NOTICE
ANSM - Updated: 22/03/2017
Name of the drug
GINKGO EG LABO TIP 40 mg, film-coated tablet
Ginkgo (dry extract of)
framed
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
You should always take this medicine exactly as described in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Talk to your pharmacist for any advice or information.
· If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effect that is not mentioned in this leaflet.
· You should talk to your doctor if you do not feel better or if you feel worse.
Do not let this medicine within the reach of children.
What does this booklet contain ?
1. What is GINKGO EG LABO TIP 40 mg, film-coated tablet and in what cases is it used?
2. What you need to know before taking GINKGO EG LABO CONSEIL 40 mg, film-coated tablet?
3. How to take GINKGO EG LABO TIP 40 mg, film-coated tablet?
4. What are the possible side effects?
5. How to store GINKGO EG LABO TIP 40 mg, film-coated tablet?
6. Contents of the package and other information.
1. WHAT GINKGO EG LABO TIP 40 mg, film-coated tablet AND WHAT IT IS USED FOR
Pharmacotherapeutic group: other drugs for dementia - ATC code: N06DX02.
Herbal medicinal product indicated for the symptomatic treatment of certain cognitive disorders in the elderly (in particular memory disorders), except for any type of confirmed dementia, disorders secondary to medication, depression or disorders. metabolic.
2. BEFORE YOU TAKE GINKGO EG LABO TIP 40 mg, film-coated tablet?
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Do not take GINKGO EG LABO TIP:
· if you are allergic (hypersensitive) to the active substance or to any of the other ingredients of this medicine, listed in section 6
· if you are pregnant.
Warnings and precautions
Due to the presence of glucose, the use of this drug is not recommended in patients with glucose and galactose malabsorption syndrome.
Due to the presence of lactose, the use of this drug is not recommended in patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).
Because of the risk of increased bleeding in the presence of ginkgo preparations, stop taking this medicine 3 to 4 days before any surgery.
Concomitant use of this medication with efavirenz is not recommended
Talk to your doctor before taking GINKGO EG LABO CONSEIL.
· if you have a predisposition to bleed (haemorrhagic site) and if you have anticoagulant or antiplatelet therapy
· if you have epilepsy
Children and adolescents
Not applicable.
Other medicines and GINKGO EG LABO CONSEIL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
GINKGO DEXTREG can modify the effect of other drugs: anticoagulants: phencoumarone, warfarin, anti-platelet drugs (clopidogrel, salicylic acid and other nonsteroidal anti-inflammatory drugs)
If this medicine is taken concomitantly with warfarin, you should consult your doctor
If concomitant use of this medicinal product with dabigatran etexilate, the effect of dabigatran may be potentiated, consult your doctor.
Concomitant use of this medication with efavirenz is inadvisable due to the potential for decreased efavirenz effect.
Ginkgo can increase the concentration of nifedipine. In some individuals this increase can be significant and cause vertigo with an increase in the intensity of hot flashes.
GINKGO EG LABO BOARD with food and drinks
Not applicable.
Pregnancy and breast feeding
This medication is contraindicated during pregnancy.
The use of this drug is not recommended during breastfeeding
Driving and using machines
Not applicable.
GINKGO EG LABO CONSEIL contains liquid glucose and lactose monohydrate.
3. HOW TO TAKE GINKGO EG LABO TIP 40 mg, film-coated tablet?
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if in doubt.
The tablets are to be taken with half a glass of water at the time of the meals.
Reserved for adults and seniors
3 tablets a day, to be distributed during the day.
Method and route of administration
Oral way.
Duration of treatment
Comply with the advice of your doctor.
If you take more GINKGO EG LABO CONSEIL, 40 mg, film-coated tablet than you should:
Immediately consult your doctor or pharmacist.
If you forget to take GINKGO EG LABO CONSEIL, 40 mg, film-coated tablet:
Do not take a double dose to make up for the dose you forgot to take.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, GINKGO EG LABO CONSEIL can cause side effects, although not everybody gets them.
The following side effects have been observed:
Very frequently:
· Nervous system disorders: headaches
Frequently
· Nervous system disorders: vertigo
· Gastrointestinal disorders: diarrhea, abdominal pain, nausea, vomiting
With an undetermined frequency:
· Blood and lymphatic system disorders : Bleeding of certain organs have been reported (eyes, nose, cerebral or gastrointestinal bleeding).
· Immune system disorders : Hypersensitivity reactions (allergic shock) may occur.
· Skin and subcutaneous tissue disorders : skin allergy reactions (erythema, edema, itching and redness) may occur.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effect that is not mentioned in this leaflet. You can also report side effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr
By reporting side effects, you can help provide more information on the safety of the medicine.
5. HOW TO STORE GINKGO EG LABO TIP 40 mg, film-coated tablet?
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of the month.
Do not dispose of any medication at the sewer or with household waste. Ask your pharmacist to eliminate medications that you no longer use. These measures will help protect the environment.
6. CONTENTS OF PACKAGING AND OTHER INFORMATION
What GINKGO EG LABO BOARD contains 40 mg, film-coated tablet
· The active substance is:
Gingko ( Ginkgo biloba L.) (refined and quantified dry leaf extract) ................................. .... 40.00 mg
Quantified at 24% ginkgo glycosides and 6% ginkgolides-bilobalide.
1 st extraction solvent: acetone 60% w / w
Drug / extract ratio: 35-67: 1
For a film-coated tablet.
· The other components are:
Freeze-dried liquid glucose, lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, white Opadry II (polyvinyl alcohol, macrogol 3350, titanium dioxide (E 171), talc), iron oxide (E 172).
What is GINKGO EG LABO TIP 40 mg, film-coated tablet and package contents
This medicine comes in the form of film-coated tablets. Box of 20, 30, 50, 60, 90, 100, 120, 300 or 500.
Not all presentations may be marketed.
Marketing Authorization Holder
EG Labo - EUROGENERIC Laboratories
12 rue Danjou
"The Quintet" - Building A
92517 Boulogne Billancourt Cedex
Operator of the marketing authorization
EG Labo - EUROGENERIC Laboratories
12 rue Danjou
"The Quintet" - Building A
92517 Boulogne Billancourt Cedex
Maker
DRAGENOPHARM APOTHEKER PÜSCHL GMBH
GÖLLSTRASSE 1
D-84529 TITTMONING
GERMANY
OR
SWISS CAPS GMBH
GRASSINGERSTRASSE 9
D-83043 BAD AIBLING
GERMANY
OR
STADA ARZNEIMITTEL AG
STADASTRASSE 2-18
61118 BAD VILBEL
GERMANY
Names of the drug in the member states of the European Economic Area
Not applicable.
The last date this leaflet was revised is:
[to be completed later by the holder]
Other
Not applicable.