NOTICE
ANSM - Updated: 15/11/2018
Name of the drug
SPECIAFOLDINE 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.
· Keep this leaflet. You might need to read it again.
· If you have further questions, ask your doctor or pharmacist.
· This medicine has been prescribed for you. Do not give this to anyone else. It could be harmful to them even if the signs of their illness are the same as yours.
· If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effects that are not mentioned in this leaflet. See section 4.
What does this booklet contain ?
1. What is SPECIAFOLDINE 0.4 mg tablet and when is it used?
2. What information do you need to know before taking SPECIAFOLDINE 0.4 mg tablet?
3. How to take SPECIAFOLDINE 0.4 mg tablet?
4. What are the possible side effects?
5. How to store SPECIAFOLDINE 0.4 mg tablet?
6. Contents of the package and other information.
1. WHAT IS SPECIAFOLDINE 0.4 mg tablet AND WHAT IT IS USED FOR?
FOLIC ACID - ANTIANEMIC (B. Blood and hematopoietic organs).
This medicine is made of folic acid (vitamin B 9).
Desire for pregnancy: primary prevention of the risk of embryonic defects in Neural Tube Closure (AFTN: spina bifida, ...) in all women except those with antecedents (personal or familial) of AFTN or treated by some anti-epileptics for which another dosage is recommended.
2. BEFORE YOU TAKE SPECIAFOLDINE 0.4 mg tablet?
Do not take SPECIAFOLDINE 0.4 mg tablets:
· if you are allergic to folic acid or any of the other ingredients of this medicine, listed in section 6.
Ask your doctor or pharmacist for advice before taking any medicine.
Warnings and precautions
Talk to your doctor or pharmacist before taking SPECIAFOLDINE 0.4 mg tablet .
Children and adolescents
Not applicable.
Other medicines and SPECIAFOLDINE 0.4 mg, tablet
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
SPECIAFOLDINE 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 have a baby, ask your doctor for advice or pharmacist before taking this medicine.
Driving and using machines
Not applicable.
SPECIAFOLDINE 0.4 mg tablet contains
Not applicable.
3. HOW TO TAKE SPECIAFOLDINE 0.4 mg tablet?
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if in doubt.
Dosage
1 tablet a day.
To be effective, supplementation must cover at least 4 weeks before conception and 8 weeks after conception.
Therefore, it is recommended to start treatment as soon as you wish to become pregnant.
In all cases, strictly comply with the medical prescription.
Method and route of administration
Oral way.
Duration of treatment
Comply strictly to your doctor's prescription.
If you take more SPECIAFOLDINE 0.4 mg tablet than you should
Immediately consult your doctor or pharmacist.
If you forget to take SPECIAFOLDINE 0.4 mg, tablet
Do not take a double dose to make up for the dose you forgot to take.
If you stop taking SPECIAFOLDINE 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.
Some side effects are very rare (less than 1 in 10,000 people)
· Allergic skin reaction
Some side effects have an indefinite frequency
· Severe allergic reaction (anaphylactic reaction such as urticaria and angioedema)
· Gastrointestinal disorder
Declaration of side effects
If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effects that are 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 SPECIAFOLDINE 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.
Store at a temperature not exceeding + 30 ° C.
Keep blister packs in the outer carton in order to protect from light.
Do not dispose of any medication in the sewage system or garbage. Ask your pharmacist to eliminate medications you no longer use. These measures will help protect the environment.
6. CONTENTS OF PACKAGING AND OTHER INFORMATION
What SPECIAFOLDINE 0.4 mg tablets contains
· The active substance is:
Folic acid (vitamin B 9) ........................................... .................................................. .0.4 mg
for one tablet.
· The other components are:
Pregelatinized maize starch, magnesium stearate, calcium hydrogen phosphate dihydrate, anhydrous colloidal silica, microcrystalline cellulose.
What SPECIAFOLDINE 0.4 mg tablets contain and contents of the pack
Marketing Authorization Holder
MERUS LABS LUXCO II SA RL
26-28 EDWARD STEICHEN STREET
L-2540 LUXEMBOURG
LUXEMBOURG
Operator of the marketing authorization
SERB
40 AVENUE GEORGE V
75008 PARIS
LA FRANCE
Maker
EUROPHARTEC
RUE HENRI MATISSE
63370 LEMPDES
LA FRANCE
OR
FAMAR THE EAGLE
ZI N ° 1 - CRULAI ROAD
61300 THE AIGLE
LA FRANCE
Names of the medicine 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).