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FERTIFOL Folic acid 400µg 90 tablets
Over-the-counter medication

FERTIFOL Folic acid 400µg 90 tablets

Brand : Effik Effik
€9.45 EXCL. VAT €9.65 INCL. VAT
This product is an over-the-counter medication. Please consult the package insert before ordering online.
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Reference : 3400930064535
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FERTIFOL Folic Acid 400µg 90 tablets helps prevent neural tube closure abnormalities in newborns of women with no particular history and who wish to conceive.

Fertifol Folic acid 400µg 90 tablets for prevention of neural tube closure abnormalities in newborns

What is folic acid? Also known as vitamin B9, it is needed to make new cells in the body. It is all the more important in women wishing to conceive a baby or pregnant because folic acid is essential for the development of the nervous system of the child.

Description of FERTIFOL Folic acid 400µg 90 tablets

FERTIFOL 400 µg tablet is indicated for the primary prevention of embryonic neural tube closure abnormalities in women of childbearing age without a specific history who wish to conceive.

FERTIFOL 400 micrograms helps prevent neural tube closure abnormalities in newborns of women with no specific history who wish to conceive

Directions for use and dosage

The prescription of FERTIFOL must begin from the month preceding conception and up to 3 months after conception, without interruption and at a rate of 1 tablet per day, except in special cases where higher doses may be required.

Comment on the recommendations for use and dosage of FERTIFOL Folic Acid 400µg 90 tablets with our partner Avis checked after your purchase.

Composition

The active substance is hydrated folic acid.

Each tablet contains: Hydrated folic acid equivalent to 400 micrograms of anhydrous folic acid.

· The other ingredients are:

Lactose monohydrate, microcrystalline cellulose, sodium carboxymethyl starch (type A), magnesium stearate.

Precaution of use

Talk to your doctor, pharmacist or nurse before taking FERTIFOL 400 micrograms, tablet .

  • If you have ever given birth to a child (or aborted a fetus) with a neural tube closure abnormality;
  • If you are taking antiepileptic drugs: carbamazepine or valproic acid;
  • If you have a family history of abnormal neural tube closure;
  • If you are being treated with a folic acid antagonist medicine (methotrexate, sulphasalazine);
  • If you have pernicious anemia, as folic acid can interfere with the diagnosis by reducing the haematological manifestations of the disease as neurological complications set in.

Presentation of FERTIFOL Folic acid

FERTIFOL 400 micrograms comes in a box of 90 tablets.

Our advice and expert opinion in pharmacy on folic acid

These malformations are any congenital defect of the brain or spinal cord, resulting from the abnormal development of the neural tube (precursor element of the spinal cord) during the early stages of embryonic life. Neural tube closure defects are usually accompanied by malformations of the spine or skull. During normal development, a plaque of nerve tissue forms along the surface of what will become the back of the fetus; the tissue is placed in a closed tube that develops from the structures of the central nervous system. The malformations are secondary to the absence of correct closure of the tube, either because it is incomplete or because it is blocked.

Other roles of folic acid?

  • contributes to the normal metabolism of amino acids,
  • the formation of blood cells
  • the normal functioning of the immune system,
  • reduction of fatigue,
  • normal mental functions,
  • to cell division

Sources of folic acid:

  • poultry offal;
  • calf's liver and lamb's liver;
  • legumes;
  • spinach ;
  • asparagus ;
  • linseed and sunflower seeds;
  • broccoli ;
  • fennel ;
  • the endives ;
  • the beets ;
  • the lettuce.

Pharmacovigilance Report an adverse drug reaction(s)

Download PDF leaflet

NOTICE

ANSM - Updated: 05/07/2016

Name of the drug

FERTIFOL 400 micrograms, 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.

· 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.

Pregnancy and breast feeding

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:

Not applicable.

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

EFFIK

BUILDING "THE NEWTON"

9-11 JEANNE BRACONNIER STREET

92366 MEUDON THE FOREST

LA FRANCE

Maker

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}.>

Other

Not applicable.

Detailed information on this medicine is available on the ANSM website (France).

VIDAL OF THE FAMILY

FERTIFOL

Vitamin group B

vitamin B9

. Presentations . Composition . Indications . Contraindications . Attention . Drug interactions . Pregnancy and breastfeeding . Instructions for use and dosage . Tips . Side effects . Lexicon

PRESENTATIONS (summary)

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

COMPOSITION (summary)
p cp
Folic acid (vitamin B9) 400 μg
Lactose +

INDICATIONS (summary)
This medicine contains folic acid ( vitamin B9), essential for metabolism . This vitamin has shown interest, when taken before and during the beginning of pregnancy, in the prevention of a serious abnormality of the development of the nervous system of the embryo.
It is used in future mothers to prevent a lack of closure of the spine (spina bifida) of the unborn child.
CONTRAINDICATIONS (summary)
This medicine should not be used in case of cancer.
ATTENTION (summary)
This dosage of folic acid is not appropriate for women who have had children with or have a history of nervous system abnormalities, or for those taking antiepileptic drugs (carbamazepine or valence acid) or treatment. containing methotrexate or sulfasalazine.
Taking folic acid can disrupt the diagnosis of certain anemias.
DRUG INTERACTIONS (summary)
Tell your doctor if you are taking any treatment that contains phenobarbital, primidone, or phenytoin.
PREGNANCY and BREASTFEEDING (summary)
Pregnancy :
This medicine is intended to be used during pregnancy.

Breastfeeding:
The use of this medicine is possible during breastfeeding.
DIRECTIONS AND DOSAGE (summary)
This medication should be taken with a glass of water, before a meal.

Usual dosage:

1 tablet per day, starting treatment at least 1 month before fertilization and continuing until 3 months after conception.
The dose can be doubled in case of folate deficiency.
TIPS (summary)
It is very important to start treatment before conception. For this purpose, treatment can be started as soon as contraception is stopped or when the decision to have a child is made. This medication can be taken for prolonged periods without inconvenience.
Foods rich in folic acid are green vegetables, liver and kidneys.
ADVERSE POSSIBLE EFFECTS (summary)
At high dose of folic acid: nausea, bloating, insomnia, irritability.
Rarely: allergic skin reaction (itching, hives ...).


LEXICON (summary)


metabolism
The whole of the transformation actions that the organism carries out, resulting in the creation of energy or the development of various substances. There is anabolism (manufacturing metabolism) of catabolism (degradation metabolism).


allergic reaction
Reaction due to the hypersensitivity of the body to a drug. Allergic reactions can be very varied: urticaria, angioedema, eczema, rash of measles-like pimples, etc. Anaphylactic shock is a generalized allergic reaction that causes discomfort by sudden drop in blood pressure.


vitamin
Substance essential for the growth and the good functioning of the organism. Vitamin requirements are normally covered by a varied diet. In developed countries, only vitamin D deficiency in young children or the elderly with little sun exposure justifies routine supplementation. An intake greater than the needs, by drugs in particular, can be at the origin of an overdose and various disorders (vitamins A and D essentially).

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