Doloproct Cream (new formulation)

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

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Active ingredient:

Fluocortolone pivalate 0.1%{relative}; Lidocaine hydrochloride 2%{relative}

Available from:

LEO Pharma Limited

INN (International Name):

Fluocortolone pivalate 0.1% w/w

Dosage:

1mg/20mg

Pharmaceutical form:

Rectal cream

Composition:

Active: Fluocortolone pivalate 0.1%{relative} Lidocaine hydrochloride 2%{relative} Excipient: Benzyl alcohol Cetostearyl alcohol Dibasic sodium phosphate dodecahydrate Liquid paraffin Monobasic sodium phosphate dihydrate Polysorbate 60 Purified water Sodium edetate Sorbitan stearate White soft paraffin

Units in package:

Tube, aluminium, epoxy resin coated with polyethylene screw cap and polypropylene nozzle, 30 g

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Bayer AG

Product summary:

Package - Contents - Shelf Life: Tube, aluminium, epoxy resin coated with polyethylene screw cap and polypropylene nozzle - 30 g - 3 years from date of manufacture stored at or below 30°C

Authorization date:

2004-11-16

Patient Information leaflet

                                 
DOLOPROCT
®
 
RECTAL CREAM OR SUPPOSITORY 
_(DOLL-O-PROKT) _
_Rectal cream: 1mg/g  fluocortolone pivalate and 20mg/g lidocaine hydrochloride  _
_Suppository: 1mg  fluocortolone pivalate and 40mg
lidocaine hydrochloride(each) _
CONSUMER MEDICINE INFORMATION 
 
WHAT IS IN THIS LEAFLET? 
This leaflet answers some common questions about DOLOPROCT
®
. 
It does not contain all the available information.  
It does not take the place of talking to your doctor or pharmacist.  
All medicines have risks and benefits. Your doctor has weighed
the risks of your 
taking DOLOPROCT
® 
against the benefits they expect it will have for you.  
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE,
ASK YOUR DOCTOR OR 
PHARMACIST.  
KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read
it again.  
WHAT DOLOPROCT
®
 IS USED FOR 
DOLOPROCT
®
 RECTAL CREAM AND DOLOPROCT
®
 SUPPOSITORIES are used for the 
relief of pain, swelling, burning and itching in
the lower part of the rectum (back 
passage) and around the anus, which can
be caused by haemorrhoids (also known as 
piles). DOLOPROCT
®
 rectal cream is also used to treat anal eczema, a skin rash 
around the anal area that can be very red, swollen and itchy. 
DOLOPROCT
®
 rectal cream and suppositories both contain
an anti-inflammatory 
medicine called FLUOCORTOLONE PIVALATE _(PRONOUNCED FLU-COR-TOE-LONE PIV-A-LATE)_ to 
reduce swelling, burning and itching as well as a
local anesthetic called LIDOCAINE 
HYDROCHLORIDE _(PRONOUNCED LIE-DOE-CANE HI-DRO-CHLOR-IDE)_ to
reduce pain. 
 
DOLOPROCT
®
 can help to reduce pain, swelling, burning and itching in
the rectum 
and anal area. However, it will
not eliminate the CAUSE of these symptoms. Speak to 
your doctor or pharmacist if you
have any further questions.  
Your doctor may have prescribed DOLOPROCT
®
 for a
                                
                                Read the complete document
                                
                            

Summary of Product characteristics

                                 
DOLOPROCT
®
 
RECTAL CREAM OR SUPPOSITORIES CONTAINING FLUOCORTOLONE PIVALATE AND 
LIDOCAINE HYDROCHLORIDE 
PRESENTATION 
1 g of white, opaque rectal cream contains 1 mg fluocortolone
pivalate and 20 
mg lidocaine hydrochloride (anhydrous). 
1 yellowish-white suppository contains 1 mg fluocortolone pivalate and
40 mg 
lidocaine hydrochloride (anhydrous). 
USES 
_ACTIONS _
Fluocortolone exerts an anti-inflammatory, antiallergenic and
antipruritic 
effect.  Capillary dilatation, intercellular edema and tissue
infiltration regress; 
capillary proliferation is suppressed. 
_PHARMACODYNAMIC PROPERTIES _
Pharmacotherapeutic group: topical antihemorrhoidal agent 
ATC code: C05 AX 03 
 Fluocortolone 
pivalate 
Fluocortolone pivalate inhibits inflammatory and allergic skin
reactions, and 
alleviates subjective symptoms, such as pruritus, smarting, and pain.
 The 
substance reduces dilatation of the capillaries, edema of the
interstitial cells 
and infiltration of the tissues.  Capillary multiplication is
inhibited
. 
 Lidocaine 
hydrochloride 
Lidocaine hydrochloride is a standard local anesthetic which has been
in use 
for many years.  As it has analgesic and antipruritic effects, it
has been found 
to be effective when used in suppositories and creams designed for
the 
treatment of hemorrhoidal complaints.  The suppression of pain and
pruritus is 
the result of the inhibition of afferent nervous pathways. 
_PHARMACOKINETIC PROPERTIES _
The DOLOPROCT rectal cream/suppositories are topical preparations
which 
display their anti-inflammatory and analgesic effects at the site of
application. 
The active ingredients diffuse out of the preparations into the
inflamed tissue, 
are partially absorbed, distributed by the circulatory system,
metabolised and 
finally excreted.  In order to obtain a local therapeutic effect, 
pharmacologically effective plasma levels are not required. 
 
In order to assess the risk of systemic effects after rectal
application of the 
D
                                
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