Patient leaflet - DEFERIPRONE LIPOMED 500 MG FILM-COATED TABLETS
4. Possible side effects
Like all medicines, this medicine c although not everybody gets the
The most serious side effect of De is a very low white blood cell (neu condition, known as severe neutro has occurred in 1 to 2 out of 100 p
edule. Do not change g to your doctor.
an cause side effects,.
feriprone Lipomed rophil) count. This penia or agranulocytosis, eople who have taken
- If you have any further q pharmacist.
- This medicine has been p pass it on to others. It ma of illness are the same as
- If you get any side effect cist. This includes any po leaflet. See section 4.
- Provided in the folding b reminder card. You shoul carefully and carry it with doctor if you develop inf sore throat or flu-like sym
What is in this leaflet
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1. What Deferiprone Lipom
-
2. What you need to know Lipomed
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3. How to take Deferiprone
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4. Possible side effects
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5. How to store Deferipron
uestions, ask your doctor or
rescribed for you only. Do not y harm them, even if their signs yours.
s, talk to your doctor or pharma-ssible side effects not listed in this
ox, you will find a patient / carer d complete and read the card you. Provide this card to your ection symptoms such as a fever, ptoms.
ed is and what it is used for before you take Deferipone
Lipomed
Lipomed
Talk to your doctor or pharmac Lipomed.
Other medicines and Deferip Do not take medicines known agranulocytosis (see “Do not t Tell your doctor or pharmacist recently taken, or might take a medicines obtained without a
Do not take aluminium-based taking Deferiprone Lipomed.
Please consult with your docto vitamin C with Deferiprone Lip
Pregnancy and breast-feedi Do not take this medicine if yo trying to become pregnant. Th harm your baby. You must use
ist before taking Deferiprone
rone Lipomed
to cause neutropenia or ake Deferiprone Lipomed”). if you are taking, have ny other medicines, including prescription.
antacids at the same time as
r or pharmacist before taking omed.
ng
u are pregnant or if you are is medicine could seriously effective contraception while
can be associated with a serious a threatening infection. Report imm any symptoms of infection such as flu-like symptoms.
Very common side effects (may a 1 in 10 people):
- abdominal pain
- nausea
- vomiting
- reddish / brown discoloration of
If you experience nausea or vomit your Deferiprone Lipomed with so is a very common effect and is not
Common side effects (may affect
- low white blood cell count (agra neutropenia)
- headache
- diarrhoea
nd potentially life-ediately to your doctor : fever, sore throat or
ffect more than
urine
ng, it may help to take
me food. Discolored urine harmful.
up to 1 in 10 people): nulocytosis and
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1. What Deferiprone Lipo
Deferiprone Lipomed cont deferiprone. Deferiprone L of medicine that removes e
Deferiprone Lipomed is us by frequent blood transfus major when current chelati inadequate.
-
2. What you need to know Lipomed
Do not take Deferiprone
- if you are allergic to defe ingredients of this medic
- if you have a history of re (low white blood cell (ne
- if you have a history of a blood cell (neutrophil) co
med is and what it is used for
ains the active substance ipomed is an iron chelator, a type xcess iron from the body.
ed to treat iron overload caused ions in patients with thalassaemia on therapy is contraindicated or
before you take Deferiprone
Lipomed:
riprone or any of the other ine (listed in section 6);
peated episodes of neutropenia utrophil) count);
granulocytosis (very low white unt);
method is best for you. If you b Deferiprone Lipomed, stop tak and tell your doctor.
Do not use Deferiprone Lipom Please refer to the patient / car the folding box.
Driving and using machines Not relevant.
Deferiprone Lipomed contai
This medicine contains less tha tablet and that is to say essenti
3. How to take Deferiprone L
Always take this medicine exac you. Check with your doctor o sure. The amount of Deferipro will depend on your weight. Th
ecome pregnant while taking ing the medicine immediately
ed if you are breast-feeding.
er reminder card provided in
ns sodium
n 1 mmol sodium (23 mg) per ally ‘sodium-free’.
ipomed
tly as your doctor has told
pharmacist if you are not
ne Lipomed that you take e usual dose is 25 mg / kg,
- fatigue
- increase in appetite
Not known (frequency cannot be available data):
- allergic reactions including skin
Events of joint pain and swelling r in one or more joints to severe dis the pain disappeared while patien deferiprone.
