FOLIFER, 1mg + 90mg, film coated tablet

Kraj: Malta

Język: angielski

Źródło: Malta Medicines Authority

Składnik aktywny:

FOLIC ACID, IRON

Dostępny od:

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

Kod ATC:

B03AD03

INN (International Nazwa):

FOLIC ACID 1 mg IRON 90 mg

Forma farmaceutyczna:

FILM-COATED TABLET

Skład:

FOLIC ACID 1 mg IRON 90 mg

Typ recepty:

POM

Dziedzina terapeutyczna:

ANTIANEMIC PREPARATIONS

Status autoryzacji:

Authorised

Data autoryzacji:

2005-09-30

Ulotka dla pacjenta

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PACKAGE LEAFLET
INORMATION FOR THE USER
FOLIFER, FILM COATED TABLETS
Iron (as dried ferrous sulfate) 90 mg; Folic acid 1 mg
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 FOLIFER is and what it is used for
2.
Before you take FOLIFER
3.
How to take FOLIFER
4.
Possible side effects
5
How to store FOLIFER
6.
Further information
1.
WHAT FOLIFER IS AND WHAT IT IS USED FOR
Pharmacotherapeutic Group: Antianemic Preparations. ATC Code B03A D03.
FOLIFER is a medicinal product that contains bivalent iron and folic
acid, two essential antianemic
factors in the successive phases of the haematopoiesis.
FOLIFER is indicated in the prophylaxis and treatment of deficiency
states of iron and folic acid
during pregnancy, lactation and puerperium.
2.
BEFORE YOU TAKE FOLIFER
DO NOT TAKE FOLIFER
−
if you are allergic (hypersensitive) to iron, folic acid or any of the
other ingredients of
FOLIFER;
−
if you have excess iron (e.g. haemochromatosis, haemosiderosis);
−
if you have vitamin B12 deficiency (megaloblastic anaemia).
-
if you have undergone repeated blood transfusions
-
if you are having concomitant parenteral iron therapy
TAKE SPECIAL CARE WITH FOLIFER
−
if you have an acute gastrointestinal disease.
-
if you are planning to become pregnant, FOLIFER should not be used to
prevent neuronal tube
defects.
-
if you have vitamin B12 deficiency or pernicious anaemia.
-
if you have intolerance to some sugars, namely lactose.
-
when taking FOLIFER, stools become dark green or black. This effect is
harmless.
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-
due to the risk of mouth ulceration and tooth dis

Charakterystyka produktu

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
FOLIFER, 1 mg + 90 mg, film coated tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains:
Folic acid 1 mg and Iron (as ferrous sulfate) 90 mg
Excipient(s): Lactose mono-hydrate: 373 mg.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Salmon, circular and biconvex film-coated tablets, engraved “Bial”
on one side and “FF” on the
other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
FOLIFER is indicated in the treatment and prophylaxis of folic acid
and iron deficiency during
pregnancy, lactation and puerperium.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The recommended dosage is 1 tablet of FOLIFER daily.
Duration of treatment is established by the doctor.
Method of administration
The tablets should not be sucked, chewed or kept in the mouth, but
swallowed whole with water.
Tablets should be taken before meals or during meals, depending on
gastrointestinal tolerance.
4.3
CONTRAINDICATIONS
Hypersensitivity to the folic acid or iron or to any of the
excipients.
Iron overload (e.g. haemochromatosis, haemosiderosis).
Patients who have undergone repeated blood transfusions.
Megaloblastic anaemia due to vitamin B
12
deficiency.
Concomitant iron parenteral therapy.
4.4
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
FOLIFER contains lactose. Patients with rare hereditary problems of
galactose intolerance, the
Lapp lactase deficiency or glucose-galactose malabsorption should not
take this medicine. The
possibility of developing hypersensitivity reactions to folic acid
exists, but is rare.
Due to the risk of mouth ulcerations and tooth discolouration, tablets
should not be sucked, chewed
or kept in the mouth, but swallowed whole with water.
Use cautiously in case of acute gastrointestinal pathologies.
This combination shall not be used to prevent neural tube defects in
women who are planning to
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become pregnant. Furthermore, it shall not be used in t