Patient Information Leaflet: Information for the patient

Celecoxib Teva 100 mg hard capsules

Generic medicine
Please read this leaflet carefully before 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, consult 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 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

What Celecoxib Teva is and what it is used for
What you need to know before taking Celecoxib Teva
How to take Celecoxib Teva
Possible side effects
How to store Celecoxib Teva
Contents of the pack and other information

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

Celecoxib Teva is used to relieve the signs and symptoms of rheumatoid arthritis, osteoarthritis, and
ankylosing spondylitis in adults.
Celecoxib Teva, containing the active substance celecoxib, belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), and specifically to the subgroup of medicines known as cyclooxygenase-2 (COX-2) inhibitors.
The body produces certain substances called prostaglandins, which can cause pain and inflammation. When suffering from conditions such as rheumatoid arthritis or osteoarthritis, the body produces higher amounts of these substances. Celecoxib Teva works by reducing the production of these substances, thereby reducing pain and inflammation.

2. What you need to know before taking Celecoxib Teva

DO NOT take Celecoxib Teva

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 group of medicines called “sulfonamides” (e.g. certain antibiotics used to treat infections);
if you currently have a stomach or intestinal ulcer, or suffer from bleeding in the stomach or intestines;
if, after taking acetylsalicylic acid or any other non-steroidal anti-inflammatory or analgesic drug (NSAID), you experienced asthma, nasal polyps, severe nasal congestion, or an allergic reaction such as a skin rash with itching, swelling of the face, lips, tongue and throat, difficulty breathing or wheezing;
if you are pregnant. If there is a possibility you may become pregnant during treatment, you should discuss with your doctor the use of contraceptive methods;
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 colitis or Crohn’s disease;
if you have heart failure;
if you have 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 pectoris, or blockages in the blood vessels supplying the heart or brain;
if you have, or have had, circulation problems (peripheral arterial disease), or if you have undergone surgery on the arteries of the legs.

Warnings and precautions
Talk to your doctor or pharmacist before taking Celecoxib Teva

If you previously had a stomach or intestinal ulcer or bleeding. Do not take Celecoxib Teva if you currently have a stomach or intestinal ulcer or bleeding.
If you are taking acetylsalicylic acid (even at low doses for heart protection).
If you are taking medicines that reduce blood clotting (e.g. warfarin/warfarin-like anticoagulants or newer oral anticoagulants, such as apixaban).
If you are taking corticosteroids (e.g. prednisone).
If you are taking Celecoxib Teva together with other NSAIDs other than acetylsalicylic acid, such as ibuprofen or diclofenac. Concomitant use of these medicines should be avoided.
If you smoke.
If you have diabetes (diabetes mellitus).
If you have high blood pressure.
If you have high cholesterol.
If your heart, liver, or kidneys do not function properly, your doctor may want to monitor you regularly.
If you suffer from fluid retention (such as swollen ankles and feet).
If you are dehydrated, for example due to nausea, diarrhoea, or use of diuretics (used to treat excess fluid in the body).
If you have had a severe allergic reaction or a serious skin reaction to any medicine.
If you feel unwell due to an infection or suspect you have an infection, as Celecoxib Teva may mask fever or other signs of infection or inflammation.
If you are over 65 years old, your doctor may want to monitor you regularly.
Alcohol consumption and NSAIDs can increase the risk of gastrointestinal problems.

As with other NSAIDs (e.g. ibuprofen or diclofenac), this medicine may cause an increase in blood pressure; therefore, your doctor may want to measure your blood pressure regularly.
Serious liver reactions, including severe hepatitis, liver damage, and liver failure (sometimes fatal or requiring liver transplantation), have been reported with celecoxib. Among cases reporting onset time, most serious liver reactions occurred within one month of starting treatment.

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

certain cough medicines (dextromethorphan);
medicines used for high blood pressure and heart failure (e.g. ACE inhibitors, angiotensin II antagonists, beta-blockers, and diuretics);
certain medicines used to treat fungal or bacterial infections (fluconazole and rifampicin);
anticoagulants that reduce blood clotting (warfarin or other warfarin-like medicines, including newer agents such as apixaban);
medicines used to treat depression (e.g. lithium);
medicines used to treat sleep disorders or irregular heartbeat;
medicines used to treat certain mental disorders (neuroleptics);
certain medicines used to treat rheumatoid arthritis, psoriasis, and leukaemia (methotrexate);
certain medicines used to treat epilepsy/seizures and certain types of pain or depression (carbamazepine);
certain medicines used to treat epilepsy/seizures and certain sleep disorders (barbiturates);
certain medicines used to suppress the immune system, e.g. after organ transplants (cyclosporine and tacrolimus);
acetylsalicylic acid. Celecoxib Teva may be taken together with acetylsalicylic acid, but only if the acetylsalicylic acid is taken at low daily doses. Consult your doctor or pharmacist before taking both medicines together.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Celecoxib Teva must not be used by women who are pregnant or who may become pregnant (i.e. women of childbearing age who are not using adequate contraceptive measures) during treatment. If you become pregnant while being treated with Celecoxib Teva, you must stop treatment and consult your doctor for an alternative therapy.

Breastfeeding
Celecoxib Teva must not be used during breastfeeding.

Fertility
NSAIDs, including Celecoxib Teva, may make it more difficult to conceive. You should inform your doctor if you are planning a pregnancy or if you have difficulty becoming pregnant.

Driving and using machines
You should be aware of how you react to Celecoxib Teva before driving or operating machinery. If you experience dizziness or drowsiness after taking Celecoxib Teva, do not drive or operate machinery until these effects have subsided.

3. How to take Celecoxib Teva

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Dosage
For osteoarthritis
The recommended daily dose is 200 mg (1 hard capsule twice daily or 2 hard capsules once daily), which may be increased by your doctor up to a maximum of 400 mg (2 hard capsules twice daily) if necessary.
For rheumatoid arthritis
The recommended initial daily dose is 200 mg (1 hard capsule twice daily), which may be increased by your doctor up to a maximum of 400 mg (2 hard capsules twice daily) if necessary.
For ankylosing spondylitis
The recommended daily dose is 200 mg (1 hard capsule twice daily or 2 hard capsules once daily), which may be increased by your doctor up to a maximum of 400 mg (4 hard capsules once daily or 2 hard capsules twice daily) if necessary.
Your doctor will tell you which dose to take. Since the risk of unwanted effects related to heart problems may increase with dose and duration of treatment, it is important to use the lowest effective dose needed to control pain and not to take Celecoxib Teva for longer than necessary to control symptoms. If you think that the effect of Celecoxib Teva is too strong or too weak, consult your doctor or pharmacist.
Contact your doctor within two weeks of starting treatment if you do not notice any benefit.
Maximum daily dose:
Do not take more than 400 mg (4 hard capsules) of Celecoxib Teva per day.
Kidney or liver problems
Ensure your doctor knows if you have liver or kidney problems, as you may need to take a lower dose.
Elderly patients, especially those weighing less than 50 kg
If you are over 65 years old and weigh less than 50 kg, your doctor may decide to monitor you more closely.
Use in children
Celecoxib Teva is for adults only and must not be used in children.
How to take Celecoxib Teva
The capsules can be taken at any time of day, with or without food. However, try to take each dose of Celecoxib Teva at the same time every day.
Celecoxib Teva capsules must be swallowed with a sufficient amount of water (e.g. a glass [200 ml] ).
If you have difficulty swallowing the capsules: the entire contents of the capsule may be sprinkled onto a spoonful of soft food (such as applesauce, rice porridge, yogurt, or mashed banana, cold or at room temperature), immediately mixed and swallowed with a drink, such as a glass of water.
To open the capsule, hold it upright to keep the powder at the bottom, then gently press the top and twist to remove, taking care not to spill the contents.
If you take more Celecoxib Teva than you should
Do not take more hard capsules than prescribed by your doctor. If you take too many capsules, contact your doctor, pharmacist, or hospital, and bring your medicines with you so the doctor can see what you are taking.
If you forget to take Celecoxib Teva
If you forget to take Celecoxib Teva, take it as soon as you remember. Do not take a double dose to make up for the forgotten dose.
If you stop taking Celecoxib Teva
Stopping treatment with Celecoxib Teva suddenly may cause your symptoms to worsen. Do not stop taking Celecoxib Teva unless your doctor tells you to. Your doctor may advise you to gradually reduce the dose a few days before completely stopping treatment with Celecoxib Teva.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

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 took celecoxib. Side effects marked with an asterisk (*) have been reported at the highest frequencies observed in patients taking celecoxib to prevent colon polyps. Patients in these studies took celecoxib at high doses and for a long period of time.
Stop taking Celecoxib Teva and contact your doctor immediately if you experience any of the following conditions:

allergic reaction such as skin rash, swelling of the face, wheezing or difficulty breathing;
skin reactions such as rash, blistering or peeling of the skin;
heart problems such as chest pain;
severe stomach pain or any sign of bleeding in the stomach or intestines, such as black or bloody stools, or vomiting blood;
liver failure (symptoms may include nausea (feeling unwell), diarrhoea, jaundice (yellowing of the skin and whites of the eyes)).

Very common (may affect more than 1 in 10 people):
High blood pressure, including worsening of pre-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 of the sinuses, sinus infection, blocked or painful sinuses), stuffy or runny nose, sore throat, cough, cold, flu-like symptoms
Dizziness, sleep disturbances
Vomiting*, stomach pain, diarrhoea, indigestion, flatulence
Skin rash, itching
Muscle stiffness
Difficulty swallowing*
Headache
Nausea (feeling unwell)
Joint pain
Worsening of pre-existing allergies
Accidental injury
Uncommon (may affect up to 1 in 100 people):
Stroke*
Heart failure, palpitations (awareness of heart beat), increased heart rate
Abnormal liver function test results in blood tests
Abnormal kidney function test results in blood tests
Anaemia (changes in red blood cells which may cause tiredness and shortness of breath)
Anxiety, depression, fatigue, drowsiness, tingling sensation (pins and needles)
Elevated potassium levels in blood test results (may cause nausea (feeling unwell), tiredness, muscle weakness or palpitations)
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
Increased itchy skin rashes (urticaria)
Eye inflammation
Difficulty breathing
Skin discolouration (bruising)
Chest pain (generalised pain not related to the heart)
Swelling of the face
Rare (may affect up to 1 in 1,000 people):
Ulcers (bleeding) in the stomach, oesophagus or intestines; or intestinal perforation (may cause stomach pain, fever, nausea, vomiting, intestinal blockage), black or dark stools, inflammation of the pancreas (may cause stomach pain), inflammation of the throat (oesophagus)
Low levels of sodium in the blood (a condition known as hyponatraemia)
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
Bleeding in the eye
Acute reaction which may lead to lung inflammation
Irregular heartbeat
Hot flushes
Blood clots in blood vessels of the lungs. Symptoms may include sudden shortness of breath, sharp pain when breathing or fainting.
Bleeding in the stomach or intestines (may cause blood in stools or vomit), inflammation of the intestine or colon
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)
Severe skin diseases, such as Stevens-Johnson syndrome, exfoliative dermatitis and toxic epidermal necrolysis (may cause rash, blistering or peeling of the skin) and generalised exanthematous pustulosis (symptoms include reddened skin with swellings covered by numerous small pustules)
Delayed allergic reaction with possible symptoms such as skin rash, swelling of the face, fever, swollen glands, abnormal blood test results (e.g. liver, full blood count (eosinophilia, a specific increase in white blood cells))
Fatal cerebral haemorrhage
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 transplant). Symptoms include nausea (feeling unwell), 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 and other kidney disorders (such as nephrotic syndrome and minimal change disease, which may be accompanied by symptoms such as fluid retention (oedema), foamy urine, fatigue and loss of appetite)
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, purple pustules 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
Impaired sense of smell
Loss of taste

Not known (frequency cannot be estimated from the available data):

Reduced fertility in women, generally reversible upon stopping the medicine

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

Heart problems: angina pectoris (chest pain);
Stomach problems: irritable bowel syndrome (may include stomach pain, diarrhoea, indigestion, flatulence);
Kidney stones (which may lead to stomach pain, back pain, blood in urine), difficulty urinating;
Weight gain;

Uncommon (may affect up to 1 in 100 people):

Deep vein thrombosis (blood clot 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 intestine)
Fracture of lower limbs
Herpes zoster (shingles), skin infection, eczema (dry, itchy rash), pneumonia (chest infection (possible cough, fever, breathing difficulties))
Eye floaters causing impaired or blurred vision, dizziness due to inner ear disorders, painful, inflamed or bleeding gums, mouth sores
Excessive urination at night, bleeding haemorrhoids, frequent bowel movements
Fatty deposits on the skin or elsewhere, ganglion cysts (harmless swellings on or around joints and 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 get any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Celecoxib Teva

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, on the blister, and on the outer carton after EXP. The expiry date refers to the last day of that month.
Aluminium/aluminium blisters
This medicine does not require any special storage conditions.
PVC/PVDC/aluminium blisters
Do not store above 30 °C.
Tablet container
This medicine does not require any special storage conditions.
Tablet container:
Period of validity after first opening: 6 months.
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 Teva contains

The active substance is celecoxib. Each hard capsule contains 100 mg of celecoxib.
The other components are: Calcium hydrogen phosphate dihydrate, sodium lauryl sulfate, crospovidone (type B), povidone (K30), povidone (K 90), magnesium stearate, gelatin, shellac, propylene glycol, purified water, titanium dioxide (E171), indigo carmine aluminium lake (E132).

Description of the appearance of Celecoxib Teva and the contents of the pack
Celecoxib Teva capsules are opaque white, hard gelatin capsules marked with the inscription “100” in blue.
Celecoxib Teva is available in packs containing 5, 10, 20, 30, 50, 60, 90 and 100 hard capsules in blisters, 50 x 1 and 60 x 1 hard capsules in unit dose perforated blister packs, and bottles containing 100 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Teva Italia S.r.l. – Piazzale Luigi Cadorna, 4 - 20123 Milan, Italy

Manufacturers
Merckle GmbH
Ludwig-Merckle-Straße 3
89143 Blaubeuren
Germany
TEVA Pharmaceutical Works Private Limited Company
Pallagi út 13,
4042 Debrecen
Hungary
TEVA UK Ltd
Brampton Road, Hampden Park,
Eastbourne, East Sussex, BN22 9AG
United Kingdom
Pharmachemie B.V.
Swensweg 5,
2031 GA Haarlem
The Netherlands
Teva Czech Industries s.r.o.
Ostravska 29, c.p. 305,
74770 Opava-Komarov
Czech Republic
Teva Operations Poland Sp. z o.o.
ul. Mogilska 80, 31-546
Krakow
Poland
HBM Pharma s.r.o.
03680 Martin, Slabinská 30
Slovak Republic

This medicinal product is authorized in the European Economic Area countries under the following names:
Belgium: Celecoxib Teva 100 mg capsules, hard
Cyprus: Celecoxib Teva 100mg Hard Capsules
France: Celecoxib TEVA 100 mg, gélules
Germany: Celecoxib AbZ 100 mg Hartkapseln
Greece: Celecoxib Teva 100 mg Καψάκια, σκληρά
Iceland: Celecoxib Teva
Italy: Celecoxib Teva
The Netherlands: Celecoxib 100 mg, capsule, hard
Portugal: Celecoxib Teva
United Kingdom: Celecoxib 100 mg capsules, hard

Package leaflet: Information for the patient

Celecoxib Teva 200 mg hard capsules

Generic medicine
Please read this leaflet carefully before 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 others, even if they have the same symptoms as yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

What Celecoxib Teva is and what it is used for
What you need to know before taking Celecoxib Teva
How to take Celecoxib Teva
Possible side effects
How to store Celecoxib Teva
Package contents and other information

7. What Celecoxib Teva is and what it is used for

Celecoxib Teva is used to relieve the signs and symptoms of rheumatoid arthritis, osteoarthritis, and
ankylosing spondylitis in adults.
Celecoxib Teva, containing the active substance celecoxib, belongs to a group of medicines called non-steroidal
anti-inflammatory drugs (NSAIDs), and specifically to the subgroup of medicines known as cyclooxygenase-2
(COX-2) inhibitors.
The body produces certain substances, known as prostaglandins, which can cause pain and inflammation.
If you suffer from conditions such as rheumatoid arthritis or osteoarthritis, the body produces increased amounts
of these substances. Celecoxib Teva works by reducing the production of these substances, thereby reducing
pain and inflammation.

8. What you should know before taking Celecoxib Teva

Do NOT take Celecoxib Teva

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 group of medicines called "sulfonamides" (e.g. certain antibiotics used to treat infections);
if you currently have a stomach or intestinal ulcer, or are suffering from bleeding in the stomach or intestines;
if you have experienced asthma, nasal polyps, severe nasal congestion, or an allergic reaction such as itchy skin rash, swelling of the face, lips, tongue or throat, difficulty breathing or wheezing after taking acetylsalicylic acid or any other non-steroidal anti-inflammatory or analgesic drug (NSAID);
if you are pregnant. If there is a possibility you may become pregnant during treatment, you should discuss the use of 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;
if you have 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 pectoris, or blockages in blood vessels supplying 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 Teva

If you have previously had a stomach or intestinal ulcer or bleeding. Do not take Celecoxib Teva if you currently have a stomach or intestinal ulcer or bleeding.
If you are taking acetylsalicylic acid (even at low doses for heart protection).
If you are taking medicines to reduce blood clotting (e.g. warfarin/warfarin-like anticoagulants or newer oral anticoagulant medicines, such as apixaban).
If you are taking corticosteroid medicines (e.g. prednisone).
If you are taking Celecoxib Teva together with other NSAIDs other than acetylsalicylic acid, such as ibuprofen or diclofenac. Concomitant use of these medicines should be avoided.
If you smoke.
If you have diabetes (diabetes mellitus).
If you have high blood pressure.
If you have high cholesterol.
If your heart, liver or kidneys do not function properly, your doctor may want to monitor you regularly.
If you suffer from fluid retention (such as swollen ankles and feet).
If you are dehydrated, for example due to nausea, diarrhea, or use of diuretics (used to treat excess fluid in the body).
If you have had a severe allergic reaction or a serious skin reaction to any medicine.
If you do not feel well due to an infection or suspect you have an infection, as Celecoxib Teva may mask fever or other signs of infection or inflammation.
If you are over 65 years old, your doctor may want to monitor you regularly.
Alcohol consumption and NSAIDs can increase the risk of gastrointestinal problems.

As with other NSAIDs (e.g. ibuprofen or diclofenac), this medicine may cause an increase in
blood pressure; therefore, your doctor may want to measure your blood pressure regularly.
Serious liver reactions have been reported with celecoxib, including severe hepatitis, liver damage,
and liver failure (sometimes fatal or requiring liver transplantation). Among cases reporting onset time,
most serious liver reactions occurred within one month of starting treatment.

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

certain cough medicines (dextromethorphan);
medicines used for high blood pressure and heart failure (e.g. ACE inhibitors, angiotensin II antagonists, beta-blockers, and diuretics);
certain medicines used to treat fungal or bacterial infections (fluconazole and rifampicin);
anticoagulants that reduce blood clotting (warfarin or other warfarin-like medicines, including newer agents such as apixaban);
medicines used to treat depression (e.g. lithium);
medicines for treating sleep disorders or irregular heartbeat;
medicines for treating certain mental disorders (neuroleptics);
certain medicines used to treat rheumatoid arthritis, psoriasis, and leukemia (methotrexate);
certain medicines used to treat epilepsy/seizures and certain types of pain or depression (carbamazepine);
certain medicines used to treat epilepsy/seizures and certain sleep disorders (barbiturates);
certain medicines used to suppress the immune system, e.g. after organ transplants (ciclosporine and tacrolimus);
acetylsalicylic acid. Celecoxib Teva may be taken together with acetylsalicylic acid, but only if the acetylsalicylic acid is taken at low daily doses. Consult your doctor or pharmacist before taking both medicines together.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Celecoxib Teva must not be used by women who are pregnant or who may become pregnant (i.e. women of childbearing age who are not using adequate contraceptive measures) during treatment. If you become pregnant while being treated with Celecoxib Teva, you must stop treatment and consult your doctor for alternative therapy.
Breastfeeding
Celecoxib Teva must not be used during breastfeeding.
Fertility
NSAIDs, including Celecoxib Teva, may make it more difficult to become pregnant. You should inform your doctor if you are planning a pregnancy or if you have difficulty becoming pregnant.
Driving and using machines
You should be aware of how you react to Celecoxib Teva before driving or operating machinery. If you experience dizziness or drowsiness after taking Celecoxib Teva, do not drive or operate machinery until these effects have subsided.

9. How to take Celecoxib Teva

Always take this medicine exactly as your doctor has instructed. If you have any doubts, consult your doctor or pharmacist.
Dosage
For osteoarthritis
The recommended daily dose is 200 mg (1 hard capsule once daily), which your doctor may increase if necessary up to a maximum of 400 mg (1 hard capsule twice daily).
For rheumatoid arthritis
The recommended initial daily dose is 200 mg (as 100 mg hard capsule twice daily), which your doctor may increase if necessary up to a maximum of 400 mg (1 hard capsule twice daily).
For ankylosing spondylitis
The recommended daily dose is 200 mg (1 hard capsule once daily), which your doctor may increase if necessary up to a maximum of 400 mg (2 hard capsules once daily or 1 hard capsule twice daily).
Your doctor will tell you which dose to take. Since the risk of unwanted effects related to heart problems may increase with dose and duration of treatment, it is important to use the lowest effective dose to control pain and not to take Celecoxib Teva for longer than necessary to control symptoms. If you think that the effect of Celecoxib Teva is too strong or too weak, consult your doctor or pharmacist.
Contact your doctor within two weeks of starting treatment if you do not notice any benefit.
Maximum daily dose:
Do not take more than 400 mg (2 hard capsules) of Celecoxib Teva per day.
Kidney or liver problems
Ensure that your doctor knows if you have liver or kidney problems, as you may need to take a lower dose.
Elderly patients, especially those weighing less than 50 kg
If you are over 65 years of age and weigh less than 50 kg, your doctor may decide to monitor you more closely.
Use in children
Celecoxib Teva is for adults only and must not be used in children.
How to take Celecoxib Teva
The capsules can be taken at any time of day, with or without food. However, try to take each dose of Celecoxib Teva at the same time every day.
Celecoxib Teva capsules must be swallowed with a sufficient amount of water (e.g. a glass [200 ml] ).
If you have difficulty swallowing the capsules: the entire contents of the capsule may be sprinkled onto a spoonful of semi-solid food (such as apple puree, rice porridge, yogurt, or mashed banana, cold or at room temperature) and swallowed immediately with a drink, approximately a glass of water.
To open the capsule, hold it upright to keep the powder at the bottom, then gently press the top and twist to remove, taking care not to spill the contents.
If you take more Celecoxib Teva than you should
Do not take more hard capsules than your doctor has prescribed. If you take too many hard capsules, contact your doctor, pharmacist, or hospital, and bring your medicines with you so the doctor can see what you are taking.
If you forget to take Celecoxib Teva
If you forget to take Celecoxib Teva, take it as soon as you remember. Do not take a double dose to make up for the forgotten dose.
If you stop taking Celecoxib Teva
Stopping treatment with Celecoxib Teva suddenly may lead to a worsening of symptoms. Do not stop taking Celecoxib Teva unless your doctor tells you to. Your doctor may advise you to gradually reduce the dose a few days before completely stopping treatment with Celecoxib Teva.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

10. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The side effects listed below have been observed in patients with arthritis who have taken celecoxib. Side effects marked with an asterisk (*) have been reported at the higher frequencies observed in patients taking celecoxib to prevent colon polyps. Patients in these studies took celecoxib at high doses and for a long period of time.
Stop taking Celecoxib Teva and contact your doctor immediately if you experience any of the following conditions:

allergic reaction such as skin rash, swelling of the face, wheezing or difficulty breathing;
skin reactions such as rash, blistering or peeling of the skin;
heart problems such as chest pain;
severe stomach pain or any sign of bleeding in the stomach or intestines, such as black or bloody stools, or vomiting blood;
liver failure (symptoms may include nausea (feeling unwell), diarrhoea, jaundice (yellowing of the skin and whites of the eyes)).

Very common (may affect more than 1 in 10 people):

high blood pressure, including worsening of pre-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 of the sinuses, sinus infection, blocked or painful sinuses), stuffy or runny nose, sore throat, cough, cold, flu-like symptoms
Dizziness, sleep disturbances
Vomiting*, stomach pain, diarrhoea, indigestion, flatulence
Skin rash, itching
Muscle stiffness
Difficulty swallowing*
Headache
Nausea (feeling unwell)
Joint pain
Worsening of pre-existing allergies
Accidental injury

Uncommon (may affect up to 1 in 100 people):

Stroke*
Heart failure, palpitations (awareness of heartbeat), increased heart rate
Abnormal liver function test results in blood tests
Abnormal kidney function test results in blood tests
Anaemia (changes in red blood cells that may cause tiredness and shortness of breath)
Anxiety, depression, fatigue, drowsiness, tingling sensation (pins and needles)
Elevated potassium levels in blood test results (may cause nausea (feeling unwell), fatigue, muscle weakness or palpitations)
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
Increased itchy skin rashes (urticaria)
Eye inflammation
Difficulty breathing
Skin discolouration (bruising)
Chest pain (generalised pain not related to the heart)
Swelling of the face
li.

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

Ulcers (bleeding) in the stomach, oesophagus or intestine; or intestinal perforation (may cause stomach pain, fever, nausea, vomiting, intestinal blockage), black or dark stools, inflammation of the pancreas (may cause stomach pain), inflammation of the throat (oesophagus)
Low levels of sodium in the blood (a condition known as hyponatraemia)
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 haemorrhage
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.
Bleeding in the stomach or intestine (may cause blood in stools or vomit), inflammation of the intestine or colon
Severe liver inflammation (hepatitis). Symptoms include nausea (feeling unwell), diarrhoea, jaundice (yellowing of the skin or eyes), dark urine, pale stools, easy bruising or 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, blistering or peeling of the skin), and generalised exanthematous pustulosis (symptoms include reddened skin with swellings covered in numerous small pustules)
Delayed allergic reaction with possible symptoms such as skin rash, facial swelling, fever, swollen glands, abnormal blood test results (e.g. liver function, full blood count (eosinophilia, a specific increase in white blood cells))
Fatal cerebral haemorrhage
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 (feeling unwell), diarrhoea, jaundice (yellowing of the skin or eyes), dark urine, pale stools, easy bruising or 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 and other kidney disorders (such as nephrotic syndrome and minimal change disease, which may be accompanied by symptoms such as fluid retention (oedema), foamy urine, fatigue and loss of appetite)
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, purple pustules 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
Impaired 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

Heart disorders: angina pectoris (chest pain);
Stomach disorders: irritable bowel syndrome (may include stomach pain, diarrhoea, indigestion, flatulence);
Kidney stones (which may lead to stomach pain, back pain or blood in the urine), difficulty urinating;
Weight gain.

