Active ingredients: Ibuprofen
MOMENT 200 mg granules for oral solution
Moment package inserts are available for pack sizes:- MOMENT 200 mg granules for oral solution
- MOMENT 200 mg effervescent tablets
- MOMENT 200 mg chewable tablets
- MOMENT 200 mg coated tablets
- MOMENT 200 mg soft capsules
- MOMENT 20 g / 100 ml oral drops, solution
Indications Why is Moment used? What is it for?
What is it
Moment belongs to the class of analgesics-anti-inflammatories, ie medicines that fight pain and inflammation
Why is it used
Pain of various origins and nature (menstrual pain, headache, toothache, neuralgia, osteo-joint and muscle pain).
Contraindications When Moment should not be used
- Hypersensitivity to the active ingredient (ibuprofen), to other antirheumatics (eg acetylsalicylic acid etc.) or to any of the excipients of the product.
- Children under 12 years old.
- Pregnancy and breastfeeding (see "What to do during pregnancy and breastfeeding")
- 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 heart failure.
- Severe hepatic or renal insufficiency.
- Patients with phenylketonuria (inborn error of the metabolism of an amino acid, phenylalanine)
Precautions for use What you need to know before you take Moment
- Ibuprofen should be taken with caution by asthmatics and, more particularly by those who have experienced bronchospasm after the use of acetylsalicylic acid or other NSAIDs (non-steroidal anti-inflammatory drugs), as well as by those who have a clinical history with a history of gastrointestinal bleeding or ulcer.
- The use of Moment should be avoided in conjunction 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.
- There is a risk of impaired renal function in dehydrated adolescents.
- In the elderly and in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section "When it should not be used"), 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. The 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 (see below and section "Which Medicines or foods may change the "effect of the medicine").
- 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.
- 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 "Undesirable effects").
- When gastrointestinal bleeding or ulceration occurs in patients taking Moment the treatment should be discontinued.
- Caution should be exercised in patients taking concomitant medications that 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 (see section "What medicines or foods can change the "effect of the medicine").
- Medicines such as Moment may be associated with a modest increased risk of heart attack ("myocardial infarction") or stroke: Any risk is more likely with high doses and prolonged treatments. Do not exceed the recommended dose or duration of treatment (3 days).
- If you have heart problems, have a history of stroke or think you may be at risk for these conditions (for example if you have high blood pressure, diabetes or high cholesterol or smoke) you should discuss your treatment with your doctor or pharmacist.
Interactions Which drugs or foods can change the effect of Moment
Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription.
- If you are following a coumarin-type anticoagulant therapy (warfarin, dicumarol etc.), use Moment only after consulting your doctor.
- Do not combine Moment with acetylsalicylic acid or other NSAIDs
- Corticosteroids: increased risk of gastrointestinal ulceration or bleeding (see Section "Appropriate precautions for" use ").
- Anticoagulants: NSAIDs may enhance the effects of anticoagulants, such as warfarin (see Section "Appropriate precautions for use").
- Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding (see Section "Appropriate precautions for use").
- 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.
- Some medicines such as anticoagulants and antiplatelet agents (eg acetylsalicylic acid, warfarin, ticlopidine), antihypertensives (ACE inhibitors, eg captopril, beta-blockers, angiotensin II antagonists) and other medicines may interact with treatment with ibuprofen. doctor before using ibuprofen with other medicines.
Warnings It is important to know that:
- The use of Moment, as with any prostaglandin synthesis and cyclooxygenase inhibitor drug, is not recommended for women intending to become pregnant.
- Moment should be discontinued in women who have fertility problems or who are undergoing fertility investigations.
- Elderly: Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal (see section "How to use this medicine").
- 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.
- Caution is required (consult your doctor or pharmacist) 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 "Undesirable effects"). In the early stages of therapy i 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.
When it can be used only after consulting your doctor
- Asthmatic patients (see "Precautions for" use ")
- Patients with a history of gastroduodenal bleeding or ulcer (see "Precautions for use")
- If you are following a coumarin-type anticoagulant therapy (warfarin, dicumarol etc.) (see "What medicines or foods can change the" effect of the medicine ").
What to do during pregnancy and breastfeeding
In pregnant or breastfeeding women, Moment should only be used after consulting your doctor and evaluating with him the risk / benefit ratio in your case.
Consult your doctor if you suspect a pregnancy or wish to plan a maternity leave.
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 has been considered to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to cause increased loss of pre- and post-implantation and of embryo-fetal mortality.
In addition, 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, 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.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
As a rule, the intake of the product does not alter the ability to drive and use other machinery. However, those who carry out an activity that requires vigilance should use caution if, during therapy, they notice drowsiness, dizziness, depression.
Important information about some of the ingredients of MOMENT
MOMENT 200 mg granules for oral solution contains:
- sucrose: if you have been told by your doctor that you have "intolerance to some sugars, contact your doctor before taking this medicine;
- potassium: contains 2.25 Mmol of potassium per sachet. To be taken into consideration in people with reduced kidney function or who follow a low potassium diet;
- aspartame: this medicine contains a source of phenylalanine. It can be harmful if you have phenylketonuria.
NOTES ON HEALTH EDUCATION
There are different types of pain, of various origins and nature, which we all face in the course of our everyday life with greater or lesser frequency: headache, toothache, muscle and joint pain, menstrual pain.
One of the most frequent pains is certainly headache (or cephalalgia). There are three main types of primary headaches (ie not due to other diseases): migraine, so called because the throbbing pain is localized only on one side of the head; tension headache, the most common type, which manifests as a circle in the head; cluster headache, characterized by attacks of excruciating pain affecting one eye or cheekbone.
Sometimes the headache can be a symptom of other diseases (allergies, anemia, myopia, intoxication, stomach upset, cervical arthrosis, sinusitis, constipation, head trauma). If you suffer from headaches it is important to try to identify the factors that can trigger it and prevent them (unregulated eating habits, particular foods, smoking, alcohol, stress, too intense physical exertion, excessive exposure to the sun, too loud noises, too much perfumes intense, etc.). If headache attacks are recurring, it is still advisable to contact your doctor. Menstrual pains (dysmenorrhea) are a very common ailment; in addition to pain, there are changes in mood (sadness, easy irritability), breast tension, generalized feeling of tiredness.
The elimination or reduction in the diet of substances such as coffee, salt or chocolate in favor of foods rich in vitamins, such as fruit, as well as the intake of hot herbal teas and chamomile, can help reduce these latter manifestations. Menstrual pain, sometimes of considerable intensity, can instead be fought with painkillers that act by reducing the amount of prostaglandins, substances produced by the uterus and considered to be the main causes of the disorder.
Dosage and method of use How to use Moment: Dosage
How many
Adults and adolescents over 12 years: 1-2 sachets, two-three times a day.
Warning: do not exceed the doses of 6 sachets per day without medical advice. Elderly patients should adhere to the minimum dosages indicated above.
When and for how long
Take the drug preferably on a full stomach (eg after breakfast, lunch or dinner).
After three days of treatment without appreciable results, consult your doctor
Consult your doctor if the disorder occurs repeatedly or if you have noticed any recent changes in its characteristics.
If the use of the drug is necessary for more than 3 days in adolescents, or in the case of worsening of symptoms, the doctor should be consulted.
Like
Dissolve the contents of a sachet in a glass of water or in a hot drink (light tea, chamomile or herbal tea), stirring with a teaspoon until dissolved and immediately drink the solution obtained.
Overdose What to do if you have taken too much Moment
In case of accidental ingestion / intake of an excessive dose of Moment, notify your doctor immediately or go to the nearest hospital. Take this leaflet with you.
Note to healthcare professional: Gastric lavage and correction of blood electrolytes are indicated in the event of overdose. There is no specific antidote to ibuprofen.
IF YOU HAVE ANY DOUBTS ABOUT USING MOMENT, CONTACT YOUR DOCTOR OR PHARMACIST.
Side Effects What are the side effects of Moment
Like all medicines, MOMENT can have side effects, although not everybody gets them.
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 (see section "It is important to know that").
The following have been reported following administration of Moment: a feeling of weight in the stomach, nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see section "It is important to know that).
Gastritis has been observed less frequently.
Cardiovascular effects
Edema, hypertension and heart failure have been reported in association with NSAID treatment.
Medicines such as Moment may be associated with a modest increased risk of heart attack ("myocardial infarction") or stroke.
These phenomena generally tend to regress with the suspension of treatment.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Expiry and Retention
Expiry: see the expiry date indicated on the package.
Do not use the medicine after the expiry date indicated on the package.
The expiry date refers to the product in intact packaging, correctly stored. Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment. It is important to have the information about the medicine available at all times, so keep both the box and the package leaflet.
Keep this medicine out of the reach and sight of children.
Composition and pharmaceutical form
Composition
Each sachet contains:
Active ingredient: ibuprofen 200 mg (as sodium salt dihydrate 256 mg)
Excipients: sucrose, potassium bicarbonate, orange flavor, acesulfame potassium, aspartame (E 951).
How it looks
Moment comes in the form of a sachet of granules for oral solution in sachets. Each pack contains 12 sachets.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
MOMENT 200 MG GRANULATE FOR ORAL SOLUTION
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
One sachet contains: active principle: ibuprofen 200 mg (as sodium salt dihydrate 256 mg).
For the full list of excipients see section 6.1.
03.0 PHARMACEUTICAL FORM
Granules for oral solution.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Pain of various origins and nature (menstrual pain, headache, toothache, neuralgia, osteo-joint and muscle pain).
04.2 Posology and method of administration
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 immediately drink the solution.
Do not exceed the dose of 6 sachets per day.
If the use of the drug 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.
04.3 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 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 heart failure.
• The sachet form, as it contains aspartame, is contraindicated in patients with phenylketonuria (see section 4.4).
04.4 Special warnings and appropriate precautions for use
• In asthmatic patients the product should be used with caution, after consulting your doctor.
• Patients whose activity requires vigilance should use caution in case they notice drowsiness, dizziness or depression while taking ibuprofen.
• The use of Moment, like any prostaglandin synthesis and cyclooxygenase inhibitor drug, is not recommended for 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 in conjunction 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 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 ( eg 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 (see section 4.2).
• 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 increasing 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 (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 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 (see section 4.5).
• 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 (see section 4.8).
• 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 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 200 mg granules for oral solution contains:
- 2.25 Mmoles of potassium per sachet. To be taken into consideration in people with reduced kidney function or who follow a low potassium diet.
- aspartame, a source of phenylanine, therefore it is contraindicated in subjects suffering from phenylketonuria.
- sucrose: patients with rare hereditary fructose disease, glucose and galactose malabsorption, or sucrase isomaltase insufficiency, should not take this medicine.
04.5 Interactions with other medicinal products and other forms of interaction
• Any interactions with coumarin-type anticoagulants should be kept in mind: patients undergoing treatment with such drugs must 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 enhance 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 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 limited data and uncertainties relating to their application to the clinical situation do not allow to draw firm conclusions for the continued use of ibuprofen; there appears to be no clinically relevant effect from the occasional use of ibuprofen (see section 5.1).
04.6 Pregnancy and lactation
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 has been considered to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to cause increased loss of pre- and post-implantation and of embryo-fetal mortality.
In addition, 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, 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
04.7 Effects on ability to drive and use machines
The use of ibuprofen does not normally affect the ability to drive or use machines. However, those patients whose activity requires vigilance should exercise caution if they experience drowsiness, dizziness or depression while taking ibuprofen.
04.8 Undesirable 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 haemorrhage, sometimes fatal, may occur, particularly in the elderly (see section 4.4).
The following have been reported following administration of Moment: feeling of stomach weight, nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see section 4.4 Special warnings and precautions for use).
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 (eg myocardial infarction. or stroke see Section 4.4).
These phenomena rapidly regress with the suspension of the treatment.
04.9 Overdose
In case of overdose, gastric lavage, correction of blood electrolytes is indicated. There is no specific antidote to ibuprofen.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Therapeutic drug category: non-steroidal anti-inflammatory and antirheumatic drugs - derivatives of propionic acid.
ATC code: M01AE01.
Ibuprofen is a synthetic analgesic-anti-inflammatory, also endowed with a marked antipyretic activity. Chemically it is the progenitor of phenylpropionic derivatives with anti-inflammatory activity. The analgesic activity is non-narcotic.
Ibuprofen is a potent inhibitor of prostaglandin synthesis and exerts its activity by inhibiting its synthesis peripherally.
Experimental data indicate that ibuprofen may inhibit the effects of low-dose acetylsalicylic acid on platelet aggregation when the drugs are administered concomitantly. In one study, following administration of a single 400 mg dose of ibuprofen, taken within 8 hours before or 30 minutes after the administration of acetylsalicylic acid (81 mg), there was a decrease in the effect of acetylsalicylic acid on thromboxane formation and platelet aggregation. However, the limited 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.
05.2 Pharmacokinetic properties
Ibuprofen is well absorbed following oral administration and rapidly reaches optimal blood levels.
Ibuprofen is excreted rapidly and completely 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.
05.3 Preclinical safety data
The toxicological tests on different animal species, for different routes of administration and repeated doses, have shown that ibuprofen is well tolerated and did not show teratogenic effects; in particular, no alterations to the main parenchyma and crase have been observed so far. blood.
However, it should be noted that the administration of NSAIDs to pregnant rats can lead to restriction of the fetal ductus arteriosus.
There is no further information on preclinical data other than that already reported elsewhere in this Summary of Product Characteristics (see section 4.6).
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Each sachet contains:
sucrose, potassium bicarbonate, orange flavor, acesulfame potassium, aspartame (E 951).
06.2 Incompatibility
Not relevant.
06.3 Period of validity
3 years.
06.4 Special precautions for storage
This medicine does not require any special storage conditions.
06.5 Nature of the immediate packaging and contents of the package
12 multilayer paper / polyethylene / aluminum / surlyn sachets. The sachets are packed in a cardboard box.
06.6 Instructions for use and handling
No special instructions.
Unused medicine and waste derived from this medicine must be disposed of in accordance with local regulations.
07.0 MARKETING AUTHORIZATION HOLDER
Joint Chemical Companies Angelini Francesco - A.C.R.A.F. S.p.A.
Viale Amelia, 70 - 00181 ROME
08.0 MARKETING AUTHORIZATION NUMBER
Moment 200 mg granules for oral solution - 12 sachets: AIC n. 025669211
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
8/03/2010
10.0 DATE OF REVISION OF THE TEXT
June 2014
