Xtradol 100mg Tablet 10'S

Introduction About XTRADOL 100MG TABLET

XTRADOL 100MG TABLET contains Tapentadol which belongs to the group of medicines
called Opioids. It is used in adults for the management of severe chronic pain
which can only be managed by a strong (opioid) painkiller.

XTRADOL 100MG TABLET is not recommended for use in patients having severe kidney
or liver problems, asthma or if your breathing is dangerously slow or shallow
(respiratory depression, hypercapnia), paralysis of the gut (muscles of the
gastrointestinal tract).

XTRADOL 100MG TABLET should be used with caution in patients who have slow or
shallow breathing, increased pressure in the brain, disturbed consciousness up
to coma, head injury or brain tumour, pancreatic or biliary tract disease
(pancreatitis), increased tendency towards epilepsy, have tendency to abuse
medicines (habituating), moderate liver problems, kidney disease and intolerance
to certain sugars (such as lactose).

XTRADOL 100MG TABLET is not recommended for use in pregnant women unless
recommended by the doctor and it is not recommended for use in breast-feeding
women. XTRADOL 100MG TABLET is not recommended for use in children and
adolescents (below 18 years of age) and it should be used with caution in
elderly patients (aged 65 years of age).

The most common side effects of taking XTRADOL 100MG TABLET are nausea,
constipation, dizziness, drowsiness, headache, decreased appetite, indigestion
and flushing. Consult your doctor if any of the side effects worsen.

Uses Of XTRADOL 100MG TABLET

• manages severe chronic pain in adults

How XTRADOL 100MG TABLET Works

XTRADOL 100MG TABLET acts directly on the central nervous system and reduces the
feeling of pain by interru
and the body. XTRADOL 100MG TABLET binds with certain receptors called µ-opioid
receptors and also increases the release of a nerve chemical called
norepinephrine which causes inhibition of certain receptors leading to pain
relief.

How to use XTRADOL 100MG TABLET

Take XTRADOL 100MG TABLET as advised by your doctor. Swallow the medicine with a
glass of water. Do not crush or chew the medicine. Your doctor will decide the
correct dose and duration for you depending upon your age, body weight and
disease condition.

Side Effects Of XTRADOL 100MG TABLET

Common

• nausea, vomiting
• constipation, diarrhoea, indigestion
• dizziness, drowsiness, headache
• decreased appetite
• anxiety, depressed mood
• sleep problem
• nervousness, restlessness
• disturbance in attention
• trembling, muscle twitches
• flushing
• shortness of breath
• itching, rash
• increased sweating
• feeling of weakness, fatigue
• feeling of body temperature change
• mucosal dryness
• accumulation of water in the tissue

Uncommon

• allergic reaction including swelling beneath the skin, hives, and in severe cases difficulty breathing, collapse or shock, a fall in blood pressure
• weight loss
• disorientation, confusion
• excitability (agitation)
• perce
• abnormal dreams
• euphoric mood (extreme happiness and excitement)
• depressed level of consciousness
• memory or mental impairment
• fainting
• sedation (excessive sleepiness)
• balance disorder
• difficulty in speaking
• numbness, abnormal sensations of the skin such as tingling, prickling
• abnormal vision
• faster or slower heart rate, palpitations, decreased blood pressure
• abdominal discomfort
• hives
• delay in passing urine or frequent urination
• sexual dysfunction
• drug withdrawal syndrome
• feeling abnormal, irritability

Rare

• drug dependence
• thinking abnormal
• epile
• near fainting
• abnormal coordination
• dangerously slow or shallow breathing (respiratory depression)
• impaired gastric emptying
• feeling drunk
• feeling of relaxation

Stop taking XTRADOL 100MG TABLET and inform your doctor immediately if you
experience any of the following side effects:

• signs of an allergic reaction (such as difficulties in breathing, wheezing, swelling of the eyelids, face or lips, rash or itching (covering your whole body)
• breathing more slowly or weakly than normal

How To Manage Side Effects

Nausea or vomiting:

Stick to simple meals while taking this medicine. Avoid eating oily rich, fried
or spicy foods. Do not lie down or sleep immediately after eating. Consult your
doctor if the symptom does not improve.

Constipation:

Eat plenty of fiber rich foods such as fresh fruits, vegetables, and cereals and
drink plenty of water. Exercise more regularly (such as daily walk). Consult
your doctor if the symptom does not improve.

Diarrhoea:

Drink lot of fluids, such as water to keep yourself hydrated. Avoid eating
high-fat or spicy foods. Try to avoid taking any medicine on your own to manage
diarrhea and consult your doctor if the symptom gets worse.

Stomach pain:

Try to rest and relax. Eat and drink slowly or try to have smaller meals more
frequently. Keep a heat pad on your stomach. If the symptom does not improve,
consult your doctor.

Headache:

Drink ample amount of water and avoid skipping meals. Get adequate rest. Try to
be relaxed and stress free. Apply pain relieving balm on your forehead if
necessary. Consult your doctor if the symptom does not improve.

Warning & Precautions

!### Pregnancy

XTRADOL 100MG TABLET is not recommended for use in pregnant women unless
recommended by the doctor as it can cause withdrawal symptoms in the new-born
baby when used for prolonged period of time, which might be life threatening and
could also possibly lead to dangerously slow or shallow breathing in the
newborn. Consult with your doctor before taking XTRADOL 100MG TABLET.

!### Breastfeeding

XTRADOL 100MG TABLET is not recommended for use in breastfeeding women as it may
pass through the breast milk. Consult your doctor before taking XTRADOL 100MG
TABLET.

!### Driving and Using Machines

Do not drive or use any machinery while taking XTRADOL 100MG TABLET if you
experience drowsiness, dizziness, blurred vision or impairment of reactions.

!### Alcohol

Avoid consum
increase the effect of drowsiness.

!### Kidney

XTRADOL 100MG TABLET is not recommended for use in patients with severe kidney
problems. It should be used with caution in patients suffering from kidney
disease. Consult your doctor before taking XTRADOL 100MG TABLET.

!### Liver

XTRADOL 100MG TABLET is not recommended for use in patients with severe liver
problems. XTRADOL 100MG TABLET should be used with caution in patients with
moderate liver problems and your doctor may adjust the dose. Consult your doctor
before taking XTRADOL 100MG TABLET.

!### Allergy

Do not take XTRADOL 100MG TABLET if you are allergic to Tapentadol or any other
ingredients of this medicine.

!### Lungs

XTRADOL 100MG TABLET is not recommended for use in patients having lung diseases
such as asthma or dangerously slow and shallow breathing (hypercapnia,
respiratory depression). It should be used with caution in patients having other
breathing issues (slow or shallow breathing). Consult your doctor before taking
XTRADOL 100MG TABLET.

Others

XTRADOL 100MG TABLET is not recommended for use if you:

• have paralysis of the gut (muscles of the gastrointestinal tract)
• have acute poisoning of alcohol, sleeping pills, pain relievers or other psychotropic medicines (medicines that affect mood and emotions)

Before taking XTRADOL 100MG TABLET inform your doctor if you:

• have increased pressure in the brain or disturbed consciousness up to coma
• had a head injury or brain tumour
• have a disease affecting the pancreas (such as pancreatitis) or biliary tract
• have tendency towards fits
• have tendency to abuse medicines (getting habitual of it)
• have lactose intolerance

Use in paediatrics:

XTRADOL 100MG TABLET is not recommended for use in children and adolescents
(below 18 years of age). Consult your child’s doctor for advice.

Use in geriatrics:

XTRADOL 100MG TABLET should be used with caution in elderly patients (aged 65
years and above) due to delayed excretion of this medicine in this age group and
your doctor may adjust the dose. Consult your doctor before taking XTRADOL 100MG
TABLET.

Interactions

A. Drug–Drug Interactions:

Before taking XTRADOL 100MG TABLET inform your doctor if you are taking any of
the following medicines:

• sedatives such as zolpidem, barbiturates (Ex. amobarbital, pentobarbital) antidepressants such as paroxetine, sertraline and anti-psychotics such as loxapine, clozapine, monoamine oxidase inhibitors (MAOIs) such as isocarboxazid (used to manage depression, anxiety, mood disorders, sleep disturbances)
• opioids such as codeine, oxymorphone, mixed mu-opioid agonist/antagonists such as pentazocine, nalbuphine, partial mu-opioid agonists such as buprenorphine (used to manage severe pain)
• antihistamines such as cetirizine, loratadine (used to manage allergy)
• rifampicin (used to manage tuberculosis)
• St. john’s wort (herbal medicine used to manage depression)

Overdosage:

If you or anyone else accidentally takes too much of XTRADOL 100MG TABLET,
consult your doctor immediately or visit the nearby hospital. Overdosage
symptoms of XTRADOL 100MG TABLET are pin-point pupils, vomiting, fast heartbeat,
drop in blood pressure, collapse, disturbed consciousness or coma (deep
unconsciousness), epile
breathing or stopping breathing may occur.

Synopsis

Drug	:	Tapentadol
Pharmacological Category	:	mu-opioid agonists
Therapeutic Indication	:	Severe chronic pain
Dosage Forms	:	Tablet, Nasal Spray, Capsule

More Information

• Keep XTRADOL 100MG TABLET out of reach of children
• Store at room temperature below 25°C

FAQs About XTRADOL 100MG TABLET

What is XTRADOL 100MG TABLET and why is it prescribed?

XTRADOL 100MG TABLET contains Tapentadol which belongs to the group of medicines
called Opioids. It is used in the management of severe chronic pain in adults
which can only be managed by a strong (opioid) painkiller.

Is XTRADOL 100MG TABLET a habit-forming medicine?

XTRADOL 100MG TABLET may cause psychological and physical addiction. If you have
a tendency to become habitual to medicines or if you are dependent on medicines,
you should only take XTRADOL 100MG TABLET for short periods. You must consult
with your doctor priorly and discuss with them.

Can XTRADOL 100MG TABLET cause sleep related breathing problems?

XTRADOL 100MG TABLET contains an active substance that belongs to the group of
opioids which can cause sleep related breathing disorders. This includes central
sleep apnoea (shallow, pause of breathing during sleep) and sleep-related
hypoxemia (lowered levels of oxygen in the blood). The risk of experiencing such
problems depends upon the dose of XTRADOL 100MG TABLET. Hence, you should not
exceed the daily recommended dose. Your doctor may consider altering your dosage
if you experience any such problems.

Can I stop taking XTRADOL 100MG TABLET on my own if I start to feel better?

You must not stop taking XTRADOL 100MG TABLET until and unless your doctor asks
you to stop. Stopping suddenly or too soon may cause your pain to return. If you
have been taking XTRADOL 100MG TABLET for quite some time and you stop suddenly,
you may experience symptoms such as restlessness, runny nose, yawning, watery
eyes, sweating, chills, muscle pain, joint pain, dilated pupils, irritability,
anxiety, backache, weakness, abdominal cramps, etc. If you feel any such
symptoms or at all you wish to discontinue taking XTRADOL 100MG TABLET, ask for
your doctor’s advice.

Does XTRADOL 100MG TABLET affect my ability to drive?

Do not drive or use any machinery if you feel drowsy, dizzy, blurring of vision
or impairment of concentration after taking XTRADOL 100MG TABLET. You can resume
with your activities once you feel normal again. Consult your doctor for advice.