500 mg film-coated tablets 
deferiprone

1. What Ferriprox is and what it is used for

Ferriprox contains the active substance deferiprone. Ferriprox is an iron complexing agent, a type of drug that removes excess iron from the body.

Ferriprox is used to treat excess iron caused by repeated blood transfusions in patients with thalassemia major when standard treatment with chelating agents is contraindicated or insufficient.

What you need to know before taking Ferriprox

Do not take Ferriprox:

  • if you are allergic to deferiprone or any of the other ingredients of this medicine (listed in section 6).
  • if you have had multiple episodes of neutropenia (low white blood cell count [neutrophils]).
  • if you have had agranulocytosis (very low white blood cell count [neutrophils]).
  • if you are currently taking medicines that give rise to neutropenia or agranulocytosis (see section “Other medicines and Ferriprox”).
  • if you are pregnant or breastfeeding.

Warnings and Precautions:

  • The most serious side effect that can occur while taking Ferriprox is that the number of white blood cells ( neutrophils ) becomes very low. This condition, called severe neutropenia or agranulocytosis, has occurred in 1 to 2 in 100 people taking Ferriprox in clinical trials. Because white blood cells help fight infection, a low neutrophil count can put you at risk for developing a serious and potentially life-threatening infection. To check that you are not getting neutropenia your doctor will ask you to provide samples for regular blood tests (to check your white blood cell count) as often as weekly while you are being treated with Ferriprox. You must come on these return visits. See the patient/carer reminder card that comes with this information. If you get any symptoms of infection such as fever, sore throat, or flu-like symptoms, tell your doctor immediately.
  • If you are HIV- positive or if your liver function is severely impaired, your doctor may recommend further tests

Your doctor will also ask you to come for a test to check for excess iron in your body. You may also be asked to do a liver biopsy.

Use of other medicines and Ferriprox

Do not take medicines that cause neutropenia or agranulocytosis (see section “Do not take Ferriprox”). Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.

Do not use aluminum-based antacids (acid-neutralizing agents) while using Ferriprox.

Talk to your doctor or pharmacist before taking vitamin C at the same time as Ferriprox

Pregnancy and breastfeeding

Do not take this medicine if you are pregnant or trying to conceive. This medicine can seriously harm your baby. You must use an effective contraceptive while taking Ferriprox. Ask your doctor which method is best for you. If you become pregnant while taking Ferriprox, stop taking the medicine immediately and tell your doctor.

Do not take Ferriprox if you are breast-feeding. See the patient/carer reminder card attached to this leaflet.

Driving and using machines

Not relevant.

3. How to take Ferriprox

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure. How much Ferriprox you should take depends on your body weight. The usual dose is 25 mg/kg, 3 times a day, to reach a total daily dose of 75 mg/kg. The total daily dose should not exceed 100 mg/kg. Take the first doseone in the morning, the second dose one in the middle of the day, and the third doseone in the evening. Ferriprox can be taken with or without food; however, it may be easier to remember to take Ferriprox if you take it with your meals.

If you take more Ferriprox then you should

There are no reports of acute overdose with Ferriprox. If you have accidentally taken more than the prescribed dose, contact your doctor.

If you forget to take Ferriprox

Ferriprox is effective if you do not skip any dose. If you forget to take a dose, take it as soon as you remember and 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 a forgotten dose, but continue as usual. 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 gets them.

The most serious side effect of Ferriprox is a very low number of white blood cells ( neutrophils ). This condition, called severe neutropenia or agranulocytosis, has occurred in 1 to 2 in 100 people taking Ferriprox in clinical trials. A low white blood cell count can be associated with a serious and potentially life-threatening infection. Report to your doctor immediately any symptoms of infection such as fever, sore throat, or flu-like symptoms.

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

  • abdominal pain
  • nausea
  • vomiting
  • reddish/brown discoloration of the urine

If you feel unwell or vomit, it may help to take Ferriprox with food. Discolored urine is a very common side effect and is not harmful.

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

  • low white blood cell count ( agranulocytosis and neutropenia )
  • headache
  • diarrhea
  • increase in liver enzymes
  • fatigue
  • increased appetite

Unknown frequency (cannot be judged from the available data):

  • allergic reactions i.a. skin rash or hives

Events with joint pain and swelling ranged from mild pain in one or more leads to severe disability. In most cases, the pain disappeared while patients continued to take Ferriprox.

Neurological disorders (eg tremors, gait disorders, double vision, involuntary muscle contractions, problems with movement coordination) have been seen in children who have been voluntarily prescribed more than double the maximum recommended dose of 100 mg/kg/day for several years and have also been seen in children at standard doses of deferiprone. The children recovered from these symptoms after Ferriprox was discontinued.

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 after EXP.

Do not store above 30 ° C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substance is deferiprone. Each 500 mg tablet contains 500 mg of deferiprone.

Other ingredients are:

Tablet core: Microcrystalline cellulose, Magnesium stearate, Colloidal silica.

Tablet coating: Hypromellose, Macrogol, Titanium dioxide.

What the medicine looks like and the contents of the pack

The Ferriprox 500 mg tablets are white to off-white, capsule-shaped, film-coated tablets marked with “APO” and “500” on one side and smooth on the other. The tablets are scored and can be broken in the middle. Ferriprox is packaged in jars of 100 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder:

Chiesi Farmaceutici SpA

Via Palermo 26 / A

43122 Parma

Italy

Manufacturer responsible for release batch:

Eurofins PROXY Laboratories BV

Archimedesweg 25

2333 CM Leiden

Netherlands

Contact the representative of the marketing authorization holder to find out more about this medicine:

Belgium / Belgique / BelgienChiesi sa / nvTel: + 32 (0) 2 788 42 00 LithuaniaChiesi Pharmaceuticals GmbHTel: + 43 1 4073919
BulgariaChiesi Bulgaria EOODTel: +359 29201205 Luxembourg / LuxemburgChiesi sa / nvTel: + 32 (0) 2 788 42 00
Czech RepublicAurovitas, spol. s roTel: +00420 234 705 700 HungaryChiesi Hungary Kft.Tel .: + 36-1-429 1060
DenmarkChiesi Pharma ABTel: + 46 8 753 35 20 MaltaChiesi Farmaceutici SpATel: + 39 0521 2791
GermanyChiesi GmbHTel: + 49 40 89724-0 The NetherlandsChiesi Pharmaceuticals BVTel: + 31 88 501 64 00
EestiChiesi Pharmaceuticals GmbHTel: + 43 1 4073919 NorwayChiesi Pharma ABTel: + 46 8 753 35 20
GreeceDEMO ABEE:Ηλ: + 30 210 8161802 AustriaChiesi Pharmaceuticals GmbHTel: + 43 1 4073919
SpainChiesi España, SAUTel: + 34 93 494 8000 PolandChiesi Poland Sp. ZooTel .: + 48 22 620 1421
FranceChiesi SASTel: + 33 1 47688899 PortugalChiesi Farmaceutici SpATel: + 39 0521 2791
CroatiaChiesi Pharmaceuticals GmbHTel: + 43 1 4073919 RomaniaChiesi Romania SRLTel: + 40 212023642
IrelandChiesi Farmaceutici SpATel: + 39 0521 2791 SloveniaChiesi Slovenija dooTel: + 386-1-43 00 901
IcelandChiesi Pharma ABPhone: +46 8 753 35 20 Slovak RepublicChiesi Slovakia sroTel: + 421 259300060
ItalyChiesi Italia SpATel: + 39 0521 2791 Finland / FinlandChiesi Pharma ABPuh / Tel: +46 8 753 35 20
LatviaChiesi Pharmaceuticals GmbHTel: + 43 1 4073919 United KingdomChiesi LtdTel: + 44 (0) 161 488 5555

Muhammad Nadeem

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