DULCOLAX BISACODYL 10 mg SUPPOSITORIES

Introduction

Package Leaflet: Information for the User

DulcoLax Bisacodyl 10 mg Suppositories

Bisacodyl

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

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

• Keep this package leaflet, as 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 package leaflet. See section 4.
• You should consult a doctor if your symptoms worsen, if you do not have a bowel movement after 12 hours, or if you do not improve after 7 days of treatment.

Package Leaflet Contents:

1. What is DulcoLax and what is it used for
2. What you need to know before using DulcoLax
3. How to use DulcoLax
4. Possible side effects
5. Storage of DulcoLax
6. Package Contents and Additional Information

1. What is DulcoLax and what is it used for

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

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 gastrointestinal 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 water or electrolyte metabolism disorders.
• If you have hemorrhoids or anal fissures.

Warnings and Precautions

• This medication should 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 in the case of debilitated patients, you should drink plenty of fluids 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 decreased urination.
• If during the use of this medication you experience dizziness and/or fainting, it may be due to constipation and not necessarily to the use of this medication. These symptoms can occur as a consequence of straining during defecation or as a response to abdominal pain.
• Stimulant laxatives, including DulcoLax, do not aid in 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 consult a doctor to diagnose whether you 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.

Using DulcoLax with other medications

Inform your doctor or pharmacist if you are using, have recently used, 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: Thiazide diuretics.
• Medications used to treat heart diseases: Cardiac glycosides such as digoxin.
• Medications based on licorice.
• Other laxatives.
• It should not be used with other medications administered rectally.

Interference with diagnostic tests:

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

Using DulcoLax with food and drinks

You should 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 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.

3. How to use DulcoLax

Follow the administration instructions for this medication contained in this package 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 suppository (10 mg of bisacodyl).

This medication is administered rectally.

They should be unwrapped and inserted into the rectum by the pointed end.

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

If your symptoms worsen, if you do not have a bowel movement after 12 hours, or if your symptoms persist after 7 days of treatment, you should consult a 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 diarrheic stools, and loss of fluid, potassium, and other electrolytes, fatigue or weakness.

Treatment in these cases will consist of discontinuing the use of the laxative and subsequent rehydration with saline solution, fluids, and 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 medication and the amount ingested.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

During the period of use of medications 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. It can also cause: 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.

The use of medications with bisacodyl, the active ingredient of this medication, for long periods of time, can cause increased loss of water, potassium, and other salts. This can lead to alterations in cardiac function, muscle weakness, and fatigue, particularly if administered simultaneously with diuretic and corticosteroid medications.

Additionally, cases of dizziness and fainting have been reported. The dizziness and fainting that appear after taking medications 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 not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of DulcoLax

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

Do not store above 30°C.

Expiration Date

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

DulcoLax Composition

• The active ingredient is bisacodyl. Each suppository contains 10 mg of bisacodyl.
• The other components (excipients) are: semi-synthetic solid glycerides c.s.

Product Appearance and Package Contents

DulcoLax are white-yellowish suppositories.

They come in packages containing an aluminum blister pack of 6 or 12 suppositories.

Marketing Authorization Holder:

Opella Healthcare Spain, S.L.

C/Rosselló i Porcel, 21

08016 – Barcelona

Spain

Sanofi Group

Manufacturer:

Istituto de Angeli, S.r.l.

Località Prulli, 103/C

50066 Reggello (Florence).

Italy

Date of the Last Revision of this Package Leaflet:October 2019

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