Rectogesic

Krajina: Nový Zéland

Jazyk: angličtina

Zdroj: Medsafe (Medicines Safety Authority)

Aktívna zložka:

Glyceryl trinitrate 0.2%{relative} (as 4%w/w glyceryl trintrate 5%w/w solution);  

Dostupné z:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (Medzinárodný Name):

Glyceryl trinitrate 0.2% w/w (as 4%w/w glyceryl trintrate 5%w/w solution)

Dávkovanie:

0.2% w/w

Forma lieku:

Rectal ointment

Zloženie:

Active: Glyceryl trinitrate 0.2%{relative} (as 4%w/w glyceryl trintrate 5%w/w solution)   Excipient: Ethanol Lanolin Liquid paraffin Yellow soft paraffin

Počet v balení:

Tube, aluminium, 20g, 20 g

Trieda:

Restricted

Typ predpisu:

Restricted

Výrobca:

ADI Limited

Terapeutické indikácie:

Rectogesic rectal ointment is indicated for the treatment of anal fissure and relief of the symptoms associated with anal fissure. May assist in relief of pain and discomfort associated with haemorrhoids and haemorrhoidectomy.

Prehľad produktov:

Package - Contents - Shelf Life: Tube, aluminium, - 20 g - 36 months from date of manufacture stored at or below 25°C - Tube, aluminium, - 30 g - 36 months from date of manufacture stored at or below 25°C

Dátum Autorizácia:

2000-11-15

Príbalový leták

NEW ZEALAND CONSUMER MEDICINE INFORMATION
RECTOGESIC
®
_GLYCERYL TRINITRATE 0.2% OINTMENT _
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about RECTOGESIC.
It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of your taking
RECTOGESIC against the benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR
PHARMACIST.
Keep this leaflet with the medicine. You may need to read it again.
WHAT RECTOGESIC IS USED FOR
WHAT IS RECTOGESIC
RECTOGESIC Ointment is used for the treatment and relief of symptoms
of anal fissure
and may assist in relief of pain and discomfort associated with
haemorrhoids and
haemorrhoidectomy.
HOW WILL IT HELP ME
If you suffer anal fissure (which has been diagnosed by your doctor),
RECTOGESIC is
used as a treatment to help reduce the fissure and relieve the pain
and spasm (muscle
contraction) associated with this condition.
If you suffer from haemorrhoids, RECTOGESIC is also used to help
relieve pain and
discomfort associated with this condition. If you have recently
undergone
haemorrhoidectomy (a surgical procedure to remove haemorrhoids), your
doctor may
have prescribed RECTOGESIC to help relieve pain and discomfort.
BEFORE USING RECTOGESIC
Before you begin using RECTOGESIC, you should be aware of some
precautions
associated with the use of RECTOGESIC.
You should not use RECTOGESIC if you suffer from:

severe anaemia (low blood count)

glaucoma (increased eye pressure)

hypotension (low blood pressure)

increased intracranial pressure (high pressure inside your head)
Also you should not use RECTOGESIC if you are pregnant or
breastfeeding or if you
are allergic to glyceryl trinitrate or any of the other ingredients in
RECTOGESIC.
USE IN CHILDREN
RECTOGESIC is not recommended for use in children.
PREGNANCY AND BREAST-FEEDING
You should not use RECTOGESIC during pregnancy or when breast-f

Súhrn charakteristických

NEW ZEALAND DATA SHEET
1 PRODUCT NAME
RECTOGESIC
®
_ _
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
0.2% w/w Glyceryl Trinitrate Ointment
3 PHARMACEUTICAL FORM
Rectogesic contains the active ingredient Glyceryl trinitrate 0.2% w/w
in a smooth light
amber ointment formulation for topical application.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the treatment of anal fissure and relief of the symptoms
associated with anal fissure.
May
assist
in
relief
of
pain
and
discomfort
associated
with
haemorrhoids
and
haemorrhoidectomy.
4.2 Dose and method of administration
_ADULTS _
Insert a 1 to 1.5 cm strip of ointment (see measurement on box) into
the anal canal, either
with the finger or an applicator.
Apply the ointment 3 times daily and do not exceed this dosage.
Close the tube tightly, immediately after each use.
For anal fissure, treatment with Rectogesic should be continued for 2
– 4 weeks, with
assessment by a medical practitioner after 2 weeks. For
haemorrhoidectomy, treatment with
Rectogesic should be continued for a minimum of 2 weeks, with
assessment by a medical
practitioner after the initial 2 weeks.
_ _
_Adverse effects _
If headache, fainting or dizziness are observed, treatment should
cease for a minimum of 8
hours and then the dosage halved. Simple analgesics such as
paracetamol may be helpful
for headaches. If headaches are severe and persist, cease
administration.
_ _
_Nitrate-free period _
A daily ‘nitrate-free period’ of 12 hours is required during
treatment with Rectogesic to avoid
the development of tolerance. This would normally be overnight.
Where Rectogesic is used concurrently with another nitric oxide donor,
the nitrate-free
period should correspond with the nitrate-free period already applying
to the nitric oxide
donor (e.g. this may be during the day for those angina patients who
require overnight
treatment with glyceryl trinitrate patches).
The frequency of use of Rectogesic may need to be reduced to twice
daily when it is used in
conjunction with another nitric oxide donor, to