Patient leaflet - Xoanacyl 1 g film-coated tablets

1. What Xoanacyl is and what it is used for

Xoanacyl is a medicine that works by binding phosphorus and that contains iron. It is used in adults with impaired kidney function who have high blood phosphorus levels and a lack of iron.

Patients with chronic impaired kidney function are not able to remove phosphorus from their body adequately. This can lead to high phosphorus levels in the blood, which can cause calcium to build-up in tissues (calcification) causing issues such as red eyes, itchy skin and bone pain.

Phosphorus is present in many foods. Xoanacyl attaches to the phosphorus from food in the digestive tract (stomach and bowels) to prevent it from being absorbed into the blood. Phosphorus that is attached to Xoanacyl is then excreted from the body in the stool.

Patients with chronic impaired kidney function can have lower levels of iron. Low iron can cause anaemia (low levels of red blood cells). Xoanacyl provides iron to the body.

2. What you need to know before you take Xoanacyl

Treatment should be initiated under the supervision of your doctor.

Do not take Xoanacyl

if you are allergic to ferric citrate (as coordination complex) or any of the other ingredients of this medicine (listed in section 6);
- if you have a severe stomach or bowel disease;
- if you have haemochromatosis, a condition causing the body to absorb too much iron from the food you eat, or any other disorder associated with absorbing high levels of iron.

Warnings and precautions

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

bowel inflammation or bleeding of the stomach (see section 2 “Do not take Xoanacyl”);
on-going severe stomach and bowel disease (see section 2 “Do not take Xoanacyl”).

Children and adolescents

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

Other medicines and Xoanacyl

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

The following medicines should not be taken during treatment with Xoanacyl

medicines containing aluminium and used to reduce the acidity in your stomach: antacids such as aluminium hydroxide;
other iron containing medicines and taken by mouth.

Your doctor may advise you to take these medicines at least 2 hours before or after Xoanacyl

a medicine to treat hypothyroidism (lack of thyroid hormone): levothyroxine. The levothyroxine dose may need to be adjusted during treatment with Xoanacyl;
antibiotic medicines to treat bacterial infections: ciprofloxacin, levofloxacin, doxycycline, cefdinir;
medicines to treat Parkinson’s disease: levodopa, benserazide, entacapone;
medicines to treat high blood pressure: captopril, methyldopa;
a medicine that is used to treat rheumatoid arthritis, Wilson’s disease, cystinuria, lead poisoning: penicillamine;
medicines used to treat bone loss and help rebuild bone: alendronate sodium, calcium;
medicines containing calcium and magnesium and used to reduce the acidity in your stomach: antacids such as oxides, hydroxides or salts of magnesium and calcium.

Pregnancy, 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

It is unknown whether Xoanacyl has any effect on unborn babies. Xoanacyl is not recommended during pregnancy and in women who are able to become pregnant not using birth control. 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.

Breast-feeding

It is unknown whether Xoanacyl passes into breast milk. Tell your doctor if you wish to breast-feed your baby when using this medicine. Your doctor will help you decide whether to discontinue breast-feeding or to abstain from Xoanacyl therapy.

Driving and using machines

Xoanacyl has no or negligible influence on your ability to drive and use machines.

Xoanacyl contains sunset yellow FCF (E110) and allura red AC (E129)

These excipients may cause allergic reactions.

3. How to take Xoanacyl

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

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 Xoanacyl.

The maximum dose is 12 film-coated tablets per day.

The recommended starting dose is:

If you are not on dialysis: 1 film-coated tablet three times per day, with or immediately after main meals of the day;
If you are on dialysis and you were not already receiving a medicine that lowers your levels of phosphorus: 1 or 2 film-coated tablets three times per day, with or immediately after main meals of the day;
If you are on dialysis and you were already taking a medicine that lowers your levels of phosphorus: 2 film-coated tablets three times per day, with or immediately after main meals of the day.

Your doctor may decrease or increase the starting dose depending on your blood iron and phosphorus levels. Your doctor will monitor your iron blood tests and phosphorus levels regularly. These blood tests may be part of your routine tests for your kidney disease.

If you have a severe hepatic disease, the recommended starting dose is 1 film-coated tablet three times per day.

Method of use

Swallow the film-coated tablets whole with one glass of water. Do not chew or crush the film-coated tablets because iron can cause discoloration of mouth and teeth. Your doctor will tell you how many film-coated tablets you should take at each meal.

If you take more Xoanacyl than you should

If you have accidentally taken too many film-coated tablets of Xoanacyl, contact a doctor or poison control centre immediately. You may feel sick or have diarrhoea, abdominal pain, headache, feel irritated or sleepy. A doctor may

need to give you treatment to remove excess iron from your body.

1g film-coated tablets

1g film-coated tablets You can have too low levels of phosphorus in your blood. A doctor may temporarily discontinue your treatment.

If you forget to take Xoanacyl

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 Xoanacyl

It is important that you continue taking Xoanacyl 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.

The following side effects have been reported:

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

diarrhoea
discoloured stool

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

belly (abdominal) pain, discomfort and/or swelling
nausea
constipation
indigestion (dyspepsia)
flatulence

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

low phosphorus levels seen in blood test results
blood in the stool
haemorrhoids

Not known (frequency cannot be estimated from the available data):

high iron levels seen in blood test results.

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:

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Xoanacyl

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 30 °C.

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

After first opening of the bottle, use within 2 months.

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 Xoanacyl contains

The active substance is ferric citrate (as coordination complex). Each film-coated tablet contains 1 g of ferric citrate (as coordination complex, containing 210 mg of ferric iron).
The other ingredients are pregelatinised starch and calcium stearate in the core tablet and hypromellose, titanium dioxide (E171), triacetin, sunset yellow FCF (E110), allura red AC (E129) and indigo carmine (E132) in the film-coating (see section 2 “Xoanacyl contains sunset yellow FCF and allura red AC”).

What Xoanacyl looks like and contents of the pack

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

The film-coated tablets are packed in high density polyethylene (HDPE) bottles sealed with child-resistant polypropylene caps, an aluminium foil sealed with a polyethylene liner and two silica gel sachets included to protect the product from moisture.

Each carton contains one bottle of 200 film-coated tablets.

Marketing Authorisation Holder

AVEROA SAS

11 Avenue Paul Verlaine

38100 Grenoble

France

Manufacturer

Patheon France

40 Boulevard de Champaret

38300 Bourgoin Jallieu