Cibalgina Due Fast 200 mg 24 gastro-resistant tablets

Cibalgina Due Fast 200 mg 24 gastro-resistant tablets is a pain reliever and anti-inflammatory based on ibuprofen , belonging to the category of NSAIDs (nonsteroidal anti-inflammatory drugs) . Each tablet contains 200 mg of ibuprofen, an active ingredient known for its effectiveness in the treatment of pain of various origins and natures , such as headache, toothache, neuralgia, muscle pain, joint pain and menstrual pain . The product is also indicated as an adjuvant in the symptomatic treatment of feverish and flu-like conditions .

The gastro-resistant tablets of Cibalgina Due Fast are designed to dissolve quickly in the mouth, without leaving unpleasant tastes, and can be easily taken even without water. This formulation guarantees a rapid analgesic and anti-inflammatory action , offering effective and long-lasting relief from painful symptoms and fever. Ibuprofen works by inhibiting the synthesis of prostaglandins, substances responsible for pain, inflammation and fever, thus ensuring a targeted and reliable action.

Thanks to the 200 mg dosage and the 24-tablet format, Cibalgina Due Fast represents a practical and versatile solution for adults and adolescents over 12 years of age who need a rapid and safe oral treatment against pain and inflammation. The presence of excipients such as ethylcellulose, corn starch and strawberry flavoring helps improve the tolerability and pleasantness of use of the product.

The choice of Cibalgina Due Fast 200 mg is ideal for those looking for an effective pain reliever and anti-inflammatory for occasional use, able to act rapidly on acute pain and fever , while ensuring good gastric tolerability thanks to the gastro-resistant formulation.

ACTIVE INGREDIENTS

Active ingredients contained in Cibalgina Due Fast 200 mg 24 gastro-resistant tablets - What is the active ingredient of Cibalgina Due Fast 200 mg 24 gastro-resistant tablets?

One tablet contains - Active substance: ibuprofen 200 mg. For the full list of excipients, see section 6.1.

EXCIPIENTS

Composition of Cibalgina Due Fast 200 mg 24 gastro-resistant tablets - What does Cibalgina Due Fast 200 mg 24 gastro-resistant tablets contain?

Ethylcellulose; cellulose acetate phthalate; corn starch; microcrystalline cellulose; saccharin; croscarmellose sodium; strawberry flavour; fumaric acid; silicon dioxide; magnesium stearate; anhydrous dibasic calcium phosphate.

DIRECTIONS

Therapeutic indications Cibalgina Due Fast 200 mg 24 gastro-resistant tablets - Why is Cibalgina Due Fast 200 mg 24 gastro-resistant tablets used? What is it used for?

Pain of various origins and nature (headache, toothache, neuralgia, osteo-articular and muscular pain, menstrual pain). Adjuvant in the symptomatic treatment of feverish and flu states.

CONTRAINDICATIONS AND SIDE EFFECTS

Contraindications Cibalgina Due Fast 200 mg 24 gastro-resistant tablets - When should Cibalgina Due Fast 200 mg 24 gastro-resistant tablets not be used?

Do not administer to children under 12 years of age. Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Subjects with hypersensitivity to acetylsalicylic acid or other analgesics, antipyretics, nonsteroidal anti-inflammatory drugs (NSAIDs), in particular when hypersensitivity is associated with nasal polyposis, asthma and angioedema, and presents with bronchospasm, urticaria or acute rhinitis (see also section 4.4). Severe or active peptic ulcer. History of gastrointestinal bleeding or perforation related to previous active treatments or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). Haematopoietic disorders of unknown origin. Cerebrovascular or other haemorrhage. Severe hepatic or renal insufficiency. Severe cardiac insufficiency (NYHA class IV). Third trimester of pregnancy (see section 4.6).

DOSAGE

Quantity and method of taking Cibalgina Due Fast 200 mg 24 gastro-resistant tablets - How to take Cibalgina Due Fast 200 mg 24 gastro-resistant tablets?

Dosage : Adults, elderly and adolescents over 12 years : 1-2 gastro-resistant tablets 2-3 times a day. Do not exceed the dose of 6 tablets (1200 mg) in 24 hours. Do not exceed the recommended doses; in particular, elderly patients should stick to the minimum dosages indicated above. If the use of the medicine is necessary for more than 3 days in adolescents, or in the event of worsening of symptoms, a doctor should be consulted. Undesirable effects can be minimised by using the lowest effective dose for the shortest possible duration of treatment necessary to control the symptoms (see section 4.4). Method of administration : the tablets dissolve quickly in the mouth without leaving any unpleasant taste, pressing them with the tongue against the palate. Follow, if necessary, with a glass of water. It is advisable to take the medicine during or after meals, particularly in the presence of gastric disorders. Use only for short periods of treatment. After 2-3 days of treatment without appreciable results, consult your doctor.

