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ANTARENE Gé 400 mg Coated tablet B/30

Elerté

ANTARENE Gé 400 mg Coated tablet B/30

CIP / EAN code: 3400935193759

Product information from VIDAL.

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Product information

Find indications, dosage and precautions in the sections below.

Automatic English translation of the French VIDAL document. Original numerical values and units are retained, including decimal commas.

VIDAL
Medicines
Update of 14/10/2024

ANTARENE®

ANTARENE® Ge
ibuprofen


Forms and presentations


Antarene:
Film-coated tablet at 100 mg (white): Box of 40, under blister packs.



Antarene Ge :
Oral suspension at 20 mg/mL for infants and children: Bottle of 150 mL, with 5 mL syringe for oral administration, graduated in kg of body weight.
Film-coated tablet at 200 mg (white): Box of 30, under blister packs.
Film-coated tablet at 400 mg:  Box of 30, under blister packs.


Composition

Lozenge: per tablet
Ibuprofen (INN) 
100 mg
or 200 mg
or 400 mg
Excipients (common): corn starch, pregelatinized corn starch, stearic acid, anhydrous colloidal silica. Film coating: Opadry white OYL 28900 (lactose, hypromellose, titanium dioxide E 171, macrogol 4000) [tabs at 100 mg and at 400 mg], Opadry white (titanium dioxide, hypromellose) [tabs at 200 mg], carnauba wax.

Excipient with known effect: lactose (tablets at 100 mg and at 400 mg).

Oral suspension: per mL
Ibuprofen (INN) 
20 mg
Excipients: citric acid monohydrate, disodium phosphate dodecahydrate, carrageenans, sorbitol, polysorbate 85, methyl and propyl parahydroxybenzoates, sodium saccharin, carmine red A (E 124), wild strawberry flavouring, purified water.

Excipients with known effect: carmine red A (E124), sodium, sorbitol.

1 graduation of 1 kg corresponds to 0,5 ml of oral suspension and contains 10 mg of ibuprofen.


Indications

This medicine contains a non-steroidal anti-inflammatory drug: ibuprofen.
100 mg tablet:
It is indicated, in children weighing 20 kg to 30 kg (i.e. approximately 6 years to 11-12 years) in the:
  • short-term treatment of fever and/or pain such as headache, flu-like states, dental pain, body aches and painful periods;
  • symptomatic treatment of juvenile chronic arthritis.
20 mg/ml oral suspension:
  • Symptomatic treatment of painful and/or febrile conditions.
  • Symptomatic treatment of juvenile chronic arthritis.
200 mg tablet:
It is indicated, in adults and children over 20 kg (i.e. approximately 6 years), in the short-term treatment of fever and/or pain such as headache, flu-like states, dental pain, body aches, painful periods.
400 mg tablet:
These derive from the anti-inflammatory activity of ibuprofen, the extent of the intolerance reactions to which the medicine gives rise, and its place among the anti-inflammatory products currently available.
They are limited, in adults (over 15 years), to the:
  • Long-term symptomatic treatment of:
    • chronic inflammatory rheumatism, notably rheumatoid polyarthritis, ankylosing spondylarthritis or related syndromes such as Fiessinger-Leroy-Reiter syndrome and psoriatic rheumatism;
    • certain disabling and painful osteoarthritis.
  • Short-term symptomatic treatment of acute flares of:
    • extra-articular rheumatism such as scapulohumeral periarthritis, tendinitis, bursitis;
    • osteoarthritis;
    • microcrystalline arthritis;
    • low back pain;
    • radiculalgia;
    • benign acute post-traumatic conditions of the locomotor system.
  • Dysmenorrhoea after etiological investigation.
  • Symptomatic treatment of painful conditions of mild to moderate intensity and/or febrile states.

Dosage and administration

To relieve symptoms, the lowest effective dose should be used for the shortest possible duration (see Warnings and Precautions for Use).

Dosage

Tablet at 100 mg: Suitable for children weighing 20 to 30 kg (i.e., approximately 6 years old, about 11-12 years).

Oral suspension: Reserved for infants and children, from 3 months to 12 years (i.e., approximately 30 kg).

