Scheriproct 0.19% / 0.5% rectal ointment, Scheriproct 1.3 mg / 1 mg suppositories prednisolone caproate, in cocaine hydrochloride
What Is Scheriproct, And What Is Scheriproct Used For?
Scheriproct rectal ointment and suppositories (suppositories) contain two active substances, prednisolone and cocaine. Prednisolone has anti-inflammatory, anti-allergic, and antipruritic effects. Cincocaine has a pain-relieving, local anaesthetic effect.
Scheriproct is used to treat haemorrhoids, associated itching, irritation, and cracks (superficial anal fissures ) at the rectum.
What Do You Need To Know Before Using Scheriproct?
Do Not Use Scheriproct:
- If you are allergic to prednisolone caproate or in cocaine hydrochloride or any of the other ingredients of this medicine (listed in section 6).
Warnings And Cautions:
- Avoid getting this medicine in your eyes. After use, hands should be washed thoroughly.
- Talk to a doctor if you suspect you have an infection caused by, e.g. bacteria or fungi in the rectal area. You may need additional treatment.
- Keep in mind that haemorrhoids often recur due to underlying constipation problems.
- Follow the recommended dosage carefully, as higher dosages may lead to more side effects.
- If the skin around the rectal opening becomes irritated or begins to bleed, discontinue treatment and consult a physician. This may indicate that you are not tolerating any active ingredients in Scheriproct.
- You should contact a doctor if there has been no improvement after 2-3 weeks of treatment with Scheriproct.
- This medicine should not be used for more than 4 weeks to reduce the risk of thinning the skin around the rectum.
- If latex-containing products, such as condoms, are used in the same area as Scheriproct, the ingredients in Scheriproct may damage the latex-containing products. This may mean their protection against pregnancy and sexually transmitted diseases, such as HIV infection, is lacking. If you have any further questions, ask your doctor or pharmacist.
- Contact a doctor if you experience blurred vision or other visual disturbances.
Children And Young People:
This medicine is not recommended for children under 18 years of age due to a lack of data on safety and efficacy.
Other Medicines And Scheriproct:
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is especially important if you are using or have recently used anaesthetics or antiarrhythmics (so-called antiarrhythmics ).
Some medicines may increase the effects of Scheriproct, and your doctor may want to monitor you closely if you are taking these medicines (e.g. some HIV medicines: ritonavir, cobicistat).
Pregnancy And Breastfeeding:
If you are pregnant, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
This medicine should not be used during pregnancy unless your doctor has carefully considered this. Scheriproct passes into breast milk, but the risk of affecting the baby is unlikely during breastfeeding. However, consult a physician if more than temporary use of Scheriproct during breastfeeding.
Driving And Using Machines:
This medicine has no known effect on the ability to drive or use machines.
Scheriproct Rectal Ointment Contains Castor Oil, Hydrogenated Castor Oil, And Macrogol Glycerol Castin Oil 400
This medicine contains castor oil, hydrogenated castor oil, and macrogol glycerol ricinoleate 400, which may cause skin reactions. Scheriproct rectal ointment contains fragrances (perfume oil, Chypre).
This medicine contains fragrances (perfume oil, Chypre) with allergens that may cause allergic reactions. For complete composition, see section 6.
How To Use Scheriproct?
- Always use this medicine as described in this leaflet or as directed by your doctor, pharmacist, or nurse. If unsure, talk to your doctor, pharmacist, or nurse.
- If you experience increased irritation or bleeding when applying Scheriproct, discontinue treatment and consult your doctor (see section 2. What you need to know before using Scheriproct).
- If necessary, gently clean the anal area before using Scheriproct. Then follow the instructions below.
- The usual dose for adults:
- Rectal ointment: Apply a thin layer, usually twice daily. Up to 4 coats can be applied during the first day for quick pain relief.
- If you are going to use the ointment inside the rectum: First take some ointment (about the size of a pea) and lubricate around the rectal opening to facilitate the insertion of the applicator. Screw the supplied applicator firmly onto the tube. Then gently insert the applicator into the rectum and squeeze out some ointment.
- Clean the outside of the applicator with a paper towel after each use. Then remove remnants of the product from the applicator with a cotton swab and clean again with a paper towel. Rinse the applicator in warm water for about 1 minute and then wipe the outside with a paper towel. Do not use the applicator if it is damaged.
- Suppositories:
- A suppository is usually inserted daily into the rectum. In severe pain, 1 suppository can be introduced 2-3 times during the first day. The suppository is inserted with the straight end first. If the suppositories have become soft due to heat, they can be placed in cold water before removing the cover.
- Improvement usually occurs quickly, but treatment should not be interrupted. To avoid the recurrence of problems, treatment should be continued for at least 1 week, even if the symptoms have completely disappeared. You should contact a doctor if there has been no improvement after 2-3 weeks of treatment with Scheriproct. However, the treatment should not exceed 4 weeks to minimize the risk of local skin problems (see section 2. What you need to know before using Scheriproct).
If You Use More Scheriproct Than You Should:
If you have used too much medicine or if, e.g. If a child has ingested the medicine by mistake, always contact a doctor or hospital for risk assessment and advice.
If You Forget To Use Scheriproct:
Do not take a double dose to make up for a forgotten dose.
Possible Scheriproct Side Effects:
This medicine can cause side effects like all medicines, although not everybody gets them.
Rare (less than 1 in 1000 patients):
- Allergic reactions
- Contact dermatitis
Has been reported (occurs in an unknown number of users):
- Blurred vision
How To Store Scheriproct?
- Keep this medicine out of sight and reach of children.
- Scheriproct should not be used after the expiry date stated on the carton.
- Rectal ointment: Do not store above 25 ° C.
- Suppositories: Store in a refrigerator (2 ° C-8 ° C). Suppositories can be stored at a maximum of 25 ° C for 2 months.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.
Contents Of The Packaging And Other Information:
Content Declaration
Rectal ointment:
- The active substances are prednisolone caproate 1.9 mg / g and in cocaine hydrochloride 5 mg / g
- The other ingredients are castor oil (refined), hydrogenated castor oil, octyldodecanol, macrogol-400-monoricinoleate, and perfume oil (Chypre).
Chypre perfume oil contains the following allergens: alpha-iso methyl-ionone, benzyl alcohol, benzyl benzoate, benzyl cinnamate, benzyl salicylate, cinnamaldehyde, cinnamon alcohol, citral, citronellol, coumarin, eugenol, farnesol, geraniol, hydroxycolonolone, limonene), embossed extract, slånlave extract (see section 2).
Suppositories:
- The active substances are prednisolone caproate 1.3 mg and cocaine hydrochloride 1 mg per suppository.
- The other ingredient is hard fat.
What The Medicine Looks Like And The Contents Of The Pack?
- Rectal ointment:
- Transparent and colourless to slightly yellowish rectal ointment.
- Pack size: 30 g ointment in an aluminium tube, applicator included.
- Suppositories:
- White-yellowish suppositories.
- Pack size: Box with 12 suppositories in blisters.
Marketing Authorization Holder And Manufacturer
Manufacturer:
Rectal ointment:
LEO Pharma Manufacturing Italy Srl, Italy
Suppositories:
Istituto de Angeli Srl, Italy