CELECOXIB KRKA 200 mg HARD CAPSULES

2. What you need to know before you take Celecoxib Krka

Your doctor has prescribed Celecoxib Krka for you. The following information will help you get better results with Celecoxib Krka. If you have any other questions, please ask your doctor or pharmacist.

Do not take Celecoxib Krka

Tell your doctor if any of the following applies to you, as patients with these conditions should not take Celecoxib Krka:

• if you are allergic to celecoxib or any of the other ingredients of this medicine (listed in section 6)
• if you have had any allergic reaction to any medicine of the group called "sulfonamides" (e.g. some antibiotics used to treat infections)
• if you currently have a stomach or intestinal ulcer or bleeding, or bleeding in the stomach or intestines
• if you have previously experienced any of the following symptoms after taking acetylsalicylic acid or any other anti-inflammatory medicine: asthma, nasal polyps, severe nasal congestion, or allergic symptoms such as skin rash with itching, swelling of the face, lips, tongue, or throat, difficulty breathing or wheezing
• if you are pregnant. If you can become pregnant during treatment, you should discuss the use of contraceptive methods with your doctor
• if you are breast-feeding
• if you have severe liver disease
• if you have severe kidney disease
• if you have inflammatory bowel disease such as ulcerative colitis or Crohn's disease
• if you have heart failure, diagnosed ischemic heart disease, or cerebrovascular disease, e.g. 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 obstruction of the blood vessels to the heart or brain
• if you have or have had circulation problems (peripheral arterial disease) or if you have had surgery on the arteries in your legs

Warnings and precautions

Consult your doctor or pharmacist before starting to take Celecoxib Krka:

• if you have previously had a stomach or intestinal ulcer or bleeding
• (Do not take Celecoxib Krkaif you currently have a stomach or intestinal ulcer or bleeding)
• if you are taking medicines to reduce blood clotting (e.g. warfarin/other warfarin-like anticoagulants or new oral anticoagulants, e.g. apixaban)
• if you are taking corticosteroid medicines (e.g. prednisone)
• if you are taking acetylsalicylic acid (even at low doses as a heart protector)
• if you are taking antiplatelet therapies
• if you are taking medicines to reduce blood clotting (e.g. warfarin)
• if you are taking Celecoxib Krka at the same time as other non-acetylsalicylic NSAIDs such as ibuprofen or diclofenac. The combined use of these medicines should be avoided.
• if you are a smoker, have diabetes, high blood pressure, or high cholesterol
• if your heart, liver, or kidneys are not working properly, your doctor may want to monitor you regularly
• if you have fluid retention (such as swollen feet or ankles)
• if you are dehydrated, for example, due to an illness with vomiting, diarrhea, or due to the 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 feel unwell due to an infection or think you have an infection, as taking Celecoxib Krka may mask fever or other signs of infection and inflammation
• if you are over 65 years old, your doctor may want to monitor you regularly.
• the consumption of alcohol and NSAIDs can increase the risk of gastrointestinal problems

As with other anti-inflammatory medicines (e.g. ibuprofen or diclofenac), this medicine may increase your blood pressure, so your doctor may perform periodic blood pressure checks.

Some cases of severe liver reactions have been reported with celecoxib, including severe liver inflammation, liver damage, liver failure (some with a fatal outcome or requiring liver transplantation). Of the cases where it was reported when the event started, most severe liver reactions occurred within the first month of treatment.

Celecoxib Krka may make it more difficult to become pregnant. You should inform your doctor if you plan to become pregnant or if you are having difficulty becoming pregnant (see section Pregnancy and breast-feeding).

Other medicines and Celecoxib Krka

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines:

• Dextromethorphan (used to treat cough)
• ACE inhibitors or angiotensin II receptor antagonists, beta-blockers, and diuretics (medicines used to treat high blood pressure and heart failure)
• Fluconazole and rifampicin (used to treat bacterial and fungal infections)

• Warfarin or other warfarin-like anticoagulants (agents that reduce blood clot formation), including newer medicines such as apixaban

• Lithium (used to treat some types of depression)
• Other medicines used to treat depression, sleep disorders, high blood pressure, or irregular heartbeat
• Neuroleptics (used to treat some mental disorders)
• Methotrexate (used in rheumatoid arthritis, psoriasis, and leukemia)
• Carbamazepine (used to treat epilepsy/seizures and some forms of pain or depression)
• Barbiturates (used to treat epilepsy/seizures and some sleep disorders)
• Ciclosporin and tacrolimus (used to suppress the immune system, e.g. after transplants)

Celecoxib Krka can be taken with low doses of acetylsalicylic acid (75 mg daily or less). Ask your doctor for advice before taking both medicines together.

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Celecoxib Krka should not be used by pregnant women or women who may become pregnant (i.e. women of childbearing potential who are not using an adequate contraceptive method) during treatment. If you become pregnant during treatment with Celecoxib Krka, you should stop treatment and contact your doctor for alternative treatment.

Breast-feeding

Celecoxib Krka should not be used during breast-feeding.

Fertility

NSAIDs, including Celecoxib Krka, may make it more difficult to become pregnant. You should inform your doctor if you plan to become pregnant or if you are having difficulty becoming pregnant.

Driving and using machines

You should know how you react to Celecoxib Krka before driving or using machinery. If you feel dizzy or drowsy after taking Celecoxib Krka, do not drive or operate machinery until these effects have passed.

Celecoxib Krka contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; this is essentially "sodium-free".

3. How to take Celecoxib Krka

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. If you think the effect of celecoxib is too strong or too weak, talk to your doctor or pharmacist.

Your doctor will tell you what dose to take. Since the risk of side effects associated with heart problems may increase with the dose and duration of treatment, it is important to use the lowest dose that controls your pain and do not take celecoxib for longer than necessary to control the symptoms.

Method of administration

Celecoxib should be swallowed whole with a glass of water.The capsules can be taken at any time of day, with or without food. However, try to take each dose of celecoxib at the same time each day.

Contact your doctor if, after two weeks of treatment, you do not experience an improvement.

The recommended dose is:

The recommended dose for the treatment of osteoarthritisis 200 mg per day, if necessary, your doctor may increase it up to a maximum of 400 mg.

The dose is usually:

• one 200 mg capsule once a day; or
• one 100 mg capsule twice a day.

The recommended dose for the treatment of rheumatoid arthritisis 200 mg per day, if necessary, your doctor may increase it up to a maximum of 400 mg.

The dose is usually:

• one 100 mg capsule twice a day.

The recommended dose for the treatment of ankylosing spondylitisis 200 mg per day, if necessary, your doctor may increase it up to a maximum of 400 mg.

The dose is usually:

• one 200 mg capsule once a day; or
• one 100 mg capsule twice a day.

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

Patient over 65 years, especially those weighing less than 50 kg: your doctor may want to monitor you more closely if you are over 65 years old and especially if you weigh less than 50 kg.

Use in children:Celecoxib is only for adults, it is not indicated in children.

Maximum daily dose:

Do not take more than 400 mg per day (4 capsules of celecoxib 100 mg or 2 capsules of celecoxib 200 mg).

If you take more Celecoxib Krka than you should

Do not take more capsules than your doctor has told you.

In case of overdose or accidental ingestion of celecoxib, consult your doctor, pharmacist, hospital, and take the medicine with you or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Celecoxib Krka

If you forget to take a capsule, take it as soon as you remember. Do not take a double dose to make up for forgotten doses.

If you stop taking Celecoxib Krka

Sudden interruption of treatment with celecoxib may cause a worsening of symptoms. Do not stop taking celecoxib unless your doctor tells you to. Your doctor will tell you to reduce the dose for a few days before stopping treatment completely. If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

If you consider that any of the adverse effects you suffer from is serious or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

The adverse effects mentioned below were observed in patients with arthritis who took Celecoxib Krka. The adverse effects marked with an asterisk (*) occurred in patients who took Celecoxib Krka for the prevention of colon polyps and have been classified taking into account the highest frequency of occurrence. The patients included in these studies took Celecoxib Krka at high doses and for a prolonged period.

If you experience any of the following adverse effects, discontinue treatment with Celecoxib Krka and inform your doctor immediately:

If you have:

• an allergic reaction such as skin rash, swelling of the face, wheezing or difficulty breathing
• heart problems such as chest pain
• severe stomach pain or any sign of bleeding in the stomach or intestines, such as dark urine or stools stained with blood, or blood in vomit
• a skin reaction such as rash, blisters or peeling of the skin
• liver failure (symptoms may include nausea, diarrhea, jaundice, dark urine, pale stools, ease of bruising, or itching)

Very common adverse effects: may affect more than 1 in 10 people:

• Increased blood pressure, including worsening of existing high blood pressure*

Common adverse effects: may affect up to 1 in 10 people:

• Heart attack*
• Fluid retention with swelling of ankles, legs and/or hands
• Urinary tract infection
• Difficult breathing*, sinusitis, stuffy nose or runny nose, sore throat, cough, cold, flu-like symptoms
• Dizziness, difficulty sleeping
• Vomiting*, stomach pain, diarrhea, indigestion, gas
• Rash, itching
• Muscle stiffness
• Difficulty swallowing*
• Headache
• Nausea
• Joint pain
• Worsening of existing allergies
• Accidental injury

Uncommon adverse effects: may affect up to 1 in 100 people:

• Stroke*
• Heart failure, palpitations, rapid heartbeat
• Abnormal blood tests related to the liver
• Abnormal blood tests related to the kidneys
• Anemia (changes in red blood cells that can cause fatigue and difficulty breathing)
• Anxiety, depression, fatigue, numbness, tingling sensation
• High levels of potassium in blood test results (can cause nausea, fatigue, muscle weakness, or palpitations)
• Blurred or altered vision, ringing in the ears, mouth ulcers, difficulty hearing*
• Constipation, belching, stomach inflammation, worsening of stomach or intestinal inflammation
• Leg cramps
• Itchy rash with relief (urticarial habon)
• Eye inflammation
• Difficulty breathing
• Discoloration of the skin (bruises)
• Chest pain (generalized pain not related to the heart)
• Facial swelling

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

• Ulcers (bleeding) in the stomach, throat, or intestines; or intestinal rupture (can cause stomach pain, fever, nausea, vomiting, intestinal obstruction), dark or black stools, pancreatitis (can cause stomach pain), esophagitis
• Low sodium levels in the blood (a condition known as hyponatremia)

• Decreased number of white blood cells and platelets (increases the possibility of bleeding and bruising)
• Difficulty with muscular coordination of movements
• Feeling of confusion, taste disturbances
• Increased sensitivity to light
• Hair loss
• Hallucinations

• Eye bleeding
• Acute reaction that can lead to lung inflammation
• Irregular heartbeat
• Redness
• Blood clots in the blood vessels of the lungs. Symptoms may include sudden difficulty breathing, sharp pain when breathing, or collapse
• Stomach or intestinal bleeding (can cause stools or vomit with blood), intestinal or colon inflammation
• Severe liver inflammation (hepatitis). Symptoms may include nausea, diarrhea, jaundice, dark urine, pale stools, ease of bruising, or itching
• Acute kidney failure
• Menstrual disorders
• Swelling in the face, lips, mouth, tongue, or throat, or difficulty swallowing

Very rare adverse effects: may affect up to 1 in 10,000 patients:

