Patient Information Leaflet

XELJANZ 5 mg film-coated tablets

XELJANZ 10 mg film-coated tablets

tofacitinib

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you are unsure about anything, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

In addition to this leaflet, your doctor will also give you a patient information leaflet card, which contains important safety information that you need to know before taking XELJANZ and during treatment with XELJANZ. Keep this patient information leaflet card with you.

1. What XELJANZ is and what it is used for

2. What you need to know before starting treatment with XELJANZ

3. How to take XELJANZ

4. Possible side effects

5. Storage of XELJANZ

6. Contents of the pack and additional information

XELJANZ is a medication that contains the active ingredient tofacitinib.

XELJANZ is used for the treatment of the following inflammatory diseases:

• Rheumatoid Arthritis
• Psoriatic Arthritis
• Ulcerative Colitis
• Ankylosing Spondylitis
• Idiopathic Juvenile Arthritis of Polyarticular Course and Juvenile Psoriatic Arthritis

Rheumatoid Arthritis

XELJANZ is used for the treatment of adult patients with moderate to severe active rheumatoid arthritis,a long-term disease that mainly produces pain and inflammation of the joints.

XELJANZ is used in combination with methotrexate when previous treatment for rheumatoid arthritis has not been effective or was not well tolerated. XELJANZ can also be taken as a single medication in cases where methotrexate treatment is not tolerated or not recommended.

It has been shown that XELJANZ reduces joint pain and swelling and improves the ability to perform daily activities when administered alone or with methotrexate.

Psoriatic Arthritis

XELJANZ is used to treat adult patients with a condition called psoriatic arthritis. This condition is an inflammatory joint disease, often accompanied by psoriasis. If you have active psoriatic arthritis, another medication will first be administered to treat your psoriatic arthritis. If you do not respond well enough or do not tolerate the medication, XELJANZ may be administered to reduce the signs and symptoms of active psoriatic arthritis and improve the ability to perform daily activities.

XELJANZ is used in combination with methotrexate to treat adult patients with active psoriatic arthritis.

Ankylosing Spondylitis

XELJANZ is used to treat a condition called ankylosing spondylitis. This condition is an inflammatory disease of the spine.

If you have ankylosing spondylitis, it is possible that other medications will first be administered. If you do not respond well enough to these medications, XELJANZ will be administered. XELJANZ may help reduce back pain and improve physical function. These effects may facilitate your normal daily activities and improve your quality of life.

Ulcerative Colitis

Ulcerative colitis is an inflammatory disease of the large intestine. XELJANZ is used in adult patients to reduce the signs and symptoms of ulcerative colitis if it has not responded well enough or has been intolerant to previous ulcerative colitis treatment.

Idiopathic Juvenile Arthritis of Polyarticular Course and Juvenile Psoriatic Arthritis

XELJANZ is used for the treatment of active idiopathic juvenile polyarticular arthritis, a long-term disease that mainly produces pain and inflammation of the joints in patients 2 years of age and older.

XELJANZ is also used for the treatment of juvenile psoriatic arthritis, a condition that is an inflammatory joint disease, often accompanied by psoriasis, in patients 2 years of age and older.

XELJANZ can be used in combination with methotrexate when previous treatment for idiopathic juvenile polyarticular arthritis or for juvenile psoriatic arthritis has not been effective or was not well tolerated. XELJANZ can also be taken as a single medication in cases where methotrexate treatment is not tolerated or not recommended.

• If you are allergic to tofacitinib or any of the other components of this medication (listed in section 6)
• If you have a severe infection such as blood infection or active tuberculosis
• If you have severe liver problems, such as cirrhosis (scarring of the liver)
• If you are pregnant or breastfeeding

Please contact your doctor if you have any doubts about any of the above points.

Warnings and precautions

Consult your doctor or pharmacist before starting to take XELJANZ:

• If you think you have an infection or have symptoms of an infection such as fever, sweating, chills, muscle aches, cough, difficulty breathing, appearance of mucus or changes in mucus, weight loss, hot, red, or painful skin, or sores on the body, difficulty or pain swallowing, diarrhea or stomach pain, burning sensation while urinating or frequent urination, or feeling very tired
• If you have a disease that increases the risk of infection (for example, diabetes, HIV/AIDS or a weakened immune system)
• If you have any type of infection, are receiving treatment for an infection, or have recurring infections. Inform your doctor immediately if you do not feel well. XELJANZ may reduce the body's ability to respond to infections and may worsen an existing infection or increase the risk of contracting a new infection
• If you have or have a history of tuberculosis or have been in close contact with someone with tuberculosis. Your doctor will perform a tuberculosis test before starting treatment with XELJANZ and may repeat the test during treatment
• If you have chronic lung disease
• If you have liver problems
• If you have or have had hepatitis B or hepatitis C (viruses that affect the liver). The virus may become active while taking XELJANZ. Your doctor may perform blood tests for hepatitis before starting treatment with XELJANZ and while taking XELJANZ
• If you are 65 years of age or older, if you have ever had any type of cancer, and also if you currently smoke or have smoked in the past. XELJANZ may increase the risk of certain types of cancer. Cases of leukemia, lung cancer, and other types of cancer (such as breast cancer, skin cancer, prostate cancer, and pancreatic cancer) have been reported in patients treated with XELJANZ. If you develop cancer while on treatment with XELJANZ, your doctor will evaluate whether to discontinue treatment with XELJANZ
• If you have a known risk of fractures, for example, if you are 65 years of age or older, are female, or take corticosteroids (for example, prednisone)

• Cases of non-melanoma skin cancer have been observed in patients taking XELJANZ. Your doctor may recommend that you undergo skin exams regularly while taking XELJANZ. If new skin lesions appear during or after treatment or if existing lesions change in appearance, inform your doctor

• If you have had diverticulitis (a type of inflammation of the large intestine) or ulcers in the stomach or intestines (see section 4)
• If you have kidney problems
• If you plan to get vaccinated, inform your doctor. Certain types of vaccines should not be administered while taking XELJANZ. Before starting to take XELJANZ, you should be up to date on all recommended vaccinations. Your doctor will decide if you need to be vaccinated against shingles
• If you have heart problems, high blood pressure, high cholesterol, and also if you currently smoke or have smoked in the past.

Cases of patients treated with XELJANZ who have developed blood clots in the lungs or veins have been reported. Your doctor will review your risk of developing blood clots in the lungs or veins and determine if XELJANZ is appropriate for you. If you have already had problems developing blood clots in the lungs and veins or have a higher risk of developing them [for example, if you have significant obesity, cancer, heart problems, diabetes, have had a heart attack (in the past 3 months), have had recent major surgery, if you use hormonal contraceptives/hormone replacement therapy, if you have been identified with any coagulation anomaly in you or your close relatives], if you are elderly or if you currently smoke or have smoked in the past, your doctor may decide that XELJANZ is not suitable for you.

Consult your doctor immediately if you experience sudden shortness of breath or difficulty breathing, chest pain or upper back pain, swelling in the legs or arms, pain or tenderness in the legs, or redness or change in color of the legs or arms while taking XELJANZ, as these may be signs of a blood clot in the lungs or veins.

Consult your doctor immediately if you experience severe changes in vision (blurred vision, partial or complete loss of vision), as this may be a sign of blood clots in the eyes.

Cases of patients treated with XELJANZ who have had a heart problem, including myocardial infarction, have been reported. Your doctor will evaluate your risk of developing a heart problem and determine if XELJANZ is suitable for you. Talk to your doctor immediately if you experience signs and symptoms of myocardial infarction, such as severe chest pain or pressure (which may extend to the arms, jaw, neck, back), difficulty breathing, cold sweat, dizziness, or sudden dizziness.

