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INTRODUCTION

MYOSPAS D TABLET is a combination of Diclofenac and Metaxalone which belongs to the group of medicines called Nonsteroidal anti-inflammatory drugs (NSAIDs) and Muscle relaxants respectively. MYOSPAS D TABLET is used to relieve pain, inflammation and swelling in conditions that affect the muscles. Also, it effectively relieves muscle stiffness or spasm, thereby improving muscle movement.

Before taking MYOSPAS D TABLET inform your doctor if you have heart, liver or kidney disease and including other conditions such as diabetes, high blood pressure and high cholesterol levels.

Pregnant and breastfeeding women should consult their doctors before taking MYOSPAS D TABLET. It should be used with caution in elderly patients above 65 years of age and not recommended for use in children.

The most common side effects of taking MYOSPAS D TABLET are nausea, vomiting, upset stomach, drowsiness, headache and nervousness. Consult your doctor if any of the side effects worsen.

USES OF MYOSPAS D TABLET

  • Relieves pain, inflammation and swelling in conditions that affect muscles
  • It also effectively relieves muscle stiffness or spasm, thereby improving muscle movement

HOW MYOSPAS D TABLET WORKS

MYOSPAS D TABLET relieves pain, inflammation, muscle stiffness or spasm and swelling, where diclofenac works by blocking the release of certain chemical messengers that cause pain and inflammation (redness and swelling). Metaxalone works on the centres in the brain and spinal cord to relieve muscle stiffness or spasm also relieves pain and improves the movement of muscles.

DIRECTIONS FOR USE

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

SIDE EFFECTS OF MYOSPAS D TABLET

COMMON

  • nausea, vomiting
  • upset stomach
  • drowsiness
  • headache, dizziness
  • nervousness or irritable
  • spinning sensation (vertigo)
  • indigestion or heartburn
  • wind (flatulence)
  • loss of appetite
  • diarrhoea
  • skin rash or spots

UNCOMMON

  • fast or irregular heartbeat (palpitations)
  • chest pain
  • heart disorders including heart attack
  • signs of heart failure (breathlessness, difficulty in breathing or swelling of the feet and legs)

RARE

  • tiredness
  • gastritis (inflammation, irritation or swelling of the stomach lining)
  • vomiting blood
  • stomach ulcers
  • nettle rash
  • low blood pressure (symptoms such as faintness, giddiness or light-headedness)
  • fluid retention resulting in swelling of the ankles or feet
  • black, tarry faeces or stools
  • itching
  • liver function disorders including hepatitis and jaundice
  • asthma (symptoms such as wheezing, breathlessness, coughing and tightness across the chest)

Stop taking MYOSPAS D TABLET and contact your doctor immediately if you experience any of the following side effects:

  • severe allergic reactions symptoms (such as swelling of the lips, tongue, throat, face or neck leading to severe difficulty in breathing, skin rash or spots, eczema, redness of the skin, scaly skin, bruise like rash, itching, very low blood pressure or shock and hives, peeling or blistering)
  • passing blood in faeces (stools/motions)
  • yellowing of the skin or whites of the eyes, blood problems, inflammation of liver, liver disorders
  • myocardial infarction or heart attack symptoms such as sudden and crushing chest pain
  • heart failure symptoms such as breathlessness, difficulty breathing when lying down, swelling of the feet or legs
  • stroke symptoms such as sudden weakness or numbness in the face, arm or leg especially on one side of the body, sudden loss or disturbance of vision, sudden difficulty in speaking or ability to understand speech, sudden migraine like headache, with or without disturbed vision
  • persistent sore throat or high temperature, infections
  • unexpected change in the amount of urine produced or its appearance
  • mild cramping and tenderness of the abdomen followed by rectal bleeding or bloody diarrhoea
  • stevens- johnson syndrome (serious illnesses with blistering of the skin, mouth, eyes and genitals)
  • kounis syndrome symptoms such as chest pain
  • weak or shallow breathing
  • confusion or weakness

HOW TO MANAGE SIDE EFFECTS

Nausea and Vomiting:

Try to take MYOSPAS D TABLET with or just after a meal or a snack. Stick to simple meals. Avoid eating oil rich or spicy foods. Consult your doctor if the symptom did not improve.

Upset stomach:

Rest and relax. Eat and drink slowly or try to have smaller and frequent meals. Keep a heat pad on your stomach. Do not self-treat on your own and consult your doctor if the symptom did not improve on its own.

Headache:

Rest and relax. Drink plenty of fluids such as water or electrolytes. Apply a pain-relieving balm on the forehead if required. Do not consume alcohol. Consult your doctor if the symptom did not improve.

Dizziness:

Try to rest and relax. Get 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.

Diarrhoea:

Drink lot 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.

WARNING & PRECAUTIONS

PREGNANCY

MYOSPAS D TABLET is not recommended for use in women who are pregnant for more than 6 months as it may affects the baby’s circulation. Consult your doctor before taking MYOSPAS D TABLET if you are planning to become pregnant or if you have problems getting pregnant because this medicine makes it more difficult to become pregnant.

BREASTFEEDING

MYOSPAS D TABLET is not recommended for use in breastfeeding women. Consult your doctor before taking MYOSPAS D TABLET.     

DRIVING AND USING MACHINES

Do not drive or operate any machines if you feel dizziness, drowsiness, sleepiness, tiredness and problems with your vision after taking MYOSPAS D TABLET.

ALCOHOL

Consumption of alcohol is not recommended during treatment with MYOSPAS D TABLET because it may enhance the effects of alcohol and cause dangerous side effects.   

KIDNEY

MYOSPAS D TABLET is not recommended for use in patients with severe kidney disease and should be used with caution in patients with kidney problems. Consult your doctor before taking MYOSPAS D TABLET. 

LIVER

MYOSPAS D TABLET is not recommended for use in patients with severe liver disease and should be used with caution in patients with liver problems. Consult your doctor before taking MYOSPAS D TABLET.

ALLERGY

Do not take MYOSPAS D TABLET if you are allergic (hypersensitive) to Diclofenac or Metaxalone or aspirin or ibuprofen or any other NSAID such as naproxen and indomethacin.  

LUNGS

MYOSPAS D TABLET is not recommended for use in patients with lung disease such as asthma, breathing difficulties after taking nonsteroidal anti-inflammatory drugs (NSAIDs) such as aspirin or ibuprofen. It should be used with caution in patients with asthma, long-term lung disease or lung infection. Consult your doctor before taking MYOSPAS D TABLET.

HEART DISEASE

MYOSPAS D TABLET is not recommended for use in patients with severe heart problems such as heart attack, blockages to blood vessels of the heart and should be used with caution in patients with heart problems, angina and high blood pressure. Consult your doctor before taking MYOSPAS D TABLET.

OTHERS

MYOSPAS D TABLET is not recommended for use if you have:

  • an itchy or runny nose
  • peptic ulceration (ulcer in your stomach or duodenum)
  • stomach or intestinal bleeding (black tarry stools or vomiting blood)
  • cerebrovascular disease such as stroke, mini stroke (TIA)
  • blockages to blood vessels to the brain or an operation to clear or bypass blockages
  • peripheral arterial disease (problems with your blood circulation)

Before taking MYOSPAS D TABLET, inform your doctor if you:

  • suffer from any stomach or bowel disorders such as ulcerative colitis, crohn's disease
  • have condition called porphyria (symptoms such as discolouration of the urine, serious skin disorders, anaemia, abdominal pain and severe mental disorders)
  • suffer from serious illness with blistering of the skin, mouth, eyes and genitals or connective tissue disorders such as lupus
  • have skin rash, appearance of lesions
  • suffer from nasal polyps
  • are recovering from major surgery
  • are a smoker
  • suffer from diabetes
  • blood clots, raised cholesterol or raised triglycerides
  • are going to have surgery of the stomach or intestinal tract
  • seasonal allergic rhinitis

Use in pediatrics:

MYOSPAS D TABLET is generally not recommended for use in children. Consult your child’s doctor for advice.  

 Use in geriatrics:

MYOSPAS D TABLET should be used with caution in elderly patients (aged 65 years or above), usually initiating the treatment with the lowest effective dose. In elderly patients with stomach problems, doctor may prescribe another medicine to protect the stomach during treatment with this medicine. Consult your doctor before taking MYOSPAS D TABLET.

INTERACTIONS

A. Drug-Drug interactions:

Before taking MYOSPAS D TABLET, inform your doctor if you are taking any of the following medicines:

  • any other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, aspirin, cyclooxygenase-2 selective inhibitors such as celecoxib (used for pain relief)
  • warfarin or aspirin in high doses (used to prevent or treat blood clots)
  • beta blockers such as metoprolol, atenolol or angiotensin-converting enzyme (ACE) inhibitors such as lisinopril, enalapril (used to treat high blood pressure)
  • gliclazide (used to treat high blood sugar)
  • diuretics such as spironolactone (used to treat edema)
  • cardiac glycosides such as digoxin (used to treat heart problems)
  • lithium (used to treat some mental problems)
  • methotrexate (used to treat some inflammatory disease or some cancers)
  • mifepristone (used to terminate pregnancy)
  • corticosteroids such as prednisolone (used to treat variety of conditions such as allergies and hormonal imbalances)
  • immunosuppressive agents such as ciclosporin, tacrolimus (used to prevent organ rejection after transplant)
  • quinolone antibiotics such as ciprofloxacin, ofloxacin (used to treat bacterial infections)
  • selective serotonin reuptake inhibitors (SSRIs) such as fluoxetine (used to treat depression)
  • zidovudine (used to treat HIV infection)
  • phenytoin (used to treat fits)
  • colestipol, cholestyramine (used to reduce the amount of cholesterol and certain fatty substances in your blood)
  • sulfinpyrazone (used to treat gout)
  • voriconazole (used to treat fungal infections)
  • trimethoprim (used to prevent or treat urinary tract infections)

Overdosage:

If you or anyone else accidentally take too much of MYOSPAS D TABLET, consult your doctor immediately or visit the nearby hospital. Overdosage symptoms of MYOSPAS D TABLET include headache, nausea, vomiting, abdominal pain, stomach or intestinal bleeding, diarrhoea, disorientation, excitation, coma, drowsiness, ringing in the ears, fainting, convulsions (seizures, uncontrolled fits) and breathing problems.

SYNOPSIS

Drug :  

Diclofenac, Metaxalone

Pharmacological Category :  

Nonsteroidal anti-inflammatory drugs (NSAIDs), Muscle relaxant

Therapeutic Indication :  

Relieve pain, inflammation and swelling in condition that affect muscles and relieves muscle stiffness or spasm

Dosage Forms :  

Tablet

MORE INFORMATION

  • Keep MYOSPAS D TABLET out of reach of children
  • Store MYOSPAS D TABLET at room temperature

FAQs ABOUT MYOSPAS D TABLET

Does MYOSPAS D TABLET cause diarrhoea?

Yes, MYOSPAS D TABLET may cause diarrhoea in some individuals. Drink lot 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.

Can I take MYOSPAS D TABLET during pregnancy?

MYOSPAS D TABLET is not recommended for use in women who are pregnant for more than 6 months as it may affects the baby’s circulation. Consult your doctor before taking MYOSPAS D TABLET if you are planning to become pregnant or if you have problems getting pregnant because this medicine makes it more difficult to become pregnant.

Can I take MYOSPAS D TABLET during liver disease?

No, MYOSPAS D TABLET is not recommended for use in patients with severe liver disease and should be used with caution in patients with liver problems. Your doctor will monitor your liver function test before the initiation of treatment and regularly during treatment with MYOSPAS D TABLET to prevent the risk of unusual effects or any liver damage. Consult your doctor before taking MYOSPAS D TABLET if you have history of liver problems.

Is MYOSPAS D TABLET safe to use in patients with heart problems?

MYOSPAS D TABLET is not recommended for use in patients with severe heart problems such as heart attack, blockages to blood vessels of the heart and should be used with caution in patients with heart problems, angina and high blood pressure. Consult your doctor before taking MYOSPAS D TABLET.

Is MYOSPAS D TABLET safe to use in elderly individuals?

MYOSPAS D TABLET should be used with caution in elderly patients (aged 65 years or above), usually initiating the treatment with the lowest effective dose. In elderly patients with stomach problems, doctor may prescribe another medicine to protect the stomach during treatment with this medicine. Consult your doctor before taking MYOSPAS D TABLET.

REFERENCES

1. KD. Tripathi. Nonsteroidal Anti-inflammatory Drugs and Antipyretic-Analgesics. Essentials of medical pharmacology. Seventh edition. 2013. Page – 204.

2. Sagar Suman Panda, Debasis Patanaik, Bera V.V. Ravi Kumar. New Stability-Indicating RP-HPLC Method for Determination of Diclofenac Potassium and Metaxalone from Their Combined Dosage Form. January 2012. [Accessed on 16th April 2022] https://www.researchgate.net/publication/220031481_New_Stability-Indicating_RP-HPLC_Method_for_Determination_of_Diclofenac_Potassium_and_Metaxalone_from_Their_Combined_Dosage_Form

3. Chintan R Patel, Ritu V Kimbahune, Prachi V Kabra, Harish AR and Nargund LVG1. Spectrophotometric Estimation of Metaxalone and Diclofenac Potassium by Multicomponent Analytical Method from Tablet Dosage Form. July 2012. [Accessed on 16th April 2022] https://www.omicsonline.org/spectrophotometric-estimation-of-metaxalone-and-diclofenac-potassium-by-multicomponent-analytical-method-from-tablet-dosage-form-2155-9872.1000137.php?aid=7711#:~:text=Metaxalone%20(400%20mg)%20and%20Diclofenac,muscle%20relaxant%20and%20pain%20relief

4. Metaxalone (400mg) + Diclofenac Potassium (50mg) tablet. Central drugs standard control organisation (CDSCO). [Accessed on 16th April 2022] https://cdscoonline.gov.in/CDSCO/Drugs

5. Vovedic-MR Tablets. Metaxalone 400 mg & Diclofenac 50 mg tablet. [Accessed on 16th April 2022] https://www.leeford.in/product/851/vovedic-mr

6. Metaxalone oral tablet (400; 800 mg). Drugs.com. [Accessed on 16th April 2022] https://www.drugs.com/mtm/metaxalone.html

7. Teva UK Ltd. Diclofenac sodium 25mg and 50 Gastro-resistant Tablets. [Revised in October 2021] [Accessed on 16th April 2022] https://products.tevauk.com/mediafile/id/51764.pdf

8. Dexcel-Pharma Ltd; Electronic Medicines Compendium (EMC) [Revised in March 2022] [Accessed on 16th April 2022] https://www.medicines.org.uk/emc/files/pil.2662.pdf

USEFUL DIAGNOSTIC TESTS

  • Kidney function test
  • Liver function test

AUTHOR DETAILS

Written By Dr. R. Dinesh John Rajkumar, Pharm.D
Last updated on 02 Nov 2022 | 07:06 PM(IST)

PRODUCT DETAILS
    Net Qty
    1 N
    Item Weight
    17.5 g
    Ingredient
    DICLOFENAC 50MG+METAXALONE 400MG
    Hsn Code
    30049069
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