NAME OF THE MEDICINE PURGATON 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient: Purified extract of senna 100 mg (equivalent to 20 mg Calcium sennoside*) *Calcium sennosides are a natural complex of anthraquinone glycosides extracted from Cassia angustifolia or Cassia acutifolia in the form of calcium salts. Excipient(s) with known effect: Lactose monohydrate. For the full list of excipients, see section 6.1 . 3. PHARMACEUTICAL FORM Brown round flat uncoated tablet. 4. CLINICAL DATA 4.1. Therapeutic indications Short-term symptomatic treatment of occasional constipation. 4.2. Dosage and method of administration Dosage Adults and children 12 years and over: 1 to 2 tablets after the evening meal (always start with a tablet). The correct dose is the smallest dose that restores normal bowel movement. Pediatric population Use in children under 12 years of age is contraindicated (see section 4.3). Duration of the treatment The treatment must be of short duration (7 days maximum). In general, taking this medication two to three times during this 7 day period is sufficient. If symptoms persist beyond a week, a doctor or pharmacist should be consulted. 4.3. Contraindications • History of hypersensitivity to sennosides or to any of the excipients listed in section 6.1. • Intestinal obstructions and stenosis, atony, appendicitis, inflammatory bowel diseases (ulcerative colitis, Crohn's disease) (e.g. liver disease, peritonitis). • Abdominal pain syndromes of undetermined cause. • Irritation of the gastrointestinal tract (e.g. nausea, vomiting, colic, spastic constipation, occlusive or sub occlusive syndrome), abdominal pain syndromes of undetermined cause. • Severe states of dehydration, with loss of water and electrolytes (particularly in case of hypokalaemia). • Pregnancy and lactation. • Children under 12 years old. 4.4. Special warnings and precautions for use Special warnings Medicines containing senna or sennosides should only be used if a therapeutic effect is not observed following a change in diet or the administration of osmotic laxatives. Drug treatment of constipation is only an adjunct to lifestyle treatment: • enrichment of the diet with vegetable fibers and drinks; • physical activity, rehabilitation of defecation reflex. In children over 12 years of age, the prescription of stimulant laxatives must be exceptional: it must take into account the risk of hindering the normal functioning of the defecation reflex. Prolonged use is not recommended as it may cause: • "laxatives disease" with severe functional colopathy, rectocolic melanosis, hydro-electrolyte abnormalities with hypokalaemia; • a situation of "dependence" with regular need for laxatives, need to increase the dosage and severe constipation in the event of withdrawal; this dependence, which varies according to the patient, can be created without the knowledge of the doctor. • The lowest effective dose should be used for the restoration of normal bowel function. In case of lack of efficacy, the dosage can be increased under medical supervision. Do not exceed the stated dose. The use of this medication requires medical supervision in the following cases: • if the use exceeds one week; • after laparotomy or abdominal surgery; This medicine should be stopped and the patient should consult a doctor in the following cases: • If the treatment does not work, • If symptoms persist or worsen, • In the event of a rash, as this may be a sign of hypersensitivity, • In case of nausea or vomiting as they may be a sign of a potential or existing intestinal obstruction (ileus), • In case of acute or persistent intestinal pain, e.g. abdominal pain, as this may be due to an underlying undiagnosed pathology (acute diverticulitis, appendicitis, peritonitis, severe diarrhoea) (See section 4.3). This medicinal product contains Lactose Monohydrate. Patients with fructose intolerance, galactose intolerance, total lactase deficiency, glucose-galactose malabsorption syndrome, sucrase/isomaltase deficiency (rare hereditary diseases) should not take this medicine. 4.5. Interactions with other medicinal products and other forms of interaction Combinations subject to precautions for use • Substances likely to cause torsade de pointes Increased risk of ventricular arrhythmias including Torsade de Pointes. Correct any hypokalaemia before administering the product and carry out clinical, electrolyte and electrocardiographic monitoring. • Digoxin: Hypokalemia promotes the toxic effects of digitalis. Correct any hypokalaemia beforehand and carry out clinical, electrolyte and electrocardiographic monitoring. Use a non-stimulant laxative. • Other potassium-lowering agents Amphothericin B (IV route), corticosteroids (gluco/mineral corticoid: general route), tetracosactide, hypokalaemic diuretics (alone or in combination). Increased risk of hypokalaemia (additive effect). Monitoring of serum potassium and if necessary correction. Use a non-stimulant laxative. 4.6. Fertility, pregnancy and lactation Pregnancy Due to experimental data showing a genotoxic risk of several anthracenics, such as emodin and aloe-emodin, PURGATON is contraindicated during pregnancy (see section 4.3). Feeding with milk Anthraquinone derivatives are excreted in breast milk and effects in neonates/infants are likely. PURGATON is contraindicated during lactation (see section 4.3). Fertility Animal studies have not shown any effect of sennosides on fertility under normal conditions of use (see section 5.3). 4.7. Effects on ability to drive and use machines Not applicable. 4.8. Side effects Possibility of diarrhea and abdominal pain particularly in subjects suffering from irritable bowel. Possibility of hypokalaemia. It sometimes happens that, under the action of sennosides, the urine is slightly tinted red. This staining due to anthraquinone does not involve any renal irritation. Adverse effects are listed by organ system and frequency. Frequencies are defined as follows: very common (>1/10), common (> 1/100, <1/10), uncommon (>1/1,000, <1/100), rare (>1/10,000, <1/1,000), very rare (<1/10,000), frequency not known (cannot be estimated from the available data). For a given frequency, the undesirable effects are classified in decreasing order of seriousness.
