COLIFOAM 10 %w/w Rectal Foam

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

HYDROCORTISONE ACETATE

Disponible desde:

Meda Health Sales Ireland Limited

Código ATC:

A07EA02

Designación común internacional (DCI):

HYDROCORTISONE ACETATE

Dosis:

10 %w/w

formulario farmacéutico:

Rectal Foam

tipo de receta:

Product subject to prescription which may be renewed (B)

Área terapéutica:

HYDROCORTISONE

Estado de Autorización:

Transfer Pending

Fecha de autorización:

2006-08-18

Información para el usuario

Patient Information Leaflet
COLIFOAM 10% W/W RECTAL FOAM
(Hydrocortisone acetate)
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. Do not pass it on to
others. It may harm them,
even if their symptoms 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.

Throughout this leaflet Colifoam 10% w/w Rectal Foam is called
Colifoam.
IMPORTANT:

COLIFOAM IS A STEROID MEDICINE, prescribed for many different
conditions, including serious
illnesses

YOU NEED TO USE IT REGULARLY TO GET THE maximum benefit

DON’T STOP USING THIS MEDICINE without talking to your doctor –
you may need to reduce the
dose gradually

COLIFOAM CAN CAUSE SIDE EFFECTS IN SOME PEOPLE (read section 4 below).
Some problems such
as mood changes (feeling depressed, or ‘high’), or stomach
problems can happen straight
away. If you feel unwell in any way, keep using your medicine, but SEE
YOUR DOCTOR STRAIGHT
AWAY

SOME SIDE EFFECTS ONLY HAPPEN AFTER WEEKS OR MONTHS. These include
weakness of arms and
legs, or developing a rounder face (read section 4 for more
information)

IF YOU USE IT FOR MORE THAN 3 WEEKS, YOU WILL GET A BLUE ‘STEROID
CARD’: always keep it with
you and show it to any doctor or nurse treating you

KEEP AWAY FROM PEOPLE WHO HAS CHICKEN-POX OR SHINGLES, if you have
never had them. They
could affect you severely. If you do come into contact with chicken
pox or shingles, see your
doctor straight away.
NOW READ THE REST OF THIS LEAFLET.
It includes other important information on the safe and effective use
of this medicine that might be
especially important for you.
IN THIS LEAFLET:
1.
What Colifoam is for
2.
What you need to know before you use Colif

Ficha técnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Colifoam 10% w/w Rectal Foam
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Hydrocortisone Acetate 10% w/w.
Excipients: contains cetyl alcohol 0.18% w/w, methyl
parahydroxybenzoate (E218) 0.10% w/w and
propyl parahydroxybenzoate (E216) 0.01% w/w
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Rectal foam
A white odourless rectal foam.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the topical intra-rectal management of distal ulcerative colitis
and allied conditions such as procto-sigmoiditis and
granular proctitis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For adults, children and the elderly:
One applicator full inserted into the rectum once or twice daily for
two to three weeks and every second day thereafter.
Shake the canister vigorously before filling the applicator. Withdraw
the plunger and hold the container upright when
filling the applicator. Fill the applicator just to the fill line.
Insert the contents into the rectum following the instructions and
explanatory pictures on the leaflet.
4.3 CONTRAINDICATIONS
Colifoam is contraindicated in patients with:
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1
Obstruction
Abscess
Perforation
Peritonitis
Fresh intestinal anastomoses
Extensive fistulae
Fungal, viral, tuberculous and other bacterial infections
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