Xoanacyl

Patient Information Leaflet

Xoanacyl 1 g film-coated tablets

ferric citrate (as coordination complex)
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Xoanacyl is and what it is used for
2. What you need to know before taking Xoanacyl
3. How to take Xoanacyl
4. Possible side effects
5. How to store Xoanacyl
6. Package contents and other information

1. What Xoanacyl is and what it is used for

Xoanacyl is a medicine containing iron that acts by binding to phosphorus. It is used in adults with impaired kidney function who have high levels of phosphorus in the blood and iron deficiency.

Patients with chronic kidney dysfunction are unable to adequately eliminate phosphorus from the body. This can lead to high levels of phosphorus in the blood, which may cause calcium accumulation in tissues (calcification), resulting in problems such as red eyes, itchy skin, and bone pain.

Phosphorus is present in many foods. In the gastrointestinal tract (stomach and intestine), Xoanacyl binds to dietary phosphorus, thereby preventing its absorption into the bloodstream. The phosphorus bound to Xoanacyl is then excreted from the body in the faeces.

Patients with chronic kidney dysfunction may also have reduced iron levels. Low iron levels can cause anaemia (low levels of red blood cells). Xoanacyl provides iron to the body.

2. What you need to know before taking Xoanacyl

Treatment must be started under the supervision of a doctor.
Do not take Xoanacyl

• if you are allergic to ferric citrate (as coordination complex) or to any of the other ingredients of this medicine (listed in section 6);
• if you have a severe disease of the stomach or intestine;
• if you have haemochromatosis, a condition causing your body to absorb excessive amounts of iron from food, or any other disorder associated with increased absorption of high levels of iron.

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

• intestinal inflammation or stomach bleeding (see section 2 “Do not take Xoanacyl”);
• active severe disease of the stomach and intestine (see section 2 “Do not take Xoanacyl”).

Children and adolescents
Do not give this medicine to children or adolescents under 18 years of age. In children and adolescents, the safety and efficacy of Xoanacyl have not been studied.
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 must not be taken during treatment with Xoanacyl:

• medicines containing aluminium and used to reduce stomach acidity: antacids such as aluminium hydroxide;
• other medicines containing iron and taken orally.
  Your doctor may advise you to take these medicines at least 2 hours before or after Xoanacyl.
• a medicine used to treat hypothyroidism (lack of thyroid hormone): levothyroxine. The dose of levothyroxine may need to be adjusted during treatment with Xoanacyl;
• antibiotic medicines used to treat bacterial infections: ciprofloxacin, levofloxacin, doxycycline, cefdinir;
• medicines used to treat Parkinson’s disease: levodopa, benserazide, entacapone;
• medicines used to treat high blood pressure: captopril, methyldopa;
• a medicine used to treat rheumatoid arthritis, Wilson’s disease, cystinuria, lead poisoning: penicillamine;
• medicines used to treat bone loss and help bone rebuilding: sodium alendronate, calcium;
• medicines containing calcium and magnesium and used to reduce stomach acidity: antacids such as oxides, hydroxides, or salts of magnesium and calcium.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
It is not known whether Xoanacyl has effects on the unborn child. The use of Xoanacyl is not recommended during pregnancy and in women of childbearing potential who do not use contraceptive measures. If you are of childbearing age, you must use contraception during treatment. If you become pregnant during treatment, consult your doctor.
Breastfeeding
It is not known whether Xoanacyl is excreted in breast milk. Inform your doctor if you intend to breastfeed while using this medicine. Your doctor will help you decide whether to discontinue breastfeeding or not to start treatment with Xoanacyl.
Driving and using machines
Xoanacyl has no effect or only a negligible effect on the 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

Take this medicine exactly as your doctor has told you. If you are unsure,
consult your doctor or pharmacist.
If you have been advised to follow a specific diet to prevent phosphorus levels in the blood
from becoming too high, you must continue to follow this diet while 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 a day, during or immediately after the main meals of the day;
• if you are on dialysis and are not already taking a medicine that lowers phosphorus levels: 1 or 2 film-coated tablets, three times a day, during or immediately after the main meals of the day;
• if you are on dialysis and are already taking a medicine that reduces phosphorus levels: 2 film-coated tablets, three times a day, during or immediately after the main meals of the day.

Depending on your blood levels of iron and phosphorus, your doctor may reduce or increase the starting dose.
Your doctor will regularly monitor your blood tests to check iron and phosphorus levels.
These tests may already be part of your routine monitoring for your kidney disease.
If you have severe liver disease, the recommended starting dose is 1 film-coated tablet, three times a day.
Method of administration
Swallow the film-coated tablets whole with a glass of water. Avoid chewing or crushing the
film-coated tablets, as iron may cause discoloration of the mouth and teeth.
Your doctor will tell you how many film-coated tablets to take with each meal.
If you take more Xoanacyl than you should
If you have accidentally taken too many Xoanacyl film-coated tablets, contact a doctor or a poison control centre immediately.
You may experience nausea, diarrhoea, abdominal pain, headache, irritability, or drowsiness.
A doctor may need to administer treatment to remove excess iron from your body.
You may develop abnormally low levels of phosphorus in the blood. A doctor may temporarily stop your treatment.
If you forget to take Xoanacyl
Take your 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 the full duration prescribed by your doctor.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects have been reported:

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

• diarrhoea
• altered stool colour

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

• abdominal pain, discomfort and/or bloating
• nausea
• constipation
• indigestion (dyspepsia)
• flatulence

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

• low phosphate levels, based on blood test results
• blood in faeces
• haemorrhoids

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

• elevated iron levels, based on blood test results.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system referred to in Annex V. 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 stated on the bottle and the carton after "Exp."
The expiry date refers to the last day of the month.
Do not store above 30 °C.
Keep the bottle tightly closed to protect the medicine from moisture.
After first opening the bottle, use the medicine within 2 months.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents 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 pregelatinized starch and calcium stearate in the tablet core, 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”).

Description of the appearance of Xoanacyl and contents of the pack
The film-coated tablets are peach-coloured and oval-shaped (19 mm in length, 7.2 mm in thickness and 10 mm in width), with the imprint “KX52” on one side.
The film-coated tablets are packaged in high-density polyethylene (HDPE) bottles, sealed with child-resistant polypropylene caps, a sealed aluminium foil sheet with a polyethylene lining, and two silica gel desiccant packets included to protect the product from moisture.
Each pack contains one bottle with 200 film-coated tablets.

Marketing Authorization Holder
AVEROA SAS
11 Avenue Paul Verlaine
38100 Grenoble
France

Manufacturer
Patheon France
40 Boulevard de Champaret
38300 Bourgoin Jallieu
France

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu