NOTICE
ANSM - Updated: 10/07/2017
Name of the drug
GINKOR FORT, capsule
GINKGO BILOBA Extract, Troxerutin, Heptaminol Hydrochloride
framed
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
· Keep this leaflet. You might need to read it again.
· Talk to your pharmacist for any advice or information.
· If you get any of the side effects, talk to your doctor or pharmacist or nurse. This also applies to any undesirable effect that is not mentioned in this leaflet. See section 4.
Do not let this medicine within the reach of children.
What does this booklet contain ?
1. What is GINKOR FORT, capsule and in what cases is it used?
2. What information do you need to know before taking GINKOR FORT, capsule?
3. How to take GINKOR FORT, capsule?
4. What are the possible side effects?
5. How to store GINKOR FORT, capsule?
6. Contents of the package and other information.
1. WHAT IS GINKOR FORT, capsule AND WHAT IT IS USED FOR?
Pharmacotherapeutic group: VASCULOPROTECTEUR - ATC code: (C: cardiovascular system)
This drug is recommended in disorders of the venous circulation of the legs (heavy legs, pain, painful sensations called "impatience" at bedtime ...) and in the treatment of symptoms related to the hemorrhoidal crisis.
2. WHAT YOU NEED TO KNOW BEFORE TAKING GINKOR FORT, capsule?
Do not take GINKOR FORT, capsule:
· Allergy (hypersensitivity to one of the components)
· Hyperthyroidism (thyroid dysfunction)
· Combination with certain antidepressants: monoamine oxidase inhibitors or MAOIs ( see Taking or using other medicines ).
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK THE ADVICE OF YOUR DOCTOR OR PHARMACIST.
Warnings and precautions
Talk to your pharmacist or doctor before taking GINKOR FORT, capsule .
Take special care with GINKOR FORT, capsule:
Special warnings
In the hemorrhoidal crisis, the symptoms must regress rapidly.
If no improvement after 7 days or if worsening: consult your doctor.
DO NOT LEAVE THE REACH OF CHILDREN.
Precautions for use
This treatment has all its effectiveness when associated with a healthy lifestyle: avoid exposure to sunlight, heat, prolonged standing, excess weight.
Prolonged walking and the use of suitable compression stockings promote venous circulation.
Use this medicine WITH CAUTION in case of severe hypertension.
Because of the risk of increased bleeding in the presence of ginkgo preparations, stop taking this medicine 3 to 4 days before any surgery.
Given the vasoactive properties of heptaminol and antiaggregating ginkgo biloba, GINKOR FORT should not be used during pregnancy.
Concomitant use of this medication with efavirenz is not recommended.
If you have a predisposition to bleed (haemorrhagic site) and if you have anticoagulant or platelet therapy, talk to your pharmacist or doctor before taking GINKOR FORT.
IF IN DOUBT, DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Children and adolescents
Efficacy and tolerance in children and adolescents are not established. No data available.
Other medicines and GINKOR FORT, capsule
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Taking or using other medicines
TO AVOID POSSIBLE INTERACTIONS BETWEEN SEVERAL MEDICINES, YOU MUST SIGNALLY REPORT ANY OTHER TREATMENT IN PROGRESS, especially if you take anti-depressants like MAOIs, anticoagulants (phenprocoumon, warfarin), anti-platelet drugs (clopidogrel, salicylic acid). and other nonsteroidal anti-inflammatory drugs) TO YOUR DOCTOR OR PHARMACIST.
If concomitant use of this medicine with warfarin, monitoring is necessary, consult your doctor.
If concomitant use of this drug 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 may be significant and cause vertigo and increased intensity of hot flashes.
GINKOR FORT, capsule with food, drinks and alcohol
Not applicable.
Pregnancy and lactation and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice. before taking this medicine.
Pregnancy and breast feeding
GINKOR FORT should not be used during pregnancy because of its vasoactive and antiplatelet properties.
The use of this medicine is not recommended during breastfeeding.
Driving and using machines
Not applicable.
GINKOR FORT capsule contains magnesium stearate and silicic acid
Sport
The attention of athletes will be drawn to the fact that this specialty contains an active ingredient (heptaminol) that can induce a positive reaction of the tests performed during doping controls.
3. HOW TO USE GINKOR FORT, capsule?
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if in doubt.
Dosage
The usual dosage varies according to the indication:
· Venous circulation disorders: 2 capsules a day, one in the morning and one in the evening.
· Hemorrhoidal crisis: 3 to 4 capsules a day, for 7 days, divided during meals.
Method and route of administration
Oral way.
Frequency of administration
The drug is to be taken at mealtimes.
Duration of treatment
In the hemorrhoidal crisis, do not exceed 7 days of treatment ( see Take special care with GINKOR FORT, capsule ).
Use in children and adolescents
Efficacy and tolerance in children and adolescents are not established. No data available.
If you take more GINKOR FORT, capsule than you should
Not applicable.
If you stop taking GINKOR FORT, capsule
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very rarely : severe allergic reactions, angioedema, stomach upset, digestive disorders (nausea or diarrhea), headache, skin disorders (itching, hives, eczema rash), hypertension.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or nurse. 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 about the safety of the medicine.
5. HOW TO STORE GINKOR FORT, capsule?
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 this month.
Store at a temperature not exceeding 30 ° C.
Store in the original package, protected from moisture.
Do not dispose of any medication in the sewage system or in the household garbage. 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 GINKOR FORT contains, capsule
· The active substances are:
Standardized GINKGO BILOBA extract titrated with 24% Ginkgo glycosides and 6% Ginkgolides-bilobalide ....................................................................................... ........................ ..14 mg
Troxerutin ................................................. .................................................. ............................... 300 mg
Heptaminol hydrochloride .............................................. .................................................. ........... 300 mg
For a capsule.
· The other components are:
Magnesium stearate, silicic acid.
Composition of the capsule shell :
Yellow iron oxide (E172), indigotine, titanium dioxide (E171), gelatin.
What GINKOR FORT, capsule and contents of the pack
Marketing Authorization Holder
TONIPHARM
3 rue des Quatre Chemées
92100 Boulogne-BILLANCOURT
LA FRANCE
Operator of the marketing authorization
TONIPHARM
3 rue des Quatre Chemées
92100 Boulogne-BILLANCOURT
LA FRANCE
Maker
BEAUFOUR IPSEN INDUSTRY
28100 DREUX
LA FRANCE
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
Detailed information on this medicine is available on the ANSM website (France).
Health Education Council:
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