Tablet at 200 mg: Suitable for adults and children from 20 kg (approximately 6 years).

Tablet at 400 mg: Reserved for adults (over 15 years).

Painful conditions and/or febrile states (all dosages):
20 mg/ml oral suspension:
The usual dosage is 20 to 30 mg/kg/day in 3 doses per day (not to exceed 30 mg/kg/day)
100 mg tablet:
In children weighing 20 to 30 kg (approximately 6 to 11 years):
The usual dosage is 20 to 30 mg/kg/day in 3 doses per day (not to exceed 30 mg/kg/day): 2 tablets at 100 mg (200 mg), to be repeated if necessary after 6 hours. In all cases, do not exceed 6 tablets at 100 mg per day (600 mg).
200 mg tablet:
  • In children weighing 20 to 30 kg (approximately 6 to 11 years): The usual dosage is 20 to 30 mg/kg/day in 3 doses per day (not to exceed 30 mg/kg/day): 1 tablet at 200 mg, to be repeated if necessary after 6 hours. In all cases, do not exceed 3 tablets at 200 mg per day (600 mg).
  • In adults and children over 30 kg (approximately 11-12 years): 1 to 2 tablets at 200 mg (200 mg to 400 mg), to be repeated if necessary after 6 hours. In all cases, do not exceed 6 tablets at 200 mg per day (1200 mg).
Duration of treatment (100 mg and 200 mg tablets):
If pain persists for more than 5 days or worsens, or if fever persists for more than 3 days, or if any new disorder occurs, the patient is advised to seek medical advice.
400 mg tablet:
1 tablet at 400 mg per dose, to be repeated if necessary, not to exceed 3 tablets at 400 mg (i.e., 1200 mg per day).
Juvenile chronic arthritis (100 mg tablets, oral suspension):
The usual dosage is 30 to 40 mg/kg/day, in 4 doses per day.
Rheumatological indications in adults over 15 years (400 mg tablets):
  • Initial treatment: 2 tablets at 400 mg, 3 times per day, i.e., 2400 mg per day.
  • Maintenance treatment: 1 tablet at 400 mg, 3 to 4 times per day, i.e., 1200 to 1600 mg per day.
Dysmenorrhea (400 mg tablets):
1 tablet at 400 mg per dose, to be repeated if necessary, not to exceed 4 tablets at 400 mg per day, i.e., 1600 mg per day.
Elderly subjects:
As age does not alter the kinetics of ibuprofen, the dosage should not need to be modified based on this parameter. However, precautions should be taken (see Warnings and Precautions for Use).
Frequency of administration:
Regular dosing prevents fluctuations in pain or fever. Doses should be spaced at least 6 hours apart (100 mg, 200 mg and 400 mg tablets) and 8 hours apart (oral suspension).

Method of administration:

Oral use.

Tablet (all dosages):
Swallow the tablet without chewing it, with a large glass of water, preferably during a meal.
Oral suspension:
Shake the bottle well before use.
The medicine is administered using the 5 ml oral dosing syringe (graduated in kg), which delivers a dose of 10 mg/kg per dose.
Administration with the oral dosing syringe:
The oral dosing syringe is graduated in kg of body weight. The use of the oral dosing syringe is strictly reserved for administering this paediatric ibuprofen suspension. The oral dosing syringe must be disassembled, rinsed and dried after each use.
The dose to be administered for 1 intake is obtained by drawing up the suspension by pulling the plunger of the oral administration syringe up to the graduation corresponding to the child's weight.
For each intake:
  • Up to 10 kg: fill the syringe up to the graduation indicating the child's weight.
  • Above 10 kg: fill the syringe a first time up to the 10 kg graduation, then a second time until reaching a total equal to the child's weight (for example: for a child of 30 kg, fill the syringe three times up to 10 kg).
  • Above 30 kg (i.e., approximately 12 years): more suitable pharmaceutical forms are available.

