Feraccru - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

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 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’.

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 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.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody getthem. 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.

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. Storebelow 25°C.

6. Contents of the pack and other information

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

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 150

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:

IT

Norgine Italia S.r.l.

+39 0267 977211

medinfoitaly@,nor­gine.com

NL

Norgine B.V.

+31 20 567 0900

PT

Norgine Portugal Farmacêutica Unipessoal, Lda +351 218952735

DK/FI/IS/NO/SE

Norgine Denmark A/S.

+45 33170400

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:.

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