Tanakan

Package Leaflet: Information for the Patient

Warning! Keep the Leaflet! Information on the Immediate Packaging in a Foreign Language.

Tanakan

40 mg, Film-Coated Tablets

Ginkgo Folium Extract Dry

Read the Leaflet Carefully Before Taking the Medicinal Product, as it Contains Important Information for You.

This Medicinal Product Should Always be Taken Exactly as Described in this Leaflet for the Patient or as Directed by Your Doctor or Pharmacist.

• You Should Keep this Leaflet, so You Can Read it Again if You Need to.
• If You Need Advice or Further Information, You Should Ask Your Pharmacist.
• If You Experience any Side Effects, including those not Listed in this Leaflet, You Should Tell Your Doctor or Pharmacist. See Section 4.
• If You Do Not Feel Better or if You Feel Worse, You Should Contact Your 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 Pack and Other Information

1. What is Tanakan and What is it Used for

Tanakan is Used to Improve Impaired Cognitive Functions in Elderly Patients and to Improve the Quality of Life of Patients with Mild Dementia.

2. Important Information Before Taking Tanakan

When Not to Take Tanakan

If You are Allergic to Ginkgo Biloba Leaf Extract or to any of the Other Ingredients of this Medicinal Product (Listed in Section 6).
In Case of Doubt, Consult Your Doctor or Pharmacist.

Warnings and Precautions

Before Taking Tanakan, Consult Your Doctor or Pharmacist.

Children

This Medicinal Product is Not Intended for Children and Adolescents Below 18 Years of Age.

Tanakan and Other Medicinal Products

Tell Your Doctor or Pharmacist About all Medicinal Products You are Taking or Have Recently Taken, as well as any Medicinal Products You Plan to Take.
Tanakan May Affect the Way Other Medicinal Products Work. Examples of Medicinal Products that Tanakan May Affect:

• Alfentanil and Fentanyl (Pain-Relieving Medicinal Products Belonging to the Opioid Group);
• Ciclosporin, Sirolimus, and Tacrolimus (Medicinal Products that Weaken the Immune System);
• Dihydroergotamine and Ergotamine (Ergot Alkaloids Used to Treat Migraine);
• Pimozide (Used to Treat Psychotic Disorders);
• Quinidine (Used to Treat Heart Rhythm Disorders).

Note that the Above List is Not Exhaustive.

Pregnancy and Breast-Feeding

If You are Pregnant or Breast-Feeding, Think You May be Pregnant or are Planning to Have a Baby, Ask Your Doctor for Advice Before Taking this Medicinal Product.
As a Precaution, Avoid Taking Tanakan During Pregnancy or Breast-Feeding.

Driving and Using Machines

Some People May Feel Dizzy After Taking Tanakan. If this Happens, Do Not Drive or Operate Machinery.

Tanakan Contains Lactose Monohydrate

Since the Medicinal Product Contains Lactose Monohydrate, it is Contraindicated in Patients with Congenital Galactosemia, Glucose-Galactose Malabsorption Syndrome, or Lactase Deficiency.

3. How to Take Tanakan

This Medicinal Product Should Always be Taken Exactly as Advised by Your Doctor. In Case of Doubt, Consult Your Doctor or Pharmacist.

Dosage

Adults: The Recommended Dose is Three Tablets a Day, Spaced Out Over the Day.

Method of Administration and Route of Administration

Oral Administration.
Tablets Should be Taken with Meals, with a Glass of Water (½ Glass).

Duration of Treatment

As Advised by Your Doctor.

Overdose of Tanakan

There is Limited Experience with Overdose of Tanakan.

Missed Dose of Tanakan

Do Not Take a Double Dose to Make Up for a Forgotten Dose.

4. Possible Side Effects

Like all Medicinal Products, Tanakan can Cause Side Effects, although not Everybody Gets them.
Summary of Safety Profile
The Most Commonly Reported Side Effects are: Abdominal Pain, Diarrhea, and Dizziness.
If You Experience a Serious Allergic Reaction (Angioedema) Causing Swelling of the Face, Lips, Tongue, or Throat, Stop Taking the Medicinal Product and Seek Immediate Medical Attention.
Other Side Effects:

• Allergic Reactions
• Breathing Difficulties
• Headache
• Fainting
• Nausea
• Malaise
• Eczema (Skin Rash)
• Itching.

Uncommon (affects Less than 1 in 100 People)

• Hives
• Rash.

Reporting of Side Effects

If You Experience any Side Effects, including those not Listed in this Leaflet, You Should Tell Your Doctor or Pharmacist. Side Effects can be Reported Directly to the Department for Monitoring of Adverse Reactions to Medicinal Products, 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.
By Reporting Side Effects, You can Help Provide More Information on the Safety of this Medicinal Product.

5. How to Store Tanakan

Keep this Medicinal Product out of the Sight and Reach of Children.
Do Not Use this Medicinal Product After the Expiry Date Stated on the Packaging. The Expiry Date Refers to the Last Day of the Month Stated.
Store Below 25°C. Store in the Original Packaging to Protect from Light and Moisture.
Medicinal Products Should Not be Disposed of via Wastewater or Household Waste. Ask Your Pharmacist How to Dispose of Medicinal Products that are No Longer Needed. This will Help Protect the Environment.

6. Contents of the Pack and Other Information

What Tanakan Contains

The Active Substance is Dry Extract of Ginkgo Biloba Leaves (Ginkgo Folium Extractum Siccum).
Each Tablet Contains 40 mg of Dry Extract of Ginkgo Biloba Leaves, Purified and Quantified (EGb761) from Ginkgo Biloba L., Folium(Ginkgo Biloba Leaf) (35-67:1), Including: 24% Ginkgo Flavone Glycosides and 6% Ginkgolides and Bilobalide.
First Extractant: Acetone 60% (w/w).
Other Ingredients are:
Core:
Lactose Monohydrate
Microcrystalline Cellulose
Corn Starch
Colloidal Silica Anhydrous
Talc
Magnesium Stearate
Coating:
Hypromellose
Macrogol 400
Macrogol 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 in a Blister Pack of Al/PVC or Al/PVC/PVDC Foil).
For More Detailed Information, Contact the Marketing Authorisation Holder or the Parallel Importer.

Marketing Authorisation Holder in the Czech Republic, the 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

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Authorisation Number in the Czech Republic, the Country of Export:94/877/92-C
Parallel Import Authorisation Number:87/09

Date of Approval of the Leaflet: 05.06.2024

[Information about the Trademark]