DULCOLAX BISACODYL 5 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the User

DulcoLax Bisacodyl 5 mg Gastro-Resistant Tablets

Bisacodyl

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

Follow the instructions for administration of the medicine contained in this leaflet or as indicated by your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if your symptoms worsen, if you do not have a bowel movement after 12 hours after taking the maximum daily dose, or if you do not improve after 7 days of treatment.

Contents of the Package Leaflet:

1. What is DulcoLax and what is it used for
2. What you need to know before taking DulcoLax
3. How to take DulcoLax
4. Possible side effects
5. Storage of DulcoLax
6. Contents of the pack and further information

1. What is DulcoLax and what is it used for

Bisacodyl, the active ingredient of this medicine, belongs to the group of stimulant laxatives, which act by direct contact with the mucosa of the intestine, stimulating the nerve endings of the intestinal wall, thus increasing its motility.

It is indicated for the symptomatic relief of occasional constipation in adults, adolescents, and children over 10 years old.

You should consult a doctor if your symptoms worsen or if you do 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 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 intestinal diseases (ulcerative colitis, Crohn's disease).
• If the patient is under 2 years old.
• If you have water or electrolyte metabolism disorders.

Warnings and precautions

• This medicine should not be taken continuously every day or for prolonged periods without investigating the cause of constipation.
• If you are over 65 years old or in the case of debilitated patients, you should drink plenty of liquids and mineral salts, and inform your doctor that you are using a laxative so that they can monitor your electrolyte levels and avoid dehydration problems. The symptoms of dehydration are excessive thirst and little urine output.
• If during the use of this medicine you experience dizziness and/or fainting, it may be due to constipation and not necessarily to the use of this medicine. These symptoms can occur as a consequence of straining during defecation or as a response to abdominal pain.
• Stimulant laxatives, including DulcoLax, do not help with weight loss.

Consult your doctor or pharmacist before taking DulcoLax:

• If, in addition to constipation, you have symptoms of appendicitis such as nausea, vomiting, or abdominal cramps, it is recommended that you consult a doctor to diagnose whether you have appendicitis or not.
• If you have chronic constipation, as in that case, the cause of constipation should be investigated.

Children and adolescents

Children from 2 to 10 years old can only take this medicine under medical supervision.

Children under 2 years old cannot take this medicine; it is contraindicated in them.

Taking DulcoLax with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or may take any other medicine.

In particular, if you are taking any of the following medicines, it may be necessary to interrupt treatment or modify the dose of one of them:

• Medicines used to treat heart rhythm: Antiarrhythmics (quinidine).
• Anti-inflammatory medicines (corticosteroids).
• Medicines used to increase urine elimination: Thiazide diuretics.
• Medicines used to treat heart diseases: Cardiac glycosides such as digoxin.
• Antacid and anti-ulcer medicines (proton pump inhibitors, H2 antihistamines), the intake of both should be separated by at least 2 hours.
• Medicines based on licorice.
• Other laxatives.

Interference with diagnostic tests:

• When taking this medicine, blood glucose levels may rise, so diabetic patients should take this into account.
• Taking this medicine can also interfere with the results of analytical tests, due to the fact that prolonged use of laxatives can lead to a decrease in potassium in the blood (hypokalemia).

Taking DulcoLax with food and drinks

Do not take licorice while taking this medicine.

Avoid taking DulcoLax simultaneously with milk, or at least separate the intake by 2 hours, as the absorption of this medicine may increase if taken at the same time.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

During the use of this type of laxative due to a vasovagal response (e.g., abdominal spasms), you may experience dizziness and/or fainting. 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 told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

This medicine may cause stomach upset and diarrhea because it contains castor oil.

3. How to take DulcoLax

Follow the instructions for administration of this medicine contained in this leaflet or as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose in adults is:

1 tablet (5 mg of bisacodyl) per day before bedtime. If necessary, 2 tablets will be taken.

Always use the lowest effective dose.

Use in children and adolescents

The recommended dose for adolescents and children over 10 years old is 1 tablet (5 mg of bisacodyl) per day before bedtime. If necessary, 2 tablets will be taken.

Always use the lowest effective dose.

Children from 2 to 10 years old

Children from 2 to 10 years old can only take this medicine under medical supervision.

1 tablet (5 mg of bisacodyl) per day before bedtime.

Children under 2 years old

Children under 2 years old cannot take this medicine; it is contraindicated in them.

How to take:

This medicine is taken orally.

It is recommended to swallow the tablet whole, without chewing, and with plenty of liquid, at night or in the morning on an empty stomach. If taken at night, defecation will occur approximately in 10 hours. If taken in the morning on an empty stomach, defecation will occur approximately in 6 hours.

If your symptoms worsen, if you do not have a bowel movement after 12 hours after taking the maximum daily dose, or if your symptoms persist for more than 7 days of treatment, you should consult a 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 will consist of suspending the administration of the laxative and subsequent rehydration with saline solution, liquids, and the administration of mineral salts. These measures are especially important in the elderly and young.

In case of overdose or accidental ingestion, consult your doctor or call the Toxicology Information Service (telephone: 91 562 04 20), indicating the medicine and the amount ingested.

4. Possible side effects

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

During the period of use of medicines with bisacodyl, the following side effects have been observed, whose frequency could not be established with precision. The most frequent side effects are abdominal pain and diarrhea. The following can occur: abdominal discomfort, anorectal discomfort, digestive disorders such as abdominal pain or cramps (which can be associated with nausea and/or vomiting), bloody stools (hematochezia), flatulence, abdominal distension, increased slowness of intestinal movement, and colitis. Less frequently, allergic reactions, skin rashes, dehydration, and swelling of the face, lips, mouth, tongue, or throat that can cause difficulty swallowing or breathing (angioedema) can also occur.

Taking medicines with bisacodyl, the active ingredient of this medicine, for long periods of time, can cause increased water loss, potassium, and other salts. This can lead to alterations in cardiac function, muscle weakness, and fatigue, especially if taken at the same time as diuretic and corticosteroid medicines.

Additionally, cases of dizziness and fainting have been reported. Dizziness and fainting that occur after taking medicines with bisacodyl may be due to a vasovagal response (e.g., abdominal spasm, defecation).

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of DulcoLax

Keep this medicine out of the 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 is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If in doubt, consult your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of DulcoLax

• The active ingredient is bisacodyl. Each gastro-resistant tablet contains 5 mg of bisacodyl.
• The other ingredients (excipients) are: sucrose, lactose, corn starch, glycerol (E-422), magnesium stearate, talc, gum arabic, titanium dioxide (E-171), methacrylic acid copolymer, and methacrylate copolymer (1:1), castor oil, macrogol 6000, yellow iron oxide (E-172), white wax, carnauba wax, and shellac.

Appearance of the product and pack contents

DulcoLax are round, yellow-brown, gastro-resistant tablets (resistant to gastric juice to act where necessary, in the intestine).

They are presented in packs containing 30 gastro-resistant tablets.

Marketing authorisation holder:

Opella Healthcare Spain, S.L.

C/ Rosselló i Porcel, 21

08016 – Barcelona

Spain

Sanofi Group

Manufacturer:

DELPHARM REIMS

10, Rue Colonel Charbonneaux

51100 Reims – France

Date of last revision of this leaflet:08/2019

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

Other additional information for the patient:

DulcoLax is also available on the market in the following forms:

Suppositories: DulcoLax bisacodyl 10 mg suppositories

Oral drops: Dulcolax picosulfate 7.5 mg/ml oral drops