Package leaflet: Information for the patient

Feraccru 30 mg hard capsules

iron (as ferric maltol)
Please read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Feraccru is and what it is used for
What you need to know before taking Feraccru
How to take Feraccru
Possible side effects
How to store Feraccru
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 reduced iron stores in the body. Low iron levels cause anaemia (insufficient number of red blood cells).

2. What you need to know before taking Feraccru

Do not take Feraccru

if you are allergic to ferric maltol or to any of the other ingredients of this medicine (listed in section 6).
if you have a disease causing iron overload or a disorder affecting your body's use of iron.
if you have received multiple blood transfusions.

Warnings and precautions
Before starting treatment, your doctor will perform a blood test to confirm that your anaemia
is not severe or due to a cause other than iron deficiency (low iron stores).
Feraccru should be avoided if you experience a flare-up ("exacerbation") of inflammatory bowel disease (IBD).
You must not take Feraccru if you are taking dimercaprol (a medicine used to remove toxic metals from the blood), chloramphenicol (used to treat bacterial infections), or methyldopa (used to treat high blood pressure).

Children and adolescents
Do not give this medicine to children or adolescents aged 17 years or younger, as it has not been studied in this age group. Excessive iron intake is dangerous in children, especially young children and infants, and may be life-threatening.

Other medicines and Feraccru
Tell your doctor or pharmacist if you are taking any other medicines.
You should leave at least 2 hours between taking Feraccru and taking:

supplements or medicines containing magnesium or calcium.
certain antibiotics such as ciprofloxacin, tetracycline, levofloxacin, moxifloxacin, norfloxacin, and ofloxacin.
bisphosphonates (used to treat bone diseases).
penicillamine (used to bind metals).
certain medicines used to treat Parkinson’s disease (entacapone, levodopa) and thyroid problems (levothyroxine).
mycophenolate (used together with other medicines to prevent organ transplant rejection).

During treatment with Feraccru, iron must not be administered by injection or infusion (intravenously).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
Feraccru is unlikely to affect your ability to drive or operate machinery.

Feraccru contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

Feraccru contains sunset yellow FCF (E 110) and allura red AC (E 129)
Sunset yellow FCF (E 110) and allura red AC (E 129) may cause allergic reactions.

Feraccru contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule and is therefore essentially "sodium-free".

3. How to take Feraccru

Take this medicine exactly as your doctor or pharmacist has told you.
If you are in any doubt, consult your doctor or pharmacist.
The recommended dose is one capsule (30 mg) twice daily, in the morning and in the evening.
Take this medicine on an empty stomach with half a glass of water (one hour before meals or at least 2 hours after meals).
Swallow the capsules whole.

If you take more Feraccru than you should
If you take too much Feraccru, you may feel unwell, vomit, and have stomach ache and diarrhoea. Contact your doctor or hospital immediately if you or someone else has taken too much Feraccru. Make sure to bring this leaflet and any remaining capsules with you to show the doctor.

If you forget to take Feraccru
Skip the missed dose and take the next dose at the usual time. Do not take a double dose to make up for the forgotten capsule.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most common side effects (which may affect up to 1 in 10 people) of Feraccru are:

Stomach ache
Flatulence (intestinal gas)
Constipation
Abdominal discomfort or bloating
Diarrhoea
Nausea
Change in stool colour

Uncommon side effects (which may affect up to 1 in 100 people) are:

Thirst
Joint stiffness
Pain in fingers/toes
Headache
Acne, skin redness
Vomiting
Abdominal swelling, abdominal pain, nausea and diarrhoea due to increased bacteria in the intestine
Blood tests may show increased levels of proteins (alkaline phosphatase, gamma-glutamyl transferase) that break down chemicals in the blood, and of a hormone (thyroid-stimulating hormone) that stimulates the thyroid gland.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system detailed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Feraccru

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after "Exp.". The expiry
date refers to the last day of that month.
After first opening the bottle, use this medicine within 45 days. Store below 25 °C.

6. Package contents and other information

What Feraccru contains
The active substance is 30 mg of iron as ferric maltol.
The other components are:

Lactose monohydrate (see section 2)
Sodium lauryl sulfate
Magnesium stearate
Anhydrous colloidal silica
Crospovidone (type A)
Hypromellose
Brilliant Blue FCF (E 133)
Allura Red AC (E 129) (see section 2)
Titanium dioxide (E 171)
Sunset Yellow FCF (E 110) (see section 2)
Shellac 45% (20% esterified) in ethanol
Black iron oxide
Propylene glycol
Ammonium hydroxide.

Description of the appearance of Feraccru and pack sizes
Feraccru is a red hard capsule marked with "30" and contains a brownish-red powder.
Feraccru is available in packs, each containing 14, 50, 56 or 100 (2 bottles of 50) capsules.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Norgine B.V.
Antonio Vivaldistraat 150
1083 HP Amsterdam
The Netherlands
Manufacturer
Patheon France
40 Boulevard de Champaret
38300 Bourgoin-Jallieu
FRANCE
For further information about this medicinal product, contact the local representative of the Marketing Authorization Holder:
BE\LU AT
Norgine NV/SA Norgine Pharma GmbH
+32 16 39 27 10 +43 1 8178120
[email protected] [email protected]
BG\CZ\HR\HU\PL\RO\SI\SK
AOP Orphan Pharmaceuticals AG
+43-1-503-72-44
[email protected]
DE IE/UK (NI)
Norgine GmbH Norgine Pharmaceuticals Ltd.
+49 641984970 +44 1895 826666
[email protected] [email protected]
ES FR
Norgine de España, S.L.U Norgine SAS
+34 91 375 8870 +33 141399400
[email protected] [email protected]
IT NL
Norgine Italia S.r.l. Norgine B.V.
+39 0267 977211 +31 20 567 0900
[email protected] [email protected]
PT EE\EL\CY\LV\LT\MT
Norgine Portugal Farmacêutica Unipessoal, Lda Norgine B.V.
+351 218952735 +44 1895 826600
[email protected] [email protected]
DK/FI/IS/NO/SE
Norgine Denmark A/S.
+45 33170400
[email protected]
Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.
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Corinne GranetLegal19-Oct-2023 13:36:22 GMT+0000

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