Oronac Plus Tablet 10'S

INTRODUCTION

ORONAC PLUS TABLET is a combination of Diclofenac and Paracetamol which belongs to the group of medicines Called Non-steroidal Anti-inflammatory drugs (NSAIDs). It is used to treat and prevent various conditions associated with pain and inflammation such as rheumatoid arthritis (chronic inflammatory condition of joints), ankylosing spondylitis (chronic inflammatory disease of the spine) and osteoarthritis (degenerative joint disorder which is categorized by swelling, stiffness, and painful joints).

ORONAC PLUS TABLET can also be used in the treatment of ear and throat pain, muscle pain, back pain, tooth ache, mensural pain, post-operative or post -traumatic pain and also athletic injuries.

Your doctor may perform complete blood test especially in patients undergoing long term treatment with this medicine to know your existing condition. Along with the treatment your doctor may also monitor for signs and symptoms for gastrointestinal bleeding.

Before taking ORONAC PLUS TABLET, inform your doctor if you have blood clotting disorders, diabetes (high blood sugar), habit of smoking, or raised levels of cholesterol. Avoid consumption of alcohol while taking ORONAC PLUS TABLET because it might aggravate your existing symptoms.

ORONAC PLUS TABLET is not recommended for use in patients having kidney, liver or heart diseases, stomach or intestinal ulcers, gastrointestinal bleeding, or inflammatory intestinal disorders such as Crohn’s disease or ulcerative colitis. Consult your doctor before taking it.

ORONAC PLUS TABLET is not recommended for use in pregnant women especially in third trimester and in breastfeeding women. Consult your doctor before taking it. ORONAC PLUS TABLET is not recommended for use in children below 10 years of age and should be used with caution in elderly patients (aged above 65 years). Consult your doctor before taking.

Most common side-effects of ORONAC PLUS TABLET are nausea, stomach pain, diarrhoea and indigestion. Consult your doctor if any of these side effects worsens or doesn’t improve.

USES OF ORONAC PLUS TABLET

• It is used to treat and prevent various conditions associated with pain and inflammation

HOW ORONAC PLUS TABLET WORKS

ORONAC PLUS TABLET helps in relieving pain and inflammation where Diclofenac and Paracetamol are Non-steroidal anti-inflammatory drugs which works by inhibiting the production of a chemical called prostaglandins in the body which are responsible for causing pain and swelling in the body.

DIRECTIONS FOR USE

Take ORONAC PLUS TABLET as advised by your physician. Swallow ORONAC PLUS TABLET with a glass of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition.

SIDE EFFECTS OF ORONAC PLUS TABLET

HOW TO MANAGE SIDE EFFECTS

Bloating

Eat smaller and more frequent meals. Eat and drink slowly, and exercise regularly. If the symptom does not improve, contact your doctor.

Constipation

Eat plenty of fibre-rich foods such as fresh fruits, vegetables, and cereals and drink plenty of water. Exercise more regularly. Discuss with your doctor if the symptom worsens.

Diarrhea

Drink lots of fluids, such as water or fruit juice to keep yourself hydrated. Do not consume any medicine on your own without consulting your doctor. Discuss with your doctor if the symptom worsens.

Dizziness Or Drowsiness

Lie, or sit down immediately when you feel dizzy. If you're feeling severe episodes of spinning(vertigo), lie in a dark and quiet place with your eyes closed. Try to avoid vehicle driving. Discuss with your doctor if the symptom worsens.

Take adequate sleep. Do not involve in rigorous activities. Do not interfere with your sleep cycle. Talk to your doctor if the drowsiness doesn’t improve.

Dry Mouth

Try chewing sugar-free gum or sugar-free candies to stimulate the flow of saliva. Avoid caffeine-containing drinks. Drink plenty of water to avoid dehydration. Discuss with your doctor if the symptom worsens.

Indigestion

Avoid foods that aggravate your heartburn. Maintain a healthy weight. Avoid lying down after a meal and try to avoid late-night meals. If the symptom does not improve, contact your doctor.

Nausea And Vomiting

Take this medicine with, or just after meals. Stick to simple meals. Avoid eating oil-rich or spicy foods. Discuss with your doctor if the symptom worsens.

Skin Rash Or Itching

Avoid hot baths because hot water can irritate your skin further. Do not scratch the affected area. Use protective clothing when going outdoors. Regularly moisturize your skin and apply calamine lotion as a coolant. Discuss with your doctor if the symptom worsens.

