Zerinoactiv 20 Tablets 200 mg + 30 mg

Zerinoactiv is a medicine indicated for the treatment of cold and flu symptoms, such as nasal congestion, headache, fever and muscle aches. It contains ibuprofen, a nonsteroidal anti-inflammatory drug, and pseudoephedrine, a nasal decongestant, to relieve congestion and reduce pain.

It is indicated for the treatment of cold and flu symptoms, including headache, fever, nasal congestion and muscle aches. Ideal for adults and adolescents over 12 years old.

ACTIVE INGREDIENTS

Active ingredients contained in Zerinoactiv 20 Tablets 200 mg + 30 mg - What is the active ingredient of Zerinoactiv 20 Tablets 200 mg + 30 mg?

Each white film-coated tablet contains 200 mg ibuprofen and 30 mg pseudoephedrine hydrochloride. Excipient with known effect: Each tablet contains 84 mg lactose monohydrate (see section 4.4). For the full list of excipients, see section 6.1.

EXCIPIENTS

Composition of Zerinoactiv 20 Tablets 200 mg + 30 mg - What does Zerinoactiv 20 Tablets 200 mg + 30 mg contain?

Core: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate (type A), colloidal anhydrous silica, magnesium stearate. Coating: polyvinyl alcohol, titanium dioxide E 171, macrogol/PEG 3350, talc.

DIRECTIONS

Therapeutic indications Zerinoactiv 20 Tablets 200 mg + 30 mg - Why is Zerinoactiv 20 Tablets 200 mg + 30 mg used? What is it used for?

Symptomatic treatment of nasal/sinus congestion with headache, fever and pain associated with the common cold. Zerinoactiv is indicated in adults and adolescents over 15 years of age.

CONTRAINDICATIONS SIDE EFFECTS

Contraindications Zerinoactiv 20 Tablets 200 mg + 30 mg - When should Zerinoactiv 20 Tablets 200 mg + 30 mg not be used?

Known hypersensitivity to ibuprofen, pseudoephedrine hydrochloride or to any of the excipients listed in section 6.1; history of allergy or asthma induced by ibuprofen or substances with similar activity, such as other nonsteroidal anti-inflammatory drugs (NSAIDs) or acetylsalicylic acid; history of gastrointestinal bleeding or perforation, related to previous therapy with anti-inflammatory drugs; history of recurrent or active peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding); cerebrovascular haemorrhage or other bleeding episodes; haematopoiesis disorders of unknown origin; severe hepatocellular insufficiency; severe renal insufficiency; severe cardiac insufficiency (NYHA class IV); severe or uncontrolled hypertension; severe coronary artery disease; risk of narrow-angle glaucoma; risk of urinary retention related to urethroprostatic disease; history of seizures; disseminated lupus erythematosus; concomitant use of other vasoconstrictors used as nasal decongestants, administered orally or nasally (see section 4.5); concomitant use of non-selective monoamine oxidase inhibitors (MAOIs) or use of monoamine oxidase inhibitors within the last two weeks (section 4.5); patients with severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake); third trimester of pregnancy (see section 4.6).

DOSAGE

Quantity and method of taking Zerinoactiv 20 Tablets 200 mg + 30 mg - How to take Zerinoactiv 20 Tablets 200 mg + 30 mg?

