Phitogalenica^® (Extract) Instructions for Use

Marketing Authorization Holder

Fitogalenika, LLC (Russia)

Manufactured By

Moscow Pharmaceutical Factory CJS (Russia)

ATC Code

V30 (Not assigned)

Dosage Form

Phitogalenica®

Extract for oral administration (liquid): bottle 50 ml or 100 ml

Dosage Form, Packaging, and Composition

Extract for oral administration (liquid) in the form of a liquid from yellowish-brown to dark brown in color, with a characteristic odor; during storage, the formation of a slight sediment is possible.

Excipients: ethanol (ethyl alcohol) 38-45% – a sufficient quantity to obtain 1000 ml of the preparation.

50 ml – dark glass bottles (1) – cardboard packs.
100 ml – dark glass bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Herbal preparation with general tonic effect

Pharmacotherapeutic Group

Herbal general tonic agent

Pharmacological Action

It is a herbal remedy. It has an antioxidant, detoxifying, and general strengthening effect, due to the complex of biologically active substances contained in the medicinal plants which are part of it.

Use in debilitated patients helps to increase appetite, improve general condition, and increase work capacity.

It has a positive effect on the state of the neutrophilic component of immunity and peripheral blood parameters.

Indications

As part of complex therapy for asthenic conditions, during convalescence after severe illnesses, in the postoperative period, during physical and mental fatigue.

ICD codes

Dosage Regimen

Administer the extract orally.

Dilute 30-40 drops in a small amount of water (approximately 50 ml).

Take three times daily, approximately 30 minutes before meals.

The maximum single dose is 40 drops.

The maximum daily dose is 120 drops.

The standard treatment course is 3 to 4 weeks.

Repeat courses are possible only after consultation with a physician.

Do not exceed the recommended dosage.

Shake the bottle well before each use.

Adverse Reactions

Possible allergic reactions, photosensitizing effect.

Contraindications

Hypersensitivity to the components of the product, acute period of infectious diseases, cholelithiasis, gastritis in the acute phase, acute pancreatitis, gastric and duodenal ulcer in the acute phase, liver diseases, alcoholism, traumatic brain injury, brain diseases, pregnancy, breastfeeding period, age under 18 years.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and breastfeeding.

Pediatric Use

Contraindicated for use in children and adolescents under 18 years of age.

Special Precautions

Effect on the ability to drive vehicles and mechanisms

During the use of the product, one should refrain from performing potentially hazardous activities that require increased concentration and speed of psychomotor reactions (driving vehicles, working with moving mechanisms, work of a dispatcher, operator).

Drug Interactions

Due to the content of St. John’s wort, when used concomitantly with warfarin, digoxin, cyclosporine, steroid drugs, antiviral agents for the treatment of HIV (amprenavir, indinavir, nevirapine, nelfinavir, ritonavir, saquinavir, efavirenz), a decrease in their effectiveness is possible.

When used concomitantly, an increase in the photosensitizing effect of other medicinal products, including piroxicam, sulfonamides, tetracyclines, thiazide diuretics, quinolones, is possible.

When used concomitantly, an increase in the antidepressant effect of monoamine oxidase inhibitors is possible, with an increased risk of their side effects.

When used concomitantly with fluoxetine, paroxetine, sertraline, fluvoxamine, or citalopram, a worsening of hemolytic reactions and the course of serotonin syndrome (dizziness, nausea, vomiting, headache, epigastric pain, anxiety, state of confusion, agitation, feeling of restlessness and irritability) is possible.

When used concomitantly, a decrease in the hypotensive effect of reserpine and the concentration of cyclosporine in the blood is possible.

When used concomitantly with ethinylestradiol and desogestrel, an increased risk of bleeding is possible.

When used concomitantly, an acceleration of the metabolism of theophylline is possible.

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.