البلد: مالطا
اللغة: الإنجليزية
المصدر: Medicines Authority
CINCHOCAINE HYDROCHLORIDE, HYDROCORTISONE
Sanofi Malta Limited Level2, Fort Business Centre, Mriehel Bypass, Birkirkara, Malta
C05AX03
CINCHOCAINE HYDROCHLORIDE 0.5 % (W/W) HYDROCORTISONE 0.5 % (W/W)
OINTMENT
CINCHOCAINE HYDROCHLORIDE 0.5 % (W/W) HYDROCORTISONE 0.5 % (W/W)
OTC
VASOPROTECTIVES
Withdrawn
2005-09-28
PROCTOSEDYL OINTMENT Cinchocaine h_y_drochloride 0.5%w/w Hydrocortisone 0.5%w/w PACKAGE LEAFLET: INFORMATION FOR THE USER 3. HOW TO USE PROCTOSEDYL OINTMENT IS THIS LEAFLET HARD TO SEE OR READ? PHONE 0845 372 7101 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 WHAT IS IN THIS LEAFLET 1. What Proctosedyl ointment is and what it is used for 2. What you need to know before you use Proctosedyl Ointment 3. How to use Proctosedyl ointment 4. Possible side effects 5. How to store Proctosedyl ointment 6. Contents of the pack and other information 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 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 اقرأ الوثيقة كاملة
Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS __________________________________________________________________ 1. TRADE NAME OF THE MEDICINAL PRODUCT Proctosedyl 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ Cinchocaine hydrochloride (micro) 0.5% w/w Hydrocortisone (micro) 0.5% w/w 3. PHARMACEUTICAL FORM _ _ Yellowish-white translucent greasy ointment. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The local anaesthetic cinchocaine relieves pain and relaxes sphincteric spasm. Pruritus and inflammation are relieved by hydrocortisone, which also decreases serious discharge. Proctosedyl is, therefore, useful for the short-term relief (not more than 7 days) of pain, irritation and pruritus associated with haemorrhoids and pruritus ani. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ _ _Adults (including the elderly) and children: _ Apply the ointment in small quantities with the finger, on the painful or pruritic area, morning and evening and after each stool. For deep application attach cannula to tube, insert to full extent and squeeze tube gently from lower end whilst withdrawing. The ointment may be used separately or concurrently with the suppositories. 4.3 CONTRA-INDICATIONS Known hypersensitivity to any of the ingredients. Page 2 of 5 Not for use in the presence of infections. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Apply the ointment only to the region of the rectum and anus and surrounding skin. Hydrocortisone can cause thinning and damage to the skin especially of the face. As with all preparations containing topical steroids, the possibility of systemic absorption should be considered. In particular, long-term continuous therapy should be avoided in infants. Adrenal suppression can occur even without occlusion. Pheochromocytoma crisis, which can be fatal, has been reported after administration of corticosteroids. Corticosteroids should only be administered to patients with suspected or identified pheochromocytoma after an appropriate risk/benefit evaluation. (See Section 4.8). Visual disturbance اقرأ الوثيقة كاملة