Niferex 30 mg/ml Orala droppar, lösning

Land: Sverige

Språk: svenska

Källa: Läkemedelsverket (Medical Products Agency)

Aktiva substanser:

ferroglycinsulfatkomplex

Tillgänglig från:

Cogmill Pharma AB

ATC-kod:

B03AA01

INN (International namn):

ferroglycinsulfatkomplex

Dos:

30 mg/ml

Läkemedelsform:

Orala droppar, lösning

Sammansättning:

ferroglycinsulfatkomplex 170 mg Aktiv substans; sorbitol Hjälpämne

Receptbelagda typ:

Receptfritt

Terapiområde:

Järn(II)glycinsulfat

Bemyndigande status:

Avregistrerad

Tillstånd datum:

2008-12-04

Bipacksedel

1/5
PACKAGE LEAFLET: INFORMATION FOR THE USER
NIFEREX 30 MG/ML ORAL DROPS, SOLUTION
Iron (Fe
2+
)
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 doctor if you do not feel better or if you feel
worse.
WHAT IS IN THIS LEAFLET
:
1.
What Niferex is and what it is used for
2.
What you need to know before you take Niferex
3.
How to take Niferex
4.
Possible side effects
5.
How to store Niferex
6.
Contents of the pack and other information
1
WHAT NIFEREX IS AND WHAT IT IS USED FOR
Niferex is a form of iron that can be taken by mouth to treat or
prevent iron deficiency. Iron is
essential for transport of oxygen and for energy transfer in the body.
Niferex is used for the
treatment of iron deficiency.
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE NIFEREX
DO NOT USE NIFEREX
•
If you are allergic to iron or any of the other ingredients of this
medicine (listed in
section 6 ).
•
If you suffer from a hereditary iron storage disease
(haemochromatosis) or other diseases
that increase iron levels.
•
If you receive repeated blood transfusions.
•
In newborns weighing 2 kg or less.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Niferex.
•
If you have diseases of the digestive system such as irritable bowel
syndrome,
inflammatory bowel disease, gastritis or gastrointestinal ulcers.
•
If you suffer from severe and chronic renal disease requiring
erythropoietin.
•
If you suffer from impaired hepatic function or alcoholism.
•
If you are have blood or iron loss of unknown origin.
Iron treatment can cause poisoning, especially in childr

Produktens egenskaper

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Niferex 30 mg/ml oral drops, solution.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml (approx. 20 drops) contains ferroglycine sulfate complex 170 mg
equivalent to Fe
2+
30 mg.
Excipient with known effect
Sorbitol, ethanol.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral drops, solution.
Green-yellow to light brown clear solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Iron deficiency.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
For all ages, body weights and dosing groups the posology should be
adjusted to suit the patient's needs. The
response of the clinical variables (eg haemoglobin, ferritin and
transferrin) should be monitored.
A daily dose of 5 mg Fe
2+
/kg body weight should not be exceeded.
ADULTS AND
ADOLESCENTS
_Body weight 50-65 kg_
At the beginning of treatment 35 drops 3-4 times daily over 1-2 weeks
and then 35 drops 1-2 times daily.
(Total dose Fe
2+
52.5-105
_ _
mg).
_Body weight ≥65 kg_
At the beginning of treatment 35 drops 4-6 times daily over 1-2 weeks
and then 35 drops 1-2 times daily.
(Total dose Fe
2+
52.5-105
_ _
mg)
Special population
_Elderly _
No clinical data on the need to adjust the dosage in the elderly are
available (see section 4.4)
2
_Impaired renal- and hepatic function_
No clinical data on the need to adjust the dosage in patients with
impaired renal or hepatic function are
available (see section 4.4)
_Paediatric population_
NEWBORN AND SMALL CHILDREN (BODY WEIGHT > 2 TO 20 KG):
Niferex is contraindicated in newborn with a body weight less than 2
kg.
The dosage of Niferex drops is based on body weight. The lower daily
doses in the table below are
recommended when taken on an empty stomach. The higher daily doses are
recommended when taken
together with a meal as adsorption is expected to be poorer (see
section 4.5).
Body weight
Dose
Total Fe
2+
dose (mg)
>2 - 3 kg
2 drops 2 - 4 times daily
6 – 12
>3 - 4 kg
3 drops 2 - 4 times daily
9 – 18
>4 - 5 kg
4 dro