Axtra Tablet 10'S

Introduction About AXTRA TABLET

AXTRA TABLET is a combination of Paracetamol and Tramadol which belongs to the
group of medicines called Analgesics and Opioid analgesics respectively. AXTRA
TABLET is used in the management of moderate to severe pain.

Pain is a complex and unpleasant sensation consisting of a physiological and a
psychological response to a noxious stimulus. Pain is a warning mech
protects us by influencing it to withdraw from harmful stimuli, which is
primarily associated with injury.

Before taking AXTRA TABLET, inform your doctor if you have respiratory
disorders, gastrointestinal obstruction, including paralytic ileus, fits or
seizures, have recently suffered from a head injury, depression, intolerance to
some sugars, kidney or liver problems.

AXTRA TABLET is not recommended for use in pregnant women and during
breast-feeding more than once as it may pass through breast milk.

AXTRA TABLET is not recommended for use in children (under 12 years of age) and
should be used with caution in elderly patients (aged 65 years and above).

The common side effects of taking AXTRA TABLET are nausea, dizziness,
drowsiness, vomiting, gastrointestinal problems (such as constipation,
flatulence, diarrhoea), stomach pain and dry mouth. Consult your physician if
any of the side effects worsen.

Uses Of AXTRA TABLET

• Manage moderate to severe pain

How AXTRA TABLET Works

AXTRA TABLET contains Tramadol and Paracetamol. Tramadol acts on pain receptors
present in the central nervous system. It blocks the nerve signals responsible
for pain.  Paracetamol acts as an analgesic by inhibiting the release of certain
chemical mediators that produce pain. Tramadol and paracetamol, in combination,
have a faster action and provide quick relief from pain.

How to use AXTRA TABLET

Take AXTRA TABLET as advised by your physician.

For tablet:

Swallow the medicine with a glass of water. Do not crush or chew the medicine.

For effervescent tablet:

Take AXTRA TABLET by dissolving in a glass of drinking water.

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

Side Effects Of AXTRA TABLET

Common

• nausea
• dizziness, drowsiness
• vomiting
• digestion problems (constipation, flatulence, diarrhoea)
• stomach pain
• dry mouth
• itching, sweating
• headache, shaking
• confusion, sleep disorders, mood changes (anxiety, nervousness, feeling of high spirits)

Uncommon

• increase in pulse or blood pressure increase in pulse or blood pressure, heart rate or heart rhythm disorders
• difficulty or pain on passing water/protein in the urine
• skin reactions (such as rashes, hives)
• tingling or numbness sensation in hands or feet, ringing in the ears, involuntary muscle twitching
• depression, nightmares, memory lapses
• difficulty swallowing, blood in the stools
• shivering, hot flushes, pain in the chest

Rare

• uncoordinated movements
• addiction
• blurred vision

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

• allergic rection (signs include skin rashes, sudden swelling of the face and neck, difficulties breathing or drop of blood pressure and fainting)
• hallucinations (hearing, seeing or sensing things that are not really there)
• breathing difficulty
• fits
• transient loss of consciousness (syncope)

How To Manage Side Effects

Nausea or vomiting:

Try to take AXTRA TABLET with or just after a meal or a snack. Stick to simple
meals. Avoid eating oil rich, fried or spicy foods. Consult your doctor if the
symptom does 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 managing diarrhea. Consult your doctor
if the symptom does not improve.

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 too much of
alcohol. Consult your doctor if the symptom does not improve.

Dry mouth:

Sip water regularly and other sugar free liquids. Do not use mouthwashes that
contain alcohol because they can make your mouth dry, use mouthwash that is used
only for dry mouth. Limit your caffeine intake. Avoid smoking or using tobacco
products. Consult your doctor if the symptom does not improve.

Warning & Precautions

Pregnancy

AXTRA TABLET is generally not recommended for use in pregnant women. Consult
your doctor before taking it.

!### Breastfeeding

AXTRA TABLET is not recommended for use during breast-feeding more than once as
it may pass through breast milk. Consult your doctor before taking it.

!### Driving and Using Machines

Do not drive or operate any machines if you feel drowsy after taking AXTRA
TABLET.

!### Alcohol

Avoid consum
feel drowsy and it is not recommended for use in patients with acute alcohol
poisoning.

