ELMIRON 100 mg Hard Capsule

Зміст інструкції

1. elmiron 100 mg hard capsules
   1. What is elmiron and what it is used for
   2. What you need to know before taking elmiron
   3. How to take elmiron
   4. Possible side effects
   5. How to store elmiron
   6. Contents of the pack and other information

elmiron 100 mg hard capsules

sodium pentosan polysulfate

Read this leaflet carefully before taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of 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 is elmiron and what it is used for

elmiron is a medicine containing the active substance sodium pentosan polysulfate. After being
taken, the medicine passes into the urine and adheres to the bladder lining, promoting the
formation of a protective layer.
elmiron is used in adult patients to treat painful bladder syndromecharacterized by
multiple minor bleeding events or distinctive lesions on the bladder wall, moderate to severe pain and the urge to urinate frequently.

2. What you need to know before taking elmiron

Do not take elmiron

• if you are allergicto the active ingredient sodium pentosan polysulfate or to any of the other ingredients of this medicine (listed in section 6);
• if you are experiencing bleeding(other than menstrual bleeding).

Warnings and precautions
Talk to your doctor or pharmacist before taking elmiron if:

• you are going to have surgery;
• you suffer from a blood coagulation disorder or an increased risk of bleeding, due to the use of a medicine that inhibits blood coagulation;
• you have ever had a reduced number of blood platelets caused by a medicine called heparin;
• you suffer from reduced liver or kidney function.

Rare cases of retinal disorders (pigmentary maculopathy) have been reported with the use of elmiron
(especially following long-term use). Immediately inform your doctor if you experience
visual changes such as difficulty reading, visual distortions, altered color vision and/or slower
adaptation to dimly lit or low-light environments. The doctor will evaluate with you the
opportunity to continue treatment. For early detection of retinal disorders, regular eye exams will
be performed.

Children and adolescents
The use of elmiron is not recommendedin patients under 18 years of age as efficacy and
safety have not been established in this patient group.

Other medicines and elmiron
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Tell your doctor or pharmacist in particular if you are using medicines that prevent blood
coagulation or painkillers that reduce blood coagulation.

Pregnancy and breastfeeding
elmiron is not recommendedduring pregnancy or breastfeeding.

Driving and using machines
elmiron does not alter or alters negligibly the ability to drive vehicles or use machines.

elmiron contains sodium.
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially ‘sodium-free’.

3. How to take elmiron

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.

The recommended dose is:
1 capsule, 3 times a day
The doctor will evaluate your response to elmiron every 6 months.

Method of administration
Take the capsules whole with a glass of water, at least 1 hour before or 2 hours after meals.

If you take more elmiron than you should
Inform your doctor in case of overdose. If you experience any undesirable effects, stop
taking elmiron, until the undesirable effects disappear.

If you forget to take elmiron
Do not take a double dose to make up for a missed capsule.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects can occur with the following frequencies.

Common: may affect up to 1 in 10 people

• infections, influenza
• headache, back pain
• dizziness
• nausea, indigestion, diarrhoea, abdominal pain, distended abdomen;
• rectal bleeding;
• fluid retention in the arms and legs;
• hair loss;
• weakness, pelvic pain (lower abdomen);
• need to urinate more frequently than usual;
• abnormal liver function.

Uncommon: may affect up to 1 in 100 people

• shortage of platelets, red blood cells or white blood cells;
• bleeding, including mild skin bleeding;
• allergic reactions, increased sensitivity to light;
• loss of appetite, weight gain or weight loss;
• severe mood swings or depression;
• increased sweating, insomnia;
• restlessness;
• abnormal sensations, such as tingling, twitching or itching;
• excessive tearing, lazy eye (amblyopia);
• tinnitus;
• difficulty breathing;
• indigestion, vomiting, flatulence, constipation;
• mouth ulcer;
• skin rash, increase in the size of moles;
• joint or muscle pain

Not known: the frequency cannot be estimated from the available data;

• blood clotting disorders;
• allergic reactions;
• abnormal liver function.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed
in this leaflet. You can also report side effects directly through the national reporting system listed in
Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store elmiron

Keep this medicine out of the sight and reach of children.

• bottleDo not use this medicine after the expiry date stated on the bottle and on the carton after “Scad.”. The expiry date refers to the last day of that month.

Keep the bottle tightly closed, to protect the medicine from moisture.
Use within 45 days of first opening. Discard any remaining capsules after this period.

• blisterDo not use this medicine after the expiry date stated on the carton and on the blister after “Scad.”. The expiry date refers to the last day of that month.

Do not store at a temperature above 30 °C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What elmiron contains

• The active ingredient is sodium pentosan polysulfate. One capsule contains 100 mg of sodium pentosan polysulfate.
• The other ingredients are: Capsule contents: microcrystalline cellulose, magnesium stearate Capsule shell: gelatin, titanium dioxide (E171)

Description of the appearance of elmiron and contents of the pack
The capsules are white and non-transparent, supplied in a plastic bottle with a child-resistant closure or plastic/aluminium blisters, packaged in a carton.

• bottleEach carton contains 90 capsules or 300 (3 bottles x 100) capsules.
• blisterEach carton contains 90 capsules.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
bene-Arzneimittel GmbH
Herterichstrasse 1-3
D-81479 Munich
tel: +49 (0)89 749870
fax: +49 (0)89 74987142
e-mail: [email protected]
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

BG, CZ, EE, EL, IS, IT, CY, LV, MT, PT, RO, SK
bene-Arzneimittel GmbH, D-81479 Munich,
Германия / Německo / Saksamaa / Γερμανία / Germany / Þýskaland / Germania / Vācija / Il-
Ġermanja / Alemanha / Nemecko,
Tel / Teл. / Τηλ / Sími / Tel.: +49 (0)89 749870, [email protected]

AT
SIGMAPHARM Arzneimittel GmbH, Leystraße 129, A-1200 Wien,
Österreich,
Tel.: +43 (0) 1 330 06 71-0, [email protected]

BE, LU, NL
Lamepro B.V., Burgemeester Guljélaan 2, NL-4837 CZ Breda,
Pays-Bas, Nederland, Niederlande,
Tél/Tel: +31 (0)76 5600030, [email protected]

DE
Dr. Pfleger Arzneimittel GmbH, D-96045 Bamberg,
Deutschland,
Tel.: +49 (0)951 6043-0, [email protected]

DK, NO
Navamedic AB, Göteborgsvägen 74, S-433 63 Sävedalen,
Sverige,
Tlf: +46 (0)31 3351190, [email protected]

ES
Lacer S.A., Sardenya 350, 08025 Barcelona,
España,
Tel: +34 (0)934465300, [email protected]

FI, SE
Navamedic AB, Göteborgsvägen 74, S-433 63 Sävedalen,
Ruotsi/Sverige,
Puh/Tel: +46 (0)31 3351190, [email protected]

FR
Inresa SAS, 1 rue Jean Monnet, F-68870 Bartenheim,
France,
Tél: +33 (0)389 707660, [email protected]

HR
MEDICOPHARMACIA d.o.o., Pere Budmanija 5, 10000 Zagreb,
Hrvatska,
Tel: + 385 1 55 84 604

HU
Kéri Pharma Hungary Kft., 4032 Debrecen, Bartha B. u. 7,
Magyarország,
Tel.: +36 52 431 313

IE
Consilient Health, Block 2A Richview Office Park, Clonskeagh, Dublin 14, D14 Y0A5
Ireland,
Tel: +353 (0) 1 2057760, [email protected]

LT
UAB Norameda, Meistrų g. 8A, LT-02189 Vilnius,
Lietuva,
Tel. +370 5 2306499

PL
Norameda Polska Sp. z o.o., Kilińskiego 20, PL-05-500 Piaseczno,
Polska,
Tel.: +48 (0) 504 278 778, [email protected]

SI
Lenis d.o.o., Litostrojska cesta 52, 1000 Ljubljana,
Slovenija,
Tel: +386(0) 1 235 07 00, [email protected]

XI
Consilient Health Limited
Tel: +353 (0)1 205 7760
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: http://www.ema.europa.eu.