For the list of inactive ingredients see section "Additional information".

Transcription

1 Patient leaflet in accordance with the Pharmacists' Regulations (Preparations) This medicine is to be supplied by physician s prescription only Proctofoam HC Rectal foam Active ingredients: Hydrocortisone acetate 1% Pramoxine hydrochloride 1% For the list of inactive ingredients see section "Additional information". Read the entire leaflet carefully before you start using this medicine. This leaflet contains essential information about this medicine. If you have any further questions, refer to the physician or to the pharmacist. Pay attention to "Directions for use" under the section "How should you use the medicine?", in order to use the product properly and prevent problems during use. This medicine has been prescribed to treat your illness. Do not pass it on to others. It may harm them, even if it seems to you that their illness is similar. What is this medicine intended for? Proctofoam HC is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses of the anal region. Therapeutic group: Hydrocortisone acetate - Corticosteroids for local treatment. Pramoxine hydrochloride - local anesthetic. Before using this medicine Do not use this medicine if: You are sensitive (allergic) or have previously experienced sensitivity to the active ingredients or to any of the other ingredients that this medicine contains (please see "Additional information"). Special warnings regarding the use of this medicine Before the treatment with Proctofoam HC, tell your physician if: You are pregnant or breastfeeding Bacterial, viral or fungal infection exists in the treated area or around it - Before starting treatment with this medicine, you must undergo a rectal examination. Do not use this medicine frequently, or for a long period, without consulting a physician. - If you are sensitive to any type of food or medicine, inform your physician before commencing treatment with this medicine. - During prolonged treatment with this medicine or if there are open wounds, there is a possibility of systemic absorption of hydrocortisone. - Avoid contact of the medicine with the eyes. In case of contact, wash immediately with water. - Do not use this medicine for more than 7 consecutive days. - Do not insert any part of the container directly into the anus. Use the applicator supplied to insert the medicine. In some users, systemic absorption of topical corticosteroids may produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and secretion of glucose in the urine. 2

2 Prolonged use of corticosteroids or use over large surface areas and occlusive dressing augment systemic absorption. Therefore, the physician will instruct you to perform periodic tests for urinary free cortisol levels and ACTH stimulation tests (A hormone produced by the pituitary gland acting on the external layer of the adrenal gland to stimulate the secretion of corticosteroid hormones from the adrenal gland). If you are taking or have recently taken other medicines, including non-prescription medicines and food supplements, inform your physician or pharmacist. Pregnancy and breastfeeding: If you are pregnant, think you may be pregnant, planning to get pregnant or breastfeeding, you should consult the physician or the pharmacist before using Proctofoam HC. How should you use the medicine? Always use according to the physician's instructions. You should check with the physician or the pharmacist if you are unsure. The dosage and manner of treatment will be determined only by the physician. The recommended dose is usually: Insertion of the applicator contents into the affected area 3-4 times daily. For anal use: Use the applicator supplied for anal administration. For perianal use: In case of perianal inflammation, transfer a small quantity of foam on a paper tissue and rub in gently. Do not exceed the recommended dosage. Do not swallow! Proctofoam HC is intended for external use only. Children: This medicine is not usually intended for use in children. The dosage and manner of treatment will be determined only by the physician. Prolonged corticosteroid use may interfere with the growth and development of children. Tests and follow-up: During prolonged period of treatment with this medicine or during treatment at high doses, blood and urine tests should be performed. Tests for urinary free cortisol levels and ACTH stimulation tests should be performed. If you have accidentally used a higher dose, or if a child has accidentally swallowed the medicine, go immediately to a physician or a hospital emergency room and bring the medicine package with you. If you forget to use the medicine at the scheduled time, do not use a double dose. Take the next dose at the usual time and consult your physician. Persist with the treatment as recommended by the physician. Directions for use: Applicator Foam container Plunger container Plastic cap with 2 flanges Fill line Applicator barrel Spout Container Proctofoam HC is supplied in 3 parts: a metal container containing the Proctofoam HC, a plastic cap with 2 flanges and a plastic applicator used to insert the foam into the anus. 3

3 1. Place the plastic cap on top of container. Hold the Proctofoam HC container in one hand and shake vigorously for 5-10 seconds before each use. Do not remove container cap during use of the product. 2. Hold the container straight, with the opening facing upwards. Gently place the tip of the applicator onto the spout of the container cap. The container must be held upright to obtain proper flow of foam into the applicator. 3. Pull the plunger of the applicator outwards up to the fill line. 4. Hold the container and applicator at the eye level. Place the index and middle fingers on the container cap flanges and the thumb supporting beneath the container. Support the applicator with your other hand. While holding the container, press down firmly on the plastic flanges several times and then release. With initial priming, a burst of air may come out of the container. It usually requires 1-2 pumps for initial release of the foam. 4

4 5. To fill the applicator barrel, press down firmly on the plastic cap flanges, hold for 1-2 seconds, and release. Wait 5-10 seconds to allow the foam to expand in the applicator barrel. Repeat until foam reaches the fill line. It usually requires 3-4 pumps for foam to reach the fill line. Remove the applicator from container cap. Note: If the foam enters beyond fill line, it will continue to expand and flow backwards resulting in foam build-up around the container spout and under the cap. Excessive pressure will increase flow of the foam downwards. 6. Hold the applicator firmly, making sure thumb and middle finger are positioned securely under the applicator wings. Place the index finger over the plunger. Gently insert the applicator spout into the anus. Once in the anus, push the plunger to expel foam, then withdraw applicator from the anus. - Caution: Do not insert any part of the medicine's container directly into the anus. Use the applicator supplied to insert the medicine. - Insert into the anus only the applicator spout. Do not insert any part of the applicator past the anus into rectum. 7. After each use, the applicator parts should be pulled apart for thorough cleaning with warm water. Since some foam will appear under the container cap, the cap should be separated from the container and rinsed to help prevent build-up of foam and interference with foam flow due to blockage. 5

5 Ensure measuring the dose in the applicator supplied. When used correctly, the container will deliver at least 14 doses. How can you contribute to the success of the treatment? Ensure normal bowel movement: sufficient fluid intake and physical activity will assist you to ensure normal bowel movement. Avoid excessive use of laxatives. If you need a laxative, it is advised to use a stool softener or medicines such as methyl cellulose, psyllium, etc. Do not take medicines in the dark! Check the label and the dose each time you take the medicine. Wear glasses if you need them. If you have any further questions regarding the use of this medicine, consult the physician or the pharmacist. Side effects As with any medicine, the use of Proctofoam HC may cause side effects in some users. Do not be alarmed by reading the list of side effects. You may not experience any of them. Immediately contact a physician if: you experience local burning sensation, irritation and itch, dryness or dermatitis which do not resolve within 7 days or are worsening, persistent irritation or bleeding in the treated area (rare). Side effects of unknown frequency (side effects whose frequency has not yet been determined): Inflammation of the hair follicles (folliculitis) A genetic disease manifested by uncontrolled hair growth over the entire body (werewolf syndrome) Acne eruptions Loss of skin color (hypopigmentation) Perioral dermatitis Allergic contact dermatitis Maceration of the skin Secondary infection Depletion of upper skin layers (skin atrophy) Skin scarring Rash due to sweating Stop treatment with the medicine if your condition worsens or if irritation develops. If any side effect appears, if any of the side effects worsens, or if you suffer from a side effect not mentioned in this leaflet, consult with the physician. Reporting side effects: Side effects can be reported to the Ministry of Health (MoH) by clicking on the "Report on side effects due to medication therapy" link on the MoH home page ( which refers to the online form for side effects reporting, or by entering the link: ctmedic@moh.gov.il How to store the medicine? Avoid poisoning! This medicine and any other medicine should be kept in a closed place out of the reach of children and/or infants in order to avoid poisoning. Do not induce vomiting without an explicit instruction from the physician. 6

6 Do not use the medicine after the expiry date (exp. date) appearing on the outer package. The expiry date refers to the last day of that month. Do not store at a temperature above 25 C. The medicine is stored in an aerosol container, therefore do not puncture, burn or expose to direct sunlight or temperature above 49 C even when it is empty. Additional information In addition to the active ingredients the medicine also contains: Purified water, Propylene glycol, Emulsifying wax, Polyoxyethylene 10 stearyl ether, Cetyl alcohol, Trolamine, Methylparaben, Propylparaben, Hydrocarbon propellant A-46. What does the medicine look like and what are the contents of the package: Aluminum container containing 10 gram of white foam, a plastic cap with 2 flanges and a plastic applicator. Marketing Authorization Holder and his address: MegaPharm Ltd., P.O.B. 519, Hod Hasharon Manufacturer and his address: Kremers Urban, Indiana, USA for MEDA Pharmaceuticals, USA. This leaflet was checked and approved by the Ministry of Health in November Registration number of the medicine in the National Drug Registry of the Ministry of Health: