Konsulaks-NP (Drops) Instructions for Use

Marketing Authorization Holder

Iris, LLC (Russia)

Manufactured By

Tula Pharmaceutical Factory, LLC (Russia)

ATC Code

A06AB08 (Sodium picosulfate)

Active Substance

Sodium picosulfate (Rec.INN registered by WHO)

Dosage Form

Konsulaks-NP

Oral drops 7.5 mg/ml: bottle or dropper bottle 30 ml or 40 ml

Dosage Form, Packaging, and Composition

Oral drops – a transparent, colorless to yellowish or slightly yellowish-brownish, slightly viscous solution.

Excipients: sodium benzoate – 0.2 g, sorbitol liquid 70% (non-crystallizing) – 64.37 g (in terms of sorbitol – 45.059 g), sodium citrate dihydrate – 0.15 g, citric acid monohydrate – 0.14 g, purified water – 49.89 g.

30 ml – bottles (1) – cardboard packs.
40 ml – bottles (1) – cardboard packs.
30 ml – dropper bottles (1) – cardboard packs.
40 ml – dropper bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Laxative drug

Pharmacotherapeutic Group

Drugs for the treatment of constipation; contact laxatives

Pharmacological Action

Laxative.

Under the action of intestinal microorganisms, it is hydrolyzed to form an active form, which irritates the receptors of the intestinal mucosa and enhances its peristalsis.

It promotes the accumulation of water and electrolytes in the large intestine, which leads to stimulation of defecation, reduction of evacuation time, and softening of stool.

Pharmacokinetics

After oral administration, it is not absorbed from the gastrointestinal tract and does not undergo enterohepatic circulation.

In the distal part of the large intestine, sodium picosulfate is cleaved to form the active metabolite bis-(p-hydroxyphenyl)-pyridyl-2-methane.

The time to onset of the laxative effect is determined by the rate of release of the active metabolite and is 6-12 hours.

Approximately 10.4% of the total dose is excreted by the kidneys as a glucuronide within 48 hours.

Indications

Constipation due to atony and hypotension of the colon (including in the elderly, in bedridden patients, after surgery, after childbirth and during lactation); constipation caused by medication; constipation due to intestinal dysbiosis, dietary disorders; for regulating stool in hemorrhoids, proctitis, anal fissures; gallbladder diseases, irritable bowel syndrome with predominant constipation.

ICD codes

Dosage Regimen

Administer orally. Determine the dose individually based on the patient’s age and clinical response.

For adults and children over 10 years of age, the usual dose is 13 to 27 drops (equivalent to 5 to 10 mg of sodium picosulfate). Take once daily, preferably in the evening before bedtime.

For children aged 4 to 10 years, the usual dose is 7 to 13 drops (equivalent to 2.5 to 5 mg of sodium picosulfate). Administer once daily in the evening.

For children under 4 years of age, determine the dose strictly by a physician based on body weight.

Measure the drops by holding the bottle vertically. Dilute the required number of drops in a small amount of water immediately before administration. The solution is tasteless and can be added to food or drink for pediatric patients.

Do not use the drug daily for more than 10 days without medical supervision. Prolonged use can lead to electrolyte imbalance and dependence.

The onset of the laxative effect typically occurs after 6 to 12 hours. Adjust the dose to achieve a soft stool consistency. If constipation persists despite treatment, discontinue use and consult a physician to determine the underlying cause.

Adverse Reactions

From the digestive system: dyspepsia, flatulence, nausea, vomiting, cramps and abdominal pain, diarrhea.

From the nervous system: dizziness, fainting, drowsiness, increased fatigue.

From the immune system: allergic reactions, angioedema, allergic dermatitis.

From the skin and subcutaneous tissues: skin rash, urticaria, itching.

From the metabolism: increased excretion of potassium, sodium and other electrolytes, dehydration.

Contraindications

Hypersensitivity to sodium picosulfate; intestinal obstruction or obstructive bowel diseases; acute diseases of the abdominal organs or severe abdominal pain that may be accompanied by nausea, vomiting, fever, including appendicitis; acute inflammatory bowel diseases; severe dehydration; first trimester of pregnancy; childhood – depending on the dosage form.

With caution: old age, hypokalemia, increased blood magnesium concentration, asthenia, renal failure.

Use in Pregnancy and Lactation

Contraindicated for use in the first trimester of pregnancy.

Use in the second and third trimesters of pregnancy should only be if the intended benefit to the mother outweighs the possible risk to the fetus.

The active metabolite and its glucuronides are not excreted in breast milk.

Use during lactation (breastfeeding) is possible according to indications in recommended doses.

Use in Renal Impairment

Should be used with caution in patients with impaired renal function.

Pediatric Use

Use in children is possible according to indications, in age-appropriate recommended doses and dosage forms.

It is necessary to strictly follow the instructions in the sodium picosulfate drug labels regarding contraindications for the use of specific sodium picosulfate dosage forms in children of different ages.

Geriatric Use

Should be used with caution in elderly patients.

Special Precautions

The product is tasteless, so it can be added to food for children.

Do not use daily without medical supervision for more than 10 days.

Dizziness and fainting occurring after taking sodium picosulfate may be associated with a vasovagal reaction (e.g., straining during defecation, abdominal cramps).

The possibility of spontaneous defecation cannot be excluded.

If the nature of the stool does not change for a long time while taking sodium picosulfate, it is necessary to consult a doctor to determine the cause of constipation.

Studies on the effect of sodium picosulfate on fertility have not been conducted.

No teratogenic effects were identified.

Effect on the ability to drive vehicles and mechanisms

If vasovagal reactions occur in patients while taking the product, they should avoid driving vehicles and engaging in other activities requiring high concentration and speed of psychomotor reactions.

Drug Interactions

With simultaneous use with broad-spectrum antibiotics, a decrease in the laxative effect of sodium picosulfate is possible.

With simultaneous use with diuretics, with corticosteroids, an increased risk of electrolyte disturbances is possible.

Electrolyte imbalance occurring while taking sodium picosulfate in high doses may lead to worsened tolerance of cardiac glycosides with their simultaneous use.

Storage Conditions

Store at 2°C (36°F) to 30°C (86°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.