Active ingredients: Folic Acid
FERTIFOL 400 micrograms tablets
Why is Fertifol used? What is it for?
Folic acid is a vitamin that is needed for the replacement of cells in the body. You need a regular supply of folic acid to stay healthy. Women planning pregnancy and pregnant women in particular need an adequate supply of acid. folic for the development of the child.
Fertifol is useful in the prevention of neural tube defects such as Spina Bifida (rare malformation of the caudal part of the spine which can lead to hernias of the spinal cord, fecal and urinary incontinence and impaired movement and sensitivity of the lower limbs).
Contraindications When Fertifol should not be used
Do not take Fertifol
- if you are allergic to folic acid or any of the other ingredients of this medicine (listed in section 6).
- if you have cancer
Precautions for use What you need to know before taking Fertifol
Talk to your doctor or pharmacist before taking Fertifol
- if you are a woman who has previously had pregnancies (whether completed or not) in which developmental defects of the neural tube have already been observed;
- if you are being treated with antiepileptic medicines: phenytoin, phenobarbital, primidone, carbamazepine or valproic acid;
- if you are a woman with a family history of neural tube developmental defects;
- if you are being treated with folic acid antagonists (methotrexate, sulfasalazine);
- if you have pernicious anemia. In fact, folic acid can make the diagnosis of pernicious anemia more difficult by reducing the haematological manifestations of this disease, but it cannot counteract the progression of its neurological complications.
In these cases, you may need to take a dose of folic acid higher than that contained in a Fertifol tablet.
Interactions Which drugs or foods can modify the effect of Fertifol
Tell your doctor if you are taking, have recently taken or might take any of the following medicines: antiepileptics, folic acid antagonists (methotrexate, sulfasalazine), oral contraceptives, anti-tuberculosis medicines, or any other medicines.
Warnings It is important to know that:
Pregnancy and breastfeeding
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.
Folic acid is excreted in breast milk.
Driving and using machines
No data are available on the effects of the product on the ability to drive.
Fertifol contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Fertifol.
Dose, Method and Time of Administration How to use Fertifol: Posology
Always take Fertifol exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
The recommended dose is 1 tablet per day from the planned pregnancy until the 12th week of gestation.
The tablet should be taken regularly before meals.
This dose is not adequate if you have previously had pregnancies in which developmental defects of the neural tube have already been observed.
The daily dose can be doubled in cases of inadequate folate intake.
FERTIFOL is not effective in preventing the development of neural tube developmental defects if treatment is started after the fourth week of pregnancy.
Overdose What to do if you have taken too much Fertifol
Even much higher doses than those contained in Fertifol should not cause harm to health.
Doses of folic acid up to 4-5 mg are well tolerated. At higher dosages, mental changes, sleep disturbances and gastrointestinal disturbances were observed.
In case of accidental ingestion / intake of an excessive dose of FERTIFOL, notify your doctor immediately or go to the nearest hospital.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Side Effects What are the side effects of Fertifol
Like all medicines, Fertifol can cause side effects, although not everybody gets them.
The most common side effects, which however occur rarely (they occur in more than 1 patient in 10,000 but less than 1 in 1,000), are allergic reactions: erythema, itching and urticaria.
At higher doses than those contained in Fertifol, gastrointestinal disorders (nausea, abdominal discomfort, flatulence), irritability and insomnia may occur.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Do not store above 30 ° C.
Store in the original container to protect the product from moisture.
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 after the abbreviation "EXP". The expiry date refers to the last day of the month. The expiry date refers to the product in intact packaging, correctly stored.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Composition and pharmaceutical form
What Fertifol contains
- The active ingredient is folic acid.
- The other ingredients are: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate (type A), magnesium stearate.
What Fertifol looks like and contents of the pack
One pack contains 28 tablets in blisters or 120 tablets in four blisters of 30 tablets each.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
FERTIFOL 400 MCG TABLETS
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains: 400 mcg folic acid.
Excipients with known effects: lactose (34 mg).
For the full list of excipients see section 6.1
03.0 PHARMACEUTICAL FORM
Tablet.
The tablets are biconvex in shape and yellow in color.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Primary prevention of neural tube defects of the unborn child in fertile women planning pregnancy
04.2 Posology and method of administration
Dosage
1 tablet per day continuously from 1 month before to three months after conception.
The daily dosage can be doubled in case of inadequate folate intake.
This dosage is not adequate if the woman has already been pregnant with newborns affected by NTD (Neural Tube Defects). (See section 4.4. "Special warnings and precautions for use")
Method of administration
The product is administered orally, before meals.
04.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients.
Patients with tumors.
04.4 Special warnings and appropriate precautions for use
The following categories of patients should undergo a more in-depth evaluation, before starting a treatment with FERTIFOL, as their clinical condition may require the administration of folic acid at higher doses than those of FERTIFOL:
• women in whom developmental defects of the neural tube have already been observed in one or more previous pregnancies (whether completed or not);
• women being treated with antiepileptic drugs: carbamazepine or valproic acid;
• women with a family history of developmental defects of the neural tube;
• women being treated with folic acid antagonists (methotrexate, sulfasalazine) (see section 4.5 "Interactions with other medicinal products and other forms of interaction")
• women with folic acid deficiency megaloblastic anemia.
