5 mg enteric 
tablet bisacodyl

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist.

  • Save this leaflet, you may need to read it again.
  • Contact the pharmacy staff if you need more information or advice.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.
  • You need to talk to a doctor if you do not feel better or if you feel worse after a week.

In this leaflet: 
1. What Dulcolax is and what it is used for 
2. What you need to know before you use Dulcolax 
3. How to use Dulcolax 
4. Possible side effects 
5. How to store Dulcolax 
6. Contents of the packaging and other information 

1. What Dulcolax is and what it is used for

Dulcolax is used for temporary constipation, for bowel emptying before, for example, X-ray examination or surgery, and for facilitating bowel emptying in hemorrhoids and other problems around the anal opening. Dulcolax has a local, direct effect on the intestinal wall. Intestinal movements are stimulated and the intestinal contents pass more quickly through the intestine. Also, the number of salts and water in the intestine increases, which also facilitates intestinal passage.

Dulcolax acts in the large intestine where it facilitates the natural intestinal emptying process. The use does not affect how much nutrition is absorbed into the body from the small intestine. Dulcolax has no calorie-reducing effect.

Dulcolax enteric tablets effect after 6-12 hours.

2. What you need to know before using Dulcolax

Do not use Dulcolax

  • If you are allergic to bisacodyl or any of the other ingredients of this medicine (listed in section 6).
  • If you have intestinal upset, intestinal obstruction, inflammatory bowel disease, or severe abdominal pain with nausea and vomiting.
  • If you have severe dehydration.

Warnings and cautions

  • If laxatives are used regularly for more than a week, a doctor should be consulted. Prolonged use can lead to disturbed fluid balance and lack of potassium in the blood.
  • Dulcolax does not contribute to weight loss.
  • If you are elderly and/or have renal impairment, discontinue treatment with Dulcolax and consult a physician for signs of dehydration (such as increased thirst and decreased urine output).
  • Dizziness and fainting have been reported by patients who have used Dulcolax, but this has probably been due to exertion during a bowel movement or was an effect of the abdominal pain caused by constipation.

Children

Dulcolax should not be used by children under 10 years of age without a doctor’s recommendation.

Other medicines and Dulcolax

The treatment effect can be affected if this medicine is taken at the same time as certain other medicines, such as diuretics, cortisone, heart medicines containing digoxin and digitoxin, and certain medicines for acid stomach and heartburn (antacids and proton pump inhibitors ).

If you are also taking other medicines that stimulate the intestines, you may have an increased effect and a greater risk of side effects from the gastrointestinal tract (see Possible side effects ).

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Use of Dulcolax with food and drink

Do not take Dulcolax with milk.

Pregnancy and breastfeeding

There are no modern studies on pregnant women. Long experience has not shown any harmful or unwanted effects during pregnancy. During pregnancy, however, Dulcolax, like all medicines, should only be taken on medical advice. Ask your doctor or pharmacist for advice before taking this medicine.

Bisacodyl does not pass into breast milk. Therefore, Dulcolax is safe to use during breast-feeding.

Driving and using machines

Dizziness and fainting may occur when using Dulcolax, most likely due to a reflex that may occur with abdominal pain or bowel movements. Therefore, if you experience abdominal pain, you should be careful about driving and handling machinery. You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. The description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Dulcolax contains lactose and sucrose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to use Dulcolax

Always use this medicine exactly as described in this leaflet or as directed by your doctor, pharmacist, or nurse. Ask your doctor or pharmacist if you are unsure.

Since the enteric-coated tablets are coated with an enteric-resistant casing so that they only work when they have reached the colon, they must be swallowed whole with liquid, but not milk.

Dosing in the evening causes bowel movements the following morning.

Constipation

The recommended dose for adults is 1-2 enteric tablets in the evening. Start with the lower amount and increase if necessary to two enteric tablets per day. Do not exceed the recommended maximum dose.

Use for children and adolescents

Children under 10 years of age should not use Dulcolax other than on a doctor’s recommendation. Children under 2 years of age should not be treated with Dulcolax.

The recommended dose is:

Children over 10 years: 1-2 enteric tablets in the evening. Start with the lower amount and increase if necessary to two enteric tablets per day. Do not exceed the recommended maximum dose.

Children 2-10 years: 1 enteric tablet in the evening.

Used for a maximum of one week per treatment occasion.

If you are going to use Dulcolax for bowel movements in connection with medical examinations or procedures (for example X-ray examination or surgery), the treatment should be done in consultation with a doctor. Then follow your doctor’s instructions.

If you take more Dulcolax then you should

If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

When you stop using Dulcolax

When Dulcolax has defecated, the colon has been completely emptied. It may therefore take a few days before the need for bowel movements arises again.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Dulcolax and contact a doctor immediately if you get any of the following symptoms (which may indicate angioedema ):

  • swelling of the face, tongue, or throat
  • difficulty swallowing
  • hives and difficulty breathing

Common ( affects more than 1 user in 100): Nausea, abdominal pain, diarrhea, abdominal cramps.

Uncommon (affects less than 1 user in 100, more than 1 in 1000 users): Local irritation of the rectum, discomfort from the stomach area, vomiting, blood in the stool (usually limited), dizziness.

Rare (affects less than 1 user in 1,000, more than 1 in 10,000 users): hypersensitivity, fainting.

No known frequency (can not be calculated from the available data): rapid and severe hypersensitivity reactions called anaphylactic reactions, angioedema, colitis (even with lack of oxygen in the colon), dehydration.

5. How to store Dulcolax

Keep out of sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is bisacodyl 5 mg per enteric-tablet.
  • The other ingredients are lactose monohydrate 35 mg, sucrose 23 mg, talc, corn starch, magnesium stearate, acacia gum, methacrylic acid-methyl methacrylate copolymer (1: 1), methacrylic acid-methyl methacrylate copolymer (1: 2), castor oil, yellow nitric oxide (dye) E 172), glycerol (85%), Macrogol 6000, shellac, carnauba wax, white wax.

What the medicine looks like and the contents of the pack

Dulcolax enteric tablets are round, beige yellow, and biconvex with a smooth, smooth surface and white core. The diameter is 6 mm.

Pressure packaging (Al / PVC / PVDC) 30 enteric tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder:

Sanofi AB

Box 30052

104 25 Stockholm

Manufacturer:

Delpharm Reims

10 Rue Colonel Charbonneaux

51100 Reims

France

Muhammad Nadeem

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