Niferex 100 mg Enterokapsel, hård

Riik: Rootsi

keel: rootsi

Allikas: Läkemedelsverket (Medical Products Agency)

Toimeaine:

järn(II)glycinsulfat

Saadav alates:

Cogmill Pharma AB

ATC kood:

B03AA01

INN (Rahvusvaheline Nimetus):

iron (II) glycinsulfat

Annus:

100 mg

Ravimvorm:

Enterokapsel, hård

Koostis:

järn(II)glycinsulfat 567,66 mg Aktiv substans; natriumlaurilsulfat Hjälpämne

Retsepti tüüp:

Receptfritt

Terapeutiline ala:

Järn(II)glycinsulfat

Volitamisolek:

Avregistrerad

Loa andmise kuupäev:

2008-12-04

Infovoldik

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PACKAGE LEAFLET: INFORMATION FOR THE USER
NIFEREX 100MG GASTRO-RESISTANT CAPSULES, HARD
iron (Fe
2+
)
[FOR MEDICINES AVAILABLE ONLY ON PRESCRIPTION]
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 your 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.
[FOR MEDICINES AVAILABLE WITHOUT A PRESCRIPTION]
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.
<[To be completed nationally]>
WHAT IS IN THIS LEAFLET
:
1.
What X is and what it is used for
2.
What you need to know before you take X
3.
How to take X
4.
Possible side effects
5.
How to store X
6.
Contents of the pack and other information
1
WHAT X IS AND WHAT IT IS USED FOR
X 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.
The capsules are called
gastro-resistant because they do not release their contents in the
stomach. They deliver the iron
to your gut where it can be absorbed.
Niferex is used for the treatment of iron deficiency.
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE X
DO NOT TAKE X

Toote omadused

1
SUMMARY OF THE PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Niferex 100mg gastro-resistant capsules, hard
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 capsule contains:
Ferrous (II) glycine-sulphate complex 567.7 mg (equivalent to 100 mg
Fe
2+
).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Gastro-resistant capsule, hard.
Hard gelatine capsule size 0 (approximately 21.7 mm x 7.5 mm) with a
chocolate-brown, opaque,
unprinted cap and an orange, opaque, unprinted body
Capsule content: grey-brownish, enteric, coated pellets
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Iron deficiency.
<[To be completed nationally]> is indicated in adults and children
from 6 years (min. 20 kg BW).
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 and the response of the clinical variables (e.g. haemoglobin,
ferritin and transferrin) should be
monitored.
A daily dose of 5mg Fe
2+
/kg BW should not be exceeded (see section 4.9).
Children from age 6 years (from a body weight of 20 kg), adolescents
and adults
Bodyweight (kg)
Capsules per intake
Frequency of intake
Total Fe
2+
dose (mg)
≥ 20
1
1 time daily
100
Adolescents from age 15 years (from a body weight of 50 kg) and adults
In adolescents from age 15 years and adults the following dosage is
recommended at the beginning of
therapy in cases of pronounced iron deficiency:
Bodyweight (kg)
Capsules per intake
Frequency of intake
Total Fe
2+
dose (mg)
50 - ˂ 60
1
2 times daily
200
≥ 60
1
2 - 3 times daily
200 - 300
_Elderly patients _
No clinical data on the need to adjust the dosage in elderly patients
are available (see section 4.4).
2
Patients with impaired renal or 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:_
X is contraindicated in children aged less than 6 years (see section
4.3).
Children from 6 y