Anacal Rectal Ointment
Country: Malta
Language: English
Source: Medicines Authority
Patient Information leaflet
(PIL)
25-04-2024
Summary of Product characteristics
(SPC)
25-04-2024
Active ingredient:
MUCOPOLYSACCHARIDE POLYSULFURIC, ACID ESTER, LAUROMACROGOL
Available from:
Genus Pharmaceuticals Limited Linthwaite, Huddersfied HD7 5QH, United Kingdom
ATC code:
C05AX03
INN (International Name):
MUCOPOLYSACCHARIDE POLYSULFURIC ACID ESTER 0.2 % (W/W) LAUROMACROGOL 400 5 % (W/W)
Pharmaceutical form:
RECTAL OINTMENT
Composition:
MUCOPOLYSACCHARIDE POLYSULFURIC ACID ESTER 0.2 % (W/W) LAUROMACROGOL 400 5 % (W/W)
Prescription type:
OTC
Therapeutic area:
VASOPROTECTIVES
Authorization status:
Withdrawn
Authorization date:
2006-08-11
Patient Information leaflet
PACKAGE LEAFLET: INFORMATION FOR THE USER
ANACAL
®
RECTAL OINTMENT
(HEPARINOID AND OXYPOLYETHOXYDODECANE)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE.
-
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 any of the side-effects get serious, or if you notice any side-effects not listed in this leaflet, please
tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What Anacal Rectal Ointment is and what it is used for
2. Before you use Anacal Rectal Ointment
3. How to use Anacal Rectal Ointment
4. Possible side-effects
5. How to store Anacal Rectal Ointment
6. Further information
1. WHAT ANACAL RECTAL OINTMENT IS AND WHAT IT IS USED FOR
Anacal Rectal Ointment is an anti-inflammatory, analgesic (pain relieving) and anti-pruritic (anti-
itching) preparation which provides relief of symptoms associated with internal and external
haemorrhoids (piles), inflammation and irritation of the anus, and other related ano-rectal conditions.
2. BEFORE YOU USE ANACAL RECTAL OINTMENT
Anacal Rectal Ointment is for external use only. Do
NOT swallow.
DO NOT USE ANACAL RECTAL OINTMENT:
•
if you are allergic (hypersensitive) to heparinoid, oxypolyethoxydodecane or any of the other
ingredients of Anacal Rectal Ointment (see section 6 – Further information for details).
Anacal Rectal Ointment should
NOT be used on children under the age of 12 years old.
USING OTHER MEDICINES
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription.
PREGNANCY AND BREAST-FEEDING
Ask
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Summary of Product characteristics
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Anacal Rectal Ointment
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Mucopolysaccharide polysulphuric acid ester (Heparinoid)
0.2%w/w
Oxypolyethoxydodecane (Lauromacrogol 400)
5.0%w/w
3. PHARMACEUTICAL
FORM
Rectal Ointment
4. CLINICAL
PARTICULARS
4.1 THERAPEUTIC
INDICATIONS
Anacal rectal ointment is indicated for the treatment of
the following conditions:
Relief of symptoms associated with haemorrhoids (including perianal
haematomas), perianal
eczema, pruritus, anal fissure, proctitis, periproctitis, and
aftercare of haemorrhoids treated
by surgery or injection.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults and the elderly:
To be applied one to four times daily.
Children:
Not recommended.
4.3 CONTRA-INDICATIONS
Known sensitivity to any active or inactive component of the
formulation.
Not recommended for use in children.
4.4
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
If condition persists or worsens, seek medical advice.
4.5
INTERACTIONS WITH OTHER MEDICAMENTS AND OTHER FORMS OF INTERACTION
Page 2 of 4
None known.
4.6
PREGNANCY AND LACTATION
There is no evidence to suggest that Anacal Rectal Ointment should
not be used during
pregnancy and lactation.
4.7
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
None.
4.8 UNDESIRABLE
EFFECTS
None known.
4.9 OVERDOSE
In the absence of any reports of the accidental ingestion of Anacal,
no specific advice is
available. General supportive measures may be appropriate.
5. PHARMACOLOGICAL
PROPERTIES
5.1 PHARMACODYNAMIC
PROPERTIES
Mucopolysaccharide polysulphate ester is recognised as having:
A weak inhibitory effect on PGE
2
synthesis and an indirect effect on LTB
4
production based
on in vitro studies.
Anti-coagulant activity:
a
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