Zoflex Tablet 10'S

Introduction About ZOFLEX TABLET

ZOFLEX 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 manage 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 ZOFLEX TABLET as it may worsen your
condition. ZOFLEX 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.
ZOFLEX TABLET should be used with caution in patients with pre-existing asthma,
COPD, mild to moderate liver or kidney disease and high blood pressure.

ZOFLEX TABLET is generally not recommended for use during pregnancy. ZOFLEX
TABLET is not recommended for use by breastfeeding mothers. ZOFLEX TABLET is not
recommended for use by children. ZOFLEX 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 ZOFLEX TABLET

Manages 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 ZOFLEX TABLET Works

ZOFLEX TABLET helps to manage 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.

How to use ZOFLEX TABLET

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 ZOFLEX 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 ZOFLEX 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 manage 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

ZOFLEX TABLET is generally not recommended for use in pregnancy. Contact your
doctor before taking it.

!### Breastfeeding

ZOFLEX 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 ZOFLEX TABLET.

!### Alcohol

Avoid consum
unwanted effects.

!### Kidney

ZOFLEX 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

ZOFLEX 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 ZOFLEX 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

ZOFLEX 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

ZOFLEX 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

ZOFLEX 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 malabsor
• have or undergoing coronary artery bypass graft (CABG) surgery
• have ethanol intoxication
• have dehydration

Before taking ZOFLEX 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 ase
• have angina

Use in paediatrics:

ZOFLEX TABLET is not recommended for use in children. Contact your doctor before
taking it.

Use in geriatrics:

ZOFLEX 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 manage insomnia)
• carbamazepine, phenytoin (medicines used to manage fits)
• rifampicin, rifampicin (medicines used to manage tuberculosis)
• methotrexate (medicines used to manage cancer)
• cyclosporine, tacrolimus (medicines used to manage rejection of transplant organ)
• lithium (medicines used to manage m
• warfarin (medicines used to manage or to manage blood clots)
• potassium-sparing drugs Ex. spironolactone (medicines used to manage high blood pressure)
• corticosteroids Ex. dexamethasone (medicines used to manage inflammation)
• anti-platelet agents Ex. aspirin (medicines used to manage platelet aggregation)
• selective serotonin reuptake inhibitors (SSRIs) Ex.  fluoxetine, sertraline (medicines used to manage depression)
• antidiabetics ex. metformin (medicines used to manage 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 manage gout)
• ketoconazole, fluconazole, miconazole and voriconazole (medicines used to manage 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 manage cancer)
• magnesium-containing antacids (medicines used to manage heartburn)
• ibuprofen (medicines used to manage pain)
• amiodarone (medicines used to manage 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 ZOFLEX TABLET below 30°C

FAQs About ZOFLEX TABLET

For what conditions ZOFLEX TABLET is used?

ZOFLEX TABLET is used to manage 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 ZOFLEX TABLET cause stroke?

Yes. ZOFLEX TABLET increase the risk of stroke when used in high doses for
long-term. Contact your doctor before taking it.

Does ZOFLEX TABLET cause bleeding?

Yes. ZOFLEX 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 ZOFLEX TABLET cause oedema?

Yes. ZOFLEX TABLET cause oedema due to fluid retention. Contact your doctor
before taking it.

Does ZOFLEX 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 ZOFLEX TABLET in pregnancy?

No. ZOFLEX TABLET is not recommended for use in pregnancy. Contact your doctor
before taking it.

Useful Diagnostic Tests

• Complete blood count
• Liver function test
• Kidney function test