Avioplant^® (Capsules) Instructions for Use

Marketing Authorization Holder

Phytopharm Kleka, S.A. (Poland)

ATC Code

V30 (Not assigned)

Active Substance

Ginger (BP British Pharmacopoeia)

Dosage Form

Avioplant®

Capsules 250 mg: 10 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, size No. 1; body opaque, light green in color; cap opaque, dark green in color; capsule contents – powder from pale yellow with a grayish tint to light brown in color, with an aromatic odor.

Excipients (capsule shell) purified water – 11.02 mg, gelatin – 63.769 mg, indigo carmine – 102 mcg, quinoline yellow dye – 75 mcg, titanium dioxide – 1.034 mg.

10 pcs. – blisters (1) – cardboard packs.

Clinical-Pharmacological Group

Antiemetic drug of plant origin

Pharmacotherapeutic Group

Herbal remedy

Pharmacological Action

Avioplant^® has an antiemetic effect, stimulates the secretion of saliva, gastric juice, bile, normalizes digestion, enhances gastrointestinal motility, and prevents the occurrence of flatulence.

Indications

• Treatment and prevention of motion sickness;
• Postoperative nausea and vomiting;
• Hypomotility of the gastrointestinal tract;
• Biliary dyskinesia of the hypotonic type;
• Flatulence.

ICD codes

Dosage Regimen

For motion sickness prevention, take 2 capsules orally 30 minutes before travel.

If nausea occurs during the journey, take 1-2 capsules every 4 hours as needed.

For prevention of postoperative vomiting, take 4 capsules1 hour before the surgical procedure.

For normalization of gastrointestinal motility, take 2-4 capsules per day, divided as directed.

Adverse Reactions

Adverse reactions are generally mild and infrequent.

Reported reactions include allergic reactions such as skin rash or itching.

Heartburn may occur, particularly in susceptible individuals.

Discontinue use and consult a healthcare professional if adverse reactions persist or worsen.

Drug Interactions

Exercise caution with anticoagulants and antiplatelet agents due to potential increased bleeding risk.

Monitor blood glucose levels when used concurrently with antidiabetic medications.

May affect absorption of other drugs by altering gastrointestinal motility and transit time.

Consult a healthcare provider before concomitant use with any prescription medications.

Contraindications

• Calculous cholecystitis due to risk of biliary colic.
• Vomiting of pregnancy; safety not established for this condition.
• Childhood under 12 years due to lack of safety data.
• Lactation period; potential risk to the infant.
• Hypersensitivity to ginger or any excipient of the formulation.

With caution gastritis, gastric and duodenal ulcer.

Overdose

Symptoms of overdose may include pronounced heartburn, abdominal discomfort, and central nervous system depression.

In case of suspected overdose, discontinue use immediately and initiate symptomatic and supportive treatment.

Gastric lavage may be considered if performed soon after ingestion. There is no specific antidote available.

Seek immediate medical attention or contact a poison control center for management recommendations.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and lactation.

Pediatric Use

Contraindicated in children under 12 years of age.

Storage Conditions

Store in a place protected from light, at a temperature not exceeding 25°C (77°F).

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.