Softovak (Powder) Instructions for Use

Marketing Authorization Holder

Lupin, Ltd. (India)

ATC Code

A06AB57 (Cascara in combination with other drugs)

Dosage Form

Softovak

Powder for oral administration 100 g: bottle.

Dosage Form, Packaging, and Composition

100 g – plastic bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Herbal laxative preparation

Pharmacotherapeutic Group

Laxative of plant origin

Pharmacological Action

A combined agent. It has a laxative effect.

It enhances peristalsis of the large intestine and normalizes stool consistency.

It has anti-inflammatory, choleretic, and carminative action.

Indications

• Constipation;
• Regulation of stool in hemorrhoids, proctitis, anal fissures.

ICD codes

Dosage Regimen

Administer orally.

Take once daily at night.

The dose is 1 to 2 teaspoons (5-10 g).

Mix the powder with a full glass of warm water or juice.

Alternatively, dissolve the dose in half a glass of warm water before ingestion.

Ensure adequate fluid intake throughout the day.

Do not exceed the recommended daily dose.

Limit the duration of use; do not use for more than two weeks without medical consultation.

If constipation persists, discontinue use and seek medical advice.

Adverse Reactions

Allergic reactions. After taking the drug, urine may turn yellow-brown or red-lilac in color.

Contraindications

• Intestinal obstruction;
• Abdominal pain of unknown origin;
• Incarcerated hernia;
• Acute inflammatory diseases of the abdominal cavity;
• Peritonitis;
• Gastrointestinal and uterine bleeding;
• Cystitis;
• Disturbances of water-electrolyte balance;
• Pregnancy;
• Lactation;
• Childhood;
• Hypersensitivity to the components of the drug.

With caution in case of liver and/or kidney diseases, and in conditions after abdominal surgery.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and lactation.

Use in Hepatic Impairment

With caution in case of liver diseases.

Use in Renal Impairment

With caution in case of kidney diseases.

Pediatric Use

Contraindicated in childhood.

Special Precautions

It is not recommended to use the drug for more than 2 weeks.

With prolonged use, especially in high doses, possible loss of electrolytes with feces, mainly potassium, albuminuria, hematuria, nausea, vomiting, diarrhea, discoloration of urine, skin rash, fatigue.

Drug Interactions

With prolonged use in high doses, it is possible to enhance the effect of cardiac glycosides and influence the effect of antiarrhythmic drugs due to the possibility of hypokalemia development.

With simultaneous use with thiazide diuretics, corticosteroids, licorice root preparations, the risk of hypokalemia increases.

Impairs the absorption of tetracyclines.

Storage Conditions

Store the drug at a temperature not exceeding 30°C (86°F), in a dry place, protected from light and out of reach of children.

Shelf Life

Shelf life – 3 years. Do not use after the expiration date printed on the package.

Dispensing Status

The drug is approved for use as an over-the-counter product.

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.