Folic acid should not be given alone to patients with pernicious anemia or other vitamin B12 deficiency states or to patients with megaloblastic anemia of unknown origin. In fact, folic acid can make the diagnosis of pernicious anemia more difficult by reducing its manifestations. pathology, but is unable to counteract the progression of its neurological complications.
This can result in severe neurological damage before the correct diagnosis is made.
It should be noted that in women who use folic acid antagonists it is more appropriate to administer folinic acid rather than higher doses of folic acid.
The concomitant use of Fertifol with phenobarbital, phenytoin or primidone is not recommended (see section 4.5 "Interaction with other medicinal products or other forms of interaction").
FERTIFOL is not effective in preventing the development of neural tube developmental defects if treatment is started after the fourth week of pregnancy.
Fertifol contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose / galactose malabsorption should not take this medicine.
04.5 Interactions with other medicinal products and other forms of interaction
Fertifol can reduce the plasma concentrations of phenobarbital, phenytoin and primidone by increasing their metabolism. Consequently, the concomitant use of Fertifol with phenobarbital, phenytoin or primidone is not recommended (see section 4.4 "Special warnings and precautions for use"). Careful monitoring of the plasma concentration of these antiepileptics should be performed if necessary.
Methotrexate and sulfasalazine can decrease the activity of folic acid due to their antagonistic activity
Concomitant administration of chloramphenicol may result in an antagonism in the hematopoietic response to folic acid.
04.6 Pregnancy and lactation
Pregnancy
Fertifol is indicated for the prevention of developmental defects of the neural tube before and during pregnancy.
Feeding time
Folic acid is excreted in breast milk.
04.7 Effects on ability to drive and use machines
No data are available on the effects of the product on the ability to drive. However, such an effect is unlikely.
04.8 Undesirable effects
Undesirable effects are listed below by system organ class and by frequency. Frequencies are defined as: very common (≥1 / 10), common (≥1 / 100, (available).
Disorders of the immune system
Rare: allergic reactions (erythema, itching, urticaria).
In treatments with folic acid at higher doses than those of FERTIFOL, gastrointestinal disturbances (nausea, abdominal discomfort, flatulence), irritability and insomnia have been reported.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
04.9 Overdose
Doses of folic acid up to 4-5 mg are well tolerated. At higher dosages, mental changes, sleep disturbances and gastrointestinal disturbances were observed.
The doses of folic acid contained in FERTIFOL are very low; the risk of overdose toxicity is therefore remote.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: folic acid.
ATC: B03BB01.
During cellular mitosis, folic acid deficiency causes imperfect DNA synthesis. This is linked to the role played by folic acid (as tetrahydrofolate) in the synthesis of nucleic acids and in cell division, as a coenzyme in the synthesis of purines and pyrimidines. For this reason folic acid is a crucial factor in the genesis of the central nervous system. which in man takes place 15 - 28 days after conception.
The conversion of 5-methyltetrahydrofolate into tetrahydrofolate can only occur in the organism, thanks to the action of methionine synthetase, through the donation of a methyl group to homocysteine, with the formation of methionine.
In conclusion, FERTIFOL corrects the metabolism of the essential amino acid methionine, an alteration that is observed in most mothers of children with developmental defects of the neural tube (NTD).
05.2 Pharmacokinetic properties
Absorption
Folic acid is rapidly absorbed in the jejunum, where it undergoes reduction and methylation forming 5-methyltetrahydrofolate, which is the form present in the portal circulation.
Distribution
Its bioavailability after oral administration is high, since it is between 76% and 93%. The maximum plasma concentration is reached in 1 hour.
Elimination
Folate undergoes an entero-hepatic circulation, and is eliminated in the urine in the form of metabolites. Folate crosses the placenta and is present in breast milk.
Folic acid binds extensively to plasma proteins, and the liver is the main reserve organ.
05.3 Preclinical safety data
Preclinical effects were observed only at doses higher than the maximum doses used in humans, therefore showing little clinical relevance.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Lactose monohydrate
Microcrystalline cellulose
Sodium starch carboxymethyl A.
Magnesium stearate
06.2 Incompatibility
Not relevant.
06.3 Period of validity
3 years.
06.4 Special precautions for storage
Do not store at temperatures above 30 ° C.
Store in the original package to protect from moisture.
06.5 Nature of the immediate packaging and contents of the package
Cardboard box containing 28 tablets in white Al / PVC blisters or 120 tablets in white Al / PVC blisters (4 blisters containing 30 tablets each).
06.6 Instructions for use and handling
No special instructions.
07.0 MARKETING AUTHORIZATION HOLDER
EFFIK ITALIA SpA - Via Lincoln 7 / A - 20092 Cinisello Balsamo (MI)
08.0 MARKETING AUTHORIZATION NUMBER
AIC 036346017
AIC 036346029
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Fertifol 400 mcg 28 tablets - June 24, 2005
Fertifol 400 mcg 120 tablets - March 15th 2014
