Xeljanz - patient leaflet, side effects, dosage

Patient leaflet - Xeljanz

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

XELJANZ 5 mg film-coated tablets

XELJANZ 10 mg film-coated tablets

tofacitinib

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

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 Alert Card, which contains important safety information that you need to be aware of before you are given XELJANZ and during treatment with XELJANZ. Keep this Patient Alert Card with you.

What is in this leaflet

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

1. What XELJANZ is and what it is used for

XELJANZ is a medicine that contains the active substance tofacitinib.

XELJANZ is used for the treatment of 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 swelling of your joints.

XELJANZ is used together with methotrexate when previous rheumatoid arthritis treatment was not sufficient or was not well tolerated. XELJANZ can also be taken on its own in those cases where methotrexate treatment is not tolerated or treatment with methotrexate is not advised.

XELJANZ has been shown to reduce pain and swelling of the joints and improve the ability to perform daily activities, when given on its own or together 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 be first given another medicine to treat your psoriatic arthritis. If you do not respond well enough or the medicine is not tolerated, you may be given XELJANZ to reduce the sign and symptoms of active psoriatic arthritis and improve the ability to perform daily activities.

XELJANZ is used together 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.

XELJANZ can be used alone or together with other medicines to treat your ankylosing spondylitis.

XELJANZ has been shown to reduce back pain and improve the ability to perform daily activities.

Ulcerative colitis

Ulcerative colitis is an inflammatory disease of the large bowel. XELJANZ is used in adult patients to reduce the signs and symptoms of ulcerative colitis when you did not respond well enough or were intolerant to previous ulcerative colitis treatment.

Polyarticular juvenile idiopathic arthritis and juvenile psoriatic arthritis

XELJANZ is used for the treatment of active polyarticular juvenile idiopathic arthritis a long-term disease that mainly causes pain and swelling of your 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 disease of the joints often accompanied by psoriasis, in patients 2 years of age and older.

XELJANZ can be used together with methotrexate when previous treatment for polyarticular juvenile idiopathic arthritis or juvenile psoriatic arthritis was not sufficient or was not well tolerated.

XELJANZ can also be taken on its own in those cases where methotrexate treatment is not tolerated or treatment with methotrexate is not advised.

2. What you need to know before you take XELJANZ

Do not 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 bloodstream infection or active tuberculosis
– if you have been informed that you have severe liver problems, including cirrhosis (scarring of

the liver)

– if you are pregnant or breast-feeding

If you are not sure regarding any of the information provided above, please contact your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking XELJANZ:

– if you think you have an infection or have symptoms of an infection such as fever, sweating,

chills, muscle aches, cough, shortness of breath, new phlegm or change in phlegm, weight loss, warm or red or painful skin or sores on your body, difficulty or pain when swallowing, diarrhoea or stomach pain, burning when you urinate or urinating more often than normal, feeling very tired

– if you have any condition that increases your chance of infection (e.g., diabetes, HIV/AIDS, or a

weak immune system)

– if you have any kind of infection, are being treated for any infection, or if you have infections

that keep coming back. Tell your doctor immediately if you feel unwell. XELJANZ can reduce your body’s ability to respond to infections and may make an existing infection worse or increase the chance of getting 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 test you for tuberculosis before starting XELJANZ and may retest during treatment

– if you have any chronic lung disease
– if you have liver problems
– if you have or had hepatitis B or hepatitis C (viruses that affect the liver). The virus may

become active while you are taking XELJANZ. Your doctor may do blood tests for hepatitis before you start treatment with XELJANZ and while you are taking XELJANZ

– if you are older than 65 years, if you have ever had any type of cancer, and also if you are a

current or past smoker. XELJANZ may increase your risk of certain cancers. White blood cell cancer, lung cancer and other cancers (such as breast, melanoma, prostate and pancreatic) have been reported in patients treated with XELJANZ. If you develop cancer while taking XELJANZ your doctor will review whether to stop XELJANZ treatment.

– if you are at high risk of developing skin cancer, your doctor may recommend that you have

regular skin examinations while taking XELJANZ.

– if you have had diverticulitis (a type of inflammation of the large intestine) or ulcers in stomach

or intestines (see section 4)

– if you have kidney problems
– if you are planning to get vaccinated, tell your doctor. Certain types of vaccines should not be

given when taking XELJANZ. Before you start XELJANZ, you should be up to date with all recommended vaccinations. Your doctor will decide whether you need to have herpes zoster vaccination.

– if you have heart problems, high blood pressure, high cholesterol, and also if you are a current

or past smoker

There have been reports of patients treated with XELJANZ who have developed blood clots in the lungs or veins. Your doctor will evaluate your risk to develop blood clots in the lungs or veins and determine if XELJANZ is appropriate for you. If you have already had problems on developing blood clots in lungs and veins or have an increased risk for developing this (for example: if you are seriously overweight, if you have cancer, heart problems, diabetes, experienced a heart attack (within previous 3 months), recent major surgery, if you use hormonal contraceptives\hormonal replacement therapy, if a coagulation defect is identified in you or your close relatives), if you are of older age, or if you smoke currently or in the past, your doctor may decide that XELJANZ is not suitable for you.

Talk to your doctor straight away if you develop sudden shortness of breath or difficulty breathing, chest pain or pain in upper back, swelling of the leg or arm, leg pain or tenderness, or redness or discoloration in the leg or arm while taking XELJANZ, as these may be signs of a clot in the lungs or veins.

There have been reports of patients treated with XELJANZ who have had a heart problem, including heart attack. Your doctor will evaluate your risk to develop a heart problem and determine if XELJANZ is appropriate for you. Talk to your doctor straight away if you develop signs and symptoms of a heart attack including severe chest pain or tightness (that may spread to arms, jaw, neck, back), shortness of breath, cold sweat, light headedness or sudden dizziness.

Additional monitoring tests

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

You should not receive XELJANZ if your white blood cell (neutrophil or lymphocyte) count or red blood cell count is too low. If needed, your doctor may interrupt your XELJANZ treatment to reduce the risk of infection (white blood cell counts) or anaemia (red blood cell counts).

Your doctor may also perform other tests, for example to check your blood cholesterol levels or monitor the health of your liver. Your doctor should test your cholesterol levels 8 weeks after you start receiving XELJANZ. Your doctor should perform liver tests periodically.

Elderly

There is a higher rate of infections in patients aged 65 years and older. Tell your doctor as soon as you notice any signs or symptoms of infections.

Patients aged 65 years and older may be at increased risk of infections, heart attack and some types of cancer. Your doctor may decide that XELJANZ is not suitable for you.

Asian patients

There is a higher rate of shingles in Japanese and Korean patients. Tell your doctor if you notice any painful blisters on your skin.

You may also be at higher risk of certain lung problems. Tell your doctor if you notice any breathing difficulties.

Children and adolescents

The safety and benefits of XELJANZ in children have not yet been established in patients less than 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.

Some medicines should not be taken with XELJANZ. If taken with XELJANZ, they could alter the level of XELJANZ in your body, and the dose of XELJANZ may require adjustment. You should tell your doctor if you are using medicines (taken by mouth) that contain any of the following active substances:

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

XELJANZ is not recommended for use with medicines that depress the immune system, including so-called targeted biologic (antibody) therapies, such as those that inhibit tumour necrosis factor, interleukin-17, interleukin-12/interleukin-23, anti-integrins, and strong chemical immunosuppressants including azathioprine, mercaptopurine, ciclosporine, and tacrolimus. Taking XELJANZ with these medicines may increase your risk of side effects including infection.

Serious infections may happen more often in people who also take corticosteroids (e.g., prednisone).

Pregnancy and breast-feeding

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

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. XELJANZ must not be used during pregnancy. Tell your doctor right away if you become pregnant while taking XELJANZ.

If you are taking XELJANZ and breast-feeding, you must stop breast-feeding until you talk to your doctor about stopping treatment with XELJANZ.

Driving and using machines

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

XELJANZ contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

XELJANZ contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

3. How to take XELJANZ

This medicine is provided to you and supervised by a specialised doctor who knows how to treat your condition.

Always take this medicine exactly as your doctor has told you, the recommended dose should not be exceeded. Check with your doctor or pharmacist if you are not sure.

Rheumatoid arthritis

The recommended dose is 5 mg twice a day.

Psoriatic arthritis

The recommended dose is 5 mg twice a day.

If you suffer from rheumatoid arthritis or psoriatic arthritis, your doctor may switch your tablets between XELJANZ 5 mg film-coated tablets twice daily and XELJANZ 11 mg prolonged-release tablet once daily. You can start the XELJANZ prolonged-release tablet once daily or XELJANZ film-coated tablets twice daily on the day following the last dose of either tablet. You should not switch between XELJANZ film-coated tablets and XELJANZ prolonged-release tablet unless instructed by your doctor.

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 10 mg twice a day treatment by an additional
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.

For patients, who have previously taken biologic medicines to treat ulcerative colitis

(such as those that block the activity of tumour necrosis factor in the body) and these medicines did not work, the doctor may decide to increase your dose of XELJANZ to 10 mg twice a day if you do not respond sufficiently to 5 mg twice a day. Your doctor will consider the potential risks, including that of developing blood clots in the lungs or veins, and potential benefits to you. Your doctor will tell you if this applies to you.

If your treatment is interrupted, your doctor may decide to restart your treatment.

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 your tablet at the same time every day (one tablet in the morning and one tablet in the evening).

Tofacitinib tablets may 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 other medicines. Your doctor may also stop treatment temporarily or permanently 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, immediately tell your doctor or pharmacist.

If you forget to take XELJANZ

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

If you stop taking XELJANZ

You should not stop taking XELJANZ without discussing this with your doctor.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some may be serious and need medical attention.

Side effects in patients with polyarticular juvenile idiopathic arthritis and juvenile psoriatic arthritis were consistent with those seen in adult rheumatoid arthritis patients 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 common in juvenile idiopathic arthritis paediatric population.

Possible serious side effects

In rare cases, infection may be life-threatening

Lung cancer, white blood cell cancer and heart attack have also been reported.

If you notice any of the following serious side effects you need to tell a doctor straight away.

Signs of serious infections (common) include

fever and chills
cough
skin blisters
stomach ache
persistent headaches

Signs of ulcers or holes in your stomach (uncommon) include

fever
stomach or abdominal pain
blood in the stool
unexplained changes in bowel habits

Holes in stomach or intestines happen most often in people who also take nonsteroidal anti-inflammatory drugs or corticosteroids (e.g., prednisone).

Signs of allergic reactions (unknown) include

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 (uncommon: venous thromboembolism) include

sudden shortness of breath or difficulty breathing
chest pain or pain in upper back
swelling of the leg or arm
leg pain or tenderness
redness or discoloration in the leg or arm

Signs of a heart attack (uncommon) include

severe chest pain or tightness (that may spread to arms, jaw, neck, back)
shortness of breath
cold sweat
light headedness or sudden dizziness

Other side effects which have been observed with XELJANZ are listed below.

Common (may affect up to 1 in 10 people): lung infection (pneumonia and bronchitis), shingles (herpes zoster), infections of nose, throat or the windpipe (nasopharyngitis), influenza, sinusitis, urinary bladder infection (cystitis), sore throat (pharyngitis), increased muscle enzymes in the blood (sign of muscle problems), stomach (belly) pain (which may be from inflammation of the stomach lining), vomiting, diarrhoea, feeling sick (nausea), indigestion, low red blood cell count (anaemia), fever, fatigue (tiredness), swelling of the feet and hands, headache, high blood pressure (hypertension), cough, rash.

Uncommon (may affect up to 1 in 100 people): lung cancer, tuberculosis, kidney infection, skin infection, herpes simplex or cold sores (oral herpes), low white blood cell counts, increased liver enzymes in the blood (sign of liver problems), blood creatinine increased (a possible sign of kidney problems), increased cholesterol (including increased LDL), weight gain, dehydration, muscle strain, pain in the muscles and joints, tendonitis, joint swelling, joint sprain, abnormal sensations, poor sleep, sinus congestion, shortness of breath or difficulty breathing, skin redness, itching, fatty liver, painful inflammation of small pockets in the lining of your intestine (diverticulitis), viral infections, viral infections affecting the gut, some types of skin cancers (non-melanoma-types).

Rare (may affect up to 1 in 1,000 people): blood infection (sepsis), lymphoma (white blood cell cancer), disseminated tuberculosis involving bones and other organs, other unusual infections, joint infections.

Very rare (may affect up to 1 in 10,000 people): tuberculosis involving the brain and spinal cord, meningitis.

In general, fewer side effects were seen when XELJANZ was used alone than in combination with methotrexate in rheumatoid arthritis.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store XELJANZ

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

Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.

This medicine does not require any special temperature storage conditions.

Store in the original package in order to protect from moisture.

Do not use this medicine if you notice the tablets show visible signs of deterioration (for example, are broken or discoloured).

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What XELJANZ contains

XELJANZ 5 mg film-coated tablet

– The active substance 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”), croscarmellose sodium (see section 2 “XELJANZ contains sodium”), magnesium stearate, hypromellose (E464), titanium dioxide (E171), macrogol, and triacetin.

XELJANZ 10 mg film-coated tablet

– The active substance 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”), croscarmellose sodium (see section 2 “XELJANZ contains sodium”), magnesium stearate, hypromellose (E464), titanium dioxide (E171), macrogol, triacetin, FD&C Blue #2/Indigo Carmine Aluminum Lake (E132), and FD&C Blue #1/Brilliant Blue FCF Aluminum Lake (E133).

What XELJANZ looks like and contents of the pack

XELJANZ 5 mg film-coated tablets

XELJANZ 5 mg film-coated tablet is white and round in appearance.

The tablets are provided in blisters containing 14 tablets. Each pack 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 tablet is blue and round in appearance.

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

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Bruxelles

Belgium

Manufacturer

Pfizer Manufacturing Deutschland GmbH

Betriebsstätte Freiburg

Mooswaldallee 1

79090 Freiburg

Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België /Belgique / Belgien Luxembourg/Luxemburg

Pfizer NV/SA

Tél/Tel: +32 (0)2 554 62 11

Lietuva

Pfizer Luxembourg SARL filialas Lietuvoje

Tel. +3705 2514000

Efc^rapufl

n$aň3ep ^WKceMOypr CÀPÆ Know Etnrapua

Ten.: +359 2 970 4333

Magyarország

Pfizer Kft.

Tel.: +36 1 488 37 00

Česká republika

Pfizer, spol. s r.o.

Tel: +420 283 004 111

Malta

Vivian Corporation Ltd.

Tel: +35621 344610

Danmark

Pfizer ApS

Tlf: +45 44 20 11 00

Nederland

Pfizer bv

Tel: +31 (0)10 406 43 01

Deutschland

Pfizer Pharma GmbH

Tel: +49 (0)30 550055–51000

Norge

Pfizer AS

Tlf: +47 67 52 61 00

Eesti

Pfizer Luxembourg SARL Eesti filiaal

Tel: +372 666 7500

Österreich

Pfizer Corporation Austria Ges.m.b.H.

Tel: +43 (0)1 521 15–0

EXXáóa

PFIZER EAAAZ A.E.

Tip.: +30 210 67 85 800

Polska

Pfizer Polska Sp. z o.o.,

Tel.: +48 22 335 61 00

España

Pfizer S.L.

Tel: +34 91 490 99 00

Portugal

Laboratórios Pfizer, Lda.

Tel: +351 21 423 5500

France

Pfizer

Tél: +33 (0)1 58 07 34 40

România

Pfizer Romania S.R.L.

Tel: +40 21 207 28 00

Hrvatska

Pfizer Croatia d.o.o.

Tel: +385 1 3908 777

Slovenija

Pfizer Luxembourg SARL

Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana

Tel: +386 (0) 1 52 11 400

Ireland

Pfizer Healthcare Ireland

Tel: 1800 633 363 (toll free)

+44 (0)1304 616161

Ísland

Icepharma hf.

Sími: +354 540 8000

Italia

Pfizer S.r.l.

Tel: +39 06 33 18 21

Kùnpoç

PFIZER EAAAZ A.E. (CYPRUS BRANCH)

Tql: +357 22 817690

Latvija

Pfizer Luxembourg SARL filiäle Latvijä

Tel: +371 670 35 775

This leaflet was last revised in

Slovenská republika

Pfizer Luxembourg SARL, organizačná zložka

Tel: +421–2–3355 5500

Suomi/Finland

Pfizer Oy

Puh/Tel: +358 (0)9 430 040

Sverige

Pfizer AB

Tel: +46 (0)8 550 520 00

United Kingdom (Northern Ireland)

Pfizer Limited

Tel: +44 (0)1304 616161

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:.

Package leaflet: Information for the patient XELJANZ 11 mg prolonged-release tablets tofacitinib

V This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You canhelp by reporting any side effects you may get. See the end of section 4 for how to report side effects.

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.

What is in this leaflet

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

1. What XELJANZ is and what it is used for

XELJANZ is a medicine that contains the active substance tofacitinib.

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

rheumatoid arthritis
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 swelling of your joints.

XELJANZ has been shown to reduce pain and swelling of the joints and improve the ability to perform daily activities, when given on its own or together 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 be first given another medicine to treat your psoriatic arthritis. If you do not respond well enough or the medicine is not tolerated, you may be given XELJANZ to reduce the sign and symptoms of active psoriatic arthritis and improve the ability to perform daily activities.

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

2. What you need to know before you take XELJANZ

Do not 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 bloodstream infection or active tuberculosis
– if you have been informed that you have severe liver problems, including cirrhosis (scarring of

the liver)

– if you are pregnant or breast-feeding

If you are not sure regarding any of the information provided above, please contact your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking XELJANZ:

– if you think you have an infection or have symptoms of an infection such as fever, sweating,

– if you have any condition that increases your chance of infection (e.g., diabetes, HIV/AIDS, or a

weak immune system)

– if you have any kind of infection, are being treated for any infection, or if you have infections

– if you have or have a history of tuberculosis or have been in close contact with someone with

tuberculosis. Your doctor will test you for tuberculosis before starting XELJANZ and may retest during treatment

– if you have any chronic lung disease
– if you have liver problems
– if you have or had hepatitis B or hepatitis C (viruses that affect the liver). The virus may

become active while you are taking XELJANZ. Your doctor may do blood tests for hepatitis before you start treatment with XELJANZ and while you are taking XELJANZ

– if you are older than 65 years, if you have ever had any type of cancer, and also if you are a

– if you are at high risk of developing skin cancer, your doctor may recommend that you have

regular skin examinations while taking XELJANZ

– if you have had diverticulitis (a type of inflammation of the large intestine) or ulcers in stomach

or intestines (see section 4)

– if you have kidney problems
– if you are planning to get vaccinated, tell your doctor. Certain types of vaccines should not be

given when taking XELJANZ. Before you start XELJANZ, you should be up to date with all recommended vaccinations. Your doctor will decide whether you need to have herpes zoster vaccination

– if you have heart problems, high blood pressure, high cholesterol, and also if you are a current

or past smoker

– if you have narrowing of the digestive tract tell your doctor as there have been rare reports of

blockage in the digestive tract in patients taking other medicines using similar prolonged-release tablets

– when you take XELJANZ 11 mg prolonged-release tablets, you may see something in your

stool that looks like a tablet. This is the empty shell from the prolonged-release tablet after the medicine has been absorbed by your body. This is to be expected and you should not be concerned

Additional monitoring tests

Elderly

There is a higher rate of infections in patients aged 65 years and older. Tell your doctor as soon as you notice any signs or symptoms of infections.

Patients aged 65 years and older may be at increased risk of infections, heart attack and some types of cancer. Your doctor may decide that XELJANZ is not suitable for you.

Asian patients

There is a higher rate of shingles in Japanese and Korean patients. Tell your doctor if you notice any painful blisters on your skin.

You may also be at higher risk of certain lung problems. Tell your doctor if you notice any breathing difficulties.

Children and adolescents

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

Other medicines and XELJANZ

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

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

Serious infections may happen more often in people who also take corticosteroids (e.g., prednisone).

Pregnancy and breast-feeding

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

If you are taking XELJANZ and breast-feeding, you must stop breast-feeding until you talk to your doctor about stopping treatment with XELJANZ.

Driving and using machines

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

XELJANZ 11 mg prolonged-release tablet contains sorbitol

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

3. How to take XELJANZ

This medicine is provided to you and supervised by a specialised doctor who knows how to treat your condition.

Always take this medicine exactly as your doctor has told you, the recommended dose should not be exceeded. Check with your doctor or pharmacist if you are not sure.

Rheumatoid arthritis

The recommended dose is one 11 mg prolonged-release tablet administered once daily.

Psoriatic arthritis

The recommended dose is one 11 mg prolonged-release tablet administered once daily.

Try to take your tablet (one 11 mg prolonged-release tablet) at the same time each day, e.g., morning or evening.

Swallow XELJANZ 11 mg prolonged-release tablets whole in order to ensure the entire dose is delivered correctly. Do not crush, split, or chew.

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 11 mg prolonged-release tablets than you should, immediately tell your doctor or pharmacist.

If you forget to take XELJANZ

Do not take a double dose to make up for a forgotten 11 mg prolonged-release tablet. Take your next 11 mg prolonged-release tablet at the usual time and continue as before.

If you stop taking XELJANZ

You should not stop taking XELJANZ without discussing this with your doctor.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some may be serious and need medical attention.

Possible serious side effects

In rare cases, infection may be life-threatening.

Lung cancer, white blood cell cancer and heart attack have also been reported.

If you notice any of the following serious side effects you need to tell a doctor straight away.

Signs of serious infections (common) include

fever and chills
cough
skin blisters
stomach ache
persistent headaches

Signs of ulcers or holes in your stomach (uncommon) include

fever
stomach or abdominal pain
blood in the stool
unexplained changes in bowel habits

Holes in stomach or intestines happen most often in people who also take nonsteroidal anti-inflammatory drugs or corticosteroids (e.g., prednisone).

Signs of allergic reactions (unknown) include

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 (uncommon: venous thromboembolism) include

sudden shortness of breath or difficulty breathing
chest pain or pain in upper back
swelling of the leg or arm
leg pain or tenderness
redness or discoloration in the leg or arm

Signs of a heart attack (uncommon) include

severe chest pain or tightness (that may spread to arms, jaw, neck, back)
shortness of breath
cold sweat
light headedness or sudden dizziness

Other side effects which have been observed with XELJANZ are listed below.

Very rare (may affect up to 1 in 10,000 people): tuberculosis involving the brain and spinal cord, meningitis.

In general, fewer side effects were seen when XELJANZ was used alone than in combination with methotrexate in rheumatoid arthritis.

Reporting of side effects

5. How to store XELJANZ

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

Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.

This medicine does not require any special temperature storage conditions.

Store in the original package in order to protect from moisture.

Do not use this medicine if you notice the tablets show visible signs of deterioration (for example, are broken or discoloured).

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What XELJANZ contains

– The active substance is tofacitinib.
– Each 11 mg prolonged-release tablet contains 11 mg of tofacitinib (as tofacitinib citrate).
– The other ingredients are sorbitol (E420) (see section 2 “XELJANZ 11 mg prolonged-release

tablet contains sorbitol”), hydroxyethyl cellulose, copovidone, magnesium stearate, cellulose acetate, hydroxypropyl cellulose (E463), hypromellose (E464), titanium dioxide (E171), triacetin, red iron oxide (E172), shellac (E904), ammonium hydroxide (E527), propylene glycol (E1520) and black iron oxide (E172).

What XELJANZ looks like and contents of the pack

XELJANZ 11 mg prolonged-release tablet is pink and oval in appearance.

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

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Bruxelles

Belgium

Manufacturer

Pfizer Manufacturing Deutschland GmbH

Betriebsstätte Freiburg

Mooswaldallee 1

79090 Freiburg

Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België /Belgique / Belgien Luxembourg/Luxemburg

Pfizer NV/SA

Tél/Tel: +32 (0)2 554 62 11

Lietuva

Pfizer Luxembourg SARL filialas Lietuvoje

Tel. +3705 2514000

Efc^rapufl

n$aň3ep ^WKceMOypr CÀPÆ Know Etnrapua

Ten.: +359 2 970 4333

Magyarország

Pfizer Kft.

Tel.: +36 1 488 37 00

Česká republika

Pfizer, spol. s r.o.

Tel: +420 283 004 111

Malta

Vivian Corporation Ltd.

