Tincture ginkgo bilobae herbapol w krakowie sa

Package leaflet: Information for the patient

TINCTURA GINKGO BILOBAE HERBAPOL W KRAKOWIE SA
(Ginkgo bilobae tinctura) 935 mg/ml, oral solution
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 6 weeks of treatment, or if you feel worse, consult your doctor.

Contents of the leaflet

1. What Tinctura Ginkgo bilobae Herbapol w Krakowie SA is and what it is used for
2. What you need to know before taking Tinctura Ginkgo bilobae Herbapol w Krakowie SA
3. How to take Tinctura Ginkgo bilobae Herbapol w Krakowie SA
4. Possible side effects
5. How to store Tinctura Ginkgo bilobae Herbapol w Krakowie SA
6. Contents of the pack and other information

1. What Tinctura Ginkgo bilobae Herbapol w Krakowie SA is and what it is used for

Tinctura Ginkgo bilobae Herbapol w Krakowie SA is a herbal medicinal product traditionally used in disorders of peripheral blood circulation and as an adjunct in cerebral circulation disorders.
This is a herbal medicinal product traditionally used, whose efficacy in the specified indications is based solely on long-standing use and experience.
If there is no improvement after 6 weeks of treatment, or if you feel worse, you should consult your doctor.

2. Important information before using the medicinal product Tinctura Ginkgo bilobae Herbapol w Krakowie SA

When not to use the medicinal product Tinctura Ginkgo bilobae Herbapol w Krakowie SA
Do not use if the patient is allergic to the active substance.

Warnings and precautions
The product contains 55%–60% (V/V) ethanol. 5 ml of the product contains up to 2.37 g of alcohol, equivalent to 60 ml of beer or 25 ml of wine. The product should not be administered to patients suffering from liver diseases, epilepsy, or alcoholism.

Children and adolescents
Use is not recommended in children and adolescents under 18 years of age.

Tinctura Ginkgo bilobae Herbapol w Krakowie SA and other medicinal products
Potential interactions may occur with medicinal products that reduce blood coagulation (risk of bleeding). There is also a possibility of interactions related to the high ethanol content.

Pregnancy and breastfeeding
Use is not recommended in pregnant or breastfeeding women without medical consultation due to the high ethanol content in the single dose and the lack of systematic clinical studies in this area.

Driving and operating machinery
Due to the high ethanol content in the single dose, the product may adversely affect the ability to drive motor vehicles and operate mechanical equipment. Driving should be avoided for up to 6 hours after taking the medicinal product due to the possibility of detecting ethanol in the blood.

3. How to use Tinctura Ginkgo bilobae Herbapol w Krakowie SA

Traditionally, the following dosing regimen is recommended for adults and elderly patients: 5 ml–10 ml (1–2 teaspoons) orally, three times daily between meals. Treatment may last up to 12 weeks. After this period, consultation with a physician is recommended regarding further use of the product.

Use in children and adolescents
Use is not recommended in children and adolescents under 18 years of age.

Taking more than the recommended dose of Tinctura Ginkgo bilobae Herbapol w Krakowie SA
After overdosing with dry extract of Ginkgo biloba leaf, no significant adverse effects have been observed. However, due to the ethanol content, an overdose may impair psychomotor performance.

Missed dose of Tinctura Ginkgo bilobae Herbapol w Krakowie SA
Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions.

Like all medicinal products, this medicine can cause adverse reactions, although not everyone will experience them. The adverse reactions of the medicine are presented according to organ systems classification as per MedDRA and frequency of occurrence: frequency unknown (cannot be estimated based on available data).
Gastrointestinal disorders – frequency unknown.
Skin and subcutaneous tissue disorders: allergic skin reactions – frequency unknown.
Nervous system disorders: headache – frequency unknown.
Reporting of adverse reactions.
If any adverse effects occur, including any adverse effects not listed in this leaflet, please inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: 22 49-21-301, fax: 22 49-21-309, e-mail: [email protected]. Adverse reactions can also be reported to the marketing authorization holder. Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Tinctura Ginkgo bilobae Herbapol w Krakowie SA.

Store in closed containers, at a temperature not exceeding 25°C.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.

6. Contents of the packaging and other information.

What the medicinal product Tinctura Ginkgo bilobae Herbapol w Krakowie SA contains
1 ml [corresponding to 0.94 g] of oral solution contains 1 ml of tincture from Ginkgo biloba L.,
folium (leaf of Ginkgo biloba) (1:5).
Extraction solvent – ethanol 60% (V/V).
Substance with known effect: ethanol.
The product contains 55-60% (V/V) ethanol.

What Tinctura Ginkgo bilobae Herbapol w Krakowie SA looks like and contents of the pack
The medicinal product is an oral solution of dark honey colour, with a characteristic herbal odour and bitter taste. The pack contains 100 ml of solution.

Marketing Authorisation Holder and Manufacturer
Krakowskie Zakłady Zielarskie „HERBAPOL” w Krakowie S.A.
ul. Chałupnika 14, 31-464 Kraków
tel. 12 411 69 11, fax 12 411 58 37
e-mail: [email protected]
Medicinal product available without medical prescription – OTC.
Marketing Authorisation number: R/6981