Patient Information Leaflet: Information for the Patient

Celecoxib Krka 200 mg Hard Capsules EFG

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

• Keep this leaflet, as 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, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Celecoxib belongs to a class of medications known as nonsteroidal anti-inflammatory drugs (NSAIDs), and specifically to the subgroup known as cyclooxygenase-2 (COX-2) inhibitors. The body produces prostaglandins that can cause pain and inflammation. In conditions such as rheumatoid arthritis or osteoarthritis, the body produces them in greater quantities. Celecoxib acts by reducing the production of prostaglandins, thereby reducing pain and inflammation.

Celecoxib is indicated in adults for alleviating the symptoms ofrheumatoid arthritis, osteoarthritis, and ankylosing spondylitis.

The medication will start to take effect a few hours after taking the first dose, but you may not experience a complete effect until several days have passed.

Your doctor has prescribed Celecoxib Krka. 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

Inform your doctor if any of the following circumstances affect you, as patients with these conditions should not take Celecoxib Krka:

• If you are allergic to celecoxib or any of the other components of this medication (listed in section 6)
• If you have had any allergic reaction to any medication in the group called "sulfonamides" (e.g. some antibiotics used to treat infections)
• If you currently have a stomach or intestinal ulcer, or bleeding in the stomach or intestines
• If you have previously experienced any of the following symptoms as a result of taking acetylsalicylic acid or any other anti-inflammatory medication: asthma, nasal polyps, severe nasal congestion, or allergic symptoms such as itchy skin rash, facial swelling, lip, tongue, or throat swelling, 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 breastfeeding your child
• 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 coronary artery disease, or cerebrovascular disease, e.g. you have been diagnosed with a heart attack, stroke, or transient ischemic attack (temporary decrease in blood flow to the brain; also known as "mini-stroke"), angina pectoris, or obstruction of the heart or brain blood vessels
• If you have or have had circulatory problems (peripheral arterial disease) or if you have been operated on on the arteries of 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
• (Do not take Celecoxib Krka if you currently have a stomach or intestinal ulcer)
• If you are taking medications to reduce blood clotting (e.g. warfarin/anticoagulant analogs or new oral anticoagulants, e.g. apixaban)
• If you are taking corticosteroids (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 medications to reduce blood clotting (e.g. warfarin)
• If you are taking Celecoxib Krka at the same time as other non-acetylsalicylic acid anti-inflammatory medications such as ibuprofen or diclofenac. You should avoid using these medications together.
• If you are a smoker, have diabetes, high blood pressure, or high cholesterol
• If your heart, liver, or kidneys are not functioning well, your doctor may want to monitor you regularly
• If you have fluid retention (e.g. swollen feet or ankles)
• If you are dehydrated, for example, due to a disease with vomiting, diarrhea, or 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 medication
• 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 may increase the risk of gastrointestinal problems

Like other anti-inflammatory medications (e.g. ibuprofen or diclofenac), this medication may increase your blood pressure, so your doctor will be able to perform regular checks.

Some cases of severe liver reactions with celecoxib have been reported, including severe liver inflammation, liver damage, and liver failure (some with fatal outcome or requiring liver transplant). Most of the severe liver reactions occurred in the first month of treatment.

Celecoxib Krka may make it difficult to become pregnant. You should inform your doctor if you plan to become pregnant or if you have difficulty becoming pregnant (see Pregnancy and breastfeeding).

Other medications and Celecoxib Krka

Inform your doctor or pharmacist if you are taking or have taken recently or may need to take any other medication:

• Dextromethorphan (used to treat cough)
• ACE inhibitors or angiotensin II receptor antagonists, beta-blockers, and diuretics (medications used to treat high blood pressure and heart failure)
• Fluconazole and rifampicin (used to treat infections caused by bacteria and fungi)

• Warfarin or other warfarin analogs (agents that reduce blood clotting), including newer medications such as apixaban

• Lithium (used to treat certain types of depression)
• Other medications used to treat depression, sleep disorders, high blood pressure, or irregular heartbeat
• Neuroleptics (used to treat certain mental disorders)
• Methotrexate (used in rheumatoid arthritis, psoriasis, and leukemia)
• Carbamazepine (used to treat epilepsy/convulsions and certain types of pain or depression)
• Barbiturates (used to treat epilepsy/convulsions and certain sleep disorders)
• Ciclosporin and tacrolimus (used to treat immunosuppression, e.g. after transplants)

Celecoxib Krka can be taken with low doses of acetylsalicylic acid (75 mg daily or less). Please consult your doctor before taking both medications together.

Pregnancy,breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

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

Breastfeeding

Celecoxib Krka should not be used during breastfeeding.

Fertility

NSAIDs, including Celecoxib Krka, may make it 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 operating machinery

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

Celecoxib Krka contains lactose and sodium

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

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

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. If you think or believe that the action of celecoxib is too strong or too weak, inform your doctor or pharmacist.

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

Administration Form

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

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

Recommended Dose:

The recommended dose is:

For the treatment of arthritis, the recommended dose is 200 mg per day, if necessary, your doctor may increase it up to a maximum of 400 mg.

The usual dose is:

• One 200 mg capsule once a day; or
• Two 100 mg capsules per day.

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

The usual dose is:

• Two 100 mg capsules per day.

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

The usual dose is:

• One 200 mg capsule once a day; or
• Two 100 mg capsules per day.

Problems with the kidneys or liver:Make sure your doctor knows if you have problems with the liver or kidneys since you may need a lower dose.

Patients 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 for children.

Maximum Daily Dose:

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

If you take more Celecoxib Krka than you should

You should not take more capsules than indicated by your doctor.

In case of overdose or accidental ingestion of celecoxib, consult your doctor, pharmacist, hospital immediately and bring the medication with you or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Celecoxib Krka

If you forgot to take a capsule, take it as soon as you remember. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Celecoxib Krka

Stopping treatment with celecoxib abruptly may cause a worsening of symptoms.Do not stop taking celecoxib unless your doctor tells you to. Your doctor will indicate that you reduce the dose over a few days before stopping treatment completely.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you consider that any of the side effects you are experiencing are serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

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

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

If you have:

• an allergic reaction such as skin rash, facial swelling, 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 the vomit
• a skin reaction such as rash, blisters or peeling of the skin
• liver insufficiency (symptoms may include nausea, diarrhea, jaundice (your skin or the white of your eyes appears yellow))

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

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

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

• Myocardial infarction*
• Fluid retention with swelling of ankles, legs and/or hands
• Urinary tract infection
• Difficulty breathing*, sinusitis (inflammation and infection of the paranasal sinuses, obstruction or pain of the paranasal sinuses), nasal congestion 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 (feeling of discomfort)
• Joint pain
• Worsening of existing allergies
• Accidental injury

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

• Ulcers (bleeding) in the stomach, throat or intestines; or intestinal rupture (may cause stomach pain, fever, nausea, vomiting, intestinal obstruction), dark or black stools, inflammation of the pancreas (may lead to stomach pain), inflammation of the esophagus
• Low sodium levels in the blood (a condition known as hyponatremia)

• Decreased white blood cell count and platelet count (may cause fatigue, frequent nosebleeds, increased risk of infections)
• Difficulty in muscle coordination of movements
• Feeling of confusion, alterations in taste
• Increased sensitivity to light
• Loss of hair
• Alucinations

• Eye hemorrhage
• Acute reaction that may lead to pulmonary inflammation
• Irregular heart rhythm
• Rubefaction
• Clots in the blood vessels of the lungs. Symptoms may include sudden difficulty breathing, sharp chest pain or collapse
• Stomach or intestinal hemorrhage (may cause stools or vomit with blood), intestinal or colon inflammation
• Severe liver inflammation (hepatitis). Symptoms may include nausea, diarrhea, jaundice (yellow discoloration of the skin and eyes), dark urine, pale stools, easy bruising, itching or chills
• Acute kidney failure
• Menstrual disorders
• Swelling in the face, lips, mouth, tongue or throat, or difficulty swallowing

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

• Severe allergic reactions (including potential fatal anaphylactic shock)
• Severe skin alterations such as Stevens-Johnson syndrome, exfoliative dermatitis and toxic epidermal necrolysis (may cause rash, blistering or peeling of the skin) and acute generalized pustular psoriasis (symptoms include skin redness with swollen areas and numerous small pustules)
• A late-onset allergic reaction with possible symptoms such as rash, facial swelling, fever, swollen lymph nodes and abnormalities in clinical test results [e.g. liver, blood cells (eosinophilia, a type of increased white blood cell count)]
• Brain hemorrhage leading to death
• Meningitis (inflammation of the membrane surrounding the brain and spinal cord)
• Severe liver insufficiency, liver damage and severe liver inflammation (hepatitis fulminant) (sometimes with fatal outcome or requiring liver transplant). Symptoms may include nausea, diarrhea, jaundice (yellow discoloration of the skin and eyes), dark urine, pale stools, easy bruising, itching or chills
• Liver problems (such as cholestasis and cholestatic hepatitis, which may be accompanied by symptoms such as dark-colored stools, nausea and yellow discoloration 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 (edema), 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 (may cause fever, pain, purple spots on the skin)
• Decreased red and white blood cell count and platelet count (may cause fatigue, frequent nosebleeds, increased risk of infections)
• Muscle pain and weakness
• Alteration of taste
• Loss of taste

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

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

The side 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 non-arthritis-related diseases or other arthritic conditions, were:

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

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

Rare side effects: may affect up to 1 in 100 people:

• Deep vein thrombosis (blood clotting usually in the leg, which may cause pain, swelling or redness of the calf or problems breathing)
• Gastrointestinal problems: stomach infection (which may cause irritation or ulcers in the stomach and intestines)
• Lower limb fractures
• Herpes, skin infection, eczema (dry, itchy rash), pneumonia (chest infection (possibility of cough, fever, difficulty breathing))
• Flies in the eye causing visual disturbance or blurred vision, vertigo due to inner ear problems, ulcers, inflammation or bleeding of the gums, mouth ulcers
• Excessive nighttime urination, bleeding hemorrhoids, frequent bowel movements

• Fatty lumps in the skin or other areas, ganglion cyst (non-painful inflammation in the joints or tendons or around them, in the hand or foot) difficulty speaking, abnormal or very heavy vaginal bleeding, chest pain
• High sodium levels in blood test results

Reporting of side effects

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

Keepthis medicationout of the sight and reach of children.

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

Do not store at a temperature above 25°C.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Celecoxib Krka Composition

• The active ingredient is celecoxib.

Each hard capsule contains 200 mg of celecoxib.

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

Product Appearance and Packaging Contents

The capsule body and cap are yellowish-brown, 18.9 mm – 19.7 mm in length. The capsules contain white or almost white granules.

The capsulessare available in blister packs of10, 20, 30, 40, 50, 60, 90, and 100 capsules.

Only some package 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 medication 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 medication is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Last review date of this leaflet: July 2024

More detailed information about this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/