Tel: +35621 344610

Danmark

Pfizer ApS

Tlf: +45 44 20 11 00

Nederland

Pfizer bv

Tel: +31 (0)10 406 43 01

Deutschland

Pfizer Pharma GmbH

Tel: +49 (0)30 550055–51000

Norge

Pfizer AS

Tlf: +47 67 52 61 00

Eesti

Pfizer Luxembourg SARL Eesti filiaal

Tel: +372 666 7500

Österreich

Pfizer Corporation Austria Ges.m.b.H.

Tel: +43 (0)1 521 15–0

EXXáóa

PFIZER EAAAZ A.E.

Tip.: +30 210 67 85 800

Polska

Pfizer Polska Sp. z o.o.,

Tel.: +48 22 335 61 00

España

Pfizer S.L.

Tel: +34 91 490 99 00

Portugal

Laboratórios Pfizer, Lda.

Tel: +351 21 423 5500

France

Pfizer

Tél: +33 (0)1 58 07 34 40

România

Pfizer Romania S.R.L.

Tel: +40 21 207 28 00

Hrvatska

Pfizer Croatia d.o.o.

Tel: +385 1 3908 777

Slovenija

Pfizer Luxembourg SARL

Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana

Tel: +386 (0) 1 52 11 400

Ireland

Pfizer Healthcare Ireland

Tel: 1800 633 363 (toll free)

Slovenská republika

Pfizer Luxembourg SARL, organizačná zložka

Tel: +421–2–3355 5500

Ísland

Icepharma hf.

Sími: +354 540 8000

Suomi/Finland

Pfizer Oy

Puh/Tel: +358 (0)9 430 040

Italia

Pfizer S.r.l.

Tel: +39 06 33 18 21

Sverige

Pfizer AB

Tel: +46 (0)8 550 520 00

Kûnpoç

United Kingdom (Northern Ireland)

Pfizer Limited

Tel: +44 (0)1304 616161

PFIZER EAAAZ A.E. (CYPRUS BRANCH)

Tql: +357 22 817690

Latvija

Pfizer Luxembourg SARL filiale Latvijâ

Tel: +371 670 35 775

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:.

Package leaflet: Information for the patient XELJANZ 1 mg/mL oral solution tofacitinib

Th This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

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.

What is in this leaflet

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

1. What XELJANZ is and what it is used for

XELJANZ 1 mg/mL oral solution is a medicine that contains the active substance tofacitinib.

XELJANZ 1 mg/mL oral solution is used for the treatment of active polyarticular juvenile idiopathic arthritis, a long-term disease that mainly causes pain and swelling of your joints, in patients 2 years of age and older.

XELJANZ 1 mg/mL oral solution is also used for the treatment of 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 1 mg/mL oral solution can be used together with methotrexate when previous treatment for polyarticular juvenile idiopathic arthritis or juvenile psoriatic arthritis was not sufficient or was not well tolerated. XELJANZ 1 mg/mL oral solution can also be taken on its own in those cases where methotrexate treatment is not tolerated or treatment with methotrexate is not advised.

2. What you need to know before you take XELJANZ

Do not 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 bloodstream infection or active tuberculosis
– if you have been informed that you have severe liver problems, including cirrhosis (scarring of

the liver)

– if you are pregnant or breast-feeding

If you are not sure regarding any of the information provided above, please contact your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking XELJANZ:

– if you think you have an infection or have symptoms of an infection such as fever, sweating,

– if you have any condition that increases your chance of infection (e.g., diabetes, HIV/AIDS, or a

weak immune system)

– if you have any kind of infection, are being treated for any infection, or if you have infections

– if you have or have a history of tuberculosis or have been in close contact with someone with

tuberculosis. Your doctor will test you for tuberculosis before starting XELJANZ and may retest during treatment

– if you have any chronic lung disease
– if you have liver problems
– if you have or had hepatitis B or hepatitis C (viruses that affect the liver). The virus may

become active while you are taking XELJANZ. Your doctor may do blood tests for hepatitis before you start treatment with XELJANZ and while you are taking XELJANZ

– if you have ever had any type of cancer, and also if you are a current or past smoker. XELJANZ

may increase your risk of certain cancers. White blood cell cancer, lung cancer and other cancers (such as breast, melanoma, prostate and pancreatic) have been reported in patients treated with XELJANZ. If you develop cancer while taking XELJANZ your doctor will review whether to stop XELJANZ treatment.

– if you are at high risk of developing skin cancer, your doctor may recommend that you have

regular skin examinations while taking XELJANZ.

– if you have had diverticulitis (a type of inflammation of the large intestine) or ulcers in stomach

or intestines (see section 4)

– if you have kidney problems
– if you are planning to get vaccinated, tell your doctor. Certain types of vaccines should not be

given when taking XELJANZ. Before you start XELJANZ, you should be up to date with all recommended vaccinations. Your doctor will decide whether you need to have herpes zoster vaccination.

– if you have heart problems, high blood pressure, high cholesterol, and also if you are a current

or past smoker

There have been reports of patients treated with XELJANZ who have developed blood clots in the lungs or veins. Your doctor will evaluate your risk to develop blood clots in the lungs or veins and determine if XELJANZ is appropriate for you. If you have already had problems on developing blood clots in lungs and veins or have an increased risk for developing this (for example: if you are seriously overweight, if you have cancer, heart problems, diabetes, experienced a heart attack (within previous 3 months), recent major surgery, if you use hormonal contraceptives\hormonal replacement therapy, if a coagulation defect is identified in you or your close relatives), or if you smoke currently or in the past, your doctor may decide that XELJANZ is not suitable for you.

Additional monitoring tests

Elderly

The safety and efficacy of tofacitinib 1 mg/mL oral solution has not been established in the elderly.

Asian patients

There is a higher rate of shingles in Japanese and Korean patients. Tell your doctor if you notice any painful blisters on your skin.

You may also be at higher risk of certain lung problems. Tell your doctor if you notice any breathing difficulties.

Children and adolescents

This medicine should not be given to patients less than 2 years of age.

This medicine contains propylene glycol and should be used with caution in patients 2 years of age and older and only if advised by the doctor (see „XELJANZ contains propylene glycol“).

Other medicines and XELJANZ

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

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

Serious infections may happen more often in people who also take corticosteroids (e.g., prednisone).

Pregnancy and breast-feeding

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

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. XELJANZ must not be used during pregnancy.

Tell your doctor right away if you become pregnant while taking XELJANZ.

If you are taking XELJANZ and breast-feeding, you must stop breast-feeding until you talk to your doctor about stopping treatment with XELJANZ.

Driving and using machines

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

XELJANZ contains propylene glycol

This medicine contains 2.39 mg propylene glycol in each mL of oral solution.

XELJANZ contains sodium benzoate

This medicine contains 0.9 mg sodium benzoate in each mL of oral solution.

XELJANZ contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per mL, that is to say essentially ‘sodium-free’.

3. How to take XELJANZ

This medicine is provided to you and supervised by a specialised doctor who knows how to treat your condition.

Always take this medicine exactly as your doctor has told you, the recommended dose should not be exceeded. Check with your doctor or pharmacist if you are not sure.

The recommended dose in patients 2 years of age and older is based upon the following weight categories (see Table 1).

Table 1. XELJANZ dose for patients with polyarticular juvenile idiopathic arthritis and juvenile

PsA two years of age and older:

Body weight (kg)	Dose regimen
10 – <20	3.2 mg (3.2 mL of oral solution) twice daily
20 – <40	4 mg (4 mL of oral solution) twice daily
>40	5 mg (5 mL of oral solution or 5 mg film-coated tablet) twice daily

If you suffer from polyarticular juvenile idiopathic arthritis or juvenile psoriatic arthritis, your doctor may switch you from XELJANZ 5 mL oral solution twice daily to XELJANZ 5 mg film-coated tablets twice daily.

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

Try to take XELJANZ at the same time every day (once in the morning and once in the evening).

If you take more XELJANZ than you should

If you take more XELJANZ 1 mg/mL oral solution than you should, immediately tell your doctor or pharmacist.

If you forget to take XELJANZ

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

If you stop taking XELJANZ

You should not stop taking XELJANZ without discussing this with your doctor.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some may be serious and need medical attention.

Possible serious side effects

In rare cases, infection may be life-threatening

Lung cancer, white blood cell cancer and heart attack have also been reported.

If you notice any of the following serious side effects you need to tell a doctor straight away.

Signs of serious infections (common) include

fever and chills
cough
skin blisters
stomach ache
persistent headaches

Signs of ulcers or holes in your stomach (uncommon) include

fever
stomach or abdominal pain
blood in the stool
unexplained changes in bowel habits

Holes in stomach or intestines happen most often in people who also take nonsteroidal anti-inflammatory drugs or corticosteroids (e.g., prednisone).

Signs of allergic reactions (unknown) include

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 (uncommon: venous thromboembolism) include

sudden shortness of breath or difficulty breathing
chest pain or pain in upper back
swelling of the leg or arm
leg pain or tenderness
redness or discoloration in the leg or arm

Signs of a heart attack (uncommon) include

severe chest pain or tightness (that may spread to arms, jaw, neck, back)
shortness of breath
cold sweat
light headedness or sudden dizziness

Other side effects which have been observed with XELJANZ are listed below.

Very rare (may affect up to 1 in 10,000 people): tuberculosis involving the brain and spinal cord, meningitis.

In general, fewer side effects were seen when XELJANZ was used alone than in combination with methotrexate in rheumatoid arthritis.

Reporting of side effects

5. How to store XELJANZ

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

Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.

This medicine does not require any special temperature storage conditions.

Store in the original bottle and package in order to protect from light.

Discard after 60 days of first opening.

Do not use this medicine if you notice the solution shows visible signs of deterioration.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What XELJANZ contains

– The active substance is tofacitinib.
– Each 1 mL contains 1 mg of tofacitinib (as tofacitinib citrate).
– The other ingredients are grape flavour [containing propylene glycol (E1520) (see section 2

“XELJANZ contains propylene glycol”), glycerin (E422), and natural flavours], hydrochloric acid, lactic acid (E270), purified water, sodium benzoate (E211) (see section 2 “XELJANZ contains sodium benzoate” and “XELJANZ contains sodium”), sucralose (E955), and xylitol (E967).