CONSERVATION

Storage Cibalgina Due Fast 200 mg 24 gastro-resistant tablets - How is Cibalgina Due Fast 200 mg 24 gastro-resistant tablets stored?

This medicinal product does not require any special storage conditions.

WARNINGS

Warnings Cibalgina Due Fast 200 mg 24 gastro-resistant tablets - About Cibalgina Due Fast 200 mg 24 gastro-resistant tablets it is important to know that:

General information Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see paragraphs below on gastrointestinal and cardiovascular risks). The use of Cibalgina Due Fast, as with any drug inhibiting the synthesis of prostaglandins and cyclo-oxygenase, is not recommended in women attempting to conceive. Administration of Cibalgina Due Fast should be suspended in women who have fertility problems or who are undergoing investigation of fertility. There is a risk of impaired renal function in dehydrated adolescents. Cibalgina Due Fast contains sodium Cibalgina Due Fast contains less than 1 mmol (23 mg) sodium per tablet, i.e. essentially 'sodium-free'. 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). Like other NSAIDs, ibuprofen may mask the signs and symptoms of infection due to its pharmacodynamic properties. The use of Cibalgina Due Fast should be avoided in combination with other NSAIDs, including COX-2 selective inhibitors (see section 4.5), as this increases the risk of adverse effects. Gastrointestinal effects Gastrointestinal bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs, including ibuprofen, and may occur at any time during treatment, with or without warning symptoms or a previous history of serious GI events. 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. When GI bleeding or ulceration occurs in patients receiving Cibalgina Due Fast, the treatment should be discontinued. The risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing doses of NSAIDs, 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 therapy with gastroprotective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients and also for patients receiving concomitant low dose acetylsalicylic acid or other drugs likely to increase the risk of gastrointestinal events (see below and section 4.5). Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as systemic 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 Cibalgina Due Fast, the treatment should be withdrawn. NSAIDs should be administered 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). Hepatic effects When ibuprofen is prescribed to patients with impaired liver function, close medical supervision is required, as their condition may be exacerbated. As with other NSAIDs, including ibuprofen, values ​​of one or more liver enzymes may increase. If ibuprofen is prescribed for a prolonged period of time, regular monitoring of liver function is indicated as a precautionary measure. If abnormal liver function values ​​persist or worsen, if signs or symptoms consistent with liver disease develop, or if other manifestations occur (e.g. eosinophilia, rash), treatment with ibuprofen should be discontinued. Hepatitis may develop with the use of ibuprofen without prodromal symptoms. Ibuprofen is contraindicated in severe hepatic insufficiency (see section 4.3). Caution is advised when ibuprofen is administered to patients with hepatic porphyria as the drug may trigger an attack. Renal effects Since fluid retention and oedema have been reported in association with NSAID therapy, including ibuprofen, particular caution is advised in patients with impaired cardiac and renal function, history of hypertension, the elderly, patients receiving concomitant treatment with diuretics or drugs that can significantly impact renal function, and in those patients with substantial extracellular volume depletion from any cause, for example before or after major surgery. In these cases when ibuprofen is administered, monitoring of renal function is recommended as a precautionary measure. Discontinuation of treatment is usually followed by recovery to the pre-treatment state. Ibuprofen is contraindicated in severe renal or cardiac insufficiency (see section 4.3). Skin effects 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, including ibuprofen (see section 4.8). Patients appear to be at highest risk early in the course 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. Cibalgina Due Fast should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. Cardiovascular and cerebrovascular effects 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 (e.g. myocardial infarction or stroke). Overall, epidemiological studies do not suggest 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 (NYHA 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. Caution is advised before initiating treatment in patients with a history of hypertension and/or heart failure, as fluid retention, hypertension and oedema have been reported in association with NSAID therapy. Pre-existing respiratory disease In patients with asthma, seasonal allergic rhinitis, oedema of the nasal mucosa (e.g. nasal polyposis), chronic obstructive pulmonary disease or chronic respiratory tract infections (especially if associated with allergic rhinitis-like symptoms), reactions to NSAIDs such as asthma exacerbation, Quincke's oedema or urticaria are more frequent than in other patients. Particular caution is advised in these (emergency-ready) patients. Ibuprofen is contraindicated in subjects with hypersensitivity to acetylsalicylic acid or to other analgesics, antipyretics, nonsteroidal anti-inflammatory drugs (NSAIDs), particularly when hypersensitivity is associated with nasal polyposis and asthma (see section 4.3). Bronchospasm may be exacerbated in patients with or with a previous history of asthma, allergic diseases or nasal polyps. Systemic Lupus Erythematosus (SLE) and mixed connective tissue disease In patients with SLE and mixed connective tissue disorders there may be an increased risk of aseptic meningitis (see below and section 4.8). Aseptic meningitis Aseptic meningitis has been observed very rarely in patients treated with ibuprofen. Although it is likely to be more likely to occur in patients with systemic lupus erythematosus and related connective tissue diseases, it has also been reported in subjects without an underlying chronic disease.

INTERACTIONS

Interactions Cibalgina Due Fast 200 mg 24 gastro-resistant tablets - Which medicines or foods can modify the effect of Cibalgina Due Fast 200 mg 24 gastro-resistant tablets?

Use caution in patients treated with any of the following medicinal products, as interactions have been reported in some patients. Acetylsalicylic acid 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 effect 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 COX-2 selective inhibitors : Avoid concomitant use of two or more NSAIDs as this increases the risk of adverse effects (see section 4.4). Lithium : Ibuprofen may increase plasma lithium concentrations due to reduced lithium elimination. Monitoring of serum lithium levels is therefore recommended. Digoxin : Ibuprofen, like other NSAIDs, may exacerbate heart failure, reduce glomerular filtration rate (GFR) and increase plasma digoxin concentrations. Monitoring of serum digoxin levels is therefore recommended. Diuretics and antihypertensive agents : Like other NSAIDs, concomitant use of ibuprofen with diuretics or antihypertensive agents (e.g. beta-blockers, ACE inhibitors, angiotensin II antagonists) may cause a reduction in their antihypertensive effect. Therefore, the combination should be administered with caution and patients, especially elderly, should be subjected to periodic monitoring of blood pressure. Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy and periodically thereafter, particularly for diuretics and ACE inhibitors, due to the increased risk of nephrotoxicity. Concomitant treatment with potassium-sparing diuretics may be associated with increased serum potassium levels, which should therefore be monitored frequently (see section 4.4). Corticosteroids : Concomitant administration of ibuprofen and corticosteroids may increase the risk of gastrointestinal ulceration or bleeding (see section 4.4). Anticoagulants : NSAIDs may enhance the effects of anticoagulants, such as warfarin (see section 4.4). Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): Increased risk of gastrointestinal bleeding (see section 4.4). Sulfonylureas: NSAIDs may enhance the effect of sulfonylureas. Rare cases of hypoglycaemia have been reported in patients treated with sulfonylureas who were taking ibuprofen. Monitoring of blood glucose levels is recommended in case of concomitant use with ibuprofen. Methotrexate: NSAIDs may reduce the clearance of methotrexate by inhibiting tubular secretion. Administration of ibuprofen 24 hours before or after methotrexate administration may lead to an increase in the concentration of methotrexate and an increase in its toxic effect. Therefore, concomitant use of NSAIDs and high doses of methotrexate should be avoided. If concomitant administration is necessary, the patient should be carefully monitored for toxicity, especially myelosuppression and gastrointestinal toxicity. Furthermore, the potential risk of interactions should also be taken into account in low-dose methotrexate treatment (< 15 mg/week), especially in patients with impaired renal function, which should be monitored during combination treatment, especially in the first weeks. Ciclosporin and tacrolimus: The risk of a nephrotoxic effect of ciclosporin and tacrolimus, due to the reduction of prostaglandin synthesis in the kidney, is increased by concomitant administration of certain nonsteroidal anti-inflammatory drugs, including ibuprofen. Therefore, ibuprofen should be administered at lower doses than those used in patients not taking these immunosuppressive agents and renal function should be closely monitored. Fluoroquinolone antibacterials: There have been isolated cases of convulsions that may have been induced by concomitant use of fluoroquinolones and NSAIDs. Phenytoin: When phenytoin is used concomitantly with ibuprofen, blood levels of phenytoin may increase. Monitoring of phenytoin plasma concentrations is therefore recommended. Colestipol and cholestyramine: When administered simultaneously with ibuprofen, they may induce a delay or decrease the absorption of the latter. Therefore, it is recommended to administer ibuprofen at least 1 hour before or 4-6 hours after administration of colestipol/cholestyramine. Potent CYP2C9 inhibitors: Concomitant administration of ibuprofen with CYP2C9 inhibitors (such as sulfinpyrazone, fluconazole and voriconazole) requires caution, as it may lead to a significant increase in peak plasma concentrations and exposure to ibuprofen, due to inhibition of ibuprofen metabolism. In a study with voriconazole and fluconazole (CYP2C9 inhibitors), an increase in exposure to S(+)-ibuprofen of approximately 80 to 100% was observed. Therefore, a dose reduction of ibuprofen should be considered when co-administered with potent CYP2C9 inhibitors, particularly when high doses of ibuprofen are administered with voriconazole or fluconazole. Zidovudine: There is an increased risk of haematological toxicity when administered concomitantly with NSAIDs. There is evidence of an increased risk of haemarthrosis and haematomas in HIV-seropositive haemophiliac patients treated concomitantly with zidovudine and ibuprofen. Aminoglycosides : When administered concomitantly with ibuprofen, they may lead to a reduction in renal function in susceptible individuals, reduced elimination of aminoglycosides and increased plasma concentrations.

