Dulcolax - Coated tablets

Dulcolax - Coated tablets are a laxative.

Application

1. What is Dulcolax and what is it used for?

Dulcolax - Dragees are a laxative. Through the contact of the active ingredient bisacodyl with the mucous membrane of the colon, they stimulate your bowel movements. Dulcolax lozenges have no effect in the stomach and small intestine when used correctly. Therefore, they do not alter digestion or the absorption of calories and nutrients in the small intestine.

	For short-term relief of intestinal sluggishness and constipation;
	for the preparation of operations and examinations;
	for diseases that require the facilitation of defecation.

How is it applied?

What is Dulcolax and what is it used for?

Dulcolax - Dragees are a laxative. Through the contact of the active ingredient bisacodyl with the mucous membrane of the colon, they stimulate your bowel movements. Dulcolax tablets have no effect in the stomach and small intestine when used correctly. Therefore, they do not alter digestion or the absorption of calories and nutrients in the small intestine.

Dulcolax - Coated tablets are taken

• For short-term relief of intestinal sluggishness and constipation,
• in preparation for operations and examinations,
• for illnesses that require relief from defecation.

What should you pay attention to before taking it?

What should you be aware of before taking Dulcolax?

Dulcolax must not be taken,

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• If you are allergic to bisacodyl or any of the other ingredients of this medicine listed in section 6,
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• If you suffer from intestinal obstruction or disorders of gastrointestinal patency,
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• If you suffer from acute inflammatory diseases of the gastrointestinal tract,
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• If you suffer from chronic inflammatory diseases of the gastrointestinal tract with acute episodes (Crohn's disease or ulcerative colitis),
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• If you have acute abdominal pain that requires surgery, such as acute appendicitis,
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• If you have severe abdominal pain along with nausea and vomiting - these may indicate a serious illness,
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• If you have a severe loss of water from the body and, as a result, a disturbance of the
  electrolyte balance.

Dulcolax - Dragees must also not be taken by children under 2 years of age.

Warnings and precautions.
Please talk to your doctor or pharmacist before taking Dulcolax - Dragees,

• If you require laxatives on a daily basis or for a prolonged period of time - in this case you mustIf you need laxatives on a daily basis or for a long period of time, you must have the cause of the constipation clarified by a doctor.Excessive use of laxatives can lead to disturbances of the fluid and electrolyte balance, for example potassium deficiency, and subsequently to renewed constipation (rebound phenomenon) (see also "Taking Dulcolax with other medicines").
• If you notice thirst or decreased urine output - these may be signs of dehydration due to fluid loss, which can be harmful for elderly patients and patients with impaired kidney function. You must stop taking Dulcolax - Coated tablets and only resume taking them under the supervision of your doctor.

The appearance of blood in the stool - usually slight and temporary - may occur.

The regular intake or the intake of higher than recommended dosages of
Dulcolax - Dragees for bulimia (binge eating disorder) is an abuse that can lead to serious side effects and must be avoided at all costs. Psychotherapeutic measures are required for bulimia.

Stimulant laxatives like Dulcolax do not help you lose weight.

Cases of dizziness and/or fainting have been reported after taking Dulcolax - Dragees. These incidents may be due to the consequences of constipation (increase in pressure during bowel movements, pain). They are not necessarily due to the intake of Dulcolax - Dragees.

Taking Dulcolax with other medicines.
Inform your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines.

If you take diuretics or medicines made from adrenal cortical hormones (adrenocorticosteroids) together with Dulcolax - Coated Tablets, your body may lose more potassium. The effects and side effects of medicines for the treatment of cardiac insufficiency (so-called cardiac glycosides) can be increased by such a possible potassium deficiency if taken at the same time.

You should not take Dulcolax - Dragees at the same time as medicines that reduce the acidity of the stomach (neutralising stomach medicines (antacids) or medicines from the group of proton pump inhibitors). If such medicines are necessary, you should take them at the earliest half an hour after Dulcolax - Dragees.

Gastrointestinal complaints can be aggravated by the simultaneous use of other laxatives.

Taking Dulcolax with food and drink.
Avoid taking Dulcolax - Coated tablets at the same time as foods that reduce the acidity of the stomach, especially milk. If such food is necessary, you should take it at the earliest half an hour after Dulcolax - Dragees.

Pregnancy and breastfeeding.
If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Dulcolax - Dragees should - like all medicines - be avoided during pregnancy and only taken on a doctor's recommendation.

Clinical studies show that bisacodyl and its metabolites do not pass into the breast milk of healthy breastfeeding women. Therefore, Dulcolax can be taken during breastfeeding.

Driving ability and ability to operate machinery.
No studies have been carried out on the effects on the ability to drive and operate machinery.

Dizziness and/or fainting may occur as a reaction to, for example, cramps in the abdomen and the increase in pressure during defecation (see section "Warnings and precautions"). If such side effects occur, you should refrain from activities that require increased attention (e.g. participating in road traffic, operating machinery).

Dulcolax tablets contain lactose, sucrose and castor oil.
Please only take Dulcolax - Dragees after consulting your doctor if you are known to suffer from a sugar intolerance.

