Fertifol Folic Acid 400 µg, 90 tablets, helps prevent neural tube closure defects in newborns of women with no specific medical history who are trying to conceive.
What is folic acid? Also known as vitamin B9, it is necessary for the production of new cells in the body. It is especially important for women who are trying to conceive or are pregnant, as folic acid is essential for the development of the child’s nervous system.
Fertifol Folic Acid 400 µg is indicated for the primary prevention of embryonic neural tube closure defects in women of childbearing age with no specific medical history who are trying to conceive. Fertifol 400 micrograms helps prevent neural tube closure defects in newborns of women with no specific medical history who are trying to conceive.
Folic acid plays an essential role in DNA synthesis and cell division. During pregnancy, an increased demand for folic acid is necessary to support fetal growth and development, particularly to ensure proper neural tube closure, which occurs during the first weeks of pregnancy. Fertifol Folic Acid 400 µg provides an adequate amount of folic acid to meet these increased needs during the preconception period and early pregnancy.
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Fertifol should be taken starting one month before conception and continuing for up to 3 months after conception, without interruption, at a dose of 1 tablet per day, except in specific cases where higher doses may be required
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What are the precautions for use?
Consult your doctor, pharmacist, or nurse before taking Fertifol 400 micrograms tablets.
The active ingredient isfolic acid hydrate.
Each tablet contains: Folic acid hydrate equivalent to 400 micrograms of anhydrous folic acid.
· The other ingredients are:
Lactose monohydrate, microcrystalline cellulose, sodium carboxymethyl starch (type A), magnesium stearate.
Packaging
Fertifol 400 micrograms is available in a box of 90 tablets.
These malformations refer to any congenital defect of the brain or spinal cord resulting from abnormal development of the neural tube (the precursor to the spinal cord) during the early stages of embryonic life. Failure of the neural tube to close is generally accompanied by malformations of the spine or skull. During normal development, a strip of nervous tissue forms along the surface of what will become the fetus’s back; the tissue forms a closed tube that develops from the structures of the central nervous system. Malformations result from the tube failing to close properly, either because it is incomplete or because it is blocked.
What are some other roles of folic acid?
Sources of folic acid:
Pharmacovigilance Report an adverse drug reaction(s)
ANSM - Updated: 05/07/2016
FERTIFOL 400 micrograms, tablet
Folic acid
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.
· If you have further questions, ask your doctor, pharmacist or nurse.
· 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, pharmacist or nurse. This also applies to any undesirable effect that is not mentioned in this leaflet. See section 4.
What does this booklet contain ?
1. What is FERTIFOL 400 micrograms tablet and when is it used?
2. What information do you need to know before taking FERTIFOL 400 micrograms tablet?
3. How to take FERTIFOL 400 micrograms, tablet?
4. What are the possible side effects?
5. How to store FERTIFOL 400 micrograms, tablet?
6. Contents of the package and other information.
1. WHAT IS FERTIFOL 400 micrograms tablet AND WHAT IT IS USED FOR
This medicine contains folic acid.
Folic acid is a vitamin needed to make new cells in the body. You need regular folic acid intake to stay healthy. In particular women wishing to conceive and pregnant women need folic acid supplementation which is used for the development of the baby.
FERTIFOL helps to prevent neural tube closure abnormalities in newborns of women with no specific history and who wish to conceive (Spina Bifida: rare malformation involving the terminal part of the spine, which can cause herniation of the spinal cord, leading to urinary and anal incontinence, and impaired motor skills and lower limb sensibility.)
2. BEFORE YOU TAKE FERTIFOL 400 microgram tablets?
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 FERTIFOL 400 micrograms, tablet:
· if you are allergic to folic acid or any other component of FERTIFOL.
· if you have cancer.
Warnings and precautions
Take care with FERTIFOL 400 micrograms, tablet:
· if you have already given birth to a child (or aborted fetus) with an abnormality of neural tube closure;
· if you are taking antiepileptic drugs: carbamazepine or valproic acid;
· if you have a family history of neural tube closure abnormality;
· if you are treated with a folic acid antagonist drug (methotrexate, sulphasalazine);
· if you have pernicious anemia, since folic acid may interfere with the diagnosis by reducing the hematological manifestations of the disease while neurological complications are established.
In all these cases, you should inform your doctor who will evaluate the need to prescribe a higher dose of folic acid than that contained in a FERTIFOL tablet.
FERTIFOL is not effective in preventing neural tube closure abnormalities if treatment is started after the 4th week of pregnancy.
Other medicines and FERTIFOL 400 micrograms, tablet
Tell your doctor if you are taking or have recently taken any of the following medicines: antiepileptics, folic acid antagonists (methotrexate, sulphasalazine), and chloramphenicol.
FERTIFOL 400 micrograms, tablet with food and drinks
Not applicable.
Ask your doctor or pharmacist for advice before taking any medicine.
Sport
Not applicable.
Driving and using machines
Not applicable.
FERTIFOL 400 micrograms, tablet contains lactose
If you know from your doctor that you are intolerant to some sugars, ask your doctor for advice before taking this medicine.
It is not recommended for use in patients with galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
FERTIFOL does not contain gluten . It is not contraindicated in patients with celiac disease.
3. HOW TO TAKE FERTIFOL 400 micrograms, tablet?
Follow the prescription of your doctor. If in doubt, consult your doctor.
The daily dosage is 1 tablet per day, starting 1 month prior to conception and continuing until 3 months after conception without interruption. To be taken regularly before meals.
This dosage is not suitable for women who have already given birth to a child with neural tube closure abnormality.
If you take more FERTIFOL 400 micrograms, tablet than you should:
Doses higher than those contained in FERTIFOL do not present any particular danger. If you have any questions, ask your doctor for advice.
If you forget to take FERTIFOL 400 micrograms, tablet:
If you stop taking FERTIFOL 400 micrograms, tablet:
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, FERTIFOL can cause side effects, although not everybody gets them.
Side effects, rare (<1/1000 patients), the most common are allergic reactions: erythema, itching, hives.
With doses higher than those contained in FERTIFOL, gastrointestinal disorders may occur (nausea, intestinal disturbances, flatulence), irritability and insomnia.
If these side effects get serious, or if any side effects not listed in this leaflet occur, consult your doctor.
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 about the safety of the medicine.
5. HOW TO STORE FERTIFOL 400 micrograms, 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 at a temperature not exceeding 30 ° C.
Store in the original package in order to protect 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 contains FERTIFOL 400 micrograms, tablet
· The active substance is:
Folic acid................................................ ................................................ 400 micrograms
For a tablet.
· The other ingredients are: lactose monohydrate, microcrystalline cellulose, sodium carboxymethyl starch (type A), magnesium stearate.
What FERTIFOL 400 micrograms, tablet and contents of the pack
This medicine comes in tablet form.
The tablet is round and yellow in color.
Box of 28 tablets in one blister or 90 tablets in three blisters or 120 tablets in four blisters of 30 tablets.
Not all presentations may be marketed.
Marketing Authorization Holder
ITALFARMACO S. p .A.
Viale F. Testi, 330
20126 Milan
Italy
Operator of the marketing authorization
BUILDING "THE NEWTON"
9-11 JEANNE BRACONNIER STREET
92366 MEUDON THE FOREST
LA FRANCE
ITALFARMACO S. p .A.
VIALE F. TESTI, 330
20126 Milan
Italy
Names of the drug in the member states of the European Economic Area
This medicine is authorized in the member states of the European Economic Area under the following names: In accordance with the regulations in force.
The last date this leaflet was revised is:
[to be completed later by the holder]
<{MM / YYYY}> <{YYYY month}.>
Not applicable.
Detailed information on this medicine is available on the ANSM website (France).
Vitamin group B
vitamin B9
. Presentations . Composition . Indications . Contraindications . Attention . Drug interactions . Pregnancy and breastfeeding . Instructions for use and dosage . Tips . Side effects . Lexicon
FERTIFOL: tablet (yellow); box of 28.
Refunded at 65%. - price: 2,28 euro (s).
FERTIFOL: tablet (yellow); box of 90.
Refunded at 65%. - price: 7,42 euro (s).
Laboratory Effik
| p cp | |
| Folic acid (vitamin B9) | 400 μg |
| Lactose | + |
Usual dosage:
1 tablet per day, starting treatment at least 1 month before fertilization and continuing until 3 months after conception.
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