Celecoxib Krka 200 mg hard capsules EFG

Patient Information Leaflet

Introduction

Package Leaflet: Information for the patient

Celecoxib Krka 200 mg hard capsules EFG

Please read all of this leaflet carefully before you start taking this medicine, as it contains important information 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 should not give it to other people, even if they have the same symptoms as you, since it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Celecoxib Krka is and what it is used for
2. What you need to know before taking Celecoxib Krka
3. How to take Celecoxib Krka
4. Possible side effects
5. How to store Celecoxib Krka
6. Contents of the pack and other information

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

Celecoxib belongs to a class of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs), and more specifically to the subgroup known as selective cyclooxygenase-2 (COX-2) inhibitors. Your body produces prostaglandins, which can cause pain and inflammation. In conditions such as rheumatoid arthritis or osteoarthritis, your body produces them in higher amounts. Celecoxib works by reducing the production of prostaglandins, thereby decreasing pain and inflammation.

Celecoxib is indicated in adults for the relief of the signs and symptoms of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis.

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

2. What you need to know before taking Celecoxib Krka

Your doctor has prescribed Celecoxib Krka. The following information will help you achieve the best results with Celecoxib Krka. If you have any further questions, please ask your doctor or pharmacist.

Do not take Celecoxib Krka

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

• if you are allergic to celecoxib or to any of the other ingredients of this medicine (listed in section 6)
• if you have previously had an allergic reaction to any medicine in 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 drug: asthma, nasal polyps, severe nasal congestion, or allergic symptoms such as itchy rash, swelling of the face, lips, tongue or throat, difficulty breathing or wheezing
• if you are pregnant. If you could become pregnant during treatment, you should discuss the use of contraceptive methods with your doctor
• if you are breastfeeding
• 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, or blockage of blood vessels to the heart or brain
• if you have or have had circulation problems (peripheral arterial disease) or have undergone 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 Krka if you currently have a stomach or intestinal ulcer or bleeding)
• if you are taking medicines to reduce blood clotting (e.g., warfarin/warfarin-like anticoagulants or newer oral anticoagulants, e.g., apixaban)
• if you are taking corticosteroid medicines (e.g., prednisone)
• if you are taking acetylsalicylic acid (even at low doses such as for heart protection)
• if you are taking antiplatelet therapies
• if you are taking other non-acetylsalicylic acid NSAIDs such as ibuprofen or diclofenac at the same time as Celecoxib Krka. 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 do not function 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 or diarrhea, or due to the use of diuretics (used to treat excess fluid in the body)
• if you have previously had a severe allergic reaction or a serious skin reaction to any medicine
• if you feel unwell due to an infection or suspect you have an infection, as taking Celecoxib Krka 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
• alcohol consumption and NSAIDs may increase the risk of gastrointestinal problems

Like other anti-inflammatory drugs (e.g., ibuprofen or diclofenac), this medicine may increase your blood pressure, so your doctor may periodically monitor it.

Serious liver reactions have been reported with celecoxib, including severe hepatitis, liver damage, and liver failure (some fatal or requiring liver transplantation). Among cases where the onset was reported, most serious 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 have difficulty becoming pregnant (see section Pregnancy and breastfeeding).

Other medicines and Celecoxib Krka

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to 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 infections caused by bacteria and fungi)
• Warfarin or other warfarin-like agents (agents that reduce blood clot formation), 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 in rheumatoid arthritis, psoriasis, and leukemia)
• 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)

Celecoxib Krka may be taken with low-dose acetylsalicylic acid (75 mg daily or less). Seek advice from your doctor before taking both medicines 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 medicine.

Pregnancy

Celecoxib Krka must 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 while being treated with Celecoxib Krka, you must stop treatment and contact your doctor for alternative therapy.

Breastfeeding

Celecoxib Krka must not be used during breastfeeding.

Fertility

NSAIDs, including Celecoxib Krka, may impair fertility. You should inform your doctor if you intend to become pregnant or are experiencing difficulties in becoming pregnant.

Driving and using machines

You should be aware of 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 have passed.

Celecoxib Krka contains lactose and sodium

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him 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

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again. If you think or believe that the effect of celecoxib is too strong or too weak, inform your doctor or pharmacist.

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

Method of administration

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

Contact your doctor if you do not experience improvement within two weeks after starting treatment.

Recommended dose:

The recommended dose for the treatment of osteoarthritis is 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 daily; or
• one 100 mg capsule twice daily.

The recommended dose for the treatment of rheumatoid arthritis is 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 daily.

The recommended dose for the treatment of ankylosing spondylitis is 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 daily; or
• one 100 mg capsule twice daily.

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

Patients over 65 years of age, especially those weighing less than 50 kg: your doctor may wish to monitor you more closely if you are over 65 years old, particularly if you weigh less than 50 kg.

Use in children: Celecoxib is for adults only and is not indicated for use 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 prescribed by your doctor.

In case of overdose or accidental ingestion of celecoxib, contact your doctor, pharmacist, or hospital immediately, and bring the medicine with you or call the Toxicology Information Service at 91 562 04 20, stating the name of the medicine and the amount ingested.

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 a missed dose.

If you stop taking Celecoxib Krka

Suddenly stopping treatment with celecoxib may cause worsening of symptoms. Do not stop taking celecoxib unless instructed by your doctor. Your doctor will advise you to gradually reduce the dose over several days before stopping treatment completely.

If you have any further 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 everyone will experience them.

If you consider any of the adverse effects you experience to be serious, or if you notice any adverse effects not listed in this leaflet, please inform your doctor or pharmacist.

The adverse effects listed below were observed in patients with arthritis taking Celecoxib Krka. The adverse effects marked with an asterisk (*) occurred in patients taking Celecoxib Krka for the prevention of colon polyps and have been classified according to 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 adverse effects, stop 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, blood-stained stools, or blood in vomit
• a skin reaction such as rash, blisters, or peeling of the skin
• liver failure (symptoms may include nausea (feeling unwell), diarrhoea, jaundice (your skin or the whites of your eyes appear yellow))

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

• Increase in blood pressure, including worsening of pre-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
• Difficulty breathing*, sinusitis (inflammation and infection of the sinuses, nasal congestion or discharge, sore throat, cough, cold, flu-like symptoms)
• Dizziness, difficulty sleeping
• Vomiting*, stomach pain, diarrhoea, indigestion, gas
• Rash, itching
• Muscle stiffness
• Difficulty swallowing*
• Headache
• Nausea (feeling unwell)
• Joint pain
• Worsening of existing allergies
• Accidental injury

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

• Stroke*
• Heart failure, palpitations (awareness of heartbeat), rapid heartbeat
• Abnormal blood test results related to the liver
• Abnormal blood test results related to the kidney
• Anaemia (changes in red blood cells that may cause fatigue and shortness of breath)
• Anxiety, depression, tiredness, numbness, tingling sensation
• High levels of potassium in blood test results (may cause nausea (feeling unwell), fatigue, muscle weakness or palpitations)
• Blurred or altered vision, ringing in the ears, mouth pain and ulcers, hearing difficulty*
• Constipation, belching, stomach inflammation (indigestion, stomach pain or vomiting), worsening of stomach or intestinal inflammation
• Leg cramps
• Itchy, raised skin rash (urticarial wheals)
• Eye inflammation
• Difficulty breathing
• Skin discolouration (bruising)
• Chest pain (generalised pain not related to the heart)
• Swelling of the face

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

• Ulcers (bleeding) in the stomach, throat or intestines; or intestinal perforation (may cause stomach pain, fever, nausea, vomiting, intestinal obstruction), dark or black stools, pancreatitis (may cause stomach pain), inflammation of the throat (oesophagus)

• Low levels of sodium in the blood (a condition known as hyponatraemia)

• Decrease in the number of white blood cells (which help protect the body from infections) and platelets (increased risk of bleeding and bruising)

• Difficulty with muscular coordination of movements

• Feeling confused, taste disturbances

• Increased sensitivity to light

• Hair loss

• Hallucinations

• Eye haemorrhage

• Acute reaction that may lead to lung inflammation

• Irregular heartbeat

• Flushing

• Blood clots in blood vessels of the lungs. Symptoms may include sudden shortness of breath, sharp chest pain when breathing, or collapse

• Bleeding from the stomach or intestines (may result in bloody stools or vomit), inflammation of the intestine or colon

• Severe liver inflammation (hepatitis). Symptoms may include nausea (feeling unwell), diarrhoea, jaundice (yellowing of the skin and eyes), dark urine, pale stools, easy bruising or bleeding, itching or chills

• Acute kidney failure

• Menstrual disorders

• Swelling of 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 life-threatening anaphylactic shock)
• Severe skin reactions such as Stevens-Johnson syndrome, exfoliative dermatitis, and toxic epidermal necrolysis (may cause rash, blistering or peeling of the skin) and acute generalised exanthematous pustulosis (symptoms include reddening of the skin with swollen areas and numerous small pustules)
• Delayed-onset allergic reaction with possible symptoms such as rashes, facial swelling, fever, swollen glands, and abnormal clinical test results [e.g.: liver, blood cells (eosinophilia, a type of increased blood cell count)]
• Brain haemorrhage leading to death
• Meningitis (inflammation of the membrane surrounding the brain and spinal cord)
• Liver failure, liver damage and severe liver inflammation (fulminant hepatitis) (sometimes fatal or requiring liver transplantation). Symptoms may include nausea (feeling unwell), diarrhoea, jaundice (yellowing of the skin and eyes), dark urine, pale stools, easy bruising or 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 seizures)
• Blockage of an artery or vein in the eye leading to partial or complete loss of vision
• Inflammation of blood vessels (may cause fever, aches, purple spots on the skin)
• Reduction in the number of red and white blood cells and platelets (may cause tiredness, easy bruising, frequent nosebleeds, and increased risk of infections)
• Muscle pain and weakness
• Disturbance of taste sensation
• Loss of taste

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

• Decreased fertility in women, which is usually reversible if the medicine is discontinued

Adverse effects reported in clinical trials where Celecoxib Krka was administered at a dose of 400 mg daily for more than 3 years in patients with conditions unrelated to Arthritis or other arthritic conditions were:

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

• Heart problems: angina (chest pain)
• Stomach problems: irritable bowel syndrome (may include abdominal pain, diarrhoea, indigestion and gas)
• Kidney stones (which may cause 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 clot usually in the leg, which may cause pain, swelling or redness in the calf or breathing problems)
• Stomach problems: stomach infection (which may cause irritation or ulcers in the stomach and intestine)
• Fracture of lower limbs
• Herpes, skin infection, eczema (dry, itchy rash), pneumonia (infection in the chest (possible cough, fever, difficulty breathing))
• Eye floaters causing visual disturbance or blurred vision, vertigo due to inner ear problems, ulcers, inflammation or bleeding of the gums, mouth ulcers
• Excessive urination at night, bleeding from haemorrhoids, frequent bowel movements
• Fatty lumps in the skin or other sites, ganglion cyst (non-painful swelling in or around joints or tendons, in the hand or foot), difficulty speaking, abnormal or very heavy vaginal bleeding, chest pain
• High levels of sodium in blood test results

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide 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 expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Celecoxib Krka

• The active substance is celecoxib.

Each hard capsule contains 200 mg of celecoxib.

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

Appearance of the product and contents of the pack

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

Capsules are available in cartons containing 10, 20, 30, 40, 50, 60, 90 and 100 capsules in blister strips.

Only certain 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

For further information about this medicine, please contact 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) under the following names:

Date of the most recent review of this leaflet: July 2024

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