Thalix 100mg Capsule 10'S

Introduction About THALIX 100MG CAPSULE

THALIX 100MG CAPSULE contains Thalidomide which belongs to the group of
medicines called Immunomodulating Agents. It is used in combination with other
medicines (melphalan and prednisone) for the management of a type of cancer
called multiple myeloma in patients aged over 65 years and have not been
prescribed with any other medicine and in patients above 65 years of age who
cannot tolerate high doses of chemotherapy.

Multiple Myeloma is a certain type of cancer which affects a specific white
blood cell called plasma cell. It is also indicated in management of skin
symptoms associated with severe Erythema Nodosum Leprosum (ENL). ENL is a
complication of leprosy which presents on the skin as tender bumps.

Before starting the management with THALIX 100MG CAPSULE, your doctor might want
you to take some diagnostic tests to understand your existing condition.

Before taking THALIX 100MG CAPSULE, inform your doctor if you have or had liver,
heart or kidney disease, diabetes, frequent infections, hepatitis B, numbness,
pain and tingling in hands or feet, severe skin rash, seizures, thyroid
problems, blood clots, high blood pressure or high cholesterol, healing wounds
and had surgery in in the previous 7 days.

THALIX 100MG CAPSULE is not recommended for use in pregnant and breast-feeding
women. Consult with your doctor before taking it.

It should be used with caution in men as it passes through the semen. Men must
not donate semen while getting managed with THALIX 100MG CAPSULE and should use
effective contrace
under 12 years of age due to lack of safety and effectiveness.

The most common side effects of taking THALIX 100MG CAPSULE are constipation,
sleepiness, tiredness, nausea, stomach pain and dry mouth. Ask for your doctor’s
advice if any of these worsen or doesn’t improve.

Uses Of THALIX 100MG CAPSULE

• Manage multiple myeloma (in combination with other medicines)
• Manage skin symptoms associated with severe erythema nodosum leprosum (ENL)

How THALIX 100MG CAPSULE Works

THALIX 100MG CAPSULE effectively helps in the management of multiple myeloma by
helping the body’s immune system and inhibiting the production of a certain type
of protein (Interleukin-6) which is responsible for the growth of cancer cells.
THALIX 100MG CAPSULE also stops the development of blood vessels in the cancer
cells and stimulates the immune system to kill the cancer cells.

How to use THALIX 100MG CAPSULE

Take THALIX 100MG CAPSULE as advised by your doctor. Take this medicine after
having food, swallow the medicine with a glass of water. Do not crush or chew
the medicine. Your doctor will decide the correct dose and duration of THALIX
100MG CAPSULE for you depending upon your age, disease condition and body
weight.

Side Effects Of THALIX 100MG CAPSULE

Common

• constipation
• indigestion
• nausea, vomiting
• stomach pain, dry mouth
• rash, dry skin
• fainting, tiredness
• dizziness, sleepiness
• shaking (tremor)
• headache, blurred vision
• difficulty in co-ordinating movements
• loss of balance
• swelling of the hands and feet
• feeling generally unwell
• weakness, feeling cold
• depression, mood changes, anxiety, confusion
• low blood pressure (spinning feeling in your head, making it difficult to stand up and move normally)
• slow heart rate
• muscle cramps
• decreased sexual drive
• abnormal periods

Rare

Stop taking THALIX 100MG CAPSULE and contact your doctor immediately if you
experience any of the following side effects:

• signs of progressive multifocal leukoencephalopathy (PML) (blurred, loss of or double vision, weakness in an arm or a leg, difficulty speaking, changes in walking or problems with balance, decreased sensation or loss of sensation, persistent numbness, memory loss or confusion)
• extremely intense and serious skin reactions appearing as rashes with or without blisters. Skin irritation, sores or swelling in the mouth, throat, eyes, nose and around the genitals, oedema, flu-like symptoms and fever
• allergic reactions which may include localised or generalised pruritic rash, angioedema and anaphylactic reaction and appear as hives, rashes, swelling of eyes, mouth or face, difficulty of breathing or itching
• peripheral neuropathy (tingling, numbness, abnormal coordination or pain in hands and feet)
• signs of pulmonary embolism, blood clot in lungs (sudden pain in chest or difficulty in breathing)
• signs of blood clots in veins of the legs (pain or swelling in legs, especially in lower leg or calves)
• signs of heart attack (chest pain spreading to the arms, neck, jaw, back or stomach, sweating, breathless, nausea, vomiting)
• signs of stroke (temporary difficulty in seeing or speaking)
• signs of infections (fever, sore throat, chills, cough, mouth ulcers)
• bleeding or bruising without any injury

How To Manage Side Effects

Nausea:

Stick to simple meals while taking this medicine. Avoid eating oil rich or spicy
foods. If the symptom does not improve, consult with your doctor.

Vomiting:

Drink clear or ice-cold drinks, eat light, bland foods and avoid eating fried,
oily or sweet foods. If the symptom does not improve, consult with your doctor.

Constipation:

Eat plenty of fiber rich foods such as vegetables, fresh fruits, cereals and
drink plenty of water while taking THALIX 100MG CAPSULE. Exercise more
regularly. If the symptom does not improve, consult with your doctor.

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.

Headache:

Try to take rest and don’t involve yourself in exertive activities. Apply a
pain-relieving balm on your forehead if necessary. If the symptom does not
improve, consult with your doctor.

Warning & Precautions

!### Pregnancy

THALIX 100MG CAPSULE is not recommended for use in pregnant women as it may
increase the chances of serious birth defects in the baby such as shortened arms
or legs, eye or ear defects, improperly formed hands or feet and problems with
internal organs. Your doctor might ask you take pregnancy tests regularly while
getting managed with THALIX 100MG CAPSULE and even after the management stops.
Consult your doctor before taking THALIX 100MG CAPSULE.

!### Breastfeeding

THALIX 100MG CAPSULE is not recommended for use in breastfeeding women as it is
not known if it passes through the breast milk. Consult your doctor before
taking THALIX 100MG CAPSULE.

!### Driving and Using Machines

Do not drive or operate any machines if you feel dizzy, tired, sleepy or
blurring of vision after taking THALIX 100MG CAPSULE.

!### Alcohol

Avoid the consum
make you sleepier.

!### Kidney

THALIX 100MG CAPSULE should be taken with caution in patients with kidney
problems. Consult your doctor before taking THALIX 100MG CAPSULE.

!### Liver

THALIX 100MG CAPSULE should be taken with caution in patients with liver
problems and hepatitis B virus infection. Consult your doctor before taking
THALIX 100MG CAPSULE.

!### Allergy

Do not take THALIX 100MG CAPSULE if you are allergic to Thalidomide or any other
ingredients of this medicine.

!### Heart Disease

THALIX 100MG CAPSULE should be taken with caution in patients with heart
diseases such as history of heart attack. Consult your doctor before taking
THALIX 100MG CAPSULE.

Others

Before taking THALIX 100MG CAPSULE, inform your doctor if you:

• have or had a blood clot
• have high blood pressure or high levels of cholesterol
• have existing nerve damage (tingling, abnormal co-ordination or pain in hands or feet)
• have had serious skin reactions
• have diabetes
• have thyroid problems or seizures
• have healing wounds
• had any surgery in the previous 7 days

Use in paediatrics:

THALIX 100MG CAPSULE is not recommended for use in children below 12 years of
age due to lack of safety and effectiveness. Consult your child’s doctor for
advice.

Use in geriatrics:

Your doctor will advise the correct dose and duration of THALIX 100MG CAPSULE
for you depending upon your age, disease condition and body weight.

Interactions

A. Drug–Drug Interactions:

Before taking THALIX 100MG CAPSULE, inform your doctor if you are taking any of
the following medicines:

• medicines that cause drowsiness (Ex. triazolam, temazepam)
• medicines used to manage depression or anxiety (Ex. citalopram, fluoxetine)
• medicines used to manage heart problems or high blood pressure (Ex. ramipril, azilsartan, propranolol)
• anticoagulants such as aspirin (used to manage or manage blood clots)
• hormonal contrace
• medicines used to manage anaemia (Ex. cyanocobalamin)
• medicines used in the management of cancer (Ex. vincristine)
• medicines used in the management of AIDS (Ex. zalcitabine, didanosine)

Overdosage:

If you or anyone else accidentally take too much of THALIX 100MG CAPSULE,
consult your doctor immediately or visit the nearby hospital. The symptoms of
overdosage of THALIX 100MG CAPSULE are numbness and tingling in hand or feet,
excessive sleepiness, constipation, dry mouth, skin rash and weakness.

Synopsis

Drug	:	Thalidomide
Pharmacological Category	:	Immunomodulating Agents
Therapeutic Indication	:	Multiple Myeloma, Skin reactions of Erythema, Nodosum Leprosum
Dosage Forms	:	Capsule

More Information

• Keep THALIX 100MG CAPSULE out of reach of children
• Store at room temperature

FAQs About THALIX 100MG CAPSULE

What is THALIX 100MG CAPSULE and why is it given?

THALIX 100MG CAPSULE contains Thalidomide which belongs to the group of
medicines called Immunomodulating Agents. It is used in combination with other
medicines (melphalan and prednisone) for the management of a type of cancer
called multiple myeloma in patients aged over 65 years and have not been
prescribed with any other medicine and in patients above 65 years of age who
cannot tolerate high doses of chemotherapy. It is also used to manage skin
symptoms associated with Severe Erythema Nodosum Leprosum (ENL).

Can I donate blood while taking THALIX 100MG CAPSULE?

No, you must not donate blood while getting managed with THALIX 100MG CAPSULE
and for at least 7 days after stopping the management. This is because THALIX
100MG CAPSULE has dose-dependent effects and can cause serious birth defects in
babies or even foetal death. Consult your doctor before donating.

How to manage if I forget to take a dose of THALIX 100MG CAPSULE?

If you forget to take a dose of THALIX 100MG CAPSULE at your regular time and
less than 12 hours have passed, then take THALIX 100MG CAPSULE immediately. If
it has been more than 12 hours, do not take the missed dose, take your next dose
at the same time of the day.

What precautions do men need to follow while taking THALIX 100MG CAPSULE?

If you are a man taking THALIX 100MG CAPSULE and have a partner who has a
potential to become pregnant, make sure that you use effective methods of
contrace
semen while on management with THALIX 100MG CAPSULE. Consult with your doctor
for advice.

What all parameters need to be monitored while taking THALIX 100MG CAPSULE?

While taking THALIX 100MG CAPSULE, your doctor might monitor your thyroid gland
functioning, amount of tumour in the body and your blood cell count as it is
important to keep a check on all of these. Consult with your doctor for advice
before taking this medicine.

Useful Diagnostic Tests

• Complete Blood Count
• Bone Marrow Biopsy
• Bone Xray
• CT Scans
• MRI