Stomach Pain

Try to rest and relax. Eat and drink slowly or try to have smaller and frequent meals. Keep a heat pad on your stomach. If the symptom does not improve, contact your doctor.

WARNING & PRECAUTIONS

PREGNANCY

Contraindicated

ORONAC PLUS TABLET is not recommended for pregnant women especially in the third trimester as it may cause miscarriage. Women of childbearing potential should use a suitable contraceptive method to avoid getting pregnant while taking ORONAC PLUS TABLET. Consult your doctor before taking aORONAC PLUS TABLET.

BREASTFEEDING

Contraindicated

ORONAC PLUS TABLET is not recommended for use in breastfeeding women as it may pass through the breast milk and may cause adverse effects in foetus. Consult your doctor before taking it.

DRIVING AND USING MACHINES

Monitoring required

Do not drive or operate any machines if you feel headache, blurred vision, dizziness or drowsiness after taking ORONAC PLUS TABLET.

ALCOHOL

Contraindicated

Avoid consumption of alcohol while taking ORONAC PLUS TABLET because it might aggravate your existing symptoms.

KIDNEY

Contraindicated

ORONAC PLUS TABLET is patients not recommended in patients with severe kidney disease such as kidney failure. ORONAC PLUS TABLET should be used with caution in patients having other kidney diseases. Consult your doctor before taking.

LIVER

Contraindicated

ORONAC PLUS TABLET is not recommended in patients with severe liver disease such as liver failure. [GBNKEYOWRD] should be used with caution in patients having other liver diseases. Consult your doctor before taking.

ALLERGY

Monitoring required

Do not take ORONAC PLUS TABLET if you are allergic to Diclofenac, Paracetamol, Aspirin, any other NSAIDs or any other ingredients of this medicine.

HEART DISEASE

Contraindicated

ORONAC PLUS TABLET is not recommended in patients having heart diseases such as congestive heart failure, stroke, mini-stroke, ischemic heart disease (narrowing of arteries causing poor blood flow) peripheral arterial disease or those patients recovering from heart surgery (coronary artery bypass graft surgery). Consult your doctor before taking ORONAC PLUS TABLET.

INTERACTIONS

A. Drug - Drug interactions:

Before taking ORONAC PLUS TABLET, inform your doctor if you are taking any of the following medicine:

• aspirin, ibuprofen (used to treat pain, inflammation, osteoarthritis or rheumatoid arthritis)
• diuretics such as spironolactone, furosemide (used to treat excess fluid in the body)
• cyclosporine or tacrolimus (used for immune system suppression such as after transplants)
• lithium (used to treat some types of depression), citalopram, fluoxetine (used to treat anxiety and depression)
• digoxin, amiodarone (used to treat an irregular heartbeat and/or heart failure), ramipril, atorvastatin (used to treat high blood pressure)
• warfarin (used to reduce blood clotting)
• metformin, sitagliptin (used to control blood sugar)
• methotrexate (used to treat rheumatoid arthritis, psoriasis and leukaemia)
• steroids such as prednisolone (used as anti-inflammatory medicines)
• magnesium-containing antacids (used to treat heartburn, indigestion)
• gatifloxacin, moxifloxacin, or chloramphenicol (used to treat some infections)
• ketoconazole, fluconazole, miconazole, voriconazole (used to treat fungal infections)
• sulphinpyrazole (used to treat gout)
• mifepristone (used to terminate pregnancy)
• metoclopramide, domperidone (used for nausea or sickness)
• colestyramine (used for high cholesterol or high blood fats)
• imatinib (used to treat certain cancers)

Overdosage:

If you or anyone else accidentally take too much of ORONAC PLUS TABLET, consult your doctor immediately or visit the nearby hospital. Symptoms of overdose are lethargy, confusion, disorientation, excitation, coma, tinnitus (ringing in ears) nausea, vomiting, stomach pain, drowsiness, black or bloody stools, coughing blood, shallow breathing and fainting.

SYNOPSIS

MORE INFORMATION

• Keep ORONAC PLUS TABLET out of reach of children
• Store ORONAC PLUS TABLET at room temperature below 30°C

FAQs ABOUT ORONAC PLUS TABLET

How does ORONAC PLUS TABLET works on my body?

ORONAC PLUS TABLET acts as an anti-inflammatory agent as well as a painkiller. It works by inhibiting the production of a chemical called prostaglandins in the body. Which are responsible for causing pain and swelling in the body. As a result, it reduces various pain and swelling in joints.

Is ORONAC PLUS TABLET advised to be taken in pregnancy?

No. ORONAC PLUS TABLET is not recommended for use in pregnant women especially in the third trimester of pregnancy because it may cross the placenta and cause malformations in the foetus. Women of childbearing potential should use a suitable non-hormonal contraceptive method to avoid getting pregnant while taking ORONAC PLUS TABLET. Consult your doctor before taking ORONAC PLUS TABLET.

Does ORONAC PLUS TABLET affects my ability to drive?

Do not drive or operate any machines if you feel headache, blurred vision, dizziness or drowsiness after taking ORONAC PLUS TABLET. You can continue doing your activities as soon as you feel normal again.

Can ORONAC PLUS TABLET cause diarrhoea?

Diarrhoea is the most common problem while taking ORONAC PLUS TABLET and is occasionally severe. You have less chance of getting diarrhoea if you take ORONAC PLUS TABLET with food. If you take an antacid (used to reduce acid in the stomach) you should avoid antacids with magnesium in them as these may make diarrhoea worse. Discuss with your doctor.

Do I need to undergo any tests while taking ORONAC PLUS TABLET?

ORONAC PLUS TABLET may lead to an increase in blood pressure and so, your doctor may advise you to monitor your blood pressure on a regular basis. If you have heart, liver or kidney problems, your doctor will advise regular monitoring of the same.

Can ORONAC PLUS TABLET be used in elderly patients?

ORONAC PLUS TABLET should be used with caution in elderly patients (aged above 65 years) because of the increased risk of side effects such as gastrointestinal (GI) adverse events, including inflammation, bleeding, ulceration and perforation of the stomach or intestines. Consult your doctor before taking ORONAC PLUS TABLET.

REFERENCES

1. KD Tripathi. NSAIDS and Anti-pyretic Analgesics. Essentials of Medical Pharmacology. Eighth Edition, 2019. Page – 220,223.

2. Bayram D, Aydin V, Sanli A, Abanoz MN, Sibic B, Pala S, Atac O, Akici A. Comparison of paracetamol and diclofenac prescribing preferences for adults in primary care. NIH National Library of Medicine, National center for biotechnology information. Pubmed Central. December 2021. [Accessed on 12th November 2022]. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8724224/

3. Tong J Gan. Diclofenac: an update on its mechanism of action and safety profile. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. July 2010. [Accessed on 12th November 2022]. https://pubmed.ncbi.nlm.nih.gov/20470236/

4. Brian J Anderson. Paracetamol (Acetaminophen): mechanisms of action. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. October 2008. [Accessed on 12th November 2022]. https://pubmed.ncbi.nlm.nih.gov/18811827/

5. Cipla Ltd. Reactin Plus Tablets (Diclofenac + Paracetamol). [Revised in December 2019] [Accessed on 12th November 2022] https://ciplamed.com/content/reactin-plus-tablets

6. M/S. Medreich Limited. Dymol (Diclofenac + Paracetamol).[Revised on August 2028] [Accessed on 12th November 2022] https://fdaghana.gov.gh/img/smpc/Dymol%2050mg_500mg%20Tablet%20(Diclofenac%20Sodium%20and%20Paracetamol).pdf

7. Lesanto Laboratories. Dicnac (Diclofenac + Paracetamol). [Accessed on 12th November 2022] https://www.nafdac.gov.ng/wp-content/uploads/Files/SMPC/a_v6/SmPC-DICNAC-550.pdf

8. Creogenic Pharma. Moufen (Diclofenac + Paracetamol). [Accessed on 12th November 2022] https://creogenicpharma.com/project/diclofenac-potassium-paracetamol/

9. Alpha drug. Diclock-P Tab (Diclofenac + Paracetamol). [Accessed on 12th November 2022] https://www.alphadrug.in/product/diclock-p-tab/

10. Franco Indian pharmaceuticals. Relaxyl Plus Tablets (Diclofenac + Paracetamol). Accessed on 12th November 2022] http://www.francoindian.com/products/relaxyl-plus.htm

11. Central Drugs Standard Control Organisation (CDSCO). Diclofenac + Paracetamol. Accessed on 12th November 2022] https://cdscoonline.gov.in/CDSCO/Drugs

USEFUL DIAGNOSTIC TESTS

• Complete blood count

AUTHOR DETAILS

Written By Dr. Priyanka Goel, BDS
Last updated on 29 Jan 2023 | 11:28 AM(IST)