NORMALENE 20CPR RIV 5MG

NORMALENE 5 MG STATEMENTS

active ingredients

A coated tablet contains: 5 mg bisacodyle.

Excellent

A coated tablet contains: microcrystalline cellulose, talc, maize starch, titanium dioxide, ethyl phthalate, triethyl citrate, sucrose, dibeenate glycerol, polyvinylpyrrolidone, sorbitol, methacrylic acid copolymer, lacquer rubber, ipromellose, macrogol stearate 400, macrogol 6000.

Therapeutic indications

Short-term treatment of occasional constipation.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients. Laxatives are contraindicated in subjects with acute or unknown abdominal pain, nausea or vomiting, obstruction or intestinal stenosis, rectal bleeding of unknown origin, severe state of dehydration. Contraindicated in children under two years. Generally contraindicated during pregnancy and nursing (see p. 4.6). Patients with rare hereditary problems of fructose intolerance, glucose–galactose mal absorption, or isomaltase sucrasis failure, should not take this medicine.

Population

Children aged 10 or under chronic constipation must be treated under medical supervision. The bisacodile should not be used in children of an age equal to or less than two years. Short-term treatment of constipation : Adults and children over 10 years old: 1–2 coated tablets (5–10 mg) per day before bed. Children from 2 to 10 years: 1 tablet coated (5 mg) per day before bed. The coated tablets should preferably be administered after the evening meal, so that the effect of laxative, which is produced after 10–12 hours, does not disturb sleep. Eating together with an adequate amount of water (a plentiful glass). The correct dose is sufficient to produce an easy evacuation of soft feces. It is advisable to initially use the minimum doses provided. When necessary, the dose may be increased, but never exceed the maximum indicated. Laxatives must be used as frequently as possible and for no more than seven days. Use for longer periods requires the doctor’s prescription after adequate evaluation of the individual case. A fluid-rich diet promotes the effect of the medicine.

Conservation

Store at temperature not exceeding 30 ° C.

Warnings

Warnings Laxative abuse (frequent or prolonged use with 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 result in cardiac or neuromuscular dysfunctions, especially in the case of contemporary treatment with cardiac glycosides, diuretics or corticosteroids. 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). Precautions for use The treatment of chronic or recurring constipation always requires doctor 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. The administration of bisacodile must be carried out with caution in patients with rectal inflammations and hemorrhoid manifestations.

Interactions

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.

Effects

Occasionally: isolated crampiform pain or abdominal colic pain, more frequent in cases of severe constipation. Communicate to your physician or pharmacist the appearance of any other side effects.

Overdosing

Excessive doses can cause abdominal pain and diarrhea; the consequent losses of liquids and electrolytes must be replaced. See also in paragraph 4.4 "Special warnings and precautions for use" about the abuse of laxatives.

There are no adequate and well-controlled studies on the use of pregnant or nursing medicine. Therefore the medicinal product 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 or for the infant.

Source: Farmadati