Scheriproct Suppositories 1,3 mg/1,0 mg/1 g Suppository

SCHERIPROCT SUPPOSITORIES contains a substance called prednisolone, which reduces inflammation and also a local anaesthetic (chinchocaine) which relieves pain. This medicine is used for the short term (usually 5 – 7 days) symptomatic relief of peri-anal (located around the anus, the opening of the rectum to the outside of the body) discomfort, inflammation and itching caused by thrombosed haemorrhoids (piles), anal fissure (a small tear in the thin, moist tissue (mucosa) that lines the anus) and pruritus ani (irritating, itchy sensation around the anus).

Do not use SCHERIPROCT SUPPOSITORIES

• if you are hypersensitive (allergic) to (prednisolone heaxanoate or chinchocaine hydrochloride) or any of the other ingredients of SCHERIPROCT SUPPOSITORIES (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 currently being treated.

Warnings and precautions

Special care should be taken with SCHERIPROCT SUPPOSITORIES:

• SCHERIPROCT SUPPOSITORIES should not be used more than 7 days. If symptoms do not improve, discontinue treatment and consult your doctor. Other anal disorders require specific treatment and your doctor might have to do a proctological examination. Tell your doctor immediately, if bleeding occurs.
• 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 SUPPOSITORIES 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 and some of the medicine may be absorbed into the blood stream.
• If the area treated with SCHERIPROCT SUPPOSITORIES is also infected your doctor should prescribe another medicine, to use with SCHERIPROCT SUPPOSITORIES, 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 SUPPOSITORIES 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.

Other medicines and SCHERIPROCT SUPPOSITORIES:

Always tell your healthcare provider if you are taking any other medicine. (This includes complementary or traditional medicines.) Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Some medicines may increase the effects of SCHERIPROCT SUPPOSITORIES and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding your baby, please consult your doctor, pharmacist or other health care provider for advice before taking SCHERIPROCT SUPPOSITORIES. SCHERIPROCT SUPPOSITORIES is contraindicated for use in pregnancy.

Do not share medicines prescribed for you with any other person. Always use SCHERIPROCT SUPPOSITORIES exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Do not use SCHERIPROCT SUPPOSITORIES for more than 7 days. Always wash your hands before and after inserting SCHERIPROCT SUPPOSITORIES.

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. Your doctor will tell you how long your treatment with SCHERIPROCT SUPPOSITORIES will last. Do not stop treatment early even if the symptoms disappear. If you have the impression that the effect of SCHERIPROCT SUPPOSITORIES is too strong or too weak, tell your doctor or pharmacist.

If you use more SCHERIPROCT SUPPOSITORIES than you should:

In the event of overdosage, consult your doctor or pharmacist without delay. If neither is available, contact the nearest hospital or poison control centre.

If you missed a dose of SCHERIPROCT SUPPOSITORIES: 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. Consult your doctor or pharmacist if you are concerned.

SCHERIPROCT SUPPOSITORIES can have side effects. Not all side effects reported for SCHERIPROCT SUPPOSITORIES are included in this leaflet. Should your general health worsen or if you experience any untoward effects while using SCHERIPROCT SUPPOSITORIES, please consult your health care provider for advice.

If any of the following happens, stop using SCHERIPROCT SUPPOSITORIES and tell your doctor immediately or go to the casualty department at your nearest hospital:

• ‘swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing’,
• ‘rash or itching’,
• ‘fainting’

These are all very serious side effects. If you have them, you may have had a serious reaction to SCHERIPROCT SUPPOSITORIES. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following:

Frequency unknown:

• Some thinning of the skin may occur if SCHERIPROCT SUPPOSITORIES is inserted 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 SUPPOSITORIES may cause a skin reaction.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get 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 to SAHPRA via the 6.04 Adverse Drug Reaction Reporting Form, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of SCHERIPROCT SUPPOSITORIES.

Store all medicines out of reach of children.

• Store in a refrigerator between 2 to 8 °C.
• Do not freeze.
• Store in the original packaging.
• Keep the packaging in the outer carton.
• Do not store in a bathroom.
• Do not use after the expiry date stated on the label / carton.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).