Nurofencaps 400mg 10 soft capsules

Nurofencaps 400mg 10 soft capsules is a medicine designed for the short-term symptomatic treatment of mild to moderate pain . Each capsule contains Ibuprofen 400 mg , an active ingredient known for its anti-inflammatory and analgesic properties. This medicine is indicated for adults, children and adolescents weighing more than 40 kg (from 12 years of age) and can be used to relieve headaches , menstrual cramps , toothache and pain associated with the common cold . The soft capsules are easy to swallow and designed for rapid absorption, providing effective and timely relief. Nurofencaps is formulated with excipients such as Sorbitol (E420) and Ponceau 4R (E124) , which contribute to its effectiveness and stability.

ACTIVE INGREDIENTS

Active ingredients contained in Nurofencaps 400mg 10 soft capsules - What is the active ingredient in Nurofencaps 400mg 10 soft capsules?

Each capsule contains Ibuprofen 400 mg Excipients with known effect: Sorbitol (E420) 36.6 mg/capsule; Ponceau 4R (E124) 0.79 mg/capsule. For the full list of excipients, see section 6.1.

EXCIPIENTS

Composition of Nurofencaps 400mg 10 soft capsules - What does Nurofencaps 400mg 10 soft capsules contain?

Filling : Macrogol 600, Potassium hydroxide, Purified water. Gelatin shell : Gelatin, Liquid sorbitol (E420) , Ponceau 4R (E124) . Ink : Titanium dioxide (E171), Propylene glycol, Hypromellose (E464). Processing aids : Triglycerides (medium chain), Lecithin (E322).

DIRECTIONS

Therapeutic indications Nurofencaps 400mg 10 soft capsules - Why is Nurofencaps 400mg 10 soft capsules used? What is it used for?

This medicine is indicated in adults, children and adolescents weighing more than 40 kg (from 12 years of age) for the short-term symptomatic treatment of mild to moderate pain, such as headache, menstrual cramps, toothache and pain associated with the common cold.

CONTRAINDICATIONS SIDE EFFECTS

Contraindications Nurofencaps 400mg 10 soft capsules - When should Nurofencaps 400mg 10 soft capsules not be used?

• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. • Patients who have experienced hypersensitivity reactions (such as bronchospasm, asthma, rhinitis, angioedema or urticaria) associated with the use of acetylsalicylic acid (ASA) or other nonsteroidal anti-inflammatory drugs (NSAIDs). • History of gastrointestinal bleeding or perforation related to previous NSAID treatment • Patients with active peptic ulcer/haemorrhage or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). • Patients with severe hepatic, renal or cardiac insufficiency (NYHA Class IV). See also section 4.4 • Patients with cerebrovascular bleeding or other active bleeding. • Patients with unexplained disorders of haematopoiesis. • Patients with severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake) • During the last trimester of pregnancy (see section 4.6). • Adolescents weighing less than 40 kg or children under 12 years of age.

DOSAGE

Quantity and method of taking Nurofencaps 400mg 10 soft capsules - How to take Nurofencaps 400mg 10 soft capsules?

Dosage For short-term treatment only. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). Adults, children and adolescents weighing more than 40 kg (from 12 years of age) . The initial dose is one capsule to be taken with water. Thereafter, if necessary, one capsule every 6 hours. Do not exceed the dose of 3 capsules (1200 mg) in 24 hours. If the use of the medicinal product is necessary for more than 3 days in adolescents or if the symptoms worsen, a doctor should be consulted. If in adults it is necessary to administer the product for more than 3 days in case of fever and 4 days for the treatment of pain, or if the symptoms worsen, a doctor should be consulted. The onset of the effect of Nurofencaps may be delayed if the medicine is taken shortly after eating. If this occurs, do not take a higher dose of Nurofencaps than recommended in section 4.2 (posology) or wait until the necessary time has elapsed between doses. Special populations Elderly : No special dose adjustment is required. Due to the possible adverse effect profile (see section 4.4) the elderly should be monitored with particular care. Renal impairment No dose reduction is required in patients with mild to moderate renal impairment (for patients with severe renal impairment see section 4.3). Hepatic impairment (see section 5.2) No dose reduction is required in patients with mild to moderate hepatic impairment (for patients with severe hepatic impairment see section 4.3). Children and adolescents For use in children and adolescents see section 4.3. Method of administration For oral use. The capsules should not be chewed. It is recommended that patients with gastric sensitivity problems take Nurofencaps with food.

