Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - feraccru

Document Subject

Generated Narrative: MedicinalProductDefinition mp02a1ba5129f4c436758a0bf386350823

identifier: http://ema.europa.eu/identifier/EU/1/15/1075/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Feraccru 30 mg hard capsules

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-02a1ba5129f4c436758a0bf386350823

identifier: http://ema.europa.eu/identifier/EU/1/15/1075/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - feraccru

Attesters

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.

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).

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 inflammatory bowel disease (IBD).

You should 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 treatment to children or adolescents 17 years and under as it has not been studied in this age group. Too much iron is dangerous in children, infants and toddlers and can 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 that contain magnesium or calcium.

• Some antibiotics, such as ciprofloxacin, tetracycline, levofloxacin, moxifloxacin, norfloxacin and ofloxacin.

• Bisphosphonates (used to treat bone diseases).

• Penicillamine (used to bind metals).

• Some medicines used to treat Parkinson s disease (entacapone, levodopa) and thyroid problems (levothyroxine)

• Mycophenolate (used with other medicines to prevent the body rejecting transplanted organs). You should not be given iron by injection or infusion (intravenously) while you are taking Feraccru.

Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines Feraccru is unlikely to have any effect on the ability to drive and use machines.

Feraccru contains lactose If you have been told by your doctor that you have an intolerance to some 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 sodium (23 mg) per capsule, that is to say essentially sodium-free .

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is one capsule (30 mg) taken twice a day, morning and evening. Take this medicine on an empty stomach with half a glass of water (one hour before a meal, or at least 2 hours after a meal).

Swallow the capsules whole.

If you take more Feraccru than you should Taking too much Feraccru can make the person feel sick or be sick and cause bellyache and diarrhoea. Call your doctor or hospital straightaway if you or another person has taken too much Feraccru. Make sure that you take this leaflet and any remaining capsules with you to show to the doctor.

If you forget to take your Feraccru Skip the missed dose and take the next dose as normal. Do not take a double dose to make up for a forgotten capsule.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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

• Stomach pain
• Flatulence (wind)
• Constipation
• Discomfort or bloating in the stomach
• Diarrhoea
• Nausea (feeling sick)

• Discoloured faeces 

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

• Thirst,
• Stiff joints
• Pain in fingers/toes
• Headache
• Acne, skin redness,
• Vomiting
• Abdominal bloating, abdominal pain, nausea and diarrhea due to increase in bacteria in the gut
• Blood tests may show increased levels of proteins (alkaline phosphatase, Gamma- glutamyltransferase) 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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

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.

Do not use this medicine for more than 45 days after first opening the bottle. Store below 25 C.

What Feraccru contains The active substance is 30 mg of iron as ferric maltol.

The other ingredients are:

• Lactose monohydrate (see section 2)
• Sodium laurilsulfate
• Magnesium stearate
• Colloidal anhydrous 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 glaze-45% (20 %esterfied) in Ethanol
• Iron oxide black
• Propylene glycol
• Ammonium hydroxide

What Feraccru looks like and contents of the pack Feraccru is a red hard capsule printed 30 containing a reddish-brown 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 Authorisation Holder Norgine B.V. Antonio Vivaldistraat 1083 HP Amsterdam Netherlands

Manufacturer Patheon France 40 Boulevard de Champaret 38300 Bourgoin-Jallieu FRANCE

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

BE\ LU Norgine NV/SA +32 16 39 27 medinfo.benelux@norgine.com

AT
Norgine Pharma GmbH +43 1 8178Info@norgine.at

BG\CZ\HR\HU\PL\RO\SI\SK AOP Orphan Pharmaceuticals AG +43-1-503-72-office@aoporphan.com

DE Norgine GmbH +49 641984info@norgine.de IE/UK (NI) Norgine Pharmaceuticals Ltd. +44 1895 826MedInfo@norgine.com

ES Norgine de Espa a, S.L.U +34 91 375 8iberiamedinfo@norgine.com

FR Norgine SAS +33 141399infomedicale.norginefrance@norgine.com

IT Norgine Italia S.r.l. +39 0267 977medinfoitaly@norgine.com

NL Norgine B.V. +31 20 567 0medinfo.benelux@norgine.com

PT Norgine Portugal Farmac utica Unipessoal, Lda +351 218952iberiamedinfo@norgine.com

EE\EL\CY\LV\LT\MT Norgine B.V. +44 1895 826GMedicalAffairs@norgine.com

DK/FI/IS/NO/SE Norgine Denmark A/S. +45 33170 Minfonordic@norgine.com

This leaflet was last revised in

Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: