FOLIORAL ORAL.SOL 10MG/ML
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SmPC - FOLIORAL 10MG/ML
To prevent first occurrence of spina bifida and other neural tube defects in the newborn.
This product is not suitable where there is an increased risk of neural tube defects in the baby, for example in women who have previously had an affected child, or are diabetic, or are receiving medication for epilepsy. In this case, an alternative product and a higher dose of folic acid should be used.
Posology
For oral administration only. Method of administration
Neural tube defects:
Prophylactic dose in pregnancy for women up to the 12 th week of pregnancy with no additional risk factors is 0.5mg (0.05mL, 1 drop) daily.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
FOLIORAL is contraindicated for children due to the amount of propylene glycol that it contains.
Folic acid is removed by haemodialysis.
The folic acid content is unlikely to mask pernicious anaemia should this condition be present. Pregnancy during pernicious anaemia is very rare.
No interactions are expected with the very low dose of folic acid recommended for the prophylaxis of neural tube defects during pregnancy.
Pregnancy
The product is indicated for use during pregnancy.
There are no known hazards to the use of folic acid, indeed folic acid supplements are often necessary in pregnancy. There is published evidence that folic acid is beneficial in the prevention of neural tube defects.
Breastfeeding
Folic acid is excreted in breast milk.
Adverse reactions that are at least possibly related to folic acid are described by MedDRA system organ class frequency. The frequency categories are defined as: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to
<1/1,000), Very rare (<1/10,000) and Not known (cannot be estimated from the available data).
| System/Organ class | Frequency | Adverse reaction |
| Gastrointestinal disorders | Rare | Mild gastrointestinal disorder |
| Immune system disorders | Rare | Allergic reaction |
| Not known | Anaphylactic reaction | |
| Pregnancy, puerperium and perinatal conditions | Not known | Morning sickness in pregnancy |
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via
National Medicines Agency Mesogeion 284,
GR-15562 Cholargos, Athens tel + 30 21 32040337
e-mail: http://www.eof.gr
http://www.kitrinikarta.gr
Φαρμακολογικές ιδιότητες - FOLIORAL 10MG/ML
Pharmacotherapeutic group: folic acid, ATC code: B03BB01
After conversion into co-enzyme forms it is concerned in single carbon unit transfers in the synthesis of purines, pyrimidines and methionine.
Absorption
About 70-80% of a 2mg oral solution of folic acid is absorbed. Larger doses are probably equally well absorbed.
Distribution
It is distributed into plasma and extracellular fluid. In plasma, folate is bound weakly to albumin (70%). There is a further high affinity binder for folate but this has a very low capacity and is barely detectable in normal sera.
Biotransformation
There is an enterohepatic circulation of folate. The retained folate is taken into cells and reduced by dihydrofolate to tetrahydrofolate. Folic acid is a relatively poor substrate for folate reduction, the normal substrate being dihydrofolate.
Folic acid itself does not occur in natural materials, it is entirely a pharmacological form of the compound. Once reduced, folate has additional glutamic acid residues added, a folate pentaglutamate being the dominant intracellular analogue. These polyglutamates are the active co-enzymes.
Elimination
About 70% of small doses of folate (about 1mg) are retained and the rest excreted into the urine. With larger doses most is excreted into the urine. With a 5mg dose of folate, urinary excretion will be complete in about 5 hours.
Φαρμακευτικές πληροφορίες - FOLIORAL 10MG/ML
Store below 25°C.
Store in the original package in order to protect from light.
Amber (Type III) glass bottle, equipped with an LDPE vertical dropper designed to deliver 20 drops per mL. A tamper-evident HDPE screw cap closure is also provided.
Capacity: 15 mL
Directions for using the dropper bottle:
-
The bottle comes with an HDPE screw cap closure and should be opened as follows:
-Push the plastic screw cap down while turning it counterclockwise (figure 1).
-Remove the unscrewed cap.
-Turn the bottle upside down vertically.
-Wait for a few instants, without shaking, until dropwise flow occurs (figure 2). If flow is delayed, it may be necessary to gently tap the bottom of the bottle.
After use:
-Close the bottle with precaution so as not to damage the drop dispenser.
Figure 1 Figure 2
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.