CONSERVATION

Storage Nurofencaps 400mg 10 soft capsules - How to store Nurofencaps 400mg 10 soft capsules?

Do not store above 25°C. Store in the original package in order to protect from moisture.

WARNINGS

Warnings Nurofencaps 400mg 10 soft capsules - About Nurofencaps 400mg 10 soft capsules it is important to know that:

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see below gastrointestinal and cardiovascular risks). Caution is advised in patients with the following conditions, which may be exacerbated: • systemic lupus erythematosus and mixed connective tissue disease - due to increased risk of aseptic meningitis (see section 4.8) • inborn errors of porphyrin metabolism (e.g. acute intermittent porphyria) • gastrointestinal disorders and chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease (see section 4.8) • hypertension and/or heart failure (see sections 4.3 and 4.8) • renal insufficiency, as renal function may be impaired (see sections 4.3 and 4.8) • liver dysfunction (see sections 4.3 and 4.8) • immediately after major surgery • in patients who have allergic reactions to other substances, as they are at higher risk of developing hypersensitivity reactions even when using Nurofencaps • in patients who suffer from hay fever, nasal polyps, respiratory disorders obstructive pulmonary disease, or who have a history of allergic disease, as there is an increased risk for these patients to develop allergic reactions. These may manifest themselves as asthma attacks (so-called “analgesic asthma”), Quincke’s oedema or urticaria. Masking of symptoms of underlying infections Nurofencaps may mask the symptoms of infection, which may delay initiating adequate treatment and therefore worsen the outcome of the infection. This has been observed in community-acquired bacterial pneumonia and bacterial complications of chickenpox. When Nurofencaps is administered for the relief of infection-related fever or pain, monitoring for infection is advised. In non-hospital settings, the patient should seek medical advice if symptoms persist or worsen. Gastrointestinal (GI) safety : Concomitant use of other NSAIDs, including cyclooxygenase-2 selective inhibitors, increases the risk of adverse reactions (see section 4.5) and should be avoided. Elderly : Elderly patients have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal (see section 4.2). Gastrointestinal bleeding, ulceration and perforation : Gastrointestinal bleeding, ulceration and perforation, which can be fatal, have been reported with all NSAIDs at anytime during treatment, with or without warning symptoms or a previous history of serious GI events. When gastrointestinal bleeding or ulceration occurs following the administration of ibuprofen, the treatment should be withdrawn. The risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing NSAID doses, in the elderly and in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3). These patients should start treatment on the lowest available dose. Concomitant use of protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients requiring concomitant low dose aspirin or other drugs likely to increase gastrointestinal risk (see section 4.5). Patients with a history of gastrointestinal toxicity, particularly when elderly, should report any unusual gastrointestinal symptoms (especially gastrointestinal bleeding), particularly in the initial stages of treatment. Caution should be advised in patients receiving concomitant medications 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). NSAIDs should be given with caution to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated (see section 4.8). Severe skin reactions : Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see section 4.8). Patients appear to be at highest risk early in the course of therapy: the onset of the reaction occurring in the majority of cases within the first month of treatment. Acute generalised exanthematous pustulosis (AGEP) has been reported in association with medicinal products containing ibuprofen. Nurofencaps should be discontinued at the first appearance of signs and symptoms of severe skin reactions, such as rash, mucosal lesions or any other sign of hypersensitivity. Chickenpox may exceptionally be the cause of serious infectious complications of the skin and soft tissues. It is advisable to avoid the use of Nurofencaps in case of chickenpox. Cardiovascular and cerebrovascular effects : Caution is advised before initiating treatment in patients with a history of hypertension and/or heart failure (consult your doctor or pharmacist) since fluid retention, hypertension and oedema have been reported in association with NSAID therapy. 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 (for example ≤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/day) should be avoided. Careful consideration should also be exercised before initiating long-term treatment in patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking), especially if high doses (2400 mg/day) of ibuprofen are required. Other considerations Severe acute hypersensitivity reactions (e.g. anaphylactic shock) are observed very rarely. At the first signs of a hypersensitivity reaction after administration/intake of Nurofencaps, therapy should be discontinued. Medical care measures required based on symptoms should be undertaken by specialist personnel. Ibuprofen, the active substance in Nurofencaps, may temporarily inhibit platelet function (thrombocyte aggregation), therefore it is recommended to carefully monitor patients with coagulation disorders. In case of prolonged administration of Nurofencaps, regular monitoring of liver values, kidney function and blood counts is required. Prolonged use of any type of painkiller for headaches may worsen the symptoms. If this situation occurs or is suspected, a doctor should be consulted and treatment should be discontinued. The diagnosis of medication overuse headache (MOH ) should be suspected in patients who experience frequent or daily headaches despite or because of the regular use of headache medications. The habitual use of painkillers, especially combinations of several analgesic active ingredients, can lead to permanent kidney damage with risk of renal failure (analgesic nephropathy). This risk may be increased by salt loss and dehydration. Undesirable effects related to the active substance, particularly those affecting the gastrointestinal tract or the central nervous system, may be increased when NSAIDs are taken in combination with alcohol. There is some evidence that medicinal products that inhibit cyclooxygenase/prostaglandin synthesis may cause impairment of female fertility by affecting ovulation. This effect is reversible after discontinuation of treatment (see section 4.6). There is a risk of impaired renal function in dehydrated children and adolescents. This medicinal product contains sorbitol : patients with rare hereditary problems of fructose intolerance should not take this medicinal product. This medicinal product contains Ponceau 4R (E124) . May cause allergic reactions.

