Consumer medicine information

Proctosedyl

Cinchocaine hydrochloride; Hydrocortisone

BRAND INFORMATION

Brand name

Proctosedyl Ointment

Active ingredient

Cinchocaine hydrochloride; Hydrocortisone

Schedule

S2

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Proctosedyl.

What is in this leaflet

This leaflet answers some common questions about PROCTOSEDYL.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor or pharmacist has weighed the risks of you taking this medicine against the benefits they expect it will have for you.

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

Keep this leaflet with the medicine.

You may need to read it again.

What PROCTOSEDYL is used for

PROCTOSEDYL Ointment and Suppositories are used for the relief of the discomfort of haemorrhoids (piles) and other painful conditions of the anus (rear end), such as fissures (tears). Haemorrhoids often result when people strain while trying to open their bowel (defecate). This problem is often, but not always, associated with low-fibre diets.

PROCTOSEDYL Ointment and Suppositories contain the active ingredients hydrocortisone, a steroid, and cinchocaine hydrochloride, a local anaesthetic. These work together to reduce swelling, numb pain and relieve itching.

Your doctor or pharmacist, however, may recommend PROCTOSEDYL for another purpose.

Ask your doctor if you have any questions about why this medicine has been recommended for you.

Before you use it

When you must not use it

Do not use PROCTOSEDYL if you are allergic to it or any of the ingredients listed at the end of this leaflet.

Some symptoms of an allergic reaction include skin rash, itching, shortness of breath or swelling of the face, lips or tongue, which may cause difficulty in swallowing or breathing.

As for all steroid preparations, do not use PROCTOSEDYL when uncontrolled infections, bacterial, viral infections (eg. herpes, cowpox), fungal, or parasitic infections or infections affecting the anus or surrounding area are present eg sexually-transmitted diseases.

PROCTOSEDYL use may hide signs of infection.

PROCTOSEDYL contains hydrocortisone which can cause thinning and damage to the skin.

Do not use PROCTOSEDYL if you have tuberculosis.

Some diseases can be made worse by using PROCTOSEDYL.

Do not give PROCTOSEDYL to children under 12 years of age.

Do not use it after the expiry date (EXP) printed on the pack.

If you use it after the expiry date has passed, it may not work as well.

Do not use it if the packaging is torn/damaged or shows signs of tampering.

Before you start to take it

Tell your doctor or pharmacist if you have allergies to:

  • any of the ingredients listed at the end of this leaflet
  • any other substances, such as foods, preservatives or dyes.

Tell your doctor or pharmacist if you have or have had any medical conditions, especially the following:

  • cuts or abrasions in the area of the anus eg if there is blood on toilet paper or in the toilet after opening the bowels (defecating).
    Your doctor or pharmacist will need to consider this when recommending treatment with PROCTOSEDYL.
  • fungal infections such as thrush, in the area of the anus.
    PROCTOSEDYL does not treat these conditions. Your doctor or pharmacist may need to provide treatment for these conditions.
  • severe or prolonged anal pain or if blood is present in the faeces, in which case you should have a doctor examine the area.

Tell your doctor or pharmacist if you are pregnant or plan to become pregnant or are breast-feeding.

Your doctor or pharmacist can discuss with you the risks and benefits involved.

Tell your doctor or pharmacist if you plan to have surgery.

If you have not told your doctor or pharmacist about any of the above, tell them before you use PROCTOSEDYL.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.

These medicines may be affected by PROCTOSEDYL, or may affect how well it works. You may need to use different amounts of your medicine, or take different medicines. Your doctor or pharmacist will advise you.

How to use it

How much to use

The standard dose for this medicine is up to three times a day (eg after your morning bowel motion, noon and evening) or as your doctor or pharmacist tells you.

Your doctor may have prescribed a different dose.

Ask your doctor or pharmacist if you are unsure of the correct dose for you.

They will tell you exactly how much to use.

Follow the instructions they give you.

If you use the wrong dose, PROCTOSEDYL may not work as well and your problem may not improve.

How to use it

For best results, first go to the toilet and empty your bowels. Do not strain. Wash and dry the anal area.

Before and after use, wash your hands well with soap and water.

