Tanakan

Package Leaflet: Information for the Patient

TANAKAN, 40 mg, Film-Coated Tablets

Ginkgo Leaf Dry Extract

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

This Medication Should Always be Taken Exactly as Described in the Package Leaflet or as Advised by a Doctor or Pharmacist.

• Keep this Package Leaflet, You May Need to Read it Again.
• If You Need Advice or More Information, Consult a Pharmacist.
• If You Experience any Side Effects, Including those not Listed in the Package Leaflet, Tell Your Doctor or Pharmacist. See Section 4.
• If There is no Improvement or if You Feel Worse, Contact Your Doctor.

Table of Contents of the Package 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. Package Contents and Other Information

1. What is Tanakan and What is it Used for

Tanakan is Used to Improve Impaired Cognitive Functions in the Elderly 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 any of the Other Ingredients of this Medication (Listed in Section 6).
In Case of Doubts Related to the Use of the Medication, Consult a Doctor or Pharmacist.

Warnings and Precautions

Before Starting to Take Tanakan, Consult a Doctor or Pharmacist.

Children

This Medication is not Intended for Children and Adolescents Under 18 Years of Age.

Tanakan and Other Medications

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

• Alfentanil and Fentanyl (Pain Relief Medications Belonging to the Opioid Group);
• Cyclosporine, Sirolimus, and Tacrolimus (Medications that Lower the Body's Immune Response);
• 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 You are Pregnant or Breastfeeding, Think You May be Pregnant or Plan to Have a Child, Consult a Doctor Before Taking this Medication.
As a Precaution, Avoid Taking Tanakan During Pregnancy or Breastfeeding.

Driving and Operating Machines

Some People May Experience Dizziness After Taking Tanakan. If this Happens, Do not Drive or Operate Machines.
The Medication Contains Less than 1 mmol (23 mg) of Sodium per Tablet, which Means the Medication is Considered "Sodium-Free".

3. How to Take Tanakan

Always Take this Medication Exactly as Advised by Your Doctor. In Case of Doubts, Consult a 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.
Take the Tablets with Meals, with a Glass of Water (½ Glass).

Duration of Treatment

As Advised by Your Doctor.

Taking More Than the Recommended Dose of Tanakan

There is no Significant Experience with Overdose of Tanakan.

Missing a Dose of Tanakan

Do not Take a Double Dose to Make Up for a Missed Dose.

4. Possible Side Effects

Like all Medications, Tanakan can Cause Side Effects, although not Everybody Gets them.
Summary of the Safety Profile
The Most Common Side Effects Reported are: Abdominal Pain, Diarrhea, and Dizziness.
If You Experience a Severe Allergic Reaction (Angioedema) Causing Swelling of the Face, Lips, Tongue, or Throat, Stop Taking the Medication 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 those not Listed in the Package Leaflet, Tell Your Doctor or Pharmacist. Side Effects can be Reported Directly to the Department of Pharmacovigilance 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
Side Effects can also be Reported to the Marketing Authorization Holder or its Representative.
By Reporting Side Effects, You can Help Gather more Information on the Safety of the Medication.

5. How to Store Tanakan

Keep the Medication out of Sight and Reach of Children.
Do not Use this Medication After the Expiration Date Stated on the Packaging.
Store in a Temperature Below 25 °C, in the Original Packaging.

6. Package Contents and Other Information

What Tanakan Contains

The Active Substance of the Medication is Dry Extract of Ginkgo Biloba Leaves (Ginkgo Folii Extractum Siccum)
Each Film-Coated Tablet Contains 40 mg of Dry Extract of Ginkgo, Purified and Quantified (EGb761) from Ginkgo Biloba L., Folium(Ginkgo Biloba Leaf) (35-67:1) which Corresponds to:

• 8.8 to 10 mg of Flavonoids Expressed as Flavonoid Glycosides
• 1.1 to 1.4 mg of Ginkgolides A, B, and C
• 1.0 to 1.3 mg of Bilobalide.

First Extractant: Acetone 60 % (m/m).
Excipients:
Microcrystalline Cellulose
Sodium Carboxymethylcellulose
Magnesium Stearate
Coating:
Hypromellose (E464)
Macrogol 6000
Red Iron Oxide (E172)

What Tanakan Looks Like and What the Package Contains

The Package Contains 30 or 90 Film-Coated Tablets (15 Film-Coated Tablets in Al/PCV or Al/PVC-PVdC Blister Packs).

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

MAYOLY PHARMA FRANCE
3 Place Renault
92500 Rueil-Malmaison
France

Manufacturer

MAYOLY INDUSTRIE
Rue Ethé Virton
28100 Dreux
France
To Obtain more Detailed Information about this Medication, Contact the Representative of the Marketing Authorization Holder.
MAYOLY POLSKA Sp. z o.o.
ul. Domaniewska 39B
02-672 Warsaw
Phone: 22 166 26 26
Date of Last Update of the Package Leaflet: April 2025
TANAKAN