FERRIPROX

Patient Information Leaflet: Information for the User

Ferriprox 500 mg film-coated tablets

deferiprone
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 their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• A patient card will be found inside the box. Detach the patient card, fill it in, read it carefully, and carry it with you. In case of signs of infection, such as fever, sore throat, and flu-like symptoms, show the patient card to your doctor.

Contents of this leaflet

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

1. What Ferriprox is and what it is used for

Ferriprox contains the active substance deferiprone. Ferriprox is an iron chelator, a type of medicine
that removes excess iron from the body.
Ferriprox is used to treat iron overload caused by frequent blood transfusions in patients with
beta-thalassaemia major, when current chelation therapy is contraindicated or inadequate.

2. What you need to know before taking Ferriprox

Do not take Ferriprox

• if you are allergic to deferiprone or to any of the other ingredients of this medicine (listed in section 6).
• if you have previously experienced repeated episodes of neutropenia (low number of a type of white blood cells (neutrophils)).
• if you have previously suffered from agranulocytosis (very low number of a type of white blood cells (neutrophils)).
• if you are currently taking medicines that cause neutropenia or agranulocytosis (see section “Other medicines and Ferriprox”).
• if you are pregnant or breastfeeding.

Warnings and precautions

• the most serious possible side effect during treatment with Ferriprox is a very low number of a type of white blood cells (neutrophils). This condition, called severe neutropenia or agranulocytosis, occurred in 1 to 2 out of 100 people who took Ferriprox in clinical studies. Since white blood cells help fight infections, a low neutrophil count may put you at risk of developing serious and potentially life-threatening infections. To monitor for neutropenia during treatment with Ferriprox, your doctor will ask you to have regular blood tests (to check your white blood cell count), weekly in frequency. It is very important that you attend all of these appointments. Refer to the patient leaflet included in the package. Contact your doctor immediately if you experience symptoms of infection, such as fever, sore throat, or flu-like symptoms. Your white blood cell count must be checked within 24 hours to detect possible agranulocytosis.

• if you are HIV-positive, or if your liver or kidney function is severely impaired, your doctor may recommend additional monitoring.

Your doctor will also ask you to have blood tests to monitor your iron levels. Additionally, your doctor may recommend liver biopsies (taking small tissue samples from the liver).

Other medicines and Ferriprox
Do not take medicines that cause neutropenia or agranulocytosis (see section “Do not take Ferriprox”). Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
Do not take aluminium-containing antacids at the same time as Ferriprox.
Consult your doctor or pharmacist before taking vitamin C together with Ferriprox.

Pregnancy and breastfeeding
Ferriprox may harm the fetus if taken during pregnancy. Ferriprox must not be taken during pregnancy unless strictly necessary. If you are pregnant or become pregnant while being treated with Ferriprox, contact your doctor immediately.
Patients of both sexes are advised to take appropriate precautions during sexual activity when there is a possibility of pregnancy. Women of childbearing potential are advised to use an effective contraceptive method during treatment with Ferriprox and for 6 months after the last dose. Men are advised to use an effective contraceptive method during treatment and for 3 months after the last dose. Please consult your doctor about this.
You must not use Ferriprox if you are breastfeeding. Refer to the patient leaflet included in the package.

Driving and using machines
Not applicable.

3. How to take Ferriprox

Take this medicine exactly as your doctor has instructed. If you have any doubts, consult your doctor or pharmacist. The amount of Ferriprox you take will depend on your body weight. The usual dose is 25 mg/kg, taken three times a day, for a total daily dose of 75 mg/kg. This total daily dose must not exceed 100 mg/kg. Take the first dose in the morning, the second at midday, and the third in the evening. Ferriprox may be taken with or without food; however, you may find it easier to remember to take Ferriprox if you take it with meals.

If you take more Ferriprox than you should
Cases of acute overdose with Ferriprox have not been reported. Contact your doctor if you accidentally take a higher dose than prescribed.

If you forget to take Ferriprox
Ferriprox will be most effective if you take all prescribed doses. If you miss just one dose, take it as soon as you remember, then take the next dose at the usual time. If you miss more than one dose, do not take a double dose to make up for the missed doses; continue taking the medicine according to your regular schedule. Do not change the daily dose of the medicine without first talking to your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most serious side effect of Ferriprox is a very marked reduction in the number of a type of white blood cells (neutrophils). This condition, known as severe neutropenia or agranulocytosis, occurred in 1 to 2 out of 100 people who took Ferriprox in clinical studies. A reduction in white blood cells may lead to a serious and potentially fatal (life-threatening) infection. Immediately inform your doctor if you experience any symptoms of infection such as: fever, sore throat, or flu-like symptoms.

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

• abdominal pain;
• nausea;
• vomiting;
• reddish-brown coloured urine.

If you have nausea or vomiting, taking Ferriprox with food may help. Discolouration of the urine is a very common effect and is not harmful.

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

• low number of white blood cells (agranulocytosis and neutropenia);
• headache;
• diarrhoea;
• increased liver enzymes;
• fatigue;
• increased appetite.

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

• allergic reactions including skin rash or tingling sensations.

Episodes of pain and swelling in the joints, ranging from mild discomfort in one or more joints to severe disability, have been reported. In most cases, the pain disappeared while continuing treatment with Ferriprox.

Neurological disorders (such as tremors, difficulty walking, double vision, involuntary muscle contractions, problems with coordination of movements) have been reported in children who were intentionally given a dose more than twice the recommended maximum dose of 100 mg/kg/day for several years. These disorders have also been observed in children receiving standard doses of deferiprone. These symptoms resolved after discontinuation of Ferriprox.

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 listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ferriprox

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 label and on the carton after
Exp. The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Ferriprox contains
The active substance is deferiprone. Each 500 mg tablet contains 500 mg of deferiprone.
The other components are:
Tablet core: microcrystalline cellulose, magnesium stearate, anhydrous colloidal silica.
Coating: hypromellose, macrogol, titanium dioxide.

Description of the appearance of Ferriprox and pack contents
Film-coated tablet, white or almost white, capsule-shaped. On one side of the tablet, divided into equal parts, the imprints “APO” and “500” appear, while the other side is plain. The tablet measures 7.1 mm x 17.5 mm x 6.8 mm and is provided with a score line. The tablet can be divided into two equal parts. Ferriprox is supplied in bottles containing 100 tablets each.

Marketing Authorization Holder:
Chiesi Farmaceutici S.p.A.
Via Palermo 26/A
43122 Parma
Italy

Manufacturer:
Eurofins PROXY Laboratories B.V.
Archimedesweg 25
2333 CM Leiden
The Netherlands

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Chiesi sa/nv Chiesi Pharmaceuticals GmbH
Tél/Tel: + 32 (0)2 788 42 00 Tel: + 43 1 4073919

България Luxembourg/Luxemburg
Chiesi Bulgaria EOOD Chiesi sa/nv
Тел.: +359 29201205 Tél/Tel: + 32 (0)2 788 42 00

Česká republika Magyarország
Chiesi CZ s.r.o. Chiesi Hungary Kft.
Tel: + 420 261221745 Tel.: + 36-1-429 1060

Danmark Malta
Chiesi Pharma AB Chiesi Farmaceutici S.p.A.
Tlf: + 46 8 753 35 20 Tel: + 39 0521 2791

Deutschland Nederland
Chiesi GmbH Chiesi Pharmaceuticals B.V.
Tel: + 49 40 89724-0 Tel: + 31 88 501 64 00

Eesti Norge
Chiesi Pharmaceuticals GmbH Chiesi Pharma AB
Tel: + 43 1 4073919 Tlf: + 46 8 753 35 20

Ελλάδα Österreich
DEMO ABEE Chiesi Pharmaceuticals GmbH
Τηλ: + 30 210 8161802 Tel: + 43 1 4073919

España Polska
Chiesi España, S.A.U. Chiesi Poland Sp. z.o.o.
Tel: + 34 934948000 Tel.: + 48 22 620 1421

