Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: bene-Arzneimittel GmbH, Herterichstrasse 1-3, D-81479 Munich, tel: ++49 (0) 89/7 49 87-0, fax: ++49 (0) 89/7 49 87-142, e-mail: contact@bene-arzneimittel.de
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).
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.
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.
The safety and efficacy of pentosan polysulfate sodium in children and adolescent below 18 years has not been established.
No data are available.
The capsules should be taken with water at least 1 hour before meals or 2 hours after meals
In the case of an accidental overdose, patients should be evaluated for potential adverse effects of pentosan polysulfate sodium like gastrointestinal symptoms or bleeding. In case of adverse reactions, treatment might be paused until the symptoms abate and treatment should be continued at the recommended dose after a critical balancing of the risks thereafter.
Bottle: 3 years. After first opening: use within 45 days.
Blister: 21 months.
Bottle: Keep the bottle tightly closed in order to protect from moisture. For storage conditions after first opening of the bottle, see section 6.3.
Blister: Do not store above 30°C.
HDPE bottle with a tamper-evident child resistant closure of PP with 90 capsules.
HDPE bottle with a tamper-evident child resistant closure of PP with 100 capsules.
PVC/Aclar-Aluminium blister with 90 (9x10) capsules.
Bottle:
Pack size of 90 capsules.
Pack size of 300 (3 bottles x 100) capsules.
Blister:
Pack size of 90 capsules.
Not all pack sizes may be marketed.
No special requirements.
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