PROCTOSEDYL OINTMENT
Active substance: HYDROCORTISONE
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50088333C PACKAGE LEAFLET: INFORMATION FOR THE USER
2. Before you use Proctosedyl ointment Do not use this medicine and tell your doctor if: You are allergic (hypersensitive) to cinchocaine hydrochloride, hydrocortisone or any of the other ingredients of Proctosedyl ointment (listed in Section 6 below) Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue You have any kind of infection Do not use this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using Proctosedyl. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Proctosedyl can affect the way some other medicines work. Also some medicines can affect the way Proctosedyl works. Pregnancy and breast-feeding Talk to your doctor before using this medicine if You are pregnant, might become pregnant or think you may be pregnant You are breast-feeding or planning to breast-feed Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding. Important information about some of the ingredients of Proctosedyl ointment This medicine contains wool fat (lanolin) which may cause local skin reactions such as contact dermatitis. Contact dermatitis causes redness, itching or irritation of the skin. 3. How to use Proctosedyl ointment Always use Proctosedyl ointment exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Using this medicine Do not use for longer than 7 days Only apply to your back passage and the surrounding areas Do not apply to the face or other parts of the body Apply this medicine in the morning, evening and after each bowel movement If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself, but ask your doctor
Proctosedyl Ointment
Cinchocaine hydrochloride 0.5%w/w Hydrocortisone 0.5%w/w
Is this leaflet hard to see or read? Phone 01483 505515 for help
Read all of this leaflet carefully before you start using this medicine Keep this leaflet. You may need to read it again If you have any further questions, ask your doctor or pharmacist This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist In this leaflet: 1. What Proctosedyl ointment is and what it is used for 2. Before you use Proctosedyl 3. How to use Proctosedyl ointment 4. Possible side effects 5. How to store Proctosedyl ointment 6. Further information 1. What Proctosedyl ointment is and what it is used for The name of your medicine is Proctosedyl ointment. Proctosedyl ointment contains two different medicines called: cinchocaine hydrochloride and hydrocortisone. Cinchocaine hydrochloride belongs to a group of medicines called local anaesthetics. It works by causing numbness in the area to which it is applied. This stops you feeling pain in this area and helps lessen the spasm of the back passage Hydrocortisone belongs to a group of medicines called corticosteroids. It works by lowering the production of substances that cause inflammation. This helps lower swelling, itching and discharge Proctosedyl ointment can be used for the short-term relief (not more than 7 days) of: Pain, irritation, discharge and itching associated with enlarged or swollen blood vessels around your back passage (haemorrhoids) Itching around your back passage
How to apply this medicine If your doctor has asked you to apply some ointment around your back passage and the surrounding area, follow the instructions below on how to apply this medicine: Wash your hands Squeeze a small amount of the ointment onto your fingertip Gently rub a small layer of ointment over the sore, painful or itching area Wash your hands If your doctor has asked you to apply some ointment deeper into your back passage, follow the instructions below on how to apply this medicine: Wash your hands Screw the plastic nozzle provided onto the tube Insert the nozzle into the back passage Squeeze the tube gently as you slowly pull it out Stay still for 1 or 2 minutes Wash your hands and the nozzle If you use more Proctosedyl ointment than you should Let your doctor know if you have used this ointment for more than 7 days by mistake. If you forget to use Proctosedyl ointment If you forget to use your ointment, use it as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose. Do not use a double dose to make up for a forgotten dose. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, Proctosedyl ointment can cause side effects, although not everybody gets them. Tell your doctor or pharmacist if the following side effect gets serious or lasts longer than a few days, or you notice any side effects not listed in this leaflet: Skin rash Thinning of the skin If you have used this ointment for a long time, it is possible that you could get something called adrenal suppression. Signs include lack of appetite, pain in the stomach, weight loss, feeling sick or being sick, lack of concentration, a feeling of hunger, nervousness and fits. Talk to your doctor or pharmacist if any of the side effects gets serious or lasts longer than a few days, or if you notice any side effects not listed in this leaflet.
5. How to store Proctosedyl ointment Keep this medicine in a safe place where children can not see or reach it. Do not use Proctosedyl ointment after the expiry date which is stated on the label, carton or tube after EXP. The expiry date refers to the last day of that month. Store below 25C. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6. Further information What Proctosedyl ointment contains Each gram of ointment contains 5 milligrams of the active substance, cinchocaine hydrochloride and 5 milligrams of the active substance hydrocortisone The other ingredients are wool fat (lanolin), liquid paraffin and white soft paraffin What Proctosedyl ointment looks like and contents of the pack Proctosedyl ointment is a yellowish-white translucent greasy ointment. It is available in a 30 gram aluminium tube with a plastic nozzle. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK. Tel: 01483 505515 Fax: 01483 535432 email: uk-medicalinformation@sanofi.com Manufacturer Fawdon Manufacturing Centre, Edgefield Avenue, Fawdon, Newcastle-upon-Tyne NE3 3TT, UK. This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist. This leaflet was last revised in October 2012 Sanofi 1998-2012
2. Before you use Proctosedyl ointment Do not use this medicine and tell your doctor if: You are allergic (hypersensitive) to cinchocaine hydrochloride, hydrocortisone or any of the other ingredients of Proctosedyl ointment (listed in Section 6 below) Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue You have any kind of infection Do not use this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using Proctosedyl. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Proctosedyl can affect the way some other medicines work. Also some medicines can affect the way Proctosedyl works. Pregnancy and breast-feeding Talk to your doctor before using this medicine if You are pregnant, might become pregnant or think you may be pregnant You are breast-feeding or planning to breast-feed Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding. Important information about some of the ingredients of Proctosedyl ointment This medicine contains wool fat (lanolin) which may cause local skin reactions such as contact dermatitis. Contact dermatitis causes redness, itching or irritation of the skin. 3. How to use Proctosedyl ointment Always use Proctosedyl ointment exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Using this medicine Do not use for longer than 7 days Only apply to your back passage and the surrounding areas Do not apply to the face or other parts of the body Apply this medicine in the morning, evening and after each bowel movement If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself, but ask your doctor
Proctosedyl Ointment
Cinchocaine hydrochloride 0.5%w/w Hydrocortisone 0.5%w/w
Is this leaflet hard to see or read? Phone 01483 505515 for help
Read all of this leaflet carefully before you start using this medicine Keep this leaflet. You may need to read it again If you have any further questions, ask your doctor or pharmacist This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist In this leaflet: 1. What Proctosedyl ointment is and what it is used for 2. Before you use Proctosedyl 3. How to use Proctosedyl ointment 4. Possible side effects 5. How to store Proctosedyl ointment 6. Further information 1. What Proctosedyl ointment is and what it is used for The name of your medicine is Proctosedyl ointment. Proctosedyl ointment contains two different medicines called: cinchocaine hydrochloride and hydrocortisone. Cinchocaine hydrochloride belongs to a group of medicines called local anaesthetics. It works by causing numbness in the area to which it is applied. This stops you feeling pain in this area and helps lessen the spasm of the back passage Hydrocortisone belongs to a group of medicines called corticosteroids. It works by lowering the production of substances that cause inflammation. This helps lower swelling, itching and discharge Proctosedyl ointment can be used for the short-term relief (not more than 7 days) of: Pain, irritation, discharge and itching associated with enlarged or swollen blood vessels around your back passage (haemorrhoids) Itching around your back passage
How to apply this medicine If your doctor has asked you to apply some ointment around your back passage and the surrounding area, follow the instructions below on how to apply this medicine: Wash your hands Squeeze a small amount of the ointment onto your fingertip Gently rub a small layer of ointment over the sore, painful or itching area Wash your hands If your doctor has asked you to apply some ointment deeper into your back passage, follow the instructions below on how to apply this medicine: Wash your hands Screw the plastic nozzle provided onto the tube Insert the nozzle into the back passage Squeeze the tube gently as you slowly pull it out Stay still for 1 or 2 minutes Wash your hands and the nozzle If you use more Proctosedyl ointment than you should Let your doctor know if you have used this ointment for more than 7 days by mistake. If you forget to use Proctosedyl ointment If you forget to use your ointment, use it as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose. Do not use a double dose to make up for a forgotten dose. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, Proctosedyl ointment can cause side effects, although not everybody gets them. Tell your doctor or pharmacist if the following side effect gets serious or lasts longer than a few days, or you notice any side effects not listed in this leaflet: Skin rash Thinning of the skin If you have used this ointment for a long time, it is possible that you could get something called adrenal suppression. Signs include lack of appetite, pain in the stomach, weight loss, feeling sick or being sick, lack of concentration, a feeling of hunger, nervousness and fits. Talk to your doctor or pharmacist if any of the side effects gets serious or lasts longer than a few days, or if you notice any side effects not listed in this leaflet.
5. How to store Proctosedyl ointment Keep this medicine in a safe place where children can not see or reach it. Do not use Proctosedyl ointment after the expiry date which is stated on the label, carton or tube after EXP. The expiry date refers to the last day of that month. Store below 25C. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6. Further information What Proctosedyl ointment contains Each gram of ointment contains 5 milligrams of the active substance, cinchocaine hydrochloride and 5 milligrams of the active substance hydrocortisone The other ingredients are wool fat (lanolin), liquid paraffin and white soft paraffin What Proctosedyl ointment looks like and contents of the pack Proctosedyl ointment is a yellowish-white translucent greasy ointment. It is available in a 30 gram aluminium tube with a plastic nozzle. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK. Tel: 01483 505515 Fax: 01483 535432 email: uk-medicalinformation@sanofi.com Manufacturer Fawdon Manufacturing Centre, Edgefield Avenue, Fawdon, Newcastle-upon-Tyne NE3 3TT, UK. This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist. This leaflet was last revised in October 2012 Sanofi 1998-2012
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