SIDE EFFECTS

Like all medicines, Cibalgina Due Fast 200 mg 24 gastro-resistant tablets can cause side effects - What are the side effects of Cibalgina Due Fast 200 mg 24 gastro-resistant tablets?

The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation or gastrointestinal bleeding, sometimes fatal, particularly in the elderly, may occur (see section 4.4). Undesirable effects are mostly dose-dependent and may vary from patient to patient. In particular, the risk of gastrointestinal bleeding is dependent on the dose and duration of treatment. After administration of Cibalgina Due Fast, the following have been reported: nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see section 4.4). Less frequently, gastritis has been observed. Oedema, hypertension and cardiac failure have been reported in association with treatment with NSAIDs. Clinical trials suggest that use of ibuprofen, particularly at high doses (2400 mg/day), may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see section 4.4). Adverse reactions are listed below, by system organ class and frequency. 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 (cannot be estimated from the available data).

Infections and infestations
Very rare:	Deterioration of inflammation associated with infection (e.g. development of necrotizing fasciitis) described in conjunction with the use of nonsteroidal anti-inflammatory drugs.¹
Pathologies of the haemolymphopoietic system
Very rare:	Thrombocytopenia, anemia, leukopenia, pancytopenia, agranulocytosis².
Immune system disorders
Uncommon:	Hypersensitivity reactions, including skin rash, urticaria, pruritus and asthmatic attacks.
Very rare:	Anaphylactic reaction, angioedema.
Psychiatric Disorders
Not known:	Psychotic reactions, depression
Nervous system disorders
Common:	Drowsiness
Uncommon:	Headache, dizziness, insomnia, agitation, irritability, fatigue.
Very rare:	Aseptic meningitis³ (see section 4.4)
Eye pathologies
Not known	Visual disturbances
Ear and labyrinth pathologies
Rare:	Tinnitus, hearing impairment.
Heart disease
Not known	Palpitations, edema, heart failure, myocardial infarction
Vascular pathologies
Not known:	Hypertension
Gastrointestinal disorders
Common:	Dyspepsia, abdominal pain, nausea, vomiting.
Rare:	Peptic ulcer, gastrointestinal perforation or bleeding, ulcerative stomatitis, gastritis. Worsening of colitis and Crohn's disease (see section 4.4).
Not known:	Esophagitis, pancreatitis, obstruction of the small intestine due to the formation of a thin diaphragm-like wall (intestinal diaphragm disease), flatulence, diarrhea, constipation.
Hepatobiliary pathologies
Very rare:	Abnormal liver function tests, abnormal liver function, jaundice, hepatitis. Liver damage 4
Skin and subcutaneous tissue disorders
Uncommon:	Rash
Very rare:	Stevens-Johnson syndrome, toxic epidermal necrolysis, dermatitis bullosa.
Not known:	Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), acute generalized exanthematous pustulosis (AGEP), photosensitivity reactions.
Kidney diseases
Rare:	Renal failure, renal tissue damage (papillary necrosis 4 ), increased serum uric acid concentration.
Not known:	Formation of edema, particularly in patients with arterial hypertension or renal insufficiency, nephrotic syndrome, interstitial nephritis which may be accompanied by acute renal failure.

