CELECOXIB 200 mg Hard Capsules

Зміст інструкції

1. Celecoxib Aurobindo 200 mg capsule
   1. What is Celecoxib Aurobindo and what it is used for
   2. What you need to know before taking Celecoxib Aurobindo
   3. How to take Celecoxib Aurobindo
   4. Possible side effects
   5. How to store Celecoxib Aurobindo
   6. Package Contents and Other Information

Celecoxib Aurobindo 200 mg capsule

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 they have the same symptoms as you, 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 Aurobindo is and what it is used for
• 2. What you need to know before you take Celecoxib Aurobindo
• 3. How to take Celecoxib Aurobindo
• 4. Possible side effects
• 5. How to store Celecoxib Aurobindo
• 6. Contents of the pack and other information

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

Celecoxib Aurobindo is used in adults for the relief of signs and symptoms of rheumatoid arthritis,

osteoarthritisand ankylosing spondylitis.
Celecoxib Aurobindo belongs to a group of medicines called non-steroidal anti-inflammatory drugs
(NSAIDs), and more precisely a subgroup known as “COX-2 inhibitors”. Your body
produces prostaglandins which can cause pain and inflammation. In some conditions such as rheumatoid
arthritis and osteoarthritis, your body produces a greater amount of them. Celecoxib Aurobindo works
by reducing the production of prostaglandins, thereby reducing pain and inflammation.
You can expect the medicine to start to have an effect within a few hours of taking the first dose,
but you may not feel a complete effect for several days.

2. What you need to know before taking Celecoxib Aurobindo

Do not take Celecoxib Aurobindo

• if you are allergic to celecoxib or 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 “sulphonamides” (e.g. some antibiotics used to treat infections);
• if you currentlysuffer from an ulcer in the stomach or intestine, or bleeding in the stomach or intestine;
• 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 wheezing;
• if you are pregnant. If there is a possibility that you may become pregnant during the current treatment, you should discuss possible contraceptive methods with your doctor;
• if you are breastfeeding;
• if you have a severe liver disease;
• if you have a severe kidney disease;
• if you have an inflammatory bowel disease such as ulcerative colitis or Crohn's disease;
• if you have heart failure, established ischaemic heart disease or cerebrovascular disease, e.g. if you have been diagnosed with a heart attack, stroke or transient ischaemic attack (a temporary reduction in blood flow to the brain; also known as “mini-stroke”), angina or blockage of the blood vessels leading to the heart or brain;
• if you have or have had problems with blood circulation (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 Aurobindo:

• if you have previously had an ulcer or bleeding in the stomach or intestine. (Do not take Celecoxib Aurobindo if you have an ongoing ulcer or bleeding in the stomach or intestine);
• if you are taking acetylsalicylic acid (even at low doses to protect the heart);
• if you are using medicines to reduce blood clotting (e.g. warfarin/similar anticoagulants to warfarin or new oral anticoagulants, e.g. apixaban);
• if you are using medicines called corticosteroids (e.g. prednisone);
• if you are using Celecoxib Aurobindo at the same time as other NSAIDs other than acetylsalicylic acid such as ibuprofen or diclofenac. The concurrent use of these medicines should be avoided;
• if you smoke, have diabetes, high blood pressure or high levels of cholesterol;
• if your heart, liver or kidneys are not functioning well, your doctor may subject you to regular checks;
• if you suffer from 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 had a severe allergic reaction or a severe skin reaction to any medicine;
• if you are unwell because of an infection or think you have an infection, as Celecoxib Aurobindo may mask a fever or other signs of infection and inflammation;
• if you are over 65 years of age, your doctor will subject you to regular checks;
• the consumption of alcohol and NSAIDs may increase the risk of gastrointestinal problems.

