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INTRODUCTION
FLEXME TABLET is a combination of Chlorzoxazone, Diclofenac sodium and Paracetamol, which belongs to the group of medicines called Muscle relaxants, Analgesics and Anti-pyrectics and Analgesics. It is used to treat painful muscle spasms associated with musculoskeletal conditions and provides effective relief from headaches, toothache, period pains, rheumatic pain, tendon pain, gout, soft tissue injuries, backache, arthritic pain, sprains, strains, frozen shoulder, muscle pain.
Avoid consuming alcohol while taking FLEXME TABLET as it may worsen your condition. FLEXME TABLET is not recommended for use by patients with nasal polyps, rhinitis, asthma precipitated by aspirin (aspirin-sensitive asthma) or other NSAIDs, severe liver, kidney or heart disease, history of active gastric or intestinal ulcer, bleeding (blood in stools, vomiting blood) or perforation. FLEXME TABLET should be used with caution in patients with pre-existing asthma, COPD, mild to moderate liver or kidney disease and high blood pressure.
FLEXME TABLET is generally not recommended for use during pregnancy. FLEXME TABLET is not recommended for use by breastfeeding mothers. FLEXME TABLET is not recommended for use by children. FLEXME TABLET should be used with caution in elderly patients (aged 65 years or above). Contact your doctor before taking it.
The most common side effects of this medicine are nausea, vomiting, stomach pain, diarrhoea, indigestion, ulcers in the stomach or intestines, bleeding/perforation, heartburn etc. Contact your physician if any of the symptoms get worse.
USES OF FLEXME TABLET
Treats pain due to the following conditions:
- musculoskeletal conditions
- headache
- toothache
- period pains
- rheumatic pain
- backache
- arthritic pain
- sprains, strains
- soft tissue injuries
- gout
- frozen shoulder
- tendon pain
- muscular pain
HOW FLEXME TABLET WORKS
FLEXME TABLET helps to treat pain, where Chlorzoxazone is a muscle relaxant, acts on the brain and spinal cord causing relaxation of muscles and relief of pain, while Diclofenac is an NSAID inhibits COX-1 and COX-2 and blocks the production of prostaglandins (which are responsible for pain) and Paracetamol is an Analgesic, increases the pain threshold by inhibiting COX-1 and COX-2 enzymes. Together, relieves pain effectively.
DIRECTIONS FOR USE
Take this medicine as advised by your physician. Swallow this medicine as a whole with a glass of water and do not crush or chew the medicine.
SIDE EFFECTS OF FLEXME TABLET
COMMON
- nausea, vomiting, stomach pain, diarrhoea, indigestion
- rash, itching
- flatulence, constipation, burping, gastritis (indigestion, stomach ache, vomiting)
- ulcers in the stomach or intestines, bleeding/perforation, heartburn
- headache, dizziness, feeling sleepy
- difficulty in sleeping
- abnormal liver function test
- inflammation of the intestines causing nausea, diarrhoea and abdominal pain
- abnormal formation of the foetus
UNCOMMON
- swelling of the mouth
- urticaria
- oedema (fluid retention in the body causing swelling of legs and feet)
- drowsiness, tiredness, shakiness
- bleeding from the vagina
- purpura (purple spots on the skin)
- infection of the vagina (itching, burning, soreness, pain during intercourse and or urination)
- blurred vision
- depression and anxiety
- high blood pressure
- fever, chills, loss of appetite
- ulcers in the mouth, dryness of mouth
- menstrual disturbances like heavy or light bleeding, and delayed periods
- vertigo or tinnitus
- pricking or tingling sensation (pins and needles)
RARE
- inflammation of the lungs causing coughing, and increased sputum
- breast pain
- vomiting blood
- worsening of ulcerative colitis
- damage to the gullet
- swelling of the tongue
- low blood pressure
- hair loss
- increased sensitivity to light
- nightmares
Stop taking FLEXME TABLET and contact your physician immediately if you experience any of the following side effects:
