CELECOXIB 100 mg Kapsułka Twarda

Treść ulotki

1. Celecoxib Sandoz 100 mg hard capsules, 200 mg hard capsules
   1. What is Celecoxib Sandoz 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. Package Contents and Other Information

Celecoxib Sandoz 100 mg hard capsules, 200 mg hard capsules

Generic medicine

Read this leaflet carefully before taking this medicine, as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Celecoxib Sandoz and what it is used for

Celecoxib Sandoz is used in adults for the treatment of signs and symptoms of rheumatoid arthritis,
osteoarthritisand ankylosing spondylitis.
Celecoxib Sandoz contains the active ingredient celecoxib. Celecoxib belongs to a class of medicines
called non-steroidal anti-inflammatory drugs (NSAIDs), and more specifically to a subgroup known
as cyclo-oxygenase-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
more of them. Celecoxib Sandoz works by reducing the production of prostaglandins, thereby also reducing
pain and inflammation.
You should expect the medicine to start working within a few hours of taking the first dose, but a full effect
may not be seen for several days.

2. What you need to know before taking Celecoxib Sandoz

Celecoxib Sandoz has been prescribed to you by your doctor. The following information will help you to get the
best results from this medicine. If you have any further questions, ask your doctor or pharmacist.

Do not take Celecoxib Sandoz
Tell your doctor if any of the following conditions apply to you, as patients in these conditions should not take Celecoxib Sandoz:

• if you are allergic to celecoxib or any of the other ingredientsof this medicine (listed in section 6)
• if you have had an allergic reactionto a class of medicines called “sulfonamides” (e.g. some antibiotics used to treat infections)
• if you currentlyhave an ulcerin the stomach or intestine, or bleeding in the stomach or intestine
• if, due to taking acetylsalicylic acid or any other anti-inflammatory or pain-relieving medicine (NSAIDs), you have had asthma, nasal polyps, severe nasal congestion, or a reaction

allergicreaction such as skin rash with itching, swelling of the face, lips, tongue or throat,
difficulty breathing or wheezing

• if you are pregnant. If you could become pregnant during treatment, you should 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 inflammatory bowel disease, such as ulcerative colitisor 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 or transient ischemic attack (temporary reduction of blood flow 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 if you have had surgeryon the arteries of your legs.

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

• you have previously had an ulceror bleeding in the stomach or intestine (do not take Celecoxib Sandozif you currently have an ulceror bleeding in the stomach or intestine)
• you smoke, have diabetes, high blood pressure or high cholesterol
• you have problems with your heart, liveror kidneys, your doctor may need to monitor you periodically
• you have fluid retention(such as swelling of the ankles and feet)
• you are dehydrated, for example due to illness, diarrhea or the use of diuretics (used to treat excess fluid in the body)
• you have had a severe allergic reactionor a severe skin reaction to any medicine
• you feel unwell because of an infectionor think you have an infection, as Celecoxib Sandoz may mask fever or other signs of infection and inflammation
• you are over 65 years old, your doctor will want to monitor you regularly.

As with other NSAIDs(e.g. ibuprofen or diclofenac), this medicine can lead to an increase
in blood pressure and therefore your doctor may ask you to check your blood pressure regularly.
Some cases of serious liver reactions, including severe
liver inflammation, liver damage, liver failure (some cases have been fatal or have
required a liver transplant) have been reported during treatment with celecoxib. Among cases for which the time to onset is known, most serious liver reactions occurred within one month of starting treatment.
Celecoxib Sandoz may make it more difficult to start a pregnancy. You should tell your
doctor if you are planning a pregnancy or have difficulty getting pregnant (see section on
“Pregnancy, breastfeeding and fertility”).

