INTERSTITIAL CYSTITIS (IC) MANAGEMENT

INTERSTITIAL CYSTITIS (IC) MANAGEMENT

About Interstitial Cystitis (IC) What is IC? IC is a chronic, yet manageable, bladder condition, characterized by bladder or pelvic pain, pain during or after sexual intercourse, urinary urgency and frequency, and waking one or more times a night to urinate 1,2 What causes IC? While the exact cause is unknown, may be caused by a breakdown of the protective lining of the bladder, the mucous layer that lines and protects the bladder wall. Damage to this layer may allow irritating substances in the urine to aggravate and inflame the bladder wall, resulting in pain. Irritation substances in the urine Bladder mucosal lining (glycosaminoglycan layer) Who gets IC? Anybody can have IC-men or women of almost any age 3 In fact, recent studies have revealed IC to be far more prevalent than previously thought 4,5 Why at certain times, a symptom gets worse? Certain factors such as allergies, the premenstrual cycle and sexual intercourse may trigger or worsen IC symptoms 6 Irritated nerve Urothelium In ammation

IC is treatable What are different treatment options? IC can be treated with a combination of treatment methods 7, 8 Lifestyle Modifications Dietary adjustments 7 Avoid spicy or acidic foods and beverages containing caffeine and alcohol Stress reduction 7 Make use of support groups 7, 8 Allowable foods include rice, pasta, potatoes, as well as chicken and meat Medications While being treated for IC, you may be prescribed a combination of medicines for optimal symptom control COMFORA (Pentosan Polysulphate sodium) is the only FDA-approved oral therapy indicated for the relief of bladder pain or discomfort associated with IC Intravesical instillation, including DMSO or other agents, may be used to treat symptom flares Bladder training 8 Practice scheduled voiding patterns Gentle stretching and pelvic floor muscle relaxation exercises

About COMFORA COMFORA (Pentosan Polysulfate Sodium) is the only FDA-approved oral therapy indicated for the relief of bladder pain or discomfort associate with IC How does COMFORA work? Although the exact way that COMFORA works is not completely understood, it is believed to act as a buffer, preventing potentially irritating substances in the urine from reaching the bladder wall COMFORA may help address an underlying issue of IC, as well as the symptoms of bladder pain and/or discomfort Replenished protective lining What's Next Step? Frequent follow-up visits to monitor your progress Visit www.comfora.in to enrol in a helpful patient support program and access valuable product information. For additional information on IC, please visit www.comfora.in Irritation resolved

Treatment with COMFORA What should I expect with COMFORA? COMFORA has helped many people with IC and it may help you. Studies show that COMFORA relieves bladder pain, in some patients, in as soon as 3 months Few important point to remember: A single 100mg capsule of COMFORA should be taken 3 times a day Symptom improvement is generally gradual and relief may require 3 to 6 months of continuous therapy. Therefore it is very important that you take COMFORA as directed and stick with it While you may use other IC treatment options as needed, you should continue to take COMFORA until otherwise instructed by your healthcare professional Do not stop taking COMFORA or reduce your dosage just because you are feeling better or because you think COMFORA may not be working right way If you don't experience improvement within 6 months, talk to your healthcare professional. You may not benefit from continued treatment

Reference: 1. Hanno PM. Interstitial cystitis and related disorders. In: Walsh PC, ed-in-chief; Retik AB, Vaughan ED Jr, Wein AJ, eds; Kavoussi LR, Novick AC, Partin AW, Peters CA, associate eds. Campbell s Urology. Vol 1. 8th ed. Philadelphia, PA; Saunders; 2002:631-670. 2. National Kidney and Urologic Diseases Information Clearinghouse. Interstitial cystitis/painful bladder syndrome. http://kidney.niddk.nih.gov/kudiseases/pubs/interstitial cystitis. Published May 2005. Accessed September 21, 2007. 3. Forrest JB. Epidemiology and quality of life. J Reprod Med. 2006;51(suppl):227-233 4. Clemens JQ, Meenan RT, O Keeffe Rosetti MC, Gao SY, Calhoun EA. Prevalence and incidence of interstitial cystitis in a managed care population. J Urol. 2005; 173:98-102. 5. Rosenberg MT, Hazzard M. Prevalence of interstitial cystitis symptoms in women: a population based study in the primary care office. J Urol. 2005; 174:2231-2234. 6. Parsons CL. Interstitial cystitis: epidemiology and clinical presentation. Clin Obstet Gynecol. 2002; 45:242-249. 7. Whitmore KE. Self-care regimens for patients with interstitial cystitis. Urol Clin North Am. 1994; 21:121-130. 8. Dell JR, Parsons CL. Multimodal therapy for interstitial cystitis. J Reprod Med. 2004; 49(suppl): 243-252. COMFORA is indicated for the relief of bladder pain or discomfort associated with interstitial cystitis. IMPORTANT SAFETY INFORMATION Pentosan Polysulfate Sodium is a weak blood thinner (anticoagulant), which may increase bleeding. Patients undergoing surgery or who have an increase risk of bleeding should be evaluated for the risk of haemorrhage. In an 8-years retrospective study, adverse events tended to be infrequent, mild, and transient. Diarrhoea, nausea, alopecia (reversible upon discontinuation), headache, rash, dyspepsia, abdominal pain, liver function abnormalities, and dizziness occurred at a frequency of 1% to 4%. In a 32-week study, 6.3% of 128 patients reported rectal haemorrhage. The severity was described mild in most patients. COMFORA is contraindicated in patients with known hypersensitivity to the drug, structurally related compounds, or excipients. The mechanism of action of COMFORA in interstitial cystitis is not fully understood.