Celecoxib Sandoz

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Celecoxib Sandoz 100 mg hard capsules, 200 mg hard capsules

Generic medicine
Please 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Celecoxib Sandoz is and what it is used for

Celecoxib Sandoz is used in adults for the treatment of the signs and symptoms of rheumatoid arthritis,
osteoarthritis, and ankylosing spondylitis.
Celecoxib Sandoz contains the active substance celecoxib. Celecoxib belongs to a class of medicines
called non-steroidal anti-inflammatory drugs (NSAIDs), and more specifically to a subgroup known
as cyclooxygenase-2 (COX-2) inhibitors. The body produces prostaglandins, which can cause
pain and inflammation. In certain conditions such as rheumatoid arthritis and osteoarthritis, the body produces
increased levels of prostaglandins. Celecoxib Sandoz works by reducing the production of prostaglandins, thereby reducing
pain and inflammation.
You should expect the medicine to start working within a few hours of taking the first dose, although
the full effect may not occur for several days.

2. What you need to know before taking Celecoxib Sandoz

Celecoxib Sandoz has been prescribed for you by your doctor. The following information will help you get the best results from this medicine. If you have any further questions, please consult your doctor or pharmacist.
Do not take Celecoxib Sandoz
Inform your doctor if any of the following apply to you, as patients with these conditions must not take Celecoxib Sandoz:

• if you are allergic to celecoxib or to any of the other ingredients of this medicine (listed in section 6)
• if you have had an allergic reaction to a class of medicines called "sulfonamides" (e.g. certain antibiotics used to treat infections)
• if you currently have a stomach or intestinal ulcer, or gastrointestinal bleeding
• if you have previously experienced asthma, nasal polyps, severe nasal congestion, or an allergic reaction (such as skin rash with itching, swelling of the face, lips, tongue or throat, difficulty breathing or wheezing) after taking acetylsalicylic acid or any other non-steroidal anti-inflammatory or pain-relieving drug (NSAID)
• if you are pregnant. If you could become pregnant during treatment, discuss contraceptive methods with your doctor.
• if you are breastfeeding
• if you have severe liver disease
• if you have severe kidney disease
• if you have an inflammatory bowel disease, such as ulcerative colitis or Crohn's disease
• if you have heart failure, established ischemic heart disease, or cerebrovascular disease (for example, if you have been diagnosed with a heart attack, stroke, transient ischemic attack [temporary reduction in blood supply to the brain, also known as “mini-stroke”], angina, or blockage of blood vessels to the heart or brain)
• if you have or have had circulatory problems (peripheral arterial disease) or have undergone surgery on the arteries in your legs.

Warnings and precautions
Talk to your doctor or pharmacist before taking Celecoxib Sandoz if:

• you previously had a stomach or intestinal ulcer or gastrointestinal bleeding (do not take Celecoxib Sandoz if you currently have a stomach or intestinal ulcer or bleeding)
• you smoke, or have diabetes, high blood pressure, or high cholesterol
• you have heart, liver, or kidney problems; your doctor may carry out regular check-ups
• you experience fluid retention (such as swollen ankles or feet)
• you are dehydrated, for example due to illness, diarrhoea, or use of diuretics (medicines used to treat excess fluid in the body)
• you have previously had a severe allergic reaction or a severe skin reaction to any medicine
• you feel unwell due to an infection or suspect you have an infection, as Celecoxib Sandoz may mask fever or other signs of infection and inflammation
• you are over 65 years old, in which case your doctor will want to monitor you regularly.

Like other NSAIDs (e.g. ibuprofen or diclofenac), this medicine may cause an increase in blood pressure, so your doctor may ask you to monitor your blood pressure regularly.
During treatment with celecoxib, there have been reports of rare but serious liver reactions, including severe hepatitis, liver damage, and liver failure (some cases have been fatal or required liver transplantation). Among cases with a known onset time, most serious liver reactions occurred within one month of starting treatment.
Celecoxib Sandoz may make it more difficult to become pregnant. Inform your doctor if you are planning a pregnancy or if you have difficulty becoming pregnant (see section on “Pregnancy, breastfeeding and fertility”).

Children and adolescents
Celecoxib Sandoz is intended for adults only. It is not indicated for use in children and adolescents under 18 years of age.

Other medicines and Celecoxib Sandoz
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine:

• dextromethorphan (used to treat cough)
• ACE inhibitors, angiotensin II antagonists, beta-blockers, and diuretics (used for high blood pressure and heart failure)
• fluconazole and rifampicin (used to treat fungal and bacterial infections)
• medicines that reduce blood clotting, such as coumarin anticoagulants like warfarin or newer oral anticoagulants (such as apixaban, dabigatran, or rivaroxaban)
• medicines called corticosteroids (e.g. prednisone)
• acetylsalicylic acid (even at low doses for heart protection). Celecoxib Sandoz may be taken with low-dose acetylsalicylic acid (75 mg daily or less). Ask your doctor before taking both medicines together
• other non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or diclofenac. Concomitant use of Celecoxib Sandoz with these anti-inflammatory medicines should be avoided
• lithium (used to treat certain types of depression)
• other medicines used to treat depression (e.g. citalopram, imipramine), sleep disorders, high blood pressure, or irregular heartbeat
• diazepam, a medicine used to treat insomnia or anxiety
• neuroleptics (used to treat certain mental disorders)
• methotrexate (used to treat rheumatoid arthritis, psoriasis, and leukaemia)
• carbamazepine (used to treat epileptic seizures and certain types of pain or depression)
• barbiturates (used to treat epileptic seizures and certain sleep disorders)
• cyclosporine and tacrolimus (used for immunosuppression, for example after organ transplants).

Celecoxib Sandoz and alcohol
Alcohol consumption is not recommended while taking Celecoxib Sandoz, as it may increase the risk of gastrointestinal problems.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

• Pregnancy: Celecoxib Sandoz must not be used in pregnant women or in women who may become pregnant (e.g. women of childbearing age who are not using adequate contraceptive methods) during treatment. If you become pregnant while taking Celecoxib Sandoz, stop treatment immediately and contact your doctor for alternative therapy.
• Breastfeeding: Celecoxib Sandoz must not be used during breastfeeding.
• Fertility: NSAIDs, including Celecoxib Sandoz, may make it more difficult to become pregnant. Inform your doctor if you are planning a pregnancy or if you have difficulty conceiving.

Driving and using machines
Before driving or operating machinery, be aware of how you react to Celecoxib Sandoz. If you feel dizzy or drowsy after taking Celecoxib Sandoz, do not drive or operate machinery until these effects have disappeared.

Celecoxib Sandoz contains lactose
Celecoxib Sandoz contains lactose (a type of sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

Celecoxib Sandoz contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per capsule, i.e. essentially “sodium-free”.

3. How to take Celecoxib Sandoz

Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Your doctor will tell you what dose to take. Since the risk of unwanted effects related to heart problems
may increase with higher doses and longer treatment duration, it is important that you use the lowest
dose possible to control your pain and that you do not take Celecoxib Sandoz for longer than necessary to
control your symptoms.
Method of administration
Celecoxib Sandoz is for oral use.
The capsules can be taken at any time of day, with or without food. However, try always to take each dose of
Celecoxib Sandoz at the same time every day.
If you have difficulty swallowing the capsules: the entire contents of the capsule may be sprinkled onto a level
teaspoon of soft food (such as cold or room temperature applesauce, rice pudding, yoghurt, or mashed
banana) and swallowed immediately with about 240 ml of water.
To open the capsule, hold it in an upright position to keep the granules at the bottom, then gently squeeze
the top part and twist to remove it, taking care not to spill the contents. Do not chew or crush the granules.
Contact your doctor within two weeks of starting treatment if you experience no improvement.
The recommended dose is:
For osteoarthritis, the recommended dose is 200 mg per day, which may be increased by your doctor up to a
maximum of 400 mg, if necessary.
The usual dose is:

• one 200 mg capsule once daily; or
• one 100 mg capsule twice daily.

For rheumatoid arthritis, the recommended dose is 200 mg per day, which may be increased by your doctor
up to a maximum of 400 mg, if necessary.
The usual dose is:

• one 100 mg capsule twice daily.

Celecoxib Sandoz 200 mg:

• The dose of one 100 mg capsule twice daily cannot be achieved with Celecoxib Sandoz 200 mg hard capsules. Consult your doctor.

For ankylosing spondylitis, the recommended dose is 200 mg per day, which may be increased by your doctor
up to a maximum of 400 mg, if necessary.
The usual dose is:

• one 200 mg capsule once daily; or
• one 100 mg capsule twice daily.

