Deferoxamine Doc

Package leaflet: Information for the user

DEFERIPRONE DOC 500 mg film-coated tablets, 1000 mg film-coated tablets

Equivalent medicine
Please read 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 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 yours, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Attached to this package leaflet you will find a patient reminder card for you or your caregiver. Detach the card, fill it in, read it carefully, and keep it with you.

Contents of this leaflet:

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

1. What DEFERIPRONE DOC is and what it is used for

DEFERIPRONE DOC contains the active substance deferiprone. DEFERIPRONE DOC is a medicine that removes iron from the body.
DEFERIPRONE DOC is used to treat iron overload caused by frequent blood transfusions in patients with beta-thalassaemia major, when current chelating therapy is contraindicated or inadequate.

2. What you need to know before taking DEFERIPRONE DOC

Do not take DEFERIPRONE DOC

• if you are allergic (hypersensitive) 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 DEFERIPRONE DOC”).
• if you are pregnant or breastfeeding.

Warnings and precautions

• the most serious possible side effect during treatment with DEFERIPRONE DOC 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 deferiprone 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 the development of neutropenia, your doctor will ask you to have regular blood tests (to measure your white blood cell count), possibly as often as once a week, during treatment with DEFERIPRONE DOC. It is very important that you attend all of these appointments. Refer to the patient/carer reminder card attached to this leaflet. Inform your doctor immediately if you experience any symptoms of infection, such as fever, sore throat, or flu-like symptoms.

• If you are HIV-positive or if you have impaired kidney or liver function, your doctor may recommend additional tests.

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 DEFERIPRONE DOC
Do not take medicines that cause neutropenia or agranulocytosis (see section “Do not take DEFERIPRONE DOC”). 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 aluminum-containing antacids during treatment with DEFERIPRONE DOC.
Consult your doctor or pharmacist before taking vitamin C together with DEFERIPRONE DOC.

Pregnancy and breastfeeding
Do not take this medicine if you are pregnant or trying to become pregnant. This medicine may seriously harm your unborn baby. You must use an effective method of contraception while taking DEFERIPRONE DOC. Ask your doctor which method is most suitable for you. If you become pregnant while taking DEFERIPRONE DOC, stop taking the medicine immediately and inform your doctor.
You must not use DEFERIPRONE DOC if you are breastfeeding. Refer to the patient/carer reminder card attached to this leaflet.

Driving and using machines
Not applicable.

3. How to take DEFERIPRONE DOC

Take DEFERIPRONE DOC exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist. The amount of DEFERIPRONE DOC you take will depend on your body weight. The usual dose is
25 mg/kg, 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. DEFERIPRONE DOC may be taken with or without food; however, you may find it easier to remember to take DEFERIPRONE DOC if you take it with meals.

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

If you forget to take DEFERIPRONE DOC
DEFERIPRONE DOC will be more effective if you take all prescribed doses. If you miss a single dose, take it as soon as you remember, then continue with your next scheduled dose. If you miss more than one dose, do not take a double dose to make up for the missed doses; continue with your regular dosing 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 everyone gets them.
The most serious side effect of DEFERIPRONE DOC is a severe reduction in the number of white blood cells (neutrophils). This condition, known as severe neutropenia or agranulocytosis, occurred in 1 to 2 out of 100 people who took deferiprone in clinical studies. A reduction in white blood cells may be associated with a serious and potentially fatal (life-threatening) infection. Immediately inform your doctor of 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
• red-brown coloured urine

If you experience nausea or vomiting, taking DEFERIPRONE DOC 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 sensations

Episodes of joint pain and swelling, 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 deferiprone.

Neurological disorders (such as tremors, difficulty walking, double vision, involuntary muscle contractions, coordination problems) have been reported in children who were intentionally given a dose exceeding 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 DEFERIPRONE DOC.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store DEFERIPRONE DOC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "Exp". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 DEFERIPRONE DOC contains

• The active substance is deferiprone. DEFERIPRONE DOC 500 mg: each tablet contains 500 mg of deferiprone. DEFERIPRONE DOC 1000 mg: each tablet contains 1000 mg of deferiprone.
• The other components are: Tablet core: pregelatinized starch (maize), magnesium stearate. Coating: hypromellose, hydroxypropylcellulose, titanium dioxide, macrogol.

Description of the appearance of DEFERIPRONE DOC and package contents
DEFERIPRONE DOC 500 mg: film-coated tablets, white or almost white, engraved with the code
“DL 500” and a breakline on one side, smooth on the other side, size 14.2 mm x 8.2 mm.
The tablet can be divided into equal parts.
DEFERIPRONE DOC 1000 mg: film-coated tablets, white or almost white, engraved with the code
“DH 1000” and a breakline on one side, smooth on the other side, size 19.2 mm x 9.2 mm.
The tablet can be divided into equal parts.
DEFERIPRONE DOC 500 mg tablets are available in packages containing 100 tablets.
DEFERIPRONE DOC 1000 mg tablets are available in packages containing 50 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
DOC Generici S.r.l. – Via Turati 40 – 20121 Milan – Italy.

Manufacturer
Genepharm S.A. - 18th Km Marathonos Avenue - 15351 Pallini Attiki – Greece.

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Italy: DEFERIPRONE DOC
Sweden: Deferiprone DOC
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PATIENT/CAREGIVER REMINDER CARD