XELJANZ 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

XELJANZ 5mg film-coated tablets

XELJANZ 10 mg film-coated tablets

tofacitinib

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

Contents of the pack

1. What is XELJANZ and what is it used for
2. What you need to know before you take XELJANZ
3. How to take XELJANZ
4. Possible side effects
5. Storing XELJANZ
6. Contents of the pack and other information

1. What is XELJANZ and what is it used for

XELJANZ is a medicine that contains the active substance tofacitinib.

XELJANZ is used to treat the following inflammatory diseases:

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

Rheumatoid Arthritis

XELJANZ is used to treat adult patients with moderate to severe active rheumatoid arthritis, a long-term disease that mainly causes 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 the only medicine in cases where treatment with methotrexate is not tolerated or not recommended.

XELJANZ has been shown to reduce joint pain and swelling and improve the ability to perform daily activities when given alone or with methotrexate.

Psoriatic Arthritis

XELJANZ is used to treat adult patients with a condition called psoriatic arthritis. This condition is an inflammatory disease of the joints, often accompanied by psoriasis. If you have active psoriatic arthritis, you will first be given another medicine to treat your psoriatic arthritis. If you do not respond well enough or do not tolerate the medicine, you may be given XELJANZ 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, you may first be given other medicines. If you do not respond well enough to these medicines, you will be given XELJANZ. XELJANZ may help reduce back pain and improve physical function. These effects may make it easier for you to perform 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 treatment for ulcerative colitis.

Polyarticular Juvenile Idiopathic Arthritis and Juvenile Psoriatic Arthritis

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

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

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

2. What you need to know before you take XELJANZ

• if you are allergic to tofacitinib or any of the other ingredients of this medicine (listed in section 6)
• if you have a severe infection such as blood infection or active tuberculosis
• if you have been informed that 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 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 phlegm or changes in phlegm, weight loss, hot, red, or painful skin, or sores on the body, difficulty or pain when swallowing, diarrhea or stomach pain, burning when urinating or urinating more frequently than usual, or if you feel very tired
• if you have any disease that increases the likelihood of infection (e.g., diabetes, HIV/AIDS, or a weakened immune system)
• if you have any type of infection, are receiving treatment for any infection, or if you have infections that keep coming back. 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 likelihood of getting a new infection
• if you have or have had 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 any 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 you are taking XELJANZ. Your doctor may perform blood tests for hepatitis before starting treatment with XELJANZ and while you are 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 white blood cell cancer, lung cancer, and other types of cancer (such as breast, skin, prostate, and pancreatic cancer) have been reported in patients treated with XELJANZ. If you develop cancer while taking XELJANZ, your doctor will assess whether to interrupt 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 (e.g., prednisone)

• cases of non-melanoma skin cancer have been observed in patients taking XELJANZ. Your doctor may recommend that you have regular skin exams 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 stomach or intestinal ulcers (see section 4)
• if you have kidney problems
• if you intend to be vaccinated, inform your doctor. Certain types of vaccines should not be given when taking XELJANZ. Before starting XELJANZ, you should be up to date with 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 blood clots in the lungs or veins have been reported in patients treated with XELJANZ. Your doctor will review your risk of developing blood clots in the lungs or veins and determine if XELJANZ is suitable for you. If you have already had problems with developing blood clots in the lungs and veins or have a higher risk of developing them [e.g., if you are significantly overweight, have cancer, heart problems, diabetes, have had a heart attack (in the last 3 months), have had recent major surgery, if you use hormonal contraceptives/hormone replacement therapy, if you have been identified with any coagulation abnormalities in you or your close relatives], if you are older 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 pain in the upper back, swelling in the legs or arms, pain or tenderness to the touch in the legs, or redness or color change in 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 total loss of vision), as this may be a sign of blood clots in the eyes.

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

Additional monitoring tests

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

You should not take XELJANZ if your count of white blood cells (neutrophils or lymphocytes) or your count of red blood cells 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 cholesterol levels in the blood or to monitor the condition of your liver. Your doctor should evaluate your cholesterol levels within 8 weeks of starting treatment with XELJANZ. Your doctor should perform liver function tests periodically.

Elderly patients

A higher number of infections, some of which can be serious, has been observed in patients 65 years of age and older. Inform your doctor as soon as you notice any sign or symptom of infection.

Patient 65 years of age and older may have a higher risk of infections, heart attack, and certain types of cancer. Your doctor may decide that XELJANZ is not suitable for you.

Asian patients

A higher number of shingles cases has 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 notice any difficulty breathing.

Children and adolescents

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

Other medicines and XELJANZ

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Tell your doctor if you have diabetes or are taking medicines to treat diabetes. Your doctor may decide that you need less diabetes medicine while taking tofacitinib.

Some medicines must 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. Tell your doctor if you are using medicines that contain any of the following active substances:

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

It is not recommended to use XELJANZ with medicines that suppress the immune system, including targeted biological 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 medicines may increase the risk of adverse effects, including infection.

Severe infections and fractures may occur more frequently in people who also take corticosteroids (e.g., prednisone).

Pregnancy and breastfeeding

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

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

If you are taking XELJANZ and are breastfeeding, stop breastfeeding until you talk to your doctor about stopping treatment with XELJANZ.

