INTRODUCTION

LAXODOL MR TABLET is a combination of Aceclofenac 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 inflammatory conditions associated with muscle spasms.

LAXODOL MR TABLET can also be used to treat pain associated with musculoskeletal (bone) disorders such as osteoarthritis, rheumatoid arthritis (inflammation of joints) or ankylosing spondylitis (back pain caused due to inflammation of bones in the spine).

Aceclofenac is a non-steroidal anti-inflammatory drug. It acts by blocking the production of certain chemicals that causes pain and inflammation in the body. 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, LAXODOL MR TABLET relieves painful muscle spasms associated with inflammatory disease conditions.

Before taking LAXODOL MR 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 or fits.

Do not take LAXODOL MR TABLET if you have asthma or varicella infection. Consult your doctor before taking LAXODOL MR TABLET if you are pregnant, think you may be pregnant or breastfeeding.

Take LAXODOL MR TABLET only as advised by your doctor. Do not take LAXODOL MR TABLET longer than recommended by your doctor as it may cause serious side effects. Avoid smoking and consumption of alcohol while undergoing therapy with LAXODOL MR TABLET to achieve better results.

The most common side effects of taking LAXODOL MR TABLET are dizziness, drowsiness, nausea, and stomach pain. Consult your doctor if any of these side effect worsens.

USES OF LAXODOL MR TABLET

It is used in adults to treat:

• painful muscle spasms
• pain associated with musculoskeletal disorders (such as osteoarthritis, rheumatoid arthritis, or ankylosing spondylitis)

HOW LAXODOL MR TABLET WORKS

LAXODOL MR TABLET is a muscle relaxant with anti-inflammatory and analgesic properties. It effectively reduces pain caused due to muscle spasms and inflammatory bone disorders, where aceclofenac acts by blocking the release of certain chemicals (prostaglandins) that causes pain and inflammation in the body and thiocolchicoside acts by blocking the effects of certain chemical messengers (GABA) in the brain that causes painful muscle spasms. Collectively, LAXODOL MR TABLET relieves painful muscle spasms associated with inflammatory disease conditions.

DIRECTIONS FOR USE

Always take LAXODOL MR TABLET as directed by your physician. Swallow the medicine with a glass of water and do not crush or chew the medicine. LAXODOL MR TABLET can be taken 1 hour before or 2 hours after meals. Your doctor will decide the correct dose for you depending upon your health condition.

SIDE EFFECTS OF LAXODOL MR 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 LAXODOL MR 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

LAXODOL MR TABLET is not recommended for use in pregnant women, as it may cause harm to an 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 LAXODOL MR TABLET.

BREASTFEEDING

Contraindicated

LAXODOL MR 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 LAXODOL MR TABLET.

ALCOHOL

Monitoring required

Avoid consumption of alcohol while taking LAXODOL MR TABLET to avoid the risk of side effects.

KIDNEY

Use with Caution

LAXODOL MR TABLET should be used with caution in patients with kidney diseases. Therefore, consult your doctor before taking it.

LIVER

Use with Caution

LAXODOL MR TABLET should be used with caution in patients with liver diseases. Therefore, consult your doctor before taking it.

ALLERGY

Contraindicated

Do not take LAXODOL MR TABLET if you are allergic to Aceclofenac or Thiocolchicoside.

LUNGS

Contraindicated

LAXODOL MR TABLET is not recommended for use in patients with asthma. Therefore, consult your doctor before taking it.

HEART DISEASE

Use with Caution

LAXODOL MR TABLET should be used with caution in patients with heart diseases (such as heart failure, or high blood pressure). Therefore, consult your doctor before taking it.

OTHERS

LAXODOL MR TABLET is not recommended for use if you:

• have varicella infection (a viral infection)

Before taking LAXODOL MR TABLET, inform your doctor if you:

• have high blood cholesterol levels
• have diabetes mellitus
• are smoker
• have a history of bleeding inside the brain
• have a history of stomach ulcer or inflammation (ulcerative colitis or with Crohn's disease), particularly if complicated with haemorrhage (bleeding) or perforation
• have epilepsy (or convulsions)

Use in pediatrics:

LAXODOL MR 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:

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

INTERACTIONS

A. Drug-Drug interactions:

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

• medicines used to treat nausea or vomiting (Ex. metoclopramide or domperidone)
• medicines used for blood thinning (Ex. warfarin)
• medicines used to reduce blood pressure (Ex. enalapril, olmesartan, losartan)
• cardiac glycosides used to treat heart failure (Ex. digoxin, digitoxin)
• medicines used to treat bacterial infection (such as ciprofloxacin, ofloxacin, levofloxacin or moxifloxacin)
• medicines used to treat HIV infections (such as zidovudine)
• medicines used to reduce blood sugar levels (such as glibenclamide, glycoside, and tolbutamide)
• medicines used for pain relief (such as aspirin or ibuprofen)
• oral corticosteroids (used to treat pain and inflammation) Ex. dexamethasone
• proton-pump inhibitors (used to reduce stomach acid production) Ex. omeprazole
• SSRI (used to treat depression) Ex. citalopram, fluoxetine, sertraline
• misoprostol (used to treat or prevent stomach ulcers)
• immunosuppressants (used to suppress immune function) Ex. cyclosporin, tacrolimus
• colestyramine (a medicine 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)