¹ This is probably related to the mechanism of action of nonsteroidal anti-inflammatory drugs. If signs of an infection appear during treatment with ibuprofen or if an infection worsens, the patient is advised to seek medical advice without delay. The need for anti-infective/antibiotic therapy should then be assessed. ² The first signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe tiredness, unexplained bruising and bleeding. ³ The first symptoms are: neck tension, headache, nausea, vomiting, fever, disorientation. Patients with autoimmune disorders (systemic lupus erythematosus, mixed connective tissue disease) appear to be predisposed (see section 4.4). ⁴ In particular in long-term therapy Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important, as 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

Overdose Cibalgina Due Fast 200 mg 24 gastro-resistant tablets - What are the risks of Cibalgina Due Fast 200 mg 24 gastro-resistant tablets in case of overdose?

Toxicity Signs and symptoms of toxicity have not generally been observed at doses below 100 mg/kg in children or adults. However, in some cases supportive treatment may be necessary. Children have been observed to show signs and symptoms of toxicity after ingestion of ibuprofen at doses of 400 mg/kg or greater. Symptoms Most patients who have ingested significant amounts of ibuprofen will show symptoms within 4 to 6 hours. The most commonly reported symptoms of overdose include: nausea, vomiting (which may be bloody), abdominal pain, lethargy and drowsiness, confusion, nystagmus. Central nervous system (CNS) effects include headache, tinnitus, dizziness, convulsions (including myoclonic convulsions in children), light-headedness and loss of consciousness. Hypothermia, renal effects, gastrointestinal bleeding, coma, apnoea, cyanosis, diarrhoea and CNS and respiratory depression have also been reported rarely. Disorientation, excitement, fainting and cardiovascular toxicity including hypotension, bradycardia and tachycardia, chest pain, palpitations, weakness, haematuria, body coldness and onset of respiratory distress have been reported. Exacerbation of the condition is possible in asthmatic patients. Renal failure and liver damage are possible in cases of significant overdose. In cases of severe poisoning, metabolic acidosis may occur and the prothrombin time/INR may be prolonged, probably due to interference with circulating coagulation factors. Treatment There is no specific antidote for ibuprofen overdose. Symptomatic and supportive treatment is therefore indicated in cases of overdose. Particular attention should be paid to monitoring blood pressure, acid-base balance and any gastrointestinal bleeding. 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 after ingestion of a potentially toxic amount of the drug. Any occurrence of frequent or prolonged convulsions should be treated with intravenous diazepam. Give bronchodilators for asthma. Other supportive measures may be necessary depending on the patient's clinical condition. For more information, contact your local poison control center.

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 Cibalgina Due Fast 200 mg 24 gastro-resistant tablets.

Pregnancy Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryo/fetal development. Results of epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiac malformations increased from less than 1%, up to approximately 1.5%. The risk has been estimated to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to cause an increase in pre- and post-implantation loss and embryo-fetal mortality. Furthermore, an increased incidence of various malformations, including cardiovascular, has been reported in animals administered prostaglandin synthesis inhibitors during the organogenetic period. During the first and second trimester of pregnancy, Cibalgina Due Fast should not be administered unless clearly necessary. If Cibalgina Due Fast is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose and duration of treatment should be kept as low as possible. 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 oligo-hydroamniosis; - the mother and the neonate, at the end of pregnancy, to: - possible prolongation of bleeding time, and anti-aggregating effect which may occur even at very low doses; - inhibition of uterine contractions resulting in delayed or prolonged labor. Consequently, Cibalgina Due Fast is contraindicated during the third trimester of pregnancy. Breastfeeding Ibuprofen passes into breast milk in small quantities. Although no adverse effects in breast-fed infants are known to date, caution should be exercised when ibuprofen is administered to a nursing woman. Fertility There is evidence that drugs that inhibit cyclooxygenase/prostaglandin synthesis may cause a reduction in female fertility by affecting ovulation. This event is, however, reversible upon discontinuation of treatment. Women planning to become pregnant should exercise caution when taking ibuprofen.

DRIVING AND USE OF MACHINERY

Taking Cibalgina Due Fast 200 mg 24 gastro-resistant tablets before driving or using machinery - Does Cibalgina Due Fast 200 mg 24 gastro-resistant tablets affect driving or using machinery?

Side effects such as dizziness, tiredness and visual disturbances are possible after taking NSAIDs. If affected, patients should not drive or operate machinery.