Angelini Alaxa 5mg product 20 Gastro-resistant Tablets

NAME
ALAXA 5 MG FOOD-RESISTANT TABLETS

PHARMACOTHERAPEUTIC CATEGORY
Constipation medications.

ACTIVE PRINCIPLES
Bisacodyl.

EXCIPIENTS
Tablet core: lactose monohydrate, corn starch, magnesium stearate, gelatin. Gastro-resistant film-coating: diethyl phthalate, cellulose acetophthalate, talc. Sugar coating: acacia, sucrose, sodium carboxymethylcellulose, macrogol 6000, titanium dioxide, calcium carbonate, talc.

INDICATIONS
Short-term treatment of occasional constipation.

CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity to the active substance, to other chemically related substances or to any of the listed excipients; children under the age of 3; generally contraindicated during pregnancy and lactation; people with acute abdominal pain or of unknown origin, nausea or vomiting, intestinal obstruction or stricture, rectal bleeding of unknown origin, severe dehydration, acute surgical abdomen, appendicitis, gastroenteritis; in case of anal fissures and / or lesions (pain and perianal bleeding may occur).

DOSAGE
Dosage: 2 tablets per day; in particularly stubborn cases, 3 tablets. >> Pediatric population. Children aged between 3 and 12 years: 1-2 tablets per day (0.3 mg / kg). 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. 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. Method of administration: the tablets should be swallowed whole, without chewing, together with an adequate quantity of water (a large glass). A diet rich in liquids favors the effect of the medicine. The 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. If taken on an empty stomach, the laxative effect occurs within approximately 5 hours. Take the drug at least 1 hour after taking milk or antacids and at least two hours after taking other medicines by mouth.

STORAGE
No special storage precautions.

WARNINGS
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 severe cases the onset of dehydration or hypokalaemia is possible, which can cause cardiac or neuromuscular dysfunction, especially in the case of simultaneous treatment with cardiac glycosides, diuretics or corticosteroids. Furthermore, the abuse of laxatives, especially contact laxatives (stimulant laxatives), can cause addiction (and therefore, possible need to gradually increase the dosage), chronic constipation and loss of normal intestinal functions (intestinal atony). Frequent or prolonged use of the drug should be avoided as it may cause addiction and atonic colitis. 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. Caution is recommended if the need for the laxative derives from a sudden change in previous bowel habits (frequency and characteristics of bowel movements) lasting more than two weeks; when rectal bleeding is present; 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. Pediatric population: in children under 12 years the medicine can 'be used only after consulting your doctor. The product contains lactose monohydrate and sucrose.

INTERACTIONS
Milk or antacids can change the effect of the medicine; leave an interval of at least one hour before taking the laxative. The concomitant use of diuretics, cardiac glycosides or adrenocorticosteroids can 'promote an electrolyte imbalance. Laxatives can reduce the residence time 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.

SIDE EFFECTS
Gastrointestinal effects. Occasionally: cramping pains in isolation or abdominal colic, more frequent in cases of severe constipation. Cases of local irritation, pain and bleeding have been described following administration of the suppository pharmaceutical form. The reporting of suspected adverse reactions that occur after the authorization of the drug is important, as it allows continuous monitoring of the benefit / risk ratio of the drug.

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.