IT SHOULD BE NOTED THAT THE USE OF THIS PRODUCT IS NOT RECOMMENDED

IBUPROFEN AND ITS SALTS

active ingredients

Each ml of oral suspension contains: Active ingredient: ibuprofene 20 mg. Excipients with known effects: liquid maltitol syrup, sodium. For the full list of excipients, see paragraph 6.1.

Excellent

IBUPROFECT EG Children 100mg/5ml oral suspension strawberry taste without sugar Monohydrate citric acid, citrate sodium, potassium acesulphame, xantana gum, benzoate sodium, strawberry aroma, maltitol syrup, glycerin, purified water. IBUPROFECT EG Children 100mg/5ml oral suspension orange taste without sugar Monohydrate citric acid, citrate sodium, potassium acesulphame, xantana gum, benzoate sodium, orange aroma, maltitol syrup, glycerin, purified water.

Therapeutic indications

Symptomatic treatment of mild or moderate fever and pain.

Contraindications

• Hypersensitivity to ibuprofen or any of the excipients listed in the paragraph 6.1. • Children under 3 months or less than 5.6 kg. • The drug is contraindicated in patients who show or have previously shown hypersensitivity (e.g. asthma, rhinitis, angioedema or urticaria) to acetylsalicylic acid or other analgesic, antipyretic, non-steroidal anti-inflammatory drugs (NSAID), especially when hypersensitivity is associated with nasal and asthma polypoxes. • Active peptic ulcer. • Severe kidney or liver failure (see paragraph 4.4). • Severe heart failure (see paragraph 4.4). • History of gastrointestinal hemorrhage or perforation related to previous NSAID therapies, history of hemorrhage / recurrent peptic ulcer (two or more distinct episodes of proven ulceration or bleeding). • Concurrent use of NSAIDs, including specific COX-2 inhibitors. • Patients with cerebrovascular bleeding history or other active bleeding. • Patients with unclear disorders of blood formation. • Patients with severe dehydration (caused by vomiting, diarrhea or insufficient liquid intake). • During the last quarter of pregnancy (see paragraph 4.6).

Population

Population The daily dose is structured according to the weight and age of the patient. The lowest effective dose should be used for the shortest period necessary to relieve symptoms (see paragraph 4.4). Undesirable effects can be minimized with the use of the minimum effective dose for the shortest possible treatment duration needed to control symptoms (see paragraph 4.4). In children aged 3 to 6 months limit administration to those weighing more than 5.6 kg. Method of administration Oral administration to infants and children aged between 3 months and 12 years should take place by means of a dose syringe provided with the product. Patients suffering from stomach problems can take the medicine during meals. The daily dose of 20-30 mg/kg body weight, divided 3 times daily at intervals of 6-8 hours, can be administered on the basis of the following diagram. The graduated scale on the syringe body highlights the heels for different dosages; in particular the 2.5 ml notch corresponding to 50 mg of ibuprofene and the 5 ml notch corresponding to 100 mg of ibuprofene.

PEOPLE	Age	Single dose in ml	maximum administration/day
From 5,6 Kg	3 - 6 months	2.5 ml	3 in 24 hours
From 7 Kg	6 - 12 months	2.5 ml
From 10 Kg	1 - 3 years	5 ml
From 15 Kg	4 - 6 years	7.5 ml (5 ml + 2.5 ml)
From 20 Kg	7 - 9 years	10 ml
From 28 to 43 Kg	10 - 12 years	15 ml

Special popularity In the case of post-vaccination fever refer to the above dosage, it is recommended to take a single dose (2.5 ml) followed, if necessary, from another dose after 6 hours. Do not administer more than two doses in 24 hours. Consult the doctor if the fever does not decrease. The product is intended for short-term treatments. In infants between 3 and 5 months, the doctor must be consulted if the symptoms persist for a period of more than 24 hours or in case of symptomatology worsening. In case the use of the medicinal product is necessary for more than 3 days in infants and children older than 6 months and in adolescents, or in case of worsening of symptomatology, the doctor must be consulted. Instructions for using the dosing syringe: 1. Unscrew the cap by pushing it down and turning it to the left. 2. Deeply introduce the syringe tip into the trap hole. 3. Shake well. 4. Turn the bottle, then, firmly holding the syringe, gently pull the plunger downwards, causing the suspension to flow into the syringe until the heel corresponding to the desired dose. 5. Put the bottle in vertical position and remove the syringe by turning it gently. 6. Introduce the syringe tip into the baby's mouth, and exert a slight pressure on the plunger to cause the suspension to flow. 7. After use screw the cap to close the bottle and wash the syringe with hot water. Let it dry, keeping it out of reach and sight of children.

