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 |