Symptomatic treatment of painful and / or febrile conditions

Dosage and mode of administration

The occurrence of adverse reactions can be minimized by the use of the lowest dose possible during the shortest duration of treatment necessary to relieve the symptoms (see section 4.4) Warnings and Precautions ).

Reserved for infants and children, from 3 months to 12 years (about 30 kg).
Oral use.

Shake the bottle well before use.

Drink water after absorption of the solution.

Dosage

The usual dosage is 20 to 30 mg / kg / day in 3 to 4 taken without exceeding 30 mg / kg / day.
The medicinal product is administered via the syringe for oral administration (graduated in kg) which delivers a dose of 7.5 mg / kg per dose.
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The dose to be administered for intake is obtained by aspirating the suspension by pulling the plunger of the syringe for oral administration to the graduation corresponding to the weight of the child

For each take

Up to 25 kg: fill the syringe up to the graduation indicating the weight of the child

· Between 25 kg and 30 kg: first fill the syringe up to the 25 kg graduation and then a second time until reaching a total equal to the child's weight (example for a child of 30 Kg: fill the syringe up to 25 kg and then a second time up to 5 kg.)

· Beyond 30 kg (about 12 years): there are more suitable pharmaceutical forms

Frequency, Administration

The systematic catch should prevent oscillations of pain or fever and should be spaced at least 6 hours apart.

Subjects, aged

This drug is intended for infants and children, however, when used in the elderly, it should be noted that since age does not alter the kinetics of ibuprofen, Not have to be modified, depending on this parameter. However, precautions should be taken (see Warnings and Precautions for Use).

No information in the marketing authorization.

OTHER ANALGESICS AND ANTIPYRETICS, ATC Code: N02B.

Ibuprofen is a non-steroidal anti-inflammatory, belonging to the group of propionics, derived from aryl carboxylic acid. It has the following properties:

· Analgesic property

· Antipyretic property

· Anti-inflammatory property

· Short-term inhibition property of platelet functions.

All of these properties are related to an inhibition of the synthesis of prostaglandins.


This medication is contraindicated in the following situations

· After 24 weeks of amenorrhea (5 months of pregnancy) (see section Pregnancy and breastfeeding)

· Hypersensitivity to ibuprofen or any of the excipients of the product

· A history of asthma triggered by taking ibuprofen or substances of similar activity such as: other NSAIDs, acetylsalicylic acid

· History of hemorrhage or perforation, digestive during previous NSAID treatment

· Gastrointestinal haemorrhage, haemorrhage, cerebrovascular or other haemorrhage in evolution

· Evolutionary peptic ulcer, history of peptic ulcer or recurrent hemorrhage (2 or more distinct episodes of haemorrhage or ulceration)
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· Severe hepatic impairment

· Severe renal impairment

· Severe heart failure

· Systemic lupus erythematosus

Warnings

Concomitant use of ADVILMED, CHILDREN AND INFANTS with other NSAIDs, including selective cyclooxygenase 2 (cox-2) inhibitors, should be avoided.
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The occurrence of adverse reactions can be minimized by the use of the lowest dose possible during the shortest treatment time necessary to relieve the symptoms (see section 4.2 Posology and Method of Administration and Effects Gastrointestinal and cardiovascular disorders below).

Patients with asthma associated with chronic rhinitis, chronic sinusitis and / or nasal polyposis have a risk of allergic manifestation when taking acid, acetylsalicylic and / or anti-inflammatory drugs Steroids higher than the rest of the population.

Administration of this specialty may lead to an asthma attack, especially in certain individuals allergic to acids, acetylsalicylic or NSAIDs (see section 4.3).

Elderly subject

Elderly subjects are at increased risk of adverse reactions to NSAIDs, particularly gastrointestinal haemorrhage and potentially fatal perforations (see Dosage and Mode of Administration and below).

Effects, gastrointestinal

Gastrointestinal haemorrhages, ulcers, or gastrointestinal perforations, sometimes fatal, have been reported with all NSAIDs at any time of treatment without necessarily warning signs or, History of adverse events, serious gastrointestinal tract

The risk of hemorrhage, ulceration or gastrointestinal perforation increases with the dose used in patients with a history of ulcer, particularly in the case of hemorrhage or perforation complications (see Contraindications) as well as in the elderly. In these patients, treatment should be started at the lowest dose possible. Protective treatment of the mucosa (eg, misoprostol or proton pump inhibitor) should be considered for these patients, as for patients requiring treatment with low doses, acetylsalicylic acid or other , Drugs likely to increase risk, gastrointestinal (see below and section Interactions with other medicines and other forms of interactions).
Patients with a gastrointestinal history, especially in elderly patients, should report any unusual abdominal symptoms (especially bleeding, gastrointestinal), especially at the beginning of treatment. Br>

Particular attention should be paid to patients receiving treatment, associates liable to increase risk, ulceration or hemorrhage, such as oral corticosteroids, oral anticoagulants such as warfarin, inhibitors; Selective serotonin reuptake inhibitors (SSRIs) and antiplatelet agents such as acetylsalicylic acid (see section Interactions with other medicines and other forms of interactions)
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In the event of hemorrhage or ulceration occurring in a patient receiving ADVILMED, CHILDREN AND INFANTS treatment should be discontinued

NSAIDs should be administered with caution and under close surveillance in patients with a history of gastrointestinal illness (Hemorrhagic Recto-Colitis, Crohn's Disease) due to a risk of aggravation of the pathology (See section 4.4).

Cardiovascular and cerebrovascular effects

Adequate monitoring and recommendations are required in patients with a history of mild to moderate hypertension and / or cardiac insufficiency, hydrosodic retention and edema reported in combination with NSAID

Clinical studies and epidemiological data suggest that the use of ibuprofen, especially when used at a high dose (2400 mg per day) and over a long period of treatment, may be associated with Slight increase in the risk of arterial thrombotic events (for example, myocardial infarction or stroke) (see section 4.4, Precautions for use). However, epidemiological data do not suggest that low doses of ibuprofen (
Skin effects

Severe skin reactions, including fatal events, including exfoliative dermatitis, Stevens-Johnson syndromes, and Lyell's syndromes have been reported very rarely during NSAID treatments (see section 4.8).

The incidence of these undesirable effects seems to be greater at the beginning of the treatment, with the onset of the disease occurring in the majority of cases during the first month of treatment ADVILMED CHILDREN AND INFANTS Onset of rash, skin, mucosal lesions or any other signs of hypersensitivity

Chickenpox may exceptionally cause severe infectious complications such as cutaneous and soft tissue. To date, the role of NSAIDs in the worsening of these infections can not be ruled out. It is therefore prudent to avoid the use of ADVILMED CHILDREN AND INFANTS in the case of chickenpox (see section 4.4).

Renal impairment, functional

NSAIDs, by inhibiting the vasodilating action of renal prostaglandins, are capable of causing renal insufficiency, which is functional by decreasing glomerular filtration.This undesirable effect is dose-dependent. >

At the start of treatment or after an increase in dosage, diuresis and renal function monitoring is recommended in patients with the following risk factors

· Elderly

· Associated drugs such as: IEC, sartans, diuretics (see section Interactions with other medicinal products and other forms of interactions)
· Hypovolemia whatever the cause

· Heart failure

· Chronic renal insufficiency

· Nephrotic syndrome

· Lupus nephropathy

· Decompensated liver cirrhosis.

Retention, hydro-soda

Hydro-sodium retention with possibility of edema, hypertension or hypertension, aggravation of heart failure. Clinical monitoring is required from the start of treatment in case of hypertension or heart failure. A decrease in the effect of antihypertensive drugs is possible (see Interactions with other medicines and other forms of interactions)

Hyperkalemia

Hyperkalemia favored by diabetes or concomitant treatment with hyperkalaemic drugs (see section Interactions with other medicinal products and other forms of interactions)
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Regular monitoring of serum potassium should be carried out under these circumstances.
The use of this medication should be avoided in case of treatment with a non-steroidal anti-inflammatory drug, with an oral anticoagulant, with lithium, with analgesic acetylsalicylic acid, antipyretic or anti-inflammatory drugs, With methotrexate at doses greater than 20 mg per week, with low molecular weight and related heparins and unfractionated heparins (at curative doses and / or in elderly subjects), with pemetrexed Patients with low to moderate renal function (see section Interactions with other medicinal products and other forms of interactions)

Special precautions for use

Ibuprofen, like any drug, inhibits the synthesis of cyclooxygenases and prostaglandins, can alter fertility. Its use is not recommended for women who wish to conceive a child

In case of visual disturbances occurring, a complete ophthalmologic examination must be carried out during treatment.

During prolonged treatment, it is recommended to check the blood form, liver and kidney functions.

This medicinal product contains sucrose. Its use is discouraged in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase / isomaltase deficiency

This medicinal product contains sorbitol and is not recommended for use in patients with fructose intolerance (rare hereditary disease)

This medicinal product contains glycerol and may cause headache and digestive disorders (diarrhea).



