Normalene 5 mg Bisacodyl Constipation 20 Coated Tablets

WARNINGS
The abuse of laxatives (frequent or prolonged use with excessive doses) can cause persistent diarrhea with consequent loss of water, saliminerals (especially potassium) and other essential nutritional factors. In the most severe cases the onset of dehydration or hypokalemia is possible which can cause cardiac or neuromuscular dysfunction, especially in the case of simultaneous treatment with cardiac glycosides, diuretics or corticosteroids. The abuse of laxatives, especially contact laxatives (stimulant laxatives), can cause addiction (and, therefore, possible need to progressively increase the dose), chronic constipation and loss of normal intestinal functions (intestinal atony). The treatment of chronic or recurrent constipation always requires medical intervention for diagnosis, prescription of drugs and surveillance during the course of therapy. Pay attention when the need for the laxative derives from a sudden change in previous bowel habits (frequency and characteristics of bowel movements) that lasted for more than two weeks or when the use of the laxative fails to produce effects. It is also advisable that elderly people or those in poor health conditions consult their doctor before using the medicine. Administration of bisacodyl should be done with caution in patients with rectal inflammation and haemorrhoidal manifestations.
PHARMACOTHERAPEUTIC CATEGORY
Constipation medications.
STORAGE
Store at a temperature not exceeding 30 degrees C.
CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity 'to the active substance or to any of the excipients; laxatives are contraindicated in subjects with acute abdominal pain or of unknown origin, nausea or vomiting, intestinal obstruction or stenosis, rectal bleeding of unknown origin, severe dehydration; contraindicated in children under two years; generally contraindicated during pregnancy and lactation; Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase isomaltase insufficiency should not take this medicine.
NAME
NORMALENE 5 MG COATED TABLETS
EXCIPIENTS
One coated tablet contains: microcrystalline cellulose, talc, maize starch, titanium dioxide, ethyl phthalate, triethyl citrate, sucrose, glycerol dibeenate, polyvinylpyrrolidone, sorbitol, methacrylic acid copolymer, shellac, hypromellose, macrogol stearate 400, macrogol 6000.
SIDE EFFECTS
Occasionally: isolated cramping pains or abdominal colic, more frequent in cases of severe constipation.
PREGNANCY AND BREASTFEEDING
There are no adequate and well-controlled studies on the use of the medicinal product in pregnancy or breastfeeding. Therefore, the medicine should be used only in case of need ', after evaluating the expected benefit to the mother in relation to the possible risk to the fetus or infant.
INDICATIONS
Short-term treatment of occasional constipation.
INTERACTIONS
Laxatives can reduce the time spent in the intestine, and therefore the absorption, of other drugs administered simultaneously orally. Therefore, avoid ingesting laxatives and other drugs at the same time: after taking a medicine, leave an interval of at least two hours before taking the laxative. Milk or antacids can change the effect of the medicine: leave an interval of at least one hour before taking the laxative.
DOSAGE
Children aged 10 years or younger with chronic constipation must be treated under medical supervision. Bisacodyl should not be used in children aged two years or less. >> Short-term treatment of constipation. Adults and children over 10 years of age: 1-2 coated tablets (5-10 mg) per day before going to bed. Children from 2 to 10 years: 1 coated tablet (5 mg) per day before going to bed. The coated tablets should preferably be administered after the evening meal, so that the effect of the laxative, which occurs after 10-12 hours, does not disturb sleep. Ingest together with an adequate quantity of water (a large glass). The correct dose is the minimum sufficient to produce an easy evacuation of soft stools. It is advisable to initially use the minimum doses provided. When necessary, the dose can then be increased, but never exceed the maximum indicated. Laxatives should be used as infrequently as possible and for no more than seven days. Use for longer periods of time requires a doctor's prescription after adequate evaluation of the individual case. A diet rich in liquids favors the effect of the medicine.
ACTIVE PRINCIPLES
Bisacodyl.