Cibalgina due fast 200 mg - analgesic 12 tablets

Product Description

Novartis

Tablets

Therapeutic indications
Cibalgina Due Fast Tablets are used for pain of various origins and nature (headache, toothache, neuralgia, osteoarticular and muscular pain, menstrual pain) and as an adjuvant in the symptomatic treatment of fever and flu.

Dosage and method of use
Cibalgina Due Fast Tablets is administered:

• Adults, elderly people and children over 12 years: 1-2 gastro-resistant tablets 2-3 times a day.

Do not exceed the dose of 6 tablets (1200 mg) within 24 hours. Do not exceed the recommended dose; Elderly patients in particular should adhere to the minimum dosages indicated above. The tablets dissolve quickly in the mouth without leaving any unpleasant taste when pressed against the palate with the tongue.

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.

Contraindications

• Do not administer to children under 12 years of age.
• Hypersensitivity to the active substance or to any of the excipients.
• Subjects with hypersensitivity to acetylsalicylic acid or other analgesics, antipyretics, non-steroidal anti-inflammatory drugs (NSAIDs), particularly when hypersensitivity is associated with nasal polyps and asthma.
• Severe or active peptic ulcer.
• History of gastrointestinal bleeding or perforation related to previous active treatments or history of recurrent peptic ulcer/hemorrhage (two or more distinct episodes of proven ulceration or bleeding).
• Severe hepatic or renal insufficiency.
• Severe cardiac insufficiency.
• Third trimester of pregnancy.

Warnings
Undesirable effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms. The use of the drug is not recommended in women attempting to conceive.
Administration should be suspended in women who have fertility problems or who are undergoing investigation of fertility.
Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal.

Ibuprofen may mask the signs and symptoms of infection due to its pharmacodynamic properties. The use of the medicine should be avoided in combination with other NSAIDs, including selective COX-2 inhibitors. 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 gastrointestinal events.

When gastrointestinal bleeding or ulceration occurs, treatment should be discontinued. In the elderly and in patients with a history of ulcers, particularly if complicated with haemorrhage or perforation, the risk of gastrointestinal bleeding, ulceration, or perforation is higher with increasing NSAID doses. These patients should start treatment on the lowest available dose.

Caution should be exercised 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 antiplatelet agents such as acetylsalicylic acid.

If gastrointestinal bleeding or ulceration occurs, treatment should be discontinued. Use with caution in patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated. When prescribing ibuprofen to patients with impaired liver function, close medical supervision is required, as their condition may be exacerbated. One or more liver enzyme values ​​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 tests persist or worsen, if signs or symptoms consistent with liver disease develop, or if other manifestations occur, ibuprofen treatment should be discontinued.

Hepatitis may develop with ibuprofen use without prodromal symptoms. Ibuprofen is contraindicated in cases of severe hepatic insufficiency. When ibuprofen is administered to patients with hepatic porphyria, caution is required as the drug may trigger an attack. Particular caution is required in patients with impaired cardiac and renal function, a 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 renal function is recommended as a precautionary measure. Discontinuation of treatment is usually followed by a return to the pre-treatment state. Ibuprofen is contraindicated in severe renal or cardiac insufficiency.
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.

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. Therapy should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. Clinical trial and epidemiological data suggest that use of ibuprofen, particularly at high doses (2400 mg/day) and in long-term treatment, may be associated with a small increased risk of arterial thrombotic events (for example, myocardial infarction or stroke).

Pregnancy and breastfeeding

• Pregnancy

Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal 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 increased 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 trimesters of pregnancy, the drug should not be administered unless clearly necessary.
If the drug is used by a woman attempting to conceive, or during the first and second trimesters 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) and/or renal dysfunction, which may progress to renal failure with oligo-hydroamniosis; the mother and the newborn, at the end of pregnancy, to: possible prolongation of bleeding time, and antiplatelet effect that may occur even at very low doses and/or inhibition of uterine contractions resulting in delayed or prolonged labor. Consequently, the medicine is contraindicated during the third trimester of pregnancy.

• Breastfeeding

Ibuprofen passes into breast milk in small amounts. Although no adverse effects in infants are known to date, caution should be exercised when ibuprofen is administered to a breastfeeding woman. There is evidence showing that drugs that inhibit the synthesis of cyclooxygenase/prostaglandins can cause a reduction in female fertility by affecting ovulation. This effect is, however, reversible upon discontinuation of treatment.

Expiry and storage
Check the expiry date indicated on the package. The expiry date indicated on the package refers to the product in its intact packaging, stored correctly.

Warning: Do not use the medicine after the expiry date indicated on the package.

Composition
Cibalgina Due Fast contains:
Active ingredients: ibuprofen 200 mg.
Excipients: Ethylcellulose; cellulose acetate phthalate; corn starch; microcrystalline cellulose; saccharin; croscarmellose sodium; strawberry flavoring; fumaric acid; silicon dioxide; magnesium stearate; anhydrous dibasic calcium phosphate.