Moment 200 mg oral suspension - anti-inflammatory analgesic 8 sachets

Product Description

Sachets to combat pain and inflammation.

Indications

Moment 200 mg oral suspension is a non-prescription drug based on ibuprofen indicated for the treatment of pain of various origins and natures such as:

• Menstrual pain.
• Headache.
• Toothache.
• Neuralgia.
• Bone and joint pain.

Also useful as an adjuvant in the symptomatic treatment of fever and flu.

Ingredients

Composition per sachet.
Active ingredients: ibuprofen 200 mg (as sodium salt dihydrate 256 mg).
Excipients: sucrose, potassium bicarbonate, orange flavoring, acesulfame potassium, aspartame (E 951).

Directions for use and Dosage

Adults and adolescents over 12 years: 1–2 sachets, two–three times a day.
Dissolve the contents of the sachet in a glass of water, stirring with a teaspoon until dissolved, and drink the solution immediately.
Do not exceed the dose of 6 sachets per day.
If the use of the medicine is necessary for more than 3 days in adolescents, or in case of worsening of symptoms, a doctor must be consulted.
Do not exceed the recommended doses; in particular, elderly patients should stick to the minimum dosages indicated above.
Take the product on a full stomach.

Warnings

• In asthmatic patients, the product should be used with caution, after consulting a doctor.
• Patients whose activities require alertness should exercise caution if they notice drowsiness, dizziness or depression during therapy with ibuprofen.
• The use of Moment, as with any drug inhibiting the synthesis of prostaglandins and cyclooxygenase, is not recommended in women intending to become pregnant.
• The administration of Moment should be suspended in women who have fertility problems or who are undergoing fertility investigations.
• The use of Moment should be avoided in conjunction with NSAIDs, including selective COX-2 inhibitors.
• Undesirable effects may occur. be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.
• Cardiovascular and cerebrovascular effects: Clinical trial and epidemiological data suggest that the use of ibuprofen, particularly at high doses (2400 mg/day) and in long-term treatment, may increase the risk of cardiovascular disease. 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 dose ibuprofen (e.g. ≥ 1200 mg/day) is 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 may be fatal.
• 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 GI events.
• In the elderly and in patients with a history of ulcer, The risk of gastrointestinal bleeding, ulceration, or perforation is higher with increased doses of NSAIDs, especially if complicated by haemorrhage or perforation.
  These patients should initiate treatment with the most appropriate dose. low dose available.
  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 the risk of gastrointestinal events.
• 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.
• 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 antiplatelet agents such as aspirin.
• When gastrointestinal bleeding or ulceration occurs in patients receiving 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 advised before initiating treatment in patients with a history of hypertension and/or heart failure as fluid retention, hypertension, and edema 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.
  In the early stages of therapy, patients appear to be more at risk of developing allergic reactions. high risk: the onset of the reaction occurs in most cases within the first month of treatment.
  Moment must be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
• Moment 200 mg granules for oral solution contain:
  – 2.25 mmol of potassium per sachet: To be taken into consideration in people with reduced renal function or who are following a low-potassium diet.
  – Aspartame: a source of phenylalanine, therefore it is contraindicated in subjects with phenylketonuria.
  – Sucrose: Patients with rare hereditary fructose malabsorption problems, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not take this medicine.

Contraindications

• 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 renal insufficiency. cardiac.
• The sachet form, as it contains aspartame, is contraindicated in patients with phenylketonuria.

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.
• Anticoagulants: NSAIDs may 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 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 initiation of concomitant therapy.
• Experimental data indicate that ibuprofen may increase the risk of renal failure. inhibit the effects of low-dose acetylsalicylic acid on platelet aggregation when the drugs are administered concomitantly.
  However, the limited data and the 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.

Undesirable 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 common adverse events are: rash, itching, redness, swelling of the skin, redness ... The most commonly observed side effects are gastrointestinal in nature.
Peptic ulcers, perforation or gastrointestinal bleeding, sometimes fatal, particularly in the elderly, may occur.
After administration of Moment, the following have been reported: feeling of heaviness in the stomach, nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease.
Less frequently, gastritis has been observed.
Cardiovascular effects
Edema, hypertension and cardiac failure have been reported in association with treatment with NSAIDs.
Clinical studies and epidemiological data suggest that the use of ibuprofen (especially at high doses 2400 mg/day) and for long-term treatment, may increase the risk of heart failure. be associated with a modest increase in the risk of arterial thrombotic events.
These phenomena rapidly regress with 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 cause an increase in the risk of arterial thrombotic events. may adversely affect pregnancy and/or embryo/fetal development.
Results from 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%, up to approximately 1.5%.
The risk was considered 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 third trimester of pregnancy, all prostaglandin synthesis inhibitors Prostaglandins 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.

Format

8 single-dose sachets