Overdosage:

If you or anyone else accidentally took more LAXODOL MR 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 LAXODOL MR TABLET out of reach of children
• Store LAXODOL MR TABLET at room temperature

FAQs ABOUT LAXODOL MR TABLET

Can higher dose of LAXODOL MR TABLET improve my disease condition?

No. Do not take a higher dose of LAXODOL MR 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.

Can LAXODOL MR TABLET cure arthritis?

No. LAXODOL MR 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 LAXODOL MR TABLET to help to treat your disease condition.

How long should I need to take LAXODOL MR TABLET?

It is not advisable to take LAXODOL MR TABLET for more than 7 days, especially while taking at higher doses. This is because, LAXODOL MR TABLET may cause chromosomal changes in the body which might lead to unwanted side effects. Strictly follow the instructions given by your doctor regarding the duration of the therapy.

Can I stop taking LAXODOL MR TABLET once my pain is relieved?

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

Who should take LAXODOL MR TABLET and who should not?

LAXODOL MR TABLET should be used under medical supervision. Do not take LAXODOL MR TABLET if you have asthma or varicella infection. Consult your doctor before taking LAXODOL MR TABLET if you are pregnant, think you may be pregnant or breastfeeding. Before taking LAXODOL MR 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 or fits.

Can LAXODOL MR TABLET be taken with vitamin B12 supplements?

LAXODOL MR 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.

For what conditions LAXODOL MR TABLET is prescribed?

LAXODOL MR TABLET is given for reliving musculoskeletal pain associated with muscle spasms.

Is LAXODOL MR TABLET safe for pregnant women?

LAXODOL MR 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.

Can I take LAXODOL MR TABLET with antibiotics?

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

Is LAXODOL MR TABLET a painkiller?

LAXODOL MR 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.

Does LAXODOL MR TABLET make you feel sleepy?

LAXODOL MR TABLET may make you feel sleepy because of its sedative property. Therefore, be caution while you drive or operate any heavy tools or machines. Do not consume alcohol or other medicine that can seduces your brain further such as antidepressants (Ex. citalopram, sertraline). Consult your doctor if you continue to feel sleepy that interferes with your day-to-day activities.

Is LAXODOL MR TABLET addictive?

LAXODOL MR TABLET is not a habit-forming medicine. However, you might feel better that only if you take LAXODOL MR TABLET. This is because, LAXODOL MR 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 LAXODOL MR TABLET, your pain may reappear once again. To avoid this, take LAXODOL MR TABLET only as advised by the physician for the stipulated duration.

Is LAXODOL MR TABLET a steroid?

No. LAXODOL MR TABLET is not a steroid. It contains aceclofenac 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.

Can LAXODOL MR TABLET be used in children?

No. LAXODOL MR TABLET is strictly not recommended for use in children aged below 16 years. Children above this age group must also consult their doctor before taking LAXODOL MR 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. Manish N. Maladkar, Chitra M. Tekchandani, Ashok S, Yadhav. National Library of Medicine. Targeting the Therapeutic Need in Musculoskeletal Inflammatory Pain with Thiocolchicoside and Aceclofenac Sustained Release with Combination Therapy. Aristo Pharmaceuticals Private Limited. ResearchGate. January 2019. [Accessed on 30th April 2022] https://www.researchgate.net/publication/335020828_Targeting_the_therapeutic_need_in_musculoskeletal_inflammatory_pain_with_thiocolchicoside_and_aceclofenac_sustained-release_combination_therapy        

3. TORRENT PHARMACEUTICALS LTD. ZULU AT. Torrent.com. [Revised on April 2021]. [Accessed on 30th April 2022] https://www.torrentian.com/pisheet/Upload/PI_Sheet/3026.pdf

4. Cipla Ltd. IBUGESIC TH Tablets (Aceclofenac + Thiocolchicoside). Ciplamed.com. [Revised in June 2018]. [Accessed on 30th April 2022] https://ciplamed.com/content/ibugesic-th-tablets

5. Thichoren- AC. La Renon Healthcare Pvt Ltd. [Accessed on 30th April 2022] https://www.larenon.com/wp-content/uploads/2020/01/THICHOREN-2-page1.pdf

6. Novel formulations of thiocolchicoside. Patents.google.com. March 2015. [Accessed on 18th April 2022] https://patents.google.com/patent/EP2848260A1/en