France Portugal
Chiesi S.A.S. Chiesi Farmaceutici S.p.A.
Tél: + 33 1 47688899 Tel: + 39 0521 2791

Hrvatska România
Chiesi Pharmaceuticals GmbH Chiesi Romania S.R.L.
Tel: + 43 1 4073919 Tel: + 40 212023642

Ireland Slovenija
Chiesi Farmaceutici S.p.A. CHIESI SLOVENIJA, d.o.o.
Tel: + 39 0521 2791 Tel: + 386-1-43 00 901

Ísland Slovenská republika
Chiesi Pharma AB Chiesi Slovakia s.r.o.
Sími: +46 8 753 35 20 Tel: + 421 259300060

Italia Suomi/Finland
Chiesi Italia S.p.A. Chiesi Pharma AB
Tel: + 39 0521 2791 Puh/Tel: +46 8 753 35 20

Κύπρος Sverige
The Star Medicines Importers Co. Ltd. Chiesi Pharma AB
Τηλ: + 357 25 371056 Tel: +46 8 753 35 20

Latvija United Kingdom (Northern Ireland)
Chiesi Pharmaceuticals GmbH Chiesi Farmaceutici S.p.A.
Tel: + 43 1 4073919 Tel: + 39 0521 2791

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

Package leaflet: Information for the user

Ferriprox 100 mg/mL oral solution

deferiprone
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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, 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, consult your doctor or pharmacist. See section 4.
• A patient card will be attached to the box. Detach the patient card, fill it in, read it carefully, and carry it with you. In case of symptoms of infection such as fever, sore throat, and flu-like symptoms, give the patient card to your doctor.

Contents of this leaflet

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

1. What Ferriprox is and what it is used for

Ferriprox contains the active substance deferiprone. Ferriprox is an iron chelator, a type of medicine
that removes excess iron from the body.
Ferriprox is used to treat iron overload caused by frequent blood transfusions in patients with
beta-thalassaemia major, when current chelation therapy is contraindicated or inadequate.

2. What you need to know before taking Ferriprox

Do not take Ferriprox

• if you are allergic to deferiprone or to any of the other ingredients of this medicine (listed in section 6).
• if you have previously experienced repeated episodes of neutropenia (low number of a type of white blood cells (neutrophils)).
• if you have previously suffered from agranulocytosis (very low number of a type of white blood cells (neutrophils)).
• if you are currently taking medicines that cause neutropenia or agranulocytosis (see section “Other medicines and Ferriprox”).
• if you are pregnant or breastfeeding.

Warnings and precautions

• the most serious possible side effect during treatment with Ferriprox is a very low number of a type of white blood cells (neutrophils). This condition, called severe neutropenia or agranulocytosis, occurred in 1 to 2 out of 100 people who took Ferriprox in clinical studies. Since white blood cells help fight infections, a low neutrophil count may put you at risk of developing serious and potentially fatal (life-threatening) infections. To monitor for neutropenia during treatment with Ferriprox, your doctor will ask you to have regular blood tests (to check your white blood cell count), weekly. It is very important that you attend all of these appointments. Refer to the patient leaflet included in the pack. Contact your doctor immediately if you experience symptoms of infection, such as fever, sore throat, or flu-like symptoms. Your white blood cell count must be checked within 24 hours to detect possible agranulocytosis.

• if you are HIV-positive, or if your liver or kidney function is severely impaired, your doctor may recommend additional monitoring.

Your doctor will also ask you to have tests to monitor your iron levels. Additionally, your doctor may ask you to undergo liver biopsies (removal of small tissue samples) of the liver.
Other medicines and Ferriprox
Do not take medicines that cause neutropenia or agranulocytosis (see section “Do not take Ferriprox”). Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
Do not take aluminium-containing antacids at the same time as Ferriprox.
Consult your doctor or pharmacist before taking vitamin C together with Ferriprox.
Pregnancy and breastfeeding
Ferriprox may harm the fetus if taken during pregnancy. Ferriprox must not be taken during pregnancy unless strictly necessary. If you are pregnant or become pregnant while being treated with Ferriprox, contact your doctor immediately.
Patients of both sexes are advised to take appropriate precautions during sexual activity where there is a possibility of pregnancy occurring. Women of childbearing potential are advised to use an effective contraceptive method during treatment with Ferriprox and for 6 months after the last dose. Men are advised to use an effective contraceptive method during treatment and for 3 months after the last dose. Please consult your doctor about this.
You must not use Ferriprox if you are breastfeeding. Refer to the patient leaflet included in the pack.
Driving and using machines
Not applicable.
Ferriprox oral solution contains Sunset Yellow FCF (E110)
Sunset Yellow FCF (E110) is a dye which may cause allergic reactions.

3. How to take Ferriprox

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist. The amount of Ferriprox you take will depend on your body weight. The usual dose is 25 mg/kg, taken three times a day, for a total daily dose of 75 mg/kg. This total daily dose must not exceed 100 mg/kg. Use the oral syringe provided to measure the volume prescribed by your doctor. Take the first dose in the morning, the second dose at midday, and the third dose in the evening. Ferriprox may be taken with or without food; however, you may find it easier to remember to take Ferriprox if you take it with meals.

If you take more Ferriprox than you should
There have been no reports of acute overdose with Ferriprox. Contact your doctor if you accidentally take more than the prescribed dose.

If you forget to take Ferriprox
Ferriprox will be most effective if you take all of your prescribed doses. If you miss a single dose, take it as soon as you remember, then continue with your next dose at the regular time. If you miss more than one dose, do not take a double dose to make up for the missed doses; continue taking the medicine according to your usual schedule. Do not change your daily dose without first talking to your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The most serious side effect of Ferriprox is a very marked reduction in the number of a type of white blood cells (neutrophils). This condition, known as severe neutropenia or agranulocytosis, occurred in 1 to 2 out of 100 people who took Ferriprox in clinical studies. A reduced number of white blood cells may lead to a serious and potentially fatal (life-threatening) infection. Immediately inform your doctor if you experience any symptoms of infection such as: fever, sore throat, or flu-like symptoms.

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

• abdominal pain;
• nausea;
• vomiting;
• reddish-brown coloured urine.

If you experience nausea or vomiting, taking Ferriprox with food may help. The discoloration of urine is a very common effect and is not harmful.

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

• low number of white blood cells (agranulocytosis and neutropenia);
• headache;
• diarrhoea;
• increased liver enzymes;
• fatigue;
• increased appetite.

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

• allergic reactions including skin rash or tingling sensations.

Episodes of pain and swelling in the joints, ranging from mild pain in one or more joints to severe disability, have been reported. In most cases, the pain disappeared while continuing treatment with Ferriprox.

Neurological disorders (such as tremors, difficulty walking, double vision, involuntary muscle contractions, problems with movement coordination) have been reported in children who were intentionally given a dose more than twice the recommended maximum dose of 100 mg/kg/day for several years. These disorders have also been observed in children receiving standard doses of deferiprone. These symptoms resolved after discontinuation of Ferriprox.

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 Ferriprox

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 label and on the carton after
Exp. The expiry date refers to the last day of that month.
After first opening of the container, use within 35 days. Do not store above 30°C.
Keep in the original packaging to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Ferriprox contains
The active substance is deferiprone. Each mL of oral solution contains 100 mg of deferiprone.
The other components are: purified water; hydroxyethylcellulose; glycerol (E422); concentrated hydrochloric acid (for pH adjustment); artificial cherry flavouring; peppermint essence; orange-yellow S (E110); sucralose (E955). See section 2 “Ferriprox oral solution contains orange-yellow S (E110)”.

Description of the appearance of Ferriprox and contents of the pack
Clear, reddish-orange liquid. Ferriprox is available in 250 mL or 500 mL bottles.

Marketing Authorisation Holder:
Chiesi Farmaceutici S.p.A.
Via Palermo 26/A
43122 Parma
Italy

Manufacturer:
Eurofins PROXY Laboratories B.V.
Archimedesweg 25
2333 CM Leiden
The Netherlands

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Chiesi sa/nv Chiesi Pharmaceuticals GmbH
Tél/Tel: + 32 (0)2 788 42 00 Tel: + 43 1 4073919

България Luxembourg/Luxemburg
Chiesi Bulgaria EOOD Chiesi sa/nv
Тел.: +359 29201205 Tél/Tel: + 32 (0)2 788 42 00

Česká republika Magyarország
Chiesi CZ s.r.o. Chiesi Hungary Kft.
Tel: + 420 261221745 Tel.: + 36-1-429 1060

Danmark Malta
Chiesi Pharma AB Chiesi Farmaceutici S.p.A.
Tlf: + 46 8 753 35 20 Tel: + 39 0521 2791

Deutschland Nederland
Chiesi GmbH Chiesi Pharmaceuticals B.V.
Tel: + 49 40 89724-0 Tel: + 31 88 501 64 00

Eesti Norge
Chiesi Pharmaceuticals GmbH Chiesi Pharma AB
Tel: + 43 1 4073919 Tlf: + 46 8 753 35 20

Ελλάδα Österreich
DEMO ABEE Chiesi Pharmaceuticals GmbH
Τηλ: + 30 210 8161802 Tel: + 43 1 4073919

España Polska
Chiesi España, S.A.U. Chiesi Poland Sp. z.o.o.
Tel: + 34 934948000 Tel.: + 48 22 620 1421

France Portugal
Chiesi S.A.S. Chiesi Farmaceutici S.p.A.
Tél: + 33 1 47688899 Tel: + 39 0521 2791

Hrvatska România
Chiesi Pharmaceuticals GmbH Chiesi Romania S.R.L.
Tel: + 43 1 4073919 Tel: + 40 212023642

Ireland Slovenija
Chiesi Farmaceutici S.p.A. CHIESI SLOVENIJA, d.o.o.
Tel: + 39 0521 2791 Tel: + 386-1-43 00 901

Ísland Slovenská republika
Chiesi Pharma AB Chiesi Slovakia s.r.o.
Sími: +46 8 753 35 20 Tel: + 421 259300060

Italia Suomi/Finland
Chiesi Italia S.p.A. Chiesi Pharma AB
Tel: + 39 0521 2791 Puh/Tel: +46 8 753 35 20

Κύπρος Sverige
The Star Medicines Importers Co. Ltd. Chiesi Pharma AB
Τηλ: + 357 25 371056 Tel: +46 8 753 35 20

Latvija United Kingdom (Northern Ireland)
Chiesi Pharmaceuticals GmbH Chiesi Farmaceutici S.p.A.
Tel: + 43 1 4073919 Tel: + 39 0521 2791

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

Package leaflet: information for the user

Ferriprox 1000 mg film-coated tablets

deferiprone
Please read this leaflet carefully before taking this medicine, as 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 their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• A patient card is attached to the package. Remove the patient card, fill it in, read it carefully, and carry it with you. In case of symptoms of infection, such as fever, sore throat, and flu-like symptoms, present the patient card to your doctor.

Contents of this leaflet

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

1. What Ferriprox is and what it is used for

Ferriprox contains the active substance deferiprone. Ferriprox is an iron chelator, a type of medicine
that removes excess iron from the body.
Ferriprox is used to treat iron overload caused by frequent blood transfusions in patients with
beta-thalassaemia major, when current chelation therapy is contraindicated or inadequate.

2. What you need to know before taking Ferriprox

Do not take Ferriprox

• if you are allergic to deferiprone or to any of the other ingredients of this medicine (listed in section 6).
• if you have previously experienced repeated episodes of neutropenia (low count of a type of white blood cells (neutrophils)).
• if you have previously suffered from agranulocytosis (very low count of a type of white blood cells (neutrophils)).
• if you are currently taking medicines that cause neutropenia or agranulocytosis (see section “Other medicines and Ferriprox”).
• if you are pregnant or breastfeeding.

Warnings and precautions

• the most serious possible side effect during treatment with Ferriprox is a very low count of a type of white blood cells (neutrophils). This condition, known as severe neutropenia or agranulocytosis, occurred in 1 to 2 out of 100 people who took Ferriprox in clinical studies. Since white blood cells help fight infections, a low neutrophil count may put you at risk of developing serious and potentially fatal (life-threatening) infections. To monitor for neutropenia during treatment with Ferriprox, your doctor will ask you to have regular blood tests (to check your white blood cell count), weekly. It is very important that you attend all these appointments. Refer to the patient leaflet included in the package. Contact your doctor immediately if you experience symptoms of infection such as fever, sore throat, or flu-like symptoms. Your white blood cell count must be checked within 24 hours to detect possible agranulocytosis.

• if you are HIV-positive, or if your liver or kidney function is severely impaired, your doctor may recommend additional monitoring.

Your doctor will also ask you to have tests to monitor your iron levels. Additionally, your doctor may ask you to undergo liver biopsies (taking small tissue samples from the liver).

Other medicines and Ferriprox
Do not take medicines that cause neutropenia or agranulocytosis (see section “Do not take Ferriprox”). Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
Do not take aluminium-containing antacids at the same time as Ferriprox.
Consult your doctor or pharmacist before taking vitamin C together with Ferriprox.

Pregnancy and breastfeeding
Ferriprox may harm the fetus if taken during pregnancy. Ferriprox must not be taken during pregnancy unless strictly necessary. If you are pregnant or become pregnant while being treated with Ferriprox, consult your doctor immediately.
Patients of both sexes are advised to take appropriate precautions in sexual activity where there is a possibility of pregnancy occurring. Women of childbearing potential are advised to use an effective method of contraception during treatment with Ferriprox and for 6 months after the last dose. Men are advised to use an effective method of contraception during treatment and for 3 months after the last dose. Please consult your doctor about this.
You must not use Ferriprox if you are breastfeeding. Refer to the patient leaflet included in the package.

Driving and using machines
Not applicable.

3. How to take Ferriprox

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
The amount of Ferriprox you take will depend on your body weight. The usual dose is 25 mg/kg, taken three times a day, for a total daily dose of 75 mg/kg. The total daily dose must not exceed 100 mg/kg. Take the first dose in the morning, the second dose at noon, and the third dose in the evening. Ferriprox may be taken with or without food; however, you may find it easier to remember to take Ferriprox if you take it with meals.

If you take more Ferriprox than you should
There have been no reports of acute overdose with Ferriprox. Contact your doctor if you accidentally take more than the prescribed dose.

If you forget to take Ferriprox
Ferriprox will be most effective if you take all prescribed doses. If you miss a single dose, take it as soon as you remember, then continue with your regular dosing schedule. If you miss more than one dose, do not take a double dose to make up for the missed doses; continue with your normal dosing schedule. Do not change the daily dose of this medicine without first talking to your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most serious side effect of Ferriprox is a very marked reduction in the number of a type of white blood cells (neutrophils). This condition, known as severe neutropenia or agranulocytosis, occurred in 1 to 2 out of 100 people who took Ferriprox in clinical studies. A reduced number of white blood cells may lead to a serious and potentially fatal (life-threatening) infection. Immediately inform your doctor if you experience any symptoms of infection such as: fever, sore throat, or flu-like symptoms.
Very common side effects (may affect more than 1 in 10 people):

• abdominal pain;
• nausea;
• vomiting;
• reddish-brown coloured urine.

If you experience nausea or vomiting, taking Ferriprox with food may help. The discoloration of urine is a very common effect and is not harmful.
Common side effects (may affect up to 1 in 10 people):

• low white blood cell count (agranulocytosis and neutropenia);
• headache;
• diarrhoea;
• increased liver enzymes;
• fatigue;
• increased appetite.

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

• allergic reactions including skin rash or tingling.

