Doloproct 0.1% + 2% rectal cream

Land: Malta

Språk: engelska

Källa: Medicines Authority

Aktiva substanser:

FLUOCORTOLONE PIVALATE, LIDOCAINE HYDROCHLORIDE

Tillgänglig från:

Jenapharm GmbH & Co. KG

ATC-kod:

C05AX03

INN (International namn):

FLUOCORTOLONE PIVALATE, LIDOCAINE HYDROCHLORIDE

Läkemedelsform:

RECTAL CREAM

Sammansättning:

FLUOCORTOLONE PIVALATE 1 milligram(s) ; LIDOCAINE HYDROCHLORIDE 20 milligram(s)

Receptbelagda typ:

POM

Terapiområde:

VASOPROTECTIVES

Bemyndigande status:

Authorised

Tillstånd datum:

2005-09-28

Bipacksedel

DOLOPROCT
® 0.1% + 2% RECTAL CREAM
30G
Active ingredients: Fluocortolone pivalate + Lidocaine hydrochloride
(water free)
1g rectal cream contains 1 mg fluocortolone pivalate (Ph.Eur.) and 20
mg lidocaine hydrochloride (water free)
Excipients: polysorbate 60, sorbitan stearate, cetostearyl alcohol
(Ph.Eur.), liquid paraffin, white soft paraffin, sodium
edetate (Ph.Eur.), sodium dihydrogen phosphate dihydrate, disodium
phosphate dodecahydrate (Ph.Eur.), benzyl
alcohol, purified water. _Contains cetostearyl alcohol. See package
leaflet for more information_
For rectal use.
Keep out of the sight and reach of children. After first opening the
rectal cream use within 4 weeks.
_Ch.-B. = Lot no. and Verwendbar bis = EXP. _ Application nozzle
enclosed. Read the package leaflet before use.
MAH Germany/Malta:
Jenapharm GmbH & Co. KG, Otto-Schott-Straße 15, D-07745 Jena,
Germany. P
rescription-only.
MAH Austria: Bayer Austria, Ges.m.b.H. 1160 Wien, Austria.
Prescription-only and Pharmacy-only.
MA No. 1013/00102
LF1039.005
PACKAGE LEAFLET: INFORMATION FOR THE USER
DOLOPROCT
® 0.1% + 2% RECTAL CREAM
fluocortolone pivalate + lidocaine hydrochloride (water free)
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 effect not listed in this leaflet. See section 4
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: fluoc

Produktens egenskaper

Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
Page 2 of 8
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.
Page 3 of 8
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.
4.3
CONTRAINDICATIONS
Doloproct is contra-indicated in case of topical infections in the
affected area and if symptoms of
the following disorders are present in the affected area:

spec