Rectogesic 0.4% rectal ointment

Država: Velika Britanija

Jezik: engleski

Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivni sastojci:

Glyceryl trinitrate

Dostupno od:

Kyowa Kirin International UK NewCo Ltd

ATC koda:

C05AE01

INN (International ime):

Glyceryl trinitrate

Doziranje:

4mg/1gram

Farmaceutski oblik:

Rectal ointment

Administracija rute:

Rectal

Razred:

No Controlled Drug Status

Tip recepta:

Valid as a prescribable product

Proizvod sažetak:

BNF: 01070400; GTIN: 5038903000327

Uputa o lijeku

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 pressure or high pressure
within your skull (e.g. head
injury or cerebral haemorrhage - bleeding from a

Svojstava lijeka

OBJECT 1
RECTOGESIC 4 MG/G RECTAL OINTMENT
Summary of Product Characteristics Updated 11-Jul-2016 | Kyowa Kirin
Ltd
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 applied intra-
anally every twelve hours. Treatment may be continued until the pain
abates, up to a maximum of 8
weeks.
Rectogesic should be used following conservative treatment