Nurofenteen 200 mg 12 orodispersible tablets lemon

Nurofenteen 200 mg 12 orosoluble tablets lemon is an analgesic, anti-inflammatory and antipyretic based on ibuprofen , ideal for the treatment of mild or moderate pain such as headache, toothache, menstrual pain and to reduce fever . The formulation in orosoluble tablets with a lemon flavour offers rapid and practical relief : the tablets dissolve directly in the mouth without the need for water, making the product particularly suitable even away from home or in emergency situations.

Designed for adults and adolescents over 12 years of age , Nurofenteen 200 mg guarantees effective action thanks to the presence of ibuprofen , an active ingredient known for its ability to reduce pain, inflammation and fever. Each pack contains 12 tablets in a practical blister, easily transportable. The lemon flavour makes taking it more pleasant, while the orodispersible technology ensures rapid dissolution and absorption of the active ingredient.

Nurofenteen 200 mg is produced by Reckitt Benckiser , a leading company in the pharmaceutical sector, synonymous with quality and safety. Its innovative formulation is ideal for those looking for an effective, practical and pleasant-tasting painkiller and antipyretic . Perfect for those who want rapid relief from pain and fever without having to resort to water, at any time of the day.

ACTIVE INGREDIENTS

Active ingredients contained in Nurofenteen 200 mg 12 orodispersible tablets lemon - What is the active ingredient in Nurofenteen 200 mg 12 orodispersible tablets lemon?

Each orodispersible tablet contains 200 mg ibuprofen. Excipients with known effect: 15.0 mg aspartame/orodispersible tablet 2.37 mg sodium/orodispersible tablet For the full list of excipients, see section 6.1.

EXCIPIENTS

Composition of Nurofenteen 200 mg 12 orodispersible tablets lemon - What does Nurofenteen 200 mg 12 orodispersible tablets lemon contain?

Ethylcellulose, precipitated silicon dioxide, hypromellose, mannitol, aspartame (E951), croscarmellose sodium, magnesium stearate, flavour (lemon).

DIRECTIONS

Therapeutic indications Nurofenteen 200 mg 12 orodispersible tablets lemon - Why is Nurofenteen 200 mg 12 orodispersible tablets lemon used? What is it used for?

Mild or moderate painful symptoms such as headache, toothache, menstrual cramps. Fever. NUROFENTEEN is indicated for adults and adolescents over 12 years of age.

CONTRAINDICATIONS AND SIDE EFFECTS

Contraindications Nurofenteen 200 mg 12 orodispersible tablets lemon - When should Nurofenteen 200 mg 12 orodispersible tablets lemon not be used?

Patients with hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Patients who have previously shown hypersensitivity reactions (e.g. bronchospasm, asthma, rhinitis, angioedema or urticaria) following the use of acetylsalicylic acid, ibuprofen or other nonsteroidal anti-inflammatory drugs. Patients with severe hepatic insufficiency, severe renal insufficiency or severe heart failure (NYHA class IV). Patients with a history of gastrointestinal bleeding or perforation, related to previous therapy with NSAIDs (nonsteroidal anti-inflammatory drugs). Patients with active or previous recurrent peptic ulcers/haemorrhages (two or more distinct episodes of proven ulceration or bleeding). Patients with active cerebrovascular haemorrhage or other types of haemorrhage. 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).

DOSAGE

Quantity and method of taking Nurofenteen 200 mg 12 orodispersible tablets lemon - How to take Nurofenteen 200 mg 12 orodispersible tablets lemon?

Dosage Do not administer to children under 12 years of age. Adults and adolescents over 12 years of age : initial dose of 200 to 400 mg of ibuprofen, then, if necessary, 200 to 400 mg of ibuprofen every 4-6 hours. Do not exceed the dose of 1200 mg of ibuprofen in 24 hours. Elderly : no changes to the dosage regimen are required. Only for a short period of treatment. If the use of the medicine is necessary for more than 3 days in adolescents or in case of worsening of symptoms, a doctor should be consulted. If the use of the medicine in adults is necessary for more than 3 days in case of fever or for more than 4 days in the treatment of pain, or in case of worsening of symptoms, the patient should be advised to consult a doctor. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). Method of administration Oral use Place one tablet on the tongue, allow to dissolve, then swallow. No water is necessary . Patients with gastric sensitivity problems are advised to take NUROFENTEEN with food.

CONSERVATION

Storage Nurofenteen 200 mg 12 orodispersible tablets lemon - How to store Nurofenteen 200 mg 12 orodispersible tablets lemon?

Store at a temperature not exceeding 25°C.

WARNINGS

Warnings Nurofenteen 200 mg 12 orodispersible tablets lemon - About Nurofenteen 200 mg 12 orodispersible tablets lemon 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 Gastrointestinal and cardiovascular risks below). 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). Elderly patients are at increased risk of consequences from adverse reactions. Caution is required in patients with: - systemic lupus erythematosus or mixed connective tissue disease due to an 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); - history of hypertension and/or heart failure since fluid retention and oedema have been reported in association with NSAID therapy; - renal impairment, as renal function may deteriorate (see sections 4.3 and 4.8); - liver dysfunction (see sections 4.3 and 4.8); - immediately after major surgery; - hay fever, nasal polyps or chronic obstructive respiratory disease, as these patients are at increased risk of developing allergic reactions. These may manifest themselves in the form of asthma attacks (so-called “analgesic asthma”), Quincke’s oedema or urticaria. - in patients who have already shown allergic reactions to other substances, as they are at higher risk of developing hypersensitivity reactions even when using NUROFENTEEN. Other NSAIDs : the use of NUROFENTEEN in conjunction with other NSAIDs, including cyclooxygenase-2 selective inhibitors, should be avoided. Masking of symptoms of underlying infections NUROFENTEEN may mask the symptoms of infection, which may delay initiation of adequate treatment and therefore worsen the outcome of the infection. This has been observed in community-acquired bacterial pneumonia and bacterial complications of varicella. When NUROFENTEEN 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. Cardiovascular and cerebrovascular effects: Clinical trials suggest that use of ibuprofen, particularly at high doses (2400 mg daily), may be associated with a modest 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 II-III), established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should be treated with ibuprofen only after careful consideration and high doses (2400 mg/day) should be avoided. Careful consideration should also be exercised before initiating long-term treatment of patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking), particularly if high doses (2400 mg/day) of ibuprofen are required. Gastrointestinal effects : 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. The risk of GI 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 dose available. Concomitant use of 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 section 4.5). Patients with a history of GI toxicity, particularly when elderly, should report any unusual GI symptoms (especially GI 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 or anti-platelet agents such as acetylsalicylic acid (see section 4.5). When gastrointestinal bleeding or ulceration occurs in patients receiving NUROFENTEEN, the treatment should be withdrawn. 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 in the early stages of therapy: the onset of the reaction occurs in the majority of cases within the first month of treatment. Acute generalized exanthematous pustulosis (AGEP) has been reported in relation to medicinal products containing ibuprofen. NUROFENTEEN 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 NUROFENTEEN in case of chickenpox. Respiratory disorders : bronchospasm may occur in patients with bronchial asthma or allergic diseases or a history of allergic disease. Other considerations Severe acute hypersensitivity reactions (for example anaphylactic shock) are observed very rarely. At the first signs of hypersensitivity reaction after administration/intake of NUROFENTEEN, therapy should be discontinued. Medical measures required based on symptoms should be undertaken by trained personnel. Ibuprofen, the active ingredient of NUROFENTEEN, may temporarily inhibit platelet function (thrombocyte aggregation), therefore it is recommended to carefully monitor patients with coagulation disorders. In case of prolonged administration of NUROFENTEEN, regular monitoring of liver values, kidney function and blood counts is required. Prolonged use of any type of headache painkiller 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. Active substance-related side effects, particularly those affecting the gastrointestinal tract or the central nervous system, may be increased when NSAIDs are taken in combination with alcohol. Renal disorders : In general, the habitual use of analgesics, especially combinations of several analgesic active ingredients, can lead to permanent renal damage with the risk of onset of renal failure (analgesic nephropathy). Paediatric population : There is a risk of impaired renal function in dehydrated adolescents. Impaired female fertility : see section 4.6. Specific warnings for this medicinal product : This medicinal product contains aspartame, a source of phenylalanine, which may be dangerous for people with phenylketonuria.

