CONFIDENCE FALQUI CM 20CPR 5MG

CONFIDENCE FALQUI C.M. 5 MG STATEMENTS

active ingredients

Each coated tablet contains: bisacodile 5 mg. Excipients with known effects: sucrose, sorbitol. For the full list of excipients, see paragraph 6.1.

Excellent

A coated tablet contains: microcrystalline cellulose, talc, pregelatinized starch, titanium dioxide, ethyl phthalate, sucrose, glycerol, povidone, sorbitol, methacrylic acid copolymer, citrate trietil, lacquer rubber, 6000 macrogol, 002 sepifilm.

Therapeutic indications

Short-term treatment of occasional constipation.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1. Falqui packaging C.M. it is also contraindicated in patients with paralytic ileum, acute abdominal conditions, such as appendicitis, and severe abdominal pain associated with nausea and vomiting that may be indicative signs of serious pathological conditions, in obstruction or intestinal stenosis, acute inflammation of the gastrointestinal tract, rectal bleeding of unknown origin, severe dehydration. Pregnancy and nursing (see paragraph 4.6). The use of Confetto Falqui C.M. is contraindicated in case of rare hereditary conditions that may be incompatible with the assumption of one of the excipients (see section 4.4 "special warnings and precautions of employment"). Falqui packaging C.M. is contraindicated in children under 2 years of age.

Population

Population Adults: 1-2 tablets coated daily. Pediatric population Children aged 10 or under chronic constipation must be treated under medical supervision. The bisacodile should not be used in children aged 2 or older. Children over 10 years: 1-2 tablets coated daily. Children from 2 to 10 years: 1 tablet covered per day. It is advisable to start with the minimum dose. The dose can then be increased to the recommended maximum dose, for a regular evacuation of the feces. The maximum daily dose should never be exceeded. Instructions for use Take the coated tablets preferably in the evening to determine an evacuation the following morning (after about 10 hours). With morning administration, fasting, the effect is achieved after about five hours. Covered tablets should not be administered along with products that reduce the acidity of the upper gastrointestinal tract, such as milk, antacids (e.g. bicarbonate) or protonic pump inhibitors. Covered tablets should be swallowed whole. Eating together with an adequate amount of water (a plentiful glass). A fluid-rich diet promotes the effect of the medicine. Laxatives must be used as frequently as possible and for no more than seven days. Use for longer periods requires the doctor’s prescription after adequate evaluation of the individual case.

Conservation

Store at temperature not exceeding 30°C.

Warnings

Warnings Like all laxatives, Confetto Falqui C.M. should not be taken continuously every day or for long periods of time without investigating the cause of constipation. In case of diabetes mellitus, hypertension or cardiopathy use only after consulting your doctor. Laxative abuse (frequent or prolonged use or excessive doses) can cause persistent diarrhea resulting in water loss, mineral salts (especially potassium) and other essential nutrients. In the most serious cases, dehydration or hypopotassiemia may occur, which may result in cardiac or neuromuscular dysfunctions, especially in the case of contemporary treatment with cardiac glycosides, diuretics or corticosteroids. The intestinal loss of liquids can cause dehydration. Symptoms can be thirsty and oliguria. In patients, for whom dehydration can be dangerous (patients with kidney failure, elderly patients), treatment with Falqui Pack C.M. must be interrupted and resumed only under the supervision of the doctor. In patients there may be hematochetia (blood in feces), which is generally mild and disappears alone. The abuse of laxatives, especially those of contact (stimulating laxatives), can cause dependence (and, therefore, possible need to gradually increase the dosage), chronic constipation and loss of normal intestinal functions (intestinal atonia). Cases of dizziness and/or syncope have been reported after intake of Confetto Falqui C.M.. The data related to these cases suggest that events, more than a phenomenon related to the intake of Confetto Falqui C.M., they may be interpreted as a manifestation of "default syncops" (adjustable to the effort of the act of defecation), or as a vasovagal response to abdominal pain related to constipation itself. The stimulant laxatives included Pack Falqui C.M. do not contribute to weight loss (see paragraph 5.1 “Property pharmacodynamics”) Falqui packaging C.M. contains sucrose and sorbitol Patients with rare hereditary problems of fructose intolerance, glucose-galactosis mal absorption, or isomaltase sucrasis failure, should not take this medicine. It doesn't contain gluten. The additive effect of co-administration of medicinal products containing sorbitol (or fructose) and the daily intake of sorbitol (or fructose) with the diet must be considered. The content of sorbitol in oral medicines may change the bioavailability of other oral medications co- administered. Precautions of employment In children between 2 years and 10 years old, the medicinal product can only be used after consulting the doctor (see paragraph 4.3). Like all laxatives it should not be taken daily or for prolonged periods without having previously assessed the cause of constipation. Treatment of chronic or recurring constipation always requires medical intervention for diagnosis, prescription of drugs and surveillance during therapy. Consult your doctor when the need for laxative comes from a sudden change of previous intestinal habits (frequency and evacuation characteristics) that lasts for more than two weeks or when the use of laxative fails to produce effects. It is also appropriate for elderly or unhealthy subjects to consult the doctor before using the medicine.

Interactions

Concurrent administration of diuretics or adrenocorticosteroids and excessive doses of Falqui Pack C.M. may result in an increase in the risk of electrolytic imbalance. This imbalance, in turn, can lead to increased sensitivity to cardioactive glycosides. Laxatives can reduce the time of stay in the intestine, and therefore the absorption, of other drugs administered simultaneously orally. Avoid ingesting laxatives and other drugs at the same time: after taking a medicine let spend a range of at least two hours before taking laxative. Milk or antacids may change the effect of the medicinal product; let spend a range of at least an hour before taking the laxative. Concurrent use of other laxatives can enhance the gastrointestinal side effects of Falqui Pack C.M..

Effects

The following table lists adverse reactions identified through clinical studies and post-marketing surveillance with classification for systems and organs and frequency. The frequency group is defined using the following convention: very common (≥ 1/10); common (≥ 1/100 a   Very common (≥ 1/10) Common (≥ 1/100 a Not common (≥ 1/1.000 a Rare (≥ 1/10.000 a Frequency not known Immune system disorders       Anaphylactic reactions, angioedema and other hypersensitivity reactions.   Disorders of the nervous system     Vertigo Synopsis   Disorders of metabolism and nutrition       Dehydration   Gastrointestinal diseases   Abdominal crimps, abdominal pain, diarrhea, nausea Ematochezia (blood in feces), vomiting, abdominal malaise, anoretal discomfort Colite, including ischemic colitis   * The phenomena of dizziness and syncopathetics that occur after taking bisacodyle seem to be ascribable to a vasovagal response (following, for example, abdominal pain, or evacuation of feces). Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

Synonyms Excessive doses can cause abdominal pain and diarrhea and significant loss of potassium and other electrolytes. The chronic overdose of Confetto Falqui C.M., as with other laxatives, may cause chronic diarrhea, abdominal pain, hypokaliemia, secondary hyperaldosteronism and kidney stones. In association with chronic laxative abuse were also described: renal piping injury, metabolic alkalosis and secondary muscle weakness to hypokaliemia. See also the paragraph “Special warnings and precautions for use” about the abuse of laxatives. Treatment If you intervene within a short time from the ingestion of Confetto Falqui C.M., absorption can be reduced or avoided by induction of vomiting or gastric lavender. Liquid and electrolyte losses must be replaced. This is particularly important in older patients and young people. Spasmolytic administration may be useful.

Pregnancy

There are no adequate and well-controlled studies on the use of the medicinal product in pregnancy. Therefore, despite never being reported side effects or toxic during pregnancy, like all medicines, Falqui Pack C.M. must be used only if necessary, under the direct control of the doctor, after evaluating the expected benefit for the mother in relation to the possible risk for the fetus.

Fertility

Studies have not been conducted to investigate the effects on human fertility.

Food

Clinical data shows that neither the active form of the BHPM bis-(p-hydroxyphenyl)- piridil-2-methane (BHPM), nor its glucuronic derivatives are excreted in breast milk, however, the medicinal product must be used only in case of need, under the direct control of the doctor, after assessing the expected benefit for the mother in relation to the possible risk for the doctor.

Source: Farmadati