Valsts: Malta
Valoda: angļu
Klimata pārmaiņas: Medicines Authority
FLUOCORTOLONE PIVALATE, LIDOCAINE HYDROCHLORIDE
Jenapharm GmbH & Co. KG
C05AX03
FLUOCORTOLONE PIVALATE, LIDOCAINE HYDROCHLORIDE
SUPPOSITORY
FLUOCORTOLONE PIVALATE 1 milligram(s) ; LIDOCAINE HYDROCHLORIDE 40 milligram(s)
POM
VASOPROTECTIVES
Authorised
2005-09-28
Page 1 of 7 PACKAGE LEAFLET Page 2 of 7 PACKAGE LEAFLET: INFORMATION FOR THE USER DOLOPROCT 1 MG + 40 MG SUPPOSITORIES fluocortolone pivalate + lidocaine hydrochloride (water free)Izlasiet visu dokumentu . <[To be completed nationally]> 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 anaesthet
Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS Page 2 of 7 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. 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) Page 3 of 7 - 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 softe Izlasiet visu dokumentu