Conservation

No details.

Warnings

Undesirable effects can be minimized with the use of the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see below paragraphs on gastrointestinal and cardiovascular risks). Other NSAIDs: The use of IBUPROFECT EG should be avoided in conjunction with NSAIDs, including selective COX-2 inhibitors. Analgesics, antipyretics, non-steroidal anti-inflammatory drugs can cause hypersensitivity reactions, potentially serious (anaphylactoid reactions), even in individuals not previously exposed to this type of medication. The risk of hypersensitivity reactions after taking ibuprofen is greater in individuals who have presented such reactions after the use of other analgesic, antipyretic, nonsteroidal anti-inflammatory drugs and in subjects with bronchial hyperreactivity (asthma), nasal polyposi or previous angioedema episodes (see paragraph 4.2 and paragraph 4.8). Gastrointestinal effects (GI): Gastrointestinal hemorrhage, ulceration and drilling: during treatment with all NSAIDs, at any time, with or without warning symptoms or previous history of serious gastrointestinal events, gastrointestinal hemorrhage, ulceration and perforation, which may be fatal. Senior patients have an increase in the frequency of adverse reactions to NSAIDs, especially hemorrhages and gastrointestinal perforations, which can be fatal (see paragraph 4.2). In the elderly and in patients with history of ulcer, especially if complicated by hemorrhage or perforation (see paragraph 4.3), the risk of gastrointestinal hemorrhage, ulceration or perforation is higher with increased doses of NSAID. These patients must begin treatment with the lowest dose available. Concurrent use of protective agents (e.g. misoprostol or protonic pump inhibitors) must be considered for these patients and also for patients taking low doses of aspirin or other drugs that may increase the risk of gastrointestinal events (see paragraph 4.5). Patients with history of gastrointestinal toxicity, particularly elderly, must report any unusual gastrointestinal symptoms (especially gastrointestinal hemorrhage) in particular in the early stages of treatment. Caute should be lent to 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 anti-aggregating agents such as acetilsalicylic acid (aspirin) (see paragraph 4.5). When bleeding or gastrointestinal ulcer occurs in patients taking IBUPROFECT EG, the treatment must be suspended. NSAIDs should be given with caution to patients with a history of gastrointestinal disease ( ulcerative colitis, Crohn's disease) since such conditions can be exacerbated (see paragraph 4.8). Dermatologic effects: Strict skin reactions: Severely severe skin reactions have been reported, some of which fatal, including exfoliatory dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis in association with the use of NSAIDs (see paragraph 4.8). Patients seem to be at higher risk in the early stages of therapy: the onset of the reaction occurs in most cases within the first month of treatment. Generalized acute urstolosis (PEAG) was reported in relation to medicines containing ibuprofen. Ibuprofen should be suspended at the first appearance of severe skin signs and symptoms such as rash, mucosa lesions or any other sign of hypersensitivity. Masking the symptoms of underlying infections IBUPROFECT EG may mask the symptoms of infection, which may delay the start of proper treatment and thus worsen the outcome of the infection. This was observed in bacterial pneumonia acquired in communities and bacterial complications of chickenpox. When IBUPROFENE EG is administered for relief from fever or pain related to infection, it is recommended to monitor the infection. In non-hospital contexts, the patient should contact the doctor if symptoms persist or worsen. The chickenpox can exceptionally be the origin of serious infectious complications to the skin and soft tissues. To date, the NSAID contribution cannot be excluded in the worsening of such infections, so it is recommended to avoid the use of IBUPROFENE EG in case of chickenpox. Cardiovascular and cerebrovascular effects: Cautisus is required (discussed with your physician or pharmacist) before starting treatment in patients with positive anamnesis for hypertension and/or heart failure because in association with the treatment with the NSAIDs, fluid retention, hypertension and edema were found. Clinical studies and epidemiological data suggest that the use of ibuprofen, especially at high doses (2400 mg/die), and for long-term treatments, may be associated with a modest increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke). In general, epidemiological studies do not suggest that low doses of ibuprofen (e.g. ≤ 1200 mg/die) are associated with an increase in the risk of myocardial infarction. Patients with uncontrolled hypertension, congestive heart failure, established ischemic cardiopathy, peripheral arterial disease and/or cerebrovascular disease should be treated with ibuprofen only after careful consideration. Analogue considerations must be made before starting a long-term treatment in patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidemia, diabetes mellitus, smoking). Kidney pathologies: in general, the usual use of analgesics, especially the combination of different analgesic substances, can cause permanent kidney injury, with risk of kidney failure (nephropathy from analgesics). In dehydrated children and adolescents there is a risk of alteration of kidney function (see paragraph 4.3 and 4.8). Other considerations Prolonged use of any type of analgesic for headaches can make your symptoms worse. If this situation occurs or is suspected, the doctor must be consulted and the treatment must be suspended. Diagnosis of drug abuse headache (medication overuse headache -MOH) must be suspected in patients who experience frequent or daily headaches despite or due to regular use of medicines for headaches Promoted female fertility: see paragraph 4.6. The use of ibuprofen, acetylsalicylic acid or other analgesic, antipyretic, non-steroidal anti-inflammatory, requires special caution: • in case of asthma or allergic diseases in place or in advance: possible deterioration of bronchoconstriction; • in the presence of clotting defects, since ibuprofen, the active ingredient of Ibuprofene EG can temporarily inhibit the functionality of platelets (thrombocytic aggregation). Therefore it is recommended to carefully monitor patients with clotting disorders; • in the presence of kidney, heart or hypertension diseases: possible critical reduction of kidney function (especially in subjects with impaired kidney or liver function, heart failure or in treatment with diuretics), nephrotoxicity or fluid retention; • in the presence of liver diseases: possible hepatotoxicity. • rehydrate the subject before the start and during the treatment in case of dehydration (e.g. for fever, vomiting or diarrhea); • immediately after increased surgery • congenital disorders of porphyrin metabolism (e.g. intermittent acute porphyria). The following precautions are relevant during prolonged treatment: • monitor the signs or symptoms of gastrointestinal ulceration or bleeding; • monitor signs or symptoms of hepatotoxicity; • monitor signs or symptoms of nephrotoxicity; • if visual disturbances arise (unused or reduced view, rhytoms, alteration of color perception): stop treatment and consult the ophthalmologist; • if signs or symptoms of meningitis arise: assess the rare possibility that it is due to the use of ibuprofene (aseptic mingitis; most frequent in subjects suffering from systemic erythematose lupus and mixed disease of connective tissue or other collagenopathies) (see paragraph 4.8). Important information about some excipients Since Ibuprofen EG contains liquid maltitol, patients with rare hereditary problems of fructose intolerance should not take this medicine. It can have a slight laxative effect. The caloric value of maltitol is 2.3 kcal/g. Ibuprofene EG contains no sugar and is therefore indicated for those patients who need to control the intake of sugar and calories. This medicine contains 4.51 mg of sodium for each 2.5 ml dose equivalent to 0.23% of the maximum daily intake recommended by the WHO that corresponds to 2 g of sodium per adult. This must be taken into account in children or in cases a poor diet of sodium is recommended. This medicine contains potassium, less than 1 mmol (39 mg) for each 2.5 ml dose, i.e. essentially ‘without potassium’. Co-administration with any dihydrogenase alcohol substrate as ethanol can induce severe adverse effects in infants.

Interactions

Hybuprofen should be avoided in association with: • Acetylsalicylic Acid: concurrent administration of ibuprofen and acetylicylic acid is not generally recommended due to the potential increase in unwanted effects. Experimental data indicates that ibuprofen can inhibit the effects of acetylsalicylic acid at low dose on pyasternic aggregation when drugs are administered in conjunction. However, data evacuity and uncertainty regarding the application of ex-live data to the clinical situation do not allow to draw definitive conclusions on the regular use of ibuprofen; clinically relevant effects are unlikely due to the occasional use of ibuprofen (see paragraph 5.1); • Other NSAIDs included selective cycloxygenase inhibitors 2: avoid the contemporary use of two or more analgesic, antipyretic, non-steroidal anti-inflammatory: increased risk of side effects (see paragraph 4.4). Hybuprofen should be used with caution in association with: • corticosteroids: increased risk of gastrointestinal ulceration or hemorrhage (see paragraph 4.4); • chinolonic antibiotics: data from animal studies indicate that NSAIDs can increase the risk of convulsions associated with chinolonic antibiotics. Patients taking NSAIDs and Chinoloni may have an increased risk of developing seizures; • anticoagulants, such as warfarin: NSAIDs can increase the effects of anticoagulants, such as warfarin (see paragraph 4.4); • Serotonin reuptake selective anti-aggregating agents and inhibitors (SSRIs): increased risk of gastrointestinal hemorrhages (see paragraph 4.4); • phenytoin: the concomitant use of Ibuprofene EG with phenytoin can increase the serum levels of these medicines. The correct use of drugs (administrated for a maximum period of 3 days) does not normally require control of serum levels of phenytoin; • antidiabetics: an increase in the hypoglycemic effect of sulfaniluree is possible. In the case of simultaneous treatment, it is recommended to monitor blood glucose levels; • antivirals, such as ritonavir, possible increase in the concentration of NSAIDs; • cyclosporin: increased risk of nephrotoxicity;• mifepristone: NSAIDs should not be administered in 8-12 days following mifepristone intake because they can reduce its effectiveness; • cytotoxic as methorate, reduction of excretion (increased risk of toxicity); • lithium: reduction of excretion (increased risk of toxicity); • tacrolimus: increased risk of nephrotoxicity; • uricosuric as probenecid and finpirazone, slows the excretion of NSAIDs (increasing plasma concentrations); • metotrexate: potential increase in plasma concentration of metotrexate; • zidovudine: increased risk of blood toxicity when NSAIDs are used in association with zidovudine. There are demonstrations of increased risk of hemartrosis and hematomas in HIV hemophilics (+) if treated simultaneously with zidovudine and ibuprofen; • antihypertensives, (ACE inhibitors and antagonists of angiotensin II) and diuretics: NSAIDs can reduce the effect of diuretics and other antihypertensive drugs. In some patients with impaired kidney function (e.g. dehydrated patients or elderly patients with impaired kidney function) co-administration of an ACE inhibitor or an angiotensin II antagonist and agents inhibiting the cyclo-oxidase system may lead to further deterioration of kidney function, which includes a possible acute kidney failure, generally reversible. These interactions must be considered in patients taking IBUPROFECT EG in conjunction with ACE inhibitors or antagonists of angiotensin II. Therefore, the combination should be given with caution, especially in elderly patients. Patients should be properly hydrated and should be taken into account the monitoring of renal function after the start of concomitant therapy and periodically. • Potassium-saving diuretics: Concurrent administration of Ibuprofene EG and potassium-saving diuretics can lead to hyperpotassium. • CYP2C9 inhibitors: Concurrent administration of ibuprofen and CYP2C9 inhibitors can increase exposure to ibuprofen (substrate of CYP2C9). In a study with voriconazole and fluconazole (CYP2C9) inhibitors, an increased exposure to S(+)-ibuprofen from approximately 80% to 100% was demonstrated. You should consider reducing the dose of ibuprofen when administering strong CYP2C9 inhibitors simultaneously, especially when high doses of ibuprofen are administered with voriconazole or fluconazole. • cardiac glycosides (Digoxin): NSAIDs can worsen heart failure, reduce VGF (glomerular filtration speed) and increase plasma levels of glycosides.

Effects

The list of the following side effects includes all those that were recognized during treatment with ibuprofen for short periods of treatment and for daily doses up to a maximum of 1200 mg. In case of therapies for chronic or prolonged high dose pathologies, other side effects may occur. Adverse reactions associated with the administration of ibuprofen are listed to follow according to the classification for systems and organs and according to the frequency. The frequencies are defined as: Very common (≥ 1/10) Common (≥ 1/100, Classification for systems and organs Frequency Action against Infections and infestations Rare Cystitis, rhinitis Very rare Increased inflammations related to infections (eg development of necrotizing bundles), in exceptional cases severe skin infections and complications to soft tissues were found during a chickenpox infection Emolinfopoietic system pathologies Very rare Amatopoiesi disorders 1 Immune system disorders Not common Reactions of hypersensitivity that manifest with hives and itching2 Very rare Severe hypersensitivity reactions that include swelling of the face, tongue and larynx, dispnea, tachycardia, hypotension (anaphylaxis, angioedema or severe shock) Asthma exacerbation. Disorders of metabolism and nutrition Notable Retention of liquids and decrease of appetite3 Psychiatric disorders Notable Reliability Rare Depression, insomnia, difficulty of concentration, emotional lability, hearing disorders Diseases of the nervous system Not common Cephalea, dizziness, drowsiness, seizures, agitation, fatigue Very rare Aseptematic Meningitis⁴ Rare Hemorrhage cerebrovascular Pathologies of the eye Rare Eye dryness Not common Visual disturbances Ear and labyrinth pathologies Notable Tinnitus Heart disease Very rare Myocardial infarction Notable Heart failure and edema⁵ Rare Palpitations Vascular diseases Notable Hypertension⁵ and shock Respiratory, chest and mediastinic pathologies Notable Reactivity of the respiratory tract that includes asthma, obstruction of the larynx, bronchospasm or apnea, dispnea Gastrointestinal diseases Not common Abdominal pain, nausea and dyspepsia⁶ Rare Diarrhea, flatulence, dry mouth, constipation and vomiting. Very rare Peptic ulcer, perforation or gastrointestinal bleeding, melena and ematemesis⁷. Mouth ulcers and gastritis Notable Exacerbation of colitis and Crohn's disease⁸, pancreatitis, duodenitis, esophagitis Hepatobiliary diseases Very rare Hepatic dysfunction, hepatitis, jaundice, liver syndrome, liver necrosis, liver failure Pathologies of skin and subcutaneous tissue Not common Various skin rashes2 Very rare Bollose reactions including Stevens-Johnson syndrome, multiform erythema and toxic epidermal necrolysis2 Rare Exfoliatory dermatitis, alopecia, photosensitivity reaction Notable Drug reaction with heosinophilia and systemic symptoms ( DRESS syndrome), generalized acute hexantholysis (PEAG) Kidney and urinary pathologies Rare Tubular necrosis, nephrite glomerulo, polyuria, hematuria Very rare Acute kidney failure⁹ Diagnostic examinations Rare Decrease in hematocrite levels Very rare Decrease of hemoglobin levels Description of some adverse reactions 1 Hematopoiesis disorders including anemia, aplastic anemia, hemolytic anemia (positiveness to the Coombs test), leukopenia, neutropenia, thrombocytopenia (with or without purple), heosinophilia, pancytopenia and agranulocytosis. The first symptoms may be: fever, throat, superficial ulcers of the mouth, flu-like symptoms, marked fatigue, hepistaxes and hemorrhage. In these cases, the patient should immediately stop the medicine, avoid any automedication medication containing analgesics or antipyretics and consult the doctor. Rarely congestive heart failure in patients with compromised heart functions. 2 Reactions of hypersensitivity: these reactions include a) non-specific allergic reactions and anaphylaxis, fever, bruises, b) reactivity of the respiratory tract that includes asthma, aggravated asthma, bronchospasm (see paragraph 4.3 and 4.4) or Stevensomnatus or c) several skin diseases that include various skin rashes (also of maculoedema without papular), itching, or hibernaryocyte. 3 Decrease of appetite: in general it quickly resolves to suspend treatment (see paragraph 4.4). ⁴ The pathogenic mechanism of aseptic meningitis induced by drugs is not completely known. However, the data available on aseptic meningitis related to the administration of NSAIDs induce to think of an immune reaction (due to a temporal relationship with the intake of the drug and the disappearance of symptoms after the suspension of treatment). Note, individual cases of aseptic meningitis symptoms (such as torcicollo, numb neck, headache, nausea, vomiting, fever and disorientation) were observed during treatment with ibuprofen in patients with autoimmune diseases (such as systemic lupus erythematosus, mixed connective disease). ⁵ Heart failure and edema: Clinical studies and epidemiological data suggest that the use of ibuprofen, especially at high doses (2400 mg/die) and for long-term treatments, may be associated with a modest increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke) (see paragraph 4.4). Congestive heart failure in patients with impaired heart functions. ⁶ The most commonly observed adverse events are gastrointestinal. Gastric disorders can be reduced by taking the medicine on a full stomach. ⁷ Peptic ulcers, perforation or gastrointestinal hemorrhage, melena and hematogenesis may occur at times fatal. ⁸ Exacerbation of Crohn's colitis and disease (see paragraph 4.4). ⁹ Acute renal insufficiency especially in case of long-lasting therapies, associated with increased uretha levels in serum and edema. Papillary necrosis may occur. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdose

Toxicity Signs and symptoms of toxicity were generally not observed at doses less than 100 mg/kg in children or adults. However, in some cases you may need a support treatment. It has been observed that children manifest signs and symptoms of toxicity after ingestion of ibuprofen at doses of 400 mg/kg or greater. The half-life of the drug in case of overdose is 1.5-3 hours. Synonyms Most patients who accidentally ingest clinically relevant amounts of ibuprofen will manifest symptoms within 4-6 hours. The most commonly reported overdose symptoms include: nausea, vomiting, abdominal pain, lethargy and drowsiness. The effects on the central nervous system (SNC) include headaches, tinnitus, dizziness, seizures and loss of consciousness. Rarely, nistagm, metabolic acidosis, hypothermia, kidney effects, gastrointestinal bleeding, coma, apnea, diarrhea and depression of the SNC and respiratory system were also reported. Disorientation, state of excitement, fainting and cardiovascular toxicity including hypotension, bradycardia and tachycardia have been reported. In cases of significant overdose are possible kidney failure and liver damage. In cases of severe poisoning, it is possible that metabolic acidosis occurs and an extension of the protrombine time (INR), probably caused by interference with the action of the factors of the coagulation present in the circle. An exacerbation of the symptoms of the disease can occur in asthmatic subjects. Treatment There is no specific antidote for overdosing ibuprofen. In case of overdose, a symptomatic and support treatment is indicated and must include the maintenance of airway pervity and the monitoring of heart function and vital signs until the patient's stabilization. Particular attention is given to the control of blood pressure, acid-base balance and gastrointestinal bleeding. Within an hour of the ingestion of a potentially toxic quantity must be considered the administration of activated charcoal. Alternatively, in the adult, within an hour of the ingestion of a potentially dangerous overdose for life, the gastric lavender must be taken into account. An adequate diuresis must be ensured and renal and hepatic functions must be closely monitored. The patient must remain under observation for at least four hours after ingestion of a potentially toxic drug. Any occurrence of frequent or prolonged seizures must be treated with diazepam or lorazepam intravenously. If ibuprofen has already been absorbed, alkaline substances must be administered to promote excretion in the urine of acid ibuprofen. Administer bronchodilators in case of asthma. Other support measures may be required in relation to the patient's clinical conditions. For more information, contact the local anti-veleni center.

It is unlikely that subjects under 12 years of age will go to pregnancy, or breast breastfeeding. The following considerations must also be taken into account in such circumstances.

Pregnancy

From the 20th week of pregnancy onwards, the use of ibuprofen could cause oligoidramnios resulting from fetal kidney dysfunction. This may occur shortly after the start of treatment and is usually reversible at the time of suspension. Moreover, there have been cases of constriction of arterial duct following treatment in the second quarter, most of which resolved after the cessation of treatment. Therefore, during the first and second trimester of pregnancy, the administration of ibuprofen should be avoided. Ibuprofen is contraindicated during the third trimester of pregnancy. Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryo/fetal development. Results of epidemiological studies suggest an increased risk of abortion and cardiac malformation and gastroschisis after the use of a prostaglandin synthesis inhibitor in the early stages of pregnancy. The absolute risk of heart failure increased from less than 1% to about 1.5%. It has been considered that the risk increases with dose and duration of therapy. In animals, the administration of prostaglandin synthesis inhibitors showed an increase in the loss of pre- and post-plant and embryo-fetal mortality. In addition, an increase in the incidence of various malformations, including cardiovascular disease, was reported in animals that had been given prostaglandin synthesis inhibitors during the organogenetic period. After exposure to ibuprofen for several days from the 20th week of gestation onwards, it must be considered the antenatal monitoring of oligoidramnios and the constriction of arterial duct. In case of oligoidramnios and constriction of arterial duct, treatment with ibuprofen should be stopped. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose the fetus to: • cardiopulmonary toxicity (constriction / premature closure of arterial duct and pulmonary hypertension); • kidney dysfunction that can progress to kidney failure with oligo-idroamnios (see above); the mother and the newborn, at the end of pregnancy, to: • possible prolongation of bleeding time, an anti-aggregating effect that can also be necessary at very low doses; • inhibition of uterine contractions resulting in delay or extension of labor.

Food

There are limited data that demonstrates that ibuprofen can go into low concentrations in breast milk and is unlikely to have side effects for infants.

Fertility

There is evidence that medicines that inhibit cycloxygenase/prostaglandine synthesis can cause a female fertility impairment due to ovulation. This effect is reversible after termination of treatment.

Source: Farmadati