INTERACTIONS

Interactions Nurofencaps 400mg 10 soft capsules - Which medicines or foods can modify the effect of Nurofencaps 400mg 10 soft capsules?

Acetylsalicylic acid (low dose) . 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 the effects of low-dose acetylsalicylic acid on platelet aggregation when the two drugs are administered concomitantly. Although there are uncertainties regarding 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 acetylsalicylic acid cannot be excluded. No clinically relevant effect is considered likely following occasional use of ibuprofen (see section 5.1). Other NSAIDs including cyclooxygenase-2 selective inhibitors . Concomitant administration of several NSAIDs may increase the risk of gastrointestinal ulcers and bleeding due to a synergistic effect. Concomitant use of ibuprofen with other NSAIDs should therefore be avoided (see section 4.4) Digoxin. Phenytoin, Lithium . Concomitant use of Nurofencaps with digoxin, phenytoin or lithium may increase the serum levels of these medicinal products. With correct use (maximum 4 days) monitoring of lithium, digoxin, phenytoin serum levels is not usually necessary. Corticosteroids . Corticosteroids may increase the risk of adverse reactions, especially of the gastrointestinal tract (gastrointestinal ulceration or bleeding) (see section 4.3) Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs) : Increased risk of gastrointestinal bleeding (see section 4.4). Anticoagulants . NSAIDs may increase the effects of anticoagulants, such as warfarin (see section 4.4) Probenecid and sulfinpyrazone . Medicinal products containing probenecid or sulfinpyrazone may delay the excretion of ibuprofen Diuretics, ACE inhibitors and Angiotensin II antagonists . NSAIDs may reduce the effect of 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 an angiotensin II antagonist and agents that inhibit cyclooxygenase may lead to further deterioration of renal function, including possible acute renal failure, which is usually reversible. Therefore, the combination should be administered with caution, especially in elderly patients. Patients should be adequately hydrated and consideration should be given to monitoring renal function after initiation of concomitant therapy, and periodically thereafter Potassium-sparing diuretics . Co-administration of Nurofencaps and potassium-sparing diuretics may cause hyperkalaemia. Methotrexate . Administration of Nurofencaps within 24 hours before and after methotrexate administration may lead to increased plasma levels of methotrexate and increased toxic effects. Ciclosporin . Co-administration with certain nonsteroidal anti-inflammatory drugs increases the risk of liver damage from ciclosporin. This effect cannot be excluded also for the combination of ciclosporin with ibuprofen. Tacrolimus . The risk of nephrotoxicity increases if the two drugs are administered concomitantly. Zidovudine . There is evidence of an increased risk of haemarthrosis and haematoma in HIV-seropositive haemophiliac patients when treated concomitantly with zidovudine and ibuprofen. There is a risk of increased haematological toxicity when NSAIDs are administered with zidovudine. Sulfonylureas Clinical investigations have shown interactions between nonsteroidal anti-inflammatory drugs and antidiabetics (Sulfonylureas). Although no interactions between antidiabetics and ibuprofen have been described so far, it is recommended to monitor plasma glucose levels as a precaution in case of co-administration. Quinolone antibiotics Experimental data in animals indicate that NSAIDs may increase the risk of convulsions associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of having convulsions. Mifepristone : NSAIDs should not be used for 8-12 days after administration of Mifepristone as NSAIDs may reduce the effect of Mifepristone. CYP2C9 inhibitors : Concomitant administration of ibuprofen and CYP2C9 inhibitors may enhance the exposure to ibuprofen (CYP2C9 substrate). In a study with voriconazole and fluconazole (CYP2C9 inhibitors), an increased exposure to S(+)-ibuprofen by approximately 80% to 100% was observed. Consideration should be given to reducing the ibuprofen dose when potent CYP2C9 inhibitors are administered concomitantly, particularly when high dose ibuprofen is administered with voriconazole and fluconazole.