Additional control tests

Your doctor should perform blood tests before starting to take XELJANZ, after 4 to 8 weeks of treatment, and then every 3 months, to determine if you have a low white blood cell count (neutrophils or lymphocytes) or a low red blood cell count (anemia).

You should not take XELJANZ if your white blood cell count (neutrophils or lymphocytes) or your red blood cell count is too low. If necessary, your doctor may suspend your treatment with XELJANZ to reduce the risk of infection (white blood cell count) or anemia (red blood cell count).

Your doctor may also perform other tests, for example, to monitor your cholesterol levels in the blood or to monitor the state of your liver. Your doctor should evaluate your cholesterol levels 8 weeks after starting treatment with XELJANZ. Your doctor should perform periodic liver tests.

Older patients

A higher number of infections, some of which may be severe, have been observed in patients aged 65 years and older. Inform your doctor as soon as you notice any signs or symptoms of infection.

Patients aged 65 years and older may have a higher risk of infections, myocardial infarction, and certain types of cancer. Your doctor may decide that XELJANZ is not suitable for you.

Asian patients

A higher number of shingles cases have been observed in Japanese and Korean patients. Inform your doctor if you notice painful blisters on the skin.

You may also have a higher risk of developing certain lung problems. Inform your doctor if you experience any difficulty breathing.

Children and adolescents

The safety and benefits of XELJANZ have not been established in patients under 2 years of age.

Other medications and XELJANZ

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Inform your doctor if you have diabetes or are taking medications to treat diabetes. Your doctor may decide that you need less diabetes medication while taking tofacitinib.

Some medications should not be taken with XELJANZ. If taken with XELJANZ, they may alter the level of XELJANZ in your body, and the dose of XELJANZ may need to be adjusted. Inform your doctor if you are using medications that contain any of the following active ingredients:

• antibiotics such as rifampicin, used to treat bacterial infections
• fluconazole, ketoconazole, used to treat fungal infections

XELJANZ should not be used with medications that suppress the immune system, including biologic therapies (antibodies), such as those that inhibit tumor necrosis factor, interleukin-17, interleukin-12/interleukin-23, integrin antagonists, and strong chemical immunosuppressants, including azathioprine, mercaptopurine, cyclosporine, and tacrolimus. The use of XELJANZ with these medications may increase the risk of adverse effects, including infection.

People taking corticosteroids (for example, prednisone) may have a higher risk of developing severe infections and fractures.

Pregnancy and lactation

If you are a woman of childbearing age, you should use effective contraception during treatment with XELJANZ and for at least 4 weeks after the last dose.

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor before using this medication. XELJANZ should not be used during pregnancy. Inform your doctor immediately if you become pregnant while taking XELJANZ.

If you are taking XELJANZ and breastfeeding, stop breastfeeding until you speak with your doctor about interrupting treatment with XELJANZ.

Driving and operating machines

XELJANZ has no or limited effect on your ability to drive or operate machines.

XELJANZ contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

XELJANZ contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor, do not exceed the recommended dose. In case of doubt, consult your doctor or pharmacist again.

Rheumatoid Arthritis

• The recommended dose is 5 mg twice a day.

Psoriatic Arthritis

• The recommended dose is 5 mg twice a day.

If you have rheumatoid arthritis or psoriatic arthritis, your doctor may switch your XELJANZ 5 mg film-coated tablets twice a day and XELJANZ 11 mg prolonged-release tablets once a day. You can start taking XELJANZ prolonged-release tablets once a day or XELJANZ film-coated tablets twice a day the day after the last dose of either tablets. Do not switch XELJANZ film-coated tablets and XELJANZ prolonged-release tablets unless your doctor tells you to.

Ankylosing Spondylitis

• The recommended dose is 5 mg twice a day.
• Your doctor may decide to stop XELJANZ if XELJANZ does not work for you within 16 weeks.

Ulcerative Colitis

• The recommended dose is 10 mg twice a day for 8 weeks, followed by 5 mg twice a day.
• Your doctor may decide to extend the initial treatment of 10 mg twice a day for another 8 weeks (16 weeks in total), followed by 5 mg twice a day.
• Your doctor may decide to stop XELJANZ if XELJANZ does not work for you within 16 weeks.
• If you have previously taken biologic medications to treat ulcerative colitis (such as those that block the tumor necrosis factor activity in the body) and these medications did not work, your doctor may decide to increase your XELJANZ dose to 10 mg twice a day if you do not respond adequately to 5 mg twice a day. Your doctor will consider the potential risks, including the development of blood clots in the lungs or veins, and the potential benefits for you. Your doctor will tell you if this applies to you.
• If your treatment is interrupted, your doctor may decide to restart it.

Use in Children and Adolescents

Idiopathic Juvenile Polyarticular Arthritis and Juvenile Psoriatic Arthritis

• The recommended dose is 5 mg twice a day for patients ≥ 40 kg.

Try to take the tablets at the same time every day (one tablet in the morning and one tablet in the evening).

XELJANZ tablets can be crushed and taken with water.

Your doctor may reduce the dose if you have liver or kidney problems, or if you are taking certain medications. Your doctor may also temporarily or permanently stop treatment if blood tests show low white blood cell or red blood cell counts.

XELJANZ is for oral use. You can take XELJANZ with or without food.

If you take more XELJANZ than you should

If you take more tablets than you should, inform your doctor or pharmacist immediately.

If you forget to take XELJANZ

Do not take a double dose to make up for the missed dose. Take the next tablet at the usual time and continue as before.

If you interrupt treatment with XELJANZ

Do not stop taking XELJANZ without consulting your doctor.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Some may be severe and require medical attention.

The adverse effects in patients with polyarticular juvenile idiopathic arthritis and juvenile psoriatic arthritis were consistent with those observed in adult patients with rheumatoid arthritis, with the exception of some infections (influenza, pharyngitis, sinusitis, viral infection) and gastrointestinal or general disorders (abdominal pain, nausea, vomiting, fever, headache, cough), which were more frequent in the pediatric population with juvenile idiopathic arthritis.

Possible severe adverse effects

In rare cases, infections can be fatal. Cases of lung cancer, leukemia, and myocardial infarction have also been reported.

If you notice any of the following severe adverse effects,inform your doctor immediately.

The signs of severe infection (frequent) include

• fever and chills
• cough
• skin blisters
• abdominal pain
• persistent headache

The signs ofulcers or holes (perforations) in the stomach (infrequent) include

• fever
• abdominal pain or abdominal pain
• blood in stool
• unjustified changes in bowel habits

Stomach or intestinal ulcers occur more frequently in patients who are also being treated with nonsteroidal anti-inflammatory drugs or corticosteroids (e.g. prednisone).

The signs of allergic reactions (unknown frequency) include

• chest tightness
• asthma
• severe dizziness or vertigo
• swelling of the lips, tongue, or throat
• urticaria (pruritus and hives)

The signs of blood clots in the lungs, veins, or eyes (infrequent: venous thromboembolism) include

• sudden shortness of breath or difficulty breathing
• chest pain or upper back pain
• swelling of the legs or arms
• pain or tenderness in the legs
• redness or change in color of legs or arms
• severe changes in vision

The signs of myocardial infarction (infrequent) include

• chest pain or pressure (which may radiate to the arms, jaw, neck, or back)
• difficulty breathing
• cold sweat
• sudden dizziness or lightheadedness

Other adverse effectsobserved with XELJANZ are listed below.

Frequent(may affect up to 1 in 10patients): respiratory infections (pneumonia and bronchitis), shingles, nasal, throat, or tracheal infections (nasopharyngitis), influenza, sinusitis, urinary tract infections (cystitis), sore throat (pharyngitis), elevated muscle enzymes in blood (signs of muscle problems), abdominal pain (gastrointestinal), vomiting, diarrhea, nausea, indigestion, low white blood cell count, low red blood cell count (anemia), swelling of feet and hands, headache, high blood pressure (hypertension), cough, skin rash, acne.

Infrequent(may affect up to 1 in 100patients): lung cancer, tuberculosis, kidney infection, skin infection, herpes simplex or oral ulcers (herpes labial), elevated creatinine in blood (a possible sign of kidney problems), elevated cholesterol (including LDL), fever, fatigue (fatigue), weight gain, dehydration, muscle strain, tendinitis, joint swelling, joint sprain, abnormal sensations, insomnia, sinus congestion, shortness of breath or difficulty breathing, skin redness, itching, fatty liver, painful inflammation of small pouches that protrude from the intestinal lining (diverticulitis), viral infections, viral infections affecting the intestine, some types of non-melanoma skin cancer.

Rare(may affect up to 1 in 10000patients): blood infection (sepsis), lymphoma (cancer of white blood cells), disseminated tuberculosis affecting bones and other organs, other unusual infections, joint infections, elevated liver enzymes in blood (sign of liver problems), muscle and joint pain.

Very rare(may affect up to 1 in 10000 patients): tuberculosis affecting the brain and spinal cord, meningitis, infection of soft tissues and fascia.

In general, fewer adverse effects were observed in rheumatoid arthritis when XELJANZ was administered alone compared to when it was combined with methotrexate.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the blister pack, bottle, or carton. The expiration date is the last day of the month indicated.

This medication does not require any special storage temperature.

Store in the original packaging to protect it from moisture.

Do not use this medication if you observe visible signs of deterioration (for example, they are broken or discolored).

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of XELJANZ

XELJANZ 5film-coated tablets

• The active ingredient is tofacitinib.
• Each 5 mg film-coated tablet contains 5mg of tofacitinib (as tofacitinib citrate).
• The other components are microcrystalline cellulose, lactose monohydrate (see section 2 “XELJANZ contains lactose”), sodium croscarmellose (see section 2 “XELJANZ contains sodium”), magnesium stearate, hypromellose (E464), titanium dioxide (E171), macrogol, and triacetin.

XELJANZ 10film-coated tablets

• The active ingredient is tofacitinib.
• Each 10mg film-coated tablet contains 10mg of tofacitinib (as tofacitinib citrate).
• The other components are microcrystalline cellulose, lactose monohydrate (see section 2 “XELJANZ contains lactosa”), sodium croscarmellose (see section 2 “XELJANZ contains sodium”), magnesium stearate, hypromellose (E464), titanium dioxide (E171), macrogol, triacetin, FD&C Blue #2/Lacquer with indigo carmine (E132) and FD&C Blue #1/Lacquer with Brilliant Blue FCF (E133).

Appearance of the product and contents of the pack

XELJANZ 5mg film-coated tablets

XELJANZ 5mg film-coated tablets are white and round.

The tablets are presented in blisters with 14 tablets. Each pack contains 56, 112or 182tablets and each bottle contains 60 or 180tablets.

XELJANZ 10mg film-coated tablets

XELJANZ 10mg film-coated tablets are blue and round.

The tablets are presented in blisters with 14tablets. Each pack contains 56, 112or 182tablets and each bottle contains 60 or 180tablets.

Only some pack sizes may be marketed.

Marketing authorisation holder

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Bruxelles

Belgium

Responsible for manufacturing

Pfizer Manufacturing Deutschland GmbH

Betriebsstätte Freiburg

Mooswaldallee 1

79090 Freiburg

Germany

For further information about this medicinal product, please contact the local representative of the marketing authorisation holder:

Spain

Pfizer, S.L.

Tel: +34 91 490 99 00

Last update of this leaflet:

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu.