Specification
INTRODUCTION
OTONAC SR 200MG TABLET is used to relieve pain and reduce redness and swelling (inflammation) in patients suffering from osteoarthritis (arthritis of the joints) which commonly occurs in patients over the age of 50 and causes the loss of the cartilage and bone tissue next to the joint.
It also treats rheumatoid arthritis (an autoimmune disorder that causes chronic inflammation of the joints) and ankylosing spondylitis (arthritis of the spine which can lead to fusion of the vertebrae).
OTONAC SR 200MG TABLET is not recommended for use in patients with a stomach ulcer, severe kidney disease, heart disease (heart attack), cerebrovascular disease (such as stroke or transient ischemic attack) or blockage of blood vessels to the heart or brain, peripheral arterial disease (poor blood circulation to extremities of the body), severe liver failure and blood clotting disorders.
Before taking OTONAC SR 200MG TABLET, inform your doctor if you have diabetes, raised cholesterol or triglyceride levels, a rare inherited disorder like porphyria, systemic lupus erythematous or other connective tissue disorders and if you are recovering from major surgery or have a habit of smoking.
OTONAC SR 200MG TABLET is not recommended for use in pregnant and breastfeeding women unless advised by the doctor. Consult your doctor before taking this medicine.
OTONAC SR 200MG TABLET is not recommended for use in children and adolescents (under 18 years of age). OTONAC SR 200MG TABLET should be used with caution in elderly patients due to the increased risk of serious side effects.
The most common side effects of taking OTONAC SR 200MG TABLET are dizziness, nausea and diarrhoea. Consult your doctor if any of the side effects worsen.
USES OF OTONAC SR 200MG TABLET
OTONAC SR 200MG TABLET is used to relieve pain and reduce redness and swelling (inflammation) in patients suffering from:
Osteoarthritis (arthritis of the joints)
Rheumatoid arthritis (an autoimmune disease that causes chronic inflammation of joints)
Ankylosing spondylitis (arthritis of the spine)
HOW OTONAC SR 200MG TABLET WORKS
OTONAC SR 200MG TABLET works by exhibiting anti-inflammatory and painkiller properties by blocking the enzyme cyclo-oxygenase, which is involved in the production of prostaglandins which are responsible for causing pain and inflammation (swelling).
DIRECTIONS FOR USE
Take OTONAC SR 200MG TABLET as advised by your physician. It can be taken with or after food.
For Tablet, Capsule: Swallow OTONAC SR 200MG TABLET with alass of water. Do not crush or chew the medicine.
For Dispersible Tablet:?Disperse the medicine in the specified quantity of water as mentioned on the label. Consume the medicine immediately after reconstitution.
Your doctor will decide the correct dose and duration for you depending on your age, body weight and disease condition.
SIDE EFFECTS OF OTONAC SR 200MG TABLET
COMMON
Dizziness
Nausea, diarrhoea
Increased liver enzymes in the blood
UNCOMMON
Inflammation or irritation of the lining of the stomach (gastritis), vomiting
Flatulence, constipation
Mouth ulcers
Itching, rash, inflammation of the skin
Red itchy, stinging or burning patches on the skin (hives)
Elevated blood urea or creatinine levels
RARE
Hypersensitivity (allergic reaction)
Visual disturbance
Shortness of breath
Heart failure
High blood pressure
Bleeding from the stomach or bowel
Stomach or bowel ulceration
Stop taking OTONAC SR 200MG TABLET and contact your doctor immediately if you experience any of the following side effects:
Severe allergic reaction (signs include fever, difficulty breathing, wheezing, abdominal pain, vomiting and swelling of the face and throat)
Severe skin rashes such as Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis symptoms such as fever, headache and aching of the joints, skin peeling and blisters
Meningitis (signs include high fever, headache, vomiting, blotchy red rashes, neck stiffness, sensitivity and intolerance to light)
Kidney failure
Passing blood in your faeces (stools/motions) or passing black tarry stools, blood vomiting
Indigestion or heartburn, abdominal pain
Blood disorders such as reduced production of blood cells, abnormal breakdown of red blood cells (haemolytic anaemia), low content of iron in the blood, low level of white blood cells, decreased platelet count and increased potassium levels (signs include extremely tired, breathlessness, aching of the joints and prone toet repeated infections and bruising)
HOW TO MANAGE SIDE EFFECTS
Nausea or Vomiting:
Take this medicine with or just after meals. Stick to simple meals. Try to avoid oil-rich or spicy foods, sugary snacks and drinks. Try to drink liquid slowly along with your meals or in between meals. Consult your doctor if your symptom is not improving.
Constipation:
Take fibre-rich foods in your diet such as fresh fruits, vegetables and wholerain cereals and drink plenty of fluids. Exercise more regularly (such as daily walk) and stay active. Consult your doctor if the symptom does not improve.
Diarrhoea:
Drink lots of fluids, such as water or fruit juices to keep yourself hydrated. Avoid taking any medicine on your own for treating diarrhoea. Consult your doctor if the symptom did not improve. ?
Stomach pain:
Rest and relax. Eat and drink slowly or try to have smaller and frequent meals. Keep a heating pad on your stomach. Do not self-treat on your own and consult your doctor if the symptom did not improve on their own.
Dizziness:
Try to rest and relax.et enough sleep. Avoid driving or operating any tools or machines while you are feeling dizzy. Do not consume alcohol as it can aggravate your dizziness. Consult your doctor if the symptom did not improve.
WARNING & PRECAUTIONS
PREGNANCY
OTONAC SR 200MG TABLET is not recommended for use in pregnant women unless advised by the doctor. It must not be used during the last three months of pregnancy. Consult your doctor before taking OTONAC SR 200MG TABLET.
BREASTFEEDING
OTONAC SR 200MG TABLET is not recommended for use in breastfeeding women unless advised by the doctor as it is not known if it passes through the breast milk. Consult your doctor before taking OTONAC SR 200MG TABLET.
DRIVING AND USING MACHINES
Do not drive or operate any machines if you feel dizziness, drowsiness, vertigo, tiredness or any visual disturbances after taking OTONAC SR 200MG TABLET.
KIDNEY
OTONAC SR 200MG TABLET is not recommended for use in patients with severe kidney disease. It should be used with caution in patients with kidney disease. Consult your doctor before taking OTONAC SR 200MG TABLET.
LIVER
OTONAC SR 200MG TABLET is not recommended for use in patients with severe liver failure. It should be used with caution in patients with liver disease. Consult your doctor before taking OTONAC SR 200MG TABLET.
ALLERGY
Do not take OTONAC SR 200MG TABLET if you are allergic to Aceclofenac, aspirin or any other nonsteroidal anti-inflammatory drugs (NSAIDs) (such as ibuprofen, naproxen or diclofenac).
LUNGS
OTONAC SR 200MG TABLET should be used with caution in patients with asthma or breathing problems. Consult your doctor before taking OTONAC SR 200MG TABLET.
HEART DISEASE
OTONAC SR 200MG TABLET is not recommended for use in patients with heart attack and blockages to blood vessels of the heart. It should be used with caution in patients with angina (chest pain) and high blood pressure. Consult your doctor before taking OTONAC SR 200MG TABLET.
OTHERS
OTONAC SR 200MG TABLET is not recommended for use if you have:
Stomach ulcer or blood vomiting or passed blood in your faeces (black tarry stools)
Cerebrovascular diseases such as stroke or mini-stroke (TIA)
Blockages of blood vessels to the brain
An operation to clear or bypass blockages
Blood circulation (peripheral arterial disease)
Suffer from bleeding or any type of blood clotting disorders
Acute rhinitis or urticaria
Active peptic ulcer
Before taking OTONAC SR 200MG TABLET, inform your doctor if you:
Have stomach orut/bowel disorders such as inflammatory bowel disease (ulcerative colitis), chronic inflammatory bowel disease (Crohn?s disease), ulceration, bleeding or perforation of the stomach or bowel
Have problems with blood circulation to the brain
Have a rare inherited disorder like porphyria
Are smoker
Have diabetes
Have blood clots, raised cholesterol or raised triglycerides
Are suffering from systemic lupus erythematous (autoimmune disorder) or other connective tissue disorders
Are infected with chicken pox
Are recovering from major surgery
Use in pediatrics:
OTONAC SR 200MG TABLET is not recommended for use in children and adolescents (under 18 years of age). Consult your child?s doctor for advice.
Use ineriatrics:
OTONAC SR 200MG TABLET should be used with caution in elderly patients due to the increased risk of serious side effects. Your doctor will initiate the treatment with the lowest effective dose for a shorter duration. Consult your doctor before taking OTONAC SR 200MG TABLET.
INTERACTIONS
A. Drug ? Drug interactions:
Before taking OTONAC SR 200MG TABLET, inform your doctor if you are taking any of the following medicines: ?
Medicines used to treat depression (Ex. citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine and sertraline) or lithium
Medicines used to treat heart failure and irregular heartbeats (Ex. digoxin)
Medicines used to treat high blood pressure (Ex. enalapril, lisinopril, losartan, candesartan, hydralazine, methyldopa, clonidine, propranalol)
Medicines used to treat infection (Ex. ciprofloxacin, ofloxacin, levofloxacin moxifloxacin)
Drugs used to increase the rate of urine excretion (Ex. thiazides, furosemide, amiloride)
Medicines that stop blood clotting (anticoagulants) Ex. warfarin, heparin
Methotrexate (used to treat cancer and autoimmune disorders such as arthritis and skin conditions)
Mifepristone (medicine used for medical abortion)
Hydrocortisone, prednisolone (for the treatment of swelling and inflammation)
Medicines used to suppress the immune system after organ transplant (Ex. cyclosporine or tacrolimus)
Zidovudine (medicines used to treat HIV infection)
Glibenclamide,licazide, tolbutamide (medicines used to treat diabetics)
Aspirin, ibuprofen, naproxen, celecoxib and etoricoxib (drugs used to treat pain and inflammation)
Clopidogrel (medicine used to treat blood clots)
Overdosage:
If you or anyone else accidentally take too much of OTONAC SR 200MG TABLET, consult your doctor immediately or visit the nearby hospital. Symptoms of overdose are low blood pressure,astrointestinal irritation, respiratory depression and convulsions.
SYNOPSIS
Drug :?? Aceclofenac
Pharmacological Category :?? Non-steroidal Anti-inflammatory drugs
Therapeutic Indication ? Osteoarthritis, Rheumatoid arthritis, Ankylosing spondylitis
Dosage Forms :?? Tablet, Dispersible tablet, Capsule, Injection
MORE INFORMATION
Keep OTONAC SR 200MG TABLET out of the sight and reach of children
Store OTONAC SR 200MG TABLET at room temperature
FAQs ABOUT OTONAC SR 200MG TABLET
Does OTONAC SR 200MG TABLET cause ulcers?
Yes, OTONAC SR 200MG TABLET may cause ulcers when used for a long time, painkillers like aceclofenac can lead to ulcers in the stomach and duodenum. But this risk can be reduced by taking the medication with food or immediately after food. Consult your doctor before taking OTONAC SR 200MG TABLET.
Can OTONAC SR 200MG TABLET be used in pregnant women?
OTONAC SR 200MG TABLET is not recommended for use in pregnant women unless advised by the doctor. It must not be used during the last three months of pregnancy. Consult your doctor before taking OTONAC SR 200MG TABLET if you are pregnant or planning toet pregnant.
Who should avoid taking OTONAC SR 200MG TABLET? ?
OTONAC SR 200MG TABLET is not recommended for use in patients having stomach ulcers or have blood vomiting or passed blood in the faeces (black tarry stools), heart diseases, stroke, blockages to blood vessels of the heart or brain, problems with blood circulation (peripheral arterial disease), severe kidney disease or liver failure, ulcerative colitis, crohn?s disease and bleeding or blood clotting disorders.?
Is OTONAC SR 200MG TABLET safe to use in patients with kidney disease?
OTONAC SR 200MG TABLET is not recommended for use in patients with severe kidney disease. It should be used with caution in patients with kidney disease. Your doctor may monitor your kidney functioning before and during treatment with OTONAC SR 200MG TABLET to prevent the risk of any unusual effects or kidney damage. Consult your doctor before taking OTONAC SR 200MG TABLET.
Can OTONAC SR 200MG TABLET be used in elderly patients?
OTONAC SR 200MG TABLET should be used with caution in elderly patients due to the increased risk of serious side effects. Your doctor will initiate the treatment with the lowest effective dose for a shorter duration. Consult your doctor before taking OTONAC SR 200MG TABLET.
REFERENCES
1. K.D Tripathi. Nonsteroidal Anti-inflammatory Drugs and Antipyretic-Analgesics. Essentials of medical pharmacology. Seventh edition. 2013. Page ? 204.
2. Parvati B. Patel and Tejas K. Patel. Efficacy and safety of aceclofenac in osteoarthritis: A meta-analysis of randomized controlled trials. NIH. National Library of Medicine, National centre for biotechnology information. PubMed Central. March 2017. [Accessed on 16th April 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5335881/
3. Daewon Pharmaceutical Co., Ltd. Phase IV Clinical Trial to Evaluate the Efficacy and Safety of PlbCR and Aceclofenac in the Treatment of Patients With Osteoarthritis of the Knee. NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised in October 2016] [Accessed on 16th April 2022] https://clinicaltrials.gov/ct2/show/NCT02682524?????????????????????????????????????????????????????????????????????????????????????????
4. Accord Healthcare Limited. Electronic Medicines Compendium (EMC). [Revised in January 2021] [Accessed on 16th April 2022] https://www.medicines.org.uk/emc/files/pil.4240.pdf
5. Laboratori Fundacio Dau. Health Products Regulatory Authority (HPRA). [Revised in May 2021] [Accessed on 16th April 2022] https://www.hpra.ie/img/uploaded/swedocuments/43eae1ca-cfe7-4f4a-a147-8a06fc552035.pdf
6. United Douglas Pharm, Inc. Aceclofenac tablet. [Revised in November 2011] [Accessed on 16th April 2022 https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8a023942-01e8-4849-aa3c-1a640ffc7fd3
USEFUL DIAGNOSTIC TESTS
Kidney function tests
Liver function tests
PRODUCT DETAILS
Net Qty
1 N
Item Weight
17.5
Ingredient
ACECLOFENAC 200 mg
Hsn Code
30049069
Show more
Additional information
Weight
17.5 g
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