SCHERIPROCT® OINTMENT AND SUPPOSITORIES

Consumer Medicine Information

Please read this leaflet carefully before you start your treatment. Keep this leaflet. You may want to read it again.

What is in this leaflet?

This leaflet answers some common questions about Scheriproct®. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

Your doctor has weighed the risks of you using Scheriproct® against the benefits he/she expects it will have for you.

If you have any concerns about this medicine, ask your doctor or pharmacist.

What Scheriproct® is used for

The active ingredient in Scheriproct® is a type of cortisone and belongs to the group of medicines called corticosteroids.

Scheriproct® is the brand name for agents containing the substances prednisolone hexanoate and cinchocaine hydrochloride.

Scheriproct® is used in the treatment of haemorrhoids(piles), tears of the anal tissue, and similar conditions. The active ingredients reduce the inflammation and pain associated with such problems.

Your doctor however, may have prescribed Scheriproct® for another purpose.

Ask your doctor if you have any questions about why Scheriproct® has been prescribed for you.

A doctor’s prescription is required for Scheriproct®.

Before you use Scheriproct®

When you must not use it

Do not use Scheriproct® if you have ever had an allergic reaction to:

• Prednisolone hexanoate or cinchocaine hydrochloride
• Any of the ingredients in Scheriproct® listed at the end of this leaflet for the product you are using.

Do not use Scheriproct® if you have:

• TB or syphilis in the area to be treated
• a viral disease (e.g. chickenpox)
• traumatised skin
• a fungal skin infection (such as thrush) unless you are also being treated for this unless your doctor tells you.

Ask your doctor to be sure you do not have any of these conditions.

Do not use Scheriproct® if you are in the first trimester of pregnancy.

Do not use Scheriproct® after the expiry date printed on the pack. If you use it after the expiry date has passed, it may not work as well.

Do not use Scheriproct® if the packaging shows signs of tampering or the seal on the tube is broken.

Before you start to use it

You must tell your doctor if:

• You are allergic to any other medicines, foods, dyes or preservatives
• You are pregnant or breastfeeding. Your doctor will tell you if you can use Scheriproct® during pregnancy or while you are breastfeeding.

Some of the ingredients in Scheriproct may interact with latex products, such as condoms. Therefore, if condoms are used in the same area of treatment with Scheriproct, these may no longer be effective as contraception or as protection against sexually transmitted infections such as HIV infection. Talk to your doctor or pharmacist, if you require more information.

Taking other medicines

Tell your doctor if you are using other creams, ointments or suppositories for this problem. This includes any that you buy without a prescription from a pharmacy, supermarket or health food shop.

Some medicines and Scheriproct may interfere with each other. These include:

• medicines used to treat Human Immunodeficiency Virus (HIV), such as ritonavir or cobicistat

Your doctor may wish to monitor you carefully  if you are taking these medicines.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

How to use Scheriproct®

Follow carefully all directions given to you by your doctor or pharmacist. They may differ from the information contained in this leaflet.

If you do not understand the instructions in this leaflet, ask your doctor or pharmacist for help.

How to use it

The area around the anus should be carefully and thoroughly cleaned before using Scheriproct®, which is best applied after the bowels have been emptied.

Ointment

Unless otherwise prescribed by your doctor, Scheriproct®. Ointment should be applied twice daily. Application up to four times on the first day may provide faster initial relief. Smear a small amount of ointment (about the size of a pea) around the anus and just inside the anus using your finger. The nozzle supplied with the tube should be screwed on to the tube, and used to apply the ointment internally. If the anus if very inflamed and painful, it is advisable to gently apply the ointment internally with your finger.

Protruding lumps should be thickly smeared and carefully pressed back with your finger.

Suppositories

Check the hardness of the suppository before unwrapping it. If it is soft, place the wrapped suppository in cold water before use. This will ensure that the suppository maintains its shape when it is used. Unless otherwise advised by your doctor, one suppository should be unwrapped and inserted high into the back passage daily. For severe symptoms, one suppository may be inserted two to three times on the first day.

How long to use it

Treatment should continue for one week, less frequently (ointment once a day or one suppository every other day) after symptoms have cleared. The length of treatment should however, not exceed four weeks.

If you forget to use it

If you forget to use Scheriproct® use it as soon as you remember and then go back to your normal times for applying Scheriproct®. Do not try to make up for the amount you missed by using more than you would normally use.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to use your medicine, ask your doctor or pharmacist for some hints.

If you swallow it

Telephone your doctor or Poisons Information Centre (Phone 13 11 26) or go to the accident and emergency centre at your nearest hospital immediately if you or anyone else swallows Scheriproct®.

Keep the telephone numbers of these places handy.

While you are using Scheriproct®

Things you must do

Tell all your doctors and pharmacists who are treating you that you are using Scheriproct®.

If you feel that Scheriproct® is not helping your condition, tell your doctor (or pharmacist).

Tell your doctor if for any reason you have not used Scheriproct® as prescribed. Otherwise your doctor may think that it was not effective and change your treatment unnecessarily.

If you become pregnant while using Scheriproct® tell your doctor.

Things you must not do

Do not give Scheriproct® to anyone else even if their symptoms seem similar to yours.

Do not use Scheriproct® to treat other conditions unless your doctor tells you.

Things to be careful of

Avoid contact with the eyes. Careful handwashing after use is recommended.

Do not use large amounts of Scheriproct® for a long time. If you use large amounts for a long time, the chance of absorption through the skin and the chance of side effects increases.

Side effects

Tell your doctor or pharmacist if you do not feel well while you are using Scheriproct®.

Scheriproct® helps most people with piles but it may have unwanted side effects in a few people.

Side effects that have been reported rarely by people using Scheriproct® include:

• Allergic skin reactions (eg rash)
• If Scheriproct® is used for more than 4 weeks, wasting of the skin in the treated area can occur.

Scheriproct® may cause other side effects.

If you have any other side effects, check with your doctor.

Do not be alarmed by this list of side effects. You may not experience any of them.

After using Scheriproct®

Storage

Keep Scheriproct® where young children cannot reach it. A locked cupboard at least one and a half metres above the ground is a good place to store medicines.

Scheriproct® Ointment should be stored below 25ºC and Scheriproct® suppositories should be stored in the fridge (at 2°C to 8°C). Do not freeze.

They should not be used after the expiry date printed on the outer box, base of the tube or on the suppository foil.

Disposal

If your doctor tells you to stop using Scheriproct® or it has passed its expiry date, ask your pharmacist what to do with any Scheriproct® left over.

Product description

Scheriproct® is presented in 10 g and 30 g tubes of ointment, and as suppositories in packs of 12.

Ingredients

The ointment contains:

• prednisolone hexanoate 1.9mg/g
• cinchocaine hydrochloride 5mg/g
• PEG-8 ricinoleate
• hydrogenated castor oil
• octyldodecanol
• castor oil for injection
• perfume oil Chypre / 740 049

Scheriproct® suppositories contain:

• prednisolone hexanoate 1.3mg
• cinchocaine hydrochloride 1mg
• hard fat

The AUST R number for the ointment is 70062 and the AUST R number for the suppositories is 70063.

Distributor

Bayer Australia Ltd
ABN 22 000 138 714
875 Pacific Highway
Pymble NSW 2073
Australia

This document was revised in August 2017.

® Registered Trademark of the Bayer Group