Uncommon (may affect up to 1 in 100 people):

Deep vein thrombosis (blood clot usually in the leg, which may cause pain, swelling or redness in the calf or breathing problems)
Stomach disorders: stomach infection (which may cause irritation and ulcers in the stomach and intestine)
Fractures of the lower limbs
Herpes zoster (shingles), skin infection, eczema (dry, itchy rash), pneumonia (chest infection (possible cough, fever, breathing difficulties))
Eye floaters causing impaired or blurred vision, vertigo due to inner ear disorders, painful, inflamed or bleeding gums, mouth sores
Excessive urination at night, bleeding haemorrhoids, frequent bowel movements
Fatty deposits under the skin or elsewhere, ganglion cysts (harmless swellings on or around joints and 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 www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

11. How to store Celecoxib Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label, blister, and outer carton after EXP. The expiry date refers to the last day of that month.
Aluminium/aluminium blisters
This medicine does not require any special storage conditions.
PVC/PVDC/aluminium blisters
Do not store above 30 °C.
Tablet container
This medicine does not require any special storage conditions.
Tablet container:
Validity period after first opening: 6 months.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

12. Package contents and other information

What Celecoxib Teva contains

The active substance is celecoxib. Each hard capsule contains 200 mg of celecoxib.
The other components are: Calcium hydrogen phosphate dihydrate, sodium lauryl sulfate, crospovidone (type B), povidone (K30), povidone (K 90), magnesium stearate, gelatin, shellac, propylene glycol, purified water, titanium dioxide (E171), iron oxide yellow (E172).

Description of the appearance of Celecoxib Teva and contents of the pack
Celecoxib Teva capsules are opaque white, hard gelatin capsules with the imprint “200” in yellow.
Celecoxib Teva is available in packs of 5, 10, 20, 30, 50, 60, 90 and 100 hard capsules in blisters, packs of 30 x 1 and 50 x 1 hard capsules in unit-dose perforated blister strips, and bottles containing 100 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Teva Italia S.r.l. – Piazzale Luigi Cadorna, 4 - 20123 Milano, Italy

Manufacturers
Merckle GmbH
Ludwig-Merckle-Straße 3
89143 Blaubeuren
Germany
TEVA Pharmaceutical Works Private Limited Company
Pallagi út 13
4042 Debrecen
Hungary
TEVA UK Ltd
Brampton Road, Hampden Park
Eastbourne, East Sussex, BN22 9AG
United Kingdom
Pharmachemie B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands
Teva Czech Industries s.r.o.
Ostravska 29, c.p. 305
74770 Opava-Komarov
Czech Republic
Teva Operations Poland Sp. z o.o.
ul. Mogilska 80, 31-546
Krakow
Poland
HBM Pharma s.r.o.
03680 Martin, Slabinská 30
Slovak Republic

This medicinal product is authorized in the European Economic Area countries under the following names:
Belgium: Celecoxib Teva 200 mg capsules, hard
Bulgaria: TevaCoxib 200 mg capsules, hard
Cyprus: Celecoxib Teva 200mg Hard Capsules
France: Celecoxib TEVA 200 mg, gélules
Germany: Celecoxib AbZ 200 mg Hartkapseln
Greece: Celecoxib Teva 200 mg Καψάκια, σκληρά
Iceland: Celecoxib Teva
Italy: Celecoxib Teva
The Netherlands: Celecoxib 200 mg, capsule, hard
Portugal: Celecoxib Teva
Spain: Celecoxib Teva 200 mg cápsulas duras EFG
United Kingdom: Celecoxib 200 mg capsules, hard