Ginkoflav Med

B. PATIENT INFORMATION LEAFLET

Leaflet attached to the packaging: information for the user

Ginkoflav Med, 80 mg, hard capsules

Ginkgo biloba extract, dry, refined, and quantified

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 this patient leaflet or as directed by
a doctor or pharmacist.

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

Table of contents of the leaflet

• 1. What is Ginkoflav Med and what is it used for
• 2. Important information before taking Ginkoflav Med
• 3. How to take Ginkoflav Med
• 4. Possible side effects
• 5. How to store Ginkoflav Med
• 6. Package contents and other information

1. What is Ginkoflav Med and what is it used for

Ginkoflav Med contains a dry, quantified extract of Ginkgo biloba leaves, which
expands blood vessels, improves blood flow in the brain, and reduces platelet aggregation.
The active substances in the extract are considered to be flavonoid glycosides, ginkgolides, and bilobalide.
Indications for use:

• to improve cognitive function in older adults (reduced mental performance and memory loss associated with age),
• as an adjunct to improve the quality of life in mild dementia (dementia).

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

2. Important information before taking Ginkoflav Med

When not to take Ginkoflav Med

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

Warnings and precautions

Before starting to take Ginkoflav Med, the patient should consult a doctor or pharmacist if:

• the patient has bleeding disorders, such as hemophilia,
• the patient is taking antiplatelet drugs, such as acetylsalicylic acid, or anticoagulant drugs, such as warfarin (Ginkoflav Med should not be taken without consulting a doctor, due to the potential risk of bleeding),
• the patient is scheduled for surgery (the doctor should be informed about the use of Ginkoflav Med, and it is recommended to stop taking the medicine at least 3-4 days before the scheduled surgery).

It cannot be ruled out that products containing Ginkgo biloba extract may affect the risk of seizures in people with epilepsy.
Concomitant use of products containing Ginkgo biloba and products containing efavirenz (an antiviral drug) is not recommended – see section "Ginkoflav Med and other medicines".

Children and adolescents

The medicine is not intended for use in children and adolescents (under 18 years of age).

Ginkoflav Med and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Due to the potential risk of interactions with the following medicines, caution should be exercised when taking Ginkoflav Med:

• In the case of concomitant use with anticoagulant medicines (e.g., acenocoumarol and warfarin) or antiplatelet medicines (e.g., clopidogrel, acetylsalicylic acid, and other nonsteroidal anti-inflammatory drugs), the effect of these medicines may be enhanced.
• Available studies do not indicate interactions with warfarin; however, caution is advised when starting treatment with Ginkgo biloba, changing the dose, or changing the product containing Ginkgo biloba extract in patients taking warfarin.
• Studies suggest that Ginkgo bilobamay inhibit glycoprotein P (P-gp) in intestinal cells (a protein involved in the transport of substances out of cells). This may enhance the effect of medicines that are subject to significant transport by P-gp in the intestine, such as dabigatran. Caution is advised when concomitantly using dabigatran and Ginkgo biloba extract.
• A study on the interaction with nifedipine indicated a possible increase in the maximum blood concentration of this medicine by Ginkgo biloba extract. In some study participants, a twofold increase in the maximum concentration of nifedipine was observed, leading to dizziness and exacerbation of symptoms such as hot flashes.
• Concomitant use of products containing Ginkgo biloba extract and products containing efavirenz (an antiviral drug) is not recommended. Efavirenz plasma concentrations may decrease due to the induction of the CYP3A4 enzyme, which may lead to reduced antiviral efficacy (see also section "Warnings and precautions").

In the case of using any of the above-mentioned medicines, the patient should consult their doctor or pharmacist before taking Ginkoflav Med.

Ginkoflav Med with food, drink, and alcohol

Ginkoflav Med can be taken independently of meals. It is not recommended to take the medicine with alcohol.

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.
Ginkoflav Med should not be taken during pregnancy (the medicine is contraindicated in pregnancy, as it may increase the risk of bleeding).
Due to the lack of sufficient data, it is not recommended to take the medicine during breastfeeding.
There are no data on the effect on fertility in humans.

Driving and using machines

No direct studies have been conducted on the effect of Ginkgo biloba extract on the ability to drive and use machines.

3. How to take Ginkoflav Med

This medicine should always be taken exactly as described in this patient leaflet or as directed by
a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
The recommended dose for adults and the elderly is 1 capsule 3 times a day.
The capsule should be taken with a liquid.
Treatment should last for at least 8 weeks.
If there is no improvement or the patient feels worse after 3 months, they should contact their doctor.
After 3 months, the patient should consult their doctor to determine whether to continue therapy.

Use in children and adolescents

There are no data on the safety and efficacy in children and adolescents.
The medicine is not intended for use in children and adolescents (under 18 years of age).

Overdose of Ginkoflav Med

In the event of taking a higher dose of the medicine than recommended, the patient should consult their doctor or pharmacist. No cases of poisoning have been reported.

Missed dose of Ginkoflav Med

A double dose should not be taken to make up for a missed dose.
The missed dose should be taken as soon as possible, unless it is almost time for the next dose. In this case, the missed dose should be skipped.
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, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur during treatment with this medicine:
Very common(in more than 1 in 10 people taking the medicine)
headache
Common(in 1 to 10 people in 100 taking the medicine)
dizziness, vomiting, nausea, abdominal pain, diarrhea
Frequency not known(frequency cannot be estimated from the available data)
bleeding in the nose, gastrointestinal tract, eye, intracranial bleeding, hypersensitivity reactions such as rash, swelling, itching, urticaria, anaphylactic shock. If such side effects occur, the patient should not take the next dose of the medicine. The patient should immediately contact their doctor or the emergency department of the nearest hospital.

Reporting side effects

If any side effects occur, including those not listed in this leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw; tel: +48 22 492 13 01; fax: +48 22 492 13 09; website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Ginkoflav Med

The medicine should be stored out of sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the carton and blister (after the EXP symbol). 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. Package contents and other information

What Ginkoflav Med contains

• The active substance is Ginkgo biloba extract. Each capsule contains 80 mg of dry, quantified extract of Ginkgo biloba leaves (35-67:1), corresponding to: 17.6-21.6 mg of flavonoids calculated as flavonoid glycosides; 2.2-2.7 mg of ginkgolides A, B, and C; 2.1-2.6 mg of bilobalide. Extraction solvent: 65% (v/v) acetone
• The other ingredients (excipients) are: microcrystalline cellulose, magnesium stearate, capsule shell (gelatin, titanium dioxide (E 171), purified water).

What Ginkoflav Med looks like and contents of the pack

30, 60, 90, or 120 hard capsules in a cardboard box with 2, 4, 6, or 8 blisters of 15 capsules each.
Not all pack sizes may be marketed.

Marketing authorization holder

OLIMP Laboratories Sp. z o.o.
Pustynia 84F
39-200 Dębica

Manufacturer

OLIMP Laboratories Sp. z o.o.
Nagawczyna 109c
39-200 Dębica
OLIMP Laboratories Sp. z o.o.
Pustynia 84F
39-200 Dębica
{Logo Olimp Laboratories}

Date of last revision of the leaflet: