TANAKAN

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

• Keep this leaflet for future reference.
• If advice or further information is needed, consult your pharmacist.
• If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement or if the patient feels worse, contact the doctor.

Contents of the leaflet:

1. What Tanakan is and what it is used for
2. Important information before taking Tanakan
3. How to take Tanakan
4. Possible side effects
5. How to store Tanakan
6. 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 individuals and to enhance the quality of life in patients with mild 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
ingredients of this medicine (listed in section 6).
If in doubt about the use of the medicine, consult a doctor or
pharmacist.
Warnings and precautions
Before starting to take Tanakan, consult a doctor or
pharmacist.
Children
Tanakan is not intended for use in children and adolescents under 18 years of age.
Tanakan and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient intends to take.
Tanakan may affect the way other medicines work. Examples of medicines that may be affected by Tanakan:

• alfentanil and fentanyl (opioid painkillers);
• cyclosporine, sirolimus and tacrolimus (immunosuppressive drugs);
• dihydroergotamine and ergotamine (ergot alkaloids used in migraine treatment);
• 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 have a child, she should consult a doctor before using this medicine.
As a precaution, Tanakan should be avoided during pregnancy or breastfeeding.
Driving and operating machinery
Some people may experience dizziness after taking Tanakan. If this occurs, do not drive or operate machinery.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is considered "sodium-free".

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
Orally.
The tablets should be taken during meals, with half a glass of water.
Duration of treatment
As directed by the doctor.
Taking more Tanakan than recommended
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 the patient develops a serious hypersensitivity reaction (angioedema) causing swelling of the face, lips, tongue or throat, treatment must be discontinued immediately and urgent medical help should be sought without delay.

Other adverse reactions:
Common (affects up to 1 in 10 people)

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

Uncommon (affects 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 your doctor or pharmacist. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl

Reporting adverse reactions helps to provide more information on the safety of this 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 stated month.
Store below 25°C. Keep in the original packaging to protect from light and moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Tanakan contains
The active substance in Tanakan is dried extract of leaves of the Japanese ginkgo tree (Ginkgo folii extractum siccum). Each coated tablet contains 40 mg of purified and quantified dried extract from Ginkgo biloba L., folium (Japanese ginkgo leaf) (EGb 761) (DER 35-67:1), including: 24% ginkgoflavonoglucosides and 6% ginkgolides and bilobalide.
Excipient: acetone 60% (w/w).
Other ingredients are:
Microcrystalline cellulose
Sodium croscarmellose
Magnesium stearate
Coating:
Polyethylene glycol 6000
Hypromellose
Iron oxide red
What Tanakan looks like and contents of the pack
The pack contains 30 or 90 coated tablets (15 coated tablets per Al/PVC blister).
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in the Czech Republic, country of export:
IPSEN Consumer HealthCare
65 quai Georges Gorse
92100 Boulogne-Billancourt
France
Manufacturer:
Beaufour Ipsen Industrie
Dreux
France
Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
Laboratorium Galenowe Olsztyn Sp. z o.o.
ul. Spółdzielcza 25A
11-001 Dywity
Synoptis Industrial Sp. z o.o.
ul. Szosa Bydgoska 58
87-100 Toruń
Marketing authorisation number in the Czech Republic, country of export: 94/877/92-C
Parallel import licence number: 274/19