NOTICE
ANSM - Updated on : 06/09/2022
Product name
VITALOGINK 40 mg, film-coated tablet
Ginkgo (dried leaf extract)
Box
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
Always take this medicine exactly as it is prescribed by your doctor, pharmacist or nurse.
- Keep this leaflet as you may need to read it again.
- Ask your pharmacist for advice and information.
- If you experience any side effects, please tell your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this leaflet. See section 4.
- You should contact your doctor if you do not feel any improvement or if you feel less well.
What does this leaflet contain?
1. What is vitalogink 40 mg, film-coated tablet and what is it used for?
2. What do I need to know before taking VITALOGINK 40 mg, film-coated tablet?
3. How do I take VITALOGINK 40 mg, film-coated tablet?
4. What are the possible side effects?
5. How do I keep VITALOGINK 40 mg, film-coated tablet?
6. Package contents and other information.
1. WHAT IS VITALOGINK 40 mg, film-coated tablet AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: other drugs for dementia - ATC code: N06DX002.
Herbal medicinal product indicated for the symptomatic treatment of certain cognitive disorders in the elderly (particularly memory disorders), with the exception of all types of confirmed dementia, disorders secondary to medication, depression or metabolic disorders.
2. WHAT DO I HAVE TO KNOW BEFORE TAKING VITALOGINK 40 mg, film-coated tablet?
Never take VITALOGINK 40 mg, film-coated tablet
- if you are allergic to the active substance or to any of the other ingredients of this medicine, as listed in section 6.
- if you are pregnant.
Warnings and precautions
Because of the risk of increased bleeding in the presence of ginkgo-based preparations, stop taking this medicine 3 to 4 days before any surgical procedure.
Concomitant use with lefavirenz is not recommended.
Talk to your doctor, pharmacist or nurse before taking VITALOGINK 40 mg, film-coated tablet.
- If you are predisposed to bleeding (hemorrhagic background) and are taking anticoagulant or anti-platelet medication,
- If you suffer from seizures.
Children and adolescents
Not applicable.
Other medicines and VITALOGINK 40 mg, film-coated tablet
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
VITALOGINK 40 mg, film-coated tablet may alter the effect of other drugs: anticoagulants (phencoumarone, warfarin), anti-platelet drugs (clopidogrel, salicylic acid and other non-steroidal anti-inflammatory drugs).
Consult your doctor if you are taking this medicine at the same time as warfarin.
The effect of dabigatran letexilate may be potentiated if this drug is taken at the same time as dabigatran.
The concomitant use of this drug with lefavirenz is not recommended due to the risk of reduced effect of the latter.
Ginkgo may increase the concentration of nifedipine. In some individuals, this increase may be significant, causing dizziness and an increase in the intensity of hot flushes.
VITALOGINK 40 mg, film-coated tablet with food, drink and alcohol
Not applicable.
Pregnancy and breast-feeding
This medicine is contraindicated during pregnancy.
The use of this medicine is not recommended during breast-feeding.
Driving and use of machinery
Not applicable.
VITALOGINK 40 mg, film-coated tablet contains lactose, cochineal red A, glucose and sodium.
If your doctor has informed you that you are intolerant to certain sugars, contact him/her before taking this medicine.
This medicine contains an azoic coloring agent (cochineal red A, E124) and may cause allergic reactions.
This medicine contains less than 1 mmol (23 mg) sodium per tablet, i.e. it is essentially "sodium-free".
3. HOW DO I TAKE VITALOGINK 40 mg, film-coated tablet?
Always take this medicine exactly as prescribed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Dosage
For adults and the elderly only.
3 tablets per day, spread over the day.
Method of administration
Take by mouth.
Tablets should be taken with half a glass of water at mealtimes.
Duration of treatment
As advised by your doctor.
If you have taken more VITALOGINK 40 mg, film-coated tablet than prescribed
Not applicable.
If you forget to take VITALOGINK 40 mg, film-coated tablet
Do not take a double dose to make up for the one you forgot to take.
If you stop taking VITALOGINK 40 mg, film-coated tablet
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, VITALOGINK may cause undesirable effects, but these do not always occur in everyone.
Summary of safety profile
The most common side effects are abdominal pain, diarrhea and dizziness.
If you develop a severe allergic reaction (angioedema) manifested by swelling of the face, lips, tongue or throat, stop taking this drug immediately and seek urgent medical advice.
Other possible side effects:
- Common (may 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 (may affect up to 1 in 100 people)
o Urticaria
o Rash
Reporting side effects
If you experience any side effects, please tell your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Centres Régionaux de Pharmacovigilance - Website: www.signalement-sante.gouv.fr
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW TO CONSERVE VITALOGINK 40 mg, film-coated tablet?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the box. The expiration date refers to the last day of that month.
No special storage precautions.
Do not dispose of any medicine with your household waste. Ask your pharmacist to dispose of any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What VITALOGINK 40 mg, film-coated tablet contains
- The active substance is :
Ginkgo(Ginkgo biloba L.) (refined dry leaf extract)........................................................ 40 mg
Quantified at 9.6 mg heterosides and 2.4 mg ginkgolides-bilobalide
Extraction solvent: acetone 60% w/w
Other excipient (glucose): 5%.
For one film-coated tablet.
Excipients: lactose monohydrate, cochineal red A, glucose.
- The other components are :
Lactose monohydrate, cellulose powder, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, OPADRY II red (macrogol 3350, titanium dioxide, talc, iron oxide red (E172), iron oxide yellow (E172), cochineal red A) (E124).
What VITALOGINK 40 mg, film-coated tablet is and what it contains
This medicine takes the form of a film-coated tablet. Boxes of 30 or 90.
Marketing authorization holder
VIATRIS SANTE
1 RUE DE TURIN
69007 LYON
Marketing authorization holder
VIATRIS SANTE
1 RUE DE TURIN
69007 LYON
Manufacturer
VIATRIS SANTE
1 RUE DE TURIN
69007 LYON
Drug names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised was :
[to be completed subsequently by the holder]
{MM/YYYY} {month YYYY}.
Other
Detailed information on this drug is available on the ANSM (France) website.