ELMIRON 100 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Elmiron 100 mg hard capsules

Pentosan polysulfate sodium

Read this package leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this package 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 experience side effects, consult your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What is Elmiron and what is it used for
2. What you need to know before you take Elmiron
3. How to take Elmiron
4. Possible side effects
5. Storage of Elmiron
6. Contents of the pack and further information

1. What is Elmiron and what is it used for

Elmiron is a medicine that contains the active substance pentosan polysulfate sodium. After taking it, the medicine 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, which is characterized by numerous small hemorrhages or distinctive lesions in the bladder wall, moderate to severe pain, and an urgent need to urinate frequently.

2. What you need to know before you take Elmiron

Do not take Elmiron

• if you are allergicto pentosan polysulfate sodium or any of the other ingredients of this medicine (listed in section 6).
• • if you have bleeding(apart from menstruation)

Warnings and precautions

Consult your doctor or pharmacist before taking Elmiron:

• If you are going to have surgery.
• If you have a blood coagulation disorder or are at high risk of bleeding, for example, if you are taking a medicine that inhibits coagulation.
• If you have ever had a low platelet count in your blood due to a medicine called heparin.
• If you have impaired liver or kidney function.

Rare cases of retinal disorders (pigmentary maculopathy) have been reported with the use of Elmiron (especially after prolonged use). Inform your doctor immediately if you experience visual disturbances such as difficulty reading or slower adaptation to dim or reduced light. Your doctor will discuss with you whether treatment should continue. You will have regular eye exams to detect any possible retinal changes early.

Children and adolescents

Elmiron is not recommended for children and adolescents under 18 years of age, as its safety and efficacy in this age group have not been established.

Other medicines and Elmiron

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Tell your doctor or pharmacist especially if you are using medicines to prevent blood clot formation or painkillers that reduce coagulation.

Pregnancy and breastfeeding

Elmiron is not recommendedduring pregnancy or breastfeeding.

Driving and using machines

Elmiron has no or negligible influence on the ability to drive and use machines.

3. How to take Elmiron

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist again.

The recommended dose is:

1 capsule, 3 times a day.

Your doctor will assess 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 side effects appear, stop taking Elmiron until they disappear.

If you forget to take Elmiron

Do not take a double dose to make up for a forgotten capsule.

If you have any further questions on 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 have occurred with the following frequencies:

Common:may affect up to 1 in 10 people.

• infections, flu
• headache, back pain
• dizziness
• nausea, indigestion, diarrhea, abdominal pain, abdominal distension
• rectal bleeding
• fluid accumulation in the arms or legs
• hair loss
• weakness, pelvic pain (lower abdomen)
• need to urinate more frequently than usual
• liver function changes

Uncommon:may affect up to 1 in 100 people

• absence of platelets or red or white blood cells in the blood
• bleeding, including small bleeding under the skin
• blood coagulation disorders
• allergic reactions, increased sensitivity to light
• loss of appetite, weight gain or loss
• significant mood changes or depression
• increased sweating, insomnia
• restlessness
• sensory disturbances, such as pins and needles, tingling, and itching
• tearfulness, vague eye
• ringing in the ears, tinnitus
• breathing difficulties
• indigestion, vomiting, gas, difficulty defecating
• mouth ulcers
• skin rash, increased size of moles
• joint or muscle pain

Frequency not known:cannot be estimated from the available data.

• blood coagulation disorders
• allergic reactions
• liver function changes

Reporting of side effects

If you experience side effects, consult your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly via 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. Storage of Elmiron

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

• bottle

Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date is the last day of the month stated.

Keep the bottle tightly closed to protect it from moisture.

After first opening, use within 30 days. After this period, discard any remaining capsules.

• blister

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date is the last day of the month stated.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Elmiron

• The active substance is pentosan polysulfate sodium.

Each hard capsule contains 100 mg of pentosan polysulfate sodium.

• The other ingredients are microcrystalline cellulose, magnesium stearate, gelatin, and titanium dioxide (E171).

Appearance and packaging

The hard capsules are white and opaque, and are available in a plastic bottle with a child-resistant closure or in plastic/aluminum blisters, packaged in a carton.

• bottle

Each carton contains 90 capsules.

Each carton contains 300 (3 x 100) capsules.

• blister

Each 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

Email: contact@bene-arzneimittel.de

You can obtain further information on this medicine from the representative of the marketing authorisation holder:

BG, CZ, EE, EL, IS, IT, CY, LV, LT, MT, PL, PT, RO, SK

bene-Arzneimittel GmbH, D-81479 Munich,

???????? / Germany / Saksamaa / Γερμαν?α / Allemagne / Þýskaland / Germania / Vokietija / Niemcy / Alemanha / Nemecko,

Tel / Te?. / Τηλ / Sími / Tel.: +49 (0)89 749870, contact@bene-arzneimittel.de

AT

SIGMAPHARM Arzneimittel GmbH, Leystraße 129, A-1200 Wien,

Österreich,

Tel.: +43 (0) 1 330 06 71-0, mail@sigmapharm.at

BE, LU, NL

Lamepro B.V., Burgemeester Guljélaan 2, NL-4837 CZ Breda,

Pays-Bas, Nederland, Niederlande,

Tél/Tel: +31 (0)76 5600030, lamepro@lamepro.nl

DE

Dr. Pfleger Arzneimittel GmbH, D-96045 Bamberg,

Deutschland,

Tel.: +49 (0)951 6043-0, info@dr-pfleger.de

DK, NO

Navamedic AB, Krokslätts Parkgata 4, PO Box 24032, S-400 22 Göteborg,

Sverige,

Tlf: +46 (0)31 3351190, infose@navamedic.com

ES

Lacer S.A., Sardenya 350, 08025 Barcelona,

España,

Tel: +34 (0)934465300, infog@lacer.es

FI, SE

Navamedic AB, Krokslätts Parkgata 4, PO Box 24032, S-400 22 Göteborg,

Sverige,

Puh/Tel: +46 (0)31 3351190, infose@navamedic.com

FR

Inresa SAS, 1 rue Jean Monnet, F-68870 Bartenheim,

France,

Tél: +33 (0)389 707660, info@inresa.fr

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, irishoffice@consilienthealth.com

SI

Lenis d.o.o., Litostrojska cesta 52, 1000 Ljubljana,

Slovenija,

Tel: +386(0) 1 235 07 00, info@lenis.si

UK

Consilient Health Ltd., 1 Church Road, Richmond upon Thames, Surrey, TW9 2QE

United Kingdom,

Tel: +44 (0)20 3751 1888, infouk@consilienthealth.com

Date of last revision of this package leaflet: <{MM/YYYY}>

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.