FOLICIL, 5mg, tablet.

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

FOLIC ACID

Available from:

Bial - Portela & C S.A. À Av. da Siderurgia Nacional, 4745-457 S. Mamede do Coronado, Portugal

ATC code:

B03BB01

INN (International Name):

FOLIC ACID 5 mg

Pharmaceutical form:

TABLET

Composition:

FOLIC ACID 5 mg

Prescription type:

POM

Therapeutic area:

ANTIANEMIC PREPARATIONS

Authorization status:

Authorised

Authorization date:

2007-04-07

Patient Information leaflet

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PACKAGE LEAFLET
INORMATION FOR THE USER
FOLICIL 5 MG, TABLETS
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them,
even if their symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET
:
1.
What FOLICIL is and what it is used for
2.
Before you take FOLICIL
3.
How to take FOLICIL
4.
Possible side effects
5
How to store FOLICIL
6.
Further information
1.
WHAT FOLICIL IS AND WHAT IT IS USED FOR
_ATC classification:_
B03B B01 – Folic acid.
FOLICIL is used to treat or prevent folic acid deficiency, especially
in pregnancy, lactation and
rapid growth periods.
Treatment with folic acid is also indicated in the prevention of
neural tube defects (spina bifida,
meningocele, anencephaly) namely in women with previous history of
having had an infant (or
fetus) with such defects.
Given that long term administration of barbiturates,
anticonvulsivants, antimalarials, laxatives, oral
contraceptives,
some
chemotherapeutic
agents,
may
cause
iatrogenic
folate
deficiency,
the
administration of FOLICIL is recommended in such situations.
2.
BEFORE YOU TAKE FOLICIL
DO NOT TAKE FOLICIL
If you are allergic (hypersensitive) to folic acid or any of the other
ingredients of FOLICIL.
TAKE SPECIAL CARE WITH FOLICIL
- If you have anaemia of unknown origin.
- If you have intolerance to some sugars, namely lactose.
TAKING OTHER MEDICINES
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines,
including medicines obtained without a prescription.
- If you are an epileptic patient being treated with phenytoin,
FOLICIL may cause an increased
frequency of seizures.
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- If you are taking medicines containing chloramphenicol

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
FOLICIL, 5 mg, tablet.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Folic acid, 5 mg
Excipient(s): Lactose
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Yellow, scored, circular and biconvex tablet, engraved “Bial” on
one side and “F|O” on the
other.
The tablet can be divided into equal halves.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
FOLICIL is used to treat or prevent folic acid deficiency, especially
in pregnancy, lactation and
rapid growth periods.
Treatment with folic acid is also indicated in the prevention of
neural tube defects (spina bifida,
meningocele, anencephaly) especially in women with previous history of
having had an infant
(or fetus) with such defects.
Given that long term administration of barbiturates,
anticonvulsivants, antimalarials, laxatives,
oral contraceptives, some chemotherapeutic agents, may cause
iatrogenic folate deficiency, the
administration of FOLICIL is recommended in such situations.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Dosage and treatment duration should be established by the physician.
_Adults_
: 1/2 to 1 tablet, once or twice daily, according to the clinical
situation.
_Prevention of neural tube defects:_
1/2 tablet, daily, one month before conception and during the
first trimester of pregnancy.
_Children_
: half of the adult dose.
The tablets should be administered with a small amount of water, at
meals or out of meals.
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4.3.
CONTRAINDICATIONS
Hypersensitivity to folic acid or to any excipient.
4.4. SPECIAL WARNING AND SPECIAL PRECAUTIONS FOR USE
Folic acid should not be administered in cases of anaemia of unknown
etiology, since folic acid
may mask pernicious anaemia.
FOLICIL contains lactose. Patients with rare hereditary problems of
galactose intolerance, the
Lapp lactase deficiency or glucose-galactose malabsorption should not
take this medicine.
4.5. INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER