Each 1 ml contains:

Sodium picosulfate ................................................................ 7.5 mg

Inactive ingredients:

Methylparaben sodium, sorbitol 70% solution, purified water.

For use in constipation and in conditions that require easier defecation.

Like other laxatives, Picolax Oral Drops should not be taken daily or for prolonged periods without differential diagnosis of constipation.

Dosage:

Adults: Adults:

Unless otherwise prescribed, adults shall take 17-33 drops of Picolax Oral Drops (equivalent to 5-10 mg sodium picosulfate).

Children from 4 years and Adolescents:

Children from 4 years onwards shall take 8-17  drops of Picolax Oral Drops (equivalent to 2.5-5 mg sodium picosulfate) as prescribed by the doctor.

It is recommended to start with the lowest dose. The dose can be adjusted up to the maximum recommended dose to allow for regular bowel movements.

The daily maximum dose of 33 drops (for adults) or 17 drops (for children over 4 years) should not be exceeded.

Administration:

For oral use.

Picolax Oral Drops are best taken in the evening, with and without liquid.

The effect usually occurs after 10-12 hours.

Handling the Dropper Bottle:

In order to produce the solution, hold the bottle vertically downwards. If necessary, lightly tap on the bottom of the bottle to "drip".

Period of Administration:

Picolax Oral Drops should not be taken uninterrupted daily or for prolonged periods without clarification of the cause of constipation.

Hypersensitivity to the active substance, other triarylmethanes or any of the excipients.

Ileus or intestinal obstruction.

Severe, acute abdominal pain with and without fever (e.g. appendicitis), possibly related to nausea and vomiting.

Acute inflammatory diseases of the gastrointestinal tract.

Severe dehydration.

Children under 4 years.

In diseases associated with water and electrolyte disturbances (e.g. severely impaired renal function), sodium picosulfate should only be used under medical supervision.

For chronic constipation, a differential diagnosis should be performed. Prolonged, excessive use of sodium picosulfate can lead to fluid and electrolyte imbalances and hypokalaemia.

If sodium picosulfate is discontinued, the symptoms may reappear. After long-term use in chronic constipation, the recurrence of symptoms may also be associated with an aggravation of constipation.

Dizziness and/or syncope associated with ingestion of sodium picosulfate has been reported. Available information suggests that these are defecation syncopes (Valsalva maneuver) or a vasovagal response to abdominal pain.

Children (from 4 years) and Adolescents:

For children 4 years of age or older, Picolax Oral Drops should only be used if expressly prescribed by the physician.

Other ingredients:

Sorbitol: Patients with hereditary fructose intolerance (HFI) should not take this medicine.

The concomitant use of diuretics or corticosteroids may increase the risk of electrolyte imbalance if sodium picosulfate is used too often.

Electrolyte imbalance can increase sensitivity to cardiac glycosides.

The concomitant use of antibiotics may result in the loss of the laxative effect of sodium picosulfate.

There are no meaningful clinical trials for use in pregnancy.

The use of sodium picosulfate during pregnancy should be avoided for safety reasons.

Lactation:

Clinical data show that neither the active metabolite bis (parahydroxyphenyl) -pyridyl-2-methane (BHPM) nor its glucuronides are excreted in breast milk. Picolax Oral Drops can therefore be used during breastfeeding.

Fertility:

There are no clinical studies on effects on fertility in humans.

No studies on the effects on the ability to drive and to use machines have been performed. However, patients should be advised that side effects such as dizziness and/or syncope may occur due to a vasovagal response (e.g. abdominal cramping). If abdominal cramping occurs, patients should avoid potentially hazardous activities, such as driving or operating machinery.

The frequencies for side effects are based on the following categories:

Very common: ≥ 1/10; Common: ≥ 1/100, < 1/10; Uncommon: ≥ 1/1.000, < 1/100; Rare: ≥ 1/10.000, < 1/1.000; Very rare: < 1/10.000; Unknown: Frequency cannot be estimated from the available data.

Immune system disorders:

Not known: Allergic reactions.

Nervous system disorders:

Uncommon: Dizziness.

Not known: Syncope.

Available evidence suggests that dizziness and syncope are vasovagal reactions (e.g. abdominal cramping or defecation).

Gastrointestinal disorders:

Very common: Diarrhea.

Common: Abdominal discomfort, abdominal pain, abdominal cramps.

Uncommon: Nausea, vomiting.

Skin and Subcutaneous tissue disorders:

Not known: Skin reactions such as angioedema, drug eruption, rash, pruritus.

Improper use of sodium picosulfate (overdosed for too long) can result in the loss of water, potassium and other electrolytes. This can lead to disorders of heart function and muscle weakness, especially when concomitant diuretics or corticosteroids are used.

Overdose may result in watery stools (diarrhea), abdominal cramps, and clinically relevant fluid, potassium, and other electrolyte losses. 

In acute overdose, the effect of the drug can be reduced or prevented within a short time after ingestion, by induced vomiting or gastric lavage. If necessary, balancing measures such as fluid and electrolyte compensation should be considered. The administration of spasmolytics may be useful under certain circumstances. 

Furthermore, isolated cases of mucosal ischemia have been reported in which the dosage of sodium picosulfate was considerably higher than that recommended for the treatment of constipation.

Note:

In general, sodium picosulfate like other laxatives, are known to cause chronic diarrhea, abdominal pain, hypokalaemia, secondary hyperaldosteronism, and renal calculi in chronic overdose. Renal tubular injury, metabolic alkalosis and hypokalaemia-related muscle weakness have also been reported in association with chronic laxative abuse.

Pharmacodynamic properties:

Pharmacotherapeutic group: Laxatives.

Sodium picosulfate, the active ingredient of Picolax Oral Drops, is a locally acting laxative from the group of triarylmethanes. After bacterial metabolism in the colon, the mucosa of the large intestine is stimulated. This leads to a stimulation of peristalsis and promotes the accumulation of water and electrolytes in the colonic lumen. This results in a stimulation of defecation, a reduction in transit time and a consistency reduction of the stool.

Sodium picosulfate acts in the colon and specifically stimulates the emptying process. Therefore, it does not affect the absorption of calories or essential nutrients in the small intestine.

Pharmacokinetic properties:

Absorption and Distribution:

After oral intake, sodium picosulfate reaches the colon without appreciable absorption.

Biotransformation:

After bacterial cleavage in the distal segment of the intestine, sodium picosulfate becomes active.

Metabolites are converted to bis (parahydroxyphenyl)-pyridyl-2-methane (BHPM).

Elimination:

After conversion, only small amounts of BHPM are absorbed. After oral administration of 10 mg sodium picosulfate, 10.4% of the total dose is excreted as BHPM glucuronide after 48 hours in the urine. BHPM is also excreted as glucuronide via the bile.

Pharmacokinetic/Pharmacodynamic relationships: 

The onset of the preparation is usually 6-12 hours, depending on the release of the active metabolite (BHPM). There is no correlation between the laxative effect and the plasma level of the active metabolite.

Store at a temperature not exceeding 30^ºC.

PICOLAX Oral Drops: 15 ml Dropper bottle.