Celecoxib Aurobindo: detailed information

Package leaflet: Information for the patient

Celecoxib Aurobindo 200 mg capsules

Generic medicine
Please read this entire 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, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Celecoxib Aurobindo is used in adults to relieve the signs and symptoms of rheumatoid arthritis,
osteoarthritis, and ankylosing spondylitis.
Celecoxib Aurobindo belongs to a group of medicines called non-steroidal anti-inflammatory drugs
(NSAIDs), and more specifically to a subgroup known as "COX-2 inhibitors". Your body
produces prostaglandins, which can cause pain and inflammation. In certain conditions such as rheumatoid
arthritis and osteoarthritis, your body produces increased amounts of these prostaglandins. Celecoxib Aurobindo works
by reducing the production of prostaglandins, thereby reducing pain and inflammation.
You may expect the medicine to start working within a few hours of taking the first dose,
although it may take several days to feel the full effect.

2. What you should know before taking Celecoxib Aurobindo

Do not take Celecoxib Aurobindo

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 bleeding in the stomach or intestines;
if, after taking acetylsalicylic acid or any other anti-inflammatory or pain-relieving medicine (NSAIDs), you have 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 shortness of breath;
if you are pregnant. If you might become pregnant during ongoing treatment, you should discuss possible 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 or transient ischemic attack (a temporary reduction in blood flow to the brain; also known as “mini-stroke”), angina, or blockage of blood vessels supplying the heart or brain;
if you have or have had circulation 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 Aurobindo:

if you have previously had a stomach or intestinal ulcer or gastrointestinal bleeding. (Do not take Celecoxib Aurobindo 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 new oral anticoagulants such as apixaban);
if you are taking corticosteroids (e.g. prednisone);
if you are using Celecoxib Aurobindo together with other NSAIDs other than acetylsalicylic acid, such as ibuprofen or diclofenac. Concomitant use of these medicines should be avoided;
if you smoke, have diabetes, high blood pressure, or high cholesterol levels;
if your heart, liver or kidneys do not function properly, your doctor may carry out regular checks;
if you experience fluid retention (such as swelling of the ankles and feet);
if you are dehydrated, for example due to vomiting, diarrhoea, or use of diuretics (used to treat excess fluid in the body);
if you have previously had a severe allergic reaction or a serious skin reaction to any medicine;
if you are unwell due to an infection or think you may have an infection, as Celecoxib Aurobindo may mask fever or other signs of infection and inflammation;
if you are over 65 years of age, your doctor may monitor you regularly;
alcohol consumption together with NSAIDs may increase the risk of gastrointestinal problems.

As with other NSAIDs (e.g. ibuprofen or diclofenac), this medicine may cause an increase in
blood pressure, and therefore your doctor may ask you to monitor your blood pressure at regular
intervals.
Serious liver reactions, including severe hepatitis, liver damage, and liver failure (some fatal or requiring liver transplantation), have been reported with celecoxib. In cases where onset time was reported, the most severe hepatic reactions occurred within one month of starting treatment.
Taking Celecoxib Aurobindo may make it more difficult to become pregnant. You should inform your
doctor if you are planning a pregnancy or if you are having difficulty becoming pregnant (see section
“Pregnancy, breastfeeding and fertility”).
Other medicines and Celecoxib Aurobindo
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 antagonists, beta-blockers, and diuretics (used for high blood pressure and heart failure)
fluconazole and rifampicin (used to treat fungal and bacterial infections)
warfarin or other medicines similar to warfarin (blood thinners that reduce blood clotting), including newer agents such as apixaban
lithium (used to treat certain types of depression)
other medicines used to treat depression, sleep disorders, high blood pressure, or irregular heartbeat
neuroleptics (used to treat certain mental disorders)
methotrexate (used to treat rheumatoid arthritis, psoriasis, and leukaemia)
carbamazepine (used to treat epilepsy/seizures and certain types of pain or depression)
barbiturates (used to treat epilepsy/seizures and certain sleep disorders)
cyclosporine and tacrolimus (used for immunosuppression, e.g. after transplants).

Celecoxib Aurobindo may be taken with low-dose acetylsalicylic acid (75 mg or less per day).
Ask your doctor for advice before taking both medicines together.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding,
consult your doctor or pharmacist before taking this medicine.
Pregnancy
Celecoxib Aurobindo must not be used by women who are pregnant or who may become pregnant (e.g. women of childbearing age not using adequate contraception) during ongoing treatment. If you become pregnant while being treated with Celecoxib Aurobindo, you must stop treatment and contact your doctor for alternative therapy.
Breastfeeding
Celecoxib Aurobindo must not be used during breastfeeding.
Fertility
NSAIDs, including Celecoxib Aurobindo, may make it more difficult to conceive. You should inform your doctor if you are planning a pregnancy or if you are having difficulty becoming pregnant.
Driving and using machines
Before driving or operating machinery, you should assess how you react to Celecoxib Aurobindo. If you experience dizziness or drowsiness after taking Celecoxib Aurobindo, do not drive or operate machinery until these effects have passed.
Celecoxib Aurobindo contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Celecoxib Aurobindo

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Your doctor will tell you what dose to take. Since the risk of unwanted side effects related to
heart problems may increase with dose and duration of use, it is important that you use the lowest dose necessary to
control your pain. You must not take Celecoxib Aurobindo for longer than necessary to control
your symptoms.
Celecoxib Aurobindo is not suitable for doses <200 mg/day. Other medicinal products containing celecoxib at appropriate doses are available.
Method of administration
Celecoxib Aurobindo is for oral use. The capsules can be taken at any time of day,
with or without food. However, try to take each dose of Celecoxib Aurobindo at the same time every day.
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 pudding, yogurt, or mashed banana, cold or at room
temperature) and swallowed immediately with about 240 ml of water.
To open the capsule, hold it upright to keep the granules at the bottom, then remove the cap by twisting it gently, taking care not to spill the contents. Do not chew or crush the granules.
Contact your doctor if you do not experience any benefit within two weeks of starting treatment.
Recommended dose:
For osteoarthritis, the recommended dose is 200 mg per day, which may be increased by your doctor to a maximum of 400 mg, if necessary.
The dose is usually:

one 200 mg capsule per day; 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 dose is usually:

one 100 mg capsule twice daily.

If the prescribed dose cannot be achieved with this dosage form, other strengths of this medicine are available. Consult your doctor.
For ankylosing spondylitis, the recommended dose is 200 mg per day, which may be increased by your doctor to a maximum of 400 mg, if necessary.
The dose is usually:

one 200 mg capsule per day; or
one 100 mg capsule twice daily.

Liver or kidney problems: make sure your doctor knows if you have liver or kidney problems, as you may
require a lower dose.
Elderly patients, particularly those weighing less than 50 kg: if you are over 65 years of age and especially
if you weigh less than 50 kg, your doctor may decide to monitor you more closely.
Do not take more than 400 mg per day.
Use in children: Celecoxib Aurobindo should only be used in adults; it must not be used in
children.
If you take more Celecoxib Aurobindo than you should
Do not take more capsules than prescribed by your doctor. If you take too many capsules, contact your doctor,
pharmacist, or hospital and bring the medicine with you.
If you forget to take Celecoxib Aurobindo
If you forget to take a capsule, take it as soon as you remember. Do not take a double dose to
compensate for the missed dose.
If you stop taking Celecoxib Aurobindo
Stopping treatment with Celecoxib Aurobindo suddenly may worsen your symptoms.
Do not stop taking Celecoxib Aurobindo unless your doctor tells you to. Your doctor
may advise you to gradually reduce the dose over several days before stopping treatment completely.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
The side effects listed below were observed in patients with arthritis treated with celecoxib. The side effects marked with an asterisk (*) are listed below according to the highest frequency observed in patients treated with celecoxib for prevention of colon polyps. Patients in these studies took celecoxib at high doses and for a long period of time.
Stop taking Celecoxib Aurobindo immediately and contact your doctor immediately if you experience any of the following:

If you have:

an allergic reaction such as rash, swelling of the face, breathlessness or difficulty breathing;
heart problems such as chest pain;
severe stomach pain or any signs of bleeding in the stomach or intestines, such as dark or bloody stools, or vomiting blood;
a skin reaction such as rash, blisters or peeling of the skin;
liver failure (symptoms may include nausea (feeling unwell), diarrhoea, jaundice (yellowing of the skin or 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, difficulty sleeping
vomiting*, stomach ache, diarrhoea, indigestion, gas
rash, itching
muscle stiffness
difficulty swallowing*
headache
nausea (feeling unwell)
painful joints
worsening of existing allergies
accidental injury

Uncommon: may affect up to 1 in 100 people

stroke*
heart failure, palpitations (awareness of heartbeat), rapid heartbeat
abnormal liver blood test results
abnormal kidney blood test results
anaemia (changes in red blood cells that may cause tiredness and shortness of breath)
anxiety, depression, fatigue, dizziness, tingling sensations (pins and needles)
high levels of potassium in blood test results (may cause nausea (feeling unwell), tiredness, muscle weakness or palpitations)
impaired or blurred vision, ringing in the ears, mouth pain or sores, hearing difficulties*
constipation, belching, inflammation of the stomach (indigestion, stomach ache or vomiting), worsening of stomach or intestinal inflammation
leg cramps
itchy raised rash (urticaria)
eye inflammation
difficulty breathing
changes in skin colour (bruising)
chest pain (general 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 intestine; or intestinal injury (may cause pain, fever, nausea, vomiting, intestinal blockage), black or dark stools, inflammation of the pancreas (may cause stomach pain), inflammation of the oesophagus (oesophagitis may cause difficulty swallowing)
low levels of sodium in the blood (a condition known as hyponatraemia)
reduced number of white blood cells (which help protect the body from infections) or platelets in the blood (increased risk of bleeding or bruising)
difficulty coordinating muscle movements
confusion, taste disturbances
increased sensitivity to light
hair loss
hallucinations
bleeding from the eye
acute reaction that may lead to lung inflammation
irregular heartbeat
hot flushes
blood clots in the blood vessels of the lungs. Symptoms may include shortness of breath, sharp pain when breathing and collapse
bleeding from the stomach or intestine (may result in blood in stools or vomit), inflammation of the intestine or colon
severe liver inflammation (hepatitis). Symptoms may include nausea (feeling unwell), diarrhoea, jaundice (yellowing of the skin or eyes), dark urine, pale stools, easy bleeding, itching and chills
acute kidney failure
menstrual disorders
swelling of the face, lips, mouth, tongue or throat, or difficulty swallowing

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

severe allergic reactions (including potentially fatal anaphylactic shock)
serious skin conditions 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 reddening of the skin with swollen areas covered with numerous small pustules)
delayed allergic reaction with possible symptoms such as rash, swelling of the face, fever, swollen glands and abnormal test results (e.g. liver, blood cells (eosinophilia, a type of increase in white blood cells))
bleeding within the brain causing death
meningitis (inflammation of the membrane around the brain and spinal cord)
liver failure, liver damage and severe liver inflammation (fulminant hepatitis) (sometimes fatal or requiring liver transplant). Symptoms may include nausea (feeling unwell), diarrhoea, jaundice (yellowing of the skin or eyes), dark urine, pale stools, easy bleeding, itching or chills.
Liver problems (such as cholestasis and cholestatic hepatitis, which may be accompanied by symptoms such as fluid retention (oedema), foamy urine, fatigue and loss of appetite)
Worsening of epilepsy (possible more frequent and/or more severe seizures)
Blockage of an artery or vein in the eye which may lead to partial or complete loss of vision
Inflamed blood vessels (may cause fever, pain, red spots on the skin)
A reduction in the number of white and red blood cells and platelets (may cause fatigue, easier bruising, frequent nosebleeds and increased risk of infections)
Muscle pain and weakness
Impaired sense of smell
Loss of taste

Frequency not known: cannot be estimated from the available data

Reduced fertility in women, usually reversible upon discontinuation of the medicine.

In clinical studies not related to arthritis or other arthritic conditions, in which 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 (chest pain)
stomach problems: irritable bowel syndrome (may include stomach ache, diarrhoea, indigestion, gas)
kidney stones (may cause stomach or back pain, blood in urine), difficulty passing urine
weight gain

Uncommon: may affect up to 1 in 100 people

deep vein thrombosis (blood clots, usually in the legs, which may cause calf pain or redness, or breathing problems)
stomach problems: stomach infection (may cause irritation and ulcers in the stomach and intestine)
fractures of the lower limbs
herpes, skin infection, eczema (rash with dry, itchy skin), pneumonia (inflammation of the lungs (possible cough, fever, difficulty breathing))
eye floaters causing blurred or impaired vision, dizziness due to inner ear problems, injury, inflamed or bleeding gums, mouth sores
excessive urination at night, bleeding from haemorrhoids, frequent bowel movements
fatty lumps on the skin or elsewhere, ganglion cysts (harmless swellings on or around joints and tendons of the hands and 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, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the Italian Medicines Agency (Agenzia Italiana del Farmaco) at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Celecoxib Aurobindo

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 carton after EXP. The
expiry date refers to the last day of that month.
Store below 30°C.
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.

6. Package contents and other information

What Celecoxib Aurobindo contains

The active substance is celecoxib. Each capsule contains 200 mg of celecoxib.
The other components are: Capsule contents: monohydrate lactose, hydroxypropyl cellulose, crospovidone (Type B) (E1202), sodium lauryl sulfate (E487), povidone (K-30) (E1201), sodium stearoyl fumarate. Capsule shell: titanium dioxide (E171), gelatin (E441).

Printing ink: shellac (E904), yellow iron oxide (E172).

Description of the appearance of Celecoxib Aurobindo and the package contents
Hard capsules.
White/white hard gelatin capsules, size “2”, printed with “Y” on the cap and “200” on the body in golden ink, containing white to off-white granular powder.
Celecoxib Aurobindo capsules are available in blister packs of 20 and 30 capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Aurobindo Pharma (Italia) s.r.l., Via San Giuseppe 102, 21047 Saronno (VA)

Manufacturer:
APL Swift services (Malta) Limited – HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia – BBG 3000, Malta
Milpharm Limited – Ares Block, Odyssey Business Park, West End Road, Ruislip HA4 6QD – United Kingdom
Generis Farmacêutica, S.A. - Rua João de Deus, 19, 2700-487 - Amadora, Portugal

This medicinal product is authorized in the European Economic Area Member States under the following names:
Italy: Celecoxib Aurobindo
Portugal: Celecoxib Generis Phar
Spain: Celecoxib Aurovitas 200 mg hard capsules EFG