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Elmiron - Patient leaflet, side effects, dosage

Contains active substance :

ATC code:

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Sources: Original PDF (ema.europa.eu)

Patient leaflet - Elmiron

B. PACKAGE LEAFLET

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 use of elmiron (especially after long term use). Tell your doctor immediately if you experience visual changes such as difficulty when reading, visual distortions, altered colour vision and/or slower adjustment to low or reduced light. Your doctor will discuss with you whether the treatment should be continued. For early detection of retinal disorders, eye examination will be performed regularly.

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.

elmiron contains sodium.

This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.

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 case of 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
  • 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, difficulty 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. Y ou can also report side effects directly via the national reporting system listed in 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 45 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 capsule contains 100 mg pentosan polysulfate sodium.

  • The other ingredients are:

Capsule content: microcrystalline cellulose, magnesium stearate

Capsule shell: gelatin, titanium dioxide (E171)

What elmiron looks like and contents of the pack

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

  • bottle

Each carton contains 90 capsules or 300 (3 bottles x 100) capsules.

  • blister

Sources: Original PDF (ema.europa.eu)

The drug is classified in the ATC tree:

G GENITO URINARY SYSTEM AND SEX HORMONES

G04 UROLOGICALS

G04B UROLOGICALS

G04BX Other urologicals in ATC

G04BX15 pentosan polysulfate sodium

Frequently Asked Questions

What is Elmiron used for?

Elmiron is primarily used to treat interstitial cystitis, a painful bladder condition that can cause discomfort and frequent urination.

How does Elmiron work?

Elmiron works by protecting the bladder lining and reducing irritation, which can help alleviate symptoms of interstitial cystitis.

Who should not take Elmiron?

People who are allergic to pentosan polysulfate sodium or any other ingredients in Elmiron should not take this medication. Always consult your doctor before starting any new medication.

What are the common side effects of Elmiron?

Some common side effects include diarrhea, nausea, and headaches. Make sure to report any severe side effects to your healthcare provider.

Can I take Elmiron if I'm pregnant or breastfeeding?

If you are pregnant, planning to become pregnant, or breastfeeding, consult your doctor to discuss the risks and benefits of taking Elmiron.

How long does it take for Elmiron to start working?

Patients may start to notice improvements in symptoms within a few weeks, but it can take several months for full benefits to be observed.

Is there a specific diet I should follow while taking Elmiron?

While there is no specific diet mandated, avoiding acidic foods and beverages may help reduce bladder irritation for those with interstitial cystitis.

Can I drink alcohol while taking Elmiron?

It's best to avoid alcohol as it may exacerbate bladder irritation and interfere with the effectiveness of the treatment.

What happens if I miss a dose of Elmiron?

If you miss a dose of Elmiron, take it as soon as you remember. If it's almost time for your next dose, skip the missed dose and continue with your regular schedule.

Are there any drug interactions with Elmiron that I should be aware of?

Yes, certain blood thinners and medications that affect blood clotting can interact with Elmiron. Always inform your doctor about all medications you are taking.

Can children take Elmiron?

Elmiron's safety and effectiveness in children have not been established, so it is typically not prescribed for pediatric patients without careful consideration.

What should I do if I experience unusual bleeding or bruising while on Elmiron?

If you experience unusual bleeding or bruising, contact your healthcare provider immediately as this could indicate a serious side effect.

How should Elmiron be stored at home?

Store Elmiron at room temperature away from moisture and heat. Keep out of reach of children.

Can I stop taking Elmiron suddenly?

Consult your healthcare provider before stopping Elmiron suddenly; they may recommend a gradual reduction in dosage instead.

Is regular monitoring needed while taking Elmiron?

Yes, regular follow-ups with your healthcare provider are important to monitor the effectiveness and any potential side effects.

What should I tell my doctor before starting Elmiron?

Inform your doctor about all medical conditions you have and any medications or supplements you are currently taking prior to starting Elmiron.

How does long-term use of Elmiron affect health?

Long-term use of Elmiron requires careful monitoring due to potential risks associated with prolonged treatment; discuss these concerns with your doctor.

Are there alternative treatments for interstitial cystitis if Elmiron isn’t effective?

Yes, alternative treatments include lifestyle changes, physical therapy, dietary adjustments, or various other medications prescribed by your healthcare provider.

Can I crush or split my Elmiron tablets if I have difficulty swallowing them?

No, do not crush or split the tablets unless directed by your doctor; this could affect how the medication works in your body.

Where can I find more information about clinical studies related to Elmiron?

You can find clinical studies related to Elmiron on reputable medical websites or through clinical trial registries; discuss findings with your healthcare provider for clarity.