Country: Malta
Tungumál: enska
Heimild: Medicines Authority
CALCIUM DOBESILATE
OM PHARMA S.A. R. da Industria, 2, 2610-088 Amadora, Lisboa, Portugal
C05BX01
CALCIUM DOBESILATE 500 mg
CAPSULE
CALCIUM DOBESILATE 500 mg
POM
VASOPROTECTIVES
Withdrawn
2006-11-20
_PIL Doxium MT_ 1 PACKAGE LEAFLET: INFORMATION FOR THE USER READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Doxium 500 is and what it is used for 2. What you need to know before you take Doxium 500 3. How to take Doxium 500 4. Possible side effects 5. How to store Doxium 500 6. Contents of the pack and other information 1. WHAT DOXIUM 500 IS AND WHAT IT IS USED FOR Doxium 500 contains calcium dobesilate monohydrate as the active substance and is indicated for the treatment of: - Microangiopathies, in particular diabetic retinopathy, - Clinical signs of chronic venous insufficiency in the lower limbs (pain, cramps, paresthesia, oedema, stasis dermatosis), as adjuvant in superficial thrombophlebitis. - Haemorrhoidal syndrome, microcirculation disorders of arteriovenous origin . Doxium 500 has a selective effect on the walls of capillary vessels; it corrects the permeability of these vessels and reduces their fragility. This means that Doxium has an antioedemic effect and determines the increase in capillary resistance. Doxium 500 is for use in adults patients. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DOXIUM 500 DO NOT TAKE DOXIUM 500 - If you are allergic to calcium d Lestu allt skjalið
_SmPC Doxium MT_ - 1 - SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT DOXIUM ® 500 500 mg, capsules, hard 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 hard capsule contains 500 mg of calcium dobesilate monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsule, hard Opaque capsules with a yellow capsule body and a dark green cap 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Microangiopathies, in particular diabetic retinopathy. Clinical signs of chronic venous insufficiency in the lower limbs (pain, cramps, paresthesia, oedema, stasis dermatosis), as adjuvant in superficial thrombophlebitis. Haemorrhoidal syndrome, microcirculation disorders of arteriovenous origin. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _For adults only_ Generally 500 to 1000 mg – 1 capsule once or twice a day Dosage should be adapted individually according to the severity of the case. Treatment duration, which is generally between a few weeks and several months, depends on the disease and its evolution. _ _ _Renal impairment _ The safety and efficacy of calcium dobesilate have not been studied in patients with renal impairment. Since the drug is excreted by the urinary route, caution is required in case of renal insufficiency. Thus, the dose may be reduced when administering Doxium 500 to these patients, especially in patients with severe renal insufficiency requiring dialysis. _Hepatic impairment _ _SmPC Doxium MT_ - 2 - The safety and efficacy of calcium dobesilate have not been studied in patients with hepatic impairment. Thus, caution is required when administering Doxium 500 to these patients. Method of administration Doxium 500 is designed for oral administratio Lestu allt skjalið