Leaflet: information for the user

DulcoLax Bisacodilo 5 mg gastro-resistant tablets

Bisacodilo

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

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

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any 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 you get worse, if no bowel movement occurs after 12 hours following the maximum daily dose, or if you do not improve after 7 days of treatment.

The bisacodyl, active ingredient of this medication, belongs to the group of stimulant laxatives, which act by direct contact with the intestinal mucosa, stimulating the intestinal wall nerve endings, thereby increasing its motility.

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

Consult a doctor if it worsens or does not improve after 7 days of treatment.

Do not take DulcoLax:

• If you are allergic to bisacodyl or any of the other components of this medication (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 digestive hemorrhage or inflammatory intestinal diseases (ulcerative colitis, Crohn's disease).
• If the patient is under 2 years old.
• If you have disorders of water and electrolyte metabolism.

Warnings and precautions

• This medicationshould not be taken continuously on a daily basis or for prolonged periods without investigating the cause of constipation.
• If you are over 65 years old or a weakened patient, 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 prevent dehydration problems. Dehydration symptoms are excessive thirst and urination.
• If during the use of this medication you experience dizziness and/or fainting, it may be due to constipation and not necessarily due to the use of this medication. These symptoms can occur as a result of straining during defecation or in response to abdominal pain.
• Stimulant laxatives, including DulcoLax, do not help with weight loss.

Consult your doctor or pharmacist before starting to take DulcoLax:

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

Children and adolescents

Children between 2 and 10 years old can only take this medication under medical supervision.

Children under 2 years old cannot take this medication, it is contraindicated in them.

Taking DulcoLax with other medications

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

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

• Medications used to treat heart rhythm: Antiarrhythmics (quinidine).
• Anti-inflammatory medications (corticosteroids).
• Medications used to increase urine elimination: Diuretic thiazides.
• Medications used to treat heart disease: Cardiac glycosides such as digoxin.
• Anti-acid and anti-ulcer medications (proton pump inhibitors, H2antihistamines), the intake of both should be separated by at least 2 hours.
• Medications based on licorice root.
• Other laxatives

Interference with diagnostic tests:

• When taking this medication, blood glucose levels may be elevated, so diabetic patients should be aware of this.
• The use of this medication can also interfere with analytical test results, as prolonged use of laxatives can lead to a decrease in blood potassium levels (hypokalemia).

Taking DulcoLax with food and drinks

You should not take licorice root while taking this medication.

You should avoid taking DulcoLax with milk, or at least separate their intake by 2 hours, as it can increase the absorption of this medication if taken at the same time.

Pregnancy, breastfeeding, and fertility

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

Driving and operating machinery

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 tasks that may be hazardous such as driving or operating machinery.

DulcoLax contains saccharose, lactose, and ricin oil

This medication contains saccharose and lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication may cause stomach discomfort and diarrhea because it contains ricin oil.

Follow exactly the administration instructions of this medication contained in this leaflet or those 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 is foradolescents and children over 10 years old1 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 take this medication only 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 medication, it is contraindicated in them.

How to take:

This medication 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 symptoms worsen, if no defecation occursafter 12hours having taken 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 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 Toxicological Information Service (phone: 91 562 04 20), indicating the medication and the amount ingested.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

During the period of use of medications with bisacodilo, the following adverse effects have been observed, whose frequency has not been established with precision. The most frequently produced adverse effects are abdominal pain and diarrhea. The following adverse effects may occur: abdominal discomfort, anorectal discomfort, digestive alterations such as abdominal pain or cramps (which may be associated with nausea and/or vomiting), bloody stools (hematochezia), flatulence, abdominal distension, slower intestinal movement, and colitis. Less frequently, allergic reactions, skin eruptions, dehydration, and swelling of the face, lips, mouth, tongue, or throat that may cause difficulty swallowing or breathing (angioedema) may also occur.

The long-term use of medications with bisacodilo, the active ingredient of this medication, may cause an increase in water loss, potassium salts, and other salts. This may lead to cardiac function alterations, muscle weakness, and fatigue, particularly if taken at the same time as diuretics and corticosteroids.

In addition, cases of dizziness and syncope have been reported. Dizziness and syncope that occur after taking medications with bisacodilo may be due to a vasovagal response (e.g., abdominal spasms, defecation).

Reporting 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 prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

No special storage conditions are required.

Expiration Date

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of DulcoLax

• The active ingredient is bisacodyl. Each gastro-resistant tablet contains 5 mg of bisacodyl.
• The other components (excipients) are: sucrose, lactose, cornstarch, 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 content of the packaging

DulcoLax are round, brown-yellow tablets,gastro-resistant (resistant to gastric juice so that it acts where it is needed, in the intestine).

It is presented in packaging that contains 30 gastro-resistant tablets.

Holder of the marketing authorization:

Opella Healthcare Spain, S.L.

C/ Rosselló i Porcel, 21

08016 – Barcelona

Spain

Sanofi Group

Responsible for manufacturing:

DELPHARM REIMS

10, Rue Colonel Charbonneaux

51100 Reims – France

Date of the last review of this leaflet:08/2019

The detailed and updated information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

Additional information for the patient:

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

Suppositories:DulcoLax bisacodyl 10 mg suppositories

Oral drops:Dulcolaxo picosulfate 7.5 mg/ml oral drops