البلد: مالطا
اللغة: الإنجليزية
المصدر: Medicines Authority
CALCIUM DOBESILATE, LIDOCAINE HYDROCHLORIDE
OM PHARMA S.A. R. da Industria, 2, 2610-088 Amadora, Lisboa, Portugal
C05BX01
CALCIUM DOBESILATE 4 g LIDOCAINE HYDROCHLORIDE 2 g
OINTMENT
CALCIUM DOBESILATE 4 g LIDOCAINE HYDROCHLORIDE 2 g
POM
VASOPROTECTIVES
Withdrawn
2006-11-20
COMPOSITION Active principles Calcium dobesilate, lidocaine hydrochloride. Calcium dobesilate: 40 mg, lidocaine hydrochloride: 20 mg, antiox. (E 320, E 310), macrogol 300, propyleneglycol. Excipients for 1 g of ointment. PROPERTIES/EFFECTS Calcium dobesilate acts on the capillary walls by regulating their impaired physiological functions - i.e. increased permeability and decreased resistance - and on different signs of inflammation. It also has an antithrombotic activity. Lidocaine hydrochloride, a local anesthetic, contributes to relieve pain. Doxiproct reduces inflammation, bleeding, oozing of serous fluids and brings a rapid relief of the signs and symptoms linked to inflammation of the anal region, such as pain, burning, pruritus and sensation of tension. PHARMACOKINETICS No pharmacokinetic data are available. It is, however, known that the active principles contained in Doxiproct are partly resorbed by the skin. INDICATIONS AND USAGE Internal and external hemorrhoids. Anal pruritus, anitis, perianitis, cryptitis, papillitis, acute hemorrhoidal thrombosis, anal fissures. Pre- and postoperative treatment in cases of hemorrhoidectomy. DOSAGE AND ADMINISTRATION 2-3 times daily. In the morning and at bedtime apply, if possible after defecation. In cases of internal hemorrhoids, use the cannula by screwing it to the tube. Insert the cannula as deep as possible in the anus then press gently the tube while withdrawing it. In this case, the tube is sufficient for 10 applications. In case of external hemorrhoids or anal pruritus apply a thin layer of the ointment several times a day. The duration of the treatment is generally of some days. The doctor must be informed if, after 1 to 2 weeks of treatment, the symptomatology has not improved or has worsened. The treatment should not be repeated without previous medical advice. LIMITATIONS FOR USE CONTRAINDICATIONS Hypersensitivity towards the components of Doxiproct. Children under 14. PRECAUTIONS In case of renal insufficiency, the application of Doxiproct اقرأ الوثيقة كاملة
Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT DOXIPROCT ® Ointment 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _Active principles : _Calcium dobesilate, lidocaine hydrochloride._ _ Calcium dobesilate : 40 mg, lidocaine hydrochloride : 20 mg, antiox. (E 320, E 310), macrogol 300, propyleneglycol. Excipients for 1 g of ointment. 3. PHARMACEUTICAL FORM Ointment, topical preparation and rectal route. 4. CLINICAL PARTICULARS 4.1. Therapeutic indications Internal and external hemorrhoids. Anal pruritus, anitis, perianitis, cryptitis, papillitis, acute hemorrhoidal thrombosis, anal fissures. Pre- and postoperative treatment in cases of hemorrhoidectomy. 4.2. Posology and method of administration 2 - 3 times daily. In the morning and at bedtime apply the ointment, if possible after defecation. In cases of internal hemorrhoids, use the cannula by screwing it to the tube. Insert the cannula as deep as possible in the anus then press gently the tube while withdrawing it. In this case, the tube is sufficient for 10 applications. In case of external hemorrhoids or anal pruritus apply a thin layer of the ointment several times a day. The duration of the treatment is generally of some days. The doctor must be informed if, after 1 to 2 weeks of treatment, the symptomatology has not improved or has worsened. The reconduction of the treatment should not be done without a prior medical advice. 4.3. Contra-indications Hypersensitivity towards the components of Doxiproct. 4.4. Special warnings and precautions for use Page 2 of 4 In case of renal insufficiency, Doxiproct should not be used during long peri اقرأ الوثيقة كاملة