The active substance in this medicine, sodium picosulfate, belongs to a group of medicines called stimulant laxatives.

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

If symptoms worsen, if no stool occurs after 12 hours after maximum daily administration, or if symptoms persist after 6 days of treatment, you should consult your doctor.

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

Do not take Dulcolaxo Picosulfate

• If you are allergic to sodium picosulfate or any of the other ingredients of this medicine (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 an acute inflammatory bowel disease, intestinal obstruction (ileus), gastrointestinal perforation, severe or undiagnosed abdominal pain, severe dehydration, or if you notice blood in your stool.
• If you notice sudden changes in bowel habits (frequency and consistency of stools) that persist for more than 2 weeks.

Warnings and cautions

Consult your doctor or pharmacist before taking Dulcolaxo picosulfate.

•      Like all laxatives, Dulcolaxo picosulfate should not be taken continuously on a daily basis or for prolonged periods without investigating the cause of the constipation. Prolonged excessive use can cause loss of water and electrolytes (diarrhea).

•      When administered to the elderly for long periods of time, it can worsen states of fatigue and / or weakness or cause a decrease in blood pressure and lack of coordination of movements.
•      Dizziness and / or syncope have been reported in patients who have used sodium picosulfate. Based on the information available, they could be due to syncope due to straining during defecation or to a reflex response to abdominal pain related to constipation and not necessarily to the use of sodium picosulfate.

Children

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

Using Dulcolaxo Picosulfate with other medicines

Tell your doctor or pharmacist if you are using, have recently used or might take any other medicines.

The simultaneous use of diuretics (medicines used to increase urine output) or adrenocorticosteroids may increase the risk of electrolyte imbalance if excessive doses of Dulcolaxo picosulfate are taken . An electrolyte imbalance can lead to an increased sensitivity of cardiac glycosides (medicines used for the heart).

Simultaneous administration of antibiotics may reduce the laxative action of Dulcolaxo picosulfate.

Pregnancy, lactation and fertility

If you are pregnant or breast-feeding, think you might be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

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

Driving and using machines

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

During treatment with this medicine, dizziness and / or syncope may occur due to a vasovagal response (eg abdominal spasms). If you have abdominal spasms, you should avoid potentially dangerous tasks such as driving or operating machines.

Dulcolaxo Picosulfate contains sorbitol

This medicine contains sorbitol. If your doctor has told you that you have an intolerance to some sugars, contact him before taking the medicine.

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

The recommended dose is:

Adults and adolescents over 12 years :

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

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

Use in children and adolescents

Children and adolescents from 6 to 12 years old :              

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

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

By increasing or decreasing the dosage the personal optimal dose can be established.

Form of administration :

It must be administered orally.

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

Dulcolaxo picosulfate should be administered in the evening, to produce a bowel movement the next morning. It should be administered in a single dose per day.

If the symptoms worsen, if no stool occurs after 12 hours after the maximum daily administration you should consult your doctor.

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

If you think that the action of Dulcolaxo picosulfate is too strong or too weak, contact your doctor or pharmacist.

If you take more Dulcolaxo Picosulfate than you should

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

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

Like all laxatives, the continued use of high doses of laxatives can cause chronic diarrhea, abdominal pain, decreased potassium in the blood, hyperaldosteronism (excessive production of the hormone aldosterone by the adrenal gland) secondary and kidney stones (kidney stones) . Lesions in the renal tubule, metabolic alkalosis (increased amount of bicarbonate in the blood) and muscle weakness due to decreased blood potassium have also been described.

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

If you forget to take Dulcolaxo Picosulfate:

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

Like all medicines, Dulcolaxo picosulfate can cause side effects, although not everyone gets them.

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

-               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
• sickness
• dizziness

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

• hypersensitivity (allergic reactions)
• angioedema (swelling that occurs under the surface of the skin)
• skin reactions
• syncope
• skin rash
• swelling of the skin or mucous membranes (rash)
• itchiness

Dizziness and syncope that appear after administration of Dulcolaxo picosulfate appear to be consistent with a vasovagal response (eg abdominal spasm, defecation).

Communication of adverse effects

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

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

Do not store above 30ºC .

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the month indicated.

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

L os Medicines should not be disposed of via wastewater or household waste. Deposit the containers and medicines that you do not need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unneeded medicine and containers. In this way , you will help protect the environment.

Composition of Dulcolaxo Picosulfate

•      The active substance is sodium picosulfate. Each ml (15 drops) contains 7.5 mg of sodium picosulfate.
•      The other ingredients (excipients) are: sodium benzoate, liquid sorbitol, sodium citrate dihydrate, citric acid monohydrate and water qs

What the product looks like and contents of the pack

Dulcolaxo picosulfate is presented as oral drops in solution, slightly viscous, clear, colorless to yellowish or slightly yellowish-brown.

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

Holder of the marketing authorization and responsible for manufacturing

Marketing authorization holder:

Sanofi - aventis, SA

C / Josep Pla, 2

08019 - Barcelona

Responsible for manufacturing:                                                                      

Istituto De Ang eli , Srl

Localita i Prulli- 50066 Reggello (Florence)

Italy

DATE OF THE LAST REVISION OF THIS PACKAGE LEAFLET: AUGUST 2019

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