Pikasil^® (Tablets) Instructions for Use

Marketing Authorization Holder

Aliym, JSC (Russia)

ATC Code

A06AB08 (Sodium picosulfate)

Active Substance

Sodium picosulfate (Rec.INN registered by WHO)

Dosage Form

Pikasil®

Tablets 5 mg: 5, 10, 15, 20, 25, 30, 40, 45, 50, 60, or 75 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, round, flat-cylindrical, with a bevel and a score line.

Excipients : lactose monohydrate, corn starch, colloidal silicon dioxide, magnesium stearate.

5 pcs. – contour cell packs (1) – cardboard packs.
5 pcs. – contour cell packs (2) – cardboard packs.
5 pcs. – contour cell packs (3) – cardboard packs.
5 pcs. – contour cell packs (4) – cardboard packs.
5 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
15 pcs. – contour cell packs (1) – cardboard packs.
15 pcs. – contour cell packs (2) – cardboard packs.
15 pcs. – contour cell packs (3) – cardboard packs.
15 pcs. – contour cell packs (4) – cardboard packs.
15 pcs. – contour cell packs (5) – cardboard packs.

Clinical-Pharmacological Group

Laxative drug

Pharmacotherapeutic Group

Laxative

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 the defecation act, reduction of evacuation time, and softening of the 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 violations; for regulating stool in hemorrhoids, proctitis, anal fissures; gallbladder diseases, irritable bowel syndrome with predominant constipation.

ICD codes

Dosage Regimen

Administer orally. Individualize the dose based on patient age and clinical response.

For adults and children over 10 years, the usual dose is 5 mg to 10 mg (1 to 2 tablets) once daily.

For children aged 4 to 10 years, the usual dose is 2.5 mg to 5 mg (1/2 to 1 tablet) once daily.

For children under 4 years, use is not recommended for this formulation; select an appropriate pediatric dosage form.

Take the tablets in the evening, before bedtime, to produce a laxative effect after 6 to 12 hours.

Swallow the tablet whole with a full glass of water. The tablet can be divided at the score line for accurate half-doses.

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

For preparatory procedures before examinations or surgery, follow the specific regimen provided by the physician, which may involve higher or split doses.

In elderly patients or those with renal impairment, initiate therapy at the lower end of the dosage range due to increased susceptibility to adverse effects.

Discontinue use if severe abdominal pain, diarrhea, or dizziness occurs. If constipation persists despite treatment, re-evaluate the underlying cause.

Adverse Reactions

From the digestive system dyspepsia, flatulence, nausea, vomiting, abdominal cramps and 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 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; children’s age – depending on the dosage form.

With caution elderly 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 potential risk to the fetus.

The active metabolite and its glucuronides are not excreted in breast milk. It is possible to use during lactation (breastfeeding) according to indications in recommended doses.

Use in Renal Impairment

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

Pediatric Use

It is possible to use in children 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 use in children of different ages for specific sodium picosulfate dosage forms.

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 ability to drive vehicles and operate machinery

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 a deterioration in the tolerability of cardiac glycosides with their simultaneous use.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°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.