- symptoms of liver damage or elevated liver enzymes such as fever, chills, headache, rash, anorexia, nausea, vomiting, fatigue, right upper quadrant pain, dark urine, or jaundice (yellowish discolouration of skin and whites of the eye)
- symptoms of pancreatitis (inflammation of the pancreas, causing severe abdominal pain radiating to the back)
- severe allergic reactions such as skin rash, reddening, blisters, swelling of the hands, feet, ankles, face, lips or throat, which may cause difficulty in swallowing or breathing or wheezing or anaphylactic shock (collapse)
- symptoms of stroke such as weakness or inability to move one side of the body (paralysis) and slurred speech
- chest pain or heart failure or change in heart rate
- decrease in white blood cells and can lead to infections with symptoms such as fever, chills, sore throat or flu-like symptoms
- passing black or bloodstained stools, or vomiting blood and severe stomach pain due to bleeding or hole formation in the stomach or intestines
- symptoms of Stevens-Johnson syndrome, exfoliative dermatitis and toxic epidermal necrolysis such as rash, blistering or peeling of the skin
- decrease in the number of blood platelets (increased risk of bleeding or bruising)
- symptoms of meningitis such as neck stiffness, headache, nausea, vomiting, fever or loss of consciousness
- difficulty in breathing
HOW TO MANAGE SIDE EFFECTS
Nausea and vomiting:
Take this medicine with, or just after meals. Stick to simple meals. Avoid eating oily or spicy foods. Contact your doctor if your symptoms do not improve.
Headache:
Rest and relax. Drink plenty of fluids such as water or electrolytes and apply a pain-relieving balm on the head if necessary. Do not consume alcohol. Contact your doctor if your symptoms do not improve.
Diarrhoea:
Drink lots of fluids, such as water or fruit juices to keep you hydrated. Do not take any medicine on your own to treat diarrhoea. Contact your doctor if your symptoms do not improve.
Constipation:
Eat fibre-rich foods such as fresh fruits, vegetables, and cereals. Drink more water and exercise regularly. Contact your doctor if your symptoms do not improve.
Stomach pain:
Try to rest and relax. Eat small meals but take them frequently. Keep a heating pad on your stomach. Contact your doctor if your symptoms do not improve.
Dizziness:
Try to rest and relax. Get enough sleep. Avoid driving or operating any machines while you are feeling dizzy. Do not consume alcohol, as it increases dizziness. Contact your doctor if your symptoms do not improve.
Indigestion:
Eat small meals but take them frequently. Eat and exercise regularly. Contact your doctor if your symptoms do not improve.
Skin rash:
Avoid hot water bath as it irritates the skin and do not scratch the affected area. Use sunscreen and protective clothing when outdoors. Regularly use unscented moisturizers to soothe and hydrate the affected area. Contact your doctor if your symptoms do not improve.
WARNING & PRECAUTIONS
PREGNANCY
FLEXME TABLET is generally not recommended for use in pregnancy. Contact your doctor before taking it.
BREASTFEEDING
FLEXME TABLET is not recommended for use in breastfeeding women as it may pass through the breast milk. Contact your doctor before taking it.
DRIVING AND USING MACHINES
Do not drive or operate any machines if you have visual disturbances, dizziness, vertigo, somnolence, drowsiness or fatigue after taking FLEXME TABLET.
ALCOHOL
Avoid consumption of alcohol while taking FLEXME TABLET as it may lead to unwanted effects.
KIDNEY
FLEXME TABLET is not recommended for use in patients with severe kidney disease and should be used with caution in mild to moderate kidney disease. Contact your doctor before taking it.
LIVER
FLEXME TABLET is not recommended for use in patients with severe liver disease and should be used with caution in mild to moderate liver disease. Contact your doctor before taking it.
ALLERGY
Do not take FLEXME TABLET if you are allergic to chlorzoxazone, diclofenac sodium or to acetylsalicylic acid, other NSAIDs, misoprostol, other prostaglandins, paracetamol, or to lactose, or to other ingredients of this medicine.