Dosage. Adults and adolescents over 15 years of age: 1 film-coated tablet (corresponding to 200 mg ibuprofen and 30 mg pseudoephedrine hydrochloride) every 6 hours, if necessary. In case of more severe symptoms, 2 film-coated tablets (corresponding to 400 mg ibuprofen and 60 mg pseudoephedrine hydrochloride) every 6 hours, if necessary, up to a maximum total dose of 6 film-coated tablets per day (corresponding to 1200 mg ibuprofen and 180 mg pseudoephedrine hydrochloride). The maximum total dose of 6 film-coated tablets per day (corresponding to 1200 mg ibuprofen and 180 mg pseudoephedrine hydrochloride) should not be exceeded. Treatment should not last more than 5 days. The lowest effective dose should be used for the shortest duration necessary to relieve symptoms (see section 4.4). This combination should be used when both the decongestant action of pseudoephedrine hydrochloride and the analgesic and/or anti-inflammatory action of ibuprofen are needed. If only one symptom is prevalent (nasal congestion or headache and/or fever), therapy with a single substance product is preferable. Paediatric population: Zerinoactiv is contraindicated in paediatric patients under 15 years of age (see section 4.3). If the use of this medicinal product is necessary for more than 3 days in adolescents, or in the event of worsening of symptoms, a doctor should be consulted. Method of administration: for oral use. The film-coated tablets should be swallowed, without chewing, with a large glass of water, preferably during meals.

CONSERVATION

Storage Zerinoactiv 20 Tablets 200 mg + 30 mg - How to store Zerinoactiv 20 Tablets 200 mg + 30 mg?

Do not store above 25 degrees C. Store in the original package. Keep the blister in the outer carton.

WARNINGS

Warnings Zerinoactiv 20 Tablets 200 mg + 30 mg - About Zerinoactiv 20 Tablets 200 mg + 30 mg it is important to know that:

The use of Zerinoactiv in combination with other NSAIDs containing cyclooxygenase (COX)-2 inhibitors should be avoided. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see sections below regarding "Gastrointestinal effects" and "Cardiovascular and cerebrovascular effects"). Serious skin reactions: Serious skin reactions such as acute generalised exanthematous pustulosis (AGEP) may occur with products containing ibuprofen and pseudoephedrine. This acute pustular eruption may occur within the first 2 days of treatment, with fever and numerous, small, mostly non-follicular pustules arising from a widespread oedematous erythema and located mainly in the skin folds, trunk and upper limbs. Patients should be carefully monitored. If signs and symptoms such as pyrexia, erythema or numerous small pustules are observed, Zerinoactiv should be discontinued and appropriate measures taken if necessary. Special warnings related to pseudoephedrine hydrochloride: Treatment should be discontinued if patients develop: hypertension; tachycardia, palpitations, cardiac arrhythmias; any neurological symptoms, such as new or worsening headache. Ischemic colitis: Some cases of ischemic colitis have been reported with pseudoephedrine. If sudden abdominal pain, rectal bleeding or other symptoms of ischemic colitis develop, pseudoephedrine should be discontinued and a doctor should be consulted. Ischemic optic neuropathy: Cases of ischemic optic neuropathy have been reported with pseudoephedrine. Pseudoephedrine should be discontinued if sudden loss of vision or reduction in visual acuity occurs, such as scotoma. Zerinoactiv should be used under medical advice in patients with: hypertension, heart disease, stroke, hyperthyroidism, psychosis, diabetes. Concomitant use of methylphenidate or antimigraine drugs, in particular vasoconstrictors based on ergot alkaloids (due to the a-sympathomimetic activity of pseudoephedrine) (see section 4.5). Neurological and psychiatric symptoms and irregular heartbeat have been described following systemic administration of vasoconstrictors, especially in case of overdose (see sections 4.8 and 4.9). Elderly patients may be more sensitive to the effects on the central nervous system (CNS). Precautions for use relating to pseudoephedrine hydrochloride: in patients who are to undergo a scheduled surgery in which it is planned to use volatile anaesthetics Zerinoactiv several days before the operation, in view of the risk of acute hypertension (see section 4.5). Athletes should be informed that treatment with pseudoephedrine hydrochloride may result in positive anti-doping tests. Interference with serological tests: pseudoephedrine may potentially reduce the uptake of iobenguane i-131 in neuroendocrine tumors, thus interfering with scintigraphy. Special warnings relating to ibuprofen: for patients with asthma associated with chronic rhinitis, chronic sinusitis and/or nasal polyposis there is an increased risk of allergic reactions when taking acetylsalicylic acid and/or NSAIDs. These may present as Quincke's edema or urticaria. Administration of Zerinoactiv may precipitate an acute asthma attack, particularly in some patients allergic to acetylsalicylic acid or an NSAID (see section 4.3). Gastrointestinal effects: GI bleeding, ulceration or perforation, sometimes fatal, have been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of GI events. The risk of GI bleeding, ulceration or perforation, sometimes fatal, is increased with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3), and in patients over 60 years of age. These patients should start treatment on the lowest dose available. Concomitant therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients taking concomitant low dose acetylsalicylic acid or other drugs likely to increase gastrointestinal risk (see below and section 4.5). Patients with a history of gastrointestinal toxicity, particularly the elderly, may present with unusual abdominal symptoms (especially gastrointestinal bleeding) in the initial stages of treatment. Particular caution should be used in patients receiving concomitant treatment with drugs which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors (SSRIs) or anti-platelet agents such as acetylsalicylic acid (see section 4.5). Treatment with Zerinoactiv should be stopped immediately if gastrointestinal bleeding or ulceration occurs. NSAIDs should be given with caution to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as their condition may be worsened (see section 4.8). Cardiovascular and cerebrovascular effects: Clinical trials suggest that use of ibuprofen, particularly at high doses (2400 mg daily), may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). Overall, epidemiological studies do not suggest that low doses of ibuprofen (e.g. <= 1200 mg daily) are associated with an increased risk of arterial thrombotic events. Patients with uncontrolled hypertension, congestive heart failure (NYHA class II-III), established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with ibuprofen after careful consideration and high doses (2400 mg daily) should be avoided.

INTERACTIONS

Interactions Zerinoactiv 20 Tablets 200 mg + 30 mg - Which medicines or foods can modify the effect of Zerinoactiv 20 Tablets 200 mg + 30 mg?'

Concomitant use of pseudoephedrine with: non-selective MAOIs; possible reactions: paroxysmal hypertension and hyperthermia, which may be fatal, due to the long duration of action of MAOIs, this interaction may occur up to 14 days after discontinuation of the MAOI, therefore, the use of zerinoactiv concomitantly with MAOIs or within 2 weeks of discontinuation of treatment with MAOIs is contraindicated (see section 4.3). Concomitant use of pseudoephedrine with: sympathomimetic agents or vasoconstrictors; possible reactions: they may have additive cardiovascular effects (see sections 4.3 and 4.4). Concomitant use of pseudoephedrine with: volatile halogenated anaesthetics; possible reactions: acute perioperative hypertension, in case of scheduled surgery, discontinue treatment with zerinoactiv several days before. Concomitant use of pseudoephedrine with: antihypertensive drugs that interfere with sympathomimetic activity; possible reactions: reduction of the decongestant pseudoephedrine. Concomitant use of pseudoephedrine with: tricyclic antidepressants; possible reactions: pseudoephedrine may be attenuated or potentiated. Concomitant use of pseudoephedrine with: digitalis, quinidine or tricyclic antidepressants; possible reactions: increased risk of arrhythmias. Concomitant use of pseudoephedrine with: antihypertensive drugs that interfere with sympathomimetic activity; possible reactions: reduction of the antihypertensive effects of antihypertensive drugs. Concomitant use of ibuprofen with: other NSAIDs, including salicylates; possible reactions: concomitant administration of several NSAIDs may increase the risk of bleeding and gastrointestinal ulcers due to a synergistic effect. Therefore, concomitant use of ibuprofen with other NSAIDs should be avoided (see section 4.4). Concomitant use of ibuprofen with: digoxin; possible reactions: concomitant use of zerinoactiv with drugs containing digoxin may increase the serum levels of the latter. Usually, if used correctly (for a maximum of 5 days), it is not necessary to monitor serum digoxin levels. Concomitant use of ibuprofen with: corticosteroids; possible reactions: corticosteroids may increase the risk of adverse reactions, especially of the gastrointestinal tract (gastrointestinal bleeding or ulceration) (see section 4.3). Concomitant use of ibuprofen with: antiplatelet agents; possible reactions: increased risk of gastrointestinal bleeding (see section 4.4). Concomitant use of ibuprofen with: acetylsalicylic acid (low dose); possible reactions: the concomitant administration of ibuprofen and acetylsalicylic acid is generally not recommended due to the potential for increased adverse effects. Experimental data suggest that ibuprofen may competitively inhibit platelet aggregation with low-dose aspirin when the two drugs are administered concomitantly. Although there are uncertainties regarding the extrapolation of these data to the clinical situation, the possibility that regular, long-term use of ibuprofen may reduce the cardioprotective effect of low-dose aspirin cannot be excluded. No clinically relevant effect is considered likely following occasional use of ibuprofen (see section 5.1). Concomitant use of ibuprofen with: anticoagulants (e.g. warfarin, ticlopidine, clopidogrel, tirofiban, eptifibatide, abciximab, iloprost); possible reactions: concomitant use of ibuprofen with: phenytoin; possible reactions: concomitant use of zerinoactiv with drugs containing phenytoin may increase the serum levels of the latter. Usually, if used correctly (for a maximum of 5 days), it is not necessary to monitor serum phenytoin levels. Concomitant use of ibuprofen with: selective serotonin reuptake inhibitors (SSRIs); possible reactions: increased risk of gastrointestinal bleeding (see section 4.4). Concomitant use of ibuprofen with: lithium; possible reactions: concomitant use of zerinoactiv with lithium-containing drugs may increase the serum levels of the latter. Usually, if used correctly (for a maximum of 5 days), it is not necessary to monitor serum lithium levels. Concomitant use of ibuprofen with: probenecid and sulfinpyrazone; possible reactions: drugs containing probenecid or sulfinpyrazone may delay the excretion of ibuprofen. Concomitant use of ibuprofen with: diuretics, ACE inhibitors, beta-blockers and angiotensin II antagonists; possible reactions: NSAIDs may reduce diuretics and other antihypertensive drugs. In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal function) the co-administration of an ACE inhibitor, a beta-blocker or angiotensin II antagonists together with agents that inhibit cyclooxygenase may result in further deterioration of renal function, including possible acute renal failure, which is usually reversible. Therefore, these combinations should be administered with caution, especially in elderly patients. Patients should be adequately hydrated and consideration should be given to monitoring renal function at the start of concomitant therapy and periodically thereafter. Concomitant use of ibuprofen with: potassium-sparing diuretics; possible reactions: concomitant intake of zerinoactiv and potassium-sparing diuretics may lead to hyperkalemia (a check of serum potassium level is recommended). Concomitant use of ibuprofen with: methotrexate; possible reactions: zerinoactiv administered within 24 hours before or after methotrexate intake may increase concentrations and therefore toxicity. Concomitant use of ibuprofen with: ciclosporin; possible reactions: the risk of renal damage induced by cephalosporins is increased by concomitant use of some nonsteroidal anti-inflammatory drugs. This effect cannot be excluded in case of concomitant intake of ciclosporins and ibuprofen. Concomitant use of ibuprofen with: tacrolimus; possible reactions: the risk of nephrotoxicity increases in case of concomitant administration of ibuprofen and tacrolimus.

SIDE EFFECTS

Like all medicines, Zerinoactiv 20 Tablets 200 mg + 30 mg can cause side effects - What are the side effects of Zerinoactiv 20 Tablets 200 mg + 30 mg?

The most commonly observed adverse events related to ibuprofen are gastrointestinal in nature. In general, the risk of developing adverse events (particularly the risk of developing serious gastrointestinal complications) increases with increasing dose and duration of treatment. Hypersensitivity reactions have been reported following treatment with ibuprofen, which may include: (a) Nonspecific allergic reactions and anaphylaxis; (b) Respiratory tract reactivity, including asthma, aggravated asthma, bronchospasm or dyspnoea; (c) Various skin disorders, including rashes of various types, pruritus, urticaria, purpura, angioedema and, more rarely, exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme). In patients with active autoimmune disorders (such as systemic lupus erythematosus, mixed connective tissue diseases), isolated cases of symptoms of aseptic meningitis, such as stiff neck, headache, nausea, vomiting, fever or disorientation, have been observed during treatment with ibuprofen. Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment. Clinical studies suggest that use of ibuprofen, particularly at high doses (2400 mg daily), may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see section 4.4). The list of adverse events reported below refers to events reported with over-the-counter doses of ibuprofen and pseudoephedrine hydrochloride for short-term use. In the treatment of chronic conditions, additional adverse effects may occur during long-term treatment. Patients should be advised to stop taking Zerinoactiv 200 mg/30 mg film-coated tablets immediately and to consult their doctor if a serious adverse drug reaction occurs. Adverse reactions considered at least possibly related to treatment are listed below by system organ class and frequency. Frequencies are defined as very common (>=1/10), common (>=1/100, <1/10), uncommon (>=1/1000, <1/100), rare (>=1/10,000, <1/1000), very rare (<1/10,000), not known (cannot be estimated from the available data). List of adverse reactions: Infections and infestations. Ibuprofen, very rare: worsening of infectious inflammation (e.g. development of necrotizing fasciitis), aseptic meningitis (stiff neck, headache, nausea, vomiting, fever or disorientation) in patients with active autoimmune diseases (SLE, mixed connective tissue disease). Blood and lymphatic system disorders. Ibuprofen, very rare: haematopoiesis disorders (anaemia, leucopenia, thrombocytopenia, pancytopenia, agranulocytosis). Immune system disorders. Ibuprofen, uncommon: hypersensitivity reactions with urticaria, pruritus and asthma attacks (with drop in blood pressure). Pseudoephedrine hydrochloride, not known: hypersensitivity reactions. Ibuprofen, very rare: severe generalised hypersensitivity reactions, signs of which may include facial oedema, angioedema, dyspnoea, tachycardia, drop in blood pressure, anaphylactic shock. Psychiatric disorders. Ibuprofen, very rare: psychotic reactions, depression. Pseudoephedrine hydrochloride, not known: agitation, hallucinations, anxiety, nervousness, manic symptoms such as insomnia, euphoric or irritable mood, increased self-esteem, increased activity or restlessness, racing thoughts, rapid talking and distraction. Nervous system disorders. Ibuprofen, uncommon: central nervous system disorders such as headache, dizziness, insomnia, agitation, irritability or tiredness. Pseudoephedrine hydrochloride, not known: stroke, headache, dizziness, somnolence, tremor. Eye disorders. Ibuprofen, uncommon: visual disturbances. Pseudoephedrine hydrochloride, not known: ischaemic optic neuropathy. Ear and labyrinth disorders. Ibuprofen, rare: tinnitus. Cardiac disorders. Ibuprofen, very rare: palpitations, cardiac failure, myocardial infarction. Pseudoephedrine hydrochloride, not known: palpitations, tachycardia, arrhythmia. Vascular disorders. Ibuprofen, very rare: arterial hypertension, vasculitis. Pseudoephedrine hydrochloride, not known: hypertension. Gastrointestinal disorders. Ibuprofen, common: dyspepsia, heartburn, abdominal pain, nausea, vomiting, flatulence, diarrhoea, constipation, slight gastrointestinal blood loss which in rare cases leads to anaemia. Ibuprofen, uncommon: gastric ulcer with haemorrhage and/or perforation, gastritis, ulcerative stomatitis, worsening of colitis and Crohn's disease (see section 4.4). Ibuprofen, very rare: esophagitis, pancreatitis, formation of diaphragmatic intestinal strictures. Pseudoephedrine hydrochloride, not known: dry mouth, nausea, vomiting, decreased appetite, ischaemic colitis. Hepatobiliary disorders. Ibuprofen, very rare: liver dysfunction, liver damage, especially with prolonged therapy, liver failure, acute hepatitis. Skin and subcutaneous tissue disorders. Ibuprofen, uncommon: various skin rashes. Ibuprofen, very rare: severe skin reactions (scars) (including erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis), alopecia, severe skin infections, soft tissue complications in varicella infection. Ibuprofen, not known: drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), photosensitivity reaction, acute generalized exanthematous pustulosis (AGEP). Pseudoephedrine hydrochloride, not known: severe skin reactions, including acute generalized exanthematous pustulosis (AGEP), rash, urticaria, pruritus, hyperhidrosis. Renal and urinary disorders. Ibuprofen, rare: damage to kidney tissue (papillary necrosis) and elevated uric acid levels in the blood. Ibuprofen, very rare: oedema formation (especially in patients with arterial hypertension or renal insufficiency), nephrotic syndrome, interstitial nephritis, acute renal failure. Pseudoephedrine hydrochloride, not known: dysuria, urinary retention. General disorders and administration site conditions. Pseudoephedrine hydrochloride, not known: tiredness, thirst, chest pain, asthenia. Respiratory, thoracic and mediastinal disorders. Pseudoephedrine hydrochloride, not known: dyspnoea.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Zerinoactiv 20 Tablets 200 mg + 30 mg.

Pregnancy: During the first and second trimester of pregnancy, the use of Zerinoactiv should be avoided. If the doctor deems treatment necessary, the dose should be kept to a minimum and the duration of treatment as short as possible. The use of Zerinoactiv is contraindicated during the third trimester of pregnancy (see section 4.3). Pseudoephedrine hydrochloride: Experience with pseudoephedrine during pregnancy is moderate, but the quality of the data is often insufficient and the results are contradictory. Although the overall risk of malformation is not increased, a significant association between gastroschisis and pseudoephedrine was found in at least one case-control study. Other case-control studies also found an increased risk, but significance was not reached. Animal studies are insufficient with respect to reproductive toxicity (see section 5.3). Therefore, the use of pseudoephedrine during pregnancy should be avoided. Ibuprofen: Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or embryo/fetal development. Data from epidemiological studies suggest an increased risk of miscarriage and cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiovascular malformations is increased from less than 1% 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-fetal lethality. In addition, an increased incidence of various malformations, including cardiovascular, has been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period. From the twentieth week of pregnancy, the use of Zerinoactiv may cause oligohydramnios resulting from fetal renal dysfunction. This condition may be observed soon after the start of treatment and is usually reversible upon discontinuation of treatment. In addition, there have been reports of narrowing of the ductus arteriosus following treatment in the second trimester, most of which resolved after discontinuation of treatment. Therefore, during the first and second trimester of pregnancy, ibuprofen should not be administered unless clearly necessary. If used by a woman attempting to conceive or during the first and second trimester of pregnancy, the dose should be kept as low as possible and the duration of treatment should be as short as possible. Prenatal monitoring for oligohydramnios and narrowing of the ductus arteriosus should be considered after prolonged exposure to Zerinoactiv from the twentieth week of gestation onwards. Zerinoactiv should be discontinued in case of oligohydramnios or narrowing of the ductus arteriosus. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the fetus to: cardiopulmonary toxicity (premature closure of the ductus arteriosus and pulmonary hypertension), renal dysfunction (see above); the mother and the neonate, at the end of pregnancy to: possible prolongation of bleeding time, antiaggregant effect which may occur even at very low doses, inhibition of uterine contractions resulting in delayed or prolonged labor. Consequently, it is contraindicated during the third trimester of pregnancy. Breastfeeding: pseudoephedrine hydrochloride passes into breast milk. Ibuprofen and its metabolites are excreted in very low concentrations in human breast milk and are unlikely to have adverse effects on nursing infants. Zerinoactiv is not recommended for women who are breastfeeding, unless the doctor considers that the potential benefit for the patient outweighs the potential risk for the newborn. Fertility: There is limited evidence that drugs that inhibit cyclooxygenase/prostaglandin synthesis may impair female fertility by affecting ovulation. Once treatment is stopped, it is reversible.