Hydrocortisone and cinchocaine hydrochloride
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about PROCTOSEDYL.
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 or pharmacist has weighed the risks
of you taking this medicine against the benefits they expect it will have 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 PROCTOSEDYL is used for
PROCTOSEDYL Ointment and Suppositories are used for the relief of the discomfort of
haemorrhoids (piles) and other painful conditions of the anus (rear end), such as
fissures (tears). Haemorrhoids often result when people strain while trying to open
their bowel (defecate). This problem is often, but not always, associated with low-fibre
diets.
PROCTOSEDYL Ointment and Suppositories contain the active ingredients hydrocortisone,
a steroid, and cinchocaine hydrochloride, a local anaesthetic. These work together
to reduce swelling, numb pain and relieve itching.
Your doctor or pharmacist, however, may recommend PROCTOSEDYL for another purpose.
Ask your doctor if you have any questions about why this medicine has been recommended
for you.
Before you use it
When you must not use it
Do not use PROCTOSEDYL if you are allergic to it or any of the ingredients listed
at the end of this leaflet.
Some symptoms of an allergic reaction include skin rash, itching, shortness of breath
or swelling of the face, lips or tongue, which may cause difficulty in swallowing
or breathing.
As for all steroid preparations, do not use PROCTOSEDYL when uncontrolled infections,
bacterial, viral infections (eg. herpes, cowpox), fungal, or parasitic infections
or infections affecting the anus or surrounding area are present eg sexually-transmitted
diseases.
PROCTOSEDYL use may hide signs of infection.
PROCTOSEDYL contains hydrocortisone which can cause thinning and damage to the skin.
Do not use PROCTOSEDYL if you have tuberculosis.
Some diseases can be made worse by using PROCTOSEDYL.
Do not give PROCTOSEDYL to children under 12 years of age.
Do not use it after the expiry date (EXP) printed on the pack.
If you use it after the expiry date has passed, it may not work as well.
Do not use it if the packaging is torn/damaged or shows signs of tampering.
Before you start to take it
Tell your doctor or pharmacist if you have allergies to:
any of the ingredients listed at the end of this leaflet
any other substances, such as foods, preservatives or dyes.
Tell your doctor or pharmacist if you have or have had any medical conditions, especially
the following:
cuts or abrasions in the area of the anus eg if there is blood on toilet paper or
in the toilet after opening the bowels (defecating).
Your doctor or pharmacist will need to consider this when recommending treatment with
PROCTOSEDYL.
fungal infections such as thrush, in the area of the anus.
PROCTOSEDYL does not treat these conditions. Your doctor or pharmacist may need to
provide treatment for these conditions.
severe or prolonged anal pain or if blood is present in the faeces, in which case
you should have a doctor examine the area.
Tell your doctor or pharmacist if you are pregnant or plan to become pregnant or are
breast-feeding.
Your doctor or pharmacist can discuss with you the risks and benefits involved.
Tell your doctor or pharmacist if you plan to have surgery.
If you have not told your doctor or pharmacist about any of the above, tell them before
you use PROCTOSEDYL.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any
that you get without a prescription from your pharmacy, supermarket or health food
shop.
These medicines may be affected by PROCTOSEDYL, or may affect how well it works. You
may need to use different amounts of your medicine, or take different medicines. Your
doctor or pharmacist will advise you.
How to use it
How much to use
The standard dose for this medicine is up to three times a day (eg after your morning
bowel motion, noon and evening) or as your doctor or pharmacist tells you.
Your doctor may have prescribed a different dose.
Ask your doctor or pharmacist if you are unsure of the correct dose for you.
They will tell you exactly how much to use.
Follow the instructions they give you.
If you use the wrong dose, PROCTOSEDYL may not work as well and your problem may not
improve.
How to use it
For best results, first go to the toilet and empty your bowels. Do not strain. Wash
and dry the anal area.
Before and after use, wash your hands well with soap and water.
Ointment:
1. If the affected area is on the surface, use your finger to apply just enough ointment
to cover the painful area.
2. If you need to apply PROCTOSEDYL Ointment deeper, first screw the plastic nozzle &
cap (which are supplied in the carton) tightly on to the tube, removing the cap immediately
before use.
3. Then gently insert the nozzle all the way into the rectum (back passage) and squeeze
the tube from the lower end, while at the same time withdrawing it from the rectum.
4. After use, wash the nozzle with warm, soapy water then recap the nozzle.
Note that if the area is very inflamed and painful, it is advisable to initially apply
the ointment with a finger, rather than insert the nozzle.
Suppositories:
1. Remove the suppository from its packaging.
2. Moisten the suppository by dipping it briefly in cool water.
3. Put one foot on the side of the bath or toilet, raising the knee to the chest.
4. Insert the suppository gently into the rectum (back passage).
5. Try not to go to the toilet for at least one hour to allow the suppository time to
work.
PROCTOSEDYL should not be used by children under 12 years of age.
How long to use it
If you bought PROCTOSEDYL without a doctor's prescription, you should check with your
doctor if you need to use it for more than 7 days.
PROCTOSEDYL should be used three times daily for first week, after morning stool,
noon and evening.
If you use it for longer than 7 days, then you may be able to reduce the number of
times you have to use it each day.
During your second week of use, you may be able to use PROCTOSEDYL twice a day after
morning stool and evening, and then once daily in your third week of use after morning
stool.
Unless your doctor advises differently, you should not use PROCTOSEDYL continuously
for longer than three weeks.
Ask your doctor or pharmacist if you are not sure how long to use the medicine for.
If you use too much (overdose)
Immediately telephone your doctor, or the Poisons Information Centre (telephone Australia
13 11 26 or New Zealand 0800 POISON or 0800 764766), or go to Accident and Emergency
at your nearest hospital, if you think you or anyone else may have used too much PROCTOSEDYL.
Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
While you are using it
Things you must do
Tell your doctor or pharmacist if the use of PROCTOSEDYL causes increased discomfort
or a rash around the anus.
If you find that your condition persists despite using PROCTOSEDYL, seek advice from
your doctor or pharmacist.
Tell all the doctors, dentists and pharmacists who are treating you that you are using
PROCTOSEDYL.
If you are about to be started on any new medicine, tell your doctor and pharmacist
that you are using PROCTOSEDYL.
If you plan to have surgery that needs a general anaesthetic, tell your doctor or
dentist that you are using this medicine.
Things you must not do
Do not use more than the recommended dose unless your doctor or pharmacist tells you
to.
Do not give this medicine to anyone else, even if they have the same condition as
you.
Do not use this medicine to treat any other complaints unless your doctor or pharmacist
tells you to.
Things to be careful of
It is not known if PROCTOSEDYL adversely affects latex rubber condoms. Thus it is
recommended that you avoid contact between latex rubber condoms and PROCTOSEDYL.
Things that may help your condition
Some self-help measures suggested below may help your condition.
Talk to your doctor or pharmacist about them.
Do not strain while trying to open your bowels.
Straining may aggravate haemorrhoids.
Increasing the amount of fibre in the diet may reduce your chance of getting haemorrhoids.
This can be achieved by eating more fruit, salads, vegetables and cereals containing
bran. It may also be helpful to drink plenty of non-alcoholic fluids and exercise
regularly.
Side effects
All medicines have some unwanted side effects. Sometimes they are serious, but most
of the time they are not. Your doctor or pharmacist has weighed the risks of using
this medicine against the benefits they expect it will have for you.
Do not be alarmed by this list of possible side effects.
You may not experience any of them.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are using PROCTOSEDYL.
It helps most people with haemorrhoids, but it may have unwanted side effects in a
few people.
Tell your doctor or pharmacist if you notice:
an uncomfortable burning sensation in the anal area.
This is a mild side effect of this medicine and usually short-lived.
Tell your doctor if you notice:
Change in your eye sight
Long term use of this medicine may lead to visual disorders including loss of vision.
skin rash
Tell your doctor or pharmacist if you notice any of the following signs:
lack of appetite
pain in the stomach
weight loss
feeling sick or being sick
lack of concentration
a feeling of hunger
nervousness
fits
Long term use of Proctosedyl Suppositories could lead to a condition called 'adrenal
suppression'. You may need to have urgent medical attention or hospitalisation.'
If any of the following happen, stop using this medicine and tell your doctor immediately,
or go to Accident and Emergency at your nearest hospital:
swelling of the face, lips, mouth or throat, which may cause difficultly in swallowing
or breathing.
These are very serious side effects. If you have them, you may have had a serious
allergic reaction to PROCTOSEDYL. You may need urgent medical attention or hospitalisation.
These side effects are very rare.
Tell your doctor or pharmacist if you notice anything else that is making you feel
unwell.
Other side effects not listed above may occur in some patients.
Do not be alarmed by this list of possible side effects.
You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
After using it
If you have any queries about any aspect of your medicine, or any questions regarding
the information in this leaflet, discuss them with your doctor or pharmacist.
Storage
Keep PROCTOSEDYL Ointment in a cool, dry, dark place where the temperature stays below
25°C.
Keep PROCTOSEDYL Suppositories at 2°C to 8°C. Refrigerate. Do not freeze.
Do not store these medicines in the bathroom, near a sink, or on a window sill.
Do not leave these medicines in the car.
Heat and damp can destroy some medicines.
Keep it where children cannot reach it.
Disposal
If your doctor or pharmacist tells you to stop using PROCTOSEDYL, or the medicine
has passed its expiry date, ask your pharmacist what to do with any that is left over.
Return any unused medicine to your pharmacist.
Product description
What it looks like
PROCTOSEDYL comes in two presentations:
PROCTOSEDYL Ointment is an odourless yellowish-white translucent greasy ointment
PROCTOSEDYL Suppositories are smooth, white suppositories contained in a blister strip
PROCTOSEDYL Ointment is available in 15 g and 30 g tubes.
PROCTOSEDYL Suppositories are available in blister packs of 12 suppositories.
Ingredients
PROCTOSEDYL Ointment:
Active Ingredients:
hydrocortisone 5 mg/g and
cinchocaine hydrochloride 5 mg/g
Inactive Ingredients:
liquid paraffin
white soft paraffin
wool fat
PROCTOSEDYL Suppositories Active Ingredients:
hydrocortisone 5 mg and
cinchocaine hydrochloride 5 mg per suppository
Inactive Ingredients:
hard fat
PROCTOSEDYL does not contain gluten, sucrose, lactose, tartrazine or any other azo
dyes.
Manufacturer/Sponsor
PROCTOSEDYL is supplied in Australia by:
Sanofi Consumer Healthcare
87 Yarraman Place
Virginia, Qld 4014
Australia
Toll-free: 1800 818 806
PROCTOSEDYL is supplied in New Zealand by:
Healthcare Logistics
58 Richard Pearse Drive
Airport Oaks
Auckland
New Zealand
Phone: (09) 918 5100
This leaflet was prepared in December 2021
Proctosedyl-ccsiv1-cmiv10-20dec21
Australian Register Numbers Ointment: AUST R 21847 Suppositories: AUST R 22614
® Registered Trademark