NOTICE
ANSM - Updated on: 21/04/2017
Name of the medicinal product
GINKGO BIOGARAN 40 mg film-coated tablet
Ginkgo (refined and quantified dry extract)
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 GINKGO BIOGARAN 40 mg film-coated tablet and when it is used?
2. What information should I take before taking GINKGO BIOGARAN 40 mg film-coated tablet?
3. How to take GINKGO BIOGARAN 40 mg film-coated tablet?
4. What are the possible side effects?
5. How to store GINKGO BIOGARAN 40 mg film-coated tablet?
6. Package contents and other information.
1. WHAT IS GINKGO BIOGARAN 40 mg film-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 (especially memory impairment) with the exception of any type of confirmed dementia, medication-related disorders, depression or disorders metabolic.
2. BEFORE YOU TAKE GINKGO BIOGARAN 40 mg film-coated tablet?
Do not take GINKGO BIOGARAN 40 mg film-coated tablets:
· if you are allergic (hypersensitive) to the active substance or to any of the other ingredients of this medication mentioned in section 6.
· if you are pregnant.
· if your doctor has informed you of an intolerance to some sugars, contact him or her before taking this medication.
Warnings and Precautions
Talk to your doctor before taking GINKGO BIOGARAN 40 mg film-coated tablet:
· if you have predispositions to bleed (hemorrhagic terrain) and if you have an anticoagulant or anti-platelet treatment.
· if you suffer from epilepsy.
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 weeks before surgery.
Concomitant use of efavirenz with efavirenz is not recommended
Children and Youth
Not applicable.
Other medicines and GINKGO BIOGARAN 40 mg film-coated tablet
Inform your doctor or pharmacist if you are taking, have recently taken or may be taking any other medicines.
GINKGO BIOGARAN 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 can be significant and cause with dizziness and an increase in the intensity of hot flushes.
GINKGO BIOGARAN 40 mg film-coated tablet with food, drink and alcohol
Not applicable.
Pregnancy and breast feeding
This medication is contraindicated during pregnancy.
Use of this medication is not recommended during breast-feeding.
If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Not applicable.
GINKGO BIOGARAN 40 mg film-coated tablet contains
Microcrystalline cellulose, lactose monohydrate, corn starch, sodium carboxymethyl starch, povidone K30, anhydrous colloidal silica, talc, magnesium stearate, red opadry II 85F250017.
Excipient with a known effect: Lactose.
3. HOW TO TAKE GINKGO BIOGARAN 40 mg film-coated tablet?
Always take this medication exactly as prescribed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Dosage
Reserved for adults and the elderly.
Always take the dose recommended by your doctor. If in doubt, consult your doctor or pharmacist.
The usual dosage is 3 tablets per day, to be distributed during the day, at the time of meals.
Administration mode
Oral use.
The tablets should be swallowed with half a glass of water at mealtime.
Duration of treatment
Follow your doctor's advice.
If you take more GINKGO BIOGARAN 40 mg film-coated tablets than you should
Not applicable.
If you forget to take GINKGO BIOGARAN 40 mg film-coated tablet
Do not take a double dose to make up for a missed dose.
If you stop taking GINKGO BIOGARAN 40 mg film-coated tablet
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
The following adverse reactions were observed:
Very frequently:
· Nervous system disorders: headaches.
Frequently:
· Nervous system disorders: vertigo.
· Gastrointestinal disorders: diarrhea, abdominal pain, nausea, vomiting.
With an indeterminate frequency:
· Blood and lymphatic system disorders: Bleeding from certain organs has been reported (eyes, nose, cerebral or gastrointestinal hemorrhage).
· Immune System Disorders: Hypersensitivity reactions (allergic shock) may occur.
· Skin and subcutaneous tissue disorders: Skin allergy reactions (erythema, edema, itching and redness) may occur.
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 GINKGO BIOGARAN 40 mg film-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 the month.
No special storage conditions.
Do not throw any medicines into drains or sewers. 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 GINKGO BIOGARAN 40 mg contains, film-coated tablets
· The active substance is:
Ginkgo (Ginkgo biloba L.) (refined and quantified dry extract of) ................................... ........ 40.0 mg
For a film-coated tablet.
Extract quantified at 22 - 27% of flavonoids, 2.6 - 3.2% of bilobalide, 2.8 - 3.4% of ginkgolides
First extraction solvent: acetone, water
Drug Report / Excerpt: 35-67: 1
· The other components are:
Microcrystalline cellulose, lactose monohydrate, corn starch, sodium carboxymethyl starch, povidone K30, colloidal anhydrous silica, talc, magnesium stearate, opadry II red 85F250017 (macrogol, talc, red iron oxide E172), polyvinyl alcohol, titanium dioxide E171) .
What is GINKGO BIOGARAN 40 mg film-coated tablets and contents of the pack
This medication is in the form of film-coated tablets.
Each box contains 30 or 90 film-coated tablets.
Marketing Authorization Holder
laboratory TOP PHARM
DOMAINE DE MONTCAUSSON
31250 REVEL
LA FRANCE
Marketing Authorization Operator
BIOGARAN
15 BOULEVARD CHARLES DE GAULLE
92707 COLOMBES CEDEX
LA FRANCE
Maker
FARMEA
10 rue Bouché Thomas
ZAC of Orgemont
49000 ANGERS
LA FRANCE
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:
[to be completed later by the holder]
Other
Detailed information on this medicine is available on the ANSM website (France).