Tincture ginkgo biloba phytopharm

Tinctura Ginkgo bilobae Phytopharm

Patient leaflet: information for the user

Tinctura Ginkgo bilobae Phytopharm, 4.525 g/5 ml, oral solution
Ginkgo bilobae folii tinctura
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, pharmacist, or nurse.

• 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 not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 21 days, or if you feel worse, you should contact your doctor.

Leaflet contents

1. What Tinctura Ginkgo bilobae Phytopharm is and what it is used for
2. Important information before taking Tinctura Ginkgo bilobae Phytopharm
3. How to take Tinctura Ginkgo bilobae Phytopharm
4. Possible side effects
5. How to store Tinctura Ginkgo bilobae Phytopharm
6. Contents of the pack and other information

1. What Tinctura Ginkgo bilobae Phytopharm is and what it is used for

Tinctura Ginkgo bilobae Phytopharm contains a tincture prepared from the leaves of
Ginkgo biloba.
Indications
Traditionally used in disorders of peripheral blood circulation.
Tinctura Ginkgo bilobae Phytopharm is a traditional herbal medicinal product, and its
therapeutic efficacy is based solely on long-standing use.

2. Information before using the medicinal product Tinctura Ginkgo bilobae

Phytopharm
When not to use the medicinal product Tinctura Ginkgo bilobae Phytopharm

• if hypersensitivity to products containing Ginkgo biloba is known.

Warnings and precautions
Before starting treatment with Tinctura Ginkgo bilobae Phytopharm, discuss this with your doctor, pharmacist, or nurse.
It is recommended to discontinue use of the product 36 hours before a planned surgical or dental procedure (e.g. tooth extraction).
Tinctura Ginkgo bilobae Phytopharm
If the patient has an increased tendency to bleeding (coagulation disorders) or suffers from haemophilia, consult a doctor or pharmacist before starting treatment with Tinctura Ginkgo bilobae Phytopharm.
Exercise particular caution when using Tinctura Ginkgo bilobae Phytopharm, as a single dose of 5 ml contains approximately 2.7 g of ethanol, equivalent to about 28 ml of wine and 69 ml of beer.
Consult your doctor, even if the above warnings refer to conditions that occurred in the past.
The medicinal product may have harmful effects in individuals with alcohol dependence. The ethanol content of the preparation should be taken into account when treating pregnant and breastfeeding women, children, and patients at high risk, such as those with liver damage.
Children and adolescents
Due to the ethanol content and lack of sufficient data, the medicinal product should not be used in children and adolescents under 18 years of age.
Tinctura Ginkgo bilobae Phytopharm and other medicinal products
Inform your doctor or pharmacist about all medicinal products currently or recently used, as well as any that you plan to use.
Due to the ethanol content of the preparation, concomitant use with other medicinal products that may adversely affect the liver is not recommended.
If the patient is taking acetylsalicylic acid or other drugs affecting blood coagulation (e.g. heparin, warfarin, coumarin derivatives) regularly, medical advice from a doctor or pharmacist should be sought before using Tinctura Ginkgo bilobae Phytopharm.
If the patient is taking: trazodone, proton pump inhibitors (PPIs) (e.g. omeprazole), nifedipine, or thiazide diuretics, contact a doctor before using Tinctura Ginkgo bilobae Phytopharm.
Use of Tinctura Ginkgo bilobae Phytopharm with food, drink, and alcohol
Food does not affect the action of the medicinal product. Concomitant use with alcohol is not recommended.
Pregnancy, breastfeeding, and fertility
Due to the possible prolongation of blood clotting time and lack of sufficient data, use of the medicinal product during pregnancy and breastfeeding is not recommended.
Please note that the preparation contains 60–70% V/V ethanol.
Driving and operating machinery
After taking the preparation, ethanol may be detected by breath alcohol testing devices. Therefore, driving motor vehicles should be avoided immediately after taking the medicinal product. A minimum interval of half an hour should be observed.
Tinctura Ginkgo bilobae Phytopharm

3. How to use Tinctura Ginkgo bilobae Phytopharm

This medicine should always be used exactly as described in this patient information leaflet, or
as directed by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.
Adults:
Unless otherwise advised by a doctor, take the medicine 3 times daily, 5–10 ml each time,
diluted with water.
A measuring device is provided with the medicine to help measure the recommended dose.
The recommended duration of treatment is 21 days; thereafter, medical advice should be sought.
Children and adolescents under 18 years of age:
Due to lack of data, use of the medicine is not recommended.
If you feel that the effect of Tinctura Ginkgo bilobae Phytopharm is too strong or too weak,
consult your doctor or pharmacist.
Use of a higher than recommended dose of Tinctura Ginkgo bilobae Phytopharm
Due to the ethanol content, overdose may cause harmful effects in cases of liver damage,
alcoholism, epilepsy, brain damage, or mental disorders, and may also impair psychomotor performance.
Missed dose of Tinctura Ginkgo bilobae Phytopharm
Continue taking the medicine as recommended. Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
During treatment, mild gastrointestinal disturbances, headaches and dizziness may occur, and occasionally cases of allergic skin reactions (rash, itching).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181 C,
02-222 Warsaw,
tel.: + 48 22 49 21 301,
fax: + 48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the use of the medicine.
Tinctura Ginkgo bilobae Phytopharm

5. How to store Tinctura Ginkgo bilobae Phytopharm

Keep this medicine out of sight and reach of children.
Store below 25 °C.
Do not use Tinctura Ginkgo bilobae Phytopharm after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Tinctura Ginkgo bilobae Phytopharm contains

• The active substance is a tincture of Ginkgo biloba leaves ( Ginkgo bilobae folii tinctura (1:5)). Extraction solvent: ethanol 70% V/V.

The ethanol content in the medicinal product is 60–70% V/V.
What Tinctura Ginkgo bilobae Phytopharm looks like and contents of the pack
The immediate packaging of the medicinal product consists of a 100 ml amber glass bottle
with a polyethylene screw cap with a flow restrictor. The bottle, together with a measuring device made of polypropylene, is placed in a cardboard box.
Marketing Authorisation Holder and Manufacturer
Phytopharm Klęka S.A.
Klęka 1, 63-040 Nowe Miasto nad Wartą
Poland
Tel.: + 48 61 28 68 000
Fax: + 48 61 28 68 529
[email protected]