Dulcolax bisacodyl 5 mg gastro-resistant tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
DulcoLax Bisacodyl 5 mg enteric-coated tablets
Bisacodyl
Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.
Always follow exactly the instructions for administration of the medicine contained in this leaflet or those provided by your doctor or pharmacist.
- Keep this leaflet, as you may need to read it again.
- If you need advice or further information, consult your pharmacist.
- If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens, if no bowel movement occurs within 12 hours after taking the maximum daily dose, or if you do not improve after 7 days of treatment.
Contents of the leaflet
- What DulcoLax is and what it is used for
- What you need to know before taking DulcoLax
- How to take DulcoLax
- Possible side effects
- How to store DulcoLax
- Contents of the pack and other information
1. What DulcoLax is and what it is used for
Bisacodyl, the active substance of this medicine, belongs to the group of stimulant laxatives, which act through direct contact with the intestinal mucosa, stimulating the nerve endings in the intestinal wall, thereby increasing intestinal motility.
It is indicated for the symptomatic relief of occasional constipation in adults, adolescents, and children over 10 years of age.
You should consult a doctor if your condition worsens or does not improve after 7 days of treatment.
2. What you need to know before taking DulcoLax
Do not take DulcoLax:
- If you are allergic to bisacodyl or to any of the other ingredients of this medicine (listed in section 6).
- If you have abdominal pain of unknown origin.
- If you have intestinal obstruction or paralytic ileus.
- If you have appendicitis or intestinal perforation.
- If you have gastrointestinal bleeding or inflammatory bowel diseases (ulcerative colitis, Crohn's disease).
- If the patient is under 2 years of age.
- If you have disturbances in water or electrolyte metabolism.
Warnings and precautions
- This medicine should not be taken continuously on a daily basis or for prolonged periods without investigating the underlying cause of constipation.
- If you are over 65 years of age or if you are a weakened patient, you should drink plenty of fluids and electrolytes and inform your doctor that you are using a laxative so that your electrolyte levels can be monitored to prevent dehydration. Symptoms of dehydration include excessive thirst and reduced urination.
- If you experience dizziness and/or fainting while using this medicine, these symptoms may be due to constipation and not necessarily to the use of this medicine. Such symptoms may occur as a result of straining during defecation or in response to abdominal pain.
- Stimulant laxatives, including DulcoLax, do not assist with weight loss.
Consult your doctor or pharmacist before taking DulcoLax:
- If, in addition to constipation, you have symptoms suggestive of appendicitis such as nausea, vomiting, or abdominal cramps. In such cases, you should see a doctor to determine whether you have appendicitis.
- If you suffer from chronic constipation, as the underlying cause should be investigated.
Children and adolescents
Children aged 2 to 10 years may only take this medicine under medical supervision.
Children under 2 years of age must not take this medicine; it is contraindicated in this age group.
Taking DulcoLax with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
In particular, if you are taking any of the following medicines, it may be necessary to interrupt treatment or adjust the dose:
- Medicines used to treat heart rhythm disorders: Antiarrhythmics (quinidine).
- Anti-inflammatory medicines (corticosteroids).
- Medicines used to increase urine elimination: Thiazide diuretics.
- Medicines used to treat heart conditions: Cardiac glycosides such as digoxin.
- Antacids and anti-ulcer medicines (proton pump inhibitors, H2 antihistamines); administration should be separated by at least 2 hours.
- Medicines containing liquorice.
- Other laxatives.
Interference with diagnostic tests:
- When taking this medicine, blood glucose levels may increase; diabetic patients should take this into account.
- This medicine may also interfere with laboratory test results, as prolonged use of laxatives may lead to decreased potassium levels in blood (hypokalaemia).
Taking DulcoLax with food and drink
You should not consume liquorice while taking this medicine.
Concomitant intake of DulcoLax with milk should be avoided, or at least separated by 2 hours, as simultaneous intake may increase absorption of this medicine.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.
Driving and use of machines
While taking this type of laxative, vasovagal responses (e.g. abdominal spasms) may cause dizziness and/or syncope. If you experience abdominal spasms, you should avoid potentially hazardous tasks such as driving or operating machinery.
DulcoLax contains sucrose, lactose and castor oil
This medicine contains sucrose and lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.
This medicine may cause stomach discomfort and diarrhoea as it contains castor oil.
3. How to take DulcoLax
Follow exactly the administration instructions for this medicine provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The recommended dose for adults is:
1 tablet (5 mg of bisacodyl) daily before bedtime. If necessary, 2 tablets may be taken.
Always use the lowest effective dose.
Use in children and adolescents
The recommended dose for adolescents and children over 10 years of age is 1 tablet (5 mg of bisacodyl) daily before bedtime. If necessary, 2 tablets may be taken.
Always use the lowest effective dose.
Children aged 2 to 10 years
Children aged 2 to 10 years may take this medicine only under medical supervision.
1 tablet (5 mg of bisacodyl) daily before bedtime.
Children under 2 years
Children under 2 years must not take this medicine; it is contraindicated in this age group.
How to take:
This medicine is taken orally.
It is recommended to swallow the tablet whole, without chewing, with plenty of liquid, either at night or in the morning on an empty stomach. If taken at night, bowel movement will occur approximately after 10 hours. If taken in the morning on an empty stomach, bowel movement will occur approximately after 6 hours.
If symptoms worsen, if no bowel movement occurs within 12 hours after taking 2 tablets, or if symptoms persist for more than 7 days of treatment, you must consult your doctor.
If you take more DulcoLax than you should
If you have taken more DulcoLax than you should, consult your doctor or pharmacist immediately.
The most frequent symptoms of overdose are: abdominal cramps, vomiting, mucous and diarrheal stools, and loss of fluid, potassium, and other electrolytes, fatigue or weakness.
Treatment in these cases consists of discontinuing the laxative and subsequent rehydration with saline solution, fluids, and administration of mineral salts. These measures are especially important in elderly and young patients.
In case of overdose or accidental ingestion, go to your doctor or call the Toxicology Information Service (telephone: 91 562 04 20), stating the medicine and the amount ingested.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.
During the period of use of bisacodil-containing medicines, the following adverse effects have been observed, although their frequency cannot be precisely established. The most frequently occurring adverse effects are abdominal pain and diarrhoea. Other possible effects include abdominal discomfort, anorectal irritation, gastrointestinal disturbances such as pain or abdominal cramps (which may be associated with nausea and/or vomiting), bloody stools (haematochezia), flatulence, abdominal distension, reduced intestinal motility, and colitis. Less frequently, allergic reactions, skin rashes, dehydration, and swelling of the face, lips, mouth, tongue, or throat that may cause difficulty swallowing or breathing (angioedema) may also occur.
Long-term use of bisacodil-containing medicines, the active substance in this medicine, may lead to increased loss of water, potassium salts, and other electrolytes. This may result in disturbances in cardiac function, muscle weakness, and fatigue, particularly if taken concomitantly with diuretics and corticosteroids.
In addition, cases of dizziness and syncope have been reported. Dizziness and syncope occurring after taking bisacodil-containing medicines may be due to a vasovagal response (e.g. abdominal spasm, defecation).
Reporting of adverse effects:
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of DulcoLax
Keep this medicine out of sight and reach of children.
No special storage conditions are required.
Expiry date
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a SIGRE Point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of DulcoLax
- The active substance is bisacodyl. Each gastro-resistant tablet contains 5 mg of bisacodyl.
- The other components (excipients) are: sucrose, lactose, maize starch, glycerol (E-422), magnesium stearate, talc, arabic gum, titanium dioxide (E-171), copolymer of methacrylic acid and methyl methacrylate (1:1), copolymer of methacrylic acid and methyl methacrylate (1:2), castor oil, macrogol 6000, yellow iron oxide (E-172), white wax, carnauba wax, and shellac.
Appearance of the product and contents of the pack
DulcoLax is yellowish-brown, round, gastro-resistant tablets (resistant to gastric juice so that it acts where needed, in the intestine).
It is available in packs containing 30 gastro-resistant tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Opella Healthcare Spain, S.L.
C/ Rosselló i Porcel, 21
08016 Barcelona,
Spain
Manufacturer:
DELPHARM REIMS
10, Rue Colonel Charbonneaux
51100 Reims – France
Date of the most recent revision of this leaflet: November 2025
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/