500 mg, 1000 mg film-coated tablet 
deferiprone

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

– Save this information, you may need to read it again.

– If you have any further questions, ask your doctor or pharmacist.

– This medicine has been prescribed for you only. Do not give it to others. It may harm them, even if they show symptoms similar to yours.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

− Attached to this leaflet you will find a reminder card for patients/carers. You should loosen the card, fill it in and read it carefully. You should always have the card with you.

This leaflet contains information about: 
1. What Deferipron Evolan is and what it is used for 
2. What you need to know before you take Deferiprone Evola 
3. How to use Deferipron Evola 
4. Possible side effects 
5. How to store Deferipron Evola 
6. Contents of the packaging and other information 

What Deferipron Evolan is and what it is used for

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

Deferiprone Evolan 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.

Deferiprone contained in Deferipron Evolan may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you take Deferiprone Evola

Do not take Deferiprone Evolan

−if you are allergic to deferiprone or any of the other ingredients of this medicine (listed in section 6).

−if you have had several 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 Deferiprone Evolan”).

−if you are pregnant or breastfeeding.

Warnings and cautions

The most serious side effect that can occur while taking Deferipron Evolan 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 Deferipron Evolan 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 take samples for regular blood tests (to check your white blood cell count) as often as weekly while you are being treated with Deferiprone Evolan. You must come on these return visits. See the patient/carer reminder card that comes with this information. If you get 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.

Other medicines and Deferipron Evolan

Use of other medicines and Deferiprone Evolan

Do not take medicines that cause neutropenia or agranulocytosis (see section “Do not take Deferiprone Evolan”). 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 take aluminum-based antacids (acid-neutralizing agents) while using Deferiprone Evolan.

Talk to your doctor or pharmacist before taking vitamin C at the same time as Deferiprone Evolan.

Pregnancy, breastfeeding, and fertility

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 Deferipron Evolan. Ask your doctor which method is best for you. If you become pregnant while taking Deferipron Evolan, stop taking the medicine immediately and tell your doctor.

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

Driving and using machines

Not relevant.

3. How to use Deferipron Evolan

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure. How much Deferipron Evolan 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 dose one in the morning, the second dose one in the middle of the day, and the third dose one in the evening. Deferiprone Evolan can be taken with or without food; however, it may be easier to remember to take Deferiprone Evolan if you take it with your meals.

If you use more Deferipron Evolan then you should  

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

There are no reports of acute overdose with Deferiprone Evolan.

If you forget to use Deferipron Evolan

Deferiprone Evolan 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 Deferiprone Evolan is a very low white blood cell count( neutrophils ). This condition, called severe neutropenia or agranulocytosis, has occurred in 1 to 2 out of 100 people who have taken Deferipron Evolan in clinical trials. A low number of white blood cells 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 Deferiprone Evolan 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 Deferiprone Evolan.

Neurological disorders (eg, tremors, gait disturbances, 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 the discontinuation of Deferiprone Evolan.

5. How to store Deferipron Evolan

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.

No special storage instructions.

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.

Deferiprone Evolan 500 mg: Each tablet contains 500 mg of deferiprone.

Deferiprone Evolan 1000 mg: Each tablet contains 1000 mg of deferiprone.

Other ingredients are:

Tablet core: Pregelatinized starch, magnesium stearate.

Tablet coating: Hypromellose, hydroxypropyl cellulose, titanium dioxide (E171), macrogol.

What the medicine looks like and the contents of the pack

Deferiprone Evolan 500 mg: white to off-white film-coated tablets, scored on one side and smooth on the other, 14.2 mm x 8.2 mm. The tablets can be divided into two equal parts.

Deferiprone Evolan 1000 mg: white to off-white film-coated tablets, scored on one side and smooth on the other, measuring 19.2 mm x 9.2 mm. The tablets can be divided into two equal parts.

Deferiprone Evolan 500 mg tablets are available as:

blister packs of 10, 20, 30, 40, 50, 60, 70, 80, 90 or 100 tablets

or

jars of 100 tablets.

Deferiprone Evolan 1000 mg tablets are available as:

blister packs of 10, 20, 30, 40, 50, 60, 70, 80, 90 or 100 tablets

or

jars of 50 and 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder:

Evolan Pharma AB

Box 120

182 12 Danderyd

Manufacturer responsible for release batch:

Genepharm SA

18 km Marathon Avenue

15351 Pallini Attikis

Greece

Muhammad Nadeem

Leave a Reply