Certain drugs or classes of therapeutics are likely to promote the onset of hyperkalaemia: potassium salts, hyperkalaemic diuretics, angiotensin II antagonists, angiotensin II antagonists, anti- Non-steroidal inflammatory drugs, heparins (low molecular weight or non-fractionated), immunosuppressants such as ciclosporin, or tacrolimus, trimethoprim.
The combination of these drugs increases the risk of hyperkalaemia. This risk is particularly important with potassium-sparing diuretics, especially when they are combined with one another or with potassium salts, while the combination of an ACE inhibitor and an NSAID, for example, is To reduce the risk as soon as the recommended precautions are implemented.

For drug-specific hazards and levels of stress, hyperkalaemia, reference should be made to the specific interactions of each substance.

However, certain substances, such as trimethoprim, are not the subject of specific interactions with respect to this risk. However, they may act as promoting factors when they are associated with other medicines such as those mentioned above.


Associations, not recommended (see Warnings and precautions for use)

+ Other NSAIDs

Increased risk, ulcerative and digestive haemorrhagic fever

+ Acetylsalicylic acid in doses, anti-inflammatory drugs (³, 1 g per dose and / or ³, 3 g daily) or analgesic or antipyretic doses (³ 500 mg per dose and / or Day)

Increased risk, ulcerative and digestive haemorrhagic fever

+ Oral anticoagulants

Increased hemorrhagic risk, oral anticoagulant (aggression of the mucosa, gastroduodenal by NSAIDs). NSAIDs are likely to increase the effects of anticoagulants such as warfarin (see section 4.4).

+ Methotrexate, used at doses greater than 20 mg / week

Increased toxicity, especially haematological methotrexate (decrease, renal clearance of methotrexate by anti-inflammatory drugs)

+ Pemetrexed (patients with low renal function, moderate creatinine clearance, 45 ml / min to 80 ml / min))
Risk of increased toxicity, pemetrexed (decreased renal clearance by NSAIDs)

Associations requiring precautions for use

+; Ciclosporin, tacrolimus

Risk of addition of effects, nephrotoxic, especially in the elderly, Monitoring renal function at the beginning of treatment, NSAID

+, Angiotensin II antagonists (AIIA), diuretics, angiotensin converting enzyme inhibitors (AIIA)

Acute renal failure in the patient at risk (elderly and / or dehydrated) by decreased filtration, glomerular (inhibition of prostaglandins, vasodilators by NSAIDs). >
Moreover, reduction of the effect, anti-hypertensive.

Moisturize the patient. Monitoring renal function at the beginning of treatment

+ Methotrexate, used at doses less than or equal to 20 mg / week

Increased toxicity, especially haematological methotrexate (decrease, renal clearance of methotrexate by anti-inflammatory drugs)

Weekly control of the hemogram during the first weeks of the association

Increased monitoring in case of alteration (even mild) of renal function, as well as in the elderly

+; Pemetrexed (patients with normal renal function)

Risk of increased toxicity, pemetrexed (decreased renal clearance by NSAIDs)

Biological monitoring of renal function

Associations, to be taken into account

+ Acetylsalicylic acid at doses, anti-aggregation (from 50 mg to 375 mg per day in 1 or more taken)
Increased risk, ulcerative and digestive haemorrhagic fever

In addition, experimental data suggest that ibuprofen may inhibit the anti-platelet aggregation effect of a low dose of acetylsalicylic acid when taken concomitantly. However, the limitations of these ex vivo data and the uncertainties with regard to their extrapolation in clinical practice do not make it possible to give a formal conclusion as to the regular use of ibuprofen, Ibuprofen used on an occasional basis, the occurrence of a clinically relevant effect appears to be unlikely.

Antiplatelet drugs and serotonin reuptake inhibitors (SSRIs)

Increased risk of gastrointestinal hemorrhage (see section 4.4) Warning and precautions for use.
+; Beta-blockers (except esmolol)

Reduction of the effect, antihypertensive (inhibition of vasodilating prostaglandins, NSAIDs and hydrosodic retention with NSAIDs, pyrazole)

+; Deferasirox

Increased risk, ulcerative and digestive haemorrhagic fever

+; Glucocorticoids (except hydrocortisone in treatment; replacement)

Increased risk of ulceration and gastrointestinal hemorrhage (see Warnings and Precautions for Use).

+ Low-molecular-weight heparin and related compounds and unfractionated heparins (at pre-emptive doses)

Increased risk, hemorrhagic.

Signs

· Non-serious effects: nausea, vomiting

Severe effects: CNS depression, seizures, attacks, digestive, bradycardia, kidney disease and acidosis, metabolism

What to do

· Immediate transfer to hospitals

· Rapid evacuation of the product ingested by gastric lavage

· Activated charcoal to decrease the absorption of ibuprofen.

· Symptomatic treatment.

This medicinal product is intended for infants and children. However, in exceptional circumstances for women of childbearing age, it is necessary to recall the following points:

Pregnancy

Aspect: malformative: 1st quarter

Animal studies have not demonstrated teratogenicity

In the absence of teratogenic effect in animals, a malformative effect in the human species is not expected. Indeed, to date, the substances responsible for malformations in the human species have been shown to be teratogenic in animals during studies, well conducted on 2 species.

In the human species, no particular malformative effect related to administration during the first trimester of pregnancy has been reported. However, supplementary epidemiological studies are needed to confirm the absence of risk.

Fetotoxic and neonatal aspect, 2nd and 3rd trimesters

This is class toxicity, involving all prostaglandin synthesis inhibitors.

Administration during the 2nd and 3rd quarter exposes to

· Renal Functional Impairment

O utero can be observed as early as 12 weeks, amenorrhea (initiation of diuresis, fetal): oligoamnios (most often reversible at cessation of treatment), or even anamnios Extended exposure.

O at birth, renal insufficiency (reversible or not) may persist especially in cases of late and prolonged exposure (with a risk of delayed severe hyperkalaemia)
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· A risk of cardiopulmonary disease

Partial or complete constriction in utero of the ductus arteriosus. The constriction of the ductus arteriosus can occur from at least 5 months and may lead to insufficiency, right fetal or neonatal heart or even fetal death, in utero. This risk is all the more important as the catch is close to the term (less reversibility). This effect even exists for a one-time catch.
· A risk of longer bleeding time for the mother and the child

As a result

Up to 12 weeks of amenorrhea, use of ADVIL INFANTS AND INFANTS 20 mg / 1 ml suspension, drinkable in vial should be considered only if necessary
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· Between 12 and 24 weeks of amenorrhea (between the beginning of the fetal diuresis and 5 months): a brief intake should only be prescribed if necessary. A prolonged take is strongly discouraged.

Above 24 weeks of amenorrhea (5 months, complete): any single dose is contraindicated (see section Contraindications). An inadvertent intake beyond 24 weeks of amenorrhea (5 months) warrants cardiac and renal, fetal and / or neonatal monitoring according to the term of exposure. The duration of this monitoring will be adapted to the half-life, elimination of the molecule.

Breastfeeding

A.I.N.S. Passing into breast milk as a precaution, it should be avoided administered to women who are breastfeeding

RELATED LINKS: IBUPROFENE

Clinical studies and epidemiological data suggest that the use of ibuprofen, especially when used, at a high dose (2400 mg per day) and over a long period of treatment may be associated with A slight increase in risk, arterial thrombotic events (eg myocardial infarction or stroke) (see Warnings and Precautions for Use)

The most commonly observed adverse reactions are gastrointestinal. Peptic ulcers, perforations, or gastrointestinal haemorrhages, sometimes fatal, may occur, especially in the elderly (see Warnings and Precautions for Use).

Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, stomatitis, ulcerative, abdominal pain, melena, hematemesis, exacerbation of recto-colitis or Crohn's disease (see Warnings and Precautions, Use) have been reported as a result of the administration of NSAIDs. Less frequently, gastritis has been observed.

Edema, hypertension and heart failure have been reported in association with NSAID therapy.

Effects, gastrointestinal

Gastrointestinal disorders have been reported to include nausea, vomiting, gastralgia, dyspepsia, transit disorders, gastrointestinal ulceration with or without bleeding, haemorrhage, occult or non-occult hemorrhage. These are all the more frequent because the dosage used is high and the duration of treatment prolonged.


Dermatologic: rash, rash, pruritus, edema, aggravation of chronic urticaria

· Respiratory: The onset of an asthma attack in some individuals may be related to an allergy to acetylsalicylic acid or a non-steroidal anti-inflammatory drug (see section Contraindications). >

· General: anaphylactic shock, edema of Quincke.

Skin Effects

Very rarely, bullous reactions (Stevens-Johnson's syndrome, Lyell's syndrome) have been observed.
Effects on the central nervous system

Ibuprofen may exceptionally cause dizziness and headache.

Other

· A few cases of visual impairment have been reported

· Oliguria, renal insufficiency

· The discovery of aseptic meningitis under ibuprofen should result in lupus, systemic erythematosus or connective tissue disease

Some biological changes could have been observed

· Hepatic: transient increase in transaminases, exceptional cases of hepatitis

· Haematological: agranulocytosis, anemia, haemolytic.
RELATIONSHIPS TO EXCIPIENTS

· Possibility of digestive disorders and diarrhea (due to the presence of glycerol and sorbitol)

· Risk of allergic reactions (due to the presence of red cochineal A)

Symptomatic treatment of painful and / or febrile conditions