Dificlir 200mg tablets

Land: Storbritannien

Språk: engelska

Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiva substanser:

Fidaxomicin

Tillgänglig från:

Astellas Pharma Ltd

INN (International namn):

Fidaxomicin

Dos:

200mg

Läkemedelsform:

Tablet

Administreringssätt:

Oral

Klass:

No Controlled Drug Status

Receptbelagda typ:

Valid as a prescribable product

Produktsammanfattning:

BNF: 05010700; GTIN: 5013346051761

Bipacksedel

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 is used in adults to treat infections of the lining of the
colon (large intestine) with certain
bacteria called
_Clostridium 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 or severe itching
(pruritus), stop taking DIFICLIR and seek
medical advice urgently from your doctor, pharmacist or at your local
hospital emergency department
(see section 4).
If you are allergic to macrolides (a class of antibiotics), ask your
doctor for advice before using this
medicine. Your doctor will tel

Produktens egenskaper

OBJECT 1
DIFICLIR 200 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 23-May-2018 | Astellas
Pharma Ltd
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 is indicated in adults for the treatment of _Clostridium
difficile_ infections (CDI) also known as
_C. difficile_-associated diarrhoea (CDAD) (see section 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 and elderly (≥65 years of age)_
The recommended dose is 200 mg (one tablet) administered twice daily
(once every 12 hours) for 10
days.
Special populations
_Renal impairment_
No dose adjustment is considered necessary. Due to the limited
clinical data in this population, DIFICLIR
should be used with caution in patients with severe renal impairment
(see sections 4.4 and 5.2).
_Hepatic impairment_
No dose adjustment is considered necessary. Due to the limited
clinical data in this population, DIFICLIR
should be used with caution in patients with moderate to severe
hepatic impairment (see sections 4.4 and
5.2).
_Paediatric population_
The safety and efficacy of fidaxomicin in children aged below 18 years
has not yet been established. No
data are available.
Method of administration
DIFICLIR is intended for oral use.
DIFICLIR can be taken with or without food.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4 Special warnings and precautions for use
Hypersensitivity reactions including severe angioedema have been
reported (see section 4.8). If a severe
allergic reactio