البلد: مالطا
اللغة: الإنجليزية
المصدر: Medicines Authority
FLUOCORTOLONE PIVALATE, LIDOCAINE HYDROCHLORIDE
Jenapharm GmbH & Co. KG
C05AX03
FLUOCORTOLONE PIVALATE, LIDOCAINE HYDROCHLORIDE
RECTAL CREAM
FLUOCORTOLONE PIVALATE 1 milligram(s) ; LIDOCAINE HYDROCHLORIDE 20 milligram(s)
POM
VASOPROTECTIVES
Authorised
2005-09-28
DOLOPROCT ® 0.1% + 2% RECTAL CREAM 30G Active ingredients: Fluocortolone pivalate + Lidocaine hydrochloride (water free) 1g rectal cream contains 1 mg fluocortolone pivalate (Ph.Eur.) and 20 mg lidocaine hydrochloride (water free) Excipients: polysorbate 60, sorbitan stearate, cetostearyl alcohol (Ph.Eur.), liquid paraffin, white soft paraffin, sodium edetate (Ph.Eur.), sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate (Ph.Eur.), benzyl alcohol, purified water. _Contains cetostearyl alcohol. See package leaflet for more information_ For rectal use. Keep out of the sight and reach of children. After first opening the rectal cream use within 4 weeks. _Ch.-B. = Lot no. and Verwendbar bis = EXP. _ Application nozzle enclosed. Read the package leaflet before use. MAH Germany/Malta: Jenapharm GmbH & Co. KG, Otto-Schott-Straße 15, D-07745 Jena, Germany. P rescription-only. MAH Austria: Bayer Austria, Ges.m.b.H. 1160 Wien, Austria. Prescription-only and Pharmacy-only. MA No. 1013/00102 LF1039.005 PACKAGE LEAFLET: INFORMATION FOR THE USER DOLOPROCT ® 0.1% + 2% RECTAL CREAM 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 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: fluoc اقرأ الوثيقة كاملة
Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS Page 2 of 8 1. NAME OF THE MEDICINAL PRODUCT Doloproct 0.1 % + 2 % rectal cream 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g Doloproct rectal cream contains: 1 mg fluocortolone pivalate and 20 mg lidocaine hydrochloride (water free). Excipients with known effect: 60 mg Cetostearyl alcohol For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Rectal cream White, opaque cream 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic relief of pain and inflammation in adults for: haemorrhoidal disease, non-infectious proctitis and anal eczema. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Doloproct rectal cream should be applied twice a day, once in the morning and once in the evening (approximately up to 1 g cream per application). In the initial days of use, it can be applied three times daily. With improvement of symptoms, a single daily application is often sufficient. 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. Page 3 of 8 Method of administration It is advisable to administer Doloproct after defecation. The anal region should be cleaned thoroughly prior to use. A finger-tip unit of Doloproct rectal cream is applied to the anal region with a finger, using the finger tip to overcome the resistance of the sphincter. A finger-tip unit is the amount of rectal cream expressed from the tube and applied from the distal skin-crease to the tip of the index finger of an adult. If Doloproct rectal cream is to be applied intra-rectally, the applicator provided has to be screwed onto the tube and the tip inserted into the anus. A small quantity of cream can then be applied by exerting slight pressure on the tube. 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: spec اقرأ الوثيقة كاملة