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Fexeric (ferric citrate coordination complex) – Package leaflet - V03AE

Updated on site: 06-Oct-2017

Medication nameFexeric
ATC CodeV03AE
Substanceferric citrate coordination complex
ManufacturerKeryx Biopharma UK Ltd

Package leaflet: Information for the patient

Fexeric 1 g film-coated tablets ferric citrate coordination complex

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

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.

What is in this leaflet

1.What Fexeric is and what it is used for

2.What you need to know before you take Fexeric

3.How to take Fexeric

4.Possible side effects

5.How to store Fexeric

6.Contents of the pack and other information

1.What Fexeric is and what it is used for

Fexeric contains ferric citrate coordination complex as the active ingredient. In adults with impaired kidney function it is used to lower high blood phosphorus levels.

Phosphorus is contained in many foods. Patients with kidneys that do not work properly are not able to eliminate phosphorus from their body adequately. This can lead to high phosphorus levels in the blood. Keeping the phosphorus level normal is important to maintain healthy bones and blood vessels and to prevent itchy skin, red eyes, bone pain or bone fractures.

Fexeric binds to the phosphorus from food in your digestive tract to prevent it from being absorbed into your blood. The Fexeric-bound phosphorus is then excreted from your body in faeces.

You may have been advised to follow a special diet to prevent the phosphorus in your blood rising to high levels. If this is the case, you must continue to follow the special diet even if you are taking Fexeric.

2. What you need to know before you take Fexeric

Do not take Fexeric

-if you are allergic to ferric citrate coordination complex or any of the other ingredients of this medicine (listed in section 6)

-if you have low levels of phosphorus in your blood

-if you have a severe stomach or bowel disease such as stomach or bowel bleeding

-if you have haemochromatosis, a condition causing the body to absorb too much iron from the diet

-if you have any other disorder associated with too much iron

Warnings and precautions

Talk to your doctor or pharmacist before taking Fexeric if you have:

-too much iron in your body

-bowel inflammation

Monitoring tests

Fexeric increases iron levels in your body. Because too much iron is unsafe, your blood will be tested at regular intervals to check iron levels. This blood test may be part of your routine tests for your kidney disease.

Children and adolescents

Do not give this medicine to children and adolescents below the age of 18 years. The safety and effectiveness of Fexeric have not been studied in this population.

Other medicines and Fexeric

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

The following medicines can affect or be affected by Fexeric:

other iron-containing medicines

Fexeric contains iron and your doctor may need to adjust the dose of your other iron-containing medicines.

aluminium containing medicines

Fexeric should not be taken at the same time as aluminium containing medicines.

Also tell your doctor or pharmacist if you are taking or might take the medicines below. Your doctor may want to change the dose of these medicines or advise you to take these medicines 2 hours before or after Fexeric. Monitoring blood levels of these medicines may also be considered:

-ciprofloxacin, doxycycline, cefdinir: medicines to treat bacterial infections

-valproic acid: a medicine to treat epilepsy and mental disorders

-sertraline: a medicine to treat depression

-methotrexate: a medicine to treat rheumatoid arthritis, cancer and the skin disease, psoriasis

-alendronate: a medicine to treat decreased bone mass and density

-levodopa: a medicine to treat Parkinson’s disease

-levothyroxine: a medicine to treat thyroid hormone deficiency

Pregnancy and 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.

pregnancy

If you are able to become pregnant, you must use birth control during treatment. If you become pregnant during treatment, you must ask your doctor for advice. It is unknown whether Fexeric has any effect on unborn babies.

breast-feeding

Tell your doctor if you wish to breast-feed your baby. It is unknown whether Fexeric may pass through breast milk and affect your baby.

Driving and using machines

Fexeric has no influence on your ability to drive and use machines.

Fexeric contains sunset yellow FCF (E110) and Allura Red AC (E129)

These may cause allergic reactions.

3.How to take Fexeric

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

The recommended dose is:

-starting dose for adults: 3 to 6 tablets daily, in separated doses, with or immediately after main meals of the day. Taking the tablets with meals will help the medicine to work.

Patients not on dialysis require the lower starting dose: 3 tablets daily, in separated doses, with or immediately after meals of the day.

Your doctor may decrease or increase the starting dose depending on the level of phosphorus in your blood. Your doctor will monitor the phosphorus levels regularly. This blood test may be part of your routine tests for your kidney disease.

-maximum dose: 12 tablets daily, in separated doses, with or immediately after meals of the day.

Method of use

Take the tablets whole, with one glass of water, with or immediately after meals.

If you take more Fexeric than you should

If you take too much Fexeric, tell your doctor of pharmacist.

Contact a doctor or poison control centre immediately if a child accidentally takes Fexeric.

If you forget to take Fexeric

Take the next dose at the usual time with a meal. Do not take a double dose to make up for a forgotten dose.

If you stop taking Fexeric

Treatment of high blood phosphorus levels is usually required for a long period of time. It is important that you continue taking Fexeric for as long as your doctor prescribes the medicine.

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 gets them.

Contact your doctor immediately if you experience:

-severe abdominal pain or constipation (uncommon)

-vomiting of blood (uncommon)

-blood in the stools (uncommon)

The following side effects have been reported with Fexeric in dialysis patients:

Very common side effects (may affect more than 1 in 10 people):

-discoloured stools

-diarrhoea

Common side effects (may affect up to 1 in 10 people):

-constipation

-abdominal pain/discomfort

-abdominal distension or bloating

-nausea, vomiting

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

-changes in iron blood test results

-decreased or increased appetite

-indigestion, flatulence

-inflammation of stomach lining, ulcer of mucosal lining of the stomach or the first part of the bowel

-reflux of stomach juices in the oesophagus

-abnormal stools, irregularity in bowel movement

-low serum phosphorus levels

-dry mouth

-taste disturbance

-headache

-dizziness

-low serum potassium levels

-incontinence

-skin rash, itching

-palpitations

-shortness of breath, wheezing, abnormal breath sounds

-pain

-thirst

-bronchitis

-muscle injury

-increased weight

-fluid in the lungs

-very high blood pressure

The most common side effects (affecting more than 1 in 10 people) in patients not on dialysis also concern the stomach or bowel:

discoloured stools

diarrhoea

constipation

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 Fexeric

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 bottle and carton after “EXP”. The expiry date refers to the last day of that month.

Do not store above 25°C.

Keep the bottle tightly closed in order to protect from moisture.

After first opening of the bottle, use within 60 days.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.Contents of the pack and other information

What Fexeric contains

The active substance is ferric citrate coordination complex.

Each film-coated tablet contains 1 g of ferric citrate coordination complex (equivalent to 210 mg of ferric iron).

The other ingredients are pregelatinised starch, calcium stearate, hypromellose, titanium dioxide, triacetin, sunset yellow FCF (E110), allura red AC (E129), indigo carmine.

What Fexeric looks like and contents of the pack

Fexeric film-coated tablets are peach-coloured, oval-shaped tablets embossed with “KX52” on one side. Tablets are 19 mm long, 7.2 mm thick and 10 mm wide.

The tablets are packed in plastic bottles with child-resistant caps. They are supplied in one pack size of 200 tablets per bottle.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Keryx Biopharma UK Ltd.

Riverbank House

2 Swan Lane

London

EC4R 3TT

United Kingdom

Manufacturer:

Propak Health Ltd.

3-4 Ballyboggan Industrial Estate

Ballyboggan Road

Finglas

Dublin 11

Ireland

For any information about this medicine, please contact the Marketing Authorisation Holder.

This leaflet was last revised in

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

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