SIDE EFFECTS

Like all medicines, Nurofencaps 400mg 10 soft capsules can cause side effects - What are the side effects of Nurofencaps 400mg 10 soft capsules?

The list of the following undesirable effects includes all the undesirable effects that have been recognized during treatment with ibuprofen, even those observed during prolonged high-dose therapy in patients with rheumatism. The reported frequencies, which extend beyond the reports of very rare undesirable effects, refer to short periods of treatment for daily doses of up to a maximum of 1200 mg of ibuprofen for oral pharmaceutical forms and up to a maximum of 1800 mg for suppositories. It should be taken into account that the following adverse reactions are predominantly dose-dependent and vary from individual to individual. The most commonly observed adverse reactions are gastrointestinal in nature. Peptic ulcers, perforation or gastrointestinal bleeding, sometimes fatal, particularly in the elderly, may occur (see section 4.4). Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported following administration of ibuprofen (see section 4.4). Less frequently, gastritis has been observed. In particular, the risk of gastrointestinal bleeding depends on the dose and duration of treatment. Oedema, hypertension and cardiac failure have been reported in association with NSAID therapy. Clinical trials suggest that use of ibuprofen, particularly at high doses (2400 mg/day), may be associated with a modest increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see section 4.4). Hypersensitivity reactions have been reported and may manifest as: (a) non-specific allergic reactions and anaphylaxis; (b) respiratory tract reactivity, such as asthma, aggravated asthma, bronchospasm, dyspnoea; (c) various skin reactions, such as pruritus, urticaria, angioedema and more rarely bullous and exfoliative dermatoses (including epidermal necrolysis and erythema multiforme). The patient should be advised to inform the doctor immediately and stop taking Nurofencaps, if any of the above-mentioned adverse reactions occur. It should be noted that for each frequency grouping, undesirable effects are presented in decreasing order of seriousness:

Infections and infestations. Very rare: Exacerbation of infection-related inflammation (e.g. development of necrotising fasciitis) has been described with the use of non-steroidal anti-inflammatory drugs. This is potentially associated with the mechanism of action of non-steroidal anti-inflammatory drugs. If signs of infection appear or worsen during the use of Nurofencaps, the patient is advised to seek medical advice immediately. The possible indication for anti-infective/antibiotic therapy should be considered. Symptoms of aseptic meningitis such as stiff neck, headache, nausea, vomiting, fever or disorientation have been observed during treatment with ibuprofen. Patients with autoimmune disorders (systemic lupus erythematosus, mixed connective tissue disease) appear to be predisposed. Blood and lymphatic system disorders . Very rare: haematopoietic disorders (anaemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). The first manifestations may be: fever, sore throat, superficial ulcers of the oral cavity, flu-like symptoms, severe fatigue, nosebleeds and skin bleeding. In these cases the patient should be informed to immediately stop the therapy, to avoid taking any over-the-counter analgesic or antipyretic medicine and to consult the doctor. For prolonged therapy the blood count should be checked regularly. Immune system disorders (hypersensitivity) . Uncommon: hypersensitivity reactions with urticaria and itching, as well as asthma attacks (possibly with a drop in blood pressure). Very rare: severe generalised hypersensitivity reactions. Symptoms may be: swelling of the face, tongue and larynx, dyspnoea, tachycardia, hypotension (anaphylaxis, angioedema or severe shock). Exacerbation of asthma and bronchospasm. Psychiatric disorders . Very rare: Psychotic reactions, depression. Nervous system disorders . Uncommon: Central nervous system disorders such as headache, dizziness, somnolence, agitation, irritability or tiredness. Eye disorders . Uncommon: Visual disturbances. Ear and labyrinth disorders . Rare: Tinnitus, hearing impairment. Cardiac disorders . Very rare: Palpitations, cardiac failure, myocardial infarction. Vascular disorders . Very rare: Arterial hypertension, vasculitis. Gastrointestinal disorders . Common: Gastrointestinal disorders such as dyspepsia, heartburn, abdominal pain, nausea, vomiting, flatulence, diarrhoea, constipation and slight gastrointestinal blood loss which in exceptional cases may cause anaemia; Uncommon: Gastrointestinal ulcers, potentially with perforation and gastrointestinal bleeding. Ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see section 4.4), gastritis; Very rare: esophagitis, pancreatitis, formation of diaphragmatic-like intestinal strictures. The patient should be advised to discontinue the medicinal product and seek medical advice immediately if severe upper abdominal pain, melaena or haematemesis occurs. Hepatobiliary disorders . Very rare: liver dysfunction, liver damage, especially after long-term treatment, liver failure, acute hepatitis. Skin and subcutaneous tissue disorders. Uncommon: various rashes; Very rare: bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell's syndrome), alopecia. In exceptional cases, severe skin infections and soft tissue complications may occur during a chickenpox infection (see also “Infections and infestations”). Not known: drug reaction with eosinophilia and systemic symptoms (DRESS syndrome). Acute generalised exanthematous pustulosis (AGEP). Photosensitivity reactions. Renal and urinary disorders . Rare: damage to renal tissue (papillary necrosis) and high blood uric acid concentrations may occur rarely. High blood urea concentrations; Very rare: formation of oedema, particularly in patients with arterial hypertension or renal insufficiency, nephrotic syndrome, interstitial nephritis which may be accompanied by acute renal failure. Renal function should therefore be monitored regularly. 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 www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Diagnostic tests . Rare: decrease in haemoglobin levels.

OVERDOSE

Nurofencaps 400mg 10 softgels Overdose - What are the risks of Nurofencaps 400mg 10 softgels in case of overdose?

In adults and adolescents there is no obvious dose-response effect. The half-life in case of overdose is 1.5-3 hours. Symptoms Most patients who have ingested clinically relevant quantities of NSAIDs present exclusively with nausea, vomiting, epigastric pain, or more rarely diarrhoea. Tinnitus, headache, and gastrointestinal bleeding may also occur. In more severe cases of poisoning, central nervous system toxicity is observed, manifested by dizziness, drowsiness, occasionally excitation and disorientation or coma. Occasionally patients develop convulsions. In severe cases of poisoning, metabolic acidosis and a prolongation of the prothrombin time/INR may occur, probably caused by interference with the action of circulating coagulation factors. Acute renal failure and liver damage may also occur. In asthmatic subjects, exacerbation of asthma may occur. Treatment Treatment should be symptomatic and supportive and should include maintaining a patent airway and monitoring cardiac function and vital signs until the patient is stable. Oral administration of activated charcoal should be considered if the patient presents within 1 hour of ingestion of a potentially toxic amount. Seizures should be treated with intravenous diazepam or lorazepam if frequent or prolonged. Bronchodilators should be given if asthma is present. There is no specific antidote.

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 Nurofencaps 400mg 10 soft capsules.

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, cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk for cardiac 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 prostaglandin synthesis inhibitors 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 should not be given unless clearly necessary. If used by women attempting to conceive or during the first and second trimester of pregnancy, the dose and duration of treatment should be as low and as short as possible, respectively. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the fetus to: - cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); - renal dysfunction which may progress to renal failure with oligohydramnios; the mother and the neonate, at the end of pregnancy, to: - possible prolongation of bleeding time, an antiaggregant effect which may occur even at very low doses; - inhibition of uterine contractions resulting in delayed or prolonged labor. Consequently, ibuprofen is contraindicated during the third trimester of pregnancy. Breastfeeding Ibuprofen and its metabolites may pass in low concentrations into breast milk. No harmful effects for newborns are known to date, therefore for short-term treatments with the recommended dose for pain and fever, interruption of breastfeeding is not generally necessary. Fertility There is some evidence that drugs that inhibit cyclooxygenase / prostaglandin synthesis may cause impairment of female fertility by an effect on ovulation. This is reversible upon discontinuation of treatment (see section 4.4).

DRIVING AND USE OF MACHINERY

Taking Nurofencaps 400mg 10 soft capsules before driving or using machines - Does Nurofencaps 400mg 10 soft capsules affect driving or using machines?

Patients who experience dizziness, drowsiness, vertigo or visual disturbances during treatment with ibuprofen should avoid driving or operating machinery. For a single administration or short periods of treatment, ibuprofen does not normally require the adoption of any special precautions. These effects are even more potentiated if alcohol is taken concomitantly.