INTRODUCTION

PANIMUN BIORAL contains Cyclosporin which belongs to the group of medicines called immunosuppressive agents. Immunosuppressive agents are the drugs that suppress or reduces the strength of body’s immune system. It is used to prevent graft rejection in patients who have had an organ transplant, bone marrow and stem cell transplantation.

It can also be used to treat various autoimmune disease like severe rheumatoid arthritis, nephrotic syndrome (kidney disease), eye problems (endogenous uveitis, including Behçet's uveitis) and skin diseases (atopic dermatitis, or eczema and psoriasis). Cyclosporin blocks the development of cells which attack the affected transplanted tissue and suppress abnormal immune function thus preventing the rejection of transplanted organs.

Limit your exposure to sunlight and UV light by wearing protective clothing and by applying a sunscreen to prevent skin cancer. Avoid consumption of alcohol or grapefruit juice while taking this medicine. This medicine should not be given to children for any non-transplant disease, except for nephrotic syndrome. Do not take this medicine if you have any uncontrollable infection or any type of cancer. Consult your doctor for advice.

USES OF PANIMUN BIORAL

• Prevents the rejection of transplanted organs
• Treats severe rheumatoid arthritis
• Treats nephrotic syndrome (kidney disease)
• Treats eye problems such as endogenous uveitis, including Behçet's uveitis
• Treats skin diseases such as atopic dermatitis, or eczema and psoriasis)

HOW PANIMUN BIORAL WORKS

Cyclosporin works by inhibiting the production of various cytokines involved in the regulation of T-cell activation. These effects of cyclosporine on T cells and on connective tissue cells can produce a range of cytokines. These in turn promote antibody (Ab) secreting plasma cells which finally bind and inactivate the antigen.

DIRECTIONS FOR USE

Take this medicine as directed by your physician. Your doctor will decide the correct dose for you depending upon your condition. Avoid drinking grapefruit juice while taking this medicine.

SIDE EFFECTS OF PANIMUN BIORAL

HOW TO MANAGE SIDE EFFECTS

Nausea or vomiting:

Try taking this medicine with, or just after meal. Stick to simple meals. Do not eat rich or spicy food.

Constipation: 

Eat fibre rich foods like fresh fruit, vegetables and cereals. Drink plenty of water. Exercise more regularly.

Diarrhea:

Drink lots of fluids to avoid dehydration. Avoid taking any medicines for diarrhoea without speaking to a doctor.

Stomach pain:

Try to rest and relax. You can eat and drink slowly or have smaller and frequent meals. Keeping a heat pad on your stomach may also help. If still pain persists, speak to your doctor.

WARNING & PRECAUTIONS

INTERACTIONS

Talk to your doctor, if you are taking,

• medicines that affects your potassium levels (e.g. spironolactone, aldosterone)
• medicines used for heart problems or high blood pressure (e.g. diltiazem, nicardipine, verapamil, amiodarone, nifedipine or digoxin)
• medicines used to treat epilepsy (e.g. carbamazepine or phenytoin)
• medicines used to treat HIV (e.g. saquinavir, indinavir, ritonavir)
• antibiotics (used to treat infections) e.g. erythromycin, gentamycin, tobramycin, ciprofloxacin
• anti-fungal agents (used to treat fungal infection) e.g. voriconazole, terbinafine, amphotericin B)
• cholic acid and derivatives (used to treat gallstones)
• telaprevir (used to treat hepatitis C).
• barbiturates (used to induce sleep)
• octreotide (used to treat acromegaly)
• orlistat (used to help weight loss)
• St. John’s wort (used to treat depression)
• ticlopidine (used after a stroke)
• repaglinide (oral anti-diabetic medicine)
• ambrisentan (used to treat pulmonary arterial hypertension)

SYNOPSIS

MORE INFORMATION

Store below 20-25°C and keep out of reach of children.

FAQs ABOUT PANIMUN BIORAL

Can PANIMUN BIORAL cause cancer?

Yes. This medicine increases your risk of developing cancers, particularly of the skin and lymphoid system. Limit your exposure to sunlight and UV light by wearing appropriate protective clothing and applying a sunscreen with a high protection factor often while taking this medicine.

Can PANIMUN BIORAL cause unwanted hair growth?

Yes. The common side effects of this medicine is excessive growth of body and facial hair However, if you experience any unusual symptoms, contact your physician.

REFERENCES

1. KD Tripathi. Immunosuppressant drugs. Essentials of medical pharmacology. Seventh edition. 2013. Page – 878-881.

2. Alan M. Krensky, William M. Bennett and Flavio Vincenti. Immunosuppressants, Tolerogens and Immunostimulants. Goodman & Gilman’s: The pharmacological basics of therapeutics. 12th Edition. New York, New York: McGraw-Hill Medical, 2011. Page – 1009-1012.

3. Russian Academy of Medical Sciences. Study Cyclosporine (CsA) Versus Tacrolimus (Tacro) After Campath Induction in Kidney Transplantation (RSCS-Campath). NIH U.S. National library of medicine Clinical trials.gov. May 2016 [Accessed 26th October 2020] https://clinicaltrials.gov/ct2/show/NCT01346397

4. University Hospital. Cyclosporine A Pretreatment and Kidney Graft Function (Cys-A-Rein). NIH U.S. National library of medicine Clinical trials.gov. 20th September 2020. [Accessed 26th October 2020] https://clinicaltrials.gov/ct2/show/NCT02907554

5. Karl Stonecipher. Innovative Medical. Efficacy of Cyclosporine for the Prevention and Treatment of Dry Eye Symptoms Following LASIK or Photorefractive Keratectomy. NIH U.S. National library of medicine Clinical trials.gov. September 2008. [Accessed 26th October 2020] https://clinicaltrials.gov/ct2/show/NCT00349440

6. G Wells, D Haguenauer, B Shea, M E Suarez-Almazor, V A Welch, P Tugwell. Cyclosporine for rheumatoid arthritis. NIH: National Library of Medicine, National center of biotechnology Information Pubmed.gov. 2000. [Accessed 26th October 2020] https://pubmed.ncbi.nlm.nih.gov/10796412/

7. Novartis Pharmaceuticals. Verification Study of Ciclosporin for Atopic Dermatitis. NIH U.S. National library of medicine Clinical trials.gov. November 2011. [Accessed 26th October 2020] https://clinicaltrials.gov/ct2/show/NCT00232076

8. Dustin Tedesco and Lukas Haragsim. Cyclosporine: A Review. NCBI; PMC US National Library of Medicine, National Institute of Health. January 2012. [Accessed 27th October 2020] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3259474/

9. Novartis Pharmaceuticals UK Limited. Electronic Medicines Compendium (EMC); [Revised on March 2020] [Accessed 26th October 2020] https://www.medicines.org.uk/emc/files/pil.1034.pdf

USEFUL DIAGNOSTIC TESTS

• Rheumatoid Factor - Agglutination
• Rheumatoid Factor - Turbidometry
• Rheumatoid Factor IgG Antibody