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FOLIC ACID 1 MG/ML ORAL SOLUTION

Active substance: FOLIC ACID

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Folic acid 1 mg/ml oral solution

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains 1 mg of folic acid.
It also contains sodium (26.1 mg per 15 ml).
For a full list of excipients, see section 6.1

3

PHARMACEUTICAL FORM
Oral solution.
A pale yellow liquid with a strawberry odour.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
1. For the prophylaxis of neural tube defects in case of a positive history of previous
NTD.
2. For the prophylaxis of neural tube defects with no previous history of fetal neural
tube defect and no other predisposing factors
3. For the treatment of folate deficiency:
a. Folate deficient megaloblastic anaemia (in pregnancy, associated with
alcoholism, drug intake such as anticonvulsants)
For the prevention of megaloblastic anemia
the cobalamin status should be established before initiation
of folic acid therapy.
b. Impaired utilization such as use of concomitant drugs, in liver
disease.inadequate intake (eg alcoholism, malnutrition etc)
c. And in increased excretion (e.g. alcoholism, haemolytic states).

4. Folate deficiency / megaloblastic anaemia associated with hemolytic
anemia (eg sickle cell anemia)

5. Treatment of Folate deficiency in malabsorption syndromes (parenteral
administration of folic acid may need to be considered if oral treatment is not
effective)
(eg.: tropical sprue. tropical sprue responds to folate supplements in the early
stages of the disease but cobalamin status must also be checked, particularly
later; coeliac disease in which case the necessity of supplementation with
folate ceases once a gluten free diet is introduced; non-tropical sprue; in
congenital folate malabsorption (oral treatment may not be effective and
parental folate may therefore be required).
Cobalamin status needs to be established in all megaloblastic states (not only
in pregnancy).

4.2

Posology and method of administration
Adults (including the elderly):

-

In folate deficient megaloblastic anaemia: 5mg daily for 4 months; up
to 15mg daily may be necessary for malabsorption states.

-

In drug-induced folate deficiency: 5mg daily for 4 months; up to 15mg
daily may be necessary for malabsorption states.

-

For prophylaxis in chronic haemolytic states: 5mg every 1-7 days
depending on underlying disease.

-

For the prophylaxis of neural tube defects in case of a positive history
of previous NTD: 5mg daily started before conception and continued
throughout the first trimester.

-

In established folate deficiency of pregnancy: 5mg daily continued to
term.

-

For the prophylaxis of neural tube defects with no previous history of
fetal neural tube defect and no other predisposing factors: 0.4mg daily
until 10 to 12 weeks after last menstrual period

Paediatric population:

-

In folate deficient megaloblastic anaemia: Child 1-18 years 5mg daily
for 4 months; maintenance 5mg every 1-7 days.

-

In haemolytic anaemia; metabolic disorders: Child 1-12 years 2.5mg5mg once daily. Child 12-18 years 5-10mg once daily.

For oral administration only.

In all patient populations the duration of the folic acid regimen has not been
determined precisely, but it is recommended to administer the vitamin for
many months until the formation of new colonies of red blood cells.
Depending on the etiological factor, diet improvement, removal of etiological
factor, treatment of an inflammation may lead to cessation of treatment. In
cases of hemolytic anemia or in cases of concomitant drug intake, a longer

treatment may be necessary in order to prevent occurrence of hematological
disorders.

4.3

Contraindications
⎯ Known hypersensitivity to folic acid.
⎯ Known hypersensitivity to hydroxybenzoate esters.
⎯ Folic acid should not be given alone in the treatment of Addisonian pernicious
anaemia and other vitamin B12 deficiency states because it may precipitate the onset
of subacute combined degeneration of the spinal cord. In elderly people, a cobalamin
absorption test should be done before long-term folate therapy. Folate given to such
patients for 3 months or longer has precipitated cobalamin neuropathy. No harm
results from short courses of folate.
⎯ Folic acid should not be used in folate-dependent tumours or malignant disease unless
megaloblastic anaemia owing to folate deficiency is an important complication

4.4

Special warnings and precautions for use
Folic acid is removed by haemodialysis.
The therapeutic effect should be monitored by laboratory analysis and the diagnosis
should be reassessed (specialist workup) in case the expected response fails to appear.
Serum Potassium levels and iron/ferritin status should be controlled.
cobalamin status needs to be established in all megaloblastic states (not only in
pregnancy).
Excipients in the Formulation:
Methyl, ethyl and propyl parahydroxybenzoates are contained in this product which
may cause allergic reactions (possibly delayed).
It also contains sodium (26.1 mg per 15 ml or 1.137 mmol per 15 ml). To be taken
into consideration for patients on a controlled sodium diet.

4.5

Interaction with other medicinal products and other forms of interaction
⎯ Antiepileptics – if folic acid supplements are given to treat folate deficiency, which
can be caused by the use of antiepileptics (phenytoin, phenobarbital and primidone),
the serum antiepileptic levels may fall, leading to decreased seizure control in some
patients.
⎯ Antibacterials – chloramphenicol and co-trimoxazole may interfere with folate
metabolism.
⎯ Sulfasalazine – can reduce the absorption of folic acid.

⎯ Methotrexate – folic acid may interfere with the toxic and therapeutic effects of
methotrexate

4.6

Fertility, pregnancy and lactation
-

Pregnancy
The product is indicated for use during pregnancy.
There are no known hazards from the use of folic acid in pregnancy; indeed folic acid
supplements are often beneficial in pregnancy. There is published evidence that folic
acid is beneficial in the prevention of neural tube defects. Lack of the vitamin or its
metabolites may also be responsible for some cases of spontaneous abortion and
intrauterine growth retardation.

-

Lactation
Folic acid is actively excreted in breast milk. Accumulation of folate in milk takes
precedence over maternal folate needs. Levels of folic acid are relatively low in
colostrum but as lactation proceeds, concentrations of the vitamin rise. No adverse
effects have been observed in breast fed infants whose mothers were receiving folic
acid.

-

Fertility
There are no known risks from the use of folic acid on fertility.See sub section
“Pregnancy”.

4.7

Effects on ability to drive and use machines
There are no known effects of this preparation on the ability to drive or use machines.

4.8

Undesirable effects
Gastrointestinal disorders
Rare
(≥ 1/10.000 to <1/1.000)

Loss of appetite, nausea, abdominal distension and
flatulence.

Immune system disorders
Rare
(≥ 1/10.000 to <1/1.000)

Allergic reactions such as erythema, rash, itching,
urticaria, difficulty in breathing and anaphylactic
reactions (including shock)

4.9

Overdose
No cases of acute overdosage appear to have been reported, but even extremely high
doses are unlikely to cause harm to patients.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
ATC Code: B03BB01
Pharmacotherapeutic group: Folic acid and derivatives
After conversion into co-enzyme forms it is concerned in single carbon unit transfers
in the synthesis of purines, pyrimidines and methionine.

5.2

Pharmacokinetic properties
About 70-80% of a 2mg oral solution of folic acid is absorbed. Larger doses are
probably equally well absorbed. 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. 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. 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.

5.3

Preclinical safety data
Effects in non-clinical studies were only observed at exposures considered
sufficiently in excess of the maximum human exposure indicating little relevance to
clinical use.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Glycerol (E422),
Mannitol (E421),
Methyl parahydroxybenzoate (E218),
Propyl parahydroxybenzoate (E216),
Ethyl parahydroxybenzoate (E214),
Disodium edetate,
Sodium dihydrogen phosphate dihydrate (E339),
Disodium phosphate anhydrous (E339),
Strawberry flavour,
Purified water

6.2

Incompatibilities
Not applicable.

6.3

Shelf life
12 months unopened.
1 month once opened.

6.4

Special precautions for storage
Store in a refrigerator (2-8°C.)
Store in the original package in order to protect from light.

6.5

Nature and contents of container
Amber (Type III) glass bottle, with child-resistant, tamper-evident plastic cap, along
with a 5 ml syringe with 0.1 ml graduation and a plastic adaptor for the first use.
Pack size: 150 ml

6.6

Special precautions for disposal and other handling

Open the bottle: press the cap and turn it anticlockwise (figure 1)

Insert the syringe adaptor into the bottle neck (figure 2)
Take the syringe and put it in the adaptor opening (figure 2)

Turn the bottle upside down (figure 3)

Fill the syringe with a small amount of solution by pulling the piston down
(figure 4A), then push the piston upward in order to remove any possible
bubble (figure 4B), finally, pull the piston down to the graduation mark
corresponding to the quantity in milliliters (ml) prescribed by your doctor
(figure 4 C).
Remove the syringe from the adaptor.

Swallow the content directly from the syringe or empty it in a spoon by
pushing the piston to the bottom.
Close the bottle with the plastic screw cap.

Wash the syringe with water and leave it to airdry (figure 5).

Any unused product or waste material should be disposed of in accordance
with local requirements.

7

MARKETING AUTHORISATION HOLDER
Alapis S.A.
2, Aftokratoros Nikolaou str.
17671, Athens, Greece

8

MARKETING AUTHORISATION NUMBER(S)
PL 35574/0014

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
11/04/2011

10

DATE OF REVISION OF THE TEXT
11/04/2011

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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