Elmiron

Active Pharmaceutical Ingredient	Volume (for 1 Capsule)
Pentosan Polysulfate	100mg

Excipients: Microcrystalline cellulose, colloidal anhydrous silica

Bladder Pain Syndrome/Interstitial Cystitis and Elmiron

Elmiron is used to treat Painful Bladder Syndrome or Bladder Pain Syndrome, also known as Chronic Cystitis. Interstitial Cystitis (IC) is a chronic inflammatory disease that can cause recurrent abdominal and pelvic discomfort or pain in the absence of urinary infection.
The active ingredient pentosan polysulfate sodium works by mimicking and strengthening the GAG (glucosaminoglycan) layer that covers the inner surface of the bladder. This makes the bladder more resistant to harmful substances and reduces inflammation. It may help relieve pain and discomfort associated with IC. Protection of the bladder wall helps reduce pain by preventing irritants from penetrating the bladder wall. It can also reduce urinary frequency and urgency by helping protect the bladder against irritants.

Frequently Asked Questions About Bladder Pain Syndrome/Interstitial Cystitis and Elmiron

What are the symptoms of Bladder Pain Syndrome/Interstitial Cystitis?

Dysuria (burning and pain during urination),
Abdominal and pelvic discomfort,
Increased bladder pressure sensation,
Bladder and tenderness and intense pain in the pelvic areas,
Pain generally increases during menstruation and may intensify during and after sexual intercourse.
Pain is also known to increase with bladder filling and relieve following bladder emptying.
It consists of increased urinary frequency and urgency or a combination of these.

What is meant by frequency here is the need to urinate more frequently than normal. Normally, a person urinates on average up to seven times a day and does not have to get up at night to use the toilet. The patient with interstitial cystitis usually wants to urinate frequently, both during the day and at night. As this frequency increases, it gradually causes a sudden feeling of urgency.
Sudden urgency is a common symptom of Interstitial cystitis. Some patients feel a constant urge to urinate that never goes away, even after urinating immediately. Others may not feel this urge as much. Bladder pain may worsen as the bladder of interstitial cystitis patients fills. Some Interstitial cystitis patients experience pain in other areas besides the bladder. Pain may be felt in the urethra, lower abdomen, back of the waist, or in the pelvic or perineal area. Women may feel pain in the vulva or vagina, and men may feel pain in the scrotum, testicles, or penis. Pain may be continuous or intermittent.

What are the conditions that trigger and increase the symptoms of cystitis?

Some people’s symptoms become worse with certain foods or drinks (usually acidic).
Many patients also report that their symptoms are worse when they are stressed (physical or mental stress).
The symptoms vary with the menstrual cycle. may change. Increasing pain attacks may occur during menstruation.
Both men and women with interstitial cystitis may experience difficulties in sexual activity. Because the bladder is right in front of the vagina, women may experience pain during intercourse. Men may also experience painful orgasm or pain the next day.

How is bladder pain diagnosed?

Making a diagnosis of Bladder Pain Syndrome (MAS/IC) is very difficult due to the differences in the presenting complaints and the lack of definitive diagnostic criteria.
Taking the patient’s history carefully. (Important points in the patient’s history: character of the pain, triggering factors, usually acidic diet)
Exclusion of other pathologies that may cause chronic pelvic pain,
Evaluation with urine analysis and urine culture when necessary
Bladder examination via cystoscopy Imaging of the inner surface is often used as an auxiliary diagnostic method. According to the general opinion based on the literature and guidelines, detecting glomerulation is not necessary for diagnosis.

What causes bladder pain?

In the studies conducted and in patients diagnosed with IC, the most common condition was the feeling of discomfort and pain caused by urination as a result of openings, defects, and lesions in the glycosaminoglycan layer in the bladder mucosa.
The glycosaminoglycan layer covering the bladder mucosa prevents the permeability of the bladder wall to urine. It enables the formation of an epithelial barrier. This barrier prevents substances such as urea and calcium in the urine from damaging the bladder wall. Pain, which is the most important symptom of the disease, is thought to be caused by substances in the urine.

Who gets bladder pain?

Although the disease begins around the age of 40 on average, 25% of patients are under the age of 30. Studies show that IC disease is very common and can be seen in almost 20% of women. The female/male ratio is approximately 10:1.

How is cystitis treated?

There are many available treatment options for painful bladder syndrome to help relieve symptoms such as bladder pain and sudden and frequent urination. One of the most effective of these is pentosan treatment. The most common mistake is to stop treatment if there is no response during pentosan treatment or to stop treatment relying on the improvement in symptoms during treatment. Patients receiving Pentosan treatment should continue to use the drug without interruption under the supervision of a doctor for at least 3 or 6 months. Otherwise, the treatment may not be completed.

What needs to be done to prevent recurrence of the disease?

Avoiding foods that can irritate the bladder;
Avoiding certain activities or stresses that can worsen interstitial cystitis.
The specific foods or activities that affect interstitial cystitis are different for different patients, so each person will need to create their own individual plan.
In order to get the best response from drug treatment, patients must pay attention to their diet and urine alkalinization. Acidic foods and drinks make urine acidic. For this reason, the feeling of pain increases due to irritation on the inner surface of the bladder. Paying attention to these parameters along with drug treatment contributes to faster and more effective recovery.

What is the role of PPS (Pentosan Polysulfate Sodium) in the treatment of cystitis?

According to the guidelines published by the European Association of Urology, Pentosan Polysulfate is the only oral agent with an evidence level of 1a and a recommendation level of “strong”.
It is the only oral drug in the world approved by the FDA (Food And Drug Administration) in 1996 with the IC indication.
/>PPS is the most studied treatment among the treatment options proposed so far for AMS (Painful Bladder Syndrome).

What is ELMIRON and what is it used for?

ELMIRON is presented as a white, opaque, colored capsule
containing 100 mg pentosan polysulphate sodium. Each box contains 100 capsules. ELMIRON is used in the treatment of interstitial cystitis (painful bladder syndrome; frequent urination and a feeling of constant pain and discomfort in the space surrounded by the pelvis, called the pelvis).

What are the things to consider before using ELMIRON?

DO NOT USE ELMIRON in the following cases
• Do not use ELMIRON if you are allergic to pentosan polysulphate sodium, related compounds or any of the other components.
ELMIRON. USE WITH CARE in the following cases
If,
• Coumarin anticoagulants (anti-clotting medicine used to prevent clots and prevent the formation of clots from growing), heparin
(anticoagulant drug used to prevent dangerous blood clots that may occur during or after surgery and to control various heart, lung and circulatory system diseases that increase the risk of clot formation), tPA (anti-heart attack). causing
a “clot busting” drug that can dissolve a blood clot in a coronary artery), streptokinase
(an enzyme that prevents blood clotting by converting plasminogen to plasmin and dissolves the existing clot), high dose aspirin or ibuprofen If you are being treated with anti-inflammatory drugs (medicine used to relieve arthritis, flu symptoms and
painkillers) Gastrointestinal lesions (sores in your digestive tract), aneurysms (balloon-shaped protrusions in your blood vessels) or diverticula (inner lining of your intestine). If you have a high risk of bleeding due to diseases such as: If it applies to you, even during the period, please consult your doctor.
Using ELMIRON with food and drink
1 hour before meals or 2 hours after meals with water.
Pregnancy
Consult your doctor or pharmacist before using the medicine.
If you are pregnant or thinking of becoming pregnant, tell your doctor before starting treatment with ELMIRON.
If you notice that you are pregnant during your treatment, consult your doctor or pharmacist immediately.
Breastfeeding
Consult your doctor or pharmacist before using the medication.
Whether this medication is excreted in mothers milk. is unknown. Since many drugs can pass into human milk, it is recommended that breastfeeding mothers be careful if ELMIRON is administered.

How is it used together with other drugs?

Since ELMIRON is a weak anticoagulant (blood thinner), inform your doctor or pharmacist if you are taking any other anticoagulant treatment such as warfarin, high dose aspirin and nonsteriodal anti-inflammatory drugs (NSAIDs) (e.g. ibuprofen).
This warning will last for a certain period of time. Please note that it can also be applied to products that have been used before or will be used at some time in the future.
If you are currently using or have recently used any prescription or non-prescription medication, please inform your doctor or pharmacist about them.

How to use ELMIRON?

Instructions for proper use and dose/administration frequency:
ELMIRON is applied as 1 capsule 3 times a day.
If your condition does not improve after 3 months or if your condition worsens, inform your doctor.
Route of administration. and method:
ELMIRON is for oral use only.
The capsule is taken with water 1 hour before meals or 2 hours after meals.
Your doctor will inform you how long your treatment with ELMIRON will last.
Different age groups
Use in children
There is no data on its safety and effectiveness in children under 16 years of age and adolescents.
Use in the elderly
There is no data on its use in the elderly.
Special usage situations
There are no special usage situations.
If you have the impression that the effect of ELMIRON is too strong or weak,
talk to your doctor or pharmacist.
If you have used more ELMIRON than you should.
If you have used more ELMIRON than you should, talk to a doctor or pharmacist.
If you forget to use ELMIRON:
If you forget to take your medicine, take this dose as soon as you realize you forgot and take the next dose at the usual time. .
If it is almost time for the next dose when you realize that you have forgotten to take your medicine,
skip the dose you forgot.
Do not take a double dose to compensate for the forgotten doses.
Possible effects when treatment with ELMIRON is terminated:
Not available.

What are the possible side effects of Elmiron?

Instructions for proper use and dose/administration frequency:
ELMIRON is applied as 1 capsule 3 times a day.
If your condition does not improve after 3 months or if your condition worsens, inform your doctor. .
Application route and method:
ELMIRON is for oral use only.
The capsule is taken with water 1 hour before meals or 2 hours after meals.
Your doctor will tell you how long your treatment with ELMIRON is. It will inform you that it will continue.
Different age groups
Use in children
There is no data on the safety and effectiveness in children and adolescents under 16 years of age.< br />Use in the elderly
There is no data on its use in the elderly.
Special use cases
No special use case.
If you have the impression that the effect of ELMIRON is too strong or weak, talk to your doctor or pharmacist.
If you have used more ELMIRON than you should, consult a doctor or pharmacist. Talk to.
If you forget to take ELMIRON:
If you forget to take your medicine, take this dose as soon as you realize you forgot and take the next dose at the usual time.
If you realize you have forgotten to take your medicine, take the next dose If the time is near,
Skip the dose you forgot.
Do not take a double dose to compensate for the forgotten doses.
Possible effects when treatment with ELMIRON is terminated:
None.

How to store ELMIRON?

Keep ELMIRON in its packaging and out of sight and reach of children. It should be stored at room temperature below 25˚C, in a dry place, protected from light. Use in accordance with expiration dates. Do not use ELMIRON after the expiration date on the packaging. Do not throw away expired or unused medicines! Give it to the collection system specified by the Ministry of Environment and Urbanization 7 / 7.