Scheriproct Suppositories

• 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.

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

• 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.

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 ointment.
• In case latex products such as condoms are used concomitantly in the area of treatment with Scheriproct its ingredient(s) may cause damage to those latex products. Therefore, these may no longer be effective as contraception or as protection against sexually transmitted diseases such as HIV infection. Talk to your doctor or pharmacist, if you require more information.
• Contact your doctor if you experience blurred vision or other visual disturbances.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Some medicines may increase the effects of Scheriproct and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).

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.

Scheriproct has no influence on the ability to drive and use machines.

Scheriproct ointment contains castor oil, castor oil hydrogenated and macrogol 400 monoricinoleate that may cause skin reactions.

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:

• Screw the separate applicator completely onto the tube. Do not use the applicator if damaged.
• Squeeze the tube until the applicator is full of ointment. The amount of ointment in the applicator is one dose.
• Insert the applicator very carefully into the anus until the whole length of the applicator is inside.
• Then, while squeezing the tube gently, withdraw the applicator.
• After each use, clean externally the applicator with a paper towel, then remove the remaining product in the applicator with a cotton swab and clean it again with a paper towel. Rinse the applicator under warm water for about 1 minute and dry externally the applicator with towel paper.

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.

1. Before you insert a suppository find the small tear in the foil packet and remove the covering foil, by tearing it in half.
2. If the suppositories have become softened, owing to warm temperature, they can be hardened by putting them into cold water before you remove the covering foil.
3. Insert the whole suppository into the anus.
4. To make insertion easier, either stand with one foot raised on a chair or squat down.

The usual treatment is one suppository a day, to be inserted preferably after a bowel movement. However, if your discomfort is severe, you should insert one suppository two or three times a day at the start of treatment.

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.

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 get any side effects, talk to your doctor or pharmacist. 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

• The active substances are prednisolone hexanoate and cinchocaine hydrochloride. 1 g of Scheriproct Ointment contains 1.9 mg prednisolone hexanoate and 5.0 mg cinchocaine hydrochloride
• The other ingredients are macrogol-400-monoricinoleate, castor oil, hydrogenated, castor oil, refined, 2 octyldodecanol.

• The active substances are prednisolone hexanoate and cinchocaine hydrochloride. Each suppository contains 1.3 mg prednisolone hexanoate and 1.0 mg cinchocaine hydrochloride
• The other ingredient is hard fat.

• Scheriproct Ointment is a colourless to slightly yellowish ointment supplied in tubes of 30 g with a separate applicator.
• Scheriproct Suppositories are yellowish-white and are supplied in packs of 12 suppositories.

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Manufacturer

The ointment is manufactured by:

The suppositories are manufactured by: