Xeljanz 11 mg comprimidos de liberacion prolongada

Patient Information Leaflet

XELJANZ 11Prolonged-Release 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 have any questions, 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, 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 section4.

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.

1.What XELJANZ is and what it is used for

2.What you need to know before starting XELJANZ

3.How to take XELJANZ

4.Side effects

1. Storage of XELJANZ
2. Contents of the pack and additional information

XELJANZ is a medication that contains the active ingredient tofacitinib.

XELJANZis used for the treatment of the following inflammatory diseases:

• Rheumatoid Arthritis
• Psoriatic Arthritis
• Ankylosing Spondylitis

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 is 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 be administered to treat your psoriatic arthritis first. 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 be administered first. 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 thus improve your quality of life.

-if you are allergic to tofacitinib or any of the other components of this medication (listed in section6)

-if you have a serious infection such as blood infection or active tuberculosis

-if you have been informed that you have severe liver problems, such as cirrhosis (liver scarring)

-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 phlegm or changes in phlegm, 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 (liver viruses). 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 65years 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, skin, prostate, and pancreatic cancer) have been reported in patients treated with XELJANZ. If you develop cancer while taking XELJANZ, your doctor will evaluate whether to discontinue treatment with XELJANZ

• if you have a known risk of fractures, for example, if you are 65years 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 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 ulcers in the stomach or intestines (see section4)
• 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 a vaccination against herpes zoster

-if you have heart problems, high blood pressure, high cholesterol, and also if you currently smoke or have smoked in the past

-if you have a narrowing of the digestive tract, inform your doctor, as rare cases of obstruction in the digestive tract have been reported in patients taking other medications with similar prolonged-release tablets

-when taking XELJANZ 11mg prolonged-release tablets, you may see something in your stool that looks like a tablet. This is the empty shell of the prolonged-release tablet after the body has absorbed the medication. This is expected and should not cause concern

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 are significantly overweight, have cancer, heart problems, diabetes, have had a heart attack (in the past 3months), have had recent major surgery, use hormonal contraceptives/hormone replacement therapy, have been identified with any coagulation anomaly in you or your close relatives], if you are elderly or 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 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 8weeks of treatment, and then every 3months, 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 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 8weeks after starting treatment with XELJANZ. Your doctor should perform periodic liver tests.

Older Patients

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

Patients 65years of age 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 herpes zoster 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

XELJANZ is not recommended for use in children or adolescents under 18years of age. The safety and benefits of XELJANZ in children have not been established.

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 containing 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 serious infections and fractures.

Pregnancy and Breastfeeding

If you are a woman of childbearing age, you should use effective contraception during treatment with XELJANZ and for at least 4weeks 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 11mg prolonged-release tablets contain sorbitol

This medication contains approximately 152mg of sorbitol in each prolonged-release tablet.

This medication has been prescribed and supervised by a specialist doctor who knows how to treat your condition.

Follow exactly the administration instructions for 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, Psoriatic Arthritis, and Ankylosing Spondylitis

The recommended dose is one prolonged-release tablet of 11 mg administered once a day.

Try to take the tablet (one prolonged-release tablet of 11 mg) at the same time every day, for example, in the morning or evening.

Swallow the prolonged-release tablets of XELJANZ 11 mg whole to ensure the full dose is released correctly. Do not crush, break, or chew them.

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

If you have rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis, 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.

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

Ankylosing Spondylitis

• Your doctor may decide to stop XELJANZ if XELJANZ does not work within 16 weeks.

If you take more XELJANZ than you should

If you take more prolonged-release 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 a missed prolonged-release tablet of 11 mg. Take the next tablet at the usual time and continue as before.

If you stop taking 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 serious and require medical attention.

Possible severe adverse effects

In rare cases, infections can be fatal. Cases of lung cancer, white blood cell cancer, 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
• stomach pain
• persistent headache

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

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

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

The signs ofallergic reactions (unknown frequency) include

• chest tightness
• whistling
• 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

• shortness of breath or sudden 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 extend 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): lung infections (pneumonia and bronchitis), shingles, nasal, throat, or tracheal infections (nasopharyngitis), flu, sinusitis, urinary tract infections (cystitis), sore throat (pharyngitis), elevated muscle enzymes in blood (signs of muscle problems), stomach pain (abdominal pain) (which may be due to stomach lining inflammation), 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 mouth ulcers (herpes labialis), elevated creatinine in blood (a possible sign of kidney problems), elevated cholesterol (including LDL), fever, fatigue (tiredness), weight gain, dehydration, muscle strain, tendonitis, 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 10,000patients): blood infection (sepsis), lymphoma (white blood cell cancer), 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 10,000patients): 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 in combination 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 not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance 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, the tablets 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

• The active ingredient is tofacitinib.
• Each prolonged-release tablet of 11 mg contains 11 mg of tofacitinib (as tofacitinib citrate).
• The other components are sorbitol (E420) (see section 2 “XELJANZ 11 mg prolonged-release tablets contain sorbitol”), hydroxyethylcellulose, copovidone, magnesium stearate, cellulose acetate, hydroxypropylcellulose (E463), hypromellose (E464), titanium dioxide (E171), triacetin, iron oxide red (E172), shellac (E904), ammonium hydroxide (E527), propylene glycol (E1520), and iron oxide red (E172).

Appearance of the product and content of the container

XELJANZ 11 mg prolonged-release tablets are pink and oval-shaped.

The tablets are presented in blisters with 7 tablets. Each container contains 28 or 91 tablets. The tablets are also available in bottles with silica gel desiccant containing 30 or 90 tablets.

Only some container sizes may be commercially available.

Marketing Authorization 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 more information about this medicine, please contact the local representative of the marketing authorization holder:

Spain

Pfizer, S.L.

Tel: +34 91 490 99 00

Date of the last review of this leaflet:

Other sources of information

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