FERRIFOL

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

FERROUS AS IRON III HYDROXIDE POLYMALTOSE COMPL.; FOLIC ACID

Available from:

CTS CHEMICAL INDUSTRIES LTD, ISRAEL

ATC code:

B03AD01

Pharmaceutical form:

TABLETS

Composition:

FOLIC ACID 0.4 MG; FERROUS AS IRON III HYDROXIDE POLYMALTOSE COMPL. 100 MG

Administration route:

PER OS

Prescription type:

Not required

Manufactured by:

CTS CHEMICAL INDUSTRIES LTD, ISRAEL

Therapeutic group:

FERROUS AMINO ACID COMPLEX

Therapeutic area:

FERROUS AMINO ACID COMPLEX

Therapeutic indications:

Prevention and treatment of anemia caused by iron and folic acid deficiency including anemia of pregnancy and lactation.

Authorization date:

2014-06-30

Patient Information leaflet

PATIENT LEAFLET IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS
)PREPARATIONS( – 1986
This medicine is dispensed without a doctor's
prescription
FERRIFOL TABLETS
Each tablet contains:
Iron )as Iron III Hydroxide Polymaltose Complex( 100 mg
and folic acid 0.4 mg.
Inactive ingredients and allergens in the medicine -
see section 6 “Additional information” and section 2
“Important information about some ingredients of the
medicine”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE
MEDICINE. This leaflet contains concise information
about the medicine. If you have any other questions,
refer to the doctor or the pharmacist.
Use the medicine according to the instructions in the
dosage section of this leaflet.
CONSULT THE PHARMACIST IF YOU HAVE FURTHER
QUESTIONS.
Refer to the doctor if signs of the ailment )symptoms(
worsen or do not improve after three weeks.
The medicine is usually intended for adults and children
above 12 years of age.
1. WHAT IS THE MEDICINE INTENDED FOR?
The medicine is intended for prevention and treatment
of anemia due to iron and folic acid deficiency, including
during pregnancy and breastfeeding.
THERAPEUTIC CLASS: Iron in combination with folic acid.
Iron is an essential constituent of red blood cells
)hemoglobin(, of muscle cells )myoglobin( and of
iron-containing enzymes. Folic acid is a vitamin that is
important for fetal development. Folic acid deficiency
in the early weeks of pregnancy may lead to fetal
malformations.
2. BEFORE USING THE MEDICINE:
DO NOT USE THIS MEDICINE IF:
You are sensitive )allergic( to the active ingredients
or to any of the additional components the medicine
contains.
You have an excess of iron in your body )e.g.,
deficiency caused by a rare disease of iron
accumulation, which may lead to build-up of iron in
the tissues(.
You have a problem with efficient utilization of
iron )e.g., when anemia is caused by inefficient
utilization of iron(.
You have anemia that is not caused by iron
deficiency )e.g., anemia caused by increased
hemoglobin breakdown or by

Summary of Product characteristics

FERRIFOL TABLETS
, per os
ACTIVE SUBSTANCES
Ferrifol tablets contain 100 mg Iron as iron III hydroxide polymaltose
complex
and 0.4 mg folic acid.
INDICATIONS
Prevention and treatment of anaemia caused by iron and folic acid
deficiency including
anaemia of pregnancy and lactation.
EXCIPIENTS
Ferrifol tablets contain:
Dextrates, Polyethylene Glycol 6000, Purified Talc, Aspartame,
Magnesium Stearate, Chocolate Essence
POSOLOGY/ADMINISTRATION
Adults and children above 12 years of age:
For prevention of anaemia: one tablet per day.
For treatment of anaemia: 3 tablets per day taken as one daily dose or
as separate
doses.
Ferrifol tablets should be taken with or directly after meals and can
be
chewed or swallowed whole.
_Paediatric Population _
Ferrifol tablets are not indicated for children and adolescents below
12
years of age.
CONTRAINDICATIONS
-
known hypersensitivity to or intolerance of the active substances or
one of
the excipients
-
iron overload (e.g. haemochromatosis, haemosiderosis)
-
iron metabolism disorders (lead anaemia, sideroachrestic anaemia,
thalassaemia)
-
any anaemia not caused by iron deficiency (e.g. haemolytic anaemia or
megaloblastic anaemia caused by vitamin B12 deficiency)
SPECIAL WARNINGS AND PRECAUTIONS
Anaemias should always be treated under the supervision of a doctor.
If therapeutic success (increase in haemoglobin by about 2 – 3 g/dL
after 3
weeks) is not achieved, treatment should be reconsidered.
Ferrifol contains folic acid which can mask a vitamin B12 deficiency.
A potential
vitamin B12 deficiency must be ruled out before the start of treatment
in anaemic
patients due to the risk of irreversible neurological dysfunctions,
see
“Contraindications”.
During treatment with
Ferrifol
there may be dark discolouration of the faeces
(stool), however this is of no clinical relevance.
Caution is recommended in patients who receive repeated blood
transfusions, as there is a supply of iron with erythrocytes, which
can lead to
iron overload.
Infections or tumours can cause anaemia. As oral ir