LUNGS
FLEXME TABLET is not recommended for use in patients with nasal polyps, rhinitis, asthma precipitated by aspirin (aspirin-sensitive asthma) or other NSAIDs and should be used with caution in patients with pre-existing asthma and COPD. Contact your doctor before taking it.
HEART DISEASE
FLEXME TABLET is not recommended for use in patients with severe congestive heart failure, ischemic heart disease (heart attack), blockages of blood vessels to the heart and should be used with caution in patients with high blood pressure and mild to moderate heart failure. Contact your doctor before taking it.
OTHERS
FLEXME TABLET is not recommended for use if you:
- have a history or active gastric or intestinal ulcer, bleeding (blood in stools, vomiting blood) or perforation or cerebrovascular bleeding
- have angioedema, urticaria
- have peripheral arterial disease
- have cerebrovascular disease (stroke), mini-stroke (TIA) or blockages of blood vessels to the brain
- have rare hereditary problems such as galactose intolerance, severe lactase deficiency and glucose-galactose malabsorption
- have or undergoing coronary artery bypass graft (CABG) surgery
- have ethanol intoxication
- have dehydration
Before taking FLEXME TABLET, inform your doctor if you:
- have ulcerative colitis or Crohn's disease
- have hyperlipidaemia
- have diabetes mellitus
- smoke
- have blood clotting disorders or haematological abnormalities
- have systemic lupus erythematosus (SLE)
- have mixed connective tissue disorders
- have aseptic meningitis
- have angina
Use in paediatrics:
FLEXME TABLET is not recommended for use in children. Contact your doctor before taking it.
Use in geriatrics:
FLEXME TABLET should be used with caution in elderly patients (aged 65 years or above). Contact your doctor before taking it.
INTERACTIONS
A. Drug-Drug interactions:
Inform your physician, if you are using:
- barbiturates Ex. butobarbital (medicines used to treat insomnia)
- carbamazepine, phenytoin (medicines used to treat fits)
- rifampicin, rifampicin (medicines used to treat tuberculosis)
- methotrexate (medicines used to treat cancer)
- cyclosporine, tacrolimus (medicines used to prevent rejection of transplant organ)
- lithium (medicines used to treat mania)
- warfarin (medicines used to treat or to prevent blood clots)
- potassium-sparing drugs Ex. spironolactone (medicines used to treat high blood pressure)
- corticosteroids Ex. dexamethasone (medicines used to treat inflammation)
- anti-platelet agents Ex. aspirin (medicines used to prevent platelet aggregation)
- selective serotonin reuptake inhibitors (SSRIs) Ex. fluoxetine, sertraline (medicines used to treat depression)
- antidiabetics ex. metformin (medicines used to treat diabetes mellitus)
- mifepristone (medicines used for abortion)
- ciprofloxacin, chloramphenicol (medicines used for bacterial infections)
- colestipol and cholestyramine (medicines used to decrease high cholesterol levels)
- sulfinpyrazone (medicines used to treat gout)
- ketoconazole, fluconazole, miconazole and voriconazole (medicines used to treat fungal infections)
- cardiac glycosides ex. digoxin (medicines used for heart failure)
- zidovudine (medicines used for HIV infection and AIDS)
- metoclopramide and domperidone (medicines used for nausea and vomiting)
- enalapril, furosemide, losartan, propranolol (medicines used for high blood pressure and heart diseases)
- imatinib (medicines used to treat cancer)
- magnesium-containing antacids (medicines used to treat heartburn)
- ibuprofen (medicines used to treat pain)
- amiodarone (medicines used to treat heart rhythm disorders)
Overdosage:
If you or anyone else accidentally took too much of this medicine, consult your doctor immediately. Symptoms of overdose are headache, nausea, vomiting, diarrhoea, anorexia, epigastric pain or abdominal pain, drowsiness, dizziness, light-headedness, malaise or sluggishness, followed by marked loss of muscle tone making voluntary movement impossible and decrease in deep tendon reflexes, pallor, gastrointestinal bleeding, confusion, disorientation, excitation, tinnitus, fainting or convulsions, hypertension, acute renal failure (with acute tubular necrosis, characterised by loin pain, haematuria and proteinuria) and liver damage. Abnormalities of glucose metabolism, metabolic acidosis, cardiac arrhythmias, pancreatitis and anaphylactic reactions may occur. In severe cases, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema, respiratory depression, low blood pressure, coma, and death.
