DULCOLAX 40CPR RIV 5MG

DULCOLAX

active ingredients

EXTERNAL REQUIREMENTS A coated tablet contains: 5 mg bisacodile. Excipients with known effects: lactose, sucrose, castor oil. SUPPLY ADULTS One suppository contains: bisacodile 10 mg One suppository contains: bisacodile 5 mg. For the full list of excipients, see paragraph 6.1.

Excellent

EXTERNAL REQUIREMENTS Lactose monohydrate, maize starch, modified starch, glycerol, magnesium stearate, sucrose, talc, arabic gum, titanium dioxide (E171), methacrylic acid/methacrylate copolymer (1:1), methacrylic acid/methyl methacrylate copolymer (1:2), castor oil, macrogol 6000, iron oxide (E172), white wax, carnauba wax, lacquer rubber. Triglycerides of saturated fatty acids.

Therapeutic indications

Short-term treatment of occasional constipation.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients. Dulcolax 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 severe 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 Dulcolax 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"). Dulcolax is contraindicated in children under 2 years of age. The suppositories are contraindicated in cases of spiders and anal ulcers (perianal pain and bleeding may occur).

Population

RIVESTITE COMPRESSE - Adults: 1-2 tablets coated daily. Pediatric population - Children over 10 years: 1-2 tablets coated daily. - Children between 2 and 10 years old: 1 tablet covered per day. It is advisable to start with the minimum dose. The dose can then be increased, up 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. SUPPLY - Adults: 1 adult substitute (10 mg) per day. Pediatric population - Children over 10 years: 1 adult substitute (10 mg) per day. - Children between 2 and 10 years old: 1 suppose children (5 mg) per day. The maximum daily dose should never be exceeded. Children under 10 years of age with chronic or persistent constipation should take Dulcolax under the supervision of the doctor. Dulcolax should not be administered in children under two years of age. Instructions for use The effect of the assumptions is usually manifested in about 20 minutes (range: 10 - 30 minutes). Do not exceed the recommended doses. Laxatives must be used as frequently as possible and for no more than seven days. Use for longer periods of time requires the doctor’s prescription after adequate evaluation of the individual case.

Conservation

Covered tablets: this medicine does not require any particular condition of conservation. Suppose: Do not store at temperature above 30°C.

Warnings

Warnings Like all laxatives, Dulcolax 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 lead to 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 Dulcolax must be stopped 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 were reported after taking Dulcolax. The data relating to these cases suggest that events, more than a phenomenon related to the intake of Dulcolax, could be interpreted as a manifestation of "default syncope" (adjustable to the effort of the act of defecation), or as a vasovagal response to abdominal pain related to constipation itself. The use of the suppositories can lead to painful sensations and local irritation, in particular, in patients with ulcerative spiders and proctitis (see section 4.3 “contraindications”). The stimulant laxatives included Dulcolax do not contribute to weight loss (see paragraph 5.1 “Property pharmacodynamics”). Important information about some excipients: Dulcolax tablets contain 33,2 mg of lactose 66.42 mg in case of taking the maximum daily dose, for treating constipation in adults and adolescents over 10 years. Patients suffering from rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose mal absorption, should not take the tablets of this medicine. Dulcolax tablets contain 23.4 mg of sucrose 46.8 mg in case of taking the maximum daily dose for treating constipation in adults and adolescents over 10 years. Patients with rare hereditary problems of fructose intolerance, glucose-galactosis mal absorption, or sucrasis-isomaltase deficiency, should not take the tablets of this medicine. Dulcolax tablets can cause gastric disorders and diarrhea. 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. You should also consult your doctor before using the medicine.

Interactions

Concurrent administration of diuretics or adrenocorticosteroids and excessive doses of Dulcolax may lead to 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 secondary gastrointestinal effects of Dulcolax.

Effects

The most commonly reported side effects during treatment with Dulcolax are abdominal pain and diarrhea. Immune system disorders: anaphylactic reactions, angiourotic edema and other hypersensitivity reactions. Disorders of metabolism and nutrition: dehydration. Disorders of the nervous system: vertigo, syncope. 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). Gastrointestinal diseases: abdominal cramps, abdominal pain, diarrhea, nausea, hematochetia (blood in the feces), vomiting, abdominal malaise, anorettal discomfort, colitis including ischemic colitis. 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: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.

Overdosing

Synonyms Excessive doses can cause abdominal pain and diarrhea, and significant losses of potassium and other electrolytes. Chronic overdose of Dulcolax, like other laxatives, can cause chronic diarrhea, abdominal pain, hypocalyemia, 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 of ingestion of the oral form of Dulcolax, the 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, Dulcolax must be used only in case of need, 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-hydroxyfenil)-piridil-2-methane (BHPM), nor its glucuronic derivatives are excreted in breast milk, however the medicinal product must be used only if necessary, under the direct control of the doctor, after assessing the expected benefit for the mother in relation to the possible risk for the infant.

Source: Farmadati