Country: Եվրոպական Միություն
language: անգլերեն
source: EMA (European Medicines Agency)
pentosan polysulfate sodium
bene-Arzneimittel GmbH
G04BX15
pentosan polysulfate sodium
Urologicals
Cystitis, Interstitial
Elmiron is indicated for the treatment of bladder pain syndrome characterized by either glomerulations or Hunner’s lesions in adults with moderate to severe pain, urgency and frequency of micturition.,
Revision: 14
Authorised
2017-06-02
22 B. PACKAGE LEAFLET 23 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ELMIRON 100 MG CAPSULES, HARD pentosan polysulfate sodium 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 elmiron is and what it is used for 2. What you need to know before you take elmiron 3. How to take elmiron 4. Possible side effects 5. How to store elmiron 6. Contents of the pack and other information 1. WHAT ELMIRON IS AND WHAT IT IS USED FOR elmiron is a medicine that contains the active substance pentosan polysulfate sodium. After taking the medicine, it passes into the urine and attaches to the lining of the bladder, helping to form a protective layer. elmiron is used in adults to treat BLADDER PAIN SYNDROME characterised by many tiny bleeds or distinctive lesions on the bladder wall and moderate to severe pain and a frequent urge to urinate. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ELMIRON DO NOT TAKE ELMIRON IF YOU ARE • ALLERGIC to pentosan polysulfate sodium or any of the other ingredients of this medicine (listed in section 6) • BLEEDING (other than menstrual bleeding) WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking elmiron if you have: • to undergo surgery • a blood clotting disorder or increased risks of bleeding, such as using a medicine that inhibits blood clotting • ever had a reduced number of blood platelets caused by the medicine called heparin • reduced liver or kidney function Rare cases of retinal disorders (pigmentary maculopathy) have been reported with us read_full_document
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT elmiron 100 mg capsules, hard 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 100 mg of pentosan polysulfate sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsule, hard. White opaque capsules size 2. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS elmiron is indicated for the treatment of bladder pain syndrome characterized by either glomerulations or Hunner’s lesions in adults with moderate to severe pain, urgency and frequency of micturition (see section 4.4). _ _ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults _ The recommended dose of pentosan polysulfate sodium is 300 mg/day taken as one 100 mg capsule orally three times daily. Response to treatment with pentosan polysulfate sodium should be reassessed every 6 months. In case no improvement is reached 6 months after treatment initiation, treatment with pentosan polysulfate sodium should be stopped. In responders pentosan polysulfate sodium treatment should be continued chronically as long as the response is maintained. _Special populations _ Pentosan polysulfate sodium has not been specifically studied in special patient populations like elderly or patients with renal or hepatic impairment (see section 4.4). No dose adjustment is recommended for these patients. _Paediatric population _ The safety and efficacy of pentosan polysulfate sodium in children and adolescent below 18 years has not been established. No data are available. Method of administration The capsules should be taken with water at least 1 hour before meals or 2 hours after meals. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 3 Due to the weak anticoagulant effect of pentosan polysulfate sodium, elmiron must not be used in patients who actively bleed. Menstruation is no contraindication. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Bladder pain syndrome is a diagnosis of exclusion read_full_document