DULCOLAX PICOSULFATE 7.5 mg/ml ORAL DROPS

Introduction

Leaflet: Information for the patient

DulcoLax Picosulfate 7.5 mg/ml oral drops

Sodium picosulfate

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

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

• Keep this 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 leaflet. See section 4.
• You should consult a doctor if your symptoms worsen, if there is no bowel movement after 12 hours after taking the maximum daily dose, or if there is no improvement after 6 days of treatment.

Contents of the leaflet

1. What DulcoLax Picosulfate is and what it is used for
2. What you need to know before taking DulcoLax Picosulfate
3. How to take DulcoLax Picosulfate
4. Possible side effects
5. Storage of DulcoLax Picosulfate
6. Package contents and additional information

1. What DulcoLax Picosulfate is and what it is used for

The active ingredient of this medication, sodium picosulfate, belongs to a group of medications called stimulant laxatives.

It is used for the symptomatic relief of occasional constipation in adults and children over 6 years of age.

If your symptoms worsen, if there is no bowel movement after 12 hours after taking the maximum daily dose, or if your symptoms persist after 6 days of treatment, you should consult your doctor.

2. What you need to know before taking DulcoLax Picosulfate

It is recommended to drink 6 to 8 glasses of liquid daily when using any type of laxative to help soften the stools.

Do not takeDulcoLax Picosulfate

• If you are allergic to sodium picosulfate or any of the other components of this medication (listed in section 6).
• If you have symptoms such as nausea, vomiting, severe abdominal pain, and/or fever, which may indicate the presence of appendicitis or other abdominal problems.
• If you suffer from any acute inflammatory intestinal disease, intestinal obstruction (ileus), gastrointestinal perforation, severe abdominal pain, or if you notice blood in your stools.
• If you notice sudden changes in bowel habits (frequency and consistency of stools) that persist for more than 2 weeks.

Warnings and precautions

Consult your doctor or pharmacist before starting to take DulcoLax Picosulfate.

• Like all laxatives, DulcoLax Picosulfate should not be taken continuously on a daily basis or for prolonged periods without investigating the cause of constipation. Prolonged excessive use can cause water and electrolyte loss (diarrhea).
• Do not use this medication to try to lose weight. This product does not reduce caloric absorption in the intestine and can cause serious side effects. This product, like other stimulant laxatives, does not help with weight loss.

• When administered to elderly people for prolonged periods, it can worsen states of fatigue and/or weakness or cause a decrease in blood pressure and lack of coordination.
• There have been reports of dizziness and/or fainting in patients who have used sodium picosulfate. Based on available information, these may be due to a vasovagal response (e.g., to abdominal spasms or defecation) and not necessarily to the use of sodium picosulfate.

Children

In children under 6 years of age, administer only under medical supervision.

Other medications and DulcoLax Picosulfate

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

The simultaneous use of diuretics (medications used to increase urine elimination) or adrenocorticosteroids may increase the risk of electrolyte imbalance if excessive doses of DulcoLax Picosulfate are taken. An electrolyte imbalance can lead to increased sensitivity to cardiac glycosides (medications used for the heart).

The simultaneous administration of antibiotics may reduce the laxative effect of DulcoLax Picosulfate.

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.

No studies have been conducted on the effect on fertility in humans.

Driving and using machines

There are no specific studies on the ability to drive vehicles and use machines.

During treatment with this medication, dizziness and/or fainting can occur due to a vasovagal response (e.g., to abdominal spasms). If you experience abdominal spasms, you should avoid potentially hazardous tasks such as driving or operating machines.

DulcoLax Picosulfate contains sorbitol (E-420), sodium benzoate (E-211), and sodium

This medication contains 450 mg of sorbitol per ml.

Sorbitol is a source of fructose. If your doctor has told you (or your child) that you have an intolerance to certain sugars, or you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease in which the patient cannot break down fructose, consult your doctor before taking this medication.

Sorbitol can cause gastrointestinal discomfort and a mild laxative effect.

This medication contains 2 mg of sodium benzoate per ml. Sodium benzoate can cause jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).

This medication contains less than 1 mmol of sodium (23 mg) per ml; that is, it is essentially "sodium-free".

3. How to take DulcoLax Picosulfate

Follow the administration instructions for the medication contained in this leaflet or as indicated by your doctor or pharmacist exactly. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults and adolescents over 12 years:

8 to 12 drops per day (4 to 6 mg of sodium picosulfate), in a single dose.

This means a maximum daily dose of 12 drops (6 mg of sodium picosulfate).

Use in children and adolescents

Children and adolescents from 6 to 12 years:

2 to 8 drops per day (1 to 4 mg of sodium picosulfate), in a single dose.

This means a maximum daily dose of 8 drops (4 mg of sodium picosulfate).

It is recommended to start with the lowest dose. The dose can be adjusted up to the maximum recommended dose capable of producing regular bowel movements.

Do not exceed the maximum recommended daily dose.

Method of administration

It should be administered orally.

The drops can be taken alone or dissolved in any type of drink (water, milk, fruit juice, etc.) or food (purées, mush, etc.).

DulcoLax Picosulfate should be administered at night, to produce evacuation the next morning. It should be administered in a single dose per day.

If your symptoms worsen, if there is no bowel movement after 12 hours after taking the maximum daily dose, you should consult your doctor.

It should not be used for more than 6 consecutive days without consulting a doctor.

If you think the effect of DulcoLax picosulfate is too strong or too weak, inform your doctor or pharmacist.

If you take more DulcoLax Picosulfate than you should

Gastrointestinal spasms, mucous and diarrheal stools, fluid loss, potassium, and other electrolytes may occur.

At much higher doses than recommended, cases of ischemia (decreased blood flow) in the colon mucosa have been reported.

Like all laxatives, continuous use of high doses of laxatives can cause chronic diarrhea, abdominal pain, decreased potassium in the blood, secondary hyperaldosteronism, and kidney stones. Renal tubular lesions, metabolic alkalosis (increased bicarbonate in the blood), and muscle weakness due to decreased potassium levels in the blood have also been reported.

If you have taken more DulcoLax picosulfate than you should, go to a medical center or call the Toxicology Information Service at 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take DulcoLax Picosulfate

Do not take a double dose to make up for forgotten doses.

4. Possible side effects

Like all medications, DulcoLax Picosulfate can cause side effects, although not everyone will experience them.

Very common side effects (may affect at least 1 in 10 patients):

• diarrhea

Common side effects (may affect more than 1 in 10 people)

• colic
• abdominal pain
• abdominal discomfort

Uncommon side effects (may affect up to 1 in 100 people)

• vomiting
• nausea
• dizziness

Side effects of unknown frequency (cannot be estimated from available data)

• hypersensitivity (allergic reactions)
• angioedema (inflammation under the skin surface)
• skin reactions
• fainting
• skin rash
• swelling of the skin or mucous membranes (exanthema)
• itching

The dizziness and fainting that occur after administration of DulcoLax Picosulfate seem to be consistent with a vasovagal response (e.g., to abdominal spasms or defecation).

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this 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 Picosulfate

Keep this medication out of sight and reach of children.

Do not store above 30°C.

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

Do not use after 6 months of opening the packaging for the first time.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection 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

Composition of DulcoLax Picosulfate

• The active ingredient is sodium picosulfate. Each ml (15 drops) contains 7.5 mg of sodium picosulfate.
• The other components (excipients) are: sodium benzoate (E-211), sorbitol liquid (E-420), sodium citrate dihydrate, citric acid monohydrate, and water.

Appearance of the product and package contents

DulcoLax Picosulfate is presented as oral drops in a slightly viscous, clear, colorless or slightly yellowish or light brownish solution.

It is presented in a 30 ml transparent plastic bottle with a dropper and screw cap.

Marketing authorization holder and manufacturer

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.

Localita i Prulli- 50066 Reggello (Florence)

Italy

Date of the last revision of this leaflet: October 2024

You can access detailed and updated information about this medication by scanning the QR code included in the leaflet with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/49903/P_49903.html

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