Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Tanakan
40 mg, coated tablets
Ginkgo folii extractum siccum
Please read the following information carefully before using 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
your doctor or pharmacist.

Keep this leaflet for future reference.
If you need advice or further information, please consult your pharmacist.
If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement or if you feel worse, contact your doctor.

Table of Contents:

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

1. What Tanakan is and what it is used for

Tanakan is used to improve impaired cognitive functions in elderly patients and to enhance the quality of life in patients with mild forms of dementia.

2. Information before taking Tanakan

When not to take Tanakan
If the patient is allergic to the extract of Ginkgo biloba leaves or to any of the other
components of this medicine (listed in section 6).
If in doubt about the use of this medicine, consult a doctor or pharmacist.
Warnings and precautions
Before starting to take Tanakan, consult a doctor or pharmacist.
Children
This medicine is not intended for children and adolescents under 18 years of age.
Tanakan and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Tanakan may affect the way other medicines work. Examples of medicines that may be affected by Tanakan:

alfentanil and fentanyl (analgesic drugs belonging to the opioid group);
cyclosporine, sirolimus, and tacrolimus (immunosuppressive drugs);
dihydroergotamine and ergotamine (ergot alkaloids used in the treatment of migraine);
pimozide (used in the treatment of psychotic disorders);
quinidine (used in the treatment of cardiac arrhythmias).

Please note that the above list is not exhaustive.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor before using this medicine.
As a precautionary measure, Tanakan should be avoided during pregnancy and breastfeeding.
Driving and operating machinery
Some individuals may experience dizziness after taking Tanakan. If this occurs, do not drive or operate machinery.
Tanakan contains monohydrate lactose
Since this medicine contains monohydrate lactose, it is contraindicated in patients with hereditary galactose intolerance, glucose-galactose malabsorption syndrome, or lactase deficiency.

3. How to take Tanakan

This medicine should always be taken according to the doctor's instructions. In case of doubts, consult your doctor or pharmacist.
Dosage
Adults: The recommended dose is three tablets per day, evenly spaced throughout the day.
Method of administration and route of administration
Oral administration.
Tablets should be taken during meals, with half a glass of water.
Duration of treatment
As directed by the doctor.
Overdose of Tanakan
There is no significant experience with overdose of Tanakan.
Missed dose of Tanakan
Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Summary of safety profile
The most commonly reported adverse reactions are: abdominal pain, diarrhoea and dizziness.
If a patient develops a serious hypersensitivity reaction (angioedema) causing swelling of the face, lips, tongue or throat, treatment must be discontinued immediately and urgent medical assistance sought.
Other adverse reactions:
Frequent: (occur in up to 1 in 10 people)

Hypersensitivity reactions
Breathing difficulties
Headache
Fainting
Indigestion
Malaise
Eczema (skin rash)
Itching

Uncommon (occur in up to 1 in 100 people)

Urticaria
Rash

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a 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, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions enables continued monitoring of the safety of the medicine.

5. How to store Tanakan

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Store below 25°C. Keep in the original packaging to protect from light and moisture.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Tanakan contains
The active substance is dried extract from leaves of Ginkgo biloba (Ginkgo folii extractum siccum).
Each tablet contains 40 mg of purified and quantified dried Ginkgo biloba extract (EGb761) from Ginkgo biloba L., folium (Ginkgo leaf) (35-67:1), containing: 24% ginkgoflavonglycosides and 6% ginkgolides and bilobalide.
Primary extraction solvent: acetone 60% (w/w).

Other ingredients are:
Core:
Lactose monohydrate
Microcrystalline cellulose
Maize starch
Colloidal anhydrous silica
Talc
Magnesium stearate

Coating:
Hypromellose
Polyethylene glycol 400
Polyethylene glycol 6000
Titanium dioxide
Iron oxide red (E 172)

What Tanakan looks like and contents of the pack
The pack contains 30 or 90 film-coated tablets (15 film-coated tablets per blister in Al/PVC or Al/PVC/PVDC foil).
For more detailed information, please contact the responsible party or the parallel importer.

Responsible party in the Czech Republic, country of export:
IPSEN Consumer HealthCare
65 quai Georges Gorse
92100 Boulogne-Billancourt
France

Manufacturer:
Beaufour Ipsen Industrie
Rue Ethe Virton
28100 Dreux
France

Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing Authorization number in the Czech Republic, country of export: 94/877/92-C
Parallel import authorization number: 87/09