INTRODUCTION

EXUDASE TH TABLET is a combination of Diclofenac and Thiocolchicoside, which belongs to the group of medicines called Non-Steroidal Anti-inflammatory Drugs and Muscle relaxants respectively. It is used in adults to treat painful muscle spasms.

EXUDASE TH TABLET can also be used to treat back pain (Ex. ankylosing spondylitis), joint pain and swelling (Ex. osteoarthritis, rheumatoid arthritis), neck pain, sports injuries and sprains.

Take EXUDASE TH TABLET with or just after meals. Avoid smoking and consumption of alcohol while undergoing therapy with EXUDASE TH TABLET to achieve better results. Before taking EXUDASE TH TABLET, inform your doctor if you have any problems in your liver, liver, kidney, heart or stomach.

You much also inform your doctor if you have diabetes, high blood cholesterol, bleeding or blood related problems, fits or allergic conditions (such as skin rash, itching or watery eyes, repeated sneezing, nasal congestion and nasal itching) as a precaution.

Do not take this medicine without consulting your doctor if you have severe bleeding, perforation or ulcers in the stomach or intestines. EXUDASE TH TABLET is also not recommended for use in pregnant or breastfeeding women.

The most common side effects of taking EXUDASE TH TABLET dizziness, headache, spinning sensation, nausea, vomiting, indigestion, stomach pain, flatulence, loss of appetite, increased liver enzymes and skin rashes. Consult your doctor if any of these side effect worsens.

USES OF EXUDASE TH TABLET

It is used in adults to treat:

• painful muscle spasms
• joint pain, back pain, neck pain
• sprains, sports injury

HOW EXUDASE TH TABLET WORKS

EXUDASE TH TABLET contains two medicines namely diclofenac and thiocolchicoside. Diclofenac is a pain-relieving medication. It acts by blocking the production of certain chemicals (prostaglandins) in the body that causes pain and inflammation.

Thiocolchicoside is a muscle relaxant. It relaxes the muscles by blocking the action of certain chemical messengers (GABA) in the brain that causes muscle spasm. As a result, EXUDASE TH TABLET relieves painful muscle spasms associated with inflammatory disease conditions.

DIRECTIONS FOR USE

Always take EXUDASE TH TABLET as directed by your physician. Swallow the medicine with a glass of water and do not crush or chew the medicine. EXUDASE TH TABLET should be taken with or after food.

Your doctor will decide the correct dose for you depending upon your age, body weight and health condition.

SIDE EFFECTS OF EXUDASE TH TABLET

HOW TO MANAGE SIDE EFFECTS

Diarrhea

Hydrate yourself by drinking plenty of fluids, such as water or fruit juices. Consuming ORS can also be beneficial. Do not self-treat diarrhea on your own. Consult your doctor if your diarrhea becomes uncontrollable.

Dizziness Or Drowsiness

Try to rest and relax. Get enough sleep. Avoid driving or operating any tools or machines completely while you are feeling dizzy. Do not consume excessive alcohol, as it could aggravate your dizziness. Consult your doctor if your dizziness worsens.

Nausea And Vomiting

Take EXUDASE TH TABLET with or just after a meal or a snack. Stick to simple meals. Avoid eating rich or spicy food. Consult your doctor if your nausea worsens.

Indigestion

Eat when you are hungry. Try to eat smaller meals more often than usual. Snack only when you're hungry. Always try to have a nutritious snack that is high in calories and protein, such as dried fruit and nuts.

WARNING & PRECAUTIONS

PREGNANCY

Contraindicated

EXUDASE TH TABLET is not recommended for use in pregnant women, as it may cause harm to unborn baby. Therefore, consult your doctor before taking it. Women of childbearing age must use a suitable contraceptive method to avoid pregnancy while undergoing therapy with EXUDASE TH TABLET.

BREASTFEEDING

Contraindicated

EXUDASE TH TABLET is not recommended for use in breastfeeding women. Therefore, consult your doctor before taking it.

DRIVING AND USING MACHINES

Use with Caution

Do not drive or handle heavy tools or machines if you feel dizzy or drowsy after taking EXUDASE TH TABLET.

ALCOHOL

Consult your doctor

Avoid consumption of alcohol while taking EXUDASE TH TABLET to avoid the risk of side effects.

KIDNEY

Consult your doctor

EXUDASE TH TABLET is not recommended for use in patients with kidney failure. It should be used with caution in patients with other kidney diseases. Therefore, consult your doctor before taking it.

LIVER

Consult your doctor

EXUDASE TH TABLET is not recommended for use in patients with liver failure. It should be used with caution in patients with other liver diseases. Therefore, consult your doctor before taking it.

ALLERGY

Contraindicated

Do not take EXUDASE TH TABLET if you are allergic to Diclofenac or Thiocolchicoside.

LUNGS

Contraindicated

EXUDASE TH TABLET is not recommended for use in patients with asthma attacks. Therefore, consult your doctor before taking it.

HEART DISEASE

Consult your doctor

EXUDASE TH TABLET is not recommended for use in patients with congestive heart failure, or heart attack. It should be used with caution in patients with high blood pressure. Therefore, consult your doctor before taking it.

USE IN PEDIATRICS

Contraindicated

EXUDASE TH TABLET is not recommended for use in children and adolescents (below 16 years) of age. Therefore, consult your doctor before taking it.

USE IN GERIATRICS

Use with Caution

EXUDASE TH TABLET should be used with caution in elderly patients. Therefore, consult your doctor before taking it.

INTERACTIONS

A. Drug-Drug interactions:

Before taking EXUDASE TH TABLET, inform your doctor if you are taking any of the following medicines such as:

• other medicines used for pain relief (Ex. aspirin, celecoxib, ibuprofen)
• medicines used for blood thinning (Ex. warfarin, clopidogrel, prasugrel)
• medicines used to reduce blood pressure (Ex. enalapril, olmesartan, losartan)
• cardiac glycosides used to treat heart failure (Ex. digoxin, digitoxin)
• potassium sparging diuretics (used to prevent potassium loss) such as spironolactone, aldosterone
• medicines used to treat bacterial infection (such as trimethoprim, ciprofloxacin, ofloxacin, levofloxacin or moxifloxacin)
• medicines used to treat fungal infections (such as voriconazole)
• medicines used to reduce blood sugar levels (such as glibenclamide, glycoside, and tolbutamide)
• oral corticosteroids (used to treat pain and inflammation) Ex. dexamethasone
• SSRI (used to treat depression) Ex. citalopram, fluoxetine, sertraline
• immunosuppressants (used to suppress immune function) Ex. cyclosporin, tacrolimus
• colestipol, colestyramine (medicines used to control blood cholesterol levels)
• diuretics (used to increase urine output) Ex. furosemide
• lithium (a medicine used to treat mental illness)
• methotrexate (a medicine used to treat auto-immune diseases or cancer)
• mifepristone (birth control pill)
• phenytoin (a medicine used to treat fits)

Overdosage:

If you or anyone else accidentally took more EXUDASE TH TABLET, contact your doctor immediately. Symptoms of overdosage might include nausea, vomiting, upper stomach pain, headache, gastrointestinal bleeding, diarrhoea, disorientation, excitation, coma, drowsiness, dizziness, tinnitus, hypotension, respiratory depression, fainting, and convulsions.

SYNOPSIS

MORE INFORMATION

• Keep EXUDASE TH TABLET out of reach of children
• Store EXUDASE TH TABLET at room temperature

FAQs ABOUT EXUDASE TH TABLET

Q: Can a higher dose of EXUDASE TH TABLET improve my disease condition?

A: No. Do not take a higher dose of EXUDASE TH TABLET without consulting your doctor as it may lead to increased risk of unwanted side effects. Only use the dose prescribed to you by your doctor. Your doctor will decide the correct dose for you depending upon your age, body weight and disease condition. If the prescribed dose does not result in effective pain relief, consult your doctor for advice.

Q: Can EXUDASE TH TABLET cure arthritis?

A: No. EXUDASE TH TABLET can only be used to relieve pain caused due to arthritis and cannot cure arthritis. Your doctor may prescribe you other medicines along with EXUDASE TH TABLET to help to treat your disease condition.

Q: How long should I need to take EXUDASE TH TABLET?

A: It is not advisable to take EXUDASE TH TABLET for more than 7 days, especially while taking at higher doses. Strictly follow the instructions given by your doctor regarding the duration of the therapy.

Q: Can I stop taking EXUDASE TH TABLET once my pain is relieved?

A: Yes. EXUDASE TH TABLET can be discontinued from use once pain is relieved. However, consult your doctor before doing so, as stopping EXUDASE TH TABLET too early may cause the pain to come back.

Q: Who should take EXUDASE TH TABLET and who should not?

A: EXUDASE TH TABLET should be used under medical supervision. Do not take EXUDASE TH TABLET if you have asthma or bleeding or perforations in the gut. Consult your doctor before taking EXUDASE TH TABLET if you are pregnant, think you may be pregnant or breastfeeding. Before taking EXUDASE TH TABLET, inform your doctor if you have any problems in your liver, liver, kidney, heart, or stomach. You much also inform your doctor if you have diabetes, high blood cholesterol, allergic conditions, fits or bleeding problems as a precaution.

Q: Can EXUDASE TH TABLET be taken with vitamin B12 supplements?

A: EXUDASE TH TABLET can be taken together with vitamin supplements as vitamins tends to improve healing of inflammation and reduces pain. However, consult your doctor before taking.

Q: For what conditions EXUDASE TH TABLET is prescribed?

A: EXUDASE TH TABLET is given for relieving musculoskeletal pain associated with muscle spasms.

Q: Is EXUDASE TH TABLET safe for pregnant women?

A: EXUDASE TH TABLET is not recommended for use in pregnant women as it may cause harm to the unborn baby. Therefore, consult your doctor for advice before taking.

Q: Can I take EXUDASE TH TABLET with antibiotics?

A: EXUDASE TH TABLET may interact with certain antibiotics (such as trimethoprim, ciprofloxacin, ofloxacin, levofloxacin or moxifloxacin) and may produce an altered response. Inform your doctor about the medicines which you use currently.

Q: Is EXUDASE TH TABLET a painkiller?

A: EXUDASE TH TABLET is an anti-inflammatory medicine with pain relieving properties. It helps in reducing pain and swelling while relaxing the muscles. It can be used for reducing pain caused due to muscle contraction or inflammatory bone conditions.

Q: Does EXUDASE TH TABLET make you feel sleepy?

A: EXUDASE TH TABLET may rarely make you feel sleepy. If you feel drowsy/sleepy, do not drive or operate any heavy tools or machines. Avoid consuming alcohol or taking other medicines that can sedate your brain easily such as antidepressants (Ex. citalopram, sertraline). Consult your doctor if you continue to feel sleepy that interferes with your day-to-day activities.

Q: Is EXUDASE TH TABLET addictive?

A: EXUDASE TH TABLET is not a habit-forming medicine. However, you might feel better that only if you take EXUDASE TH TABLET. This is because, EXUDASE TH TABLET can only reduce pain caused due to inflammatory conditions. It cannot treat the actual cause of the pain. And so, if you stop taking EXUDASE TH TABLET, your pain may reappear once again. To avoid this, take EXUDASE TH TABLET only as advised by the physician for the stipulated duration.

Q: Is EXUDASE TH TABLET a steroid?

A: No. EXUDASE TH TABLET is not a steroid. It contains Diclofenac which is a non-steroidal anti-inflammatory drug and thiocolchicoside which is a muscle relaxant. They act by blocking the production of certain chemicals in the body that causes pain, inflammation, and muscle spasms. As a result, it relaxes skeletal muscles and reduces pain associated with musculoskeletal disorders such as muscle spasm, arthritis etc.

Q: Can EXUDASE TH TABLET be used in children?

A: No. EXUDASE TH TABLET is strictly not recommended for use in children aged below 18 years. Children above this age group must also consult their doctor before taking EXUDASE TH TABLET.

REFERENCES

1. K.D. Tripathi. Nonsteroidal Anti-inflammatory Drugs and Antipyretic-Analgesics. Skeletal muscle relaxants. Essentials of Medical Pharmacology. Seventh edition. Page 204 & 368.

2. Justyna Kolodziejska and Michal Kolodziejczyk. Diclofenac in the treatment of pain in patients with rheumatic diseases. NIH. National Library of Medicine. National Center for Biotechnology Information. PMC. PubMed Central. June 2018. [Accessed on 6th February 2023] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6052370/

3. Darius F Soonawalla, Niteen Joshi. Efficacy of thiocolchicoside in Indian patients suffering from low back pain associated with muscle spasm. Journal of Indian Medical Association. June 2008. [Accessed on 6th February 2023] https://www.researchgate.net/publication/23304092_Efficacy_of_thiocolchicoside_in_Indian_patients_suffering_from_low_back_pain_associated_with_muscle_spasm#:~:text=shown%20that%20thiocolchicoside%20is%20an,Soonawalla%20and%20Joshi%2C%202008%20).

4. Dexcel Pharma. Diclofenac sodium 50mg. Electronic Medicines Compendium. [Revised in April 2021]. [Accessed on 6th February 2023] https://www.medicines.org.uk/emc/files/pil.2660.pdf

5. Pinewood Laboratories Ltd. DICLO 75 mg prolonged release tablets Diclofenac sodium. Electronic Medicines Compendium. [Revised in April 2021]. [Accessed on 6th February 2023] https://www.hpra.ie/img/uploaded/swedocuments/3dd59799-3d2e-4ca3-93cf-ade68e6de330.pdf

6. Salutas Pharma GmbH. Diclac 25mg & 50mg Gastro-resistant Tablets Diclofenac Sodium. Electronic Medicines Compendium. [Revised in August 2016]. [Accessed on 6th February 2023] https://www.hpra.ie/img/uploaded/swedocuments/2182591.PA0711_009_007.63ec5a97-112b-46cc-a493-f4564ff3c8ef.000001Diclac%20Gastro%20Tabs%20PIL.161011.pdf

7. European Medicines Agency. Thiocolchicoside 4 mg and 8mg. [Accessed on 6th February 2023] https://www.ema.europa.eu/en/documents/referral/thiocolchicoside-article-31-referral-annex-iii_en.pdf

8. Torrent Pharmaceuticals Ltd. Diclogesic-TH. Diclofenac Sodium and Thiocolchicoside Tablets. [Revised in August 2017]. [Accessed on 6th February 2023] https://www.torrentian.com/pisheet/Upload/PI_Sheet/2580.pdf

9. Central Drugs Standard Control Organization. Diclofenac Sodium IP (as sustained release Pellets) 100mg + Thiocolchicoside (as sustained release pellets) 16mg Capsule. (New Dosage Form). November 2011. Diclofenac + Thiocolchicoside (50mg (EC) + 8mg) Capsules. October 2008. Diclofenac + Thiocolchicoside (50 mg + 4 mg) Capsules. December 2008. [Accessed on 6th February 2023] https://cdscoonline.gov.in/CDSCO/Drugs