As with other NSAIDs (e.g. ibuprofen or diclofenac) this medicine may lead to an increase in
blood pressure and therefore your doctor may ask you to monitor your blood pressure at regular
intervals.
Some cases of serious liver reactions, including severe hepatitis, liver damage, and liver failure (some with fatal outcome or requiring liver transplantation) have been reported with celecoxib. In cases where
the time to onset was reported, the most serious liver reactions occurred within one month
of the start of 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 have problems getting 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 medicine:

• dextromethorphan (used to treat cough)
• ACE inhibitors, angiotensin II receptor 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-thinning agents that reduce blood clotting) including new medicines such as apixaban
• lithium (used to treat some types of depression)
• other medicines to treat depression, sleep disorders, high blood pressure or an irregular heartbeat
• neuroleptics (used to treat some mental disorders)
• methotrexate (used to treat rheumatoid arthritis, psoriasis and leukaemia)
• carbamazepine (used to treat epilepsy/seizures and some forms of pain or depression)
• barbiturates (used to treat epilepsy/seizures and some sleep disorders)
• cyclosporine and tacrolimus (used for suppression of the immune system e.g. after transplants).

Celecoxib Aurobindo can be taken with acetylsalicylic acid at low doses (75 mg or less per day).
Ask your doctor for advice before taking the two medicines together.

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

Pregnancy
Celecoxib Aurobindo 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 contraception) during the
course of treatment. If you become pregnant while taking Celecoxib Aurobindo, you should stop the
treatment and contact your doctor for alternative treatment.

Breastfeeding
Celecoxib Aurobindo should not be used during breastfeeding.

Fertility
NSAIDs, including Celecoxib Aurobindo, may make it more difficult to become pregnant. You should inform your
doctor if you are planning a pregnancy or if you have problems getting pregnant.

Driving and using machines
Before driving or using machines you must see how you react to Celecoxib Aurobindo. If you experience
dizziness or drowsiness after taking Celecoxib Aurobindo, do not drive or use machines until
these effects have worn off.

Celecoxib Aurobindocontains lactose. If your doctor has told you that you have an intolerance to some sugars,
contact him/her before taking this medicine.

3. How to take Celecoxib Aurobindo

Take this medicine following the doctor's instructions exactly. If you have any doubts, consult your
doctor or pharmacist.
The doctor will tell you which dose you should take. Because the risk of side effects associated with heart
problems may increase with the dose and duration of use, it is important that you use the lowest dose necessary to
control the pain. You should not take Celecoxib Aurobindo for longer than necessary to control
your symptoms.
Celecoxib Aurobindo is not suitable for doses <200 mg/day. Other medicinal specialties containing
celecoxib are available at the appropriate doses.

Method of administration
Celecoxib Aurobindo is for oral use. The capsules can be taken at any time of the day,
with or without food. However, try to take each dose of celecoxib Aurobindo at the same time each day.
If you have difficulty swallowing the capsules: the entire contents of the capsule can be sprinkled on a spoonful
of semi-solid food (such as apple sauce, rice pudding, yogurt or mashed banana, cold or at room
temperature) and swallowed immediately with approximately 240 ml of water.
To open the capsule, hold it upright to keep the granules at the bottom, then remove the
upper part by twisting it with slight pressure, being careful 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 osteoarthritisthe recommended dose is 200 mg per day, which may be increased by the 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 a day.

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

• one 100 mg capsule twice a day.

If the prescribed dose cannot be obtained with this dosage of medicine, other
strengths of this medicine are available to obtain the dose. Consult your doctor.

For ankylosing spondylitisthe recommended dose is 200 mg per day, which may be increased by the
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 a day.

Liver or kidney problems:make sure your doctor knows if you have liver or kidney problems as you
may need a lower dose.

Elderly patients, especially 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.

You should not take more than 400 mg per day.
Use in children:Celecoxib Aurobindo should only be used in adults; it should not be used in
children.

If you take more Celecoxib Aurobindothan you should
Do not take more capsules than indicated by your doctor. If you take too many capsules, contact your doctor, your
pharmacist or the hospital and take 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
make up for a missed dose.

If you stop taking Celecoxib Aurobindo
Suddenly stopping treatment with Celecoxib Aurobindo may worsen your symptoms.
Do not stop taking Celecoxib Aurobindo unless your doctor tells you to do so. Your doctor
may tell you to reduce the dose over a few days before stopping treatment completely.
If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