What XELJANZ looks like and contents of the pack

XELJANZ 1 mg/mL oral solution is a clear, colourless solution.

The 1 mg/mL oral solution is provided in white coloured HDPE 250 mL bottles containing 240 mL of solution. Each pack contains one HDPE bottle, one press-in bottle adapter, and one oral dosing syringe with 3.2 mL, 4 mL, and 5 mL graduations.

Marketing Authorisation Holder

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Bruxelles

Belgium

Manufacturer

Pfizer Service Company BVBA

Hoge Wei 10

1930 Zaventem

Belgium

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België /Belgique / Belgien Luxembourg/Luxemburg	Lietuva
Pfizer NV/SA	Pfizer Luxembourg SARL filialas Lietuvoje
Tél/Tel: +32 (0)2 554 62 11	Tel. +3705 2514000
Efc^rapufl	Magyarorszag
n$aÖ3ep ^WKceMOypr C’ÀPÆ K.toh Etarapua	Pfizer Kft.
Tea.: +359 2 970 4333	Tel.: +36 1 488 37 00

Česká republika

Pfizer, spol. s r.o.

Tel: +420 283 004 111

Malta

Vivian Corporation Ltd.

Tel: +35621 344610

Danmark

Pfizer ApS

Tlf: +45 44 20 11 00

Nederland

Pfizer bv

Tel: +31 (0)10 406 43 01

Deutschland

Pfizer Pharma GmbH

Tel: +49 (0)30 550055–51000

Norge

Pfizer AS

Tlf: +47 67 52 61 00

Eesti

Pfizer Luxembourg SARL Eesti filiaal

Tel: +372 666 7500

Österreich

Pfizer Corporation Austria Ges.m.b.H.

Tel: +43 (0)1 521 15–0

EÀLàôa

PFIZER EAAAZ A.E.

Tip.: +30 210 67 85 800

Polska

Pfizer Polska Sp. z o.o., Tel.: +48 22 335 61 00

España

Pfizer S.L.

Tel: +34 91 490 99 00

Portugal

Laboratórios Pfizer, Lda.

Tel: +351 21 423 5500

France

Pfizer

Tél: +33 (0)1 58 07 34 40

România

Pfizer Romania S.R.L.

Tel: +40 21 207 28 00

Hrvatska

Pfizer Croatia d.o.o.

Tel: +385 1 3908 777

Slovenija

Pfizer Luxembourg SARL

Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana

Tel: +386 (0) 1 52 11 400

Ireland

Pfizer Healthcare Ireland

Tel: 1800 633 363 (toll free) +44 (0)1304 616161

Slovenská republika

Pfizer Luxembourg SARL, organizačná zložka

Tel: +421–2–3355 5500

Ísland

Icepharma hf.

Sími: +354 540 8000

Suomi/Finland

Pfizer Oy

Puh/Tel: +358 (0)9 430 040

Italia

Pfizer S.r.l.

Tel: +39 06 33 18 21

Sverige

Pfizer AB

Tel: +46 (0)8 550 520 00

Kùnpoç

PFIZER EAAAZ A.E. (CYPRUS BRANCH)

Tip.: +357 22 817690

United Kingdom (Northern Ireland)

Pfizer Limited

Tel: +44 (0)1304 616161

Latvija

Pfizer Luxembourg SARL filiäle Latvijä

Tel: +371 670 35 775

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:.

7. Instructions for Use of XELJANZ oral solution

Read this Instructions for Use before you start taking XELJANZ oral solution. There may be new information.

Important information about measuring XELJANZ oral solution

Always use the oral dosing syringe that comes with your XELJANZ oral solution to measure and administer your prescribed dose. Ask your healthcare provider or pharmacist to show you how to measure your prescribed dose if you are not sure.

How should I store XELJANZ?

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

Discard remaining XELJANZ oral solution after 60 days.

To help you remember when to dispose of your XELJANZ bottle you can write the date of first use on the carton and below:

Date of first use ____/ ____/ ____.

Before each use:

Wash your hands with soap and water and place the items from the carton on a clean flat surface.

Each carton of XELJANZ oral solution contains

1 press-in bottle adapter
1 bottle of XELJANZ oral solution
1 oral dosing syringe

Xeljanz - patient leaflet, side effects, dosage

Table of contents

Patient leaflet - Xeljanz

1. What XELJANZ is and what it is used for

2. What you need to know before you take XELJANZ

3. How to take XELJANZ

4. Possible side effects

5. How to store XELJANZ

6. Contents of the pack and other information

1. What XELJANZ is and what it is used for

2. What you need to know before you take XELJANZ

3. How to take XELJANZ

4. Possible side effects

5. How to store XELJANZ

6. Contents of the pack and other information

1. What XELJANZ is and what it is used for

2. What you need to know before you take XELJANZ

3. How to take XELJANZ

4. Possible side effects

5. How to store XELJANZ

6. Contents of the pack and other information

7. Instructions for Use of XELJANZ oral solution