100 mg capsule, hard 
pentosan polysulphate sodium

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

– Save this information, 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 give it to others. It may harm them, even if they show symptoms similar to yours.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information.

In this leaflet you will find information about: 
1. What Elmiron is and what it is used for 
2. What you need to know before you use Elmiron 
3. How to use Elmiron 
4. Possible side effects 
5. How to store Elmiron 
6. Contents of the packaging and other information 

1. What Elmiron is and what it is used for

Elmiron is a medicine that contains the active substance pentosan polysulphate sodium. Once you have taken the medicine, it is excreted in the urine and settles on the inside of the bladder to form a protective layer. Elmiron is used in adults to treat interstitial cystitis which is characterized by many small bleedings or obvious damage to the wall of the bladder as well as moderate to severe pain and a need to urinate frequently.

2. What you need to know before using Elmiron

Do not use Elmiron

Do not take Elmiron if you

• is allergic to pentosan polysulphate sodium or any of the other ingredients of this medicine (listed in section 6);

• bleeding (other than during menstruation)

Warnings and cautions

Talk to your doctor or pharmacist before taking Elmiron if you

• must be operated on,

• has a disorder that affects the blood’s coagulation or an increased risk of bleeding, e.g. if you are taking a medicine that inhibits blood clotting,

• have ever had a reduced platelet count due to a medicine called heparin ;

• has impaired liver or kidney function.

Rare cases of diseases of the retina of the eye ( maculopathy ) have been reported with the use of Elmiron (especially after prolonged use). Talk to your doctor immediately if you experience vision-related changes such as reading difficulties, visual distortions, altered color vision, and/or slower adaptation to dim or reduced light. Your doctor will discuss with you whether to continue treatment. To detect changes in the retina early, eye examinations will be performed regularly.

Children and young people

Elmiron is not recommended for use in children below 18 years of age 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. You must tell your doctor or pharmacist if you are taking medicines that block the blood’s ability to coagulate, such as painkillers that reduce the blood’s ability to coagulate.

Pregnancy, breastfeeding, and fertility

Elmiron should not be used during pregnancy and lactation.

Driving and using machines

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

elmiron contains excipients

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

3. How to use Elmiron

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

The recommended dose is:

1 capsule, 3 times daily

Your doctor will assess how you respond to Elmiron every six months.

How to take the capsules

Swallow the capsules whole with a glass of water, at least 1 hour before or 2 hours after a meal.

If you use more Elmiron than you should 

Tell your doctor if you have taken too many capsules. Stop taking Elmiron if you get side effects until they stop.

If you forget to use Elmiron

Do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Adverse reactions with the following frequencies have been observed:

Common (may affect up to 1 in 10 people):

• infection is, flu

• headache, back pain

• dizziness

• nausea, indigestion, diarrhea, abdominal pain, distended abdomen

• bleeding from the rectum

• fluid retention in arms or legs

• hair loss

• weakness, pelvic pain (lower abdomen)

• need to urinate more often than usual

• abnormal liver function

Uncommon (may affect up to 1 in 100 people):

• lack of platelets, red or white blood cells

• bleeding, including minor bleeding under the skin

• allergic reactions increased photosensitivity

• lack of appetite, weight gain, or weight loss

• severe mood swings or depression

• increased sweating, insomnia

• restlessness

• abnormal sensations such as tingling, burning, or numbness

• tear formation, impaired vision (amblyopia)

• tinnitus (ringing in the ears)

• difficulty breathing

• indigestion, vomiting, gas, difficulty emptying the bowel

• sores in the mouth

• skin rash, enlarged liver spots

• joint or muscle pain

No known frequency: can not be calculated from the available data

• disturbance of the blood’s ability to coagulate

• allergic reactions

• abnormal liver function

5. How to store Elmiron

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

• jar Used before the expiry date which is stated on the label and carton after “EXP.” or “EXP”. The expiration date is the last day of the specified month.

Close the bottle tightly. Moisture sensitive. Used within 45 days after first opening. Get rid of any leftover capsules when that period is over.

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

Do not store above 30 ° C.

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

6. Contents of the packaging and other information

Content declaration

The active substance is pentosan polysulphate sodium. One hard capsule contains 100 mg of pentosan polysulfate sodium.

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

What the medicine looks like and the contents of the pack

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

• can

Each carton contains 90 capsules.

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

• blister

Each carton contains 90 capsules.

Not all pack sizes may be marketed.

Marketing Authorization 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

FI, SE

Navamedic AB,

Göteborgsvägen 74,

Tel: +46 (0) 31 3351190,

infose@navamedic.com

Muhammad Nadeem

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