Contraindications

This medicine is contraindicated in the following situations:
  • Hypersensitivity to the active substance or to any of the excipients listed in section Composition.
  • History of asthma triggered by taking ibuprofen or substances with similar activity such as: other NSAIDs, acetylsalicylic acid.
  • History of gastrointestinal haemorrhage or perforation during a previous treatment with NSAIDs.
  • Gastrointestinal haemorrhage, cerebrovascular haemorrhage or other active haemorrhage.
  • Active peptic ulcer, history of peptic ulcer or recurrent haemorrhage (2 or more distinct documented episodes of haemorrhage or ulceration).
  • Severe hepatic insufficiency.
  • Severe renal insufficiency.
  • Severe heart failure.
  • Systemic lupus erythematosus.
  • Pregnancy, from the beginning of the 6th month (24 weeks of amenorrhoea) (see Fertility/Pregnancy/Breastfeeding).
Tablet or capsule intake is contraindicated in children under 6 years of age because it may cause choking.

Warnings and precautions

Risk of fetal death

Antarène exposes the foetus to a risk of foetal death even after a single intake due to its cardiopulmonary toxicity (constriction of the ductus arteriosus and occurrence of oligohydramnios, see Contraindications).

Effects on the unborn child

Antarène also exposes the newborn to a risk of renal damage (renal insufficiency), premature closure of the ductus arteriosus and pulmonary hypertension (see Fertility/Pregnancy/Breastfeeding).

Antarène is contraindicated in pregnant women from the beginning of the 6th month of pregnancy (24 weeks of amenorrhoea).

In case of planned pregnancy or during the first 5 months (before 24 weeks of amenorrhoea), Antarène should only be prescribed if absolutely necessary.

Special warnings

Concomitant use of Antarène with other NSAIDs, including selective cyclo-oxygenase 2 (COX-2) inhibitors, should be avoided.

The occurrence of adverse effects may be minimised by using the lowest possible dose for the shortest duration of treatment necessary to relieve symptoms (see Posology and Method of administration, and Gastrointestinal and cardiovascular effects below).

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

Administration of this medicinal product may cause an asthma attack, particularly in certain subjects allergic to acetylsalicylic acid or NSAIDs (see Contraindications).

Elderly:
Elderly patients have an increased risk of adverse effects with NSAIDs, in particular gastrointestinal haemorrhage and perforations which may be fatal (see Posology and Method of administration, and below).
Gastrointestinal effects:
Gastrointestinal hemorrhage, ulceration or perforation, sometimes fatal, has been reported with all NSAIDs, at any time during treatment, with or without warning symptoms or a history of serious gastrointestinal adverse events.
The risk of gastrointestinal bleeding, ulceration or perforation increases with the dose used in patients with a history of ulcer, particularly in the case of a complication such as bleeding or perforation (see Contraindications) as well as in elderly patients. In these patients, treatment should be started at the lowest possible dose. Mucosal protective treatment (for example misoprostol or a proton pump inhibitor) should be considered for these patients, as well as for patients requiring low-dose acetylsalicylic acid or treated with other medicinal products likely to increase the gastrointestinal risk (see below and Interactions).
Patients with a history of gastrointestinal disorders, especially elderly patients, should report any unusual abdominal symptoms (particularly gastrointestinal bleeding), especially at the start of treatment.
Particular attention should be paid to patients receiving concomitant treatments that may increase the risk of ulceration or bleeding, such as oral corticosteroids, oral anticoagulants such as warfarin, selective serotonin reuptake inhibitors (SSRIs) and antiplatelet agents such as acetylsalicylic acid (see Interactions).
If gastrointestinal hemorrhage or ulceration occurs in a patient receiving Antarène, treatment must be stopped.
NSAIDs should be administered with caution and under close supervision in patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease), due to the risk of exacerbation of the condition (see Undesirable effects).
Cardiovascular and cerebrovascular effects:
Appropriate monitoring and advice are required in patients with a history of hypertension and/or mild to moderate heart failure, as cases of fluid retention and oedema have been reported in association with NSAID treatment.
Clinical studies and epidemiological data suggest that the use of ibuprofen, especially when used at high dose (2400 mg per day) and over a long duration of treatment, may be associated with a slight increase in the risk of arterial thrombotic events (for example myocardial infarction or stroke): see Warnings and Precautions for Use. However, epidemiological data do not suggest that low doses of ibuprofen (≤ 1200 mg per day) are associated with an increased risk of myocardial infarction.
Patients with uncontrolled hypertension, congestive heart failure, ischemic heart disease, peripheral arterial disease, and/or a history of stroke (including transient ischemic attack) should only be treated with ibuprofen after careful evaluation.
Similar attention should be paid before initiating long-term treatment in patients with risk factors for cardiovascular disease (such as hypertension, hyperlipidemia, diabetes or smoking).
Cases of Kounis syndrome have been reported in patients treated with ibuprofen. Kounis syndrome has been defined as cardiovascular symptoms secondary to an allergic or hypersensitivity reaction associated with constriction of the coronary arteries and which may lead to myocardial infarction.
Skin effects:
Severe cutaneous adverse reactions (SCAR):
Severe cutaneous adverse reactions (SCAR), such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS or hypersensitivity syndrome) and acute generalized exanthematous pustulosis (AGEP), which may be life-threatening or fatal, have rarely been reported in association with the use of ibuprofen (see Undesirable effects). Most of these reactions occurred during the first month of treatment. .
If signs and symptoms suggestive of these reactions appear, ibuprofen should be stopped immediately and another treatment should be considered (where appropriate).
Tablets at 100 mg, 200 mg and oral suspension: Chickenpox may exceptionally be the cause of serious infectious complications of the skin and soft tissues. To date, the possible role of NSAIDs in worsening these infections cannot be excluded. It is therefore prudent to avoid the use of Antarène in case of chickenpox (see Undesirable effects).
Functional renal insufficiency:
NSAIDs, by inhibiting the vasodilatory action of renal prostaglandins, may cause functional renal insufficiency through decreased glomerular filtration. This adverse effect is dose-dependent.
At the start of treatment or after dose increase, monitoring of diuresis and renal function is recommended in patients with the following risk factors:
  • elderly subjects;
  • concomitant medicinal products such as: ACE inhibitors, sartans, diuretics (see Interactions) ;
  • hypovolemia, whatever the cause;
  • heart failure;
  • chronic renal failure;
  • nephrotic syndrome;
  • lupus nephropathy;
  • decompensated hepatic cirrhosis.
Sodium and water retention:
Sodium and water retention with possible oedema, hypertension or worsening of hypertension, and worsening of heart failure. Clinical monitoring is necessary from the start of treatment in cases of hypertension or heart failure. A decrease in the effect of antihypertensives is possible (see Interactions).
Hyperkalaemia:
Hyperkalemia promoted by diabetes or concomitant treatment with hyperkalemic medicinal products (see Interactions).
Regular monitoring of serum potassium should be carried out in these circumstances.
The taking of this medicine should be avoided in cases of treatment with another non-steroidal anti-inflammatory drug, with an oral anticoagulant, with lithium, with acetylsalicylic acid at analgesic, antipyretic or anti-inflammatory doses, with methotrexate at doses above 20 mg per week, with low molecular weight heparins and related compounds, and unfractionated heparins (at curative doses and/or in elderly subjects), with pemetrexed, in patients with low to moderate renal function (see Interactions).
Masking of symptoms of an underlying infection:
Ibuprofen may mask the symptoms of an infection, which may delay the initiation of appropriate treatment and thus worsen the course of the infection. This has been observed in the case of community-acquired bacterial pneumonia and bacterial complications of chickenpox. When ibuprofen is administered to relieve fever or pain associated with an infection, it is advisable to monitor the infection. In a non-hospital setting, the patient should consult a doctor if symptoms persist or if they worsen.

Precautions for use

  • Ibuprofen, like any medicine that inhibits cyclo-oxygenase and prostaglandin synthesis, may impair fertility. Its use is not recommended in women who wish to conceive a child.
  • In case of visual disturbances occurring during treatment, a complete ophthalmological examination should be carried out.
  • During prolonged treatment, it is recommended to monitor the blood count and liver and renal function.
  • Tablets at 400 mg and at 100 mg: These medicines contain lactose. Their use is not recommended in patients with galactose intolerance, Lapp lactase deficiency, or glucose or galactose malabsorption syndrome (rare hereditary diseases).
  • Oral suspension:
    This medicine contains an azo colouring agent (E 124) and may cause allergic reactions.
    This medicine contains sorbitol. Its use is not recommended in patients with fructose intolerance (a rare hereditary disease).
    This medicine contains sodium. This medicine contains 1,50 mg of sodium per ml of oral suspension. To be taken into account in patients on a strict low-sodium diet.

Interactions

Drug interactions
Risk related to hyperkalaemia:
Certain medicines or therapeutic classes may promote the occurrence of hyperkalaemia: potassium salts, potassium-sparing diuretics, angiotensin-converting enzyme inhibitors, angiotensin II antagonists, non-steroidal anti-inflammatory drugs, heparins (low molecular weight or unfractionated), immunosuppressants such as ciclosporin or tacrolimus, trimethoprim.
The combination of these medicinal products increases the risk of hyperkalaemia. This risk is particularly important with potassium-sparing diuretics, especially when they are combined with each other or with potassium salts, whereas the combination of an ACE inhibitor and an NSAID, for example, carries a lower risk provided the recommended precautions are implemented.
To learn about the risks and specific levels of constraint for potassium-raising medicinal products, refer to the interactions specific to each substance.
However, some substances, such as trimethoprim, are not subject to specific interactions with regard to this risk. Nevertheless, they may act as contributing factors when combined with other medicines such as those mentioned above.
Simultaneous administration of ibuprofen with the following products requires close monitoring of the patient's clinical and biological condition.
Not recommended:
See Warnings and Precautions for use.
  • Other NSAIDs: increased risk of gastrointestinal ulceration and bleeding.
  • Acetylsalicylic acid at anti-inflammatory doses (≥ 1 g per dose and/or ≥ 3 g per day) or at analgesic or antipyretic doses (≥ 500 mg per dose and/or < 3 g per day): increased risk of gastrointestinal ulceration and bleeding.
  • Oral anticoagulants: increased risk of bleeding with the oral anticoagulant (damage to the gastroduodenal mucosa by NSAIDs). NSAIDs may increase the effects of anticoagulants such as warfarin (see Warnings and Precautions for Use). If the combination cannot be avoided, close clinical and biological monitoring.
  • Unfractionated heparins, low molecular weight heparins and related agents (at curative doses and/or in elderly subjects): increased risk of bleeding (aggression of the gastroduodenal mucosa by NSAIDs). If the combination cannot be avoided, close clinical monitoring.
  • Lithium: increase in lithium levels which may reach toxic values (decreased renal excretion of lithium). If the combination cannot be avoided, closely monitor lithium levels and adjust the lithium dosage during the combination and after stopping the NSAID.
  • Methotrexate (used at doses above 20 mg/week): increased toxicity, particularly haematological, of methotrexate (decreased renal clearance of methotrexate by anti-inflammatory drugs).
  • Pemetrexed (patients with low to moderate renal function, creatinine clearance between 45 ml/min and 80 ml/min): risk of increased toxicity of pemetrexed (decreased renal clearance by NSAIDs).
Subject to precautions for use:
  • Ciclosporin, tacrolimus: risk of additive nephrotoxic effects, particularly in elderly subjects. Monitor renal function at the start of treatment with the NSAID.
  • Diuretics, angiotensin-converting enzyme (ACE) inhibitors, angiotensin II antagonists (AIIA): acute renal failure in at-risk patients (elderly and/or dehydrated subjects) due to decreased glomerular filtration (inhibition of vasodilatory prostaglandins by NSAIDs). In addition, reduced antihypertensive effect. Hydrate the patient. Monitor renal function at the start of treatment.
  • Methotrexate (used at doses less than or equal to 20 mg/week): increased toxicity, particularly haematological, of methotrexate (decreased renal clearance of methotrexate by anti-inflammatory drugs). Weekly monitoring of the blood count during the first weeks of the combination. Increased monitoring in case of impairment (even mild) of renal function, as well as in elderly subjects.
  • Pemetrexed (patients with normal renal function): risk of increased toxicity of pemetrexed (decreased renal clearance by NSAIDs). Biological monitoring of renal function.
To be taken into account:
  • Acetylsalicylic acid at antiplatelet doses (from 50 mg to 375 mg per day in 1 or several intakes): increased risk of ulcerogenic and gastrointestinal bleeding. In addition, experimental data suggest that ibuprofen may inhibit the antiplatelet effect of a low dose of acetylsalicylic acid when taken concomitantly. However, the limits of these ex vivo data and uncertainties about their extrapolation to clinical practice do not allow a formal conclusion to be drawn regarding regular use of ibuprofen; furthermore, regarding occasional use of ibuprofen, the occurrence of a clinically relevant effect appears unlikely.
  • Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal haemorrhage (see Warnings and Precautions for Use).
  • Beta-blockers (except esmolol): reduced antihypertensive effect (inhibition of vasodilatory prostaglandins by NSAIDs and sodium and water retention with pyrazolone NSAIDs).
  • Deferasirox: increased ulcerogenic and gastrointestinal bleeding risk.
  • Glucocorticoids (except hydrocortisone in replacement therapy): increased risk of gastrointestinal ulceration and haemorrhage (see Warnings and Precautions for Use).
  • Low molecular weight heparins and related agents, and unfractionated heparins (at prophylactic doses): increased risk of bleeding.

Fertility, pregnancy and breastfeeding

Pregnancy

From the beginning of the 6th months of pregnancy (24 weeks of amenorrhoea): any intake of Antarene, even occasional, is contraindicated. Even a single intake from 24 weeks of amenorrhoea justifies cardiac and renal ultrasound monitoring of the fetus and/or newborn.

Except in absolute necessity, Antarene must not be prescribed in a woman planning pregnancy or during the first 5 months of pregnancy (before 24 weeks of amenorrhoea). Where applicable, the dose should be as low as possible and the duration of treatment as short as possible. Prolonged intake is strongly discouraged.

In case of intake from the 20th week of amenorrhoea, cardiac and renal monitoring of the foetus may prove necessary.

If oligohydramnios or constriction of the ductus arteriosus occurs, treatment with Antarene must be discontinued.

Inhibition of prostaglandin synthesis by NSAIDs may affect the course of pregnancy and/or the development of the embryo or foetus.

Risks associated with use during the 1st trimester

Epidemiological studies suggest that treatment with a prostaglandin synthesis inhibitor during the 1st trimester of pregnancy is associated with an increased risk of miscarriage.

For certain NSAIDs, an increased risk of cardiac and abdominal wall malformations (gastroschisis) has also been described. The absolute risk of fetal cardiovascular malformation increased from less than 1% to approximately 1,5% with exposure to 1er trimester. The risk appears to increase with dose and duration of treatment.

In animals, administration of a prostaglandin synthesis inhibitor during the organogenesis phase causes increased pre- and post-implantation loss, an increase in embryo-fetal lethality, and a higher incidence of certain malformations, including cardiovascular ones.

Risks associated with use during the 2rd and 3th trimester

From the 12th week of amenorrhea:
Maternal intake of an NSAID exposes the fetus to a risk of renal functional impairment:
  • In utero (initiation of fetal diuresis): oligohydramnios may occur shortly after the start of treatment. This is generally reversible upon discontinuation of treatment. It may progress to anhydramnios, particularly with prolonged exposure to an NSAID.
  • At birth: renal failure (reversible or not) may be observed or may even persist, especially in cases of late and prolonged exposure, with a risk of delayed severe hyperkalemia.
From the 20th week of amenorrhea:
In addition to the renal functional impairment (see above), maternal intake of an NSAID exposes the fetus to a risk of constriction of the ductus arteriosus (most often reversible on discontinuation of treatment).
From the 24th week of amenorrhea:
The risk of cardiopulmonary toxicity (premature closure of the ductus arteriosus and pulmonary arterial hypertension) becomes greater and may lead to foetal or neonatal right heart failure or even foetal death in utero. This risk is all the greater and less reversible the closer the intake is to term. This effect exists even with a single intake.

In late pregnancy (close to term), NSAID intake also exposes the mother and the newborn to:

  • prolongation of bleeding time due to an anti-aggregant action, which may occur even after administration of very low doses of the medicinal product;
  • inhibition of uterine contractions resulting in delayed labour or prolonged delivery.

Breast-feeding

As NSAIDs pass into breast milk, this medicine is not recommended for women who are breastfeeding.

Fertility

Like all NSAIDs, use of this medicinal product may temporarily impair female fertility by affecting ovulation; it is therefore not recommended in women wishing to conceive. In women having difficulty conceiving or undergoing fertility investigations, discontinuation of treatment should be considered.


Driving and using machines

Warn patients of the possible occurrence of dizziness and visual disturbances.

Adverse effects

Related to ibuprofen:
Clinical studies and epidemiological data suggest that the use of ibuprofen, especially when used at high dose (2400 mg per day) and over a long duration of treatment, may be associated with a slight increase in the risk of arterial thrombotic events (for example myocardial infarction or stroke): see Warnings and Precautions for Use.
The most frequently observed adverse effects are gastrointestinal in nature. Peptic ulcers, perforations or gastrointestinal bleeding, sometimes fatal, may occur, particularly in the elderly (see Warnings and Precautions for Use).
Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, ulcerative stomatitis, abdominal pain, melena, hematemesis, exacerbation of colitis or Crohn's disease (see Warnings and Precautions for Use) have been reported following administration of NSAIDs. Less frequently, gastritis has been observed.
Oedema, hypertension and heart failure have been reported in association with NSAID treatment.
Gastrointestinal effects:
Gastrointestinal disorders such as nausea, vomiting, gastralgia, dyspepsia, transit disorders, digestive ulcerations with or without haemorrhage, occult or non-occult bleeding have usually been reported. These are all the more frequent the higher the dose used and the longer the duration of treatment.
Hypersensitivity reactions:
  • Dermatological: rash, eruptions, pruritus, oedema, worsening of chronic urticaria.
  • Respiratory: the occurrence of asthma attacks in some subjects may be linked to an allergy to acetylsalicylic acid or to a non-steroidal anti-inflammatory drug (see Contraindications).
  • General: anaphylactic shock, Quincke's oedema.
Cardiac disorders:
Kounis syndrome (frequency: undetermined frequency).
Skin and subcutaneous tissue disorders:
  • Severe cutaneous adverse reactions (SCAR) (including erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis) - very rare frequency.
  • Drug reaction with eosinophilia and systemic symptoms (DRESS or hypersensitivity syndrome) - undetermined frequency.
  • Acute generalised exanthematous pustulosis (AGEP) - undetermined frequency.
  • Photosensitivity reactions - frequency unknown.
  • Tablets at 100 mg and 200 mg, oral suspension: Exceptionally, occurrence of serious skin and soft tissue infectious complications during chickenpox (see Warnings and Precautions for Use).
Effects on the central nervous system:
Ibuprofen may, exceptionally, be responsible for dizziness and headaches.
Others:
  • A few rare cases of visual disturbances have been reported.
  • Oliguria, renal failure.
  • The discovery of aseptic meningitis under ibuprofen should prompt a search for systemic lupus erythematosus or connective tissue disease.
Some laboratory changes may have been observed:
  • Hepatic: transient increase in transaminases, exceptional cases of hepatitis.
  • Haematological: agranulocytosis, haemolytic anaemia.
Related to excipients (oral suspension):
  • Risk of allergic reactions due to the presence of carmoisine red A (E 124).
  • Possibility of digestive disorders and diarrhoea, due to the presence of sorbitol.
Reporting of suspected adverse reactions:

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals should report any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centres. Website: https://signalement.social-sante.gouv.fr.


Overdose

Signs:
  • Non-serious effects: nausea, vomiting.
  • Serious effects: CNS depression, convulsions, digestive disorders, bradycardia, renal damage and metabolic acidosis.
Action to be taken:
  • Immediate transfer to a hospital setting.
  • Rapid removal of the ingested product by gastric lavage.
  • Activated charcoal to reduce the absorption of ibuprofen.
  • Symptomatic treatment.

