IBUPROFENE ARI 12CPR RIV 400MG

IBUPROFENE ARISTO 400 MG COMPRESSE RIVESTITES WITH FILM

active ingredients

Each film-coated tablet contains 400 mg of ibuprofen.Excipient with known effects Each tablet contains 44 mg lactose (as monohydrate) For the full list of excipients, see paragraph 6.1.

Excellent

Compressed core: Ipromellosa, Croscamellosa sodica, Lactose monohydrate, Cellulose microcrystalline, Corn starch, Silice colloidal anidra, Sodium laurilsolfato, Magnesium stearato. Coating Film: Ipromellose, Titanium Dioxide (E171), Talco, propylene glycol.

Therapeutic indications

Adults and adolescents with body weight from 40 kg (ages older or equal to 12 years). Short-term symptomatic treatment of: – mild to moderate pain; fever.

Contraindications

: Hypersensitivity to the active ingredient or any of the excipients listed in the Paragraph 6.1. – Patients with anamnesis of hypersensitivity reactions (e.g. bronchospasm, asthma, rhinitis, urticaria or angioedema) associated with the use of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAID). – Patients with severe heart failure (IV NYHA class). – Patients with severe liver failure or severe kidney failure. – Patients with unidentified hematoid disorders. – Anamnesi or active phase of hemorrhage/recurring peptic ulcer (two or more distinct episodes of proven ulceration or hemorrhage). – Anamnesi of gastrointestinal hemorrhage or perforation associated with previous treatments with NSAID. – Patients with cerebrovascular hemorrhage or other active hemorrhage. – Patients with severe dehydration (e.g. caused by vomiting, diarrhea or insufficient intake of liquids). – Last trimester of pregnancy (see paragraph 4.6).

Population

Population: Undesirable effects can be minimized using the minimum effective dose for the shortest period necessary to control symptoms (see paragraph 4.4). Adults and adolescents with body weight ≥ 40 kg (ages older or equal to 12 years): The initial dose of ibuprofen is 200 mg or 400 mg. If necessary, additional doses of 200 mg or 400 mg of ibuprofen can be taken. The respective dosage range must be chosen according to the observed symptoms and the recommended maximum daily dose. It should not be less than 6 hours. A total dose of 1200 mg of ibuprofen should not be exceeded in a period of 24 hours Ibuprofene Aristo is only for short term use Special popularity . . Seniors: In the elderly there is a greater risk of serious consequences in case of adverse reactions. If you need to administer an NSAID, the lowest effective dose and the shortest possible duration should be used. During therapy with NSAIDs, the patient must be regularly checked for gastrointestinal bleeding. If kidney function or liver function is compromised, the dosage must be adjusted individually. Renal insufficiency: You should use caution with the dosage of ibuprofen in patients with kidney impairment. The dosage must be evaluated individually and must be kept as low as possible and the kidney function must be controlled. The use of ibuprofen is contraindicated in patients with severe kidney failure (see paragraph 4.3). Epathetic insufficiency: You should use caution with the dosage of ibuprofen in patients with liver impairment. The dosage should be evaluated individually and should be kept as low as possible. The use of this medicine is contraindicated in patients with severe liver dysfunction (see paragraph 4.3). Pediatric population: Other pharmaceutical forms / dosages can be more appropriate for administration. Ibuprofen Aristo is not suitable for use in children and adolescents with a body weight of less than 40 kg or in children under 12 years of age. Method of administration. . Oral use: Ibuprofen Aristo must be taken with a glass of water. Tablets should not be crushed, chewed or sucked to prevent stomach or throat irritations. Patients with a sensitive stomach are recommended to take Ibuprofene Aristo with food.

Conservation

Do not store at temperature above 25 °C.

