30 mg hard capsules of 
iron (as iron maltol)

What Feraccru is and what it is used for

Feraccru contains iron (in the form of iron maltol). Feraccru is used in adults to treat low iron stores in the body. Low iron levels cause anemia (lack of red blood cells ).

What you need to know before you take Feraccru

Do not take Feraccru:

  • if you are allergic to iron maltol or any of the other ingredients of this medicine (listed in section 6)
  • if you have a disease that causes you to have too much iron in your body or a disorder in how your body uses iron
  • if you have had multiple blood transfusions you

Warnings and cautions

Before starting treatment, your doctor will check with blood tests that you do not have severe anemia ( anemia ), and that the anemia is not caused by anything other than iron deficiency (low iron stores).

Avoid taking Feraccru if you have an ongoing relapse of inflammatory bowel disease.

Do not take Feraccru if you are taking dimercaprol (a medicine used to cleanse the blood of toxic metals), chloramphenicol (used to treat bacterial infections ), or methyldopa (used to treat high blood pressure ).

Children and young people

Do not give this medicine to children and adolescents 17 years of age or younger. The drug has not been studied in this age group. Too much iron is dangerous for children, infants and toddlers can be life-threatening.

Other medicines and Feraccru

Tell your doctor or pharmacist if you are taking any other medicines.

It should take at least two hours between taking Feraccru and taking:

  • nutritional supplements or medicines containing magnesium or calcium
  • certain antibiotics, such as ciprofloxacin, tetracycline, levofloxacin, moxifloxacin, norfloxacin, and ofloxacin.
  • bisphosphonates (for the treatment of skeletal diseases)
  • penicillamine (used to bind metals)
  • certain medicines for Parkinson’s disease (entacapone, levodopa ) and thyroid problems (levothyroxine)
  • mycophenolate (used with other medicines to prevent rejection after transplantation).

You should not be injected or infused (into a vein) with iron while you are being treated with Feraccru.

Pregnancy and breastfeeding

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

Driving and using machines

Feraccru is not expected to have any effect on the ability to drive or use machines.

Feraccru capsules contain lactose, para-orange FCF (E110) and allura red AC (E129).

Lactose: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Para-orange FCF (E 110) and Allura red AC (E 129): Para-orange FCF (E110) and Allura red AC (E129): May cause allergic reactions.

How to take Feraccru

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

The recommended dose is one capsule (30 mg) twice daily, morning and evening.

Take this medicine on an empty stomach with half a glass of water (one hour before a meal, or at least two hours after a meal).

Swallow the capsules whole.

If you take more Feraccru than you should

If you take too much Feraccru you may experience nausea or vomiting, stomach pain, or diarrhea. Contact your doctor or hospital immediately if you or anyone else has taken too much Feraccru. Bring this leaflet and remaining capsules and show them to your doctor.

If you forget to take Feraccru

Skip the missed dose one and take the next dose as usual. Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this product, ask 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 with Feraccru (may affect up to 1 in 10 people) are:

  • stomach ache
  • gas formation
  • constipation
  • feelings of discomfort in the stomach or bloating
  • diarrhea
  • discolored stools
  • nausea

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

  • thirst,
  • stiff joints,
  • pain in fingers/toes,
  • headache,
  • acne, reddened skin,
  • vomiting
  • bloated stomach, abdominal pain, nausea, and diarrhea due to increased amount of bacteria in the small intestine.
  • Blood tests can show an increased amount of protein ( alkaline phosphatase, gamma-glutamyltransdered) that breaks down chemicals in the blood and an increased amount of a hormone that stimulates the thyroid gland (thyroid-stimulating hormone ).

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 expiration date is the last day of the specified month.

Do not use this medicine for more than 45 days after opening the jar.

Do not store above 25 ° C.

6. Contents of the packaging and other information

Content declaration

The active substance is 30 mg of iron in the form of iron maltol.

Other ingredients are:

  • lactose monohydrate (see section 2)
  • sodium lauryl sulfate
  • magnesium stearate
  • colloidal anhydrous silica
  • crospovidone (type A)
  • gelatine
  • brilliant blue FCF (E133)
  • all-red AC (E129) (see section 2)
  • titanium dioxide (E171)
  • para-orange FCF (E110) (see section 2).

What the medicine looks like and the contents of the pack

Feraccru is a red, hard capsule containing a reddish-brown powder.

Feraccru is packaged in jars, each containing 56 capsules.

Marketing Authorisation Holder

Norgine BV

Antonio Vivaldi Street 150

1083 HP Amsterdam

Netherlands

Manufacturer

Piramal Healthcare UK Limited

Whalton Road

Morpeth

Northumberland

NE61 3YA, UK

Patheon France

40 champaret boulevard

38300 Bourgoin-Jallieu

France

Contact the representative of the marketing authorization holder to find out more about this medicine:

BE \ LU
Norgine NV / SA+32 16 39 27 10 medinfo.benelux@norgine.com
AT \ BG \ CZ \ HR \ HU \ PL \ RO \ SI \ SK \
AOP Orphan Pharmaceuticals AG+ 43-1-503-72-44office@aoporphan.com
THE
Norgine GmbH+49 641984970 info@norgine.de
IE / UK
Norgine Pharmaceuticals Ltd.+44 1895 826666MedInfo@norgine.com
ES
Norgine de España, SLU+34 91 375 8870 iberiamedinfo@norgine.com
FR
Norgine SAS+33 141399400 infomedicale.norginefrance@norgine.com
IT
Norgine Italia Srl+39 0267 977211 medinfoitaly@norgine.com
NL
Norgine BV+31 20 567 0900medinfo.benelux@norgine.com
PT
Norgine Portugal Pharmacêutica Unipessoal, Lda+351 218952735 iberiamedinfo@norgine.com
DK / FI / IS / NO / SE
Norgine Danmark A / S.+45 33170400Minfonordic@norgine.com
EE \ EL \ CY \ LV \ LT \ MT
Norgine BV+44 1895 826600GMedicalAffairs@norgine.com

Muhammad Nadeem

Leave a Reply