Gindjaleling (Capsules) Instructions for Use

Marketing Authorization Holder

PT. Phytochemindo Reksa (Indonesia)

ATC Code

G04BC (Drugs for the treatment of nephrourolithiasis)

Dosage Form

Gindjaleling

Capsules 250 mg: 75 or 100 pcs.

Dosage Form, Packaging, and Composition

Capsules size 1, with a green body and cap; the capsule contents are a homogeneous powder ranging from light brown to brown in color.

Excipients: nipagin, nipazol, Aerosil 200, corn starch, talc, magnesium stearate.

10 pcs. – blisters (10) – cardboard packs.
75 pcs. – polymer bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Drug used for urolithiasis

Pharmacotherapeutic Group

Spasmolytic agent of plant origin

Pharmacological Action

A herbal remedy. It has a spasmolytic and weak diuretic effect, and promotes the excretion of small stones from the urinary tract.

Indications

• Use as part of complex therapy for urolithiasis.

Specifically indicated for stones located in the renal pelvises with a size not exceeding 0.3-0.4 cm, with a maximum size of 0.6 cm.

Also used for the expulsion of small calculi from the upper urinary tract and for clearing the ureter of stone fragments after lithotripsy procedures.

ICD codes

Dosage Regimen

Take orally three times per day. The standard course of treatment is three to six weeks.

Adhere strictly to the prescribed dosage and duration of therapy. Do not exceed the recommended daily intake.

Consult a physician for dosage adjustments or if there is no improvement in symptoms after the initial treatment period.

Adverse Reactions

No adverse effects have been identified when used in accordance with the approved indications and recommended dosage.

Discontinue use immediately and consult a healthcare professional if any unusual symptoms or suspected allergic reactions occur.

Report any adverse events to the relevant national pharmacovigilance system.

Contraindications

• Do not use in patients with a known hypersensitivity to any of the active or excipient components of the drug.

• Contraindicated in individuals with a history of allergic reactions to plants from the Lamiaceae, Acanthaceae, Phyllanthaceae, or Poaceae families.

Special Precautions

During the course of treatment, it is recommended to increase the amount of fluid consumed.

Storage Conditions

Store at 15°C (59°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.