Doloproct 0.1% + 2% rectal cream

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

FLUOCORTOLONE PIVALATE, LIDOCAINE HYDROCHLORIDE

Available from:

LEO Pharma A/S Industriparken 55, 2750-DK Ballerup, Denmark

ATC code:

C05AA08

INN (International Name):

FLUOCORTOLONE PIVALATE 1 mg LIDOCAINE HYDROCHLORIDE 20 mg

Pharmaceutical form:

RECTAL CREAM

Composition:

FLUOCORTOLONE PIVALATE 1 mg LIDOCAINE HYDROCHLORIDE 20 mg

Prescription type:

POM

Therapeutic area:

VASOPROTECTIVES

Authorization status:

Withdrawn

Authorization date:

2005-09-28

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
DOLOPROCT 0.1 % + 2 % RECTAL CREAM
fluocortolone pivalate + lidocaine hydrochloride (water free)

.
IN THIS LEAFLET
:
1.
What Doloproct is and what it is used for
2.
What you need to know before you use Doloproct
3.
How to use Doloproct
4.
Possible side effects
5.
How to store Doloproct
6.
Contents of the pack and other information
1.
WHAT DOLOPROCT IS AND WHAT IT IS USED FOR
Doloproct contains two different active substances: fluocortolone
pivalate and lidocaine
hydrochloride.
-
The active substance fluocortolone pivalate belongs to the group of
corticosteroids. It lowers
the production of substances that cause inflammation in your body.
This relieves ailment such
as swelling, itching and smarting.
-
The active substance lidocaine hydrochloride belongs to the group of
local anaesthetics. It
causes numbness at the site to which it is applied.

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Doloproct 0.1 % + 2 % rectal cream
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g Doloproct rectal cream contains:
1 mg fluocortolone pivalate and
20 mg lidocaine hydrochloride (water free).
Excipients with known effect:
60 mg Cetostearyl alcohol
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Rectal cream
White, opaque cream
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic relief of pain and inflammation in adults for:
haemorrhoidal disease,
non-infectious proctitis and
anal eczema.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Doloproct rectal cream should be applied twice a day, once in the
morning and once in the evening
(approximately up to 1 g cream per application). In the initial days
of use, it can be applied three
times daily. With improvement of symptoms, a single daily application
is often sufficient.
The total duration of treatment should not exceed 2 weeks.
_Paediatric population _
Doloproct is not recommended for use in children below 18 years due to
a lack of data on safety
and efficacy.
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Method of administration
It is advisable to administer Doloproct after defecation. The anal
region should be cleaned
thoroughly prior to use.
A finger-tip unit of Doloproct rectal cream is applied to the anal
region with a finger, using the
finger tip to overcome the resistance of the sphincter.
A finger-tip unit is the amount of rectal cream expressed from the
tube and applied from the distal
skin-crease to the tip of the index finger of an adult.
If Doloproct rectal cream is to be applied intra-rectally, the
applicator provided has to be screwed
onto the tube and the tip inserted into the anus. A small quantity of
cream can then be applied by
exerting slight pressure on the tube (for use and cleaning of the
applicator see section 6.6).
4.3
CONTRAINDICATIONS
Doloproct is contra-indicated in case of topical infections in the
affected area and if symptoms of
the following disorde