Package leaflet: Information for the user

GINKOFAR INTENSE
120 mg, coated tablets
Ginkgonis extractum siccum raffinatum et quantificatum
Please read the entire leaflet carefully before taking this medicine, as it contains important information for the patient.
This medicine should always be used exactly as described in this patient information leaflet or as directed by a doctor or pharmacist.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, consult your pharmacist.
If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 3 months, or if you feel worse, consult your doctor.

Contents of the leaflet:

What Ginkofar Intense is and what it is used for
Important information before taking Ginkofar Intense
How to take Ginkofar Intense
Possible side effects
How to store Ginkofar Intense
Contents of the pack and other information

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

Ginkofar Intense contains a quantified extract of leaves of Ginkgo biloba, which improves cerebral blood flow, dilates blood vessels, and prevents platelet aggregation. The active components of the extract are considered to be flavonoid glycosides, ginkgolides, and bilobalide.
Indications
Ginkofar Intense is indicated:

to improve cognitive function in elderly individuals (age-related memory and mental performance decline),
to improve quality of life in mild dementia. This medicine is intended for adults.

If there is no improvement after 90 days, or if you feel worse, consult your doctor.

2. Important information before using Ginkofar Intense

When not to use Ginkofar Intense

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

Warnings and precautions
Before starting treatment with Ginkofar Intense, consult a doctor or pharmacist
if the patient has an increased tendency to bleed (bleeding diathesis).
Patients taking anticoagulant or antiplatelet medicines (so-called blood-thinning agents)
should contact their doctor before using this medicine.
Before undergoing any surgical procedure, inform your doctor or dentist that you are taking
Ginkofar Intense.
It is recommended to discontinue treatment with Ginkofar Intense at least 3–4 days before any planned
surgical or dental procedure, such as tooth extraction.
Caution is advised in patients with epilepsy, as seizures cannot be excluded during treatment with Ginkofar Intense.
Do not exceed the recommended doses.
If allergic reactions occur, discontinue use of the medicine immediately.
If there is no improvement or if symptoms worsen during treatment, consult a doctor or pharmacist.

Children and adolescents
Ginkofar Intense should not be used in children and adolescents due to lack of indications and limited safety data in this patient group.

Ginkofar Intense with other medicines
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take (including those available without a prescription).
In particular, inform your doctor or pharmacist if the patient is regularly taking any of the following medicines:

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

Also inform your doctor or pharmacist if you are taking any of the following medicines:

efavirenz (used in the treatment of HIV infection),
nifedipine (used in the treatment of high blood pressure),
talinolol (used in the treatment of heart conditions and high blood pressure),
dabigatran (used to prevent blood clots).

Ginkofar Intense with food and drink
Ginkofar Intense is taken orally, independently of meals, swallowing the tablet with water.
It is not recommended to take the medicine together with alcohol.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Ginkofar Intense is contraindicated during pregnancy due to insufficient data and the risk of increased bleeding tendency.
Due to insufficient data, Ginkofar Intense is not recommended during breastfeeding.

Driving and operating machinery
There is no data available on the influence of Ginkofar Intense on the ability to drive or operate machinery.

Ginkofar Intense contains lactose.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to take Ginkofar Intense

This medicine should always be taken exactly as described in this patient leaflet or as advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Dosage
The recommended dose of Ginkofar Intense in adults is 1 tablet taken twice daily (preferably in the morning and evening).
Duration of treatment
Treatment should last at least 8 weeks.
If symptoms worsen or there is no improvement after 3 months of treatment, consult your doctor.
After three months, consult your doctor to determine whether treatment should be continued.
Use in children and adolescents
Ginkofar Intense should not be used in children and adolescents.
Method of administration
Ginkofar Intense is taken orally, independently of meals. The tablet should be swallowed with water.
The break line on the tablet is intended only to facilitate splitting for easier swallowing.
Overdose of Ginkofar Intense
If more medicine has been taken than recommended, contact your doctor or pharmacist immediately.
Missed dose of Ginkofar Intense
Do not take a double dose to make up for a missed dose.
If a dose is missed, it should be taken as soon as remembered, unless it is almost time for the next dose.
Stopping Ginkofar Intense
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
The following adverse reactions may occur during treatment with Ginkofar Intense:
Very common (affects more than 1 in 10 people):

headache.

Common (affects 1 to 10 in 100 people):

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

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

bleeding from various organs (eyes, nose, gastrointestinal tract, and cerebral vessels). The risk of bleeding increases when used concomitantly with anticoagulant or antiplatelet medicines (see section 2).
allergic reactions (anaphylactic shock),
allergic skin reactions (rash, swelling, itching, and skin eruption).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. 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 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Email: [email protected]
Adverse reactions may 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 Ginkofar Intense

Keep this medicine out of the sight and reach of children.
Store in the original packaging.
Store at a temperature below 25°C.
Do not use this medicine after the expiry date stated on the carton and blister pack.
The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Ginkofar Intense contains

The active substance is a dry extract of Ginkgo biloba leaves. Each coated tablet contains 120 mg of quantified dry extract from Ginkgo biloba leaves (Ginkgo biloba L., folium) (35 - 67 : 1), equivalent to:
26.4 to 32.4 mg of flavonoids expressed as flavonoid glycosides,
3.36 to 4.08 mg of ginkgolides A, B and C,
3.12 to 3.84 mg of bilobalide. The solvent used for the first extraction: 65% (v/v) acetone.
Other ingredients are: tablet core: microcrystalline cellulose, crospovidone, lactose monohydrate, talc, magnesium stearate, sodium croscarmellose, colloidal anhydrous silica; tablet coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 3000, yellow iron oxide (E172), talc.

What Ginkofar Intense looks like and contents of the pack
Ginkofar Intense are coated tablets, beige-yellow in colour, elongated, biconvex, with a break line on one side.
The coated tablets are packed in blisters made of PVC/PVDC-Aluminium, placed together with the patient leaflet in a cardboard box.
The pack contains 10, 20, 30, 40, 50, 60, 90 or 120 tablets (a multipack containing 2 packs of 60 coated tablets each).
Not all pack sizes may be marketed.
Prescription information
OTC - Medicinal product available without a doctor's prescription.
Marketing Authorisation Holder and Manufacturer
Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
tel.: +48 61 66 51 500
fax: +48 61 66 51 505
[email protected]
{Farmakod}