Warnings

Undesirable effects can be minimized using the minimum effective dose for the shortest period necessary to control symptoms (see paragraph 4.2 and gastrointestinal and cardiovascular risks below). Caution is required in patients with certain diseases that may suffer worsening: − erythematous systemic lupus (LSE) or mixed connective tissue disease - increased risk of aseptic meningitis (see paragraph 4.8); – congenital disorder of porphyrin metabolism (e.g. intermittent acute porphyria); – mild to moderate renal impairment; – mild to moderate liver impairment; – immediately after important surgery; – in patients with allergic reaction to other substances, because for them there is an increased risk of hypersensitivity reactions even with the use of Ibuprofene Aristo; – in patients suffering from hay fever, nasal polyps or chronic obstructive respiratory disorders, as for them there is an increased risk of allergic reactions. These can be presented as attacks of asthma (the so-called analgesic asthma), edema of Quincke or hive; – dehydration. Gastrointestinal safety : Concurrent use of ibuprofen with NSAIDs, including specific cycloxygenase-2 inhibitors, increases the risk of adverse reactions (see paragraph 4.5) and must be avoided. Senior Patients : The elderly have a greater frequency of adverse reactions to the NSAIDs, especially hemorrhage and gastrointestinal perforation, which can be fatal. It is recommended to monitor with particular attention the elderly. Hemorrhage, ulcers and gastrointestinal perforation : During treatment with all NSAIDs, at any time during treatment, with or without prior warning symptoms or previous anamnesis of serious gastrointestinal events, bleeding, ulcers and gastrointestinal perforation have been reported, which may be fatal. The risk of hemorrhage, ulceration or gastrointestinal perforation is higher with increasing doses of NSAIDs and in patients with ulcer anamnesis, especially with hemorrhage or perforation complications (see paragraph 4.3) and in elderly patients. These patients must begin treatment with the lowest dose available. For these patients, and also for patients requiring concurrent therapies with low doses of acetylsalicylic acid or other medicines that may increase the gastrointestinal risk (see paragraph 4.5), the concomitant use of protective agents (e.g. misoprostol or protonic pump inhibitors) must be considered (see below and paragraph 4.5). Patients with gastrointestinal toxicity anamnesis, especially elderly patients, must report all unusual abdominal symptoms (especially gastrointestinal hemorrhage) in particular in the early stages of treatment. Precaution should be given if patients take medications at the same time that may increase the risk of ulceration or hemorrhage, e.g. oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or piastrinic aggregation inhibitors such as acetilsalicylic acid (see paragraph 4.5). In case of hemorrhage or gastrointestinal ulcer in patients who are using ibuprofen, treatment must be stopped. NSAIDs should be administered with caution to patients with a gastrointestinal disease analogy ( ulcerative colitis, Crohn's disease) since these conditions may be exacerbated (see paragraph 4.8). NSAIDs can mask symptoms of infection and fever. Cardiovascular and cerebrovascular effects: Caution is necessary (discussion with the doctor or pharmacist) before starting treatment in patients with anamnesi of hypertension and/or heart failure since retention of fluid, hypertension and edema were found in association with NSAIDs. Clinical studies suggest that the use of ibuprofen, particularly at high doses (2400 mg/day), 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 indicate that low doses of ibuprofen (e.g. ≤ 1200 mg/day) are associated with an increased risk of arterial thrombotic events. Patients with uncontrolled hypertension, congestive heart failure (II-III class NYHA), proven ischemic cardiopathy, peripheral arterial disease and/or cerebrovascular disease, should be treated with ibuprofen only after careful consideration and should be avoided high doses (2400 mg/day). Particular attention should also be paid to patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidemia, diabetes mellitus, cigarette smoking habit), especially if high doses (2400 mg/day) are required of ibuprofen. Skin reactions: Severe skin reactions, some of which fatal, including exfoliative dermatitis, Stevens-Johnson's syndrome and toxic epidermal necrolysis, have rarely been reported in association with the use of NSAIDs (see paragraph 4.8). Patients seem to be at higher risk for these reactions in the early stages of therapy: the onset of the reaction occurs in most cases within the first month of treatment. Acute generalized exantematic pustulosis (PEGA) has been reported with medicines containing ibuprofen. Treatment with Ibuprofene Aristo must be stopped at the first appearance of skin rash, mucosa lesions or any other sign of hypersensitivity. Outstandinglying, chickenpox can be the origin of serious complications of skin infections and soft tissues. To date, the role of NSAs in contributing to the worsening of these infections cannot be excluded. Therefore it is advisable to avoid the use of Ibuprofene Aristo in case of chickenpox. Other information: Reactions of severe acute hypersensitivity (e.g. anaphylactic shock) have been observed very rarely. To the first signs of reaction of hypersensitivity after administration of ibuprofen the treatment must be stopped. Medical measures required by specialized medical personnel must be initiated, in line with symptomatology. Ibuprofen can temporarily inhibit the piastrinic function (aggregation of thrombocytes). Therefore, patients with clotting disorders must be monitored carefully. In the course of prolonged use of ibuprofen, regular monitoring of the values of liver function tests, kidney function and hemochrome is required. Prolonged use of any kind of painkiller for cephalee may worsen headaches. In case you happen or suspect this eventuality, the treatment must be stopped and you must request medical advice. The diagnosis of Cephalea caused by excessive use of the drug (MOH) must be suspected in patients with frequent or daily headaches, despite (or due to) regular use of cephalea medications. In general terms, the usual use of painkillers, in particular the combination of different painkillers, can lead to permanent kidney damage with risk of kidney failure (analgesic nephropathy). This risk can be increased in physical stress conditions associated with loss of salt and dehydration. Therefore the combined use of different painkillers must be avoided. When using NSAIDs, adverse reactions, especially those concerning gastrointestinal tract or central nervous system, can be enhanced by concurrent consumption of alcohol. The risk of kidney failure has increased in dehydrated patients, the elderly and those taking diuretics and ACE inhibitors. NSAIDs can mask symptoms of an infection or fever. Patients who report eye disorders during treatment with ibuprofen should stop therapy and be examined. Pediatric population: There is a risk of kidney impairment in dehydrated adolescents. Ibuprofene Aristo contains lactose: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose mal absorption, should not take this medicine.

Interactions

Ibuprofen should only be taken with caution in combination with the following active ingredients: Other NSAs including salicytes: Concurrent administration of several NSAIDs can increase the risk of gastrointestinal ulcers and bleeding due to a synergistic effect. Concurrent use of ibuprofen with other NSAIDs must therefore be avoided (see paragraph 4.4). Selective cycloxygenase-2 inhibitors: Concurrent administration of ibuprofen with other NSAIDs, including selective cycloxygenase-2 inhibitors, must be avoided due to the potential additive effect (see paragraph 4.4). Acetylsalicylic acid: Concurrent administration of ibuprofen and acetylsalicylic acid is generally not recommended due to the potential increase in adverse reactions. Experimental data suggests that ibuprofen can competitively inhibit the effect of low doses of acetylsalicylic acid to piastrinic aggregation, when the two drugs are administered simultaneously. Although there are uncertainties regarding the extrapolation of these data to the clinical situation, it cannot be excluded the possibility that regular long-term use of ibuprofen can reduce the cardioprotective effect of acetylsalicylic acid at low doses. No significant clinical effect is considered likely due to occasional use of ibuprofen (see paragraph 5.1). Digoxin, phenytoin, lithium: Concurrent use of ibuprofen with preparations based on digoxin, phenytoin or lithium can increase the serum levels of these medicines. It is not generally required to monitor the serum levels of lithium, digoxin and phenytoin, if used as indicated (for a maximum of 3 or 4 days). Diuretics, inhibitors of angiotensin conversion enzyme (ACE), beta-blockers and antagonists of angiotensin II (AIIA): Non-steroidal anti-inflammatory drugs can mitigate the effectiveness of diuretics and other antihypertensive drugs. Diuretics can also increase the risk of nephrotoxicity associated with NSAIDs. In patients with compromised kidney function (e.g. dehydrated patients or elderly patients with impaired kidney function) the concomitant administration of an inhibitor ACE, beta blockers or an angiotensin II antagonist with a cycloxygenase inhibitor can lead to further deterioration of kidney function, including a possible acute kidney failure, generally reversible. Therefore co-administration must be done with caution, especially in elderly patients. Patients should be educated to maintain adequate hydration and regularly monitor renal function values after the start of concomitant therapy. Concurrent administration of ibuprofen and potassium-saving diuretics can lead to hyperkaliemia. Courtesy: Increased risk of gastrointestinal ulcers or hemorrhage (see paragraph 4.4). Anti-aggregating medicines and selective serotonin re-captation inhibitors (SSRI): Increased risk of gastrointestinal hemorrhage (see paragraph 4.4). Methodology: NSAIDs can inhibit the tubular secretion of metotrexate and reduce its clearance. The administration of ibuprofen within 24 hours before or after the administration of metotrexate may lead to increased metotrexate concentrations and an increase in its toxic effect. Ciclosporin: The risk of a nephrotoxic effect by cyclosporin has increased by co-administration of some non-steroidal anti-inflammatory drugs. Similarly, this effect cannot be excluded for the combination of cyclosporin and ibuprofen. Antiagulants: Non-steroidal anti-inflammatory drugs can increase the effects of anticoagulants, such as warfarin (see paragraph 4.4). Sulfaniluree: The NSAIDs can increase the effects of sulfaniluree. Rare cases of hypoglycemia have been reported in patients with concomitant administration of sulfaniluree and ibuprofene. In the case of simultaneous treatment, it is recommended as a precaution to monitor blood glucose levels. Aminoglycosides: NSAIDs can reduce the elimination of aminoglycosides. Tacrolimus: Co-administration of both medicines increases the risk of nephrotoxicity. Zidovudina: Increased risk of hematological toxicity when an NSAID is administered with zidovudine. There is evidence of an increased risk of hematoma and hematoma in positive hemophiliacs patients taking zidovudine with ibuprofen. Probenecid and the Finpirazone: Drugs containing probenecid and sulfinpirazone may delay the excretion of ibuprofene. Chinolonic Antibiotics: Animal data indicate that NSAIDs in combination with chinolonic antibiotics can increase the risk of convulsions. Patients taking NSAIDs and kinolonics may have an increased risk of developing seizures. Colestiramina: Concurrent administration of ibuprofen and choleramine can reduce the absorption of ibuprofen at the gastrointestinal tract level. However, the clinical relevance of this interaction is not known. CYP2C9 inhibitors: Concurrent use of ibuprofen and inhibitors of CYP2C9 can increase exposure to ibuprofen (substrate of CYP2C9). In a study with voriconazole and fluconazole (CYP2C9) inhibitors, an increased exposure, from 80% to 100%, to S(+)-ibuprofene was demonstrated. A reduction in the dose of ibuprofen should be considered in cases of co-administration with powerful CYP2C9 inhibitors, especially when high doses of ibuprofen are given along with voriconazole or fluconazole. Ginkgo Biloba: Ginkgo can increase the risk of bleeding if taken in association with NSAIDs. Mifepristone: If NSAIDs are used within 8-12 days after mifepristone administration can reduce the effect of mifepristone. Ritonavir: Concurrent use with ritonavir can lead to an increase in plasma concentrations of NSAIDs. Alcohol, biphosphonate and pentoxyphylline: They can enhance the unwanted gastrointestinal effects and the risk of bleeding and ulceration. Baclofene: High toxicity of baclofene.

Effects

The list of side effects listed below includes all adverse reactions reported during treatment with ibuprofen, including those in rheumatic patients subjected to long-term high dose therapy. Beyond very rare signals the frequencies refer to the short-term use of daily doses up to a maximum of 1200 mg of ibuprofen for oral formulations and a maximum of 1800 mg per supposed. As for the following adverse reactions, it must be taken into account that they are mostly dose-dependent and vary among individuals. The most commonly observed adverse reactions are gastrointestinal. Peptic ulcers, perforation or gastrointestinal hemorrhage may occur, sometimes fatal, especially in elderly patients (see paragraph 4.4). After administration were reported nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melena, ematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see paragraph 4.4). Less often gastritis was observed. In particular, the risk of gastrointestinal hemorrhage is dependent on the dose range and duration of use. In association with the treatment with NSAIDs were reported edema, hypertension and heart failure. Clinical studies suggest that the use of ibuprofen, particularly at high doses (2400 mg/day), may be associated with a modest increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke) (see paragraph 4.4). The following categories are used to express the frequency of adverse reactions: very common (≥1/10); common (≥1/100, Classification for organs and systems Frequency Undesirable effects Infections and infestations Very rare The exacerbation of infection-related inflammations (e.g. development of necrotizing bundles) was described in conjunction with the systemic use of non-steroidal anti-inflammatory drugs. This is probably associated with the mechanism of action of non-steroidal anti-inflammatory drugs. If the signs of an infection occur or worsen during the use of Ibuprofene Aristo, it is recommended that the patient go immediately to a doctor. It should be evaluated if there is an indication for anti-infective/antibiotic therapy. During treatment with ibuprofen, symptoms of aseptic meningitis with stiffness of the neck, headache, nausea, vomiting, fever or depletion of the state of consciousness were observed. Patients with autoimmune diseases (LES, mixed connective tissue disease) seem to be predisposed. Emolinfopoietic system pathologies Very rare Hematopoietic disorders (anemia, leucopenia, thrombocytopenia, pancitopenia, agranulocytosis). Eosinophilia. Coagulopathy (coagulation alterations) Aplastic anemia Hemolytic anemia Neutropenia The first signs can be: fever, sore throat, superficial wounds to the mouth, flu-like symptoms, severe fatigue, epistaxis and skin bleeding. In these cases, the patient must be trained to immediately suspend Ibuprofene Aristo, to avoid self-medication with analgesic and antipyretic medicines and to consult a doctor. Immune system disorders Not common Hypersensitivity reactions with rash and itching, as well as as asthma attacks (sometimes also with decrease in blood pressure). In this case, the patient must be instructed to stop taking Ibuprofene Aristo and immediately inform the doctor. Very rare General serious reactions of hypersensitivity. These can be presented as facial edema, swelling of the tongue, swelling of the inside of the larynx with airway constriction, respiratory stress, tachycardia, decrease in blood pressure up to mortal shock. If you experience any of these symptoms, which may also occur when you first use, an immediate medical assistance is required. Disorders of metabolism and nutrition Very rare Hypoglycemia Iponatriemia Psychiatric disorders Very rare Psychological reactions Hallucinations Confusion Depression Anxiety Diseases of the nervous system Not common Central nervous system disorders such as headaches, dizziness, insomnia, agitation, irritability or fatigue. Notable Parestesia Neurite optics Pathologies of the eye Not common Visual disturbances. In this case, the patient must be trained to suspend the use of ibuprofen and immediately inform the doctor. Ear and labyrinth pathologies Rare Tinnitus Hearing Loss Heart disease Very rare Palpitations, heart failure, myocardial infarction. Vascular diseases Very rare Vasculite hypertension Respiratory, chest and mediastinic pathologies Very rare Asthma Dispnea Broncospasmo Notable Rehabilitation Gastrointestinal diseases Town Gastrointestinal disorders such as pyrosis, abdominal pain, nausea, vomiting, flatulence, digestive problems, diarrhea, constipation and slight loss of blood at the gastrointestinal level which, in exceptional cases, may cause anemia. Not common Gastrointestinal ulcer, with potential hemorrhage and perforation. Ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see paragraph 4.4), gastritis. Very rare Esophagitis, pancreatis, formation of symil-diaphragm intestinal stenosis. The patient must be instructed to suspend the medicinal product and to go immediately to a doctor if it has a relatively severe pain at the top of the abdomen or occurs melena or ematemesis. Hepatobiliary diseases Very rare Hepatic dysfunction, liver damage, especially in long-term therapy, liver failure, acute hepatitis, jaundice. Pathologies of skin and subcutaneous tissue Very rare Bollose skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell syndrome), multiform erythema, in exceptional cases severe skin infections and complications to soft tissues during a chickenpore infection (see also "Infections and infestations"), alopecia, purple, photosensitivity reactions. Notable Skin eruption with heosinophilia and systemic symptoms induced by drug (DRESS), generalized acute esantematic pustolosis (AGEP). Kidney and urinary pathologies Rare Damage to renal tissue (paint necrosis), high concentrations of uric acid in the blood, high concentrations of urea in the blood. Very rare Edema formation, especially in patients with arterial hypertension or kidney impairment, nephrosic syndrome, interstitial nephritis that can be accompanied by acute kidney impairment. Notable Proven kidney function. Reporting of suspicious adverse reactions. The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

Symptoms of an 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. Synonyms Most patients who have ingested clinically important amounts of NSAID will develop at most: nausea, vomiting, epigastric pain and more rarely diarrhea. In addition, nistagm may occur, blurred vision, tinnitus, headache and gastrointestinal bleeding. In case of more severe poisoning, toxicity is observed in the central nervous system, which is manifested as dizziness, dizziness, drowsiness, and occasionally excitation and disorientation, loss of knowledge or coma. Occasionally patients develop seizures. Children can also develop myoclonic cramps. In case of severe poisoning, metabolic acidosis, hypothermia and hyperkaliemia may occur, and protrombine/INR time may be prolonged, probably due to interference with circulating coagulation factors. Acute kidney failure, liver damage, hypotension, respiratory depression and cyanosis can occur. Asthma exacerbation is possible in asthma patients. Treatment for overdose There is no specific antidote.Therefore, symptomatic and supportive treatment is indicated in the event of overdose.Particular attention should be paid to monitoring blood pressure, acid-base balance and any gastrointestinal bleeding.Administration of activated charcoal should be considered within one hour of ingestion of a potentially toxic amount.Alternatively, gastric lavage should be considered in adults within one hour of ingestion of a potentially life-threatening overdose.Adequate diuresis should be ensured and renal and hepatic function should be closely monitored.The patient should remain under observation for at least four hours following ingestion of a potentially toxic amount.Frequent or prolonged convulsions should be treated with intravenous diazepam.Other supportive measures may be necessary depending on the patient's clinical condition.

Pregnancy

: Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo-foetal development.Data from epidemiological studies suggest an increased risk of miscarriage and/or cardiac malformation and/or gastroschisis after use of a prostaglandin synthesis inhibitor during the first trimester of pregnancy.The absolute risk for cardiovascular malformations increased from less than 1%, up to approximately 1.5%.The risk is believed to increase with dose and duration of therapy.In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation loss and embryo-foetal 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 first and second trimester of pregnancy, Ibuprofen Aristo should not be administered unless clearly necessary.If Ibuprofen Aristo is used by women attempting to conceive or during the first and second trimester of pregnancy, the dose should be as low and duration of treatment as short as possible.During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose: - the fetus to: o cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension);o renal dysfunction which may progress to renal failure with oligohydroamnios;- the mother and the neonate, at the end of pregnancy, to: o possible prolongation of bleeding time, an antiaggregant effect which may occur even at very low doses;o inhibition of uterine contractions resulting in delayed or prolonged labor.Consequently, Ibuprofen Aristo is contraindicated during the third trimester of pregnancy (see section 4.3).

Food

: Only small amounts of ibuprofen and its metabolites go into breast milk. Since there are no known harmful effects for infants today, breast-feeding interruption is generally not necessary in short-term treatment with the recommended dose for fever and pain.

Fertility

: The use of ibuprofen can compromise female fertility and is not recommended in women who try conception. In women who have difficulty in conceiving or who are being investigated on infertility, we must consider the interruption of treatment with Ibuprofene Aristo. There are some evidence that drugs that inhibit cyclo-oxidase/prostaglandin synthesis can cause a female fertility impairment due to an effect on ovulation. This is reversible with the interruption of treatment

Source: Farmadati