Additional side effects in childr In post-marketing experience with disorders (such as tremors, walkin involuntary muscle contractions, p coordination) have been reported voluntarily prescribed more than recommended dose of 100 mg / kg They recovered from these sympt of deferiprone.
estimated from the
rash or hives
anged from mild pain ability. In most cases, ts continued taking
n
deferiprone, neurological g disorders, double vision, roblems with movement in children who had been ouble the maximum
/ day for several years.
oms after discontinuation
- if you are currently takin neutropenia or agranulo Deferiprone Lipomed”);
- if you are pregnant or br
g medicines known to cause cytosis (see “Other medicines and
east-feeding;
s
t that may occur while taking ery low white blood cell dition, known as severe
tosis, has occurred in 1 to ve taken deferiprone in clinical od cells help to fight infection, place you at risk of developing
e-threatening infection. To our doctor will ask you to have a hite blood cell count) performed very week, while you are being pomed. It is very important for ointments. Please refer to the
daily dose should not exceed 1 dose in the morning. Take you your third dose in the evening. taken with or without food; ho to remember to take Deferipro your meals.
If you take more Deferiprone There are no reports of acute o you have accidentally taken m you should contact your docto
If you forget to take Deferipr Deferiprone Lipomed will be m miss any doses. If you do miss you remember and take your n scheduled time. Ifyou miss mo a double dose to make up for f
00 mg / kg. Take your first r second dose midday. Take
Deferiprone Lipomed can be wever, you may find it easier ne Lipomed if you take it with
Lipomed than you should verdose with deferiprone. If ore than the prescribed dose, r.
one Lipomed
ost effective if you do not one dose take it as soon as ext dose at its regularly re than one dose do not take orgotten individual doses,
Reporting of side effects
If you get any side effects, talk to y This includes any possible side eff leaflet. You can also report side eff Card Scheme, website: search for MHRA Yellow Card in th App Store. By reporting side effect more information on the safety of
5. How to store Deferiprone Lipo
Keep this medicine out of the sigh
Do not store above 25 °C.
Do not use this medicine after the stated on the carton and on the bl date refers to the last day of that m
our doctor or pharmacist. ects not listed in this ects directly via the Yellow.gov.uk / yellowcard or e Google Play or Apple s you can help provide this medicine.
med
t and reach of children.
expiry date which is ister after EXP. The expiry onth.
| Do not throw away any me household waste. Ask your medicines you no longer u protect the environment. |
6. Contents of the pack an
What Deferiprone Lipom The active substance is def film-coated tablet contains
The other ingredients are:
dicines via wastewater or pharmacist how to throw away se. These measures will help
d other information
ed contains
eriprone. Each 500 mg
500 mg deferiprone.
Tablet core: hypromellose, colloidal anhydrous, micro stearate
Coating: hypromellose, ma
What Deferiprone Lipom of the pack
Deferiprone Lipomed 500 white to off-white, glossy s The tablets are scored and Lipomed is packaged in bli 100 film-coated tablets.
Marketing Authorisation Lipomed GmbH Hegenheimer Strasse 2 79576 Weil am Rhein Germany
Phone number: +49 7621 1 Fax number: +49 7621 1693
croscarmellose sodium, silica, crystalline cellulose, magnesium
crogol 6000, titanium dioxide
ed looks like and contents
mg film-coated tablets are urface, oval film-coated tablets. breakable in half. Deferiprone sters. One pack contains
Holder and Manufacturer
693 472
474
This leaflet was last revis
Detailed information on th on the European Medicine
ed in January 2020.
is medicine is available
s Agency web site:
.
DEF-00.T.500.UK 202006
DEF-00.T.500.UK_202006.indd 2
22.06.20 11:45