CELARTROX 100 mg Hard Capsule

Зміст інструкції

1. CELARTROX 100 mg hard capsules, 200 mg hard capsules
   1. What is CELARTROX and what it is used for
   2. What you need to know before taking CELARTROX
   3. How to take CELARTROX
   4. Possible side effects
   5. How to store CELARTROX
   6. Package Contents and Other Information

CELARTROX 100 mg hard capsules, 200 mg hard capsules

Celecoxib
Generic medicine

Read this leaflet carefully before you start taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not 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 CELARTROX is and what it is used for
• 2. What you need to know before you take CELARTROX
• 3. How to take CELARTROX
• 4. Possible side effects
• 5. How to store CELARTROX
• 6. Contents of the pack and other information

1. What is CELARTROX and what it is used for

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

osteoarthritisand ankylosing spondylitis.
CELARTROX contains the active ingredient celecoxib. Celecoxib 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.
Celecoxib works by reducing the production of prostaglandins, thereby reducing pain and
inflammation.

2. What you need to know before taking CELARTROX

CELARTROX has been prescribed for you by your doctor. The following information will help you to get the
best results with CELARTROX. If you have any further questions, ask your doctor or pharmacist.

Do not take CELARTROX
Tell your doctor if any of the following apply to you, as patients in these conditions should not take Celartrox.

• 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 a stomach or intestinal ulcer, or bleeding in the stomach or intestine
• if, after taking acetylsalicylic acid (aspirin) 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 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 had heart disease, confirmed 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 your legs

Warnings and precautions
Talk to your doctor or pharmacist before taking CELARTROX:

• if you have previouslyhad a stomach or intestinal ulcer or bleeding (Do not takeCELARTROXif you have an ongoing stomach or intestinal ulcer or bleeding)
• if you are taking acetylsalicylic acid (aspirin), even at low doses to protect your heart
• if you are using medicines to reduce blood clotting (e.g. warfarin/anticoagulants such as warfarin or new oral anticoagulants, e.g. apixaban)
• if you are using corticosteroids (e.g. prednisone)
• if you are using CELARTROX at the same time as other NSAIDs other than acetylsalicylic acid, such as ibuprofen or diclofenac. Concurrent 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 are not functioning well. Your doctor may want to carry out 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 CELARTROX may mask a fever or other signs of infection and inflammation
• if you are over 65 years of age. Your doctor will want to monitor you regularly.

If you consume alcohol together with NSAIDs as this can increase the risk of gastrointestinal problems.
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 monitor your blood pressure at
regular intervals.
Some cases of serious liver reactions, including severe liver inflammation, liver damage, liver failure (some with fatal outcome or requiring liver transplantation) have been reported with celecoxib. In cases where the time of onset was reported, the most serious liver reactions occurred within one month of starting treatment.
Taking CELARTROX may make it more difficult to become pregnant. You should inform
your doctor if you are planning a pregnancy or if you have problems starting a pregnancy (see
section Pregnancy and breastfeeding).

Other medicines and CELARTROX
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Talk to your doctor if you take:

• 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 and other medicines like warfarin (blood-thinning agents that reduce blood clotting) including new medicines such as apixaban
• lithium (used to treat some types of depression)
• other medicines for treating 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 cancer)
• 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). CELARTROX can be taken with acetylsalicylic acid at low doses (aspirin), 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 or are planning to become pregnant, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
CELARTROX 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 current treatment. If you become pregnant during treatment with CELARTROX, you should
stop treatment and contact your doctor for options for alternative treatment.
Breastfeeding
CELARTROX should not be used during breastfeeding.
Fertility
NSAIDs, including CELARTROX, can make it more difficult to become pregnant. You should inform
your doctor if you are planning a pregnancy or if you have problems starting a pregnancy.

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

CELARTROX contains lactose
If you have been diagnosed with intolerance to some sugars, contact your doctor before
taking this medicine.

3. How to take CELARTROX

Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor or pharmacist. If you think that the effect of CELARTROX is too strong or too weak, talk to your
doctor or pharmacist.
The doctor will tell you which dose to take. Because the risk of undesirable 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 CELARTROX for longer than necessary to
control the symptoms.
CELARTROX is for oral use.
CELARTROX capsules must be swallowed whole with a sufficient amount of water (e.g.
a glass [200 ml]). The capsules can be taken at any time of the day, with or without food.
However, always try to take each dose of celecoxib every day at the same time.
If you do not experience any benefit, contact your doctor within two weeks of starting treatment.

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 to a maximum of 400 mg, if necessary.
The dose is usually:

• one 100 mg capsule twice a day.

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.

Maximum daily dose:
You should not take more than 400 mg of celecoxib per day (4 capsules of CELARTROX 100 mg or 2
capsules of CELARTROX 200 mg).
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.

Use in children
CELARTROX should only be used in adults; it should not be used in children.

If you take more CELARTROXthan you should:
You should not take more capsules than indicated by your doctor. If you take too many capsules, contact
your doctor, pharmacist or hospital and take the medicine with you.

If you forget to take CELARTROX:
If you forget to take a capsule, take it as soon as you remember. Do not take a double dose
to make up for the missed dose.

If you stop taking CELARTROX:
Suddenly stopping treatment with CELARTROX may worsen your symptoms. Do not
stop taking CELARTROX 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 who were
treated with celecoxib. Side effects marked with an asterisk (*) are listed below
with the higher 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 CELARTROX immediately and tell your
doctor immediately if you experience:

• 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 or bloody stools, or vomiting blood
• a skin reaction such as rash, blisters or peeling skin
• liver failure (symptoms may include nausea (feeling unwell), diarrhea, 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 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), stuffy or runny nose, sore throat, cough, cold, flu-like symptoms
• dizziness, difficulty sleeping
• vomiting*, stomach pain, diarrhea, indigestion, gas
• skin rash, itching
• muscle stiffness
• difficulty swallowing*
• headache
• nausea (feeling unwell)
• joint pain
• 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 relating to the liver
• abnormalities in blood test values relating to the kidneys
• anemia (alterations in red blood cells that can cause fatigue and shortness of breath)
• anxiety, depression, fatigue, drowsiness, tingling sensations
• 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 sores in 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 skin rash (urticaria)
• eye inflammation
• difficulty breathing
• alteration of skin color (bruising)
• chest pain (generalized 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 intestine; or rupture of 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 (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 sense of taste
• increased sensitivity to light
• hair loss
• hallucinations
• bleeding in the eye
• acute reaction that can lead to inflammation of the lungs
• irregular heartbeat
• hot flashes
• blood clot in the blood vessels of the lungs. Symptoms may include shortness of breath, sharp pains when breathing or collapse
• bleeding from the stomach or intestines (can lead to blood in the stool or vomit), inflammation of the intestine or colon, nausea
• severe liver inflammation (hepatitis). Symptoms may include nausea (feeling unwell), diarrhea, jaundice (yellowing of the skin and whites of the eyes), dark urine, pale stools, easy bruising, itching or chills
• acute kidney failure
• menstrual disorders
• swelling of the face, lips, mouth, tongue or throat, or difficulty breathing

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

• severe allergic reactions (including potentially life-threatening 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 pustulosis (symptoms include reddened 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 elevated white blood cell count))
• bleeding inside the brain which can be fatal
• meningitis (inflammation of the membrane around the brain and spinal cord)
• liver failure, liver damage and severe inflammation of the liver (fulminant hepatitis) (sometimes fatal or requiring a liver transplant). Symptoms may include nausea (feeling unwell), diarrhea, jaundice (yellowing of the skin and whites of the eyes), dark urine, pale stools, easy bruising, itching or chills
• problems with the liver (such as cholestasis and cholestatic hepatitis, which can be accompanied by symptoms such as discolored stools, nausea and yellowing of the skin or eyes)
• Inflammation of the kidneys and other kidney problems (such as nephrotic syndrome and minimal change disease, which can be accompanied by symptoms such as fluid retention (edema), foamy urine, fatigue and loss of appetite)
• worsening of epilepsy (possible more frequent and/or severe seizures)
• blockage of an artery or vein in the eye leading to partial or complete loss of vision
• inflamed blood vessels (can cause fever, pain, red spots on the skin)
• a reduction in the number of red blood cells, white 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 taste

Not known:frequency cannot be estimated from available data

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

In clinical studies not associated with arthritis or other arthritic conditions, in which celecoxib
was taken at doses of 400 mg per day for up to 3 years, the following side
effects have been observed:
Common: may affect up to 1 in 10 people

• heart problems: angina (chest pain)
• stomach problems: irritable bowel syndrome (may include stomach pain, diarrhea, 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 inner ear problems, 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 cysts (benign lumps on the joints and tendons of the hands and feet or around them), difficulty speaking, abnormal or very heavy vaginal bleeding, breast pain
• elevated 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 CELARTROX

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the blister and the outer packaging
after Exp. 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 wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What CELARTROX contains

• The active ingredient is celecoxib. Each CELARTROX 100 mg hard capsule contains 100 mg of celecoxib. Each CELARTROX 200 mg hard capsule contains 200 mg of celecoxib.
• The other ingredients are: Sodium lauryl sulfate, lactose monohydrate, crospovidone, povidone K29-32, magnesium stearate. The capsule shell contains: titanium dioxide (E171), gelatin, sodium lauryl sulfate. The ink contains: shellac, indigo carmine (E132) (100 mg capsules) or yellow iron oxide (E172) (200 mg capsules).

Description of the appearance of CELARTROX and package contents
CELARTROX 100 mg hard capsules are hard gelatin capsules consisting of an opaque white cap with a blue band and an opaque white body with “100” written in reverse on a blue band, containing granular powder.
CELARTROX 200 mg hard capsules are hard gelatin capsules consisting of an opaque white cap with a yellow band and an opaque white body with “200” written in reverse on a yellow band, containing granular powder.
CELARTROX 100 mg hard capsules are packaged in transparent or opaque white PVC/Aluminum blisters in packs of 20, 60 capsules.
CELARTROX 200 mg hard capsules are packaged in transparent or opaque white PVC/Aluminum blisters in packs of 20, 30 capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder
S.F. Group S.R.L.,
Via Tiburtina, 1143
00156 Rome Italy

Manufacturers
Balkanpharma – Dupnitsa AD
3 Samokovsko Shosse Str., Dupnitza
2600 Bulgaria