Feraccru

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

ferric maltol

Available from:

Shield TX (UK) Limited

ATC code:

B03AB

INN (International Name):

ferric maltol

Therapeutic group:

Antianemic preparations

Therapeutic area:

Anemia, Iron-Deficiency

Therapeutic indications:

Feraccru is indicated in adults for the treatment of iron deficiency anaemia (IDA) in patients with inflammatory bowel disease (IBD).

Authorization status:

Authorised

Authorization date:

2016-02-18

Patient Information leaflet

18
B. PACKAGE LEAFLET
19
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FERACCRU 30 MG HARD CAPSULES
Iron (as ferric maltol)
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. Do not pass it onto 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 Feraccru is and what it is used for.
2.
What you need to know before you take Feraccru.
3.
How to take Feraccru.
4.
Possible side effects.
5.
How to store Feraccru.
6.
Contents of the pack and other information.
1.
WHAT FERACCRU
IS AND WHAT IT IS USED FOR
Feraccru contains iron (as ferric maltol). Feraccru is used in adults
to treat low iron stores in your body.
Low iron causes anaemia (too few red blood cells).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FERACCRU
DO NOT TAKE FERACCRU:
-
If you are allergic to ferric maltol or any of the other ingredients
of this medicine (listed in section 6).
-
If you have any illness causing iron overload or a disturbance in how
your body uses iron.
-
If you have received multiple blood transfusions.
WARNINGS AND PRECAUTIONS
Before starting treatment, your doctor will use a blood test to make
sure that your anaemia is not severe or
caused by anything other than iron deficiency (low iron stores).
You should avoid taking Feraccru if you are experiencing a “flare”
of your IBD.
CHILDREN AND ADOLESCENTS
Do not give Feraccru to children or adolescents 17 years and under as
it has not been studied in this age
group. Too much iron is dangerous in young children and can be
life-threatening.
OTHER MEDICINES AND FERACCRU
Tell your doctor or pharmacist if you are taking any other medicines.
You shoul

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Feraccru 30 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 30 mg iron (as ferric maltol).
Excipient(s) with known effect:
Each capsule contains 91.5 mg of lactose, 0.5 mg of Allura Red AC
(E129) and 0.3 mg Sunset Yellow
FCF (E110).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsules, hard.
Red capsule (19 mm long x 7 mm diameter).
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Feraccru is indicated in adults for the treatment of iron deficiency.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is one capsule twice daily, morning and evening,
on an empty stomach (see
section 4.5).
Treatment duration will depend on the severity of iron deficiency but
generally at least 12-weeks
treatment is required. The treatment should be continued as long as
necessary to replenish the body
iron stores according to blood tests.
_Paediatric population_
The safety and efficacy of Feraccru in children (17 years and under)
has not yet been established. No
data are available (see section 4.4).
_The elderly and patients with hepatic or renal impairment _
No dose adjustment is needed in elderly patients. No clinical data on
the need to adjust the dosage in
patients with impaired hepatic or renal function are available (see
section 4.4).
_ _
Method of administration
Oral use.
Feraccru capsules should be taken whole on an empty stomach (with half
a glass of water), as the
absorption of iron is reduced when Feraccru is taken with food (see
section 4.5).
3
4.3
CONTRAINDICATIONS
•
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
•
Haemochromatosis and other iron overload syndromes.
•
Patients receiving repeated blood transfusions.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Feraccru should not be used in patients with inflammatory bowel
disease (IBD) flare or in IBD-
patients with haemoglobin (Hb) <9.5 g/dl.
Iron preparat