TOTYLEM 60 mg/0.4 mg, film-coated tablet

Land: Malta

Taal: Engels

Bron: Medicines Authority

Beschikbaar vanaf:

Laboratoire Innotech International 22 Avenue Aristide Briand, Arcueil 94110, France

ATC-code:

B03AD05

INN (Algemene Internationale Benaming):

FERROUS GLUCONATE 60 mg FOLIC ACID 0.40 mg

farmaceutische vorm:

FILM-COATED TABLET

Samenstelling:

FERROUS GLUCONATE 60 mg FOLIC ACID 0.40 mg

Prescription-type:

OTC

Therapeutisch gebied:

ANTIANEMIC PREPARATIONS

Autorisatie-status:

Authorised

Autorisatie datum:

2023-07-31

Bijsluiter

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PACKAGE LEAFLET: INFORMATION FOR THE USER
TOTYLEM 60 MG/0.4 MG, FILM-COATED TABLET
iron/folic acid
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist has told
you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
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.
-
You must talk to a doctor if you do not feel better or if you feel
worse.
WHAT IS IN THIS LEAFLET
1.
What TOTYLEM is and what it is used for
2.
What you need to know before you take TOTYLEM
3.
How to take TOTYLEM
4.
Possible side effects
5.
How to store TOTYLEM
6.
Contents of the pack and other information
1.
WHAT TOTYLEM IS AND WHAT IT IS USED FOR
TOTYLEM contains iron and folic acid as active substances.
This medicinal product belongs to a group of medicines used to treat
iron deficiency disorders.
TOTYLEM is used for the prophylaxis and treatment of iron deficiency
with increased need for folic
acid during pregnancy, after delivery and while breastfeeding.
Medicinal product for women only during pregnancy, after delivery and
while breastfeeding.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TOTYLEM
DO NOT TAKE TOTYLEM
-
If you are allergic to iron, folic acid or any of the other
ingredients of this medicine (listed in
section 6),
-
If you suffer from iron overload,
-
If you have anaemia that is not due to iron deficiency (e.g. due to
Vitamin B12 deficiency),
-
If you receive frequent blood transfusions.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking TOTYLEM
-
If you have difficulties swallowing. You may be at risk of ulceration
of the throat or the
oesophagus (the tube that connects your mouth with your stomach) or
bronchus (the major air
passages of the lungs), if the tablet enters the airwa

Productkenmerken

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
TOTYLEM 60 mg/0.4 mg, film-coated tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Iron (as ferrous gluconate hydrate)
...........................................................................................60.000
mg
Folic acid (as folic acid hydrate)
.................................................................................................0.400
mg
For one film-coated tablet.
Excipient with known effect: each film-coated tablet contains 158 mg
of lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Pearly pink, round film-coated tablet of 12 mm diameter and 7 mm
thickness.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prophylaxis and treatment of iron deficiency with increased need for
folic acid during pregnancy,
postpartum and breastfeeding.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
1 tablet daily (60 mg iron and 0.4 mg folic acid).
_ _
_Duration of the treatment_
In case of prophylactic treatment, pregnant women should be treated
for 6 months, or, if 6 months of
treatment cannot be achieved during the pregnancy, continue the
prophylaxis during postpartum period
(6 to 12 weeks after childbirth).
In case of iron deficiency, duration of use should be long enough to
restore the iron stores (serum iron,
serum transferrin receptor and transferrin saturation coefficient).
Serum hemoglobin and ferritin levels should be checked 8 weeks after
treatment initiation. The need of
any subsequent monitoring is left to the discretion of the physician.
In pregnant women, these tests
should be repeated at least once during the second trimester.
_Children and adolescents _
The product is not intended for use in the pediatric population as
only indicated in women during
pregnancy, postpartum and breastfeeding.
_Elderly patients _
The product is not intended for use in the elderly population as only
indicated in women during
pregnancy, postpartum and breastfeeding.
_Patients wit