Regulax Oral Drops 20ml – for Short-Term Treatment of Constipation

What is Regulax Picosulfate Oral Drops?

Regulax Picosulfate Oral Drops contain sodium picosulfate (7.23 mg/ml) as the active substance. They are a laxative used for constipation and disorders which require easier passage of stools. Regulax should not be taken daily or over a prolonged period without prior medical assessment of the cause of constipation.

Active Substance and Composition

Each ml (20 drops) contains 7.5 mg sodium picosulfate monohydrate (equivalent to 7.23 mg sodium picosulfate). Other ingredients: sorbitol solution 70% (non-crystallising), propylene glycol, and purified water. Suitable for diabetics: contains sugar substitutes; 1 ml is equivalent to 0.03 bread units (BU). If you have been told you have an intolerance to some sugars, consult your doctor before taking this medicine.

Do Not Take Regulax Picosulfate Oral Drops If You:

• Are allergic to sodium picosulfate, related active substances from the triarylmethane group, or any other ingredient
• Have narrowing of the intestines with impaired bowel passage, bowel obstruction, or acute abdominal complaints such as appendicitis, severe abdominal pain with nausea and vomiting
• Have an acute inflammatory disease of the gastrointestinal tract
• Are severely dehydrated

Children below 4 years of age must not take Regulax Picosulfate Oral Drops.

Constipation associated with abdominal pain, vomiting, and fever may indicate serious illness (bowel obstruction, acute abdominal inflammation). If such complaints occur, do not take Regulax and consult your doctor immediately.

Warnings and Precautions

• Children aged 4 and older should only take Regulax Picosulfate Oral Drops if their doctor advises it.
• If symptoms are spontaneous, persist over a prolonged period, or are accompanied by bloody stools or fever, consult your doctor before use.
• Use under medical supervision if you have a condition associated with fluid and electrolyte imbalance (e.g. severely impaired kidney function).
• Dizziness and brief loss of consciousness (syncope) have been reported, possibly due to severe straining during bowel movements or a circulatory reaction caused by abdominal pain.

Interactions with Other Medicines

• Antibiotics taken at the same time may reduce the laxative effect of Regulax.
• Excessive use alongside diuretics or corticosteroids may cause an imbalance of potassium and other salts, leading to heart dysfunction, muscle weakness, and increased sensitivity to cardiac glycosides.

Pregnancy and Breastfeeding

Avoid use as much as possible during pregnancy. The active substance is not excreted in human milk; Regulax Picosulfate Oral Drops can therefore be used during breastfeeding. Consult your doctor or pharmacist for advice.

Driving and Using Machines

Should symptoms such as dizziness, brief loss of consciousness (syncope), or abdominal cramps occur, the ability to drive and use machines may be impaired.

Dosage

Take Regulax Oral Drops preferably in the evening. The laxative effect normally occurs after 10 to 12 hours.

• Adults and adolescents: 14–27 drops (equivalent to 5–10 mg sodium picosulfate) as a single dose.
• Children aged 4 and older (if prescribed by a doctor): 7–14 drops (equivalent to 2.5–5 mg sodium picosulfate) as a single dose.

Possible Side Effects

• Very common: Diarrhoea
• Common: Flatulence, abdominal pain or cramps
• Uncommon: Nausea, vomiting, dizziness
• Frequency unknown: Brief loss of consciousness (syncope), allergic reactions including skin reactions and angioedema (swelling of skin and/or mucous membranes, e.g. in the face and throat, possibly with shortness of breath)

Incorrect use such as extended periods or high doses can result in loss of water, potassium, and other electrolytes, potentially leading to heart dysfunction and muscle weakness, particularly when taken alongside diuretics or corticosteroids.

Overdose

Overdose may cause acute diarrhoea, abdominal discomfort, fluid loss, and potassium and mineral deficiencies. Seek medical attention. Chronic overdose is associated with chronic diarrhoea, abdominal pain, low potassium levels, excessive secretion of aldosterone, kidney stones, damage to kidney tissue, metabolic alkalosis, and muscle weakness due to low potassium levels.

Storage and Pack Contents

Keep out of the sight and reach of children. Do not use after the expiry date. Once opened, Regulax Picosulfate Oral Drops can be used for 6 months. Available in 20 ml (N1) and 50 ml (N3) packs.