Do not exceed 400 mg per day in all therapeutic uses.
Kidney or liver problems
Ensure that your doctor knows if you have liver or kidney problems, as a lower dose may be required.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects listed below were observed in patients with arthritis who were taking
celecoxib. The side effects marked with an asterisk (*) are reported at the highest frequencies
observed in patients taking celecoxib to prevent colon polyps.
Patients in these studies took celecoxib at higher doses and for a longer duration.
If any of the following conditions occur, stop taking Celecoxib Sandoz and inform your
doctor immediately.
If you have:

• an allergic reaction such as skin rash, facial swelling, wheezing or difficulty breathing
• heart problems such as chest pain
• severe stomach pain or any signs of bleeding in the stomach or intestines, such as black stools or blood in the stool, or vomiting blood
• a skin reaction such as skin rash, blisters or peeling of the skin
• liver failure, whose symptoms include nausea, diarrhoea, jaundice (yellowing of the skin or the whites of the eyes)

Possible side effects
Very common (may affect more than 1 in 10 people)

• High blood pressure, including worsening of existing high blood pressure*

Common (may affect up to 1 in 10 people)

• heart attack*
• fluid retention with swollen ankles, legs and/or hands
• urinary tract infections
• shortness of breath*, sinusitis (inflammation or infection of the sinuses, blocked or painful sinuses), stuffy or runny nose, sore throat, cough, cold, flu-like symptoms
• dizziness, difficulty sleeping
• nausea (feeling unwell)
• vomiting*, stomach pain, diarrhoea, indigestion, flatulence
• difficulty swallowing*
• skin rash, itching
• muscle stiffness
• headache
• joint pain
• worsening of existing allergies
• accidental injury

Uncommon (may affect up to 1 in 100 people)

• stroke*
• heart failure, awareness of heartbeat, increased heart rate
• abnormal blood test results related to liver function
• abnormal blood test results related to kidney function
• anaemia (changes in red blood cells which may cause tiredness and shortness of breath)
• anxiety, depression, fatigue, drowsiness, tingling sensation (pins and needles)
• elevated levels of potassium in the blood which may cause irregular heart rhythm or muscle weakness
• blurred or impaired vision, ringing in the ears, mouth pain and sores, hearing difficulties*
• constipation, belching, inflammation of the stomach (indigestion, stomach pain or vomiting), worsening of stomach or intestinal inflammation
• leg cramps
• increase in itchy skin rashes (urticaria)
• eye inflammation
• difficulty breathing
• change in skin colour (bruising)
• chest pain (generalised pain not related to the heart)
• facial swelling

Rare (may affect up to 1 in 1,000 people)

• bleeding in the stomach or intestines (may lead to blood in stools or vomiting), inflammation of the intestine or colon
• ulcers (bleeding) in the oesophagus, stomach, or intestines; or bowel herniation (may cause stomach pain, fever, nausea, vomiting, intestinal blockage), dark or black stools, inflammation of the pancreas (may cause stomach pain), inflammation of the oesophagus (oesophagitis)
• low levels of sodium in the blood (a condition known as hyponatraemia), which may cause tiredness and confusion, muscle spasms, seizures and coma
• reduction in white blood cells (which help protect the body from infections) and platelets (increased risk of bleeding or bruising)
• difficulty coordinating muscle movements
• feeling confused, changes in taste
• increased sensitivity to light
• hair loss
• hallucinations
• eye bleeding
• acute reaction that may lead to lung inflammation
• irregular heartbeat
• hot flushes
• blood clots in the blood vessels of the lungs. Symptoms may include sudden shortness of breath, sharp chest pain during breathing or fainting
• severe liver inflammation (hepatitis). Symptoms include nausea (feeling unwell), diarrhoea, jaundice (yellowing of the skin or eyes), dark urine, pale stools, easy bleeding, itching or chills
• acute kidney failure
• menstrual disorders
• swelling of the face, lips, mouth, tongue or throat, difficulty swallowing

Very rare (may affect up to 1 in 10,000 people)

