Proctofoam HC (Hydrocortisone/Pramoxine)

Proctofoam-HC is for anal and rectal use only. Do not take it by mouth or by any other route. This medication may be harmful if swallowed.

Proctofoam-HC should be taken as prescribed by your doctor. Talk to your doctor if your condition worsens or is not getting any better after 7 days of treatment.

Do not use Proctofoam-HC after the expiry date which is printed on the canister. The expiry date refers to the last day of that month inclusively.

Usual dose:

One applicatorful into the anus two or three times daily and after bowel evacuation. The foam may also be placed on a pad or gauze and applied externally to relieve pain or itching.

CAUTION:

• The applicator supplied with the medication is for anal use only. Never insert canister, internal or external cap into the anus.
• Fingers or any other device should not be used to administer the foam.
• Wash your hands before and after each application.

Please read the directions for internal and external use carefully before you use Proctofoam-HC.

Directions for Internal Use:

If possible, clean and pat dry the affected area before using the product.

Ensure that internal wing-tip cap has been placed on canister.

Hold canister in an upright position and shake vigorously for 20-30 seconds.

Withdraw plunger slowly until it stops at the catch line. This is the dotted line near the top of the applicator barrel (see diagram). It is not the fill line.

Hold applicator by barrel. With index finger, hold plunger in place. Holding the canister in an upright position, place applicator tip over wing-tip cap and push down gently so that applicator is firmly attached.

Press down gently on the wings of the internal cap to release the foam. Only a short press is needed to do this. If required, repeat until foam reaches the fill line.

Remove applicator from wing-tip cap, leaving some foam on applicator tip. Hold applicator by barrel and gently insert applicator tip into the anus and then push plunger to release foam and complete treatment.

To clean, pull applicator and plunger apart and wash with warm tap water after each use. The wing-tip cap should be removed from the canister. The wing-tip cap and stem rising from the canister should be rinsed with warm tap water after each use. Ensure all parts are gently dried with a clean cloth.

Directions for External Use:

If possible, clean and pat dry the affected area before using the product.

Remove internal wing-tip cap from canister. Replace with external cap. Take special care not to crush the stem rising from the canister when changing caps.

Hold canister in an upright position and shake vigorously for 20-30 seconds.

Holding the canister in an upright position, dispense foam onto a pad or gauze by pushing gently down on external canister cap with fingers. Only a short press is needed to do this. Repeat as required.

Apply to affected area as indicated by your doctor.

To clean, the external cap should be removed from the canister. The external cap and stem rising from the canister should be rinsed with warm tap water after each use. Ensure all parts are gently dried with a clean cloth.

Overdose:

In case of drug overdose or accidental ingestion, contact a healthcare practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed dose:

In the event that a dose is missed, you should take it as soon as possible. However, if it is almost time for the next dose, skip the missed dose and continue the prescribed dosing schedule; do not double the next dose.

The most common side effects with the use of Proctofoam-HC include:

• itching;
• burning;
• pain upon application;
• dryness;
• irritation, thinning of the skin;
• abnormal hair growth;
• loss of skin color (hypopigmentation);
• secondary infection;
• stinging, skin swelling.

Prolonged use of Proctofoam-HC could cause systemic corticosteroid effects which may include Cushing's syndrome (weight gain, rounding of the face and/or abnormal hair growth). Other possible side effects may include increased sugar levels in your blood or urine, high blood pressure, cloudy lens in the eye, increased pressure in the eye and weakening of the bones through gradual mineral loss.

You should talk to your doctor or pharmacist if you have any signs of local or systemic side effects.

Avoid Proctofoam-HC foam from getting into the eyes, nose and ears. Prolonged use of Proctofoam-HC may cause Cushing's syndrome (weight gain, rounding of the face and/or abnormal hair growth, thinning of the skin).

BEFORE you use Proctofoam-HC talk to your doctor or pharmacist if you:

• have low thyroid function;
• have severe rectal or intestinal ulcers;
• have blood clotting problem (prothrombin deficiency);
• have venous insufficiency that causes skin sore or ulcer in the lower leg (statis dermatitis and ulcers);
• have liver disease or severe liver impairment;
• have low immune system (e.g. impaired T-cell function, immunosuppressive therapy);
• are suffering or have suffered from psychotic tendencies or emotional instabilities;
• are pregnant, trying to become pregnant or breastfeeding; or
• just had an ileorectostomy.

Tell your doctor, pharmacist or healthcare professional if you are taking any other drugs, including prescription, non-prescription or natural health products, as well as herbal and alternative medicines since drug interactions can affect how Proctofoam-HC works and may increase the risk of side effects.

Drugs that may interact with Proctofoam-HC include:

• drugs to treat Alzheimer's disease;
• blood thinning drugs (such as warfarin);
• drugs for high blood sugar (diabetes);
• drugs for tuberculosis;
• water pills (diuretics);
• drugs affecting hepatic microsomal enzymes [including HIV medicines, some macrolide antibiotics, drugs to treat fungal infections, and some medications used to treat hypertension and angina (e.g. calcium channel blockers)];
• products containing benzoyl peroxide as these products may reduce numbing effect of pramoxine hydrochloride;
• hormones (such as estrogen);
• nonsteroidal anti-inflammatory agents such as ibuprofen and aspirin;
• vaccines.