Patient leaflet - Scheriproct suppositories
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 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.
Other medicines and Scheriproct
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).
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.
Scheriproct ointment contains castor oil, castor oil hydrogenated and macrogol 400 monoricinoleate that may cause skin reactions.
Scheriproct ointment contains fragrance (perfume oil, chypre) with allergens that may cause allergic reactions. For the complete allergen’s composition, see section 6.
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:
- •
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 a paper towel.
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.
How to use 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.
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.
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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.
You must get urgent medical help if you have any of the following symptoms. You may be having an allergic reaction. This is rare and may affect up to 1 in 1,000 people:
- Angioedema (rapid swelling under the skin)
- Eye swelling
- Swelling face
- Dyspnoea (shortness of breath)
Not known (frequency cannot be estimated from the available data): Blurred vision
Reporting of side effects
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.
5. How to store Scheriproct®
- Keep this medicine out of the sight and reach of children.
- Do not store Scheriproct Ointment above 25°C.
Store Scheriproct Suppositories in a refrigerator
(2°C to 8°C).
Do not use Scheriproct after the expiry date which is
stated on the pack after EXP. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Scheriproct Ointment contains
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, perfume oil, Chypre.
Perfume oil, chypre contains the following allergens: 3-Methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one; Benzyl alcohol; Benzyl benzoate; Benzyl cinnamate; Benzyl salicylate; Cinnamal; Cinnamyl alcohol; Citral; Citronellol; Coumarin; Eugenol; Farnesol; Geraniol; Hydroxycitronella; Isoeugenol; Linalool;
Limonene (d-and l-Limonene); Oak moss (see section 2).
What Scheriproct Suppositories contain
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.
What Scheriproct looks like and contents of the pack
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.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Karo Pharma AB
Box 16184
103 24 Stockholm
Sweden
Manufacturer
The ointment is manufactured by:
LEO Pharma Manufacturing Italy S.r.l. Via E. Schering 21
20054 Segrate (Milan)
Italy
The suppositories are manufactured by: Istituto de Angeli S.r.l.
Località Prulli, 103/C
50060 Reggello (Florence)
Italy
This leaflet was last revised in October 2021.
® Registered Trade Mark
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