Ferofix 100 mg Tuggtablett

Land: Sverige

Språk: svenska

Källa: Läkemedelsverket (Medical Products Agency)

Aktiva substanser:

järn(III)hydroxidpolymaltoskomplex

Tillgänglig från:

Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.

ATC-kod:

B03AB05

INN (International namn):

iron (III) hydroxidpolymaltoskomplex

Dos:

100 mg

Läkemedelsform:

Tuggtablett

Sammansättning:

dextrat, hydratiserat Hjälpämne; järn(III)hydroxidpolymaltoskomplex 357 mg Aktiv substans

Receptbelagda typ:

Receptbelagt

Produktsammanfattning:

Förpacknings: Blister, 30 tabletter; Blister, 50 tabletter; Blister, 100 tabletter

Bemyndigande status:

Godkänd

Tillstånd datum:

2017-11-06

Bipacksedel

PACKAGE LEAFLET: INFORMATION FOR THE USER
FEROFIX 100 MG CHEWABLE TABLETS
Iron (III) hydroxide polymaltose complex
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
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 only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Ferofix is and what it is used for
2.
What you need to know before you take Ferofix
3.
How to take Ferofix
4.
Possible side effects
5.
How to store Ferofix
6.
Content of the pack and other information
1.
WHAT FEROFIX IS AND WHAT IT IS USED FOR
Ferofix contains the active substance iron, in the form of iron (III)
hydroxide polymaltose
complex.
Iron is an essential element required for the oxygen-carrying capacity
of haemoglobine (the red
pigment in the blood cells) and of myoglobin (the red pigment in
muscle tissue). In iron
deficiency the contents of the pigment are decreased and, if the iron
deficiency persists, iron
deficiency anemia (low level of hemoglobin and depletion of red blood
cells) will occur.
Ferofix is used in the treatment of iron deficiency
in adults and adolescents above the age of 12.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FEROFIX
DO NOT TAKE FEROFIX

if you are allergic to the active substance or any of the other
ingredients of this medicine
(listed in section 6),

if iron is overloaded in your body (e.g. hemochromatosis or
hemosiderosis),

if you have problems in uptake of iron in your body, (e.g.
thalassemia),

if you have anemia not caused by iron deficiency (e.g. haemolytic
anemia – due to
hemolysis, with abnormal breakdown of red blood cells – or
megaloblastic anemia – a
blood disorder with v

Produktens egenskaper

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Ferofix 100 mg chewable tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each chewable tablet contains Iron (III) hydroxide polymaltose complex
equivalent to
100 mg Iron (III).
Excipient(s) with known effect
Each tablet contains glucose (from dextrates).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Chewable tablet.
Beige/brown spotted, round tablets of approximately 12 mm diameter.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Treatment of iron deficiency
in adults and adolescents above the age of 12.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dosage and duration of treatment depend on the degree of iron
deficiency.
Adolescents (> 12 years old) and adults:
_Iron deficiency:_
100 to 300 mg (1 to 3 tablets) daily depending on the severity of the
iron deficiency. The effect of treatment should be monitored by
laboratory tests, such as
haemoglobin
and
/
or
iron
storage
levels,
for
dose
optimisation
and
duration
of
treatment.
_Paediatric population_
Ferofix 100 mg chewable tablets are not recommended in children aged
12 years old
and younger.
Method of administration
It is recommended to take this medicine during or immediately after a
meal, for better
absorption. Ferofix 100 mg chewable tablets can be chewed or swallowed
whole.
4.3. CONTRAINDICATIONS

Hypersensitivity to the active substance or to any of the excipients
listed in
section 6.1,

Patients with iron overload syndromes, e.g.
hemochromatosis or hemosiderosis,

Patients with iron storage or assimilation diseases, e.g. thalassemia,

Patients with anemia not caused by iron deficiency, e.g. haemolytic
anemia, or
megaloblastic anemia due to vitamin B12 deficiency.
4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Only patients with iron deficiency with or without anemia should be
treated. The reason
for iron deficiency should be investigated. In cases of anemia related
to inflammation,
for example in infections, iron treatment is prefera