Ointment:

  1. If the affected area is on the surface, use your finger to apply just enough ointment to cover the painful area.
  2. If you need to apply PROCTOSEDYL Ointment deeper, first screw the plastic nozzle & cap (which are supplied in the carton) tightly on to the tube, removing the cap immediately before use.
  3. Then gently insert the nozzle all the way into the rectum (back passage) and squeeze the tube from the lower end, while at the same time withdrawing it from the rectum.
  4. After use, wash the nozzle with warm, soapy water then recap the nozzle.

Note that if the area is very inflamed and painful, it is advisable to initially apply the ointment with a finger, rather than insert the nozzle.

Suppositories:

  1. Remove the suppository from its packaging.
  2. Moisten the suppository by dipping it briefly in cool water.
  3. Put one foot on the side of the bath or toilet, raising the knee to the chest.
  4. Insert the suppository gently into the rectum (back passage).
  5. Try not to go to the toilet for at least one hour to allow the suppository time to work.

PROCTOSEDYL should not be used by children under 12 years of age.

How long to use it

If you bought PROCTOSEDYL without a doctor's prescription, you should check with your doctor if you need to use it for more than 7 days.

PROCTOSEDYL should be used three times daily for first week, after morning stool, noon and evening.

If you use it for longer than 7 days, then you may be able to reduce the number of times you have to use it each day.

During your second week of use, you may be able to use PROCTOSEDYL twice a day after morning stool and evening, and then once daily in your third week of use after morning stool.

Unless your doctor advises differently, you should not use PROCTOSEDYL continuously for longer than three weeks.

Ask your doctor or pharmacist if you are not sure how long to use the medicine for.

If you use too much (overdose)

Immediately telephone your doctor, or the Poisons Information Centre (telephone Australia 13 11 26 or New Zealand 0800 POISON or 0800 764766), or go to Accident and Emergency at your nearest hospital, if you think you or anyone else may have used too much PROCTOSEDYL.

Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

While you are using it

Things you must do

Tell your doctor or pharmacist if the use of PROCTOSEDYL causes increased discomfort or a rash around the anus.

If you find that your condition persists despite using PROCTOSEDYL, seek advice from your doctor or pharmacist.

Tell all the doctors, dentists and pharmacists who are treating you that you are using PROCTOSEDYL.

If you are about to be started on any new medicine, tell your doctor and pharmacist that you are using PROCTOSEDYL.

If you plan to have surgery that needs a general anaesthetic, tell your doctor or dentist that you are using this medicine.

Things you must not do

Do not use more than the recommended dose unless your doctor or pharmacist tells you to.

Do not give this medicine to anyone else, even if they have the same condition as you.

Do not use this medicine to treat any other complaints unless your doctor or pharmacist tells you to.

Things to be careful of

It is not known if PROCTOSEDYL adversely affects latex rubber condoms. Thus it is recommended that you avoid contact between latex rubber condoms and PROCTOSEDYL.

Things that may help your condition

Some self-help measures suggested below may help your condition.

Talk to your doctor or pharmacist about them.

  • Do not strain while trying to open your bowels.
    Straining may aggravate haemorrhoids.
  • Increasing the amount of fibre in the diet may reduce your chance of getting haemorrhoids.
    This can be achieved by eating more fruit, salads, vegetables and cereals containing bran. It may also be helpful to drink plenty of non-alcoholic fluids and exercise regularly.

Side effects

All medicines have some unwanted side effects. Sometimes they are serious, but most of the time they are not. Your doctor or pharmacist has weighed the risks of using this medicine against the benefits they expect it will have for you.

Do not be alarmed by this list of possible side effects.

You may not experience any of them.

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using PROCTOSEDYL.

It helps most people with haemorrhoids, but it may have unwanted side effects in a few people.

Tell your doctor or pharmacist if you notice:

  • an uncomfortable burning sensation in the anal area.

This is a mild side effect of this medicine and usually short-lived.

Tell your doctor if you notice:

  • Change in your eye sight
    Long term use of this medicine may lead to visual disorders including loss of vision.
  • skin rash

Tell your doctor or pharmacist if you notice any of the following signs:

  • lack of appetite
  • pain in the stomach
  • weight loss
  • feeling sick or being sick
  • lack of concentration
  • a feeling of hunger
  • nervousness
  • fits

Long term use of Proctosedyl Suppositories could lead to a condition called 'adrenal suppression'. You may need to have urgent medical attention or hospitalisation.'

If any of the following happen, stop using this medicine and tell your doctor immediately, or go to Accident and Emergency at your nearest hospital:

  • swelling of the face, lips, mouth or throat, which may cause difficultly in swallowing or breathing.

