Anacal Suppositories
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 4 mg LAUROMACROGOL 400 50 mg
Pharmaceutical form:
SUPPOSITORY
Composition:
MUCOPOLYSACCHARIDE POLYSULFURIC ACID ESTER 4 mg LAUROMACROGOL 400 50 mg
Prescription type:
OTC
Therapeutic area:
VASOPROTECTIVES
Authorization status:
Withdrawn
Authorization date:
2006-08-11
Patient Information leaflet
PACKAGE LEAFLET: INFORMATION FOR THE USER
ANACAL
®
SUPPOSITORIES
(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 Suppositories are and what they are used for
2. Before you use Anacal Suppositories
3. How to use Anacal Suppositories
4. Possible side-effects
5. How to store Anacal Suppositories
6. Further information
1. WHAT ANACAL SUPPOSITORIES ARE AND WHAT THEY ARE USED FOR
Anacal Suppositories are anti-inflammatory, analgesic (pain
relieving) and anti-pruritic (anti-itching)
preparations which provide 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 SUPPOSITORIES
Anacal Suppositories are for external use only. Do NOT swallow.
DO NOT USE ANACAL SUPPOSITORIES:
• if you are allergic (hypersensitive) to heparinoid,
oxypolyethoxydodecane or any of the other
ingredients of Anacal Suppositories (see section 6 – Further
information for details).
Anacal Suppositories 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 your doctor or pharmacist for advice before taking any
medicine.
3. HOW TO USE ANACAL SUPPOSITORIES
Always use Anacal Suppositories
Read the complete document
Summary of Product characteristics
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Anacal Suppositories
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2g suppository contains:
Mucopolysaccharide polysulphuric acid ester (Heparinoid)
4.0mg
Oxypolyethoxydodecane (Lauromacrogol 400)
50.0mg
3 PHARMACEUTICAL
FORM
Suppository
4 CLINICAL
PARTICULARS
4.1 THERAPEUTIC
INDICATIONS
Anacal suppositories are 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:
Insert one suppository once or twice daily.
Children:
Not
recommended.
4.3 CONTRAINDICATIONS
Known sensitivity to any active or inactive component.
Not recommended for use in children.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
None.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None known.
4.6
PREGNANCY AND LACTATION
There is no evidence to suggest that Anacal Suppositories should not
be used during
pregnancy and lactation.
Page 2 of 3
4.7
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
None known.
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:
as a heparinoid.
Thrombolytic activity:
through potentiation of urokinase activity.
Anti-exudatory activity:
through inhibition of hyaluronidase.
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