Tanakan

LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Tanakan

40 mg, coated tablets

Ginkgo folii extractum siccum

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or according to the doctor's or pharmacist's instructions.

• You should keep this leaflet, so that you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse, you should contact a doctor.

Table of contents of the leaflet:

• 1. What is Tanakan and what is it 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 package and other information

1. What is Tanakan and what is it used for

Tanakan is used to improve impaired cognitive functions in older people and to improve the quality of life of patients with mild dementia.

2. Important 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).
In case of doubts related to the use of the medicine, you should consult a doctor or pharmacist.

Warnings and precautions

Before starting to take Tanakan, you should consult a doctor or pharmacist.

Children

The medicine is not intended for children and adolescents under 18 years of age.

Tanakan and other medicines

You should tell your doctor or pharmacist about all medicines that the patient is currently taking or has recently taken, as well as about medicines that the patient plans to take.
Tanakan may affect the way other medicines work. Examples of medicines that Tanakan may affect:

• alfentanil and fentanyl (pain-relieving medicines belonging to the opioid group);
• cyclosporine, sirolimus, and tacrolimus (medicines that lower the body's immune system);
• dihydroergotamine and ergotamine (ergot alkaloids used to treat migraines);
• pimozide (used to treat psychotic disorders);
• quinidine (used to treat heart rhythm disorders).

Note that the above list is not exhaustive.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a doctor before taking this medicine.
As a precaution, the use of Tanakan should be avoided during pregnancy or breastfeeding.

Driving and using machines

Some people may experience dizziness after taking Tanakan. If this happens, you should not drive or operate machines.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine 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, you should consult a doctor or pharmacist.

Dosage

Adults: The recommended dose is three tablets a day, evenly distributed throughout the day.

Method of administration and route of administration

Orally.
Tablets should be taken during meals, with ½ glass of water.

Duration of treatment

According to the doctor's instructions.

Taking a higher dose of Tanakan than recommended

There is no significant experience with overdose of Tanakan.

Missing a dose of Tanakan

You should not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, Tanakan can cause side effects, although not everybody gets them.
Summary of safety profile
The most common side effects reported are: abdominal pain, diarrhea, and dizziness.
If the patient experiences a severe allergic reaction (angioedema) causing swelling of the face, lips, tongue, or throat, you should stop taking the medicine and seek immediate medical attention.
Other side effects:
Common: (occurring in no more than 1 in 10 people)
o Allergic reactions
o Breathing difficulties
o Headache
o Fainting
o Nausea
o Malaise
o Eczema (skin rash)
o Itching
Uncommon: (occurring in no more than 1 in 100 people)
o Hives
o Rash

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the 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
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Tanakan

The medicine should be stored 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 in a temperature below 25°C. Store in the original packaging to protect from light and moisture.
Medicines should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the package and other information

What Tanakan contains

The active substance of the medicine is dry extract of Ginkgo biloba leaves (Ginkgo folii extractum siccum). Each coated tablet contains 40 mg of dry extract of Ginkgo biloba, purified and quantified (EGb 761) from Ginkgo biloba L., folium(Ginkgo biloba leaf) (DER 35-67:1), including: 24% ginkgo flavonoid glycosides and 6% ginkgolides and bilobalide.
Extractant: 60% acetone (w/w).
Other ingredients are:
Microcrystalline cellulose
Sodium croscarmellose
Magnesium stearate
Coating:
Polyethylene glycol 6000
Hypromellose
Iron oxide red

What Tanakan looks like and what the package contains

The package contains 30 or 90 coated tablets (15 coated tablets in an Al/PVC blister pack).
To obtain more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in the Czech Republic, the 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 by:

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 authorization number in the Czech Republic, the country of export: 94/877/92-C
Parallel import authorization number: 274/19

Date of approval of the leaflet: 25.07.2024

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