Dulcolax - Coated tablets contain the recommended maximum daily dose for constipation (2 tablets).
66.4 mg lactose (milk sugar) and 46.8 mg sucrose (cane sugar) or in the maximum daily dose for the preparation of examinations (4 coated tablets) 132.8 mg lactose and 93.6 mg sucrose. If you have a rare inherited metabolic disorder (fructose intolerance, galactose intolerance, Lapp lactase deficiency, glucose-galactose or sucrase-isomaltase utilisation disorder), you should not take this medicine.

Note for diabetics: Dulcolax - Dragees contain 57.6 mg of carbohydrates in one dragee corresponding to 0.005 bread units (BE), of which 23.4 mg is sucrose corresponding to 0.002 bread units (BE).

Dulcolax - Coated tablets contain castor oil and can cause stomach upset and diarrhoea.

How should the medicine be taken?

How to take Dulcolax?

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is:

For constipation

Adults: 1-2 lozenges (5-10 mg) daily

It is recommended to start with the lowest dose. To restore regular bowel movements, the recommended maximum daily dose can be increased. The maximum recommended daily dose should not be exceeded.

Use in children and adolescents

Children and adolescents over 1-2 dragées (5-10 mg) daily
10 years:

It is recommended to start with the lowest dose. To restore regular bowel movements, the recommended maximum daily dose can be increased. The recommended maximum daily dose should not be exceeded.

Children from 2 to 10 years: 1 coated tablet (5 mg) daily

The recommended maximum daily dose should not be exceeded.

Children up to 10 years of age with chronic constipation should only be given Dulcolax - Dragees under medical supervision. Dulcolax - Coated tablets must not be given to children under 2 years of age.

To take.
Dulcolax - Coated tablets are taken once a day before bedtime if required. If taken in the evening, 1-2 soft discharges occur after about 6-12 hours.
Dulcolax tablets are taken unchewed with plenty of liquid. Avoid taking it with milk or medicines that reduce the acidity of the stomach (see sections 'Taking Dulcolax with other medicines' and 'Taking Dulcolax with food and drink').

Duration of use
Prolonged use should be avoided. The need for continued use should be reviewed after one week and the required duration of use determined on a case-by-case basis.

In preparation for surgery and examinations
Complete bowel evacuation should always be performed under medical supervision. The attending physician will determine the laxatives required on a case-by-case basis, taking into account the particular circumstances.

In order to ensure complete bowel emptying, you should use both Dulcolax coated tablets and Dulcolax suppositories as instructed by the physician.

On the day before the examination in the morning and evening
adults, adolescents
2 Dulcolax - Dragees (10 mg) each and on the morning of
and children over 10 years:
examination 1 Dulcolax - suppository (10 mg)

Applications in conditions requiring facilitated bowel evacuation
In conditions requiring facilitated bowel evacuation, the dosage is initially as for short-term use in the treatment of constipation (1-2 Dulcolax lozenges). Your doctor will continuously adjust the dosage to the specific requirements of your condition.

If you have taken more Dulcolax than you should
If you have accidentally taken more than the prescribed dose, please tell a doctor. He will decide on any necessary action.

In acute overdose, there may be increased watery stools, stomach cramps and loss of fluid, potassium and other electrolytes.

Persistent overdose of laxatives in general may lead to persistent diarrhoea, abdominal pain, potassium deficiency, excessive production of the adrenocortical hormone aldosterone and kidney stones. Damage to the kidneys, disturbances of the acid-base balance with hypoacidification of the blood and muscle weakness due to potassium deficiency have also been described as a consequence of prolonged abuse of laxatives.

Note to healthcare professionals
For overdose information, see the end of the leaflet.

If you forget to take Dulcolax
Continue taking it at the next time. Do not take double the amount if you have forgotten to take it before.

If you stop taking Dulcolax
Dulcolax - Coated tablets are only taken when needed and should be stopped when symptoms have subsided.

If you have any further questions about taking this medicine, ask your doctor or pharmacist.

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What are the possible side effects?

How to store Dulcolax?

No special storage conditions are required for this medicinal product.

Keep this medicine out of the reach of children.

You must not use this medicine after the expiry date which is stated on the carton/blister. The expiry date refers to the last day of the month indicated.

Do not dispose of medicines in waste water or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In doing so, they contribute to the protection of the environment.

Special instructions for storage

5 How to store Dulcolax?

Keep this medicine out of the reach of children.

No special storage conditions are required for this medicine.

Do not use this medicine after the expiry date which is stated on the carton/blister. The expiry date refers to the last day of the month indicated.

Do not dispose of medicines in waste water or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In this way, they contribute to the protection of the environment.

Special notes on the content

Contents of the pack and other information
What Dulcolax contains

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• The active ingredient is: bisacodyl. 1 dragée contains 5 mg bisacodyl.
• The other ingredients are:
  Tablet core: lactose monohydrate (33.2 mg), maize starch, modified starch (maize starch, oxidised), glycerol, magnesium stearate
  Tablet coating: Magnesium stearate, sucrose (23.4 mg), talc, gum arabic, methacrylic acid-methyl methacrylate copolymer (1:1), methacrylic acid-methyl methacrylate copolymer (1:2), castor oil, macrogol 6000, bleached wax, carnauba wax, shellac, colourants: titanium dioxide (E171), iron oxide yellow (E172)

What Dulcolax looks like and contents of the pack.
Round, shiny, beige-yellow coated tablets (dragées).

PVC/PVDC/aluminium blister pack
Packs of 40 and 100 dragées