Deferiprone Lipomed
Italy
Table of Contents
Package leaflet: Information for the patient
Deferiprone Lipomed 500 mg film-coated tablets
deferiprone
Please read all of 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 their symptoms are the same as yours, as 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.
- Inside the folding carton, you will find a patient card. Please complete it, read it carefully, and carry it with you. In case of symptoms of infection such as fever, sore throat, or flu-like symptoms, show this card to your doctor.
Contents of this leaflet:
- What Deferiprone Lipomed is and what it is used for
- What you need to know before taking Deferiprone Lipomed
- How to take Deferiprone Lipomed
- Possible side effects
- How to store Deferiprone Lipomed
- Contents of the pack and other information
1. What Deferiprone Lipomed is and what it is used for
Deferiprone Lipomed contains the active substance deferiprone. Deferiprone Lipomed is an iron chelator, a type of medicine that removes excess iron from the body.
Deferiprone Lipomed 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 Deferiprone Lipomed
Do not take Deferiprone Lipomed
- 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 levels of a type of white blood cells (neutrophils));
- if you have previously suffered from agranulocytosis (very low levels 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 Lipomed”);
- if you are pregnant or breastfeeding.
Warnings and precautions
The most serious possible side effect during treatment with Deferiprone Lipomed is a very low count of a type of white blood cells (neutrophils). This condition, known as severe neutropenia or agranulocytosis, occurred in 1–2 out of 100 people who took deferiprone in clinical studies. Since white blood cells help fight infections, a low neutrophil count may increase your risk of developing severe and potentially fatal (life-threatening) infections. To monitor for neutropenia during treatment with Deferiprone Lipomed, 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. Please refer to the patient leaflet included in the carton. Seek immediate medical advice 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 request liver biopsies (small tissue samples taken from the liver).
Consult your doctor or pharmacist before taking Deferiprone Lipomed.
Other medicines and Deferiprone Lipomed
Do not take medicines that cause neutropenia or agranulocytosis (see section “Do not take Deferiprone Lipomed”). 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 Deferiprone Lipomed.
Consult your doctor or pharmacist before taking vitamin C together with Deferiprone Lipomed.
Pregnancy and breastfeeding
Deferiprone Lipomed may harm the foetus if taken during pregnancy. Deferiprone Lipomed must not be taken during pregnancy unless strictly necessary. If you are pregnant or become pregnant while being treated with Deferiprone Lipomed, consult your doctor immediately.
Patients of both sexes are advised to take appropriate contraceptive precautions whenever there is a possibility of pregnancy. Women of childbearing potential are advised to use an effective method of contraception during treatment with Deferiprone Lipomed 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 Deferiprone Lipomed if you are breastfeeding. Refer to the patient leaflet included in the carton.
Driving and using machines
This medicine does not affect or has a negligible effect on the ability to drive and use machinery.
Deferiprone Lipomed contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet; therefore, it is essentially sodium-free.
3. How to take Deferiprone Lipomed
Take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist. The amount of Deferiprone Lipomed you take depends on your body weight. The usual dose is 25 mg/kg, taken 3 times daily, for a total daily dose of 75 mg/kg. This total daily dose should not exceed 100 mg/kg. Take the first dose in the morning, the second at midday, and the third in the evening. Deferiprone Lipomed may be taken with or without food; however, you may find it easier to remember to take Deferiprone Lipomed if you take it with meals.
If you take more Deferiprone Lipomed than you should
Acute deferiprone overdose has not been reported. Contact your doctor if you accidentally take more than the prescribed dose.
If you forget to take Deferiprone Lipomed
Deferiprone Lipomed will be most effective if you take all prescribed doses. If you miss a single 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 with your regular 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 Deferiprone Lipomed is a 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 deferiprone in clinical studies. A reduction in white blood cells may lead to a serious and potentially 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 discoloration of urine
If you experience nausea or vomiting, taking Deferiprone Lipomed with food may help. 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
Episodes of pain and swelling in the joints, ranging from mild discomfort in one or more joints to severe disability. In most cases, the pain disappeared while continuing treatment with deferiprone.
Additional side effects in children
In post-marketing experience with deferiprone, neurological disorders (such as tremors, difficulty walking, double vision, involuntary muscle contractions, problems with movement coordination) 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 resolved after discontinuation of deferiprone.
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 Deferiprone Lipomed
Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the label and carton after
Exp. The expiry date refers to the last day of the stated month.
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 Deferiprone Lipomed contains
The active substance is deferiprone. Each film-coated tablet contains 500 mg of
deferiprone.
The other components are:
Tablet core: hypromellose, sodium croscarmellose (see section 2 “Deferiprone
Lipomed contains sodium”), anhydrous colloidal silica, microcrystalline cellulose, magnesium stearate
Coating: hypromellose, macrogol 6000, titanium dioxide
Description of the appearance of Deferiprone Lipomed and packaging contents
Deferiprone Lipomed 500 mg tablets are white or almost white, shiny-surfaced, oval-shaped and film-coated. The tablets are marked with a central line and can be divided into two parts. Deferiprone Lipomed is packaged in blisters containing 100 film-coated tablets each.
Marketing Authorisation Holder and Manufacturer
Lipomed GmbH
Hegenheimer Strasse 2
79576 Weil am Rhein
Germany
Telephone: +49 7621 1693 472
Fax: +49 7621 1693 474
E-mail: [email protected]
More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu .