Date: {{$ActivityAssignDate}}

Dear Dr. {{$doctorName}},

Subject: In-Practice Usage and Performance (IPUP) Study of Bilasure 20mg tablets;

Study code: IPUP/Bilasure/Maxxim/May’ 2023.

Allergic rhinitis and urticaria are considered the most significant atopic conditions which affect quality of life. Along with intranasal corticosteroids, leukotriene receptor antagonists like Montelukast, mast cell stabilizers and modern antihistamines are pillars of pharmacotherapy of allergic rhinitis. Bilastine is a modern, non-sedative, second-generation H1 antihistamine which has the highest number of desired features for a modern antihistamine according to international ARIA guidelines, 2018. Its efficacy is comparable to cetirizine and desloratadine in allergic rhinitis, and to levocetirizine in chronic urticaria. Bilastine is longer acting than fexofenadine. Bilastine shows no sedation, no effect on psychomotor and cognitive function and no impairment of driving performance. A 2 times higher than the recommeded dose of bilastine does not impair psychomotor function and safe to use in driving at dose upto 40 mg per day. A 4 times higher than recommnded dose of bilastine dose not increase incidence of sedation. Also, upto 5 times higer than the recommeded dose of bilastine has no cardiotoxicity. Bilastine does not potentiate the central depressant effect of lorazepam and alcohol. Long term safety study up to one year has demonstrated safety of bilastine in perinnial allergic rhinits.

Bilasure tablets (Bilastine 20 mg tablets) are marketed by the ‘Maxxim’ team of Sun Pharmaceutical Industries Ltd. It is approved by DCGI for symtomatic treatment of allergic rhino-conjuctivits (seasonal & perennial) & urticaria in adults.

Although every product is marketed only after regulatory approval, it is important to know how it performs in day-to-day practice of individual medical practitioners. This retrospective study will help to assess the real-life performance of ‘Bilasure’ in patients with allergic rhinitis and urticaria.

We invite you to participate in this study. All you need to do is to report on a standard form your experience with ‘Bilasure’ in 20 consecutive number of patients (to avoid any bias) in whom you prescribe this product in the normal course of your practice. Thus, this is not an experimental / internetional study because the product will be prescribed and purchased as you and your patients normally do.

If you agree to participate, you will need to copy the relevant information from the suggested number of patient’s case papers, and investigational reports, if any (which we call source documents), on to the standard case report forms (which we call CRF).

A monitor will assist you in verifying the CRF with the source documents to ensure that the CRF signed by you are free from errors or omissions. Let us assure you that the CRF will not contain the patients’ names, so as to ensure confidentiality.

If any serious adverse events (AE) occur during ‘Bilasure’ therapy, you will be expected to report them to the monitor or to me immediately on the AE reporting form.

As you will be spending some extra time to keep, copy and verify these patients records, we offer to pay you by cheque a professional fee of Rs. {{$contractAmount}}/- , and accordingly on receiving the completed CRFs.

We trust you and we are partners in promoting safe and effective drug therapy. In that spirit, we hope you will consent to participate in this study. If you do, please sign and return the enclosed reply along with your visiting card for accuracy of records.