Celecoxib Zentiva: detailed information

Package leaflet: Information for the user

Celecoxib Zentiva 200 mg hard capsules

Equivalent 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 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, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Celecoxib Zentiva is used in adults to relieve the signs and symptoms of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis.
Celecoxib Zentiva belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), and specifically to a subgroup known as cyclooxygenase-2 (COX-2) inhibitors.
The body produces prostaglandins, which can cause pain and inflammation. In conditions such as rheumatoid arthritis and osteoarthritis, the body produces higher levels of prostaglandins. Celecoxib Zentiva works by reducing the production of prostaglandins, thereby reducing pain and inflammation.
You should expect the medicine to start working within a few hours of taking the first dose, but it may take several days to achieve the full effect.

2. What you need to know before taking Celecoxib Zentiva

Celecoxib Zentiva has been prescribed by your doctor. The information below will help you get the best results with Celecoxib Zentiva. If you have any further questions, please ask your doctor or pharmacist.
Do not take Celecoxib Zentiva:

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” (such as 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 and pain-relieving medicines ( NSAIDs ) you have experienced asthma, nasal polyps, severe nasal congestion, or an allergic reaction such as itchy rash, swelling of the face, lips, tongue or throat, difficulty breathing or shortness of breath,
if you are pregnant. If you could become pregnant during treatment, you should discuss with your doctor an alternative method of contraception,
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 problems, heart failure, confirmed cardiac ischemia or cerebrovascular disorders, for example if you have been diagnosed with a heart attack, stroke, or transient ischemic attack (temporary reduction in blood flow to the brain; also known as “mini-stroke”), angina pectoris, or blockage of the blood vessels supplying the heart or brain,
if you have or have had circulatory problems (peripheral arterial disease), or if you have undergone surgical procedures on the arteries of the legs.

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

if you have previously had ulcers or bleeding in the stomach or intestines ( do not take Celecoxib Zentiva 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 antiplatelet medicines,
if you are taking medicines to reduce blood clotting (such as warfarin / oral anticoagulants like warfarin or new oral anticoagulant medicines, e.g. apixaban),
if you are taking corticosteroid medicines (e.g. prednisone),
if you are using Celecoxib Zentiva at the same time as other non-steroidal anti-inflammatory drugs (NSAIDs) not containing 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,
if your heart, liver or kidneys do not function properly, your doctor may decide to monitor you regularly,
if you have fluid retention (such as swelling in the ankles and feet),
if you are dehydrated, for example due to illness, diarrhoea, or use of diuretics (used to treat excess fluid in the body),
if you have had severe allergic reactions or serious skin reactions to any medicine,
if you feel unwell due to infections or think you may have an infection, as Celecoxib Zentiva may mask fever or signs of infection and inflammation,
if you are over 65 years of age, your doctor will decide whether to monitor you.
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, so your doctor may ask you to monitor your blood pressure regularly.
Serious liver reactions, including severe hepatitis, liver damage, and liver failure (some fatal or requiring liver transplantation), have been reported with celecoxib. The most severe liver reactions reported occurred within one month of starting treatment.
Celecoxib Zentiva 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 on Pregnancy, breastfeeding and fertility).

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

Dextromethorphan (used to treat cough),
ACE inhibitors or angiotensin II antagonists, beta-blockers, and diuretics (e.g. used for high blood pressure or heart failure),
Fluconazole and rifampicin (used to treat fungal and bacterial infections),
Warfarin or other medicines like warfarin (“blood thinners” that reduce blood clotting), including newer agents such as apixaban, dabigatran, and rivaroxaban,
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, 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 transplantation).

Celecoxib Zentiva may be taken with a low dose of acetylsalicylic acid (75 mg or less per day). Talk to your doctor to inform them that you are taking both medicines together.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Celecoxib Zentiva must not be used in pregnant women or in women who may become pregnant (i.e. women who are potentially fertile and not using an adequate contraceptive method) during treatment.
If you become pregnant while being treated with Celecoxib Zentiva, you must stop treatment and contact your doctor for an alternative treatment.

Breastfeeding
Celecoxib Zentiva must not be used during breastfeeding.

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

Driving and using machines
Before driving or operating machinery, make sure you know how you react to Celecoxib Zentiva.
If you feel dizzy or drowsy after taking Celecoxib Zentiva, do not drive or operate machinery until these effects have disappeared.

Celecoxib Zentiva contains lactose monohydrate (a type of sugar) and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, please consult them before taking this medicine. This medicine contains less than 1 mmol of sodium (23 mg) per capsule, i.e. essentially “sodium-free”.