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

These side effects are very rare.

Tell your doctor or pharmacist if you notice anything else that is making you feel unwell.

Other side effects not listed above may occur in some patients.

Do not be alarmed by this list of possible side effects.

You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

After using it

If you have any queries about any aspect of your medicine, or any questions regarding the information in this leaflet, discuss them with your doctor or pharmacist.

Storage

Keep PROCTOSEDYL Ointment in a cool, dry, dark place where the temperature stays below 25°C.

Keep PROCTOSEDYL Suppositories at 2°C to 8°C. Refrigerate. Do not freeze.

Do not store these medicines in the bathroom, near a sink, or on a window sill.

Do not leave these medicines in the car.

Heat and damp can destroy some medicines.

Keep it where children cannot reach it.

Disposal

If your doctor or pharmacist tells you to stop using PROCTOSEDYL, or the medicine has passed its expiry date, ask your pharmacist what to do with any that is left over.

Return any unused medicine to your pharmacist.

Product description

What it looks like

PROCTOSEDYL comes in two presentations:

  • PROCTOSEDYL Ointment is an odourless yellowish-white translucent greasy ointment
  • PROCTOSEDYL Suppositories are smooth, white suppositories contained in a blister strip

PROCTOSEDYL Ointment is available in 15 g and 30 g tubes.

PROCTOSEDYL Suppositories are available in blister packs of 12 suppositories.

Ingredients

PROCTOSEDYL Ointment:

Active Ingredients:

  • hydrocortisone 5 mg/g and
  • cinchocaine hydrochloride 5 mg/g

Inactive Ingredients:

  • liquid paraffin
  • white soft paraffin
  • wool fat

PROCTOSEDYL Suppositories

Active Ingredients:

  • hydrocortisone 5 mg and
  • cinchocaine hydrochloride 5 mg per suppository

Inactive Ingredients:

  • hard fat

PROCTOSEDYL does not contain gluten, sucrose, lactose, tartrazine or any other azo dyes.

Manufacturer/Sponsor

PROCTOSEDYL is supplied in Australia by:

sanofi-aventis australia pty ltd
12-24 Talavera Road
Macquarie Park NSW 2113

PROCTOSEDYL is supplied in New Zealand by:

sanofi-aventis new zealand limited
Level 8, James and Wells Tower 56 Cawley Street
Ellerslie Auckland

This leaflet was prepared in September 2017

Proctosedyl-ccdsv1-cmiv9-04sep2017

Australian Register Numbers

Ointment: AUST R 21847

Suppositories: AUST R 22614

® Registered Trademark

BRAND INFORMATION

Brand name

Proctosedyl Ointment

Active ingredient

Cinchocaine hydrochloride; Hydrocortisone

Schedule

S2

 

Name of the medicine

Suppositories.

Cinchocaine Hydrochloride BP 5 mg, Hydrocortisone BP 5 mg.

Ointment.

Cinchocaine Hydrochloride BP 5 mg/g, Hydrocortisone BP 5 mg/g.

Excipients.

Suppositories.

Hard fat.

Ointment.

White soft paraffin, liquid paraffin and wool fat.

Description

Proctosedyl is supplied as suppositories or as an odourless, yellowish-white, translucent, greasy ointment.
Each suppository contains Cinchocaine Hydrochloride BP 5 mg, Hydrocortisone BP 5 mg and the excipient hard fat.
Each gram of ointment contains Cinchocaine Hydrochloride BP 5 mg, Hydrocortisone BP 5 mg and the excipients white soft paraffin, liquid paraffin and wool fat.

Pharmacology

The rationale of the combination is to combine the local anaesthetic, analgesic and spasmolytic effect of cinchocaine with the antipruritic and anti-inflammatory action of hydrocortisone. These ingredients are presented in emollient vehicles.
Cinchocaine hydrochloride is a potent local anaesthetic agent with antipyretic properties resulting from its inhibition of the transmission of nerve impulses. It is recognised as being one of the longest acting of those agents commonly employed. It is included in Proctosedyl for the relief of pain and spasm.
Topical corticosteroids have anti-inflammatory, antipruritic and vasoconstrictive actions. Hydrocortisone is a low potency glucocorticoid which is safe and effective as a topical anti-inflammatory drug in the concentration employed in Proctosedyl.

Indications

For symptomatic relief of external and internal haemorrhoids, anal pruritus, anal fissure. Preoperative and postoperative treatment of haemorrhoidectomy patients.
Post-partum haemorrhoidal conditions. Non-infective proctitis.

Contraindications

Hypersensitivity to hydrocortisone or cinchocaine or any of the excipients (see Description). All steroid preparations are contraindicated in uncontrolled infections, bacterial, viral (e.g. herpes simplex, herpes zoster and vaccinia), fungal, or parasitic infections and when infective pathologies of sexually transmissible diseases occur in the area to be treated. In tuberculosis the use of steroids may exacerbate the disease process.

Precautions

Hydrocortisone can cause thinning and damage to the skin.
As with all preparations containing topical corticosteroids, the possibility of systemic absorption should be considered. Hydrocortisone is systemically bioavailable from suppositories applied to the rectum. Absorption of hydrocortisone may be increased across abraded or inflamed surfaces. Adrenal suppression can occur even without occlusion. (See Adverse Effects.)
Visual disturbance may be associated 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).
Pheochromocytoma crisis, which can be fatal, has been reported after administration of corticosteroids. In patients with suspected or identified pheochromocytoma, corticosteroids should only be administered after an appropriate risk/ benefit evaluation. (See Adverse Effects.)
Hypertrophic cardiomyopathy has been reported after systemic administration of hydrocortisone in preterm infants. In infants receiving hydrocortisone, echocardiograms should be performed to monitor myocardial structure and function. (See Adverse Effects.)
Long-term continuous therapy should be avoided. Except on medical advice, the maximum duration of therapy with these products should not exceed that recommended (see Dosage and Administration). If treatment is required beyond seven days, the patient should be advised to consult a physician for assessment of the condition. This may include a proctological examination. Discontinue use if sensitisation occurs. Specific measures against infections, allergy and other causal factors must not be neglected.

Use in pregnancy.

(Category A)
In pregnant animals, administration of corticosteroids can cause abnormalities of foetal development. The relevance of this finding to human beings has not been established. However, topical steroids should not be used extensively in pregnancy, i.e. in large amounts or for long periods.

Use in lactation.

Hydrocortisone may pass into human breast milk. Given the possible maternal systemic absorption and lack of data, Proctosedyl should preferably not be used during lactation.

Paediatric use.

Proctosedyl is not recommended for use in children under 12 years of age.

Interactions

No interactions with other medicines have been identified.

Adverse Effects

Certain patients may experience: burning upon application, especially if the mucous membrane is not intact; eye disorder. Urticaria has been reported.

For suppository only.

In persons sensitive to any of the ingredients of the suppositories, anal irritation may occur.

Applies to topical and systemic hydrocortisone.

Endocrine disorders.

Not known: Adrenal suppression.
When applied topically and to a large enough area, especially of damaged skin for long enough, or if under occlusive dressing, hydrocortisone may have this adverse effect.

Eye disorders.

Not known: Chorioretinopathy (see Precautions), blurred vision.

Skin and subcutaneous disorders.

Not known: Urticaria, Rash.

Applies to systemic hydrocortisone.

Endocrine disorders.

Not known: Pheochromocytoma crisis (corticosteroids class effect) (see Precautions).

Cardiac disorders.

Not known: Hypertrophic cardiomyopathy in preterm infants (see Precautions).

Dosage and Administration

Suppository or ointment applications.

Three times daily for first week, after morning stool, noon and evening. Proctosedyl should not be used for longer than 7 days unless prescribed by a doctor.
If a longer period of treatment is required, the following dosage regimen should be implemented. This length of treatment should only occur upon medical advice.
Twice daily for second week, after morning stool and evening; and once daily for third week after morning stool. Duration of treatment should, as far as possible, not exceed three weeks.

Suppositories.

Insert one suppository in the rectum.

Ointment.

15 g and 30 g tubes.

Apply a small quantity of ointment (only that necessary to cover the affected area), with the finger, to the painful or pruritic area. For deeper application, attach cannula, gently insert in the rectum to full extent and squeeze tube from the lower end whilst withdrawing.

Overdosage

Overdosage has not been reported.

Presentation

Suppositories.

Strip pack of 12.

Ointment (with cannula).

15 g and 30 g tubes.

Storage

Suppositories.

Store at 2°C to 8°C. Refrigerate. Do not freeze. Protect from light.

Ointment (with cannula).

Store below 25°C. Protect from light.

Poison Schedule

S2.