Dulcobis 5mg (20 Tablets)

Description

Dulcobis 5mg (20 Tablets)

Dulcobis is intended for short-term symptomatic treatment of constipation. In preparation for diagnostic tests, in pre-and postoperative treatment, in conditions requiring defecation facilitation.

Active substance: Bisacodylum

Composition

One gastro-resistant tablet contains 5 mg of bisacodyl. Excipients: lactose 33.2 mg, sucrose 23.4 mg.

Dosage

The product is intended for short-term use. The period of self-administration of Dulcobis should not exceed 5 days.

Unless otherwise prescribed by your doctor, the following dosage is recommended:

Short-term treatment of constipation:

• Adults:

1-2 gastro-resistant tablets (5-10 mg) daily at bedtime.

It is recommended to start treatment with the lowest dose. The dose can be adjusted to the highest dose recommended in order to achieve regular bowel movements.

The maximum daily dose should not be exceeded.

• Adolescents and children over 10 years of age:

1-2 gastro-resistant tablets (5-10 mg) daily at bedtime.

It is recommended to start treatment with the lowest dose. The dose can be adjusted to the highest dose recommended in order to achieve regular bowel movements.

The maximum daily dose should not be exceeded.

• Children 4-10 years:

1 gastro-resistant tablet (5 mg) daily at bedtime.

The maximum daily dose should not be exceeded.

Children 10 years of age and younger with chronic or persistent constipation should only be treated under medical supervision.

Method of administration:

To defecate in the morning, the drug should be applied the day before in the evening. The gastro-resistant tablets should be swallowed whole and washed down with plenty of water.

Preparation for diagnostic tests and surgical procedures:

The product should be used under the supervision of medical personnel.

Adults, adolescents and children over 10 years of age: 1-2 gastro-resistant tablets (5-10 mg) in the morning and 1-2 gastro-resistant tablets (5-10 mg) in the evening before the study, and the next morning the administration of an immediate laxative is recommended. (e.g. a suppository).

Children 4-10 years: one gastro-resistant tablet (5 mg) in the evening, and the next morning administration of an immediate laxative (e.g. a suppository).

Use of the drug in children and adolescents

Short-term treatment of constipation:

Adolescents and children over 10 years of age: 1-2 gastro-resistant tablets (5-10 mg) daily at bedtime. It is recommended to start treatment with the lowest dose. The dose can be adjusted to the highest dose recommended in order to achieve regular bowel movements. The maximum daily dose should not be exceeded.

Children 4-10 years: 1 gastro-resistant tablet (5 mg) daily at bedtime. The maximum daily dose should not be exceeded. Children 10 years of age and younger with chronic or persistent constipation should only be treated under medical supervision.

Preparation for diagnostic tests and surgical procedures:

The product should be used under the supervision of medical personnel. Children 4-10 years : one gastro-resistant tablet (5 mg) in the evening, and the next morning administration of an immediate laxative (e.g. a suppository).

Adults dosage

Short-term treatment of constipation:

Adults:

1-2 gastro-resistant tablets (5-10 mg) daily at bedtime. It is recommended to start treatment with the lowest dose. The dose can be adjusted to the highest dose recommended in order to achieve regular bowel movements. The maximum daily dose should not be exceeded.

Preparation for diagnostic tests and surgical procedures:

The product should be used under the supervision of medical personnel. Adults, adolescents and children over 10 years of age: 1-2 gastro-resistant tablets (5-10 mg) in the morning and 1-2 gastro-resistant tablets (5-10 mg) in the evening before the study, and the next morning the administration of an immediate laxative is recommended. (e.g. a suppository).

Contraindications

Dulcobis is contraindicated in patients with intestinal obstruction, acute abdominal conditions including appendicitis, acute inflammatory bowel disease, and severe abdominal pain accompanied by nausea and vomiting, which may be a symptom of serious illness. Dulcobis is also contraindicated in states of severe dehydration and in patients with known hypersensitivity to bisacodyl or any other component of the product. In rare genetic diseases where there is intolerance to the excipient component of the product (see “Special warnings and precautions”), the use of the product is contraindicated.

Contents:

20 gastro-resistant tablets

Storage method

15°C-25°C

Manufacturer

SANOFI

Warnings

Gastro-resistant tablets should not be taken with agents that reduce acidification of the upper gastrointestinal tract, such as milk, antacids or proton pump inhibitors, to prevent premature dissolution of the tablet coating. As with other laxatives, this medicinal product should not be used daily for long periods without investigating the cause of constipation. Long-term use may lead to fluid and electrolyte disturbances and hypokalaemia. Losing water from the gut can promote dehydration. Symptoms include thirst and oliguria. In patients with fluid loss where dehydration may be hazardous (e.g. renal failure, the elderly), Dulcobis treatment should be discontinued. and treatment can only be resumed under medical supervision. Patients may notice the presence of blood in the stool, but the symptom is usually mild and self-limiting. Dizziness and syncope have been reported in patients taking Dulcobis. The available data on these cases indicate that these syncope is related to the effort to defecate or to a vasovagal reaction to abdominal pain, which may be related to constipation but not necessarily directly related to the administration of the medicinal product. During pregnancy, the preferred treatments for constipation are increasing fluid intake, increasing dietary fiber content and increasing physical activity. The use of drugs that stimulate intestinal motility, such as bisacodyl, is not recommended, except in strictly justified cases. This medicinal product contains 33.2 mg of lactose in one gastro-resistant tablet resulting in the maximum daily dose of 66.4 mg for the treatment of constipation in adults, adolescents and children over 10 years of age and 33.2 mg for the treatment of constipation in children aged 4 years. -10 years. In preparation for radiological examinations, this amount will be 132.8 mg in the recommended maximum daily dose for adults and 33.2 mg for children 4-10 years of age. The drug should not be used in patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. This medicinal product contains 23.4 mg of sucrose in one gastro-resistant tablet, corresponding to the maximum daily dose, which is 46.8 mg for the treatment of constipation in adults, adolescents and children over 10 years of age, and 23.4 mg for constipation in children aged 4 years. -10 years. In preparation for radiological examinations, this amount will be 93.6 mg in the recommended maximum daily dose for adults and 23.4 mg for children 4-10 years of age. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take Dulcobis.

Pregnancy and breastfeeding

• Pregnancy: Animal studies are insufficient with regard to effects on pregnancy, embryonic development, parturition and postnatal development. The risk for humans is unknown. Dulcobis should not be used during pregnancy unless clearly necessary.
• Breast-feeding: Clinical data show that neither the active substance of bisacodyl BHPM (bis- (p-hydroxyphenyl) -pyridyl-2-methane) nor its glucuronide derivatives are excreted in the milk of healthy, lactating women. Therefore, Dulcobis can be used during breastfeeding.

Driving vehicles

No studies on the effects of the medicinal product on the ability to drive and use machines have been performed. However, patients should be advised that due to a vasovagal response (e.g. abdominal cramps) they may experience dizziness and / or fainting. If abdominal cramps occur, potentially hazardous activities such as driving and operating machinery should be avoided.

Overdosage

• Symptoms: Overdose may lead to diarrhea, intestinal cramps, abdominal pain, and clinically significant loss of fluid, potassium and other electrolytes. Long-term abuse of the medicinal product may lead to chronic diarrhea, abdominal pain, hypokalaemia, secondary aldosteronism and nephrolithiasis. Renal tubular damage, metabolic alkalosis, and muscle weakness occur secondary to hypokalemia as a result of chronic overuse of laxatives.
• Treatment: Absorption following oral administration of the medicinal product can be minimized or inhibited by induction of vomiting or gastric lavage. You may need to balance fluids and electrolytes. This is especially important in the elderly and in children and adolescents. The use of drugs with a spasmolytic effect may be beneficial.

Interactions with other drugs

Taking excessive doses of the medicinal product and the concomitant use of diuretics and glucocorticosteroids may increase the risk of electrolyte disturbances. Electrolyte imbalance may potentiate the effect of cardiac glycosides.

The most commonly reported side effects during treatment are abdominal pain and diarrhea.

The frequencies of adverse reactions are based on a pooled dataset from 23 clinical trials with Dulcobis including 3,368 patients.