Boehringer Ingelheim

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DULCOLAX PICO is a locally active laxative that stimulates intestinal peristalsis and softens stools.

DULCOLAX is used for:

- use in patients with constipation (difficulty passing stools);
- in conditions where facilitation of defecation is required.

Do not take DULCOLAX PICO:

- if you are allergic (hypersensitive) to sodium picosulphate or any of the other ingredients of DULCOLAX PICO;
- if you have intestinal entanglement (temporary suppression of intestinal peristalsis) or intestinal obstruction;
- if you have an acute surgical abdomen, including appendicitis or acute inflammation of the intestines;
- if you are severely dehydrated;
- if you experience severe abdominal pain associated with nausea and vomiting - these conditions may be indicators of more serious ones;
- if you have rare congenital diseases that may lead to incompatibility with some of the excipients of the medicinal product (see section "Important information about some of the ingredients of DULCOLAX PICO").

Take special care with DULCOLAX PICO: if you need laxatives every day or for a long period of time - you should contact your doctor to determine the cause of constipation, as prolonged use of high doses may lead to disturbance of water and electrolyte balance and lowering the level of potassium in the blood (hypokalemia).

Dizziness and nausea have been reported in patients taking DULCOLAX PICO.
These events may be associated with constipation (contractions during bowel movements, abdominal pain), but not necessarily with the administration of sodium picosulphate itself.
Children should not take DULCOLAX PICO without a prescription.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
When taking high doses of DULCOLAX PICO, concomitant use of diuretics (dehydrators) or steroids may increase the risk of electrolyte imbalance. Electrolyte imbalance can lead to increased sensitivity to cardiac glycosides (a group of medicines used in heart failure and irregular heartbeat, such as digoxin). Co-administration with antibiotics (medicines to treat bacterial infections) may reduce the laxative effect of DULCOLAX PICO.

Fertility, pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Like all medicines, DULCOLAX PICO should only be taken with a prescription during pregnancy.
DULCOLAX PICO can be used safely during breast-feeding.
No studies on the effects of the medicinal product on human fertility have been performed. Preclinical studies have not shown any effect on fertility (please see section 5.3 "Preclinical safety data").

Driving and using machines
No studies on the effects of DULCOLAX PICO on the ability to drive and use machines have been performed.
However, patients should be informed that due to a reaction of the autonomic nervous system (eg abdominal spasm), they may experience dizziness or nausea. If patients experience abdominal cramps, they should avoid potentially dangerous activities such as driving or operating machinery.

Important information about some of the ingredients of DULCOLAX PICO
1 ml of the drops contain 0.45 g of sorbitol, which corresponds to 0.6 g of sorbitol in the maximum recommended daily dose for the treatment of adults and children over 10 years of age. Patients with congenital fructose intolerance should not take this medicine.

Always take DULCOLAX PICO exactly as your doctor has told you. If you are not sure, talk to your doctor or pharmacist.

The usual dose is:

Adults and children over 10 years: 10 - 20 drops (5 - 10 mg);
Children 4 - 10 years: 5 - 10 drops (2.5 - 5 mg).

For children under 4 years of age, the recommended dose is 250 micrograms / kg body weight.
DULCOLAX PICO should be taken in the evening to induce defecation the next morning.
The duration of action is usually 6-12 hours after ingestion.

If you take or take more DULCOLAX PICO than
you should If you take more DULCOLAX PICO than you should, you should seek advice from your doctor or pharmacist.
If high doses are taken, watery stools (diarrhea), abdominal cramps and loss of fluids, potassium and other electrolytes may occur.
In addition, cases of damage to the inner lining of the colon (ischemia of the colonic mucosa) have been reported when DULCOLAX PICO has been taken at doses significantly higher than those recommended for the treatment of constipation.
Chronic overdose with DULCOLAX PICO, as well as all laxatives, can cause chronic diarrhea, abdominal pain, decreased blood potassium, secondary hyperaldosteronism (increased production of the hormone aldosterone, which controls sodium and potassium levels in the blood) and kidney stones. disease. Cases of damage to the renal tubules (a type of kidney disorder), metabolic alkalosis (acid-base imbalance) and muscle weakness due to reduced blood potassium have been described as a result of chronic abuse of laxatives.

If you forget to take DULCOLAX PICO
If you forget to take DULCOLAX PICO, do so as soon as you remember, but do not take a double dose to make up for a forgotten dose.

If you stop taking DULCOLAX PICO
DULCOLAX PICO should be taken only when needed and should be stopped if necessary.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

DULCOLAX PICO Possible side effects:
Like all medicines, DULCOLAX PICO can cause side effects, although not everybody gets them.

To determine the frequency of adverse reactions, the following classification is used:

very common: in more than 1 in 10 patients;
common: in more than 1 in 100, and in less than 1 in 10 patients;
uncommon: in more than 1 in 1,000, and in less than 1 in 100 patients;
rare: in more than 1 in 10,000, and in less than 1 in 1,000 patients);
very rare: in less than 1 in 10,000 patients;
not known: no estimate can be made from the available data.

Gastrointestinal disorders:

Very common: diarrhea;
Common: abdominal cramps, abdominal pain, stomach discomfort;
Uncommon: vomiting, nausea.

Immune system disorders:

Not known: Hypersensitivity, including angioneurotic edema (rapid swelling of the skin or mucous membranes, which may cause difficulty breathing) and skin reactions.

Nervous system

disorders: Uncommon: dizziness;
Not known: nausea.

Dizziness and nausea following sodium picosulphate appear to be compatible with a vascular innervation response (eg abdominal cramps, defecation).

DULCOLAX PICO Composition:
The active substance is: 7.5 mg sodium picosulphate per 1 ml of solution (= 15 drops).
The other ingredients are: sodium benzoate, 70% sorbitol solution, sodium citrate dihydrate, citric acid monohydrate, purified water.

Istituto de Angeli Srl, Italy.