• severe allergic reactions (including potentially fatal anaphylactic shock)
• serious skin diseases such as Stevens-Johnson syndrome, exfoliative dermatitis and toxic epidermal necrolysis (may cause rash, blisters or peeling of the skin) and acute generalised exanthematous pustulosis (symptoms include reddened skin with swellings covered by numerous small pustules)
• delayed allergic reaction with possible symptoms such as skin rash, facial swelling, fever, swollen lymph nodes, abnormal blood test results regarding, for example, liver function or blood count (eosinophilia, a specific increase in white blood cells)
• cerebral haemorrhage, including fatal cases
• meningitis (inflammation of the membrane covering the brain and spinal cord)
• liver failure, liver damage and severe liver inflammation (fulminant hepatitis) (some cases fatal or requiring liver transplantation). Symptoms include nausea, diarrhoea, jaundice (yellowing of the skin or eyes), dark urine, pale stools, easy bleeding, itching or chills
• liver disorders (such as cholestasis and cholestatic hepatitis, which may be accompanied by symptoms such as altered stool colour, nausea and yellowing of the skin or eyes)
• kidney inflammation or other kidney disorders, such as nephrotic syndrome and minimal change glomerulopathy, which may be accompanied by symptoms such as fluid retention (oedema), foamy urine, fatigue and loss of appetite
• seizure or worsening of epilepsy (increased frequency and/or severity of seizures)
• blockage of an artery or vein in the eye, causing partial or complete loss of vision
• inflamed blood vessels (may cause fever, pain, reddish spots on the skin)
• reduction in red blood cells, white blood cells and platelets (may cause fatigue, easy bruising, frequent nosebleeds and increased risk of infections)
• muscle pain and weakness
• impairment of the sense of smell
• loss of taste

Not known: frequency cannot be estimated from the available data

• reduced fertility in women, generally reversible upon discontinuation of the medicine

In clinical studies not related to arthritis or other arthritis-related conditions, where celecoxib was
taken at doses of 400 mg daily for up to 3 years, the following side effects were observed:
Common (may affect up to 1 in 10 people)

• heart problems: angina (chest pain)
• stomach problems: irritable bowel syndrome (may include stomach pain, diarrhoea, indigestion, flatulence)
• kidney stones (may cause stomach or back pain, blood in urine), difficulty urinating, elevated creatinine levels in the blood (indicative of kidney failure)
• weight gain

Uncommon (may affect up to 1 in 100 people)

• deep vein thrombosis (blood clotting, usually in the leg, which may cause pain, swelling or redness in the calf or breathing problems)
• stomach problems: stomach infection (which may cause irritation and ulcers in the stomach and intestines)
• lower limb fracture
• shingles, skin infection, eczema (dry, itchy rash), pneumonia (chest infection with possible signs such as cough, fever, difficulty breathing)
• floaters in the eye causing impaired or blurred vision, conjunctival haemorrhage, vertigo due to inner ear disorders, painful, inflamed or bleeding gums, mouth sores
• excessive urination at night, bleeding haemorrhoids, frequent bowel movements
• fat deposits under the skin or elsewhere, ganglion cyst (a harmless swelling on joints and around tendons of the hands or feet), difficulty speaking, abnormal or heavy vaginal bleeding, breast pain
• elevated sodium levels in blood test results

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your
doctor or pharmacist. You can also report side effects directly via the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Celecoxib Sandoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after "EXP". The first two digits indicate the month and the last four digits the year. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Celecoxib Sandoz contains
The active substance is celecoxib.
Each hard capsule contains 100 mg of celecoxib.
Each hard capsule contains 200 mg of celecoxib.
The other components are monohydrate lactose, povidone (E 1201), sodium croscarmellose (E 468), sodium lauryl sulfate (E 487), magnesium stearate (E572); gelatin (E441), titanium dioxide (E171), yellow iron oxide (E172).
100 mg hard capsules
The ink components are shellac (E904), propylene glycol (E1520), strong ammonium solution (E527) and indigotin FD & C Blue aluminum lake (E132).
200 mg hard capsules
The ink components are shellac (E904), propylene glycol (E1520), strong ammonium solution (E 527) and yellow iron oxide (E172).

Description of the appearance of Celecoxib Sandoz and package contents
100 mg hard capsules
White, opaque hard gelatin capsule. The capsule is marked with a blue band and white print "C9OX-100".
200 mg hard capsules
White, opaque hard gelatin capsule. The capsule is marked with a yellow band and white print "C9OX-200".
The capsules are packaged in ALU/PVC blisters placed inside a carton box.
Pack sizes:
Blister packs: 1, 20, 30, 40, 60 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder:
Sandoz S.p.A.
L.go U. Boccioni 1
21040 Origgio (VA)
Italy

Manufacturers:
Synthon BV
Microweg 22
6503 GN Nijmegen
The Netherlands

Synthon Hispania, S.L.
Castelló 1
08830 Sant Boi de Llobregat (Barcelona)
Spain

Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana
Slovenia

This medicinal product is authorized in the European Economic Area Member States under the following names:
Netherlands: Lexicel 100 mg, capsules
Lexicel 200 mg, capsules
Spain: Celecoxib Genthon 100 mg cápsulas duras EFG
Celecoxib Genthon 200 mg cápsulas duras EFG
Italy: Celecoxib Sandoz