Consumer medicine information

Scheriproct Ointment and Suppositories

Cinchocaine hydrochloride + Prednisolone hexanoate

BRAND INFORMATION

Brand name

Scheriproct

Active ingredient

Cinchocaine hydrochloride + Prednisolone hexanoate

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Scheriproct Ointment and Suppositories.

What is in this leaflet?

This leaflet answers some common questions about Scheriproct®. It does not contain all the available information.

It does not take the place of talking to your doctor or pharmacist.

Your doctor has weighed the risks of you using Scheriproct® against the benefits he/she expects it will have for you.

If you have any concerns about this medicine, ask your doctor or pharmacist.

What Scheriproct® is used for

The active ingredient in Scheriproct® is a type of cortisone and belongs to the group of medicines called corticosteroids.

Scheriproct® is the brand name for agents containing the substances prednisolone hexanoate and cinchocaine hydrochloride.

Scheriproct® is used in the treatment of haemorrhoids(piles), tears of the anal tissue, and similar conditions. The active ingredients reduce the inflammation and pain associated with such problems.

Your doctor however, may have prescribed Scheriproct® for another purpose.

Ask your doctor if you have any questions about why Scheriproct® has been prescribed for you.

A doctor’s prescription is required for Scheriproct®.

Before you use Scheriproct®

When you must not use it

Do not use Scheriproct® if you have ever had an allergic reaction to:

  • Prednisolone hexanoate or cinchocaine hydrochloride
  • Any of the ingredients in Scheriproct® listed at the end of this leaflet for the product you are using.

Do not use Scheriproct® if you have:

  • TB or syphilis in the area to be treated
  • a viral disease (e.g. chickenpox)
  • traumatised skin
  • a bacterial or fungal skin infection (such as thrush) unless you are also being treated for this or unless your doctor tells you.

Ask your doctor to be sure you do not have any of these conditions.

Do not use Scheriproct® if you are in the first trimester of pregnancy.

Do not use Scheriproct® after the expiry date printed on the pack. If you use it after the expiry date has passed, it may not work as well.

Do not use Scheriproct® if the packaging shows signs of tampering or the seal on the tube is broken.

Before you start to use it

You must tell your doctor if:

  • You are allergic to any other medicines, foods, dyes or preservatives
  • You are pregnant or breastfeeding. Your doctor will tell you if you can use Scheriproct® during pregnancy or while you are breastfeeding.

Some of the ingredients in Scheriproct® may interact with latex products, such as condoms. Therefore, if condoms are used in the same area of treatment with Scheriproct®, these may no longer be effective as contraception or as protection against sexually transmitted infections such as HIV infection. Talk to your doctor or pharmacist, if you require more information.

Taking other medicines

Tell your doctor if you are using other creams, ointments or suppositories for this problem. This includes any that you buy without a prescription from a pharmacy, supermarket or health food shop.

Some medicines and Scheriproct® may interfere with each other. These include:

  • medicines used to treat Human Immunodeficiency Virus (HIV), such as ritonavir or cobicistat

Your doctor may wish to monitor you carefully if you are taking these medicines.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

How to use Scheriproct®

Follow carefully all directions given to you by your doctor or pharmacist. They may differ from the information contained in this leaflet.

If you do not understand the instructions in this leaflet, ask your doctor or pharmacist for help.

How to use it

The area around the anus should be carefully and thoroughly cleaned before using Scheriproct®, which is best applied after the bowels have been emptied.

Ointment

Unless otherwise prescribed by your doctor, Scheriproct® Ointment should be applied twice daily. Application up to four times on the first day may provide faster initial relief. Smear a small amount of ointment (about the size of a pea) around the anus and just inside the anus using your finger. The applicator supplied with the tube should be screwed on to the tube, and used to apply the ointment internally. If the anus if very inflamed and painful, it is advisable to gently apply the ointment internally with your finger.

Protruding lumps should be thickly smeared and carefully pressed back with your finger. After each use, clean the applicator with a paper towel, 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 well and dry the applicator with a paper towel. Do not use the applicator if damaged.

Suppositories

Check the hardness of the suppository before unwrapping it. If it is soft, place the wrapped suppository in cold water before use. This will ensure that the suppository maintains its shape when it is used. Unless otherwise advised by your doctor, one suppository should be unwrapped and inserted high into the back passage daily. For severe symptoms, one suppository may be inserted two to three times on the first day.

How long to use it

Treatment should continue for one week, less frequently (ointment once a day or one suppository every other day) after symptoms have cleared. The length of treatment should however, not exceed four weeks.

If you forget to use it

If you forget to use Scheriproct® use it as soon as you remember and then go back to your normal times for applying Scheriproct®.

Do not try to make up for the amount you missed by using more than you would normally use.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to use your medicine, ask your doctor or pharmacist for some hints.

If you swallow it

Telephone your doctor or Poisons Information Centre (Phone 13 11 26) or go to the accident and emergency centre at your nearest hospital immediately if you or anyone else swallows Scheriproct®.

Keep the telephone numbers of these places handy.

While you are using Scheriproct®

Things you must do

Tell all your doctors and pharmacists who are treating you that you are using Scheriproct®.

If you feel that Scheriproct® is not helping your condition, tell your doctor (or pharmacist).

Tell your doctor if for any reason you have not used Scheriproct® as prescribed. Otherwise your doctor may think that it was not effective and change your treatment unnecessarily.

If you become pregnant while using Scheriproct® tell your doctor.

Contact your doctor if you experienced blurred vision or other visual disturbances.

Things you must not do

Do not give Scheriproct® to anyone else even if their symptoms seem similar to yours.

Do not use Scheriproct® to treat other conditions unless your doctor tells you.

Things to be careful of

Avoid contact with the eyes. Careful handwashing after use is recommended.

Do not use large amounts of Scheriproct® for a long time. If you use large amounts for a long time, the chance of absorption through the skin and the chance of side effects increases.

Side effects

Tell your doctor or pharmacist if you do not feel well while you are using Scheriproct®.

Scheriproct® helps most people with piles but it may have unwanted side effects in a few people.

Side effects that have been reported rarely by people using Scheriproct® include:

  • Allergic skin reactions (e.g. rash)
  • If Scheriproct® is used for more than 4 weeks, wasting of the skin in the treated area can occur
  • Blurred vision.

Scheriproct® may cause other side effects.

If you have any other side effects, check with your doctor.

Do not be alarmed by this list of side effects. You may not experience any of them.

After using Scheriproct®

Storage

Keep Scheriproct® where young children cannot reach it. A locked cupboard at least one and a half metres above the ground is a good place to store medicines.

Scheriproct® Ointment should be stored below 25ºC. Discard 4 weeks after opening.

Scheriproct® suppositories should be stored in the fridge (at 2°C to 8°C). Do not freeze.

They should not be used after the expiry date printed on the outer box, base of the tube or on the suppository foil.

Disposal

If your doctor tells you to stop using Scheriproct® or it has passed its expiry date, ask your pharmacist what to do with any Scheriproct® left over.

Product description

Scheriproct® is presented in 10 g and 30 g tubes of ointment, and as suppositories in packs of 12.

Ingredients

The ointment contains:

  • cinchocaine hydrochloride 5mg/g
  • prednisolone hexanoate 1.9mg/g
  • castor oil for injection
  • hydrogenated castor oil
  • octyldodecanol
  • PEG-8 ricinoleate
  • perfume oil Chypre / 740 049

Scheriproct® suppositories contain:

  • cinchocaine hydrochloride 1mg
  • prednisolone hexanoate 1.3mg
  • hard fat

The AUST R number for the ointment is 70062 and the AUST R number for the suppositories is 70063.

Sponsor

AFT Pharmaceuticals Pty Ltd
113 Wicks Road
North Ryde, NSW 2113
Australia

This document was revised in January 2021.

Published by MIMS June 2021

BRAND INFORMATION

Brand name

Scheriproct

Active ingredient

Cinchocaine hydrochloride + Prednisolone hexanoate

Schedule

S4

 

1 Name of Medicine

Prednisolone hexanoate and cinchocaine hydrochloride.

2 Qualitative and Quantitative Composition

The active ingredients of Scheriproct are synthetic corticosteroids, prednisolone hexanoate and cinchocaine hydrochloride.
Scheriproct 1 g ointment contains 1.9 mg prednisolone hexanoate (equivalent to 1.5 mg of prednisolone) and 5 mg cinchocaine hydrochloride in an ointment base.
Scheriproct suppository, 1 suppository contains 1.3 mg prednisolone hexanoate (equivalent to 1 mg of prednisolone) and 1 mg cinchocaine hydrochloride in a hard fat base.

Excipients with known effect.

Contains benzoates. For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Scheriproct ointment.

Colourless to slightly yellow translucent ointment.

Scheriproct suppositories.

Yellowish-white suppositories.

4 Clinical Particulars

4.1 Therapeutic Indications

Symptomatic relief of pain and irritation associated with haemorrhoids, superficial anal fissures and proctitis.

4.2 Dose and Method of Administration

The anal region should be cleaned thoroughly before using Scheriproct, which is best applied after defecation. There is usually a rapid improvement, but this should not mislead one into stopping treatment too soon. To avoid relapses, Scheriproct should be continued for at least one week, though less frequently (ointment once a day or one suppository every other day), even when the symptoms have completely disappeared. However, duration of treatment should, as far as possible, not exceed 4 weeks.

Scheriproct ointment.

Unless otherwise prescribed by the doctor, generally, apply twice daily, on the first day, for faster symptomatic relief, up to four times.
Smear a little ointment (about the size of a pea) around the anus and in the anal ring with a finger and use the fingertip to overcome the resistance of the sphincter. Before applying within the rectum, the enclosed nozzle should be screwed on to the tube (for use and cleaning of the applicator, see Use of the applicator). However, for very inflamed and hence painful lesions, it is advisable initially to apply the ointment internally with the finger.
Protruding lumps should be thickly smeared and carefully pressed back with the finger.

Use of the applicator.

Do not use the applicator if damaged. Screw the applicator completely on the tube. 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 well and dry externally the applicator with paper towel.

Scheriproct suppositories.

In general, insert one suppository daily high into the rectum. If symptoms are severe, insert one suppository two to three times on the first day.
The consistency of suppositories that have become soft due to warmth should be restored by placing them in cold water before the covering is removed.

4.3 Contraindications

Tuberculous or syphilitic processes in the area to be treated.
Virus diseases (e.g. vaccinia, chickenpox).
Hypersensitivity to individual components.
Traumatised skin.
Local infections where concomitant therapy is not in place (see Section 4.4 Special Warnings and Precautions for Use).

4.4 Special Warnings and Precautions for Use

Additional specific therapy is required in fungal, bacterial, virus infections.
Inadvertent contact of the preparation with the eyes should be avoided.
Careful hand washing after use is recommended.
Prolonged use leads to atrophy.
Systemic absorption may be increased when there is local trauma or prolonged use.
The excipient(s) in Scheriproct ointment and suppository may reduce the effectiveness of latex products such as condoms.
Scheriproct contains castor oil, which can cause skin reactions.

Visual disturbance.

Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

Use in the elderly.

No data available.

Paediatric use.

No data available.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No interaction studies have been performed.
Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects, including adrenal suppression. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, and patients should be monitored accordingly.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No animal studies have investigated the potential of prednisolone hexanoate or cinchocaine hydrochloride to impair fertility. However, a study in which rats were administered the related anaesthetic prilocaine hydrochloride or lignocaine hydrochloride at up to 30 mg/kg/day SC for 8 months, showed no effects on reproduction.
(Category A)
Epidemiological studies suggest that there could possibly be an increased risk of oral clefts among newborns of women who were treated with glucocorticosteroids during the first trimester of pregnancy.
No animal studies have investigated the teratogenic potential of any of the active substances in Scheriproct. However, teratology studies with prednisolone administered to mice on gestation days 11-14 showed dose related increases in cleft palate at SC doses of 3 mg/kg/day and above, and at oral doses of 15 mg/kg/day and above, typical of high exposures to other glucocorticoids. Since epidemiological studies have as yet given no indications of teratogenicity due to systemic glucocorticoid therapy, no teratogenic effects are to be expected from the glucocorticoids in Scheriproct under therapeutic conditions. However, taking animal experimental results into consideration, particular care should be taken when prescribing Scheriproct during pregnancy.
As a general rule, topical preparations containing glucocorticoids should not be applied during the first trimester of pregnancy.
The clinical indication for treatment with Scheriproct must be carefully reviewed and the benefits weighed against the risks in pregnant women. In particular, prolonged use must be avoided.
 There is insufficient information on the excretion of prednisolone hexanoate and cinchocaine hydrochloride in human milk.
The clinical indication for treatment with Scheriproct must be carefully reviewed and the benefits weighed against the risks in lactating women. In particular, prolonged use must be avoided.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

If Scheriproct is applied for long periods of time (more than 4 weeks), local concomitant symptoms, such as atrophy of the skin, cannot be excluded. Allergic skin reactions may occur in rare cases.

Post marketing.

Eye disorders.

vision blurred.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

In the case of accidental oral intake of the preparation (e.g. by swallowing a few grams of the ointment or several suppositories) mainly systemic effects of the local anaesthetic cinchocaine hydrochloride are to be expected, which, according to the dose, may manifest themselves as severe cardiovascular (depression to cessation of cardiac function) and CNS symptoms (convulsions; inhibition to arrest of respiratory function).
For information on the management of overdose, contact the Poisons Information Centre on 131 126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Prednisolone exerts an anti-inflammatory, anti-allergic and anti-pruritic effect. Capillary dilatation, intercellular oedema and tissue infiltration regress; capillary proliferation is suppressed.
As a local anaesthetic, cinchocaine eases the pain.
The Scheriproct haemorrhoidals are topical preparations, which display their anti-inflammatory and analgesic effects at the site of application.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

The active ingredients diffuse out of the preparations into the inflamed tissue, are partly absorbed, distributed by the circulatory system, metabolised and finally excreted. In order to obtain a local therapeutic effect, pharmacologically effective plasma levels are not required.
Cinchocaine exerts its analgesic effect locally. Since no absorption studies are available, risk assessment was performed under the assumption of a complete absorption. If complete absorption takes place the plasma concentration is too low to elicit adverse effects.

Distribution.

The active ingredients diffuse out of the preparations into the inflamed tissue, are partly absorbed and distributed by the circulatory system.

Metabolism.

Following absorption cinchocaine is biotransformed into a number of metabolites. Of special importance here are the oxidative de-ethylation of the di-ethylamino function, hydroxylation and oxidative degradation of the butyloxy-chain and the additional formation of unidentified polar metabolites.

Excretion.

The active ingredients diffuse out of the preparations into the inflamed tissue, are partly absorbed, distributed by the circulatory system, metabolised and finally excreted.

5.3 Preclinical Safety Data

Genotoxicity.

In mouse lymphoma L5178Y cells, prednisolone induced DNA strand breaks, without metabolic activation, but was not mutagenic. In mutagenicity tests in Salmonella typhimurium strains TA98, 100, 1535, 1537 and 1538, prednisone was weakly mutagenic in strain TA 100 only, with metabolic activation, but was not mutagenic in Chinese hamster V79 cells.

Carcinogenicity.

In male rats, administration of prednisolone in the drinking water at a daily dose of 0.4 mg/kg for 2 years caused an increased incidence of hepatocellular tumours. Similar results were obtained with triamcinolone acetonide and budesonide, indicating a class effect of glucocorticosteroids. However, mice given dietary prednisone at daily levels up to 5 mg/kg for 18 months showed no increases in tumour incidences, and some decreases, and an epidemiology study in rheumatoid arthritis patients showed a trend towards lower malignancy in patients treated with prednisone. The carcinogenic potential of cinchocaine hydrochloride has not been investigated.

6 Pharmaceutical Particulars

6.1 List of Excipients

Scheriproct ointment contains an ointment base consisting of the excipients castor oil, octyldodecanol, hydrogenated castor oil, PEG-8 ricinoleate and Perfume Oil Chypre/740 049.
Scheriproct suppository contains the excipient hard fat.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Scheriproct ointment.

Store below 25°C.
Discard 4 weeks after opening.

Scheriproct suppositories.

Store at 2°C to 8°C. Refrigerate. Do not freeze.
Store all medicines properly and keep them out of reach of children.

6.5 Nature and Contents of Container

Scheriproct ointment.

Aluminium tubes containing 10 g and 30 g of colourless to slightly yellow translucent ointment.

Scheriproct suppositories.

Boxes containing an aluminium laminated strip pack of 6 or 12 yellowish-white suppositories.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Chemical structure.

Prednisolone-21-hexanoate is a corticosteroid. The chemical name for prednisolone-21-hexanoate is 11β, 17, 21-trihydroxypregna-1,4-diene-3,20-dione 21-hexanoate and has the following structural formula:
Molecular formula: C27H38O6.
Molecular weight: 458.6.
Prednisolone hexanoate is an odourless, white or almost white, crystalline, hygroscopic powder.
M.P. 230°C. Very slightly soluble in water, soluble 1 in 27 of dehydrated alcohol, 1 in 30 of alcohol.
Cinchocaine hydrochloride is a corticosteroid. The chemical name for cinchocaine hydrochloride is 2-butoxy-N- [2-(diethylamino)ethyl] quinoline-4-carboxamide hydrochloride and has the following structural formula:
Molecular formula: C20H29N3O2.HCl.
Molecular weight: 379.9.
Cinchocaine hydrochloride is a fine, colourless or white; odourless or almost odourless hygroscopic crystals or white to off white crystalline powder. M.P. 96°-100°C. Soluble in 1 in 0.5 of water; freely soluble in alcohol and acetone; soluble in chloroform.

CAS number.

Prednisolone hexanoate: 69164-69-8.
Cinchocaine hydrochloride: 61-12-1.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes