Dificlir
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
22-12-2022
Charakterystyka produktu
(SPC)
22-12-2022
Sprawozdanie z oceny publicznego
(PAR)
11-03-2020
Składnik aktywny:
fidaxomicin
Dostępny od:
Tillotts Pharma GmbH
Kod ATC:
A07AA12
INN (International Nazwa):
fidaxomicin
Grupa terapeutyczna:
Antidiarrheals, intestinal antiinflammatory / antiinfective agents
Dziedzina terapeutyczna:
Clostridium Infections
Wskazania:
Dificlir film-coated tablets is indicated for the treatment of Clostridioides difficile infections (CDI) also known as C. difficile-associated diarrhoea (CDAD) in adult and paediatric patients with a body weight of at least 12.5 kg.Consideration should be given to official guidelines on the appropriate use of antibacterial agents.Dificlir granules for oral suspension is indicated for the treatment of Clostridioides difficile infections (CDI) also known as C. difficile-associated diarrhoea (CDAD) in adults and paediatric patients from birth to < 18 years of age.Consideration should be given to official guidelines on the appropriate use of antibacterial agents.
Podsumowanie produktu:
Revision: 17
Status autoryzacji:
Authorised
Data autoryzacji:
2011-12-05
Ulotka dla pacjenta
32
B. PACKAGE LEAFLET
33
PACKAGE LEAFLET: INFORMATION FOR THE USER
DIFICLIR 200 MG FILM-COATED TABLETS
fidaxomicin
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 further questions, ask your doctor or pharmacist.
−
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
−
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What DIFICLIR is and what it is used for
2.
What you need to know before you take DIFICLIR
3.
How to take DIFICLIR
4.
Possible side effects
5.
How to store DIFICLIR
6.
Contents of the pack and other information
1.
WHAT DIFICLIR IS AND WHAT IT IS USED FOR
DIFICLIR is an antibiotic which contains the active substance
fidaxomicin.
DIFICLIR film-coated tablets are used in adults, adolescents and
children with a body weight of at
least 12.5 kg to treat infections of the lining of the colon (large
intestine) with certain bacteria called
_Clostridioides difficile_
. This serious illness can result in painful, severe diarrhoea.
DIFICLIR works by
killing the bacteria that cause the infection and helps to reduce the
associated diarrhoea.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DIFICLIR
DO NOT TAKE DIFICLIR
−
If you are allergic to fidaxomicin or any of the other ingredients of
this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking DIFICLIR.
If you feel that you might have a severe allergic reaction such as
trouble breathing (dyspnea), swelling
of the face or throat (angioedema), severe rash, severe itching
(pruritus) or severe hives (urticaria),
stop taking DIFICLIR and seek medical advice urgently from your
doctor, pharmacist or at your local
hospital emergency department (see section
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
DIFICLIR 200 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 200 mg of fidaxomicin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Capsule shaped tablets of 14 mm, white to off-white in colour,
debossed with “FDX” on one side and
“200” on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
DIFICLIR film-coated tablets is indicated for the treatment of
_Clostridioides difficile_
infections (CDI)
also known as
_C. difficile_
-associated diarrhoea (CDAD) in adult and paediatric patients with a
body
weight of at least 12.5 kg (see section 4.2 and 5.1).
Consideration should be given to official guidelines on the
appropriate use of antibacterial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
Standard dosing
_ _
The recommended dose is 200 mg (one tablet) administered twice daily
(once every 12 hours) for
10 days (see section 5.1).
DIFICLIR 40 mg/ml granules for oral suspension may be used in adult
patients with difficulties in
swallowing tablets.
Extended-pulsed dosing
Fidaxomicin 200 mg tablets administered twice daily for days 1-5 (no
intake of a tablet on day 6) then
once daily on alternate days for days 7-25 (see section 5.1).
If a dose has been forgotten, the missed dose should be taken as soon
as possible or, if it's nearly time
for the next dose, the tablet should be skipped altogether.
Special populations
_Elderly population _
No dose adjustment is considered necessary (see section 5.2).
_Renal impairment _
No dose adjustment is considered necessary. Due to the limited
clinical data in this population,
fidaxomicin should be used with caution in patients with severe renal
impairment (see sections 4.4 and
3
5.2).
_Hepatic impairment _
No dose adjustment is considered necessary. Due to the limited
clinical data in this population,
fidaxomicin should be used with caution in patients with moderat
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