• Severe allergic reactions (including potentially fatal anaphylactic shock)
• Severe skin disorders such as Stevens-Johnson syndrome, exfoliative dermatitis, and toxic epidermal necrolysis (can cause rash, blisters, or peeling of the skin) and generalized acute pustular exanthema (symptoms include redness of the skin with swollen areas and numerous small pustules)
• A late allergic reaction with possible symptoms such as rash, facial swelling, fever, swollen glands, and abnormalities in clinical test results [e.g., liver, blood cells (eosinophilia, a type of increase in blood cell count)]
• Bleeding in the brain that causes death
• Meningitis (inflammation of the membrane surrounding the brain and spinal cord)
• Liver failure, liver damage, and severe liver inflammation (fulminant hepatitis) (sometimes with fatal outcome or requiring liver transplant). Symptoms may include nausea, diarrhea, jaundice, dark urine, pale stools, ease of bruising, or itching
• Liver problems (such as cholestasis and cholestatic hepatitis, which may be accompanied by symptoms such as discolored stools, nausea, and yellowing of the skin or eyes)
• Kidney problems (such as nephrotic syndrome and minimal change disease, which may be accompanied by symptoms such as fluid retention, foamy urine, fatigue, and loss of appetite)
• Worsening of epilepsy (seizures possibly more frequent and/or severe)
• Obstruction of an artery or vein in the eye leading to partial or complete loss of vision
• Inflammation of blood vessels (can cause fever, pain, purple spots on the skin)
• Decrease in the number of red and white blood cells and platelets (can cause fatigue, ease of bruising, frequent nosebleeds, and increased risk of infections)
• Muscle pain and weakness
• Taste disturbance
• Loss of taste

Adverse effects of unknown frequency: their frequency cannot be estimated from the available data:

• Decreased fertility in women, which is normally reversible if the medication is discontinued

Adverse effects reported in clinical trials in which Celecoxib Krka was administered at a dose of 400 mg per day for more than 3 years, in patients with diseases unrelated to arthritis or other arthritic conditions, were:

Common adverse effects: may affect up to 1 in 10 people:

• Cardiac problems: angina pectoris (chest pain)
• Stomach problems: irritable bowel syndrome (may include abdominal pain, diarrhea, indigestion, and gas)
• Kidney stones (which can lead to stomach or back pain, blood in the urine), difficulty urinating
• Weight gain

Uncommon adverse effects: may affect up to 1 in 100 people:

• Deep vein thrombosis (blood clotting generally in the leg, which can cause pain, swelling, or redness of the calf or breathing problems)
• Stomach problems: stomach infection (which can cause irritation or ulcers in the stomach and intestines)
• Fracture of lower limbs
• Herpes, skin infection, eczema (dry rash with itching), pneumonia (chest infection, possibility of cough, fever, difficulty breathing)
• Floaters in the eye that cause vision disturbance or blurred vision, vertigo due to problems in the inner ear, mouth ulcers, gum inflammation or bleeding
• Excessive urination at night, bleeding hemorrhoids, frequent bowel movement

• Fat lumps on the skin or other places, ganglion cyst (painless inflammation in the joints or tendons or around them, in the hand or foot), difficulty speaking, abnormal or heavy vaginal bleeding, chest pain
• High levels of sodium in blood test results

Reporting of adverse effects

If you experience any type of adverse effects, consult your doctor or pharmacist, even if it is an adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Celecoxib Krka

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date that appears on the box and on the blister after CAD. The expiration date is the last day of the month indicated.

Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines that you no longer need in the SIGRE collection point at the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Celecoxib Krka composition

• The active ingredient is celecoxib.

Each hard capsule contains 200 mg of celecoxib.

• The other ingredients (excipients) of the hard capsule are: lactose monohydrate, povidone K30, croscarmellose sodium, sodium lauryl sulfate, and magnesium stearate (E470b) in the capsule core and gelatin, titanium dioxide (E171), and yellow iron oxide (E172) in the capsule shell.

Product appearance and package contents

The body and cap of the capsules are yellow-brown, 18.9 mm - 19.7 mm in length. The capsules contain white or almost white granules.

The capsules are available in blister packs of 10, 20, 30, 40, 50, 60, 90, and 100 capsules.

Only some pack sizes may be marketed.

Marketing authorization holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Krka Farmacéutica, S.L., C/ Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Date of last revision of this leaflet: July 2024

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/