SYNOPSIS
| Drug | : | Chlorzoxazone, Diclofenac sodium, Paracetamol |
| Pharmacological Category | : | Muscle relaxants, Analgesics, Antipyretics and Analgesics |
| Therapeutic Indication | : | Pain |
| Dosage Forms | : | Tablet |
MORE INFORMATION
- Keep out of reach from children
- Store FLEXME TABLET below 30°C
FAQs ABOUT FLEXME TABLET
For what conditions FLEXME TABLET is used?
FLEXME TABLET is used to treat painful muscle spasm associated with musculoskeletal conditions and provides effective relief from headache, toothache, period pains, rheumatic pain, back ache, arthritic pain, sprains, strains, soft tissue injuries, gout, frozen shoulder, tendon pain and muscular pain. Contact your doctor before taking it.
Does FLEXME TABLET cause stroke?
Yes. FLEXME TABLET increase the risk of stroke when used in high doses for long-term. Contact your doctor before taking it.
Does FLEXME TABLET cause bleeding?
Yes. FLEXME TABLET increases the risk of bleeding, ulceration and perforation in stomach and intestine and it is not recommended for use in patients with history or active gastric or intestinal ulcer, bleeding (blood in stools, vomiting blood) or perforation. Contact your doctor before taking it.
Does FLEXME TABLET cause oedema?
Yes. FLEXME TABLET cause oedema due to fluid retention. Contact your doctor before taking it.
Does FLEXME TABLET cause Kidney damage?
Yes. [GBNKKEYWORD] cause kidney damage and it is not recommended for use in patients with severe kidney disease and should be used with caution in mild to moderate kidney disease. Contact your doctor before taking it.
Can I use FLEXME TABLET in pregnancy?
No. FLEXME TABLET is not recommended for use in pregnancy. Contact your doctor before taking it.
REFERENCES
1. K.D. Tripathi. Skeletal Muscle Relaxants, NSAIDs and Antipyretic-Analgesics. Essentials of medical pharmacology. Seventh edition. 2013. Page – 357, 204, 206.
2. Bethesda (MD). Chlorzoxazone. National Institute of Health. NLM. National Centre for Biotechnology Information. PubChem Compound Summary. 2004. [Accessed on 27th June 2022] https://pubchem.ncbi.nlm.nih.gov/compound/2733
3. Bethesda (MD). Diclofenac. National Institute of Health. NLM. National Centre for Biotechnology Information. PubChem Compound Summary. 2004. [Accessed on 27th June 2022] https://pubchem.ncbi.nlm.nih.gov/compound/3033
4. Bethesda (MD). Paracetamol National Institute of Health. NLM. National Centre for Biotechnology Information. PubChem Compound Summary. 2004. [Accessed on 27th June 2022] https://pubchem.ncbi.nlm.nih.gov/compound/1983
5. Cipla Ltd. Chlorzoxazone + Diclofenac sodium + Paracetamol. [Revised in December 2019] [Accessed on 2nd July 2022] https://www.ciplamed.com/content/cip-zox-tablets
6. Bliss GVS Pharma Ltd. Chlorzoxazone + Diclofenac sodium + Paracetamol. [Revised in March 2021] [Accessed on 2nd July 2022] https://fdaghana.gov.gh/img/smpc/Lofnac%20MR%20Tablets%20(Diclofenac,%20Paracetamol,%20Chlorzoxazone).pdf
USEFUL DIAGNOSTIC TESTS
- Complete blood count
- Liver function test
- Kidney function test
AUTHOR DETAILS
Written By Dr. Dhivakaran R, BDS
Last updated on 21 Nov 2022 | 05:18 PM(IST)
PRODUCT DETAILS
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