NOTICE
ANSM - Updated on: 02/08/2017
Name of the medicinal product
TANAKAN 40 mg coated tablet
Ginkgo (dry extract of)
framed
Please read this leaflet carefully before you start taking this medicine because it contains important information for you.
You should always take this medication exactly as prescribed in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Ask your pharmacist for advice or information.
· If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
· You should talk to your doctor if you do not feel better or feel less well.
What is in this leaflet?
1. What is TANAKAN 40 mg, coated tablet and in which cases it is used?
2. What should be known before taking TANAKAN 40 mg, coated tablet ?
3. How to take TANAKAN 40 mg, coated tablet ?
4. What are the possible side effects?
5. How to store TANAKAN 40 mg, coated tablet ?
6. Package contents and other information.
1. WHAT IS TANAKAN 40 mg coated tablet AND WHAT IT IS USED FOR?
Pharmacotherapeutic group: other drugs of dementia - ATC code: N06DX02.
A herbal medication indicated for the symptomatic treatment of certain cognitive disorders of the elderly (particularly memory disorders) with the exception of any type of confirmed dementia, medication-related disorders, depression or disorder metabolic.
2. BEFORE YOU TAKE TANAKAN 40 mg coated tablet?
If your doctor has told you about an intolerance to some sugars, contact your doctor before taking this medicine.
Do not take TANAKAN 40 mg, coated tablet :
· if you are allergic to ginkgo or any of the other ingredients of this medication mentioned in section 6.
· if you are pregnant.
Warnings and Precautions
The use of this medication is not recommended in patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).
Due to the risk of increased bleeding in the presence of ginkgo preparations, stop this medication 3 to 4 days before surgery.
Concomitant use of efavirenz with efavirenz is not recommended.
Talk to your doctor before taking TANAKAN 40 mg, coated tablet .
· If you have predispositions to bleed (hemorrhagic terrain) and if you have an anticoagulant or anti-platelet treatment
· If you have epilepsy
children
Not applicable.
Other medicines and TANAKAN 40 mg, coated tablet
Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
TANAKAN may affect the effect of other medicines: anticoagulants (phencoumarone, warfarin), antiplatelet drugs (clopidogrel, salicylic acid and other non-steroidal anti-inflammatory drugs).
If this medication is used concomitantly with warfarin, monitoring is necessary, consult your doctor.
If this medication is taken with dabigatran etexilate, the effect of this medication may be potentiated, consult your doctor.
Concomitant use of efavirenz with efavirenz is not recommended due to the risk of decreased effect of efavirenz.
Ginkgo may increase the concentration of nifedipine. In some individuals, this increase may be significant and cause dizziness and increased intensity of hot flushes.
TANAKAN 40 mg, tablet coated with food and drink
Not applicable.
Pregnancy and breast feeding
This medication is contraindicated during pregnancy.
Use of this medication is not recommended during breast-feeding.
Driving and using machines
Not applicable.
TANAKAN 40 mg, coated tablet contains lactose monohydrate.
3. HOW TO TAKE TANAKAN 40 mg coated tablet?
Always take this medication exactly as prescribed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
The tablets should be taken with half a glass of water at mealtime.
Dosage
Reserved for adults and the elderly.
3 tablets per day, to be distributed throughout the day.
Administration mode
Oral use
Duration of treatment
Follow your doctor's advice.
If you take more TANAKAN 40 mg, coated tablet that you should not have
Not applicable.
If you forget to take TANAKAN 40 mg, coated tablet
Do not take a double dose to make up for a missed dose.
If you stop taking TANAKAN 40 mg, coated tablet
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
Security Profile Summary
The most common adverse reactions are: abdominal pain, diarrhea and dizziness.
If you develop a severe allergic reaction (angioedema) with swelling of the face, lips, tongue or throat, stop taking this medication immediately and seek medical advice immediately.
Other possible side effects:
· Frequent (can affect up to 1 in 10 people)
o Allergic reaction
o Difficulty breathing
o Headache
o Syncope
o Indigestion
o nausea
o Eczema
o itching
· Uncommon (can affect up to 1 in 100 people)
o Urticaria
o Skin rash
Declaration of side effects
If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr .
By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE TANAKAN 40 mg coated tablet?
Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the package. The expiry date refers to the last day of that month.
Store at a temperature not exceeding 25 ° C for platelet packaging (PVC / Aluminum).
Store at temperatures not exceeding 25 ° C for platelet packaging (PVC / PVDC / Aluminum) in zones III and IVa.
Store at a temperature not exceeding 30 ° C for platelet packaging (PVC / PVDC / Aluminum) in zone IVb.
Do not throw any medicines into drains or rubbish. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What Tanakan 40 mg contains: coated tablet
· The active substance is:
Ginkgo (Ginkgo biloba L.) (refined and quantified leaf extract of) ................................. 40.00 mg
Quantified:
· 8.8 to 10.8 mg of flavonoids expressed as flavonic heterosides
· 1.1 to 1.4 mg of ginkgolides A, B and C
· 1.0 to 1.3 mg bilobalide
1 Extraction solvent: acetone 60% m / m
Drug Report / Excerpt: 35-67: 1
For a coated tablet
· The other components are:
Lactose monohydrate, microcrystalline cellulose, corn starch, anhydrous colloidal silica, talc, magnesium stearate, hypromellose, macrogol 400, macrogol 6000, titanium dioxide, red iron oxide .
What is TANAKAN 40 mg, coated tablet and contents of the pack
This medication is in the form of coated tablets. Box of 30, 60, 90 or 500.
Marketing Authorization Holder
IPSEN PHARMA
65 QUAI GEORGES GORSE
92 100 BOULOGNE-BILLANCOURT
Marketing Authorization Operator
IPSEN PHARMA
65 QUAI GEORGES GORSE
92 100 BOULOGNE-BILLANCOURT
Maker
BEAUFOUR IPSEN INDUSTRIE
STREET VIRTON
28100 DREUX
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
The last date on which this leaflet was revised is:
16/11/2015
Other
Detailed information on this medicine is available on the ANSM website (France).