INTERACTIONS

Interactions Nurofenteen 200 mg 12 orodispersible tablets lemon - Which medicines or foods can modify the effect of Nurofenteen 200 mg 12 orodispersible tablets lemon?

Ibuprofen should be avoided in combination with: Acetylsalicylic acid (ASA): Concomitant administration of ibuprofen and acetylsalicylic acid is generally not recommended due to the potential for increased adverse effects. Other NSAIDs including cyclooxygenase-2 selective inhibitors: Avoid concomitant use of two or more NSAIDs as this may increase the risk of adverse events (see section 4.4). Experimental data suggest that ibuprofen may competitively inhibit the effect of low dose acetylsalicylic acid on platelet aggregation when the drugs are administered concomitantly. Although there are uncertainties regarding the extrapolation of these data to the clinical situation, the possibility that long-term regular 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). Ibuprofen (like other NSAIDs) should be used with caution in combination with: - Corticosteroids: increased risk of gastrointestinal ulceration or bleeding (see section 4.4) - Anticoagulants: NSAIDs may increase the effects of anticoagulants, such as warfarin (see section 4.4) - Phenytoin: concomitant use of NUROFENTEEN with phenytoin preparations may increase the serum levels of both substances. Correct use of the drugs (administered for a maximum period of 4 days) does not normally require monitoring of serum phenytoin levels. - Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding (see section 4.4). - Antihypertensives (ACE inhibitors, beta-blockers and angiotensin II antagonists) and diuretics: NSAIDs may decrease the effects of these 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 the cyclo-oxygenase system 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 at regular intervals thereafter. Diuretics may increase the risk of nephrotoxicity of NSAIDs. - Cardiac glycosides (Digoxin): NSAIDs may worsen cardiac failure, reduce GFR and plasma glycoside levels. Concomitant use of NUROFENTEEN with digoxin preparations may increase the serum levels of these medicinal products. Correct use of the drugs (administered for a maximum period of 4 days) does not normally require monitoring of serum digoxin levels. - Ciclosporin: increased risk of nephrotoxicity - Lithium. There is evidence of the possibility of a potential increase in lithium levels in the blood. Correct use of the drugs (administered for a maximum period of 4 days) does not normally require monitoring of serum lithium levels. - Probenecid and sulfinpyrazone: medicinal products containing probenecid or sulfinpyrazone may delay the excretion of ibuprofen. - Potassium-sparing diuretics: concomitant administration of NUROFENTEEN and potassium-sparing diuretics may lead to hyperkalaemia (monitoring of serum potassium is recommended). - Methotrexate. There is evidence of the possibility of an increase in plasma levels of methotrexate. Administration of NUROFENTEEN within 24 hours before and after methotrexate administration may lead to an increase in plasma levels of methotrexate and an increase in its toxic effects. - Zidovudine. There is evidence of an increased risk of haemarthrosis and haematoma in HIV-seropositive haemophiliac patients when treated simultaneously with zidovudine and ibuprofen. - Sulfonylureas: Clinical studies have shown interactions between nonsteroidal anti-inflammatory drugs and antidiabetics (sulfonylureas). Although no interactions between ibuprofen and sulfonylureas have been described so far, monitoring blood glucose levels is recommended as a precautionary measure during concomitant administration. - Tacrolimus: Possible increased risk of nephrotoxicity when NSAIDs are administered with tacrolimus. - Quinolone antibiotics: Animal data indicate that NSAIDs may increase the risk of convulsions associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing convulsions. - CYP2C9 inhibitors: Concomitant administration of ibuprofen with CYP2C9 inhibitors may increase the exposure to ibuprofen (CYP2C9 substrate). In a study with voriconazole and fluconazole (CYP2C9 inhibitors), an increased exposure to S(+)-ibuprofen of approximately 80% to 100% was observed. Consideration should be given to reducing the dose of ibuprofen when potent CYP2C9 inhibitors are co-administered, particularly when high doses of ibuprofen are administered with voriconazole or fluconazole.

