ANUGESIC HC CREAM 0 Unknown Cream

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PRAMOCAINE HYDROCHLORIDE, BISMUTH OXIDE, ZINC OXIDE, BENZYL BENZOATE, HYDROCORTISONE ACETATE, BALSAM PERU

Available from:

Pfizer Healthcare Ireland

ATC code:

C05AA01

INN (International Name):

PRAMOCAINE HYDROCHLORIDE, BISMUTH OXIDE, ZINC OXIDE, BENZYL BENZOATE, HYDROCORTISONE ACETATE, BALSAM PERU

Dosage:

0 Unknown

Pharmaceutical form:

Cream

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Corticosteroids

Authorization status:

Authorised

Authorization date:

2000-03-15

Patient Information leaflet

Pfleet number: 2016-0014537
Page 1 of 5   AU 9_2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ANUGESIC HC CREAM
pramocaine hydrochloride, hydrocortisone acetate, zinc
oxide, balsam peru, benzyl benzoate, 
bismuth oxide
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, pharmacist or
nurse.
- 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, pharmacist or
nurse. This includes any possible side 
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Anugesic HC Cream is and what it is used for
2. What you need to know before you use Anugesic HC Cream
3. How to use Anugesic HC Cream 
4. Possible side effects
5. How to store Anugesic HC Cream
6. Contents of the pack and other information
Important things that you SHOULD know about your medicine:
 Anugesic HC Cream is used to treat severe pain and
discomfort associated with haemorrhoids (piles), 
and pruritus ani (itching around the anus) in adults. Anugesic HC Cream may be used for either of 
these conditions.
 Anugesic HC Cream is for topical use and should only be used as
directed. Do not swallow the cream 
or use on other areas of the skin. If you accidentally swallow Anugesic HC Cream, tell your doctor 
immediately.
 Anugesic HC Cream can sometimes cause burning, itching or
stinging around the anus (See Section 4 
for more details). See your doctor immediately if these symptoms do
not go away
Please read the rest of this
leaflet. It includes other important information on the safe and effective use of 
this medicine that might be especially important to you.
1. WHAT ANUGESIC HC CRE

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Anugesic HC Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 100g of cream contains:
Zinc oxide
12.35g
Balsam peru
1.85g
Benzyl benzoate
1.2g
Pramocaine hydrochloride
1.0g
Bismuth oxide
0.875g
Hydrocortisone acetate
0.5g
Excipients with known effect:
Propyl parahydroxybenzoate (E216) 0.01g
Methyl parahydroxybenzoate (E218) 0.11g
Propylene Glycol 8.0g
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream.
A smooth, homogeneous buff coloured cream with the characteristic odour of balsam peru.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Anugesic HC Cream is indicated for the comprehensive symptomatic treatment of severe and acute discomfort or pain
associated with internal and external haemorrhoids, proctitis, cryptitis, anal fissures, pruritus ani and perianal sinuses. It
is also indicated post-operatively in ano-rectal surgical procedures.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults:_
Apply cream to the affected area at night, in the morning and after each evacuation. Thoroughly cleanse the affected
area, dry and apply cream by gently smoothing onto the affected area. For internal conditions use rectal nozzle
provided and clean it after each use.
Not to be taken orally.
_Elderly (over 65 years):_
As for adults.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 06/10/2016_
_CRN 2176308_
_page number: 1_
_Paediatric population:_
Not recommended.
Method of administration
For topical use only.
4.3 CONTRAINDICATIONS
Tubercular, fungal and viral lesions including herpes simplex, vaccinia and varicella.
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
4.4 SPE