RECTOGESIC 4 mg/g Rectal Ointment

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

GLYCERYL TRINITRATE

Tersedia dari:

Kyowa Kirin Ltd

INN (Nama Internasional):

GLYCERYL TRINITRATE

Dosis:

4 mg/g

Bentuk farmasi:

Rectal Ointment

Jenis Resep:

Product subject to prescription which may be renewed (B)

Area terapi:

05AE01

Status otorisasi:

Authorised

Tanggal Otorisasi:

2006-09-29

Selebaran informasi

PACKAGE LEAFLET: INFORMATION FOR THE USER
RECTOGESIC
®
 4 MG/G RECTAL OINTMENT
Glyceryl trinitrate
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 side effects not listed in 
  this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Rectogesic is and what it is used for 
2. What you need to know before you use Rectogesic 
3. How to use Rectogesic
4. Possible side effects
5. How to store Rectogesic 
6. Contents of the pack and other information
1. WHAT RECTOGESIC IS AND WHAT IT IS USED FOR
Rectogesic is a rectal ointment which contains the active substance
glyceryl trinitrate. Glyceryl 
trinitrate belongs to a group of medicines called organic nitrates.
The ointment will help to relieve the symptom of pain caused by
chronic anal fissures. An anal 
fissure is a tear in the skin lining the anal canal. Topical
application of glyceryl trinitrate to the anal 
canal reduces the anal pressure and increases the blood flow, thereby
reducing pain.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE RECTOGESIC
DO NOT USE RECTOGESIC:
•  if you are allergic to glyceryl trinitrate or to similar
medicines 
•  if you are allergic to any of the other ingredients in the
product (listed in section 6) 
•  if you suffer from low blood pressure 
•  if you suffer from heart or blood vessel disorders 
•  if you suffer from closed-angle glaucoma – a condition where
pressure inside the eye rises rapidly 
  causing loss of vision 
•  if you suffer from migraine or recurrent headaches 
•  if you suffer from increased intracranial press

Karakteristik produk

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rectogesic 4 mg/g Rectal Ointment
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Glyceryl trinitrate: 4 mg/g.
One gram of rectal ointment contains 4 mg Glyceryl trinitrate (GTN). The delivered dose from 375 mg of this
formulation is approximately 1.5 mg GTN.
Excipient(s) with known effect:
The ointment also contains 36 mg Propylene Glycol, and 140 mg Lanolin, per gram rectal ointment.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Rectal ointment.
Off-white smooth opaque ointment formulation.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Rectogesic 4 mg/g Rectal Ointment is indicated in adults for relief of pain associated with chronic anal fissure.
In the clinical development of the drug, a modest effect has been shown on improvements in average daily pain
intensity (see Section 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ROUTE OF ADMINISTRATION: rectal use
ADULTS:
A finger covering, such as cling film or a finger cot, may be placed on the finger to be used to apply the ointment.
(Finger cots to be obtained separately from local pharmacy or surgical supplies retailer or cling film from local store.)
The finger is placed along side a 2.5cm dosing line, which is provided on the outside carton in which Rectogesic is
supplied, and a strip of ointment the length of the line is expressed onto the end of the finger by gently squeezing the
tube. The amount of ointment expressed is approximately 375 mg (1.5 mg GTN). The covered finger is then gently
inserted into the anal canal to the distal interphalangeal joint of the finger and applied circumferentially to the anal
canal.
The dose delivered from the 4 mg/g ointment is 1.5 mg glyceryl trinitrate. The dose is to be a