Alliomint 300 mg - informacja o leku

Lek ziołowy na cholesterol i odporność Alliomint

30 January 2024

Circulatory system – information

Alliomint 300 mg – product information

Summary of Product Characteristics

NAME OF MEDICINAL PRODUCT

Alliomint 300 mg, tablets

QUALITATIVE AND QUANTITATIVE COMPOSITION

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

1 tablet contains at least 0.6 mg of allicin.

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:
As an aid in prevention of atherosclerosis: 2-3 tablets, 3 times a day. In prevention of upper respiratory infections: 2-3 tablets, 3-4 times a day.
Method of administration:
Oral.
- Contraindications

Hypersensitivity to active substance or any of the excipients listed or to menthol.

Special warnings and precautions for use

Before surgery it should be determined whether the patient used garlic products, to avoid prolonged bleeding. Patients should be advised to take special caution after surgery. A single dose of 4 g of garlic may intensify blood vessel dilation.

Drug interactions and other interactions
Concomitant use with anticoagulants, e.g. salicylates, may intensify their anti-aggregation effect. Due to its ability to induce hepatic metabolism, garlic may decrease the blood concentration of concomitantly used protease inhibitor antivirals (e.g. indinavir).
- Impact on fertility, pregnancy and lactation

No contraindications for use during pregnancy and lactation. Sulfur compounds are absorbed into breast milk. No data on impact on fertility.

Impact on ability to drive vehicles and operate machinery

None.

Adverse effects

Rare symptoms include gastrointestinal irritation and allergic reactions (≥1/10 000 do <1/1000).

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. Website:
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 overdose, vomiting should be induced. In case of drop in blood pressure, administer antihypotensive medication.

PHARMACOLOGICAL PROPERTIES

Pharmacodynamics

Use for stated indications is based on traditional use. No pharmacodynamic studies have been conducted.

According to data, powdered garlic decreases cholesterol (9-12%) and triglyceride (13%) levels in the plasma.

In in vitro studies on Alliomint indicate its antimicrobial activity. Studies show activity against yeasts from the genus Candida. The activity is attributed to allicin, which inhibits the development of yeasts.

Pharmacokinetics

No pharmacokinetic studies have been conducted.

Preclinical safety data

No data on acute toxicity of powdered garlic. No data on teratogenicity and carcinogenicity. No appropriate studies on genotoxicity and reproductive toxicity have been conducted.

Garlic is also a culinary ingredient, and there have never been any reports of adverse effects.

Literature suggests that garlic weakens spermatogenesis in rats.