is higher with increased doses of NSAIDs. These patients must begin treatment with the lowest dose available. Concurrent use of protective agents (misoprostol or protonic pump inhibitors) must 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 (see below and section 4.5). • Patients with history of gastrointestinal toxicity, especially elderly, must report any unusual gastrointestinal symptoms (especially gastrointestinal hemorrhage) in particular in the early stages of treatment. • Carefully check patients taking concomitant drugs that could increase the risk of ulceration or hemorrhage, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors (SSRIs) or anti-aggregating agents such as aspirin (see section 4.5). • When bleeding or gastrointestinal ulceration occurs in patients taking ANALGESICO MOMENTACT treatment must be suspended. • NSAIDs should be administered with caution in patients with a history of gastrointestinal disease ( ulcerative colitis, Crohn's disease) since such conditions can be exacerbated (see section 4.8). • Caution is required before starting treatment in patients with positive anamnesiums for hypertension and/or heart failure since retention of fluids, hypertension and edema were found in association with NSAIDs. • Severe skin reactions some of which fatal, including exfoliative dermatitis, Stevens–Johnson syndrome and epidermal toxic necrolysis, have been reported very rarely in association with the use of NSAIDs (see section 4.8). In the early stages of therapy patients seem to be at higher risk: the onset of reaction occurs in most cases within the first month of treatment. ANALGESICO MOMENTACT must be interrupted by the first appearance of skin rash, mucosa lesions or any other sign of hypersensitivity. • ANALGESICO MOMENTACT contains: – sucrose: patients with problems of rare hereditary fructose disease, glucose and galactose mal absorption or saccarase–isomaltase failure should not take this medicine. – 45 mg sodium (1.9 mm) per sachet. To be taken into consideration in people with reduced kidney function or following a hypoxodic diet. – 90 mg potassium (2,3 mmoli) per sachet. To be taken into consideration in people with reduced to kidney function or following a hypopotassic diet. – aspartame, a source of phenylalanine, therefore is contraindicated in subjects suffering from phenylchetonuria (see section 4.3).

Interactions

• Any interactions with cumarinic anticoagulants must be kept in mind: patients subjected to treatment with such drugs should consult the doctor before taking the product. It is also advisable to use the doctor's advice in case of any concomitant therapy prior to administration of the product. • Corticosteroids: increased risk of gastrointestinal ulceration or hemorrhage (see section 4.4). • Antiagulants: NSAIDs can increase the effects of anticoagulants, such as warfarin (see section 4.4). • Serotonin reuptake selective agents and inhibitors (SSRIs): increased risk of gastrointestinal hemorrhage (see section 4.4). • Diuretics, ACE inhibitors and antagonists of angiotensin II: NSAIDs can reduce the effect of diuretics and other antihypertensive drugs. In some patients with impaired kidney function (e.g. dehydrated patients or elderly patients with impaired kidney function) the co-administration of an inhibitor ACE or an angiotensin II antagonist and agents that inhibit the cycle–oxygenase system can lead to further deterioration of kidney function, which includes a possible acute kidney failure, generally reversible. These interactions must be considered in patients taking ANALGESIC MOMENTACT in conjunction with ACE inhibitors or antagonists of angiotensin II. Therefore, the combination should be given with caution, especially in elderly patients. Patients should be properly hydrated and monitoring the kidney function should be taken into consideration after the start of the concomitant therapy. • Experimental data suggests that ibuprofen can inhibit the effects of acetylylcylic acid at low doses on platelet aggregation when drugs are administered in conjunction. However, the exigity of data and uncertainties related to their application to the clinical situation do not allow to draw definitive conclusions for the continued use of ibuprofen; it seems that there are no clinically relevant effects from the occasional use of ibuprofen (see section 5.1).

Effects

Cutaneous effects Sometimes skin rashes can occur on an allergic basis (herites, itching, hives). Bollose reactions including Stevens Johnson Syndrome and epidermal toxic necrolysis (very rarely). Gastrointestinal effects The most commonly observed adverse events are gastrointestinal. Peptic ulcers, perforation or gastrointestinal hemorrhage may occur, sometimes fatal, especially in the elderly (see section 4.4). After administration of MOMENTACT ANALGESICO have been reported: sense of weight in the stomach, nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melena, ematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see section 4.4) Less frequently gastritis were observed. Cardiovascular effects In association with the treatment with the NSAIDs were reported edema, hypertension and heart failure. Clinical studies and epidemiological data suggest that the use of ibuprofen (especially at high doses 2400 mg/die) and for long-term treatments, may be associated with a modest increase in the risk of arterial thrombotic events (p.es. infarction of myocardial or stroke) (see section 4.4). Such phenomena quickly regress with the suspension of treatment.

Overdosing

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

Pregnancy Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryo/fetal development. Results of epidemiological studies suggest an increased risk of abortion and cardiac malformation and gastroschisis after the use of an inhibitor of prostaglandin synthesis in the early stages of pregnancy. The absolute risk of heart failure increased from less than 1% to about 1.5%. It has been considered that the risk increases with dose and duration of therapy. In animals, the administration of prostaglandin synthesis inhibitors showed an increase in the loss of pre and post-plant and embryo–fetal mortality. In addition, an increase in the incidence of various malformations, including cardiovascular disorders, was reported in animals that had been 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 arterial duct and pulmonary hypertension); – kidney dysfunction, which can progress in kidney failure with oligo–idroamnios; the mother and the newborn, at the end of pregnancy, to: – possible prolongation of bleeding time, and anti-aggregating effect that can also take place at very low doses; – inhibition of uterine contractions resulting in delay or extension of labor.

Source: Farmadati