FERACCRU 30 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Feraccru 30 mg Hard Capsules

Iron (as ferric maltol)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• 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.

Contents of the pack

1. What is Feraccru and what is it used for.
2. What you need to know before you take Feraccru.
3. How to take Feraccru.
4. Possible side effects.
5. Storage of Feraccru.
6. Contents of the pack and other information.

1. What is Feraccru and what is it used for

Feraccru contains iron (as ferric maltol). Feraccru is used in adults to treat low iron levels in the body. Low iron levels cause anaemia (very 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 disease that causes iron overload or an alteration in the way your body uses iron.
• If you have received multiple blood transfusions.

Warnings and precautions

Before starting treatment, your doctor will do a blood test to make sure your anaemia is not severe and is not caused by anything other than low iron levels.

Do not take Feraccru if you are experiencing an "exacerbation or flare-up" of your IBD.

Children and adolescents

Do not give Feraccru to children or adolescents under 18 years, as the use of this medicine has not been studied in this age group. Excess iron is dangerous in young children and can be potentially fatal.

Using Feraccru with other medicines

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

You should leave a gap of two hours between taking Feraccru and taking:

• Supplements or medicines that contain magnesium or calcium.
• Some antibiotics, such as ciprofloxacin or tetracyclines.
• Bisphosphonates (used to treat bone diseases).
• Penicillamine (used to chelate metals).
• Some medicines used to treat Parkinson's disease (entacapone, levodopa) and thyroid problems (levothyroxine).
• Mycofenolate (used with other medicines to prevent the body from rejecting transplanted organs).

Do not receive iron by injection or infusion (intravenously) while taking Feraccru.

Do 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).

Pregnancy and breast-feeding

Preferably, do not take Feraccru if you are pregnant or breast-feeding.

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 affect your ability to drive and use machines.

The Feraccru capsules contain lactose, Sunset Yellow FCF (E110) and Allura Red AC (E129)

Lactose: If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Sunset Yellow (E110) and Allura Red (E129): May cause allergic reactions.

3. How to take Feraccru

Follow exactly the administration instructions of this medicine given by your doctor.

Adults (18 years and over)

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

Swallow the capsules whole.

If you take more Feraccru than you should

Taking too much Feraccru may make you feel sick or vomit and may cause stomach pain and diarrhoea. Call your doctor or hospital immediately if you or someone else has taken too much Feraccru. Make sure to take this leaflet and any remaining capsules with you to show to your doctor.

If you forget to take Feraccru

Miss the dose that you forgot and take the next dose as normal. Do not take a double dose to make up for a forgotten capsule.

If you have any other questions about 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 gets them.

The most common side effects of Feraccru (may affect up to 1 in 10 people) are:

• Stomach pain
• Flatulence (gas)
• Constipation
• Stomach discomfort or abdominal distension
• Diarrhoea
• Nausea
• Change in stool colour

Uncommon side effects (may affect up to 1 in 100 people) are: thirst, joint stiffness, pain in the fingers/toes, headache, erythema, vomiting and increased intestinal bacteria. Blood tests may show higher levels of enzymes that break down chemicals in the blood and of a hormone that stimulates the thyroid gland.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are 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. Storage of 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 more than 45 days after first opening the bottle.

Do not store the capsules above 25°C.

6. Contents of the pack and other information

What is in Feraccru

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)
• Gelatin
• Brilliant Blue (E133)
• Allura Red AC (E129) (see section 2)
• Titanium dioxide (E171)
• Sunset Yellow FCF (E110) (see section 2)

Appearance of Feraccru and pack contents

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

Feraccru is available in bottles, each containing 56 capsules.

Marketing Authorisation Holder

Norgine B.V.

Antonio Vivaldistraat 150

1083 HP Amsterdam

Netherlands

Manufacturer

Piramal Healthcare UK Limited

Whalton Road

Morpeth

Northumberland

NE61 3YA, UNITED KINGDOM

Patheon France

40 boulevard de champaret

38300 Bourgoin-Jallieu

FRANCE

You can request more information about this medicine from the local representative of the Marketing Authorisation Holder:

Date of last revision of this leaflet xxx

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.