Ginkofar forte
Poland
Table of Contents
Patient Information Leaflet
Ginkofar Forte
80 mg, coated tablets
Ginkgo bilobae folium extractum siccum
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.
Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist.
- Keep this leaflet, as you may need to read it again.
- If you need advice or further information, please consult your pharmacist.
- If you experience any adverse effects, 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 of treatment, or if your condition worsens, consult your doctor.
Table of contents:
- What Ginkofar Forte is and what it is used for
- Important information before taking Ginkofar Forte
- How to take Ginkofar Forte
- Possible side effects
- How to store Ginkofar Forte
- Contents of the pack and other information
1. What Ginkofar Forte is and what it is used for
Ginkofar Forte contains a dried extract of Ginkgo biloba leaves, which improves blood flow to the brain, dilates blood vessels, and inhibits platelet aggregation. The active components of the extract are considered to be flavonoid glycosides, ginkgolides, and bilobalide.
Indications
Ginkofar Forte is indicated:
- To improve cognitive function in elderly patients (age-related memory and mental performance decline),
- To improve quality of life in mild dementia.
This medicine is intended for adults only.
If there is no improvement after 3 months of treatment, or if your condition worsens, consult your doctor.
2. Important information before taking Ginkofar Forte
When not to use Ginkofar Forte
- If you are allergic to Ginkgo biloba leaf extract or to any of the other ingredients of this medicine (listed in section 6).
- If you are pregnant (see section "Pregnancy and breastfeeding").
Warnings and precautions
Before starting treatment with Ginkofar Forte, consult your doctor or pharmacist if you have an increased tendency to bleed (bleeding diathesis).
Patients taking anticoagulant or antiplatelet drugs (so-called blood-thinning medications) should consult their doctor before using this medicine.
Before undergoing any surgical or dental procedure, inform your doctor or dentist that you are taking Ginkofar Forte. It is recommended to discontinue Ginkofar Forte at least 3–4 days before any planned surgical or dental procedure, such as tooth extraction.
Exercise caution in patients with epilepsy, as seizures cannot be ruled out during treatment with Ginkofar Forte.
If your symptoms do not improve or worsen during treatment, consult your doctor or pharmacist.
Children and adolescents
Ginkofar Forte is not intended for use in children and adolescents.
Ginkofar Forte and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
In particular, inform your doctor or pharmacist if you are regularly taking 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 with Ginkofar Forte may increase the risk of bleeding.
You should 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 to treat high blood pressure),
- Talinolol (used to treat heart conditions and high blood pressure),
- Dabigatran (used to prevent blood clots).
Ginkofar Forte with food and drink
Ginkofar Forte should be taken orally, after meals, with a drink.
Pregnancy, breastfeeding, and fertility
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Ginkofar Forte is contraindicated during pregnancy due to insufficient data and the potential risk of increased bleeding tendency.
Breastfeeding
Due to insufficient data, Ginkofar Forte is not recommended during breastfeeding.
Driving and operating machinery
There is no data available regarding the effect on the ability to drive or operate machinery.
Ginkofar Forte contains lactose.
If you have been previously diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicine.
3. How to take Ginkofar Forte
Always take this medicine exactly as described in this leaflet or as directed by your doctor. If in doubt, consult your doctor or pharmacist.
Recommended dose for adults:
1 tablet three times daily.
Daily dose: 3 tablets
Duration of treatment
Treatment should last at least 8 weeks.
If your symptoms worsen or no improvement occurs after 3 months of treatment, consult your doctor.
After 3 months, consult your doctor to determine whether continued treatment is necessary.
If you take more Ginkofar Forte than you should
If you take more tablets than recommended, contact your doctor or pharmacist immediately.
If you forget to take Ginkofar Forte
Do not take a double dose to make up for a missed dose.
If you stop taking Ginkofar Forte
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.
The following adverse effects may occur during treatment with Ginkofar Forte:
Very common (more than 1 in 10 people):
- headache.
Common (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 this medicine is taken concomitantly with anticoagulant or antiplatelet medicines (see section 2).
- allergic reactions (anaphylactic shock),
- allergic skin reactions (erythema, swelling, itching and rash).
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.
5. How to store Ginkofar Forte
Keep the medicine out of the sight and reach of children.
Store below 25°C.
Keep 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 stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to 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 – acetone 60% (v/v)
- dry extract of Ginkgo biloba leaves (Ginkgo biloba L., folium) 80 mg, including:
- native extract: 90-100%, composition:
- 22-27% ginkgoflavonglycosides,
- 5-7% terpene lactones (including 2.8-3.4% ginkgolides A, B and C and 2.6-3.2% bilobalide),
- not more than 5 ppm ginkgolic acids;
- excipient: liquid glucose 0-10%.
- Other ingredients: tablet core: microcrystalline cellulose, lactose monohydrate, povidone K30, crospovidone type A, magnesium stearate, colloidal anhydrous 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
Film-coated tablets, round, smooth, beige-yellow in colour, without chipping, with possible
slight colour spots allowed.
Available pack sizes: cardboard carton containing 20, 60 and 90 tablets.
Marketing Authorisation Holder and Manufacturer
Biofarm Sp. z o.o.
Wałbrzyska Street 13
60-198 Poznań, Poland
For more detailed information, please contact the Marketing Authorisation Holder's representative:
Poland
Biofarm Sp. z o.o.
Wałbrzyska Street 13
60-198 Poznań
Tel. 061 66 51 500
Date of first authorisation of the leaflet: