Stixenil 5mg

Coated Tablets

Composition :

One coated tablet contains: active ingredient: BISACODYL 5 mg. Excipients: lactose, sucrose. For the full list of excipients see section 6.1

Excipients

Lactose, corn starch, sucrose, talc, glyceryl behenate, magnesium carbonate, methacrylic copolymers, PEG 4000, titanium. dioxide.

Therapeutic indications

Short-term treatment of occasional constipation

Contraindications

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. Generally contraindicated during pregnancy and lactation (see p. 4.6). Generally contraindicated in pediatric age (see p. 4.4). The medicine contains sucrose: therefore patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase isomaltase insufficiency, should not take this medicine. The medicine contains lactose therefore patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.

Dosage

Children aged 10 years and younger with chronic constipation should be treated under close medical supervision. Bisacodyl should not be used in children 2 years of age or younger. Short-term treatment of constipation Adults and children over 10 years of age 1-2 coated tablets (5-10 mg) daily at bedtime Children 2-10 years of age 1 coated tablet (5 mg) daily at bedtime Do not take with milk or antacids; take the medicine apart by at least an hour. Do not take together with other medicines by mouth: space out the laxative by at least two hours. The correct dose is the minimum sufficient to produce an easy evacuation of soft faeces. It is advisable to initially use the minimum doses provided. When necessary, the dose can then be increased, but without ever exceeding the maximum indicated. Take preferably in the evening. 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. The tablets should be swallowed whole. Swallow with an adequate amount of water (a large glass). A diet rich in liquids favors the effect of the medicine.

Warnings and Precautions

The abuse of laxatives (frequent or prolonged use or with excessive doses) can cause persistent diarrhea with consequent loss of water, mineral salts (especially potassium) and other essential nutritional factors. In the most serious cases the onset of dehydration or hypokalemia is possible which can cause cardiac or neuromuscular dysfunctions, 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, the possible need to gradually increase the dosage), chronic constipation and loss of normal intestinal functions (intestinal atony). The treatment of chronic or recurrent constipation always requires the intervention of the doctor for the diagnosis, the prescription of drugs and the surveillance during the course of therapy. Consult your doctor when the need for the laxative derives from a sudden change in previous bowel habits (frequency and characteristics of bowel movements) that has lasted for more than two weeks or when the use of the laxative fails to produce effects or when the patient is suffering from diabetes mellitus, hypertension or heart disease. It is also advisable that elderly people or those in poor health conditions consult their doctor before using the medicine. In children under the age of 12, the medicine can only be used after consulting your doctor. The use of laxatives in patients with inflammatory bowel disease or in the presence of abdominal pain, nausea or vomiting, can be dangerous and therefore requires careful consideration by the physician. Cases of dizziness or syncope during defecation have been reported with the use of bisacodyl, compatible with defecation syncope (attributable to the effort of defecation itself) or with a vasovagal response to abdominal pain that can be associated with constipation. The product contains sucrose (20 mg for each tablet): this should be taken into account when the product is to be taken by diabetics or those who follow low-calorie diets.

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 2 hours before taking the laxative. Concomitant use of diuretics or corticosteroids may increase the risk of electrolyte imbalance if bisacodyl is taken in excessive quantities. Electrolyte imbalance can lead to increased sensitivity to glycosides. Milk and antacids can change the effect of the medicine; leave an interval of at least one hour before taking the laxative.

Undesirable effects

The most commonly reported side effects during treatment with STIXENIL are abdominal pain and diarrhea. Immune system disorders: anaphylactic reactions, angioedema and other hypersensitivity reactions. Nervous system disorders: dizziness, syncope (the phenomena of dizziness and syncope that occur after taking bisacodyl appear to be attributable to a vasovagal response resulting from, for example, abdominal pain, or stool evacuation). Metabolism and nutrition disorders: dehydration. Gastrointestinal disorders: colitis, abdominal cramps, abdominal pain, diarrhea, vomiting, nausea, haematochezia (blood in the stool), abdominal discomfort, anorectal discomfort Tell your doctor or pharmacist if you have any other side effects.

Pregnancy and breastfeeding

There are no adequate and well-controlled studies on the use of STIXENIL in pregnancy or breastfeeding. Therefore, the medicine should only be used in case of need, under the direct supervision of the doctor, after evaluating the expected benefit to the mother in relation to the possible risk to the fetus or infant.