Pharmacodynamics

Tablets at 100 mg and 200 mg, oral suspension:
Pharmacotherapeutic class: Other analgesic and antipyretic (ATC code: N02B).
400 mg tablet:
Non-steroidal anti-inflammatory drug (M: muscles and skeleton).

Ibuprofen is a non-steroidal anti-inflammatory drug, belonging to the propionic group, derived from aryl-carboxylic acid.

It has the following properties:
  • analgesic;
  • antipyretic;
  • anti-inflammatory;
  • short-term inhibition of platelet functions.

All of these properties are linked to inhibition of prostaglandin synthesis.


Pharmacokinetics

The pharmacokinetics of ibuprofen is linear at therapeutic doses.

Absorption:
  • Food delays the absorption of ibuprofen.
  • Tablet at 100 mg: In children, maximum serum concentrations are reached 1 to 2 hours approximately after oral administration of the tablets. They are proportional to the dose (Cmax between 38 and 65 µg/ml for doses of 10 to 20 mg/kg per dose).
  • Oral suspension: The maximum serum concentration is reached 90 minutes approximately after oral administration. After a single dose, maximum serum concentrations in adults are proportional to the dose (Cmax between 25 and 50 µg/ml for the dose of 10 mg/kg).
  • Tablets at 400 mg and 200 mg: The maximum serum concentration is reached 90 minutes approximately after oral administration. After a single dose, maximum serum concentrations in adults are proportional to the dose (Cmax = 14 µg/ml ± 3,5 for a 200 mg tablet and 30,3 µg/ml ± 4,7 for a 400 mg tablet).
Distribution:
  • Administration of ibuprofen does not give rise to accumulation phenomena. It is bound to plasma proteins in the proportion of 99%.
  • In synovial fluid, ibuprofen is found with stable concentrations between the 2e and the 8e hour after intake, the synovial Cmax being approximately equal to one third of the plasma Cmax.
  • Tablets at 400 mg and 200 mg: After intake of 400 mg of ibuprofen every 6 hours by breastfeeding women, the quantity of ibuprofen found in their milk is less than 1 mg per 24 hours.
Metabolism:
Ibuprofen has no enzyme-inducing effect. It is metabolised to 90% as inactive metabolites.
Excretion:
  • Elimination is essentially urinary. It is complete within 24 hours, at a rate of 10% as unchanged substance and 90% as inactive metabolites, essentially glucuroconjugated.
  • Tablet at 100 mg and oral suspension: The elimination half-life is approximately 1 to 2 hours.
  • Tablets at 200 mg and at 400 mg: The elimination half-life is approximately 2 hours.
  • The kinetic parameters of ibuprofen are minimally modified in patients with renal impairment and hepatic impairment. The disturbances observed do not justify a change in dosage.

Storage conditions

Shelf life (all dosages):
3 years.
Tablets:
No special precautions for storage.
Oral suspension:
After opening:
The suspension may be kept for a maximum of 6 months.

HANDLING/DISPOSAL INSTRUCTIONS

No special requirements.


Prescription, supply and reimbursement

LIST II (tablet at 400 mg)

Marketing authorisation (AMM) 3400935199904 (1999, SmPC rev 18.09.2024) tablet at 100 mg.
3400933665814 (1994, SmPC rev 18.09.2024) tablet at 200 mg.
3400935193759 (1999, SmPC rev 18.09.2024) tablet at 400 mg.
3400936192959 (2003, SmPC rev 18.09.2024) oral suspension.
   
Price: 1,96 euros (40 tablets at 100 mg).
1,34 euros (30 tablets at 200 mg).
1,99 euros (30 tablets at 400 mg).
1,52 euros (oral suspension, bottle of 150 mL).
Social security reimbursement at 65 % based on the TFR: 1,34 euros (30 tablets at 200 mg). Collect.


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Source: VIDAL · Updated on 10/11/2026. This information does not replace advice from a healthcare professional.