Consumer medicine information

What is ELMIRON?

ELMIRON is supplied in white opaque hard gelatin capsules, each capsule containing 100 mg pentosan polysulfate sodium (the active drug), microcrystalline cellulose and magnesium stearate. It is formulated for oral use.

The Australian Register Number is AUST R 48446.

What ELMIRON is used for and how it works

ELMIRON is an oral treatment for interstitial cystitis otherwise known as a chronic inflammation of the bladder wall. ELMIRON is passed by the kidneys into the urine, where it coats the damaged bladder wall. This improves the bladder’s protective lining. After taking ELMIRON, it may be at least six to eight weeks before you notice improvement in your symptoms.

Advice before using ELMIRON

Use ELMIRON only when prescribed by your doctor.

All medicines have benefits and risks. In deciding to give you ELMIRON, your doctor has weighed the risks of taking ELMIRON against the benefits he/she expects it will have for you.

When should I not use ELMIRON?

ELMIRON should not be used by people who:

• have known hypersensitivity to these kinds of drugs,
• have haemophilia,
• have active (or a recent history of) bleeding,
• are currently using heparin or oral anti-coagulant therapy,
• are pregnant, or intend to become pregnant,
• are less than 18 years of age.

If you are not sure whether you should start using ELMIRON, contact your doctor.

When should I be careful using ELMIRON?

If you have a bleeding disorder, or you are taking anti-coagulant therapy, or you are at greater risk of bleeding (e.g. you are an alcoholic), you should tell your doctor before beginning treatment with ELMIRON.

Eating and drinking (e.g. milk, tea, coffee) interferes with the absorption of ELMIRON and so it is very important that you do not eat or drink for one hour after taking ELMIRON and that you take ELMIRON at least two hours after meals.

Call your doctor (including eye doctor) if you notice any changes in your vision.

Should I use ELMIRON during pregnancy or breast-feeding?

• Pregnancy
  ELMIRON should not be used during pregnancy. You should tell your doctor if you are pregnant or intend to become pregnant.
• Breast-feeding
  Do not use ELMIRON while breast-feeding. If you intend to breast feed, consult your doctor.

Am I restricted in my daily activities while using ELMIRON?

There are no known restrictions associated with taking ELMIRON.

Should I use ELMIRON with other medicines?

There are some medicines which may affect the way ELMIRON works. Tell your doctor about any other medicines that you take, especially heparin or oral anti-coagulant therapy. Also tell your doctor about all the medicines you have bought without a doctor’s prescription.

How to use ELMIRON properly

How much ELMIRON should I take?

The dose will be decided by your doctor and will depend on your condition. Do not take more capsules than you have been prescribed.

When should I take ELMIRON?

Normally, you should take ELMIRON three times a day unless your doctor tells you to do otherwise. Follow the pharmacist label on the pack. For the best results take the capsules at the same time each day. This will also help you to remember.

It is very important that you take ELMIRON:

• with a small glass of water,
• at least 2 hours after eating food or drinking, and
• that you do not eat food or drink for one hour after taking ELMIRON.

It is suggested that you take ELMIRON when your stomach is empty.

How long do I need to take ELMIRON?

ELMIRON controls your condition but does not cure it. Therefore ELMIRON must be taken every day. Continue taking ELMIRON for as long as your doctor prescribes. If you stop taking ELMIRON, the positive effects may gradually wear off.

What if I miss a dose?

If you miss taking your ELMIRON, skip the missed dose and take your next dose as you normally would. If you have trouble remembering to take your tablets, talk to your pharmacist for some helpful hints.

Further information

Doctor’s prescription required: Yes.

Regular examinations or tests: Various tests should be monitored periodically if you are taking ELMIRON on a long term basis. Your doctor will advise you regarding these tests.

Surgery: Tell your dentist or doctor that you are taking ELMIRON if you plan on having surgery.

Habit-forming potential: ELMIRON is not addictive.

Remember: This medicine is for you. Only a doctor can prescribe it for you. Never give it to someone else. It may harm them even if they have the same condition as you.

What unwanted effects may ELMIRON cause?

If your bladder condition or symptoms become worse, you should consult your doctor immediately and stop taking ELMIRON.

Some people may experience mild effects of swelling, headache, dizziness, nausea, indigestion, or diarrhoea. If any of these occur and are bothersome, contact your doctor. Other unwanted effects not listed may also occur in some patients. Tell your doctor if you notice any other effects.

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 reading difficulty and 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.

In case of overdose

If you accidentally take too many capsules, you should contact your Doctor or contact the Poisons Information Centre on 131126 (Australia)There are no known instances of people suffering damage from taking too much ELMIRON.

How should I store ELMIRON?

• Keep ELMIRON out of the reach of children.
• Keep the capsules away from sunlight and away from the damp and store in a cool place. Therefore, do not store ELMIRON in the bathroom or near the kitchen sink.
• Keep ELMIRON in the bottle given to you by your pharmacist.
• Do not use the capsules past the expiry date on the bottle.
• If your doctor tells you to stop taking ELMIRON, return any left over capsules to your pharmacist for disposal.

Where should I go for further information?

This is not all the information that is available on ELMIRON. If you have any more questions or are not sure about anything, ask your doctor or pharmacist.

Arthropharm Pty Ltd is committed to the better health of all Australians. Consumer Product Information is part of this commitment.

Arthropharm Pty Limited
111 Bronte Road, Bondi Junction NSW 2022

Revised 30/07/2021

Published by MIMS October 2021

1 Name of Medicine

Pentosan polysulfate sodium.

2 Qualitative and Quantitative Composition

Each capsule contains 100 mg pentosan polysulfate sodium.
For the full list of excipients, (see Section 6.1 List of Excipients).

3 Pharmaceutical Form

Elmiron 100 mg is supplied in white opaque hard gelatin capsules.
It is formulated for oral use.

4 Clinical Particulars

4.1 Therapeutic Indications

Elmiron is indicated for the treatment of interstitial cystitis. Relief of symptoms in patients with interstitial cystitis may not be experienced until after 6 to 8 weeks of therapy with Elmiron. Continuing long-term therapy is necessary for persistent relief of symptoms.
Relief of symptoms may not occur in all patients, and relapse is likely to occur gradually if treatment is discontinued, even after long periods of therapy.

4.2 Dose and Method of Administration

The recommended dose of Elmiron is 300 mg/day taken as one 100 mg capsule orally three times daily or as directed by the physician. The capsules should be taken with water at least 1 hour before meals or 2 hours after meals.

4.3 Contraindications

Elmiron is contraindicated in patients with known hypersensitivity to it or related compounds, haemophilia, active (or a recent history of) bleeding and concurrent heparin or oral anti-coagulant therapy.

4.4 Special Warnings and Precautions for Use

Because of its weak anti-coagulant action, Elmiron should be used with caution in patients with bleeding disorders or who are taking anti-coagulant therapy or who are at greater risk of bleeding (e.g. the elderly or the alcoholic patient). Elmiron should not be used as empirical treatment for undiagnosed urogenital bleeding or symptoms. The diagnosis of interstitial cystitis should be established before treatment commences.
Rare cases of pigmentary maculopathy have been reported with use of pentosan polysulfate sodium (PPS), especially after long term use. Visual symptoms might include complaints of reading difficulty and slow adjustment to low or reduced light environments. All patients should have regular ophthalmic examinations for early detection of pigmentary maculopathy, particularly those with long-term use of PPS. In such situations, treatment cessation should be considered.

Monitoring.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

See Section 4.3 Contraindications; Section 4.4 Special Warnings and Precautions for Use.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration. However, adverse effects of Elmiron include dizziness and visual disturbances which could affect the ability to drive or use the machines and therefore patients should be advised accordingly (see Section 4.4 Special Warnings and Precautions for Use; Section 4.8 Adverse Effects (Undesirable Effects)).

4.8 Adverse Effects (Undesirable Effects)

Peripheral oedema, headache, dizziness, nausea, indigestion, diarrhoea and elevation of liver function tests have been reported in patients receiving Elmiron, and have necessitated discontinuation of therapy occasionally. Mood swings (including suicidal ideation) have been reported rarely.
Indication of osteoporosis, that has occurred with heparin, has not been reported with Elmiron.
Post-marketing experience: Pigmentary changes in the retina.

Reporting suspected adverse effects.

4.9 Overdose

There are no known overdosage incidents. In human studies, Elmiron has been administered intravenously in single bolus doses of 150 mg; in oral bolus doses of 400 mg for 3 weeks; and orally in total daily doses of 900 mg for up to 3 months without untoward effect.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

In human volunteers using I¹²⁵ labelled Elmiron, the pattern of distribution, metabolism, and elimination of Elmiron was shown to be similar to that of heparin. In these subjects Elmiron was rapidly cleared from the plasma. The data indicated that the liver and spleen were major sites of desulfation and that depolymerisation occurred in the kidneys. Sulfated macromolecular Elmiron, as well as desulfated macromolecular and depolymerised Elmiron, was shown to be present in urine post-injection.
The half-life of Elmiron administered intravenously to normal human volunteers and measured by a competitive binding assay was estimated as 22 minutes at a dose of 10 mg and 55 minutes at a dose of 100 mg.
Using tritiated Elmiron given orally to normal volunteers, it was shown that 40 to 60% of the radioactivity was absorbed, and it was calculated that 11% of the dose was excreted in the urine and 78% in the faeces. The data indicated that about 1 - 3% of the Elmiron dose appeared in the urine as unchanged compound resulting in a concentration of Elmiron of up to 12 microgram/mL in the urine 2 to 6 hours after administration.
Using ³⁵S radiolabelled Elmiron given to rats intravenously, it was observed that within 1 hour after injection a large amount of radioactivity was localised in the kidneys with lesser amounts in the liver, lungs, skin, and periosteum.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Microcrystalline cellulose, magnesium stearate, Tekprint SW-9008 Black Ink PI (2328).

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C. Protect from light.

6.5 Nature and Contents of Container

Opaque white hard gelatin capsules imprinted with "ELM" in bottles of 100 capsules.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Prescription Only Medicine (Schedule 4).

Summary Table of Changes