1 ANUGESIC-HC PATIENT INFORMATION LEAFLET THINGS TO REMEMBER ABOUT MEDICINES 1. Before using your medicine, please read this leaflet carefully and ash your doctor or pharmacist for advice if you have any questions or are unsure about anything. Make sure you read section (1) of this leaflet. 2. It is important to use your medicine as directed by your doctor. Look at the label on the pack and section (2) of this leaflet for details. 3. Medicines occasionally cause problems. For more information, see the section marked (3) in this leaflet. 4. Keep medicines out of the reach of children. 5. Tell hospital staff you are using this medicine: for example, if you go into hospital or see another doctor. The name of this medicine is Anugesic-HC. It comes in two presentations; a cream or a suppository. Anugesic-HC cream is used to treat discomfort, itching and pain associated with internal and external haemorrhoids (piles). Anugesic-HC suppositories are used to treat discomfort, itching and pain associated with internal haemorrhoids (piles). HELPFUL NOTES FOR PATIENTS USING ANUGESIC-HC Your doctor has chosen Anugesic-HC to treat your condition. This leaflet is designed to help you get maximum benefit from your medicine. (1) Before using your Anugesic-HC If the answer to any of the following is YES, tell your doctor or pharmacist, as special instructions may be necessary. - Are you pregnant or breast feeding? - Are you allergic to Anugesic-HC or similar products? - Are you suffering from an infection of the affected area? Anugesic-HC is not normally used for children; check with your doctor if Anugesic-HC has been prescribed for a patient under the age of 12. (2) Using Anugesic-HC Anugesic-HC Cream Directions for use: Wash the anal area thoroughly and then dry carefully with a very soft towel. Apply cream to the affected area at night, in the morning and after each bowel movement. For internal application, use the plastic applicator nozzle provided. After use the nozzle should be carefully washed each time in a hot solution of detergent and then thoroughly rinsed in clear water. In cold weather, if difficulty is experienced in squeezing the cream out of the tube, the tube should be warmed in the hand for a few minutes, or by dipping in warm water. Anugesic-HC Suppositories Directions for use: 1. Tear along the perforation to remove one suppository from the strip (see figure 1). 2. Grasp the two halves of the plastic cover firmly, holding between the thumb and forefinger of each hand (as indicated in figure 2). Gently pull apart to fully expose the suppository. 3. Remove the suppository, and insert as deeply into the anus as possible. One suppository should be inserted at night, in the morning and after each bowel movement, until the condition is controlled. Anugesic-HC suppositories are buff coloured suppositories. 3 Anugesic-HC suppositories are specially shaped for easy insertion into the anus. You may find insertion of the suppositories easier if you place one foot on a chair or lie on your side with one leg drawn up as high as possible under the chin. Do not take Anugesic-HC orally. If Anugesic-HC is swallowed see your doctor immediately. Do not use Anugesic-HC for periods longer than seven days unless your doctor tells you to. If your condition has not cleared up within seven days see your doctor for advice. (3) After using Anugesic-HC Like all medicines, Anugesic may occasionally cause side effects in some people. These may include: - Sensitivity reactions, eg. rash or swelling - A temporary burning sensation Side effects are rare. Tell your doctor about any effects you experience, particularly if they are troublesome or persistent. If you develop a rash (or swelling) stop using the medicine and tell your doctor as soon as possible. Each 2.8 g Anugesic-HC suppository contains: Pramoxine hydrochloride USP Hydrocortisone acetate PhEur Benzyl benzoate PhEur Bismuth oxide Bismuth subgallate BP 1980 Balsam Peru PhEur Zinc oxide PhEur 27 mg 5 mg 33 mg 24 mg 59 mg 49 mg 296 mg REMEMBER: This medicine is yours. Never give it to others. It may not be suitable for them, even if the symptoms are the same as yours. Only a doctor can prescribe AnugesicHC for you. This leaflet is produced in line with guidance given by the Association of the British Pharmaceutical Industry. The information applies only to Anugesic-HC. This is not the complete information. Please speak to your doctor or pharmacist should you require further information. STORING ANUGESIC-HC - Keep your Anugesic-HC medication in a cool dry place where children cannot get hold of it. - Check the expiry date and do not use the medicine if the date has been passed. - If your doctor decides to stop treatment, any remaining medication should be returned to the pharmacy. Only keep it if your doctor tells you to. - If the cream or suppositories look as if they have deteriorated in any way, do not use them, and return them to your doctor or pharmacist. For further information write to: Parke Davis Research Laboratories, Lambert Court, Chestnut Avenue, Eastleigh, Hampshire, S05 3ZQ. Product Licence/Authorisation holder, Parke, Davis & Company, Usk Road, Pontypool, Gwent, U.K. WHAT IS IN ANUGESIC-HC Anugesic-HC cream is a buff coloured cream with an antiseptic odour. Anugesic HC Cream Each 100 g of Anugesic-HC cream contains: Pramoxine hydrochloride USP Hydrocortisone acetate PhEur Benzyl benzoate PhEur Bismuth oxide Balsam Peru PhEur Zinc oxide PhEur 1.00 g 0.50 g 1.20 g 0.875 g 1.85 g 12.35 g PL 0018/0161 PA 56/51/1 Anugesic HC Suppositories PL 0018/0162 PA 56/51/2 Anugesic is a trade mark of Parke Davis Nov. 1992