Ginkofar forte

Leaflet attached to the packaging: patient information

Ginkofar Forte

80 mg, coated tablets

Ginkgo bilobae folium extractum siccum

Read the leaflet carefully before taking the medicine, as it contains

important information for the patient.
This medicine should always be taken exactly as described in the patient leaflet or as advised by
the doctor or pharmacist.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, the pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 3 months there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

• 1. What is Ginkofar Forte and what is it used for
• 2. Important information before taking Ginkofar Forte
• 3. How to take Ginkofar Forte
• 4. Possible side effects
• 5. How to store Ginkofar Forte
• 6. Contents of the packaging and other information

1. What is Ginkofar Forte and what is it used for

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

Indications for use

Ginkofar Forte is used:

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

If after 3 months there is no improvement or the patient feels worse, they should consult their doctor.

2. Important information before taking Ginkofar Forte

When not to take Ginkofar Forte

• if the patient is allergic to the extract of Ginkgo biloba leaves 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 take Ginkofar Forte, the patient should consult their doctor or pharmacist if they have an increased tendency to bleed (bleeding disorder).
Patients taking anticoagulant or antiplatelet medicines (so-called blood-thinning medicines) should consult their doctor before taking this medicine.
Before surgery, the patient should inform their doctor or dentist about taking Ginkofar Forte. It is recommended to stop taking Ginkofar Forte 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 treatment with Ginkofar Forte.
If there is no improvement or worsening of symptoms during treatment, the patient should consult their doctor or pharmacist.

Children and adolescents

Ginkofar Forte is not intended for use in children and adolescents.

Ginkofar Forte 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 patient should inform their doctor or pharmacist if they regularly take any of the following medicines:

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

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

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

Ginkofar Forte with food and drink

Ginkofar Forte should be taken orally, after a meal, 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 their doctor or pharmacist before taking this medicine.
Pregnancy
Ginkofar Forte 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 Forte is not recommended during breastfeeding.

Driving and using machines

There are no data on the effects on the ability to drive and use machines.
Ginkofar Forte contains lactose.
If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicine.

3. How to take Ginkofar Forte

This medicine should always be taken exactly as described in the patient leaflet or as advised by
the doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
The recommended dose for adults is:
3 times a day, 1 tablet.
Daily dose: 3 tablets

Duration of treatment

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

Taking a higher dose of Ginkofar Forte than recommended

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

Missing a dose of Ginkofar Forte

The patient should not take a double dose to make up for a missed dose.

Stopping treatment with Ginkofar Forte

In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Ginkofar Forte can cause side effects, although not everybody gets them.
The following side effects may occur during treatment with Ginkofar Forte:
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 taking blood-thinning medicines (anticoagulants and antiplatelet agents, see section 2).
• allergic reactions (anaphylactic shock),
• allergic skin reactions (redness, swelling, itching, and rash).

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform 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, more information can be collected on the safety of the medicine.

5. How to store Ginkofar Forte

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C.
Store in the original packaging.
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 Forte contains

• The active substance is: Ginkgo bilobae folium extractum siccum(35-67:1), extractant - 60% (v/v) acetone
• dry extract of Ginkgo biloba leaves ( Ginkgo bilobaL., folium) 80 mg, including:
• native extract: 90-100%, with a composition of:
• 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, povidone K30, crospovidone type A, magnesium stearate, anhydrous colloidal silica; tablet coating: polyvinyl alcohol, titanium dioxide (E 171), macrogol 4000, talc, yellow iron oxide (E 172).

What Ginkofar Forte looks like and contents of the pack

Coated tablets, round, smooth, beige-yellow in color, without cracks, with permissible spots of a different color.
Available packs: carton containing 20, 60, and 90 tablets.

Marketing authorization holder and manufacturer

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

Poland

Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
Tel. 061 66 51 500

Date of approval of the leaflet: