RECTOGESIC

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

GLYCERYL TRINITRATE

Available from:

PADAGIS ISRAEL AGENCIES LTD, ISRAEL

ATC code:

C01DA02

Pharmaceutical form:

OINTMENT

Composition:

GLYCERYL TRINITRATE 0.4 %

Administration route:

RECTAL

Prescription type:

Required

Manufactured by:

PHARBIL WALTROP GMBH (A SUBSIDIARY OF NEXT PHARMA)

Therapeutic group:

GLYCERYL TRINITRATE

Therapeutic area:

GLYCERYL TRINITRATE

Therapeutic indications:

For relief of pain associated with chronic anal fissure. In the clinical development of the drug a modest effect has shown on improvement in average daily pain intensity.

Authorization date:

2014-04-30

Patient Information leaflet

PATIENT PACKAGE INSERT
IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS
(PREPARATIONS) - 1986
The medicine is dispensed with
a doctor’s prescription only.
RECTOGESIC
®
RECTAL OINTMENT
Each 1 gram contains 0.4% glyceryl
trinitrate.
Inactive and allergenic ingredients in the
medicine - see section 6 in the leaflet.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY
BEFORE USING THIS MEDICINE. This leaflet
contains concise information about the
medicine. If you have further questions, refer
to the doctor or pharmacist.
This medicine has been prescribed for you.
Do not pass it on to others. It may harm them,
even if it seems to you that their medical
condition is similar.
THE MEDICINE IS NOT INTENDED FOR CHILDREN
AND ADOLESCENTS UNDER THE AGE OF 18, since
studies have not been performed in this
population.
1. WHAT IS THE MEDICINE INTENDED
FOR?
To relieve pain caused by chronic anal fissures.
An anal fissure is a tear in the skin lining the
anal canal. Topical application of glyceryl
trinitrate reduces the anal pressure and
increases the blood flow, thereby reducing
pain.
THERAPEUTIC GROUP: Organic nitrates.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
∙ you are sensitive (allergic) to the active
ingredient or any of the additional
ingredients contained in the medicine (see
section 6 for the list of inactive ingredients),
or to similar medicines.
∙ you are pregnant or breastfeeding.
∙ you suffer from low blood pressure.
∙ you suffer from blood vessel or heart
disorders.
∙ you suffer from closed-angle glaucoma – a
condition where pressure inside the eye
rises rapidly, causing loss of vision.
∙ you suffer from migraines or recurrent
headaches.
∙ you suffer from increased intracranial
pressure or high pressure within the
skull (such as: head injury or cerebral
hemorrhage - bleeding from a ruptured
blood vessel in the brain that can be fatal
without prompt medical treatment, cerebral
hemorrhage [a type of stroke] or abnormal
cerebral circulation [inadequate amount of
blood reaches the brain]).
∙

Summary of Product characteristics

PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
Rectogesic
®
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 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 failure for
acute symptoms of anal
fissure.
ELDERLY (OVER 65 YEARS):
No specific information concer