Patient leaflet - Deferiprone Lipomed 500 mg film-coated tablets
1. What Deferiprone Lip is used for
- 2.
What you need to kno
for you.
may need to read it again. r questions, ask your doctor
en prescribed for you only. thers. It may harm them, even are the same as yours. ects, talk to your doctor or des any possible side effects t. See section 4.
g box, you will find a patient plete and read the card with you. Provide this card develop infection symptoms hroat or flu-like symptoms.
omed is and what it
w before you take
Deferipone Lipomed
- 3. How to take Deferipro
- 4. Possible side effects
- 5. How to store Deferipr
- 6. Contents of the pack
- 1. What Deferiprone it is used for
Deferiprone Lipomed co deferiprone. Deferipron a type of medicine that the body.
Deferiprone Lipomed is caused by frequent bloo with thalassaemia majo therapy is contraindicat
ne Lipomed
one Lipomed
and other information
Lipomed is and what
ntains the active substance e Lipomed is an iron chelator, removes excess iron from
used to treat iron overload d transfusions in patients r when current chelation ed or inadequate.
2. What you need to Deferiprone Lipo
Do not take Deferipro
- if you are allergic to d ingredients of this me • if you have a history o neutropenia (low whi count);
- if you have a history o white blood cell (neut • if you are currently ta cause neutropenia or medicines and Deferi
if you are pregnant or
know before you take med
ne Lipomed
eferiprone or any of the other dicine (listed in section 6); f repeated episodes of te blood cell (neutrophil)
f agranulocytosis (very low rophil) count);
king medicines known to agranulocytosis (see «Other prone Lipomed»);
breast-feeding.
Warnings and precaution
The most serious side effec taking Deferiprone Lipome blood cell (neutrophil) cou as severe neutropenia or ag occurred in 1 to 2 out of 10 deferiprone in clinical trials cells help to fight infection, may place you at risk of dev potentially life-threatening neutropenia, your doctor w
s
t that may occur while d is a very low white nt. This condition, known ranulocytosis, has
0 people who have taken . Because white blood a low neutrophil count eloping a serious and infection. To monitor for ill ask you to have a blood test (to check your white bl regularly, as frequently as e being treated with Deferipr important for you to keep a Please refer to the patient c folding box. If you get any s such as fever, sore throat or immediately seek medical blood cell count must be c order to detect potential ag
If you are HIV positive or if function is severely impaire recommend additional test
Your doctor will also ask yo monitor body iron load. In ask you to undergo liver bi
Talk to your doctor or phar
ood cell count) performed very week, while you are one Lipomed. It is very ll of these appointments. ard provided in the ymptoms of infection flu-like symptoms, attention. Your white hecked within 24 hours in ranulocytosis.
your liver or kidney d, your doctor may s.
u to come in for tests to addition, he or she might opsies.
macist before taking
Deferiprone Lipomed.
Other medicines and Def
Do not take medicines kno or agranulocytosis (see «Do Lipomed»). Tell your doctor taking, have recently taken medicines, including medic prescription.
Do not take aluminium-bas time as taking Deferiprone
Please consult with your do taking vitamin C with Defer
Pregnancy and breast-fe
Deferiprone Lipomed may babies when used by pregn Lipomed must not be used
eriprone Lipomed wn to cause neutropenia not take Deferiprone or pharmacist if you are , or might take any other ines obtained without a ed antacids at the same Lipomed.
ctor or pharmacist before iprone Lipomed.
eding
cause harm to unborn ant women. Deferiprone during pregnancy unless clearly necessary. If y become pregnant during tr Lipomed, get medical advi
Both female and male patie to take special precautions if there is any possibility for Women of childbearing po to use effective contracepti Deferiprone Lipomed and f last dose. Men are recomm contraception during treat after the last dose. This sho doctor.
Do not use Deferiprone Lip feeding. Please refer to the the folding box.
ou are pregnant or you eatment with Deferiprone ce immediately.
nts are recommended in their sexual activity pregnancy to occur. tential are recommended on during treatment with or 6 months after the ended to use effective ment and for 3 months uld be discussed with your omed if you are breast-patient card provided in
Driving and using machines
This medicine has no or neglig ability to drive and use machin
Deferiprone Lipomed contai
This medicine contains less th (23 mg) per tablet and that is t ‘sodium-free’.
3. How to take Deferipron
ible influence on the ery.
ns sodium an 1 mmol sodium
o say essentially e Lipomed
Always take this medicine exa told you. Check with your doct are not sure. The amount of D that you take will depend on y usual dose is 25 mg/kg, 3 time daily dose of 75 mg/kg. The to not exceed 100 mg/kg. Take yo morning. Take your second do third dose in the evening. Defe be taken with or without food; it easier to remember to take D if you take it with your meals.
If you take more Deferipron you should
There are no reports of acute o deferiprone. If you have accide the prescribed dose, you shou
ctly as your doctor has or or pharmacist if you eferiprone Lipomed our weight. The s per day, for a total tal daily dose should ur first dose in the se midday. Take your riprone Lipomed can however, you may find eferiprone Lipomed e Lipomed than verdose with ntally taken more than ld contact your doctor.
If you forget to take Deferip
Deferiprone Lipomed will be m do not miss any doses. If you d it as soon as you remember an at its regularly scheduled time one dose do not take a double forgotten individual doses, jus normal schedule. Do not chan without first talking to your do
4. Possible side effects
Like all medicines, this medicin effects, although not everybo
The most serious side effect of is a very low white blood cell ( This condition, known as sever agranulocytosis, has occurred i
rone Lipomed ost effective if you
o miss one dose take d take your next dose . If you miss more than dose to make up for t continue with your ge your daily dose ctor.
e can cause side dy gets them.
Deferiprone Lipomed neutrophil) count. e neutropenia or n 1 to 2 out of 100 people who have taken deferiprone in white blood cell count can be a and potentially life-threatenin immediately to your doctor an such as: fever, sore throat or flu
Very common side effects
(may affect more than 1 in 10 p • abdominal pain
- nausea
- vomiting
- reddish/brown discolourati
If you experience nausea or vo to take your Deferiprone Lipo Discoloured urine is a very com is not harmful.
clinical trials. A low ssociated with a serious g infection. Report y symptoms of infection -like symptoms.
eople):
on of urine miting, it may help med with some food. mon effect and
Rohformat: 240 x 280 mm / Endformat gefalzt: 40 x 70 mm
Common side effects
(may affect up to 1 in 10 • low white blood cell c and neutropenia) • headache
- diarrhoea
- increase in liver enzy • fatigue
- increase in appetite
Not known
people):
ount (agranulocytosis
mes
(frequency cannot be es data):
- allergic reactions incl
Events of joint pain and pain in one or more join cases, the pain disappea taking deferiprone.
Additional side effects
In post-marketing exper neurological disorders ( disorders, double vision contractions, problems have been reported in c voluntarily prescribed m maximum recommende for several years and ha children with standard d recovered from these sy
timated from the available
uding skin rash or hives
swelling ranged from mild ts to severe disability. In most red while patients continued
in children
ience with deferiprone, such as tremors, walking , involuntary muscle
with movement coordination) hildren who had been
ore than double the
d dose of 100 mg/kg/day ve also been observed in oses of deferiprone. They mptoms after discontinuation
of deferiprone.
Reporting of side effec
If you get any side effec pharmacist or nurse. Thi effects not listed in this side effects directly via t Website: www.mhra.go MHRA Yellow Card in th Store. By reporting side more information on th
5. How to store Defe
Keep this medicine out children.
Do not store above 25 °
ts
ts, talk to your doctor, s includes any possible side leaflet. You can also report he Yellow Card Scheme v.uk/yellowcard or search for e Google Play or Apple App effects, you can help provide e safety of this medicine.
riprone Lipomed
of the sight and reach of
C.
Do not use this medicin is stated on the carton a The expiry date refers to
Do not throw away any household waste. Ask y away medicines you no will help protect the env
- 6. Contents of the p information
What Deferiprone Lip
The active substance is tablet contains 500 mg
e after the expiry date which nd on the blister after EXP. the last day of that month.
medicines via wastewater or our pharmacist how to throw longer use. These measures ironment.
ack and other
omed contains
deferiprone. Each film-coated deferiprone.
The other ingredients are:
Tablet core: hypromellose, (see section 2 «Deferiprone sodium»), silica, colloidal an cellulose, magnesium stear
Coating: hypromellose, ma dioxide
What Deferiprone Lipom
croscarmellose sodium Lipomed contains hydrous, microcrystalline ate
crogol 6 000, titanium ed looks like and
contents of the pack
Deferiprone Lipomed 500 white to off-white, glossy s tablets. The tablets are scor Deferiprone Lipomed is pa pack contains 100 film-coat
Marketing Authorisation Manufacturer
Lipomed GmbH
Hegenheimer Strasse 2 79576 Weil am Rhein Germany
Phone number: +49 7621 1 Fax number: +49 7621 1693 Electronic mail: lipomed@li
This leaflet was last revis
mg film-coated tablets are urface, oval film-coated ed and breakable in half. ckaged in blisters. One ed tablets.
Holder and
693 472
474
pomed.com
ed in May 2023.