Tabletki z czosnku Labofarm - informacja o leku

Lek ziołowy na cholesterol i odporność Tabletki czosnku

30 January 2024

Circulatory system – information

Garlic tablets Labofarm – product information

Summary of product characteristics

PRODUCT NAME

Garlic tablets Labofarm, 300 mg

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 300 mg of Allium sativum L., bulbus (garlic bulb)

See below for full list of excipients.

PHARMACEUTICAL FORM

Tablet

CLINICAL PARTICULARS

Traditional herbal medicinal product with stated indications, derived solely from long-term use.

Indications

Used traditionally for the prevention of atherosclerosis and for treating symptoms of the common cold.

Posology and method of administration

Posology:

In prevention of atheromatosis, adults: 2-3 tablets, 3 times a day.

In common colds, adults and adolescents over 12 years: 2-3 tablets, 3-4 times a day. Use after first symptoms of common cold occur.

Method of administration:

Oral.

Contraindications

Hypersensitivity to garlic or sulfur compounds.

Special warnings and precautions for use

Due to anti-aggregation activity, do not use at least 14 days before planned surgery and take caution after surgery.

Drug interactions and other interactions

Concomitant use with anticoagulants (e.g. salicylates, warfarin) may intensify their effect.

May affect the metabolism of medication transported by P-glycoprotein and medication metabolised by cytochrome P450 isoenzymes.

Concomitant use of garlic with protease inhibitor antivirals (e.g. indinavir, saquinavir) may decrease their concentration in the blood.

Impact on fertility, pregnancy and lactation

Due to lack of safety data, not recommended for use during pregnancy and lactation. Sulfur compounds contained in the product are absorbed into breast milk.

Impact on ability to drive vehicles and operate machinery

None.

Adverse effects

May change the smell of skin and breath.

Rare symptoms include gastrointestinal irritation and allergic reactions.

Reporting suspected adverse effects

After a medicinal product receives marketing authorisation, it is important to report suspected adverse effects. It allows for continuous monitoring of the medicinal product's risk-benefit ratio. Medical professionals should report all suspected adverse effects to the Department for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warszawa,
tel.: + 48 22 49-21-301, fax: +48 22 49-21-309, e-mail: ndl@urpl.gov.pl.

Adverse effects can also be reported to the marketing authorisation holder.

Overdose

No reports of toxicity. In case of drop in blood pressure, administer antihypotensive medication.

PHARMACOLOGICAL PROPERTIES

Pharmacodynamics

Use in stated indications is based on traditional use. According to literature, powdered garlic decreases cholesterol and triglyceride levels in blood plasma of healthy volunteers and patients with mild hyperlipidemia.

Components of garlic also showed anti-aggregation and hypotensive activity in healthy volunteers. The anti-aggregation effect is attributed to allicin and hypotensive activity to peptide compounds (especially gamma-glutamyl S-allyl sulfoxide), previously called scordinins.

- Pharmacokinetics

Absorption and excretion of orally administered, radioactively marked ³⁵S-allinin was investigated in trials on rats. After administering 8 mg of ³⁵S-allinin/kg of BW, maximum concentration in the blood was attained after 10 minutes. Excretion of allinin metabolites occurs mostly through kidneys.

Allicin is excreted by the liver; its metabolites, such as diallyl disulfide and allyl mercaptan, are found in the liver and gallbladder. Allicin metabolism was analysed in an experiment on isolated rat liver. After passing through the liver, unaltered allicin was identified only after high doses (1.2 mg of allicin/min). After 400 g of allicin/min – 95% of the compound was metabolised after first passage through the liver.

S-allylcysteine, orally administered to rats, mice and dogs, was absorbed quickly and easily and distributed mainly in the plasma, liver and kidneys. Its bioavailability remained at 98.2% in rats, 103.0% in mice and 87.2% in dogs. S-allylcysteine was excreted mainly with urine, as an N-acetylated metabolite in rats, while in mice the excretion had two forms: free and N-acetylated.

Preclinical safety data

Acute toxicity of allicin, as studied in mice, is equal to LD₅₀=60 mg/kg after IV administration (corresponding to 13.3 g/kg of BW of garlic) and 120 mg/kg injected subcutaneously (corresponding to 26.6 g/kg of garlic). For garlic extracts, the lethal dose administered orally, intraperitoneally and subcutaneously exceeds 30 ml/kg.

According to literature, 6-month-long oral administration of 2000 mg/kg dose of garlic extract to rats did not cause weight loss. It was observed that the animals were taking in less food. No changes in parenchymal organs, hematopoietic system or serological parameters were observed. Examined garlic products were not genotoxic. Significant overdose resulted in reduction in blood clotting and hemorrhages in animals.