Scheriproct Ointment
POM
PATIENT INFORMATION LEAFLET
Scheriproct® Ointment
(cinchocaine hydrochloride / prednisolone hexanoate)
Your medicine is known by the above name but will be referred to as Scheriproct throughout this leaflet.
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 any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Scheriproct is and what it is used for
2. What you need to know before you use Scheriproct
3. How to use Scheriproct
4. Possible side effects
5. How to store Scheriproct
6. Contents of the pack and other information
1. WHAT SCHERIPROCT IS AND WHAT IT IS USED FOR
Scheriproct contains a substance which reduces inflammation (prednisolone) and a local anaesthetic (cinchocaine) which relieves pain.
This medicine is used for the relief of the inflammation, swelling, itching and soreness of piles (haemorrhoids) and to relieve itching of the anus (back passage). It is used short-term usually for 5 to 7 days.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE SCHERIPROCT
Do not use Scheriproct
• if you are allergic to prednisolone hexanoate, cinchocaine hydrochloride, other local anaesthetics or any of the other ingredients of this medicine (listed in section 6).
• if you have a viral infection (e.g. herpes, shingles, chicken-pox)
• if you have any bacterial or fungal infections of the skin or elsewhere for which you are not receiving treatment.
Warnings and precautions
Talk to your doctor or pharmacist before using Scheriproct
• Long-term continuous treatment should be avoided because it increases the possibility of side effects. This is particularly important for infants and small children because continuous treatment with Scheriproct for long periods may reduce the activity of the adrenal glands and so lower resistance to disease. Also, long-term treatment can cause the skin to thin and deteriorate in the affected area (see section 4) and some of the medicine may be absorbed into the blood stream.
• If the area treated with Scheriproct is also infected your doctor should prescribe another medicine, to use with Scheriproct, to treat the infection.
• Do not use a waterproof dressing to cover areas where you have applied the cream.
Other medicines and Scheriproct
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. There may be a very small risk to the development of a baby in pregnant women treated with Scheriproct. As with most medicines, this risk is likely to be greatest during the first 3 months of pregnancy.
Driving and using machines
Scheriproct has no influence on the ability to drive and use machines.
3. HOW TO USE SCHERIPROCT
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Do not use Scheriproct for more than 7 days.
Always wash your hands before and after applying Scheriproct.
How to use Scheriproct Ointment:
1. Before you use the ointment, gently but thoroughly wash and dry the anus (back passage) and the skin around it.
2. If the ointment is to be used for the area around the anus:
• Squeeze a small quantity (about the size of a pea) on to the top of your finger.
• Spread it gently over the skin and just inside the anus.
• Do not rub it in.
3. If the ointment is to be used inside the anus:
• Put the separate nozzle (applicator) onto the tube.
• Squeeze the tube until the nozzle is full of ointment. The amount of ointment in the nozzle is one dose.
• Insert the nozzle very carefully into the anus until the whole length of the nozzle is inside.
• Then, while squeezing the tube gently, withdraw the nozzle.
• Wash the nozzle carefully in hot soapy water and rinse thoroughly.
Generally, the ointment should be applied twice a day, but it may be applied three or four times on the first day, to obtain quick relief.
If you use more Scheriproct than you should or if you accidentally swallow some Scheriproct
If you use too much Scheriproct or accidentally swallow Scheriproct it is unlikely to be dangerous but contact your doctor or pharmacist if you are worried.
If you forget to use Scheriproct
Do not use a double dose to make up for a forgotten dose. When you remember, use the next prescribed dose and continue with the treatment. See your doctor or pharmacist, if you are worried.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some thinning of the skin may occur if too much Scheriproct is applied for long periods of time (much longer than 5 to 7 days).
Allergic skin reactions may occur in rare cases.
Castor oil, one of the ingredients of Scheriproct Ointment may cause a skin reaction.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE SCHERIPROCT
• Keep this medicine out of the sight and reach of children.
• Do not store above 25°C.
• Do not use Scheriproct after the expiry date which is stated on the pack.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
• If the medicine becomes discoloured or show any signs of deterioration, you should seek the advice of your pharmacist.
6. CONTENTS OF THE PACK AND OTHER INFORMATION What Scheriproct contains
• The active substances are prednisolone hexanoate and cinchocaine hydrochloride.
1g of ointment contains 1.5mg prednisolone (as hexanoate) and 5mg cinchocaine hydrochloride.
• Excipients: 2-octyldodecanol, castor oil, hydrogenated castor oil, polyethylene glycol 400 monoricinoleate, chypre perfume oil
No 6466.
What Scheriproct looks like and contents of the pack
A colourless to slightly yellowish translucent ointment available in tubes of 30g with white plastic screw caps.
Manufacturer
Bayer HealthCare Manufacturing s.r.l.
Milan, Italy.
Procured from within the EU and repackaged by: Amimed Direct Ltd, Hendon London, NW9 6AQ.
Product Licence holder: Sam Pharma Ltd, Unit 20 Garrick Industrial Estate, Irving Way, Hendon, London, NW9 6AQ.
PL 33902/0583
Leaflet revision date: 09/10/2015
Scheriproct® is a registered trademark.
S0583-30-GR-PIL-09.10.2015