Episodes of pain and swelling in the joints, ranging from mild pain in one or more joints to severe disability. In most cases, the pain disappeared while continuing treatment with Ferriprox.
Neurological disorders (such as tremors, difficulty walking, double vision, involuntary muscle contractions, coordination problems) have been reported in children who had been intentionally prescribed a dose more than twice the recommended maximum dose of 100 mg/kg/day for several years. These disorders have also been observed in children receiving standard doses of deferiprone. These symptoms disappeared after discontinuation of Ferriprox.
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 through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ferriprox

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and the 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 to protect the medicine from moisture.
After first opening the container, use within 50 days.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What Ferriprox contains
The active substance is deferiprone. Each 1,000 mg tablet contains 1,000 mg of deferiprone.
The other components are:
Tablet core: methylcellulose, crospovidone, magnesium stearate.
Coating: hypromellose, hydroxypropylcellulose, macrogol, titanium dioxide.
Description of the appearance of Ferriprox and pack contents
Film-coated tablet, white or almost white, capsule-shaped. On one side of the tablet, "APO" and "1000" are printed in equal halves, while the other side is plain. The tablet measures 7.9 mm x 19.1 mm x 7 mm and has a score line allowing it to be divided into two equal parts. Ferriprox is packaged in bottles containing 50 tablets.
Marketing Authorization Holder:
Chiesi Farmaceutici S.p.A.
Via Palermo 26/A
43122 Parma
Italy
Manufacturer:
Eurofins PROXY Laboratories B.V.
Archimedesweg 25
2333 CM Leiden
The Netherlands
For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:
België/Belgique/Belgien Lietuva
Chiesi sa/nv Chiesi Pharmaceuticals GmbH
Tél/Tel: + 32 (0)2 788 42 00 Tel: + 43 1 4073919
България Luxembourg/Luxemburg
Chiesi Bulgaria EOOD Chiesi sa/nv
Тел.: +359 29201205 Tél/Tel: + 32 (0)2 788 42 00
Česká republika Magyarország
Chiesi CZ s.r.o. Chiesi Hungary Kft.
Tel: + 420 261221745 Tel.: + 36-1-429 1060
Danmark Malta
Chiesi Pharma AB Chiesi Farmaceutici S.p.A.
Tlf: + 46 8 753 35 20 Tel: + 39 0521 2791
Deutschland Nederland
Chiesi GmbH Chiesi Pharmaceuticals B.V.
Tel: + 49 40 89724-0 Tel: + 31 88 501 64 00
Eesti Norge
Chiesi Pharmaceuticals GmbH Chiesi Pharma AB
Tel: + 43 1 4073919 Tlf: + 46 8 753 35 20
Ελλάδα Österreich
DEMO ABEE Chiesi Pharmaceuticals GmbH
Τηλ: + 30 210 8161802 Tel: + 43 1 4073919
España Polska
Chiesi España, S.A.U. Chiesi Poland Sp. z.o.o.
Tel: + 34 934948000 Tel.: + 48 22 620 1421
France Portugal
Chiesi S.A.S. Chiesi Farmaceutici S.p.A.
Tél: + 33 1 47688899 Tel: + 39 0521 2791
Hrvatska România
Chiesi Pharmaceuticals GmbH Chiesi Romania S.R.L.
Tel: + 43 1 4073919 Tel: + 40 212023642
Ireland Slovenija
Chiesi Farmaceutici S.p.A. CHIESI SLOVENIJA, d.o.o.
Tel: + 39 0521 2791 Tel: + 386-1-43 00 901
Ísland Slovenská republika
Chiesi Pharma AB Chiesi Slovakia s.r.o.
Sími: +46 8 753 35 20 Tel: + 421 259300060
Italia Suomi/Finland
Chiesi Italia S.p.A. Chiesi Pharma AB
Tel: + 39 0521 2791 Puh/Tel: +46 8 753 35 20
Κύπρος Sverige
The Star Medicines Importers Co. Ltd. Chiesi Pharma AB
Τηλ: + 357 25 371056 Tel: +46 8 753 35 20
Latvija United Kingdom (Northern Ireland)
Chiesi Pharmaceuticals GmbH Chiesi Farmaceutici S.p.A.
Tel: + 43 1 4073919 Tel: + 39 0521 2791
Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency, http://www.ema.europa.eu.