SIDE EFFECTS

Like all medicines, Nurofenteen 200 mg 12 orodispersible tablets lemon can cause side effects - What are the side effects of Nurofenteen 200 mg 12 orodispersible tablets lemon?

The following list of undesirable effects includes all undesirable effects that have been recognized during treatment with ibuprofen, including 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 adverse reactions associated with the administration of ibuprofen are listed below according to system organ class and frequency. The frequencies are defined as: Very common (≥1/10); Common (≥1/100, <1/10); Uncommon (≥1/1,000, <1/100); Rare (≥1/10,000, <1/1,000); Very rare (<1/10,000); Not known (frequency cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in decreasing order of seriousness. The most frequently observed adverse reactions are gastrointestinal in nature. Adverse reactions are in most cases dose-dependent. In particular, the risk of gastrointestinal bleeding depends on the dosage and duration of treatment. 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. Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment. Clinical trials suggest that use of ibuprofen, particularly at a high dose (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). Worsening of infection-related inflammation (for example development of necrotising fasciitis) has been described with the use of non-steroidal anti-inflammatory drugs. This is probably due to the mechanism of action of non-steroidal anti-inflammatory drugs. If signs of infection appear or worsen during the use of NUROFENTEEN, the patient should be advised to seek medical advice immediately to assess whether anti-infective/antibiotic therapy is necessary. For prolonged treatment, blood counts should be monitored regularly. The patient should be instructed to immediately inform the doctor and stop taking NUROFENTEEN if any symptoms of hypersensitivity reactions occur; this may also occur on first use, in which case immediate medical attention is required. The patient should be instructed to stop taking the medicine and consult a doctor immediately if severe upper abdominal pain or melaena or haematemesis occurs.

Classification by systems and organs	Frequency	Adverse reaction
Infections and infestations	Very rare	Worsening of infection-related inflammation (e.g. development of necrotizing fasciitis) has been described. In exceptional cases, severe skin infections and soft tissue complications have been reported during varicella infection.
Pathologies of the haemolymphopoietic system	Very rare	Hematopoiesis disorders (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). The first manifestations are: fever, sore throat, superficial ulcers of the oral cavity, flu-like symptoms, severe fatigue, nosebleeds and skin bleeding, bruises. In these cases, the patient should be advised to immediately stop the drug, avoid any over-the-counter medicine containing analgesics or antipyretics and consult a doctor.
Psychiatric disorders	Very rare	Psychotic reactions, depression
Immune system disorders		Hypersensitivity reactions manifested by¹:
	Uncommon	Hives and itching
	Very rare	Severe hypersensitivity reactions. Symptoms may include: swelling of the face, tongue and larynx, dyspnoea, tachycardia, hypotension (anaphylaxis, angioedema or severe shock). Exacerbation of asthma
	Not known	Respiratory tract reactivity including asthma, bronchospasm and dyspnea.
Nervous system disorders	Uncommon	Central nervous system disorders such as headache, dizziness, insomnia, agitation, irritability or tiredness.
	Very rare	Aseptic meningitis²
Eye pathologies	Uncommon	Vision problems
Ear and labyrinth pathologies	Rare	Tinnitus
Heart disease	Very rare	Heart failure, palpitations and edema, myocardial infarction
Vascular pathologies	Very rare	Hypertension, vasculitis
Gastrointestinal disorders	Common	Gastrointestinal problems, such as abdominal pain, nausea and dyspepsia. Diarrhea, flatulence, constipation, heartburn, vomiting and slight loss of blood in the stomach and/or intestines which in exceptional cases may cause anemia.
	Uncommon	Gastrointestinal ulcers, gastrointestinal perforation or bleeding, ulcerative stomatitis, worsening of colitis or Crohn's disease (see section 4.4), gastritis.
	Very rare	Esophagitis and formation of membranous strictures in the intestine (diaphragmatic-like intestinal strictures), pancreatitis.
Hepatobiliary pathologies	Very rare	Liver dysfunction, liver damage, especially in long-term therapy, liver failure, acute hepatitis.
Skin and subcutaneous tissue disorders	Uncommon	Various skin rashes
	Very rare	severe forms of skin reactions such as bullous reactions including Stevens-Johnson syndrome, erythema multiforme and toxic epidermal necrolysis, alopecia.
	Not known	Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), acute generalized exanthematous pustulosis (AGEP). Photosensitivity reactions.
Kidney and urinary disorders	Rare	Rarely, damage to kidney tissue (papillary necrosis) and high concentrations of uric acid in the blood may occur.
	Very rare	Formation of edema, particularly in patients with arterial hypertension or renal insufficiency, nephrotic syndrome, interstitial nephritis which may be accompanied by renal insufficiency.
Diagnostic tests	Rare	Decrease in hemoglobin levels

Description of selected adverse reactions ¹ Hypersensitivity reactions have been reported following treatment with ibuprofen. These reactions include a) non-specific allergic reactions and anaphylaxis, b) respiratory tract reactivity including asthma, aggravated asthma, bronchospasm or dyspnoea or c) various skin conditions including various rashes, pruritus, urticaria, purpura, angioedema and very rarely bullous and exfoliative dermatitis (including toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme) ² The pathogenic mechanism of drug-induced aseptic meningitis is not fully understood. However, available data on aseptic meningitis associated with NSAID administration suggest an immune reaction (due to a temporal relationship with drug intake and the disappearance of symptoms after cessation of treatment). Of note, single cases of symptoms of aseptic meningitis (such as stiff neck, numb neck, headache, nausea, vomiting, fever and disorientation) have been observed during treatment with ibuprofen in patients with autoimmune diseases (such as systemic lupus erythromatosus, mixed connective tissue disease). 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

Nurofenteen 200 mg 12 orodispersible tablets lemon Overdose - What are the risks of Nurofenteen 200 mg 12 orodispersible tablets lemon in case of overdose?

In children, intake of more than 400 mg/kg may cause symptoms. In adults, the dose-response effect is not clearly defined in overdose. The half-life in overdose is 1.5-3 hours. Symptoms Most patients who have ingested clinically relevant quantities of NSAIDs present exclusively with nausea, vomiting, abdominal pain and more rarely diarrhoea. Nystagmus, blurred vision, tinnitus, headache and gastrointestinal haemorrhages may also occur. In more severe cases of poisoning, central nervous system toxicity is observed, manifested by vertigo, dizziness, drowsiness, occasionally excitation and disorientation, loss of consciousness or coma. Occasionally, patients develop convulsions. In cases of severe poisoning, metabolic acidosis may occur. Hyperkalemia, hypothermia, and prolonged prothrombin time/INR may occur, probably due to interference with the action of circulating clotting factors. Acute renal failure, liver damage, hypotension, respiratory depression, and cyanosis may also occur. Exacerbation of asthma may occur in asthmatics. Treatment There is no specific antidote. Treatment should be symptomatic and supportive and should include maintaining a patent airway and monitoring cardiac function and vital signs until the patient is stabilized. Oral administration of activated charcoal or gastric emptying should be considered if the patient presents within 1 hour of ingestion of a potentially toxic amount. If ibuprofen has already been absorbed, alkaline agents should be given to promote excretion of the acidic ibuprofen in the urine. Seizures should be treated with intravenous diazepam or lorazepam if frequent or prolonged. Bronchodilators should be given if asthma is present. Contact your local poison control center for more information.

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 Nurofenteen 200 mg 12 orodispersible tablets lemon

Pregnancy Inhibition of prostaglandin synthesis may adversely affect the pregnant woman and/or the embryonic/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 may 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. Studies in animals have shown reproductive toxicity (see section 5.3). 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 should be as low and duration of treatment 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 generally not necessary. Fertility There is evidence that drugs that inhibit cyclooxygenase/prostaglandin synthesis may cause impairment of female fertility by effect on ovulation. This effect is reversible after discontinuation of treatment.

DRIVING AND USE OF MACHINERY

Taking Nurofenteen 200 mg 12 orodispersible tablets lemon before driving or using machines - Does Nurofenteen 200 mg 12 orodispersible tablets lemon affect driving or using machines?

For short periods of treatment, NUROFENTEEN does not alter or negligibly alters the ability to drive and use machines.