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

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

• dextromethorphan(used to treat cough)
• ACE inhibitors, angiotensin II receptor antagonists, beta blockersand diuretics (used for high blood pressure and heart failure)
• fluconazoleand rifampicin(used to treat fungal and bacterial infections)
• medicines that reduce blood clotting, for example coumarinic anticoagulantssuch as warfarinor the new oral anticoagulants(such as apixaban, dabigatran or rivaroxaban)
• medicines called corticosteroids(e.g. prednisone)
• acetylsalicylic acid(even at low doses to protect the heart). Celecoxib Sandoz can be taken with low-dose acetylsalicylic acid (75 mg per day or less). Ask your doctor before taking both medicines at the same time
• other non-steroidal anti-inflammatory drugs (NSAIDs)such as ibuprofen or diclofenac. You should avoid taking Celecoxib Sandoz at the same time as these anti-inflammatory drugs
• lithium(used to treat some types of depression)
• other medicinesfor the treatment of depression such as citalopram, imipramine, sleep disorders, high blood pressure or irregular heartbeat
• diazepam, a medicine for the treatment of insomnia or anxiety
• neuroleptics(used to treat some mental disorders)
• methotrexate(used to treat rheumatoid arthritis, psoriasis and leukemia)
• carbamazepine(used to treat epilepsy/seizures and some forms of pain or depression)
• barbiturates(used to treat epilepsy/seizures and some sleep disorders)
• cyclosporineand tacrolimus(used to suppress the immune system, for example after transplants).

Celecoxib Sandoz with alcohol
Drinking alcohol is not recommended while taking Celecoxib Sandoz as it may increase
the risk of gastrointestinal problems.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine

• Pregnancy Celecoxib Sandoz should not be used by women who are pregnant or who may become pregnant (e.g. women of childbearing potential who are not using adequate contraceptive methods) during treatment. If you become pregnant while taking Celecoxib Sandoz, you should stop treatment and contact your doctor for alternative therapy.
• Breastfeeding Celecoxib Sandoz should not be used during breastfeeding.
• Fertility NSAIDs, including Celecoxib Sandoz, may make it more difficult to become pregnant. You should tell your doctor if you are planning a pregnancy or have difficulty getting pregnant. Driving and using machinesBefore driving or operating machines, you should be aware of how you may react to Celecoxib Sandoz. If you feel dizzy or drowsy after taking Celecoxib Sandoz, do not drive and do not operate machines until these effects have worn off.

Celecoxib Sandoz contains lactose
Celecoxib Sandoz contains lactose (a type of sugar). If your doctor has told you that you have an intolerance
to some sugars, contact him 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 following exactly the instructions of your doctor or pharmacist. If you have
any doubts, ask your doctor or pharmacist.
Your doctor will tell you which dose to take. Because the risk of side effects related to heart problems
may increase with increasing dose and duration of therapy, it is important that you use the lowest
possible dose to control pain and do not take Celecoxib Sandoz for a longer time than
necessary to control the symptoms.

Method of administration
Celecoxib Sandoz is for oral use
The capsules can be taken at any time of the day, with or without food. However, always try
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 can be sprinkled on a level teaspoon
of semi-solid foods (such as cold or room temperature apple juice, rice porridge, yogurt or
banana puree) and swallowed immediately with approximately 240 ml of water.
To open the capsule, hold it upright to keep the granules at the bottom, then gently squeeze
the top and twist to remove, being careful not to spill the contents. Do not
chew or crush the granules.
Contact your doctor within two weeks of starting treatment if you do not feel any improvement.

The recommended dose is:
For osteoarthritisthe 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 as follows:

• one 200 mg capsule once a day; or
• one 100 mg capsule twice a day.

For rheumatoid arthritisthe 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 as follows:

• one 100 mg capsule twice a day.

Celecoxib Sandoz 200 mg:

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

For ankylosing spondylitisthe 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 as follows:

• one 200 mg capsule once a day; or
• one 100 mg capsule twice a day.

Do not take more than 400 mg per day in all therapeutic uses.
Kidney or liver problems
Make sure your doctor knows if you have liver or kidney problems, as a lower dose may be
necessary.

4. Possible side effects

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

The side effects listed below have been observed in patients with arthritis who were taking
celecoxib. Side effects marked with an asterisk (*) are reported at the higher frequencies with which they
occurred in patients taking celecoxib to prevent colon polyps.
Patients in these studies took celecoxib at high doses and for a longer duration.
If you experience any of the following conditions, 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 sign of bleeding in the stomach or intestines, such as black stools or blood in the stools, or vomiting blood
• a skin reaction such as rash, blisters or peeling skin
• liver failure, the symptoms of which include nausea, diarrhea, jaundice (yellowing of the skin or the white of the eye)

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 swelling of 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 sick)
• vomiting*, stomach pain, diarrhea, indigestion, gas
• difficulty swallowing*
• skin rash, itching
• muscle stiffness
• headache
• joint pain
• worsening of existing allergies
• accidental injury

Not common(may affect up to 1 in 100 people)

• stroke*
• heart failure, feeling of palpitations, fast heartbeat
• abnormal blood tests for liver values
• abnormal blood tests for kidney values
• anemia (alterations of red blood cells that can cause fatigue and shortness of breath)
• anxiety, depression, fatigue, drowsiness, tingling sensation (pins and needles)
• high levels of potassium in the blood which can cause abnormal heart rhythms or muscle weakness
• blurred or impaired vision, ringing in the ears, pain and sores in the mouth, hearing difficulties*
• constipation, belching, inflammation of the stomach (indigestion, stomach pain or vomiting), worsening of inflammation of the stomach or intestines
• leg cramps
• increased skin rashes with itching (urticaria)
• eye inflammation
• difficulty breathing
• alteration of skin color (bruising)
• chest pain (generalized pain not related to the heart)
• facial swelling

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

• bleeding of the stomach or intestine (can lead to blood in the stools or vomit), inflammation of the intestine or colon
• ulcers (bleeding) in the esophagus, stomach, or intestine; or herniation of the intestine (can cause stomach pain, fever, nausea, vomiting, bowel obstruction), dark or black stools, inflammation of the pancreas (can cause stomach pain), inflammation of the esophagus (esophagitis)
• low blood levels of sodium (a condition known as hyponatremia), which can cause fatigue and confusion, muscle spasms, convulsions and coma
• reduction of white blood cells (which help protect the body from infections) and platelets (increased possibility of bleeding or bruising)
• difficulty coordinating muscle movements
• feeling of confusion, alterations of taste
• increased sensitivity to light
• hair loss
• hallucinations
• eye bleeding
• acute reaction that can lead to pulmonary inflammation
• irregular heartbeat
• hot flashes
• blood clots in the blood vessels of the lungs. Symptoms may include sudden shortness of breath, sharp pains during breathing or fainting
• severe liver inflammation (hepatitis). Symptoms include nausea (feeling sick), diarrhea, jaundice (yellowing of the skin or eyes), dark urine, pale stools, easy bruising, 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 life-threatening anaphylactic shock)
• serious skin diseases such as Stevens-Johnson syndrome, exfoliative dermatitis and toxic epidermal necrolysis (can cause rash, blisters or peeling skin) and acute generalized pustulosis exanthematica (symptoms include reddened skin with bumps covered with numerous small pustules)
• delayed allergic reaction with possible symptoms such as skin rash, facial swelling, fever, swollen lymph nodes, altered blood test values ​​regarding, for example, liver function or blood count (eosinophilia, a specific increase in white blood cells)
• cerebral hemorrhage including fatal cases
• meningitis (inflammation of the membrane covering the brain and spinal cord)
• liver failure, liver damage and severe liver inflammation (fulminant hepatitis) (cases sometimes fatal or requiring liver transplantation). Symptoms include nausea, diarrhea, jaundice (yellowing of the skin or eyes), dark urine, pale stools, easy bruising, itching or chills
• liver disorders (such as cholestasis and cholestatic hepatitis, which may be accompanied by symptoms such as altered stool color, nausea and yellowing of the skin or eyes)
• inflammation of the kidneys or other kidney disorders, such as nephrotic syndrome and minimal change glomerulopathy, which may be accompanied by symptoms such as fluid retention (edema), foamy urine, fatigue and loss of appetite) seizure or worsening of epilepsy (possibility of more frequent and/or severe seizures)
• blockage of an artery or vein in the eye, causing partial or total loss of vision
• inflamed blood vessels (can cause fever, pain, reddish patches on the skin)
• reduction of red blood cells, white blood cells and platelets (can cause fatigue, easy bruising, frequent nosebleeds and increased risk of infections)
• muscle pain and weakness Impaired sense of smell
• loss of taste

Not known:frequency cannot be estimated based on available data

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

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

• heart problems: angina (chest pain)
• stomach disorders: irritable bowel syndrome (may include stomach pain diarrhea, indigestion, flatulence)
• kidney stones (which can cause stomach or back pain, blood in the urine), difficulty urinating, high levels of creatinine in the blood (an index of kidney failure)
• weight gain

Not common(may affect up to 1 in 100 people)

• deep vein thrombosis (blood clotting generally in the leg, which can cause pain, swelling or redness in the calf or breathing problems)
• stomach disorders: stomach infection (which can cause irritation and ulcers in the stomach and intestines)
• lower limb fractures
• herpes zoster, skin infection, eczema (dry and itchy rash), pneumonia (chest infection with possible signs such as cough, fever, difficulty breathing)
• floaters in the eye causing impaired or blurred vision, conjunctival bleeding, dizziness due to inner ear disorders, painful, inflamed or bleeding gums, mouth sores
• excessive urination at night, bleeding hemorrhoids, frequent bowel movements
• build-up of fat on the skin or elsewhere, ganglion cysts (benign swelling on the joints and around the tendons of the hands or feet), difficulty speaking, abnormal or very heavy vaginal bleeding, breast pain
• high levels of sodium in blood test results

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 through 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 which is stated on the blister and the packaging box after “EXP”. The
first two numbers indicate the month while the last four indicate the year. The expiry date refers to
the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in the 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 ingredient is celecoxib.
Each hard capsule contains 100 mg of celecoxib.
Each hard capsule contains 200 mg of celecoxib.
The other ingredients are lactose monohydrate, povidone (E 1201), sodium croscarmellose (E 468), sodium
lauryl sulfate (E 487), magnesium stearate (E572); gelatin (E441), titanium dioxide (E171), iron
oxide yellow (E172)

100 mg hard capsules
The ink components are shellac (E904), propylene glycol (E1520), strong ammonia solution
(E527) and indigotine FD & C Blue aluminum Lake (E132)

200 mg hard capsules
The ink components are shellac (E904), propylene glycol (E1520), strong ammonia solution
(E 527) and iron oxide yellow (E172)

Description of the appearance of Celecoxib Sandoz and package contents

100 mg hard capsules
Hard gelatin capsule, opaque white. The capsule is marked with a blue band with white writing
"C9OX-100".

200 mg hard capsules
Hard gelatin capsule, opaque white. The capsule is marked with a yellow band with white writing
"C9OX-200".
The capsules are packaged in ALU/PVC blisters which are inserted inside a carton.
Pack sizes:
Blisters: 1, 20, 30, 40, 60 hard capsules.
Not all pack sizes may be marketed.

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

Manufacturers:
Synthon BV
Microweg 22
6503 GN Nijmegen
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 authorised in the Member States of the European Economic Area under the
following denominations
Netherlands Lexicel 100 mg, capsules
Lexicel 200 mg, capsules
Spain Celecoxib Genthon 100 mg hard capsules EFG
Celecoxib Genthon 200 mg hard capsules EFG
Italy Celecoxib Sandoz