Prednisolone 20 mg Rectal Foam

Երկիր: Իռլանդիա

Լեզու: անգլերեն

Աղբյուրը: HPRA (Health Products Regulatory Authority)

Ակտիվ բաղադրիչ:

Prednisolone

Հասանելի է:

Chemidex Pharma Limited

ATC կոդը:

D07AA; D07AA03

INN (Միջազգային անվանումը):

Prednisolone

Դոզան:

20 milligram(s)

Դեղագործական ձեւ:

Rectal foam

Թերապեւտիկ տարածք:

Corticosteroids, weak (group I); prednisolone

Լիազորման կարգավիճակը:

Marketed

Հաստատման ամսաթիվը:

2011-02-11

Տեղեկատվական թերթիկ

IR3-1/L/z/5
PACKAGE LEAFLET: INFORMATION FOR THE USER
PREDNISOLONE 20 MG RECTAL FOAM
PREDNISOLONE as Prednisolone Metasulphobenzoate Sodium
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 Prednisolone 20 mg Rectal Foam is and what it is used for
2. What you need to know before you use Prednisolone 20 mg Rectal Foam
3. How to use Prednisolone 20 mg Rectal Foam
4. Possible side effects
5. How to store Prednisolone 20 mg Rectal Foam
6. Contents of the pack and other information
1. WHAT PREDNISOLONE 20 MG RECTAL FOAM
IS AND WHAT IT IS USED FOR
Prednisolone 20 mg Rectal Foam is a foam enema which is inserted into
the rectum. Prednisolone
20 mg Rectal Foam belongs to a group of medicines called
corticosteroids which are used to reduce
inflammation.
This medicine is used to treat ulcerative colitis (inflammation of
the bowels) and may be used to
treat proctitis (inflammation of the rectum).
2. WHAT YOU NEED TO KNOW BEFORE YOU USE PREDNISOLONE 20 MG RECTAL FOAM
DO NOT USE PREDNISOLONE 20 MG RECTAL FOAM:
•
If you are allergic to prednisolone or any of the other ingredients of
this medicine (listed in
section 6).
•
If you suffer from peritonitis (inflammation of the peritoneum –
(abdominal lining)).
•
If you suffer from bowel problems such as obstruction, perforation or
rectal/colonic fistulae
(abnormal connection between internal organs) or if you have a
possible infection.
If you think this may apply to you speak to your doctor.
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR BEFORE US

Ապրանքի հատկությունները

Health Products Regulatory Authority
05 April 2023
CRN00DHG0
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Prednisolone 20 mg Rectal Foam
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered dose contains 31.4mg of the active ingredient
prednisolone metasulphobenzoate sodium, equivalent to
prednisolone 20.0mg
Excipients with known effect: Cetostearyl alcohol 4.4mg and Sorbic
Acid 1.74mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Rectal Foam
A white to pale cream coloured, metered-dose rectal foam.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of proctitis and ulcerative colitis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults and elderly patients:
One metered dose rectally once or twice daily for 2 weeks, extending
treatment for a further 2 weeks when a good response is
obtained. Use should be discontinued at the discretion of the
physician once the disease is stable and under control.
Paediatric population:
Not recommended.
Shake canister before use. When using for the first time remove and
discard the small plastic safety tag from under the button.
An applicator nozzle is then pushed onto the side arm of the canister.
The semi-circular cut-out on the cap is lined up with the
nozzle. The easiest way to administer Prednisolone 20 mg Rectal Foam
is to stand with one foot raised on a chair and gently
insert the nozzle tip into the rectum.
Smearing the nozzle with lubricating jelly may help insertion. Holding
the canister with the dose button pointing down, press
the button on the canister firmly and release. Only press the button
once so as not to exceed the recommended dose.
Method of administration:
For rectal administration only.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients.
Health Products Regulatory Authority
05 April 2023
CRN00DHG0
Page 2 of 4
Local conditions where infection might be masked or healing impaired,
e.g. peritonitis, fistulae, intestinal obstruction,
perf