GEPABENE

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT HEPABENE (Hepabene®)

Composition:

Active substances: dry extract of herb of fumitory (Fumaria officinalis), dry extract of fruits of spotted milk thistle (Silybum marianum);

1 capsule contains:
dry extract of herb of fumitory (Fumaria officinalis, herb to extract ratio 4–6:1, extraction solvent – water) – 275.1 mg;
dry extract of fruits of spotted milk thistle (Silybum marianum, herb to extract ratio 20–50:1, extraction solvent – acetone) – 83.33–100 mg, equivalent to silymarin 50 mg;

Excipients: microcrystalline cellulose, corn starch, talc, macrogol, copovidone, magnesium stearate, colloidal anhydrous silicon dioxide, gelatin, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172).

Pharmaceutical form. Hard capsules.

Main physicochemical characteristics: capsule contents: powder of light to dark brown, heterogeneous color with small particles of white, yellowish, or gray color (presence of agglomerates or compacted mass is acceptable).

Capsule shell:

body: light brown, opaque;

cap: light brown, opaque;

size: 0.

Pharmacotherapeutic group. Agents used in diseases of the liver and biliary tract. Agents used in biliary pathology.
ATC code: A05AX.

Pharmacological properties.

Pharmacodynamics.

Hepabene is a combined herbal medicinal product containing an extract of greater celandine and a dry extract of fruits of milk thistle.

The extract of greater celandine contains the alkaloid chelidonine, which exerts a choleretic effect, normalizes bile secretion, and reduces the tone of the sphincter of Oddi.

The extract of milk thistle fruits contains silymarin – a bioflavonoid comprising isomers silybin, silydianin, and silychristin. Silymarin exerts hepatoprotective effects in acute and chronic intoxications, demonstrates membrane-stabilizing properties, and promotes regeneration of liver cells.

Pharmacokinetics.

After oral administration, silymarin is mainly eliminated with bile and undergoes enterohepatic circulation.

Clinical characteristics.

Indications.

Additional treatment of patients with biliary tract dyskinesia (including post-cholecystectomy) and concomitant chronic liver diseases.

Contraindications.

Hypersensitivity to the active substances or to other plants of the Asteraceae family, or to any of the excipients of the drug; acute inflammatory diseases of the liver and biliary tract; acute hepatitis and cholangitis; inflammation of the gallbladder; acute poisonings of various etiologies; cholelithiasis; biliary tract obstruction; pediatric age (under 18 years); pregnancy and breastfeeding period.

Interaction with other medicinal products and other types of interactions.

When silimarins-containing drugs are used concomitantly with oral contraceptives and drugs used in estrogen replacement therapy, a possible reduction in effectiveness of the latter may occur.

The drug may enhance the effects of medicinal products such as diazepam, alprazolam, ketoconazole, lovastatin, vinblastine, fexofenadine, clopidogrel, and warfarin, due to inhibition of the cytochrome P450 system.

Alcohol consumption is prohibited during the use of the drug.

Special precautions for use.

General principles for the treatment of parenchymal liver diseases include rest and complete abstinence from alcohol, which should not be ignored.

For elderly patients, dosage adjustment is not required.

Due to the possible estrogen-like effect of silymarin at the highest doses, it should be used with caution in patients with hormonal disorders (endometriosis, uterine fibroids, breast, ovarian or uterine carcinoma, prostate carcinoma). In such cases, medical consultation is necessary.

If jaundice develops, medical advice must be sought to adjust therapy.

Use during pregnancy or breastfeeding.

Do not use during pregnancy or breastfeeding due to insufficient clinical data.

Ability to affect reaction speed when driving or operating machinery.

Has no effect. However, patients with existing vestibular disorders should use the medication cautiously when driving or operating machinery.

Dosage and Administration.

Hepabene capsules should be taken during meals. The capsule should be swallowed whole, without chewing, and taken with sufficient liquid.

The recommended dose for adults is 1 capsule of Hepabene three times daily.

In the presence of nocturnal pain, an additional dose of 1 capsule before bedtime is recommended. If necessary, the daily dose may be increased up to the maximum dose of 6 capsules (2 capsules three times daily).

The duration of treatment is determined individually by a physician, depending on the nature and course of the disease.

If no improvement occurs after prolonged use (2 weeks), a consultation with a physician is necessary.

Children.

Do not use in children (under 18 years of age) due to insufficient data on safety and efficacy of the medicinal product.

Overdose.

Cases of overdose have not been reported. In the event of overdose, diarrhea and abdominal pain may occur. In such cases, the use of the drug should be discontinued.

Treatment is symptomatic.

Adverse reactions.

Frequency of adverse reactions according to the MedDRA classification: rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), including isolated cases.

Gastrointestinal disorders: nausea, vomiting, dyspepsia, heartburn, mild diarrhea (rare).

Urinary system disorders: increased diuresis.

Immune system disorders: allergic reactions, including skin rash, itching, dyspnea (very rare).

Vascular disorders: flushing.

Skin and subcutaneous tissue disorders: increased alopecia; skin rash (very rare).

Other: worsening of pre-existing vestibular disorders.

Shelf life. 3 years.

Storage conditions.

Store at temperatures not exceeding 25 °C in the original packaging to protect from moisture. Keep out of reach of children.

Packaging. 10 capsules per blister; 3 blisters per carton.

Availability. Over-the-counter.

Manufacturer. Merckle GmbH.

Manufacturer's address and place of business.

Ludwig-Merckle-Straße 3, 89143 Blaubeuren, Germany.