NOTICE
ANSM - Updated: 26/09/2017
Name of the drug
FOLIC ACID CCD 0.4 mg, tablet
Folic acid
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. See section 4.
· You should talk to your doctor if you do not feel better or if you feel worse.
What does this booklet contain ?
1. What is FOLIC ACID CCD 0.4 mg, tablet and in what cases is it used?
2. What information do you need to know before taking FOLIC ACID CCD 0.4 mg tablet ?
3. How to take FOLIC ACID CCD 0.4 mg tablet ?
4. What are the possible side effects?
5. How to store FOLIC ACID CCD 0.4 mg tablet ?
6. Additional information.
1. WHAT Folic Acid 0.4 mg tablet AND WHAT IT IS USED FOR
Pharmacotherapeutic group: FOLIC ACID - ANTIANEMIC (B. Blood and hematopoietic organs)
This medication is a group B vitamin indicated in:
· the prevention of embryonic neural tube closure abnormalities in women with no particular history and who wish to conceive.
· deficiencies in folic acid.
2. BEFORE YOU TAKE FOLIC ACID CCD 0.4 mg tablet?
Do not take Folic Acid CCD 0.4 mg, tablet:
· If you are allergic (hypersensitive) to folic acid or any of the other ingredients of this medicine, listed in section 6.
Warnings and precautions
Talk to your doctor or pharmacist before taking Folic Acid CCD 0.4mg tablets.
Children and adolescents
Not applicable.
Other medicines and Folic Acid CCD 0.4 mg, tablet
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Folic Acid CCD 0.4 mg, tablet with food, drinks and alcohol
Not applicable.
Pregnancy and breast feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to seek advice from your doctor or pharmacist before taking any medicine.
Driving and using machines
Not applicable.
Folic Acid CCD 0.4 mg, tablet contains
Not applicable.
3. HOW TO TAKE FOLIC ACID CCD 0.4 mg tablet?
Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Dosage
The recommended dose is 1 tablet a day.
To be effective, prevention must be undertaken 4 weeks before conception and continue for 8 weeks after conception.
Always take this medicine exactly as described in this leaflet or your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Administration mode
Oral way.
If you take more Folic Acid CCD 0.4 mg tablet than you should
Immediately consult your doctor or pharmacist.
If you forget to take Folic Acid CCD 0.4 mg, tablet
Do not take a double dose to make up for the dose you forgot to take.
If you stop taking Folic Acid CCD 0.4 mg, tablet
Not applicable.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist for more information.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
· Very rare cases of allergic skin reactions.
· Possibility of gastrointestinal disorders.
· Anaphylactic reactions such as: urticaria, angioedema have been reported in very rare cases.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not listed 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 FOLIC ACID CCD 0.4 mg 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 this month.
Store in the original packaging, protected from light.
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's in Folic Acid CCD 0.4 mg, tablet
· The active substance is:
Folic acid................................................ .................................................. 0.4 mg
For a tablet.
· The other ingredients are: microcrystalline cellulose, pregelatinized maize starch, magnesium trisilicate, magnesium stearate, anhydrous colloidal silica.
What is FOLIC ACID CCD 0.4 mg, tablet and contents of the pack
This medicine comes in tablet form.
Box of 30, 200, 500, 750 or 1000 tablets.
Marketing Authorization Holder
LABORATORY ccd
48, RUE DES PETITES ECURIES
75010 PARIS
Operator of the marketing authorization
LABORATORY ccd
48, RUE DES PETITES ECURIES
75010 PARIS
Maker
BAILLY-CREAT LABORATORY
PATH OF DAMAGE
PLACE-SAYS THE 150 ARPENTS
28500 VERNOUILLET
or
RODAEL PHARMACEUTICAL LABORATORIES
1 SOCX ROAD
ZAC OF BIERENDYCK AND RED CROSS
59380 BIERNE
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).