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Elmiron (pentosan polysulfate sodium) – Package leaflet - G04BX15

Updated on site: 06-Oct-2017

Medication nameElmiron
ATC CodeG04BX15
Substancepentosan polysulfate sodium
Manufacturerbene-Arzneimittel GmbH

Package leaflet: Information for the patient

elmiron 100 mg hard capsules 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

Children and adolescents

elmiron is not recommended in children under 18 years as safety and efficacy have not been established in this group.

Other medicines and elmiron

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

Inform your doctor or pharmacist, particularly if you use medicines that prevent blood clotting, or painkillers that reduce blood clotting.

Pregnancy and breast-feeding

elmiron is not recommended during pregnancy or breast-feeding.

Driving and using machines

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

3.How to take elmiron

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is:

1 capsule, 3 times daily

Your doctor will assess your response to elmiron every 6 months.

Method of use

Take the capsules whole with one 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 the case of an overdose. Stop taking elmiron if side effects occur, 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 been observed with the following frequencies:

Common: may affect up to 1 in 10 people

infections, flu

headache, back pain

dizziness

nausea, indigestion, diarrhoea, abdominal pain, abdomen enlarged

rectal bleeding

accumulation of fluid in arms or legs

hair loss

weakness, pelvic (lower abdomen) pain

need to urinate more frequently than usual

abnormal liver function

Uncommon: may affect up to 1 in 100 people

lack of blood platelets, red or white blood cells

bleeding, including small bleeding beneath the skin

blood clotting disorders

allergic reactions, increased sensitivity to light

loss of appetite, weight gain or loss

severe mood swings or depression

increased sweating, sleeplessness

restlessness

abnormal sensation such as prickling, tingling and itchiness

flow of tears, lazy eye

ringing or buzzing in the ears

breathing difficulties

indigestion, vomiting, wind, difficultiy passing stools

mouth ulcer

skin rash, increased mole size

joint or muscle pain

Not known: 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 possible side effects not listed in this 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.How to store 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 refers to the last day of that month.

Keep the bottle tightly closed in order to protect from moisture.

After first opening: use within 30 days. Dispose any remaining capsules after this period.

blister

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

Do not store above 30 C.

Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.Contents of the pack and other information

What elmiron contains

The active substance is pentosan polysulfate sodium.

One hard capsule contains 100 mg pentosan polysulfate sodium.

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

What elmiron looks like and contents of the pack

The hard capsules are white and non-transparent, provided in a plastic bottle with child resistant closure or plastic/aluminium blisters, packed in a carton.

Each carton contains 90 capsules.

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: contact@bene-arzneimittel.de

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

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