• an allergic reaction such as skin rash, swelling of the face, shortness of breath 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 stools containing blood, or vomiting blood;
• a skin reaction such as rash, blisters or peeling 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 already 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 of the sinuses, sinus infection, blocked or painful sinuses), runny or stuffy nose, sore throat, cough, cold, flu-like symptoms
• dizziness, difficulty sleeping
• vomiting*, stomach pain, diarrhoea, indigestion, gas
• skin 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 (feeling of a racing heartbeat), fast heartbeat
• abnormalities in blood test values related to the liver
• abnormalities in blood test values related to the kidneys
• anaemia (alterations in red blood cells that can cause fatigue and shortness of breath)
• anxiety, depression, fatigue, dizziness, tingling sensations (pins and needles sensation)
• high levels of potassium in blood test results (can cause nausea (feeling unwell), fatigue, muscle weakness or palpitations)
• impaired or blurred vision, ringing in the ears, pain and injury to the mouth, difficulty hearing*
• constipation, belching, inflammation of the stomach (indigestion, stomach pain or vomiting), worsening of inflammation in the stomach or intestines
• leg cramps
• itchy, raised rash (urticaria)
• eye inflammation
• difficulty breathing
• alteration of 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, esophagus or intestines; or injury to the intestine (can cause pain, fever, nausea, vomiting, bowel obstruction), black or tarry stools, inflammation of the pancreas (can lead to stomach pain), inflammation of the esophagus (the esophagus can cause difficulty swallowing)
• low levels of sodium in the blood (a condition known as hyponatremia)
• 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
• feeling confused, altered taste
• increased sensitivity to light
• hair loss
• hallucinations
• bleeding from the eye
• acute reaction that can lead to inflammation of the lungs
• 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 intestines (can lead to blood in the 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 bruising, 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)
• severe skin conditions such as Stevens-Johnson syndrome, exfoliative dermatitis and toxic epidermal necrolysis (can cause rash, blisters or peeling skin) and acute generalized exanthematous pustulosis (symptoms include redness of the skin with swollen areas covered with numerous small pustules)
• a 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 inside 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 a liver transplant). Symptoms may include nausea (feeling unwell), diarrhoea, jaundice (yellowing of the skin or eyes), dark urine, pale stools, easy bruising, itching or chills.
• Problems with the liver (such as cholestasis and cholestatic hepatitis, which may be accompanied by symptoms such as fluid retention (edema), 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 that can lead to partial or complete vision loss
• Inflamed blood vessels (can cause fever, pain, red spots on the skin)
• A reduction in the number of white blood cells and red blood cells and platelets (can cause fatigue, bruising more easily, frequent nosebleeds and increased risk of infection)
• Muscle pain and weakness
• Impaired sense of smell
• Loss of sense of taste

Frequency not known:the frequency cannot be estimated from the available data

• Reduced fertility in women, usually reversible with discontinuation of the drug.

In clinical studies not related to arthritis or other arthritic conditions, in which celecoxib was taken at
doses of 400 mg per day 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 pain, diarrhoea, indigestion, gas)
• kidney stones (which can lead to stomach or back pain, blood in the 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 can cause pain or redness of the calf or problems breathing)
• stomach problems: stomach infection (which can cause irritation and ulcers in the stomach and intestines)
• fracture of the lower limbs
• herpes, skin infection, eczema (rash with dry and itchy skin), pneumonia (inflammation of the chest (possible cough, fever, difficulty breathing))
• corpuscles in the eye causing blurred or impaired vision, dizziness due to problems with the inner ear, injury, inflamed or bleeding gums, mouth sores
• excessive urination at night, blood from hemorrhoids, frequent bowel movements
• fatty lumps on the skin or elsewhere, ganglion cyst (benign bumps on the joints and tendons of the hands and feet or around them), 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, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the Italian
Medicines Agency 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 the carton after EXP. The
expiry date refers to the last day of that month.
Store at a temperature below 30°C.
Do not dispose of any medicine in waste water 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 ingredient is celecoxib. Each capsule contains 200 mg of celecoxib.
• The other ingredients are: Capsule content: Lactose monohydrate, hydroxypropyl cellulose, crospovidone (Type B) (E1202), sodium lauryl sulfate (E487), povidone (K-30) (E1201), sodium stearyl fumarate. Capsule shell: titanium dioxide (E171), gelatin (E441).

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

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

Marketing Authorisation 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 authorised in the Member States of the European Economic Area with the following
denominations:
Italy: Celecoxib Aurobindo
Portugal: Celecoxib Generis Phar
Spain: Celecoxib Aurovitas 200 mg hard capsules EFG