3. How to take Celecoxib Zentiva

Take this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist. If you think or feel that the effect of Celecoxib Zentiva is too strong or too weak, speak to your doctor or pharmacist.
Your doctor will tell you what dose to take. Since the risk of heart-related side effects may increase with dose and duration of treatment, it is important to use the lowest effective dose needed to control your pain, and you should not take Celecoxib Zentiva longer than necessary to control your symptoms.
When a 100 mg dose is recommended, an alternative medicine containing celecoxib should be used. Contact your doctor.

Method of administration
Celecoxib Zentiva is for oral use only.
Celecoxib Zentiva capsules should be swallowed whole with a glass of water. The capsules may be taken at any time of day, with or without food. However, try to take each dose of Celecoxib Zentiva at the same time every day.
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 daily, increased by your doctor to 400 mg if necessary.
The usual dose is:

one 200 mg capsule once daily

For rheumatoid arthritis, the recommended dose is 200 mg daily (divided into two doses), increased by your doctor to a maximum dose of 400 mg (divided into two doses), if necessary.
The usual dose is:

one 100 mg capsule twice daily
the 200 mg dose (taken as one 100 mg capsule twice daily) cannot be achieved with Celecoxib Zentiva 200 mg hard capsules. Consult your doctor.

For ankylosing spondylitis, the recommended dose is 200 mg daily, increased by your doctor to a maximum dose of 400 mg, if necessary.
The usual dose is:

one 200 mg capsule once daily

Kidney or liver problems: make sure your doctor is aware of any kidney or liver problems you have, as a lower dose may be required.
Elderly patients, especially those weighing less than 50 kg: if you are over 65 years of age and especially weigh less than 50 kg, your doctor may monitor you more closely.
Do not take more than 400 mg per day.

Use in children: Celecoxib Zentiva is for adults only and is not intended for use in children.

If you take more Celecoxib Zentiva than you should
Do not take more capsules than your doctor has prescribed. If you take too many capsules, contact your doctor, pharmacist, or go to hospital, and bring the medicine with you.

If you forget to take Celecoxib Zentiva
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 Celecoxib Zentiva
Suddenly stopping treatment with Celecoxib Zentiva may lead to a worsening of your symptoms. Do not stop taking Celecoxib Zentiva unless your doctor tells you to do so.
Your doctor may advise you to gradually reduce the dose a few days before completely stopping.

If you have any questions about how to use 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 taking
Celecoxib. The side effects listed below marked with an asterisk (*) occurred at higher frequencies
in patients taking Celecoxib to prevent colon polyps. Patients in these studies took Celecoxib at higher doses and for longer durations.
If you experience any of the side effects listed below, stop taking
Celecoxib Zentiva and contact your doctor immediately.
If you have:

An allergic reaction such as skin rash, swelling of the face, difficulty breathing or wheezing,
Heart problems such as chest pain,
Severe stomach pain or any signs of bleeding in the stomach or intestines, such as passing dark or bloody stools or vomiting blood,
A skin reaction such as rash, blistering 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 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 (sinus inflammation, sinus infection, sinus pain or blockage), runny or blocked nose, sore throat, cough, cold, flu-like symptoms,
Dizziness, difficulty sleeping,
Vomiting*, stomach pain, diarrhoea, indigestion, flatulence,
Rash, itching,
Muscle stiffness,
Difficulty swallowing*,
Headache,
Nausea (feeling unwell),
Joint pain,
Worsening of an existing allergy,
Accidental injuries.

Uncommon: may affect up to 1 in 100 people:

Stroke*,
Heart failure, palpitations (feeling your heart beat), rapid heartbeat,
Abnormal liver function, abnormal liver blood tests,
Abnormal kidney blood tests,
Anaemia (changes in red blood cells which may cause tiredness and breathlessness),
Anxiety, depression, fatigue, drowsiness, tingling sensation (pins and needles),
High levels of potassium in blood tests (which may cause nausea (feeling unwell), fatigue, muscle weakness or palpitations),
Blurred or impaired vision, ringing in the ears, mouth pain and congestion, hearing difficulties*,
Constipation, belching, stomach inflammation (indigestion, stomach pain or vomiting), worsening of stomach or intestinal inflammation,
Leg cramps,
Increased itching (urticaria),
Eye inflammation,
Difficulty breathing,
Changes in skin colour (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 intestine; or intestinal hernia (which may cause stomach pain, fever, nausea, vomiting, intestinal blockage), dark or black stools, pancreatitis (which may cause stomach pain), oesophagitis,
Low levels of sodium in the blood (a condition known as hyponatraemia),
Reduction in the number of white blood cells (which help protect the body from infections) or platelets (increased bleeding or bruising),
Difficulty coordinating muscle movements,
Feeling confused, changes in taste,
Increased sensitivity to light,
Hair loss,
Hallucinations,
Blood in the eyes,
Acute reaction that may lead to lung inflammation,
Irregular heartbeat,
Hot flushes,
Blood clots in the veins of the legs. Symptoms may include sudden breathlessness, sharp pains when breathing or collapse,
Bleeding in the stomach or intestines (which may lead to bloody stools or vomiting), 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 or chills,
Acute kidney failure,
Changes in menstrual cycle,
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 life-threatening anaphylactic shock),
Severe skin conditions such as Stevens-Johnson syndrome, exfoliative dermatitis and toxic epidermal necrolysis, erythema multiforme and blistering rash (may cause skin rash, blisters, peeling of the skin) and acute generalized exanthematous pustulosis (symptoms include reddening of the skin with swollen areas covered with small and numerous pustules),
Delayed allergic reaction with possible symptoms such as skin rash, facial swelling, fever, swollen glands, and abnormal test results (e.g. liver or blood cell counts (eosinophilia, a specific type of increase in white blood cell count)),
Bleeding in the brain causing death,
Meningitis (inflammation of the membranes surrounding 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 or cholestatic hepatitis which may be accompanied by symptoms such as change in stool colour, nausea and yellowing of the skin or eyes),
Kidney inflammation or kidney problems (such as nephrotic syndrome and minimal change disease, which may be accompanied by symptoms such as water retention (oedema), foamy urine, fatigue and loss of appetite),
Worsening of epilepsy (possible worsening of seizures or more frequent 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, purple spots on the skin),
Reduction in the number of red and 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

Decrease in female fertility, which is usually reversible upon discontinuation of the medicine.
In clinical studies not related to arthritis or other arthritic conditions, where Celecoxib Zentiva was taken at a dose 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 pectoris (chest pain),
Stomach problems: irritable bowel syndrome (may include stomach pain, diarrhoea, indigestion, flatulence),
Kidney stones (which may cause stomach or back pain, blood in urine), difficulty urinating, elevated blood creatinine levels (indicative of kidney failure),
Weight gain,
Benign prostatic hyperplasia (enlargement of the prostate).

Uncommon: may affect up to 1 in 100 people

Deep vein thrombosis (usually blood clots in the legs, which may cause pain, swelling or redness in the calf or breathing problems),
Stomach problems: stomach infections (which may cause irritation or ulcers in the stomach and intestines),
Fractures of the lower limbs,
Shingles, skin infections, eczema (dry, itchy rash), pneumonia (chest infections (possible cough, fever, breathing difficulties)),
Foreign body sensation in the eyes causing blurred or impaired vision, blood in the eyes, vertigo caused by inner ear disorder, congestion, inflammation or bleeding of the gums, mouth pain,
Excessive nighttime urination, bleeding haemorrhoids, frequent bowel movements,
Fat deposits in the skin or elsewhere, ganglion cysts (swelling on or around joints and tendons of the hands and feet), difficulty speaking, abnormal or heavy vaginal bleeding, breast pain,
High levels of sodium as a result of blood tests,
Allergic dermatitis (skin allergic reactions).

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
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 Celecoxib Zentiva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
Store below 30°C. Keep in the original packaging to protect the medicine from moisture.
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 Zentiva contains
The active substance is celecoxib. One capsule contains 200 mg of celecoxib.
The other components are monohydrate lactose, povidone 40, sodium croscarmellose, sodium lauryl sulfate, magnesium stearate. The capsule shell contains gelatin, titanium dioxide (E171), and the capsule cap contains gelatin, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172). The capsule ink contains shellac, propylene glycol, strong ammonia solution (E527), potassium hydroxide, black iron oxide (E172).

Description of the appearance of Celecoxib Zentiva and package contents
Celecoxib Zentiva 200 mg are opaque size "1" hard capsules with a white body and yellow cap, printed "200" in black on the body, filled with white or almost white granular powder.
Transparent PVC/PVDC/Al blister, thermo-sealed.
Pack sizes:
10, 20, 30, 40, 50, 60 and 100 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zentiva Italia S.r.l. - Via P. Paleocapa 7, 20121 Milan, Italy

Manufacturer
Saneca Pharmaceuticals a.s.
Nitrianska 100, 920 27 Hlohovec
Slovak Republic
ZENTIVA, k.s.
U kabelovny 130, Dolní Měcholupy, 102 37 Prague 10
Czech Republic

This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Czech Republic, Germany, Italy, Lithuania, Latvia, Portugal, France: Celecoxib Zentiva
Romania, Bulgaria: Algoxib
United Kingdom (Northern Ireland): Celecoxib