Instructions for Imbrovil film-coated tablets No. 30
Composition
active ingredients: dry extract of medicinal herb (Fumariae herbae extractum siccum) (4–6 : 1) (extractant: water), dry extract of milk thistle fruit, purified and standardized (Silybi mariani fructus extractum siccum raffinatum et normatum) (25.0–28.6 : 1) (extractant: acetone);
1 tablet contains dry extract of the medicinal herb Fumariae herbae extractum siccum (4–6:1) (extractant: water) — 275.1 mg; dry, purified and standardized extract of milk thistle fruit (Silybi mariani fructus extractum siccum raffinatum et normatum) (25.0–28.6:1) (extractant: acetone) — 76.9–166.7 mg, which is 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)].
Dosage form
Film-coated tablets.
Main physicochemical properties: round tablets with a biconvex surface, coated with a brown-red film coating.
Pharmacotherapeutic group
Drugs used in diseases of the liver and biliary tract. Drugs used in biliary pathology.
ATX code A05A X.
Pharmacological properties
Pharmacodynamics
Imbrolyv is a combined herbal preparation containing dry extract of the medicinal herb rutabaga and dry extract of milk thistle fruit, purified and standardized.
Rutka herb dry extract contains the alkaloid fumarin, which has a choleretic effect, normalizes bile secretion, and reduces the tone of the sphincter of Oddi.
Milk thistle fruit extract is dry, purified and standardized, contains silymarin, a bioflavonoid that includes isomers silibinin, silidianin and silychristin. Silymarin has a hepatoprotective effect in acute and chronic intoxications, exhibits membrane-stabilizing properties and promotes the restoration of liver cells.
Pharmacokinetics
After oral administration, silymarin is mainly eliminated in the bile and undergoes enterohepatic circulation.
Indication
For additional treatment of patients with biliary dyskinesia (including after cholecystectomy) and with concomitant chronic liver diseases.
Contraindication
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; inflammation of the gallbladder; acute poisoning of various etiologies; cholelithiasis; obstruction of the biliary tract; childhood (up to 18 years); pregnancy and breastfeeding.
Interaction with other medicinal products and other types of interactions
With the simultaneous use of drugs containing silymarin and oral contraceptives and drugs used in estrogen replacement therapy, the effectiveness of the latter may decrease.
Imbrovil may enhance the effects of drugs such as diazepam, alprazolam, ketoconazole, lovastatin, vinblastine, fexofenadine, clopidogrel, warfarin, due to inhibition of the cytochrome P450 system.
There is a slight risk of possible pharmacokinetic interactions between silymarin, as an inhibitor of the CYP3A4 and UGT1A1 isoenzymes, and cytostatics that are substrates of these enzymes.
It is forbidden to drink alcohol while using the medicine.
Application features
The general principles of treating liver parenchymal diseases are rest and avoiding alcohol, which should not be ignored.
For the elderly, dosage adjustment of the drug is not required.
Due to the possible estrogen-like effect of silymarin in the highest possible doses, it should be used with caution in patients with hormonal disorders (endometriosis, uterine fibroids, breast, ovarian and uterine carcinoma, prostate carcinoma). In these cases, consultation with a doctor is required.
In the event of jaundice (appearance of a light yellow to dark yellow skin color, yellowing of the whites of the eyes), it is necessary to consult a doctor to correct the therapy.
Use during pregnancy or breastfeeding
Do not use during pregnancy and breastfeeding due to lack of clinical data.
Ability to influence reaction speed when driving vehicles or other mechanisms
No effect. Patients with vestibular disorders should use the drug with caution when driving or operating other mechanisms.
Method of administration and doses
Imbrovil tablets should be taken with meals. The tablet should be swallowed whole, without chewing, and washed down with sufficient liquid.
Adults are recommended to take the drug Imbrovil 1 tablet 3 times a day.
If there is night pain, it is recommended to take an additional 1 tablet before bedtime. If necessary, the daily dose of the drug can be increased to the maximum - 6 tablets (2 tablets 3 times a day).
If there is no improvement after prolonged use (2 weeks), you should consult a doctor.
Children
Do not use in children (under 18 years of age) due to insufficient data on the safety and efficacy of the medicinal product.
Overdose
No cases of overdose have been observed. In case of overdose, diarrhea and abdominal pain are possible. In this case, the drug should be discontinued.
Treatment is symptomatic.
Adverse reactions
Frequency of adverse reactions according to MedDRA [Medical Dictionary for Regulatory Activities] classification: rare (≥ 1/10,000 -
On the part of the digestive tract: dry mouth, nausea, vomiting, dyspepsia, heartburn, mild diarrhea (rare).
On the part of the urinary system: increased diuresis (unknown).
On the part of the immune system: allergic reactions, including urticaria, skin rash, itching, anaphylactic reactions, difficulty breathing (very rare).
Vascular disorders: hot flashes (not known).
Skin and subcutaneous tissue disorders: increased alopecia; skin rash (very rare).
Nervous system: headache (unknown).
Other: exacerbation of existing vestibular disorders (unknown).
Reporting adverse reactions after registration of a medicinal product is of great importance. This allows monitoring of the benefit/risk ratio when using this medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and lack of efficacy of a medicinal product via the Automated Information System for Pharmacovigilance at the link: https://aisf.dec.gov.ua
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
10 tablets in a blister; 3 blisters in a cardboard pack.
Vacation category
Without a prescription.
Manufacturer/Applicant
"Ternofarm" LLC.
Location of the manufacturer and address of its place of business / location of the applicant
Ukraine, 46010, Ternopil, Fabrychna St., 4.
Phone/fax: (0352) 521-444, www.ternopharm.com.ua
