Imbroliv

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT IMBROLIV (IMBROLIV)

Composition:

Active substances: dry extract of fumitory herb (Fumariae herbae extractum siccum) (4–6 : 1) (extractant: water), dry purified and standardized extract of milk thistle fruits (Silybi mariani fructus extractum siccum raffinatum et normatum) (25.0–28.6 : 1) (extractant: acetone);

Each tablet contains: dry extract of fumitory herb (Fumariae herbae extractum siccum) (4–6 : 1) (extractant: water) — 275.1 mg; dry purified and standardized extract of milk thistle fruits (Silybi mariani fructus extractum siccum raffinatum et normatum) (25.0–28.6 : 1) (extractant: acetone) — 76.9–166.7 mg, equivalent to silymarin 50 mg;

Excipients: microcrystalline cellulose, crospovidone, colloidal anhydrous silicon dioxide, magnesium stearate, film coating "Wincoat WT-MPAQ-01274 Brown" [polyvinyl alcohol, triethyl citrate, titanium dioxide (E 171), talc, red iron oxide (E 172)].

Pharmaceutical form. Film-coated tablets.

Main physicochemical properties: round, biconvex film-coated tablets, with a brown-red colored coating.

Pharmacotherapeutic group. Agents used in liver and biliary tract disorders. Agents used in biliary pathology.

ATC code A05A X.

Pharmacological Properties

Pharmacodynamics

Imbrolyv is a combined herbal medicinal product containing dry extract of Chelidonium majus herb and purified, standardized dry extract of Silybum marianum fruits.

Dry extract of Chelidonium majus herb contains the alkaloid chelidonine, which exerts a cholagogue effect, normalizes bile secretion, and reduces the tone of the sphincter of Oddi.

Purified and standardized dry extract of Silybum marianum fruits contains silymarin—a bioflavonoid comprising the isomers silybin, silydianin, and silychristin. Silymarin has hepatoprotective effects in acute and chronic intoxications, exhibits membrane-stabilizing properties, and promotes liver cell regeneration.

Pharmacokinetics

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

Clinical characteristics

Indications

As an adjunctive treatment for patients with biliary tract dyskinesia (including post-cholecystectomy) and associated 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 medicinal product; acute inflammatory diseases of the liver and biliary tract; acute hepatitis and cholangitis; gallbladder inflammation; acute poisonings of various etiologies; cholelithiasis; biliary tract obstruction; pediatric use (under 18 years of age); pregnancy and lactation period.

Interaction with other medicinal products and other forms of interaction

When silimarins are used concomitantly with oral contraceptives and drugs used in estrogen replacement therapy, a reduced efficacy of the latter may occur.

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

There is a minor risk of possible pharmacokinetic interactions between silimarins, as inhibitors of the CYP3A4 and UGT1A1 isoenzymes, and cytostatic agents that are substrates of these enzymes.

Alcohol consumption is prohibited during the use of this medicinal product.

Special precautions for use

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

For elderly patients, dosage adjustment of the medicinal product is not required.

Due to the potential 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 required.

If jaundice develops (appearance of skin discoloration ranging from light yellow to dark yellow, yellowing of the sclera), medical advice must be sought to adjust the therapy.

Use during pregnancy or breastfeeding

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

Ability to affect reaction rate while driving or operating machinery

No effect. However, patients with vestibular disorders should use the medicinal product with caution when driving or operating machinery.

Dosage and Administration

Take Imbrolyv tablets during meals. Swallow the tablet whole, without chewing, with an adequate amount of liquid.

The recommended dose for adults is 1 tablet of Imbrolyv three times daily.

In case of nocturnal pain, an additional dose of 1 tablet before bedtime is recommended. If necessary, the daily dose may be increased up to the maximum dose — 6 tablets (2 tablets 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), consult a physician.

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, discontinue use of the medicinal product.

Treatment is symptomatic.

Adverse reactions

Frequency of adverse reactions according to the MedDRA classification [Medical Dictionary for Regulatory Activities]: rare (≥ 1/10,000 – < 1/1,000), very rare (< 1/10,000), including isolated cases.

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

Renal and urinary disorders: increased diuresis (unknown frequency).

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

Vascular disorders: hot flushes (unknown frequency).

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

Nervous system disorders: headache (unknown frequency).

Other: exacerbation of pre-existing vestibular disorders (unknown frequency).

Reporting suspected adverse reactions after registration of the medicinal product is of great importance. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare and pharmacy professionals, as well as patients or their legal representatives, are encouraged to report all suspected adverse reactions and lack of efficacy through the Automated Pharmacovigilance Information System at: https://aisf.dec.gov.ua

Shelf life. 3 years.

Storage conditions

Store at a temperature not exceeding 25 °C.

Keep out of reach and sight of children.

Packaging. 10 tablets per blister; 3 blisters per cardboard pack.

Availability. Over-the-counter (without prescription).

Manufacturer/Marketing Authorization Holder. LLC "Ternopharm".

Manufacturer’s address / Marketing Authorization Holder’s address

4 Fabrychna St., Ternopil, 46010, Ukraine.

Tel./fax: (0352) 521-444, www.ternopharm.com.ua