Active ingredients: Folic Acid
FOLIDEX 400 micrograms tablets
Why is Folidex 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.
In particular, women planning a pregnancy and pregnant women need an adequate supply of folic acid for the development of the baby.
Folidex 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 Folidex should not be used
Do not take Folidex
- if you are allergic to folic acid or any of the other ingredients of Folidex.
- if you have cancer
Precautions for use What you need to know before taking Folidex
Warnings and Precautions
- 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 a woman being treated with antiepileptic drugs: carbamazepine or valproic acid;
- if you are a woman with a family history of neural tube developmental defects;
- if you are a woman being treated with folic acid antagonists (methotrexate, sulfasalazine)
- if you suffer from 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 all these cases you may need to take a dose of folic acid higher than that contained in a Folidex tablet.
Interactions Which drugs or foods can modify the effect of Folidex
Tell your doctor if you are taking or have recently taken any of the following medicines: antiepileptics, folic acid antagonists (methotrexate, sulfasalazine) and chloramphenicol
Warnings It is important to know that:
Folidex contains lactose
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking Folidex.
Dose, Method and Time of Administration How to use Folidex: Posology
Always take Folidex exactly as your doctor or parmacist has told you. If in doubt, consult them before taking it.
The usual dose is one tablet a day from when the pregnancy is planned 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.
Overdose What to do if you have taken too much Folidex
Even much higher doses than those contained in Folidex should not cause harm to health
If you have any further questions on the use of this medicine, ask your doctor.
Side Effects What are the side effects of Folidex
Like all medicines, Folidex can cause side effects, although not everybody gets them.
The most common side effects, which however occur rarely (occurring in more than 1 in 10,000 but less than 1 in 1,000 patients, are allergic reactions: erythema, itching and hives
At doses higher than those contained in Folidex, 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 or nurse. 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 Folidex out of the sight and reach of children.
Do not use Folidex 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.
Do not throw any medicines down the drain. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment
What Folidex contains
- The active ingredient is folic acid.
- The other ingredients are: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate (type A), magnesium stearate
What Folidex looks like and contents of the pack
The tablets have a biconvex shape and are yellow in color.
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
FOLIDEX 400 MCG TABLETS
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains: 400 mcg folic acid
Excipients: lactose (34 mg)
For the full list of excipients see section 6.1.
03.0 PHARMACEUTICAL FORM
Tablets of biconvex form and yellow 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
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. The product is administered orally, before meals.
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").
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 be subjected to a more in-depth evaluation, before starting a treatment with Folidex, as their clinical condition may require the administration of folic acid at higher doses than those of Folidex:
• 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 Folidex with phenobarbital, phenytoin or primidone is not recommended (see section 4.5 "interaction with other medicinal products or other forms of interaction").
As the medicinal product contains lactose, it must not be taken by patients with hereditary galactose intolerance problems, with Lapp lactase deficiency, and with glucose / galactose malabsorption syndrome.
Folidex is not effective in preventing the development of neural tube developmental defects if treatment is started after the fourth week of pregnancy.
04.5 Interactions with other medicinal products and other forms of interaction
Folidex can reduce the plasma concentrations of phenobarbital, phenytoin and primidone by increasing their metabolism. Consequently, the concomitant use of folidex 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
Folidex is indicated for the prevention of developmental defects of the neural tube before and during pregnancy.
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
Allergic reactions (erythema, pruritus, urticaria) have been reported rarely.
In treatments with folic acid at higher doses than those of Folidex, gastrointestinal disturbances (nausea, abdominal discomfort, flatulence), irritability and insomnia have been reported.
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 Folidex 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, Folidex 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
Folic acid is rapidly absorbed in the fast, where it undergoes reduction and methylation forming 5-methyltetrahydrofolate, which is the form present in the portal circulation. Its bioavailability after oral administration is high, since it is between 76% and 93% The maximum plasma concentration is reached in 1 hour 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 carboxymethyl starch (type 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
Italfarmaco S.p.A. - Viale Fulvio Testi, 330 - 20126 Milan
08.0 MARKETING AUTHORIZATION NUMBER
FOLIDEX 400 mcg 28 tablets - AIC 036345015
FOLIDEX 400 mcg 120 tablets - AIC 036345027
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
FOLIDEX 400 mcg 28 tablets - June 24, 2005
FOLIDEX 400 mcg 120 tablets - March 18, 2014
10.0 DATE OF REVISION OF THE TEXT
March 2014
