Feraccru – Package Leaflet: InfoCons – Consumer Protection presents, in an accessible format, the official package leaflet of the medicine Feraccru, as authorised in the European Union and published in the Union Register of medicinal products.
Before anything else
ℹ️ 1. What Feraccru is and what it is used for
Feraccru contains iron (as ferric maltol). Feraccru is used in adults and adolescents aged 12 years and older , 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 ha ve any illness causing iron overload or a disturbance in how your body uses iron.
- If you ha ve received multiple blood transfusions.
Warn ings and precautions Before starting treatment, your doctor will use a blood test to make sure that your anaemia is not severe or caus ed by anything other than iron deficiency (low iron stores).
You sho uld avoid taking Feraccru if you are experiencing a “flare” of your inflammatory bowel disease ( IBD).
You sho uld not take Feraccru if you are taking dimercaprol (a medicine used to remove toxic metals from the blood), chloramphen icol (used to treat bacterial infections), or methyldopa (used to treat high blood p ressure).
Children and ad olescents Do not give Feraccru to children under 12 years of age .
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 sho uld leave at least 2 hours between taking Feraccru and taking:
- Supp lements or medicines that contain magnesium or calcium.
21 • Some antibiotics, such as ciprofloxacin, tetracycline, levofloxacin, moxifloxacin, no rfloxacin and ofloxacin.
- Bisphosphon ates (used to treat bone diseases).
- Penicillamine (used to bind metals).
- Some medicines used to treat Parkinson’s disease (entacapon e, levodopa) and thyroid problems (levothyroxine).
- Mycophen olate (used with other medicines to prevent the body rejecting transplanted organs).
You sho uld not be given iron by injection or infusion (intravenously) while you are taking Feraccru.
Pregnancy and br east-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 u sing machines Feraccru is unlikely to have any effect on the ability to drive and use machines.
Feraccru co ntains lactose If you ha ve been told by your doctor that you ha ve an intolerance to some sugars, contact your doc tor before taking this medicine.
Feraccru co ntains Suns et Yellow FCF (E 110) and Allura Red AC (E 129) Suns et 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’.
💊 3. How to take Feraccru
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 for adults and adolescents aged 12 years and older is one capsule (30 mg) taken twice a day, morning and e vening.
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 shou ld Taking too much F eraccru 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 Fe raccru. 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 caps ule.
If you ha ve any further questions on the use of this medicine, ask your doctor or pharmacist.
❗ 4. Possible side effects
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 peo ple) of Feraccru are
- Stomach pa in 22 • 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 pe ople) are
- Thirst
- Stiff joints
- Pain in fingers/toes
- Headache
- Acne , skin redne ss
- 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 che micals in the blood and of a hormone (Thyroid stimulating hormone ) that stimulates the thyroid gland.
Repor ting 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.
🌡️ 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.
Do not use this medicine for more than 45 days after first opening the bottle. Store below 25°C.
📦 6. Contents of the pack and other information
What Feraccru co ntains The active substance is 30 mg of iron as ferric maltol.
The other ingredients are:
- Lactose monoh ydrate (see section 2)
- Sodium laurilsulfate
- Magnesium stearate
- Colloidal anhydrous silica
- Crospo vidone (Type A)
- Hypromellose
- Brilliant Blue FCF (E 133)
- Allura Red AC (E 129) (see section 2)
- Titanium dioxide (E 171)
- Suns et Yellow FCF (E 110) (see section 2)
- Shellac glaze -45% (20 %esterfied) in Ethanol
- Iron oxide black
- Propylene glycol 23 • Ammonium hydroxide What Feraccru looks like and con tents of the pack Feraccru is a red hard capsule printed “30” contai ning a reddish -brown powder. Fera ccru is available in packs , each containing 14, 50, 56 or 100 (2 bottles of 50) capsules.
Not all pack sizes may be marketed.
Mark eting Authorisation Holder Norgine B.V.
Antonio Vivaldistraat 150 1083 HP Amsterdam Netherlands Man ufacturer 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 43 [email protected] AT Norgine Pharma GmbH +43 1 817812020 [email protected] DK/FI/IS/NO/SE Norgine Denmark A/S . +45 33170400 medinfo@n orgine.com BG\CY\CZ\EE\EL\HR\HU\LV\LT\M T\ PL\RO\SI\SK Norgine B.V. +44 (0) 1895 826 600 [email protected] DE Norgine GmbH +49 641984970 info@no rgine.de IE Norgine Pharmaceuticals Ltd. +44 1895 826606 medinfo@no rgine.com ES Norgine de España, S.L.U. +34 91 375 8870 iberiamedinfo@no rgine.com FR Norgine SAS +33 (0)1 41 39 93 90 [email protected] IT Norgine Italia S.r.l. +39 0267 977211 [email protected] NL Norgine B.V. + 31 20 567 0998 [email protected] PT Norgine Portugal Farmacêutica Unipessoal, Lda +351 218952735 iberiamedinfo@no rgine.com
This leaflet was last revised in <{MM/YYYY}>
Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: https://www .ema.europa.eu.
📄 Package Leaflet – official source
This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Feraccru (PDF, ec.europa.eu).
You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/15/1075).
⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.