Ginkofar

1. What is Ginkofar and what is it used for

Ginkofar medicine contains an extract of Ginkgo biloba leaves, which improves blood flow in the brain, dilates blood vessels, and prevents platelet aggregation. The active substances of the extract are considered to be flavonoid glycosides, ginkgolides, and bilobalide.

Indications for use

Ginkofar is used:

• to improve cognitive abilities in older people (memory impairment and mental fitness related to age),
• to improve the quality of life in mild dementia. The medicine is intended for adults.

If after 90 days there is no improvement or the patient feels worse, they should contact their doctor.
2.Important information before using Ginkofar

When not to use Ginkofar

• if the patient is allergic to Ginkgo biloba extract or any of the other ingredients of this medicine (listed in section 6),
• if the patient is pregnant (see "Pregnancy and breastfeeding").

Warnings and precautions

Before starting to use Ginkofar, you should consult a doctor or pharmacist if the patient has an increased tendency to bleeding (hemorrhagic diathesis).
People taking anticoagulant or antiplatelet medicines (so-called blood thinners),
should consult a doctor before using this medicine.
Before surgery, the doctor or dentist should be informed about the use of Ginkofar.
It is recommended to stop using Ginkofar at least 3-4 days before a planned surgical or dental procedure, such as tooth extraction.
Caution should be exercised in patients with epilepsy, as it cannot be ruled out that further seizures may occur during the use of Ginkofar.
In case of no improvement or worsening of symptoms during the use of the medicine, the patient should consult a doctor or pharmacist.

Children and adolescents

Ginkofar is not intended for use in children and adolescents.

Ginkofar and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
In particular, the doctor or pharmacist should be informed if the patient regularly uses any of the following medicines:

• anticoagulants (fenprocoumon, warfarin)
• antiplatelet agents (clopidogrel, acetylsalicylic acid, and other non-steroidal anti-inflammatory drugs)Concurrent use of these medicines and Ginkofar may increase the risk of bleeding.

The patient should also inform their doctor or pharmacist about the use of the following medicines:

• efavirenz(used to treat HIV infection),
• nifedipine(used to treat high blood pressure),
• talinolol(used to treat heart diseases and high blood pressure),
• dabigatran(used to prevent the formation of blood clots).

Using Ginkofar with food and drink

Ginkofar should be taken orally, after a meal, washing the tablet down with a liquid.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before using this medicine.
Pregnancy
Ginkofar is contraindicated during pregnancy due to the lack of sufficient data and the risk of increased bleeding tendency.
Breastfeeding
Due to the lack of sufficient data, Ginkofar is not recommended during breastfeeding.

Driving and using machines

There is no data on the effect on the ability to drive and use machines.

Ginkofar contains lactose.

If the patient has previously been diagnosed with intolerance to some sugars, they should consult a doctor before taking this medicine.
3.How to use Ginkofar
This medicine should always be used exactly as described in the patient leaflet or according to the doctor's instructions. In case of doubts, the patient should consult a doctor or pharmacist.
The recommended dose for adults is:
3 times a day, 2 tablets.
Daily dose: 6 tablets

Duration of use

Treatment should last at least 8 weeks.
If the symptoms worsen or after 3 months of using the medicine there is no improvement, the patient should consult a doctor.
After three months, the patient should consult a doctor to determine whether to continue treatment.

Use in children and adolescents

Ginkofar should not be used in children and adolescents.

Using a higher dose of Ginkofar than recommended

In case of taking a higher dose of the medicine than recommended, the patient should immediately consult a doctor or pharmacist.

Missing a dose of Ginkofar

The patient should take the missed dose as soon as possible, still following the dosing schedule of Ginkofar.
The patient should not take a double dose to make up for the missed dose.

Stopping the use of Ginkofar

In case of any further doubts about the use of this medicine, the patient should consult a doctor or pharmacist.
4.Possible side effects
Like all medicines, Ginkofar can cause side effects, although not everybody gets them.
The following side effects may occur during the use of Ginkofar:
Very common(more than 1 in 10 people):

• headache.

Common(between 1 and 10 people in 100):

• dizziness,
• gastrointestinal disorders (diarrhea, abdominal pain, nausea, vomiting).

Frequency not known(cannot be estimated from the available data):

• bleeding from individual organs (eyes, nose, gastrointestinal bleeding, and cerebral vessels). The risk of bleeding increases when using blood thinners (anticoagulants and antiplatelet agents, see section 2).
• allergic reactions (anaphylactic shock),
• allergic skin reactions (redness, swelling, itching, and rash).

Reporting side effects

If any side effects occur, including any possible side effects not listed in the leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of the medicine.

5. How to store Ginkofar

The medicine should be stored in a place that is out of sight and reach of children.
Store in a temperature below 25°C.
Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Ginkofar contains

• The active substance of the medicine is: Ginkgo bilobae folium extractum siccum(35-67:1), extractant - 60% (v/v) acetone
• dry extract of Ginkgo biloba leaves ( Ginkgo bilobaL., folium) 40 mg, including:
• native extract: 90-100%, with the composition:
• 22-27% ginkgo flavonoid glycosides,
• 5-7% terpene lactones (including 2.8-3.4% ginkgolides A, B, and C, and 2.6-3.2% bilobalide),
• no more than 5 ppm ginkgolic acids;
• excipient: liquid glucose 0-10%.
• Other ingredients are: tablet core:microcrystalline cellulose, lactose monohydrate, crospovidone type A, magnesium stearate, povidone K30, anhydrous colloidal silica; tablet coating:polyvinyl alcohol, titanium dioxide (E171), macrogol 4000, yellow iron oxide (E172), talc.

What Ginkofar looks like and what the pack contains

Ginkofar has the form of coated tablets, round, biconvex, smooth, beige-yellow in color, without cracks, with permissible local discoloration.
The coated tablets are packaged in PVC/PVDC-Aluminum blisters, placed in a cardboard box.
The packaging contains 20, 60, or 90 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
To obtain more detailed information, you should contact the local representative of the marketing authorization holder:

Poland

Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
Tel. +48 61 66 51 500

Date of the last update of the leaflet: