Tabletki tonizujące Labofarm - informacja o leku

Ziołowy lek na serce - Tabletki tonizujące Labofarm

30 January 2024

Toning-Up Labofarm – product information

Summary of product characteristics

1. NAME OF MEDICINAL PRODUCT

TONING-UP LABOFARM, tablets

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 150 mg of Crataegus spp., folium cum flore (kwiatostanu głogu), 30 mg Crataegus spp., fructus (hawthorn fruit), 100 mg of Leonurus cardiaca L., herba (motherwort), 40 mg Melilotus officinalis (L.) Lam., herba (melilot)

One tablet contains 0.02-0.5 mg of coumarins and at least 1.25 mg of flavonoids expressed as hyperoside.

See below for full list of excipients.

3. PHARMACEUTICAL FORM

Tablet

4. CLINICAL PARTICULARS

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

4.1. Indications for use

Traditionally used for supporting heart function and the circulatory system (in the lack of edema, especially in the lower limb area, and if other mediciations are not required).

4.2. Posology and method of administration

Posology:

Adults: 2 tablets, 2-3 times a day before meals.

Do not exceed the daily dose of 6 tablets, which corresponds to 3 mg of coumarins per day.

Children and adolescents:

Not recommended for children and adolescents.

Method of administration:

Oral.

Duration of use:

Do not use for extended periods.

4.3. Contraindications:

Hypersensitivity to any ingredient. Do not use concomitantly with anticoagulants, and do not give to patients with liver disease.

4.4. Special warnings and precautions for use

Not recommended for use in children and adolescents. In case of pain in the heart area radiating towards the arms, upper abdomen or neck pain, edema (especially of lower limbs), shortness of breath, dermatitis, thrombophlebitis, subcutaneous sclerosis, skin ulcers, skin afflictions with acute pain, heart or kidney failure, immediately contact a doctor.

If there is no improbement or symptoms worsen during use, consult a doctor.

4.5 Drug interactions and other interactions

May cause interactions with anticoagulants.

4.6. Impact on fertility, pregnancy and lactation

Due to lack of data, not recommended during pregnancy and lactation. No data on impact on fertility.

4.7. Impact on ability to drive vehicles and operate machinery

None.

4.8. Adverse effects

Possible gastrointestinal symptoms 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.

4.9. Overdose

Nausea, vomiting, headaches may occur.

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamics

Use for stated indications is based on traditional use.

5.2. Pharmacokinetics

No data on pharmacokinetic propeties. There have been animal trials concerning hawthorn procyanidins. It was found that 50-55% of procyanidins are absorbed after oral administration in animals. Procyanidin oligomers accumulate in the myocardium. After 15 hours of treatment, 10% of the administered dose was found in the myocardium, after 7 days – 30%.

5.3. Preclinical safety data

Not tested.

6. PHARMACEUTICAL PARTICULARS

6.1. List of excipients

Colloidal anhydrous silica

Potato starch

6.2. Incompatibilities

No data.

6.3. Expiry date

3 years

6.4. Special precautions for storage

Store closed in max. 25° C, keep away from children.