Leaflet: information for the user

DulcoLax Bisacodilo 10 mg suppositories

Bisacodilo

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

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

• Keep this leaflet, as you may need to read it again.
• For advice on any aspect of your dose, consult your pharmacist.
• Consult your doctor or pharmacist if you experience any side effects, even if they do not appear in this leaflet. See section 4
• You must consult a doctor if you get worse, if no bowel movement occurs after 12 hours 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 use 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 bleeding or inflammatory intestinal diseases (ulcerative colitis, Crohn's disease).
• If the patient is under 10 years old, as this medication contains 10 mg of bisacodyl.
• If you have disorders of water and electrolyte metabolism.
• If you have hemorrhoids or anal fissures.

Warnings and precautions

• This medicationshould not be used continuously on a daily basis or for prolonged periods without investigating the cause of constipation.
• If you are over 65 years old or have 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 to defecate or in response to abdominal pain.
• Stimulant laxatives, including DulcoLax, do not help with weight loss.

Consult your doctor or pharmacist before starting to use 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 or do not have appendicitis.
• If you have chronic constipation, as in that case the cause of constipation should be investigated.
• If you have anal fissures or inflammation of the anal mucosa (ulcerative proctitis), as the use of suppositories can cause local pain and irritation.

Children and adolescents

Children under 10 years old cannot use this medication.

Use of DulcoLax with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

In particular, if you are using 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.
• Medications based on licorice.
• Other laxatives
• Do not use with other medications administered rectally.

Interference with diagnostic tests:

• The use of this medication may interfere with analytical test results, as prolonged use of laxatives can lead to a decrease in blood potassium levels (hypokalemia).

Use of DulcoLax with food and beverages

Do not take licorice while using this medication.

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 using 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 syncope. If you experience abdominal spasms, you should avoid potentially hazardous tasks such as driving or operating machinery.

Follow exactly the administration instructions for 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 suppository (10 mg of bisacodyl).

This medication is administered rectally.

It must be unfolded and inserted into the rectum through the pointed part.

The effect usually appears within 20 minutes of administration (between 10 and 30 minutes).

If symptoms worsen, if no bowel movement occurs after 12 hours or if symptoms persist after 7 days of treatment, you must consult your doctor.

Use in children and adolescents

Adolescents and children over 10 years old

The recommended dose is 1 suppository (10 mg of bisacodyl)

Children under 10 years old cannot use this medication as it contains 10 mg of bisacodyl.

If you use more DulcoLax than you should

If you have used 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 stopping the use of the laxative and subsequent rehydration with saline solution, liquids, and administration of mineral salts.These measures are especially important in the elderly and young.

In case of overdose or accidental ingestion, visit 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 frequent adverse effects are abdominal pain and diarrhea. The following 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 use of medications with bisacodilo, the active principle of this medication, over long periods of time 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 administered at the same time as diuretics and corticosteroids.

In addition, cases of dizziness and syncope have been reported. Dizziness and syncope that appear 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 that does not appear 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 about the safety of this medication.

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

Do not store at a temperature above 86°F (30°C).

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 packaging and unused medications at the SIGRE collection point at your 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 bisacodilo. Each suppository contains 10 mg of bisacodilo.
• The other components (excipients) are: solid semisynthetic glycerides c.s.

Appearance of the product and contents of the packaging

DulcoLax are yellowish white suppositories.

They are presented in packaging containing an aluminum blister of 6 or 12 suppositories.

Holder of the marketing authorization:

Opella Healthcare Spain, S.L.

C/Rosselló i Porcel, 21

08016 – Barcelona

Spain

Sanofi Group

Responsible for manufacturing:

Istituto de Angeli, S.r.l.

Località Prulli, 103/C

50066 Reggello (Florence).

Italy

Date of the last review of this leaflet:October 2019

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