TOFASHINE XR 11 Tablet 10's

Introduction About TOFASHINE XR 11 TABLET

TOFASHINE XR 11 TABLET contains Tofacitinib, which belongs to the group of
medicines called Antirheumatics. It is used to manage inflammatory diseases such
as rheumatoid arthritis (chronic inflammatory diseases affecting the joints,
causing pain and swelling), psoriatic arthritis (an arthritic condition that
occurs in an individual with psoriasis), ulcerative colitis (ulcerative
inflammation of the digestive tract) and ankylosing spondylitis (fusion of bones
in the spine).

TOFASHINE XR 11 TABLET is also used to manage polyarticular juvenile idiopathic
arthritis and juvenile psoriatic arthritis, which cause pain and inflammation of
joints in children. TOFASHINE XR 11 TABLET is used alone or together with other
drugs, such as methotrexate.

TOFASHINE XR 11 TABLET is not recommended for use in patients with severe liver
diseases (including cirrhosis), bloodstream infections or active tuberculosis.
TOFASHINE XR 11 TABLET should be used with caution in patients who have an
infection or a condition that increases their risk of infection (for example,
diabetes, HIV/AIDS or a weak immune system), chronic lung disease, tuberculosis,
hepatitis B or C, liver, kidney or heart diseases, cancer or are at risk of
developing skin cancer, smoking habits, lactose intolerance, inflammation of the
large intestine, stomach or intestine ulcers, blood pressure, high cholesterol
or at risk of developing a blood clot, are planning to get vaccinated, have
undergone major surgery.

TOFASHINE XR 11 TABLET should not be used by pregnant or breastfeeding women.
TOFASHINE XR 11 TABLET should be used with caution in patients over the age of
65. The safety and effectiveness of TOFASHINE XR 11 TABLET in children under the
age of two have not yet been established.

Lung infection, sore throat, sinusitis, vomiting, nausea, diarrhoea, indigestion
and headache are the most common side effects of TOFASHINE XR 11 TABLET. Ask for
your doctor’s advice if any of these worsen or don’t improve.

Uses Of TOFASHINE XR 11 TABLET

Manages inflammatory conditions such as:

• rheumatoid arthritis
• psoriatic arthritis
• ulcerative colitis
• ankylosing spondylitis
• polyarticular juvenile idiopathic arthritis
• juvenile psoriatic arthritis

How TOFASHINE XR 11 TABLET Works

TOFASHINE XR 11 TABLET helps in managing inflammatory diseases by modifying the
immune system. It manages the body from responding to these substances called
cytokines (controls growth and activity of other immune system cells and blood
cells). It also inhibits the inflammation process via a new pathway (Janus
kinases).

How to use TOFASHINE XR 11 TABLET

Take TOFASHINE XR 11 TABLET as advised by your physician. Swallow the medicine
with a glass of water. It can also be crushed and taken with water. Do not chew
the medicine. Your doctor will decide the correct dose and duration of TOFASHINE
XR 11 TABLET for you depending on your age, disease condition and body weight.

Side Effects Of TOFASHINE XR 11 TABLET

Common

• lung infection such as pneumonia or bronchitis
• shingles (herpes zoster)
• nasopharyngitis (infections of the nose, throat or windpipe)
• influenza
• sinusitis
• urinary bladder infection
• sore throat
• signs of muscle problems
• stomach pain (possibly due to inflammation of the stomach lining)
• vomiting, nausea
• diarrhoea
• indigestion
• anaemia
• fever, fatigue
• swelling of the feet and hands
• headache
• high blood pressure
• cough
• rash

Uncommon

• tuberculosis
• signs of kidney problems (blood creatinine increase)
• skin infection, skin redness, itching
• cold sores (tiny painful blisters at the border of the lip)
• low white blood cells
• signs of liver problems (increase in liver enzyme,)
• increased cholesterol
• weight gain
• dehydration
• muscle strain
• pain in the muscles and joints, tendonitis (inflammation of tendons)
• joint swelling and sprain
• abnormal sensations
• poor sleep
• sinus congestion
• shortness of breath or difficulty breathing
• fatty liver
• painful inflammation of small pockets in the lining of your intestine (diverticulitis)
• viral infections, viral infections affecting the digestive tract
• some types of skin cancers (non-melanoma types)
• lung cancer

Rare

• blood infection (sepsis)
• lymphoma (white blood cell cancer)
• disseminated tuberculosis involving bones and other organs
• other unusual infections
• joint infections

Stop taking TOFASHINE XR 11 TABLET and inform your doctor immediately if you
experience any of the following side effects:

• signs of serious infections such as fever and chills, cough, skin blisters, stomach pain, persistent headaches
• signs of ulcers or perforations in the stomach such as fever, stomach or abdominal pain, blood in the stool, unexplained changes in bowel habits
• signs of allergic reactions such as chest tightness, wheezing, severe dizziness or light-headedness, swelling of the lips, tongue or throat, hives (itching or skin rash)
• signs of blood clots in lungs or veins such as sudden shortness of breath or difficulty breathing, leg pain or tenderness, chest pain or pain in the upper back, swelling of the leg or arm, redness or discolouration in the leg or arm
• signs of a heart attack such as severe chest pain or tightness (that may spread to arms, back, jaw, neck), shortness of breath, cold sweat, light-headedness or sudden dizziness

How To Manage Side Effects

Nausea:

Take this medicine with or just after meals. Stick to simple meals. Avoid eating
rich or spicy food. Ask for your doctor’s advice if the nausea does not improve.

Vomiting:

Drink clear or ice-cold drinks, eat bland, light foods and avoid oily, fried or
sweet foods. Ask for your doctor’s advice if vomiting does not improve.

Diarrhea:

Drink a lot of fluids, such as squash, water or fruit juice to keep yourself
hydrated. Do not consume any medicine by yourself without consulting your
physician. Ask for your doctor’s advice if the diarrhea does not improve.

Stomach pain:

Try to rest and relax. Try to have smaller and more frequent meals and eat and
drink slowly. Keep a heating pad on your stomach. Ask for your doctor’s advice
if stomach pain does not improve.

Headache:

Try to take rest and avoid involving yourself in exertive activities. Apply a
pain-relieving balm on your forehead. Ask for your doctor’s advice if the
headache does not improve.

Warning & Precautions

!### Pregnancy

TOFASHINE XR 11 TABLET is not recommended for use in pregnant women or women
planning to have a baby. If you are a woman of childbearing age, you should use
effective birth control during management and for at least 4 weeks after the
last dose. Consult your doctor before taking it.

!### Breastfeeding

TOFASHINE XR 11 TABLET is not recommended for use in breastfeeding women.
Consult your doctor before taking it.

!### Driving and Using Machines

TOFASHINE XR 11 TABLET does not affect your ability to drive or use machines.

!### Kidney

TOFASHINE XR 11 TABLET should be taken with caution in patients with kidney
disease. The dose will be adjusted by your doctor Consult your doctor before
taking it.

!### Liver

TOFASHINE XR 11 TABLET is not recommended in patients with severe liver problems
such as cirrhosis (scarring of the liver). It should be used with caution in
patients having other liver diseases such as hepatitis B or hepatitis C. Dose
will be adjusted by your doctor. Consult your doctor before taking it.

!### Allergy

Do not take TOFASHINE XR 11 TABLET if you are allergic to Tofacitinib or any
other ingredients of this medicine.

!### Lungs

TOFASHINE XR 11 TABLET is not recommended for use in active tuberculosis.

TOFASHINE XR 11 TABLET should be taken with caution in patients with chronic
lung disease or a history of tuberculosis. Consult your doctor before taking it.

!### Heart Disease

TOFASHINE XR 11 TABLET should be taken with caution in patients with heart
diseases such as heart attack and high blood pressure. Consult your doctor
before taking it.

Others

TOFASHINE XR 11 TABLET is not recommended for use if you have:

• severe bloodstream infection

Before taking TOFASHINE XR 11 TABLET inform your doctor if you have:

• infection, being managed for an infection or having symptoms of it (fever, sweating, chills, muscle aches, cough, shortness of breath, phlegm, weight loss, warm or red or painful sores, difficulty or painful swallowing, diarrhoea or stomach pain, problems with urination, tiredness)
• conditions that increase the chances of infections (Ex. diabetes, HIV/AIDS or a weak immune system)
• tendency of having infections/ recurrent infections
• cancer or at risk of developing cancer, especially skin cancer
• habit of smoking
• lactose intolerance
• inflammation of the large intestine (diverticulitis)
• stomach or intestine ulcers
• high cholesterol
• risk of developing blood clots (seriously overweight, cancer, heart problems, diabetes)
• plans for getting vaccinated
• have undergone a major surgery

Use in paediatrics:

The safety and effectiveness of TOFASHINE XR 11 TABLET in children below 2 years
of age have not been established yet. Consult with your doctor before taking it.

Use in geriatrics:

TOFASHINE XR 11 TABLET should be used with caution in patients above the age of
65 years of age as they may be at increased risk of infections, heart attack and
some types of cancer. Consult with your doctor before taking it.

Interactions

A, Drug-Drug Interactions:

Before taking TOFASHINE XR 11 TABLET Inform your physician if you are taking any
of the following medicines:

• antibiotics such as rifampicin (used in managing bacterial infections)
• fluconazole, ketoconazole (used to manage fungal infections)
• azathioprine, mercaptopurine, ciclosporin, tacrolimus (medicines that depress the immune system)
• corticosteroids such as prednisone (used in managing pain and inflammation)

Overdosage:

If you or anyone else accidentally take too much of TOFASHINE XR 11 TABLET,
consult your doctor immediately or visit the nearby hospital.

Synopsis

Drug	:	Tofacitinib
Pharmacological Category	:	Janus Kinase Inhibitors
Therapeutic Indication	:	Inflammatory diseases
Dosage Forms	:	Tablet

More Information

• Keep TOFASHINE XR 11 TABLET out of reach from children
• Store at below 30°C

FAQs About TOFASHINE XR 11 TABLET

What is TOFASHINE XR 11 TABLET and why is it prescribed?

TOFASHINE XR 11 TABLET contains tofacitinib, which belongs to the group of
medicines called immunosuppressants. It is used to manage inflammatory diseases
such as rheumatoid arthritis (chronic inflammatory diseases of the joints that
cause pain and swelling), psoriatic arthritis (arthritis that affects people who
have psoriasis), ulcerative colitis (inflammation and ulcers in the digestive
tract) and ankylosing spondylitis (inflammatory disease that causes the bones in
the spine to fuse).TOFASHINE XR 11 TABLET is also used to manage polyarticular
juvenile idiopathic arthritis and juvenile psoriatic arthritis, which cause pain
and inflammation of joints in children. TOFASHINE XR 11 TABLET is used together
with drugs such as methotrexate when previous rheumatoid arthritis management
was not sufficient or was not well tolerated.

What should I know before starting to take TOFASHINE XR 11 TABLET?

TOFASHINE XR 11 TABLET can lower the ability of your immune system to fight
infections. Do not start stating TOFASHINE XR 11 TABLET if you have any kind of
infection, a history of infection or are at risk of developing one. Consult with
your doctor before taking TOFASHINE XR 11 TABLET.

Can TOFASHINE XR 11 TABLET be taken by pregnant or breastfeeding women?

TOFASHINE XR 11 TABLET is not recommended for use by pregnant or breastfeeding
women. If you are a woman of childbearing age, effective birth control methods
must be used during management with TOFASHINE XR 11 TABLET and for at least 4
weeks after the last dose. Tell your doctor immediately if you become pregnant
while taking TOFASHINE XR 11 TABLET. Consult your doctor before taking it.

Is TOFASHINE XR 11 TABLET used by children?

TOFASHINE XR 11 TABLET is used to manage polyarticular juvenile idiopathic
arthritis and juvenile psoriatic arthritis, which cause pain and inflammation of
joints in children over 2 years of age. Ask for your doctor’s advice before
giving it to your child.

Do I need to undergo routine diagnostic tests while taking TOFASHINE XR 11
TABLET?

Your doctor might check you regularly for the levels of white blood cells and
red blood cells in your blood while you take TOFASHINE XR 11 TABLET. He must
also check his cholesterol levels and liver and kidney functions regularly.How do I manage if I forget to take a dose of TOFASHINE XR 11 TABLET?

If you forgot to take a dose of TOFASHINE XR 11 TABLET, then do not take the
missed dose between meals. Continue taking your medication as usual until your
next scheduled dose and meal. Do not take a double dose of TOFASHINE XR 11
TABLET to make up for a forgotten dose. Consult your doctor for advice.

Can TOFASHINE XR 11 TABLET be used safely on elderly patients?

Patients aged 65 years and older may be at increased risk of infections, heart
attacks and some types of cancer; therefore, TOFASHINE XR 11 TABLET should be
used with caution in patients above the age of 65 years. Consult with your
doctor before taking it.

Useful Diagnostic Tests

• X-ray
• MRI
• Complete Blood Count
• Skin test
• Liver/kidney function test