!### Kidney

AXTRA TABLET should be used with caution in patients with kidney problems.
Consult your doctor before taking AXTRA TABLET.

!### Liver

AXTRA TABLET is not recommended for use in patients with severe liver disorder
and should be used with caution in patients with liver problems or jaundice.
Consult your doctor before taking AXTRA TABLET.

!### Allergy

Do not take AXTRA TABLET if you are allergic to Paracetamol, Tramadol or any
other ingredients of this medicine.

!### Lungs

AXTRA TABLET should be used with caution in patients who have severe
difficulties in breathing like asthma or severe lung problems. Consult your
doctor before taking AXTRA TABLET.

Others

AXTRA TABLET is not recommended for use if you:

• have epilepsy (which is not adequately controlled by your current medicine)
• known or suspected gastrointestinal obstruction including paralytic ileus

Before taking AXTRA TABLET, inform your doctor if you:

• have epilepsy or already experienced fits or seizures
• have recently suffered from a head injury, shock or severe headaches associated with vomiting
• have intolerance to certain sugars
• have depression

Use in pediatrics:

AXTRA TABLET is not recommended for use in children (under 12 years of age).
Consult your child’s doctor for advice.

Use in geriatrics:

AXTRA TABLET should be used with caution in elderly patients (aged 65 years and
above). Consult your doctor before taking it.

Interactions

A. Drug - Drug interactions:

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

• medicines used to manage nausea and vomiting (Ex. metoclopramide, domperidone or ondansetron)
• medicines used against infections (Ex. ketoconazole, flucloxacillin, erythromycin)
• medicine used to reduce cholesterol in the blood (Ex. cholestyramine)
• medicine used in the management of depression or Parkinson’s disease (Ex. monoamine oxidase inhibitors such as phenelzine, isocarboxazid)
• amitriptyline (used to manage depression)
• medicine used to help stop smoking (Ex. bupropion)
• baclofen (used as muscle relaxant)
• warfarin, phenprocoumon (used to manage or manage blood clots)
• medicine used to manage epilepsy (Ex. carbamazepine)
• morphine, buprenorphine, nalbuphine or pentazocine (used to manage severe pain)

Overdosage:

If you or anyone else accidentally take too much of AXTRA TABLET, consult your
doctor immediately or visit the nearby hospital. Overdosage symptoms of AXTRA
TABLET includes loss of appetite, nausea, vomiting, malaise, pallor, excess
sweating, respiratory depression and seizures.

Synopsis

Drug	:	Paracetamol, Tramadol
Pharmacological Category	:	Analgesics, Opioid analgesics
Therapeutic Indication	:	Moderate to severe pain
Dosage Forms	:	Tablet, Injection

More Information

• Keep AXTRA TABLET out of reach of children
• Store at room temperature

FAQs About AXTRA TABLET

What is AXTRA TABLET used for?

AXTRA TABLET is used in the management of moderate to severe pain. Tramadol and
paracetamol, in combination, have a faster action and provide quick relief from
pain. Your doctor may recommend this combination only when it is needed.

What are the common side effects of AXTRA TABLET?

The common side effects of taking AXTRA TABLET are nausea, dizziness,
drowsiness, vomiting, digestion problems (such as constipation, flatulence,
diarrhoea), stomach pain, dry mouth, itching, headache, confusion, sleep
disorders and mood changes. Consult your physician if any of the side effects
worsen.

Is AXTRA TABLET safe to use in breastfeeding women?

AXTRA TABLET is not recommended for use during breast-feeding more than once as
it may pass through breast milk. Consult your doctor for advice before taking
this medicine.

Can AXTRA TABLET be used in patients with liver problems?

AXTRA TABLET is not recommended for use in patients with severe liver disorder
and should be used with caution in patients with liver problems or jaundice.
Consult your doctor before taking it.

DoesAXTRA TABLET cause dry mouth?

AXTRA TABLET may cause dry mouth in some individuals. To manage this effect,sip
water regularly and other sugar free liquids. Do not use mouthwashes that
contain alcohol because they can make your mouth dry, use mouthwash that is used
only for dry mouth. Limit your caffeine intake. Avoid smoking or using tobacco
products. Consult your doctor if the symptom does not improve.

Useful Diagnostic Tests

• Liver function test
• Kidney function test