Traceta Tablet 10'S

Introduction About TRACETA TABLET

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

Pain is a complex and unpleasant sensation consisting of a physiological and
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 TRACETA 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.

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

TRACETA 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 TRACETA 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 TRACETA TABLET

• Manage moderate to severe pain

How TRACETA TABLET Works

TRACETA 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 TRACETA TABLET

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

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

Side Effects Of TRACETA 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 TRACETA TABLET and contact your doctor immediately if you experience
any of the following side effects:

• allergic reaction (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 TRACETA 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 to manage diarrhoea. 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

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

!### Breastfeeding

TRACETA TABLET is not recommended for use during breastfeeding 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 TRACETA
TABLET.

!### Alcohol

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

!### Kidney

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

!### Liver

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

Allergy

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

!### Lungs

TRACETA 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 TRACETA TABLET.

Others

TRACETA 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 TRACETA 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 an intolerance to certain sugars
• have depression

Use in pediatrics:

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

Use in geriatrics:

TRACETA 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 TRACETA 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 TRACETA TABLET, consult your
doctor immediately or visit the nearby hospital. Overdosage symptoms of TRACETA
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 TRACETA TABLET out of reach of children
• Store at room temperature

FAQs About TRACETA TABLET

What is TRACETA TABLET used for?

TRACETA 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 TRACETA TABLET?

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

Is TRACETA TABLET safe to use in breastfeeding women?

TRACETA 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 TRACETA TABLET be used in patients with liver problems?

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

DoesTRACETA TABLET cause dry mouth?

TRACETA 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