देश: माल्टा
भाषा: अंग्रेज़ी
स्रोत: Medicines Authority
FLUOCORTOLONE PIVALATE, LIDOCAINE HYDROCHLORIDE
LEO Pharma A/S Industriparken 55, 2750-DK Ballerup, Denmark
C05AA08
FLUOCORTOLONE PIVALATE 1 mg LIDOCAINE HYDROCHLORIDE 40 mg
SUPPOSITORY
FLUOCORTOLONE PIVALATE 1 mg LIDOCAINE HYDROCHLORIDE 40 mg
POM
VASOPROTECTIVES
Withdrawn
2005-09-28
Page 1 of 5 PACKAGE LEAFLET: INFORMATION FOR THE USER DOLOPROCT 1 MG + 40 MG SUPPOSITORIES fluocortolone pivalate + lidocaine hydrochloride (water free) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effect not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Doloproct is and what it is used for 2. What you need to know before you use Doloproct 3. How to use Doloproct 4. Possible side effects 5. How to store Doloproct 6. Contents of the pack and other information 1. WHAT DOLOPROCT IS AND WHAT IT IS USED FOR Doloproct contains two different active substances: fluocortolone pivalate and lidocaine hydrochloride. - The active substance fluocortolone pivalate belongs to the group of corticosteroids. It lowers the production of substances that cause inflammation in your body. This relieves ailment such as swelling, itching and smarting. - The active substance lidocaine hydrochloride belongs to the group of local anaesthetics. It causes numbness at the site to which it is applied. This alleviates pain and itching in this area. Doloproct can be used in adults for the relief of ailments associated with - nodular enlargement of blood vessels around your anus (haemorrhoidal disease), - inflammation of the lining of your rectum (non-infectious proctitis). Doloproct cannot eliminate the causes that led to haemorrhoidal disease and inflammation of the lining of the rectum (non-infectious proctitis). _ _ You must talk to a doctor if you do not feel better or if you feel worse after 7 days. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE DOLOPROCT DO NOT USE DOLOPROCT: - if you पूरा दस्तावेज़ पढ़ें
Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Doloproct 1 mg + 40 mg suppositories 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 Doloproct suppository contains: 1 mg fluocortolone pivalate and 40 mg lidocaine hydrochloride (water free). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suppositories Yellowish-white suppositories 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic relief of pain and inflammation in adults for: - haemorrhoidal disease and non-infectious proctitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology One suppository should be inserted twice a day, once in the morning and once in the evening. With improvement of symptoms, it is in many cases sufficient to insert one suppository per day or every second day. The total duration of treatment should not exceed 2 weeks. _Paediatric population _ Doloproct is not recommended for use in children below 18 years due to a lack of data on safety and efficacy. Method of administration It is advisable to administer Doloproct after defaecation. The anal region should be cleaned thoroughly prior to use. Insert the suppositories deep into the anus. Page 2 of 6 4.3 CONTRAINDICATIONS Doloproct is contra-indicated in case of topical infections in the affected area and if symptoms of the following disorders are present in the affected area: - specific skin lesions (syphilis, tuberculosis) - chickenpox - vaccination reactions - herpes genitalis. Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Since Doloproct contains the active substance lidocaine and approximately 30% of the dose applied is systemically available, this should be considered in patients taking medicines to treat irregular heart beat (arrhythmia). Care should be taken to ensure that Doloproct s does not come into contact with the eyes. It is advisable to wash one's hands thoroughly after use. If suppositories have become softened owing to पूरा दस्तावेज़ पढ़ें