Elmiron
Country: European Union
Language: English
Source: EMA (European Medicines Agency)
Patient Information leaflet
(PIL)
15-07-2022
Summary of Product characteristics
(SPC)
15-07-2022
Public Assessment Report
(PAR)
20-06-2017
Active ingredient:
pentosan polysulfate sodium
Available from:
bene-Arzneimittel GmbH
ATC code:
G04BX15
INN (International Name):
pentosan polysulfate sodium
Therapeutic group:
Urologicals
Therapeutic area:
Cystitis, Interstitial
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.,
Product summary:
Revision: 14
Authorization status:
Authorised
Authorization date:
2017-06-02
Patient Information leaflet
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 the complete document
Summary of Product characteristics
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 the complete document