Driving and using machines

XELJANZ has no or negligible influence on your ability to drive or use machines.

XELJANZ contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

XELJANZ contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.

3. How to take XELJANZ

Follow the instructions for administration of this medicine exactly as told by your doctor, do not exceed the recommended dose. If in 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 may 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 tablet. 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 has not worked 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 has not worked within 16 weeks.
• In the case of patients who have previously taken biologic medicines for the treatment of ulcerative colitis (such as those that block the activity of tumor necrosis factor in the body) and these medicines did not work, the doctor may decide to increase the dose of XELJANZ to 10 mg twice a day if there is not an adequate response 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

Polyarticular Juvenile Idiopathic 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).

The tablets of tofacitinib can be crushed and taken with water.

Your doctor may reduce the dose if you have liver or kidney problems, or if you are prescribed certain medicines. Your doctor may also interrupt treatment temporarily or permanently if blood tests show low counts of white blood cells or red blood cells.

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 forgotten doses. Take the next tablet at the usual time and continue as before.

If you stop treatment with XELJANZ

Do not stop taking XELJANZ without consulting your doctor.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Some may be serious and require medical attention.

Adverse effects in patients with juvenile idiopathic polyarticular arthritis and juvenile psoriatic arthritis were consistent with those observed in adult patients with rheumatoid arthritis, with the exception of some infections (flu, 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 Serious Adverse Effects

In rare cases, infections can be fatal. There have also been reports of lung cancer, white blood cell cancer, and myocardial infarction.

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

Signs of severe infection (frequent) include

• fever and chills
• cough
• blistering of the skin
• stomach pain
• persistent headache

Signs ofulcers or holes (perforations) in the stomach (infrequent) include

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

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

Signs of allergic reactions (frequency unknown) include

• chest tightness
• wheezing
• severe dizziness or vertigo
• swelling of the lips, tongue, or throat
• hives (itching and hives)

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 to the touch in the legs
• redness or color change of the legs or arms
• severe changes in vision

Signs of myocardial infarction (infrequent) include

• chest pain or tightness (which may extend to the arms, jaw, neck, and back)
• difficulty breathing
• cold sweat
• sudden dizziness or fainting

Other Adverse Effectsthat have been observed with XELJANZ are listed below.

Frequent(may affect up to 1 in 10 patients): lung infections (pneumonia and bronchitis), shingles, infections in the nasal passages, throat, or trachea (nasopharyngitis), flu, sinusitis, urinary bladder infection (cystitis), sore throat (pharyngitis), increased muscle enzymes in blood (signs of muscle problems), stomach pain (abdominal pain) (which may be due to stomach lining inflammation), vomiting, diarrhea, discomfort (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 100 patients): lung cancer, tuberculosis, kidney infection, skin infection, simple herpes or oral ulcers (cold sores), increased creatinine in blood (a possible sign of kidney problems), increased cholesterol (including increased LDL), fever, fatigue (tiredness), weight gain, dehydration, muscle tear, tendinitis, joint swelling, joint sprain, abnormal sensations, insufficient sleep, sinus congestion, shortness of breath or difficulty breathing, skin redness, itching, fatty liver, painful inflammation of the small pouches that protrude from the intestinal lining (diverticulitis), viral infections, viral infections that affect the intestine, some types of non-melanoma skin cancer.

Rare(may affect up to 1 in 1,000 patients): blood infection (sepsis), lymphoma (white blood cell cancer), disseminated tuberculosis that affects bones and other organs, other unusual infections, joint infection, increased liver enzymes in blood (sign of liver problems), muscle and joint pain.

Very Rare(may affect up to 1 in 10,000 patients): tuberculosis that affects the brain and spinal cord, meningitis, infection of the soft tissues and fascia.

In general, in rheumatoid arthritis, fewer adverse effects were observed when XELJANZ was administered alone than in combination with methotrexate.

Reporting Adverse Effects

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

5. Storage of XELJANZ

Keep this medication out of 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 notice that the tablets show visible signs of deterioration (e.g., they are broken or discolored).

Medications should not be thrown down the drain or into the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

XELJANZ Composition

XELJANZ 5 mg film-coated tablets

• The active ingredient is tofacitinib.
• Each 5 mg film-coated tablet contains 5 mg of tofacitinib (as tofacitinib citrate).
• The other ingredients 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 10 mg film-coated tablets

• The active ingredient is tofacitinib.
• Each 10 mg film-coated tablet contains 10 mg of tofacitinib (as tofacitinib citrate).
• The other ingredients 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, triacetin, FD&C Blue #2/Aluminum Lake with carmine (E132), and FD&C Blue #1/Aluminum Lake with brilliant blue FCF (E133).

Product Appearance and Package Contents

XELJANZ 5 mg film-coated tablets

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

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

XELJANZ 10 mg film-coated tablets

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

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

Only some package sizes may be marketed.

Marketing Authorization Holder

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Brussels

Belgium

Manufacturer

Pfizer Manufacturing Deutschland GmbH

Betriebsstätte Freiburg

Mooswaldallee 1

79090 Freiburg

Germany

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Spain

Pfizer, S.L.

Tel: +34 91 490 99 00

Date of the Last Revision of this Prospectus:

Other Sources of Information

Detailed information about this medication is available on the European Medicines Agency website: http://www.ema.europa.eu.