Normalene 5mg - against occasional constipation 40 tablets

Product Description

Remedy for occasional constipation.

Indications

NORMALENE coated tablets are used for the short-term treatment of occasional constipation.

Composition

Active ingredients

One coated tablet contains: bisacodyl 5 mg.

Excipients

One coated tablet contains: microcrystalline cellulose, talc, corn starch, titanium dioxide, ethyl phthalate, triethyl citrate, sucrose, glycerol dibehenate, polyvinylpyrrolidone, sorbitol, methacrylic acid copolymer, shellac, hypromellose, macrogol stearate 400, macrogol 6000.

How to use and Dosage

Children aged 10 years and under with chronic constipation should be treated under medical supervision. Bisacodyl should not be used in children aged two years and under. Short-term treatment of constipation:

• Adults and children over 10 years: 1–2 coated tablets (5–10 mg) daily before going to bed.
• Children aged 2 to 10 years: 1 coated tablet (5 mg) daily before going to bed.

The coated tablets should preferably be taken after the evening meal, so that the laxative effect, which occurs after 10–12 hours, does not disturb sleep. Swallow with an adequate quantity of water (a large glass). The correct dose is the minimum sufficient to produce easy evacuation of soft stools. It is advisable to initially use the minimum recommended doses. When necessary, the dose can then be increased, but never 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. A diet rich in liquids promotes the effect of the medicine.

Warnings

Warnings: Laxative abuse (frequent or prolonged use with excessive doses) can cause persistent diarrhea with consequent loss of water, mineral salts (especially potassium), and other essential nutrients. In more severe cases, dehydration or hypokalemia may occur, which can lead to cardiac or neuromuscular dysfunction, especially in the case of concomitant treatment with cardiac glycosides, diuretics, or corticosteroids. Abuse of laxatives, especially contact laxatives (stimulant laxatives), can cause dependence (and, therefore, the possible need to gradually increase the dosage), chronic constipation, and loss of normal intestinal function (intestinal atony). Precautions for use: The treatment of chronic or recurrent constipation always requires medical intervention for diagnosis, prescription of medications, and monitoring during therapy. Consult your doctor when the need for a laxative arises from a sudden change in previous bowel habits (frequency and characteristics of bowel movements) that lasts more than two weeks, or when laxative use fails to produce effects. It is also advisable for elderly or otherwise unhealthy individuals to consult their doctor before using the medicine. Bisacodyl should be administered with caution in patients with rectal inflammation and hemorrhoidal manifestations.

When it should not be used

Hypersensitivity to the active substance or to any of the excipients. Laxatives are contraindicated in subjects with acute or unknown abdominal pain, nausea or vomiting, intestinal obstruction or stenosis, rectal bleeding of unknown origin, or severe dehydration. Do not administer to children under two years of age.

Interactions

Laxatives can reduce the residence time in the intestine, and therefore the absorption, of other drugs administered orally at the same time. Therefore, avoid taking laxatives and other medications at the same time: after taking a medicine, wait at least two hours before taking the laxative. Milk or antacids can alter the effect of the medicine: wait at least one hour before taking the laxative.

Side effects

Occasionally: isolated cramping pain or abdominal colic, more frequent in cases of severe constipation. Report any other side effects to your doctor or pharmacist.

Overdose

Excessive doses may cause abdominal pain and diarrhea; the resulting loss of fluids and electrolytes must be replaced. See also section 4.4 "Special warnings and precautions for use" regarding laxative abuse.

Pregnancy and breastfeeding

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

Format

40 tablets