Celartrox

Package leaflet: Information for the patient

CELARTROX 100 mg hard capsules, 200 mg hard capsules

Celecoxib
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 other people, 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:

1. What CELARTROX is 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. Contents of the pack and other information

1. What CELARTROX is and what it is used for

CELARTROX is used in adults for the relief of signs and symptoms of rheumatoid arthritis,
osteoarthritis, and ankylosing spondylitis.
CELARTROX contains the active substance celecoxib. Celecoxib 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 prostaglandins.
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 information below will help you get the best results with CELARTROX. If you have any further questions, please ask your doctor or pharmacist.
Do not take CELARTROX
Inform your doctor if any of the following conditions apply to you, as patients in these conditions must not take Celartrox.

• 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 (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 treatment, 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 had heart disease, confirmed ischemic heart disease or cerebrovascular disease, e.g. 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 the blood vessels supplying 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 in your legs

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

• if you have previously had a stomach or intestinal ulcer or bleeding ( Do not take CELARTROX if you have a current stomach or intestinal ulcer or bleeding)
• if you are taking acetylsalicylic acid (aspirin), even at low doses for heart protection
• if you are taking medicines to reduce blood clotting (e.g. warfarin/anticoagulants such as warfarin or new oral anticoagulants, e.g. apixaban)
• if you are taking 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. The combined 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 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 serious skin reaction to any medicine
• if you are unwell due to an infection or think you may have an infection, as CELARTROX may mask fever or other signs of infection and inflammation
• if you are over 65 years of age. Your doctor may want to monitor you regularly.

Avoid alcohol consumption while taking NSAIDs, as this 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, so 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 the onset time was reported, the most severe 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 difficulty becoming pregnant (see section Pregnancy and breastfeeding).
Other medicines and CELARTROX
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Talk to your doctor if you are taking:

• 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 and other medicines like 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 cancer)
• 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). CELARTROX may be taken with low-dose acetylsalicylic acid (aspirin), 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 a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
CELARTROX 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 treatment. If you become pregnant while being treated with CELARTROX, you must stop treatment and contact your doctor to discuss alternative treatment options.
Breastfeeding
CELARTROX must not be used during breastfeeding.
Fertility
NSAIDs, including CELARTROX, 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, assess how you react to CELARTROX. If you experience dizziness or drowsiness after taking CELARTROX, do not drive or operate machinery until these effects have passed.
CELARTROX contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

3. How to take CELARTROX

Always take this medicine exactly as instructed by 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, discuss it with your doctor or pharmacist.
Your doctor will tell you what dose to take. Since the risk of unwanted effects related to heart problems may increase with dose and duration of use, it is important to use the lowest dose needed to control your pain. You must not take CELARTROX for longer than necessary to control your 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 may be taken at any time of day, with or without food. However, always try to take each dose of celecoxib at the same time every day.
If you do not experience any benefit, contact your doctor within two weeks of starting treatment.

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

• one 100 mg capsule twice daily.

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.

Maximum daily dose:
You must 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
Ensure that 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.

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

If you take more CELARTROX 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 immediately and bring 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 forgotten 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. Your doctor may instruct you to gradually reduce the dose over several days before stopping treatment completely.

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 were being treated with celecoxib. Side effects marked with an asterisk (*) are listed below according to the highest frequency observed 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 of time.
Stop taking CELARTROX immediately and contact your doctor immediately if you experience:

• an allergic reaction such as skin rash, facial swelling, 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 swelling of the 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, diarrhoea, indigestion, flatulence
• 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 (awareness of heartbeat), rapid heartbeat
• abnormal results in liver function blood tests
• abnormal results in kidney function blood tests
• anaemia (changes in red blood cells which may cause tiredness and shortness of breath)
• anxiety, depression, fatigue, drowsiness, tingling sensations
• 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
• itchy, raised skin rash (urticaria)
• eye inflammation
• difficulty breathing
• changes in skin colouration (bruising)
• chest pain (generalised pain not related to the heart)
• facial swelling

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

• ulcers (bleeding) in the stomach, oesophagus or intestines; or intestinal perforation (may cause pain, fever, nausea, vomiting, bowel obstruction), black or tarry stools, inflammation of the pancreas (may lead to stomach pain), inflammation of the oesophagus (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 in the eye
• acute reaction that may lead to lung inflammation
• irregular heartbeat
• hot flushes
• blood clot in the blood vessels of the lungs. Symptoms may include shortness of breath, sharp pain when breathing or collapse
• bleeding from the stomach or intestines (may lead to bloody stools or vomiting), inflammation of the intestine or colon, nausea
• severe liver inflammation (hepatitis). Symptoms may include nausea (feeling unwell), diarrhoea, jaundice (yellowing of the skin and whites of the eyes), dark urine, pale stools, easy bleeding, 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 fatal anaphylactic shock)
• severe skin conditions such as Stevens-Johnson syndrome, exfoliative dermatitis and toxic epidermal necrolysis (may cause rash, blisters or peeling of the skin) and acute generalized exanthematous pustulosis (symptoms include reddened skin with swollen areas covered with numerous small pustules)
• delayed allergic reaction with possible symptoms such as rash, facial swelling, fever, swollen glands and abnormal test results (e.g. liver, blood cells (eosinophilia, a type of elevated white blood cell count))
• bleeding within the brain which may be fatal
• 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 and whites of the 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 pale stools, nausea and yellowing of the skin or eyes)
• kidney inflammation and other kidney problems (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 (possibly more frequent and/or severe epileptic seizures)
• blockage of an artery or vein in the eye leading to partial or complete loss of vision
• inflamed blood vessels (may cause fever, pain, red spots on the skin)
• reduced number of red and white blood cells and platelets (may cause fatigue, increased tendency to bruise, 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, 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 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, flatulence)
• kidney stones (may 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 may cause calf pain or redness, or breathing problems)
• stomach problems: stomach infection (which may cause irritation and ulcers in the stomach and intestines)
• lower limb fractures
• herpes, skin infection, eczema (rash with dry, itchy skin), pneumonia (lung inflammation (possible cough, fever, difficulty breathing))
• eye deposits 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 heavy vaginal bleeding, breast pain
• elevated sodium levels in blood test results

Reporting of side effects
If you get 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: 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 stated on the blister and outer carton
after Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 CELARTROX contains

• The active substance 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 components are: Sodium lauryl sulfate, monohydrate lactose, crospovidone, povidone K29-32, magnesium stearate. The capsule shell contains: titanium dioxide (E171), gelatin, sodium lauryl sulfate. The printing 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" printed 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" printed in reverse on a yellow band, containing granular powder.
CELARTROX 100 mg hard capsules are packaged in PVC/aluminum blisters, transparent or opaque white, in pack sizes of 20, 60 capsules.
CELARTROX 200 mg hard capsules are packaged in PVC/aluminum blisters, transparent or opaque white, in pack sizes 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., Dupnitsa
2600 Bulgaria