INTRODUCTION

OTIUM GEL is a combination of Diclofenac, Linseed Oil, Menthol and Methyl Salicylate which belongs to the group of medicines called Analgesics, Flaxseed oil, Cooling agents and Organic esters. It is indicated to provide relief from acute musculoskeletal disorders such as sprains, strains, tendonitis, shoulder pain, bursitis, hand, neck, sciatica, muscle stiffness, joint pain, backache and pain of osteoarthritis of joints which is treatable by topical medicines.

OTIUM GEL is not recommended for use in patients who have advanced kidney disease, had asthma, urticaria (allergic reaction) after use of NSAIDs such as aspirin, setting of coronary artery bypass graft surgery, broken or irritated skin.  

OTIUM GEL should not be used in pregnant women especially in the late pregnancy and it should be used with caution in breast-feeding women. It should not be used in children below 2 years of age and children having flu, chickenpox or fever.  

Caution must be exercised while using OTIUM GEL in elderly patients. The most common side effects of using OTIUM GEL are skin rash, oedema, wheals, papules (tender bump), scaly skin, reddening of the skin, itching or prickling sensation may occur at the site of application. Ask for your doctor’s advise if any of these doesn’t improve or worsens.

USES OF OTIUM GEL

Treats pain, swelling and inflammation associated with:

• sprains, strains, tendonitis, shoulder pain, bursitis, hand, neck, sciatica, muscle stiffness, joint pain and backache

HOW OTIUM GEL WORKS

OTIUM GEL helps in relieving aches and pain, where diclofenac is a non-steroidal anti-inflammatory drug which causes relief in pain and inflammation by inhibiting the factors that cause inflammation and pain called prostaglandins. Linseed oil helps in minimizing the skin irritation and soothes and calms the skin. Methyl salicylate is an organic ester, which is derived from plants acts by dilating the blood vessels and increasing the blood flow. It causes irritation of the skin and as a result of counter irritation, there is a sensation of warmth and relief in musculoskeletal pain. Menthol acts by imparting coolness to the skin and then warmth.

DIRECTIONS FOR USE

Apply OTIUM GEL as advised by your physician. It is for topical use only. Wash your hands before and after use. Gently rub OTIUM GEL on the affected area till it disappears. Do not cover the applied areas with a bandage and do not apply on cuts and open wounds. Bathing should be avoided for at least 1 hour after the application of OTIUM GEL. Avoid the contact of this medicine in your eyes, ears or nose and mouth.

Your doctor will decide the duration and frequency of the treatment depending upon your age and disease condition.

SIDE EFFECTS OF OTIUM GEL

HOW TO MANAGE SIDE EFFECTS

Skin redness or itching:

Avoid hot showers because hot water can irritate your skin further. Do not scratch the affected area. Avoid sun exposure or UV rays as it may sensitize your skin. Use sunscreen and protective clothing when going outdoor. Regularly moisturize your skin after consulting the doctor. Consult your doctor if the symptom does not improve.

WARNING & PRECAUTIONS

PREGNANCY

OTIUM GEL should not be used in pregnant women especially in the late pregnancy. Consult your doctor before using it.

BREASTFEEDING

OTIUM GEL should be used with caution in breastfeeding women only if considered clearly necessary. Consult your doctor before using it.

DRIVING AND USING MACHINES

Effects of OTIUM GEL on driving and using machines is not known. Consult with your doctor.

ALCOHOL

Avoid consumption of alcohol while using OTIUM GEL.

KIDNEY

OTIUM GEL is not recommended for use in patients having advanced renal disease. It should be used with caution in patients with impaired kidney function. Consult your doctor before using it.

LIVER

OTIUM GEL should be used with caution in patients having liver diseases. Consult your doctor before using it.

ALLERGY

Do not use OTIUM GEL if you are allergic to Diclofenac, Linseed Oil, Menthol, Methyl Salicylate or other NSAIDs (such as aspirin).

LUNGS

OTIUM GEL is not recommended for use in patients who had an asthmatic attack after the use of NSAIDs such as aspirin or indomethacin. Consult your doctor before using it.

HEART DISEASE

OTIUM GEL is not recommended for use in patients in the setting of coronary artery bypass graft surgery. Consult your doctor before using it.

INTERACTIONS

A. Drug–Drug Interactions:

Before using OTIUM GEL, inform your doctor if you are taking any of the following medicines:

• NSAIDs such as aspirin, ibuprofen (used to treat pain and inflammation), cyclo-oxygenase-2 (COX2) inhibitors such as celecoxib, valdecoxib (used to treat osteoarthritis or rheumatoid arthritis)
• diuretics such as spironolactone, furosemide (used to treat excess fluid in the body)
• cyclosporine, tacrolimus (used to supress immune system such as after transplants)
• lithium, selective serotonin-re-uptake inhibitors (SSRIs) such as citalopram, sertraline (used to treat anxiety and depression)
• digoxin, amiodarone (medicine used in treating an irregular heartbeat or heart failure), antihypertensives such as ramipril, azilsartan (used to lower down the blood pressure)
• warfarin (used as a blood-thinning agents that reduce blood clotting)
• oral hypoglycaemics such as metformin, sitagliptin (used to control blood sugar)
• corticosteroids such as prednisolone (used as anti-inflammatory medicines)
• antacids such as magnesium sulphate (used to treat heartburn, indigestion)
• chloramphenicol, quinolone antibiotics such as ciprofloxacin, moxifloxacin (used to treat some infections)
• ketoconazole, fluconazole, miconazole, voriconazole (used to treat fungal infections)
• sulfinpyrazone (used to treat gout)
• mifepristone (used to terminate pregnancy)
• metoclopramide, domperidone (medicines used to control nausea)
• cholestyramine (used to treat high cholesterol or high blood fats)
• imatinib, methotrexate (used to treat certain cancers)
• sunscreens, cosmetics, lotions, moisturizers, insect repellents

Overdosage:

In case of accidental ingestion or too much application of OTIUM GEL, consult your doctor immediately or visit the nearby hospital.

SYNOPSIS

MORE INFORMATION

• Keep OTIUM GEL out of reach of children
• Store below 30°C

FAQs ABOUT OTIUM GEL

Q: What is OTIUM GEL and why is it prescribed?

A: OTIUM GEL is a combination of diclofenac, linseed oil, menthol and methyl salicylate which belongs to the group of medicines called analgesics, flaxseed oil, cooling agents and organic esters. It is indicated to provide relief from acute musculoskeletal disorders such as sprains, strains, tendonitis, shoulder pain, bursitis, hand, neck, sciatica, muscle stiffness, joint pain, backache and pain of osteoarthritis of joints which is treatable by topical medicines.

Q: What are the precautions I need to take care while using OTIUM GEL?

A: OTIUM GEL is for topical use only. Wash your hands before and after use. Gently rub OTIUM GEL on the affected area till it disappears. Do not cover the applied areas with a bandage and do not apply on cuts and open wounds. Bathing should be avoided for at least 1 hour after the application. External heat should not be given to the treated areas. Exposure to direct sunlight must be avoided after applying OTIUM GEL. Avoid the contact of this medicine in your eyes, ears or nose and mouth.

Q: Can OTIUM GEL be used in pregnant and breast-feeding women?

A: OTIUM GEL should not be used in pregnant women especially in third trimester or late pregnancy. It should be used with caution in breastfeeding women only if clearly advised by the doctor. Consult your doctor before using OTIUM GEL.

Q: Does OTIUM GEL cause skin irritation?

A: Yes, OTIUM GEL may cause skin irritation. OTIUM GEL contains methyl salicylate which acts by dilating the blood vessels and increasing blood flow. It causes irritation of the skin and as a result of counter irritation, there is a sensation of warmth and relief in musculoskeletal pain.

Q: Is OTIUM GEL safe for use in children?

A: OTIUM GEL is not recommended for use in children below 2 years of age. It should not be used in children having flu, chickenpox or fever. OTIUM GEL should be used with caution in children above 2 years of age. Consult your child’s doctor for advice.

REFERENCES

1. K.D. Tripathi. NSAIDs and Antipyretic Analgesics, Drugs Acting on Skin and Mucous Membranes. Essentials of medical pharmacology. Seventh edition. 2013. Page – 204, 888 & 889.

2. Diclofenac Sodium. NIH National Library of Medicine, National center for biotechnology information. Pubchem. [Accessed on 19th July 2022] https://pubchem.ncbi.nlm.nih.gov/compound/Diclofenac

3. Methyl Salicylate. NIH National Library of Medicine, National center for biotechnology information. Pubchem. [Accessed on 19th July 2022] https://pubchem.ncbi.nlm.nih.gov/compound/Methyl-salicylate

4. J V Pergolizzi Jr, R Taylor Jr, J-A LeQuang, R B Raffa, NEMA Research Group. The role and mechanism of action of menthol in topical analgesic products. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. June 2018. [Accessed on 19th July 2022] https://pubmed.ncbi.nlm.nih.gov/29524352/#:~:text=Results%3A%20Menthol%20is%20a%20selective,nociceptors%20and%20then%20desensitizing%20them

5. Gaurav Kaithwas, Dipak K. Majumdar. Effect of L. usitatissimum (Flaxseed/Linseed) Fixed Oil against Distinct Phases of Inflammation. International Scholarly Research Notices. February 2013. [Accessed on 19th July 2022] https://www.hindawi.com/journals/isrn/2013/735158/

6. Cipla Ltd. Omni Gel. Ciplamed. [Revised in February 2020]. [Accessed on 19th July 2022] https://www.ciplamed.com/content/omni-gel

7. Lincoln Pharmaceuticals Limited. Sedimol Roll on gel. [Accessed on 19th July 2022] https://fdaghana.gov.gh/img/pils/Sedimol%20Rollon%20Gel%20(Diclofenac%20Diethylamine+Linseed%20oil+Menthol+Methyl%20Salicylate).pdf

AUTHOR DETAILS

Written By Dr. R. Dinesh John Rajkumar, Pharm.D
Last updated on 14 Jan 2023 | 05:14 PM(IST)