CELECOXIB KERN PHARMA 200 mg HARD CAPSULES

2. What you need to know before taking Celecoxib Kern Pharma

Do not take Celecoxib Kern Pharma

• if you are allergic to celecoxib or any of the other components of this medication (listed in section 6).
• if you have had an allergic reaction to the group of medications called "sulfonamides" (e.g., some antibiotics used to treat infections).

• if you currently have a stomach or intestinal ulcer or bleeding.
• if, as a result of taking acetylsalicylic acid or any other anti-inflammatory and analgesic medication (NSAID), you have experienced asthma, nasal polyps, severe nasal congestion, or an allergic reaction such as skin rash, swelling of the face, lips, tongue, or throat, difficulty breathing, or wheezing.
• if you are pregnant. If you can become pregnant during this 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 an 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 of blood flow to the brain, also known as a "mini-stroke"), angina pectoris, or obstruction of the blood vessels that supply the heart or brain.
• if you have or have had circulation problems (peripheral arterial disease) or if you have undergone surgery on the arteries in your legs.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Celecoxib Kern Pharma:

• if you have previously had a stomach or intestinal ulcer or bleeding.

(Do not take Celecoxib Kern Pharmaif you currently have a stomach or intestinal ulcer or bleeding)

• if you are currently taking acetylsalicylic acid (even in low doses as cardioprotective therapy).
• if you are taking medications to reduce blood clotting (e.g., warfarin/anticoagulants like warfarin or new anticoagulant medications like apixaban).

if you are taking corticosteroid medications (such as prednisone)

• if you are taking Celecoxib Kern Pharma at the same time as other non-acetylsalicylic NSAIDs such as ibuprofen or diclofenac. The concomitant use of these medications should be avoided.
• if you are a smoker, have diabetes, have high blood pressure, or have 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 ankles and feet).
• if you are dehydrated due to 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 may have an infection, as taking Celecoxib Kern Pharma may mask fever or other symptoms of infection or inflammation.
• if you are over 65 years old, your doctor will want to monitor you regularly.
• the consumption of alcohol and NSAIDs can increase the risk of gastrointestinal problems

This medication may increase blood pressure, and your doctor may perform periodic monitoring of this.

During treatment with celecoxib, some cases of severe liver reactions have been reported, such as severe liver inflammation, liver damage, and liver failure (some with fatal consequences or requiring liver transplantation). Of the cases that specified the time of onset, most severe liver reactions occurred during the first month of treatment.

Other Medications and Celecoxib Kern Pharma

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

• Dextromethorphan (medication to treat cough);
• ACE inhibitors, angiotensin II receptor antagonists, beta-blockers, and diuretics (medications used to treat hypertension and heart failure);
• Fluconazole and rifampicin (medications to treat fungal or bacterial infections)
• Warfarin or other warfarin-like medications, including new medications like apixaban (agents that reduce blood clotting);
• Lithium (medication to treat depression)
• certain medications to treat depression, sleep disorders, high blood pressure, or cardiac arrhythmias
• Neuroleptics (medications to treat mental disorders)
• Methotrexate (medication to treat rheumatoid arthritis, psoriasis, and leukemia)
• Carbamazepine (medication to treat epilepsy/seizures and some types of pain or depression)
• Barbiturates (medications to treat epilepsy/seizures and some sleep disorders)
• Cyclosporine and tacrolimus (medications used to suppress the immune system, e.g., after transplants)

Celecoxib Kern Pharma can be administered concomitantly with acetylsalicylic acid in low doses (75 mg or less per day). Consult your doctor or pharmacist before starting to take both medications at the same time.

Pregnancy, Breastfeeding, and Fertility

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

Pregnancy

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

Breastfeeding

Celecoxib Kern Pharma should not be taken during breastfeeding.

Fertility

NSAIDs, including Celecoxib Kern Pharma, may make it more difficult to become pregnant. You should inform your doctor if you are planning to become pregnant or if you have problems becoming pregnant.

Driving and Using Machines

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

Celecoxib Kern Pharma Contains Lactose and Sodium

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

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

3. How to Take Celecoxib Kern Pharma

Follow the administration instructions indicated by your doctor for this medication exactly. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

For Osteoarthritis:the recommended dose is 200 mg per day. If necessary, your doctor may increase the dose up to a maximum of 400 mg.

The usual dose is:

• One 200 mg capsule once a day, or
• One 100 mg capsule twice a day

For Rheumatoid Arthritis:the recommended dose is 200 mg per day. If necessary, your doctor may increase the dose up to a maximum of 400 mg.

The usual dose is:

• One 100 mg capsule twice a day

For Ankylosing Spondylitis:the recommended dose is 200 mg per day. If necessary, your doctor may increase the dose up to a maximum of 400 mg.

The usual dose is:

• One 200 mg capsule once a day, or
• One 100 mg capsule twice a day

Because the risk of side effects associated with heart problems increases with the dose and duration of treatment, it is important that you take the lowest dose to control pain and that you do not use Celecoxib Kern Pharma for longer than necessary to control symptoms.

You should not take more than 400 mg of celecoxib per day.

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

Patient Over 65 Years Old, Especially Those Weighing Less Than 50 kg:if you are over 65 years old, and especially if you weigh less than 50 kg, your doctor may want to monitor you more closely.

Contact your doctor if you do not notice improvement within two weeks of starting treatment.

Use in Children

Celecoxib Kern Pharma is for adults only and is not indicated in children.

Method of Administration

Celecoxib Kern Pharma is for oral use.

The capsules can be taken at any time of the day, with or without food. But try to take all doses of Celecoxib Kern Pharma at the same time each day.

If you have difficulty swallowing capsules: The entire contents of the capsule can be sprinkled over a spoonful of semi-solid food (such as apple sauce, rice pudding, yogurt, or mashed banana at cold or room temperature) and swallowed immediately with a drink (approximately 240 ml or a glass of water).

To open the capsule, hold it in a vertical position to contain the powder at the bottom and then gently press the top and twist it to remove it, being careful not to spill the contents.

If You Take More Celecoxib Kern Pharma Than You Should

Do not take more capsules than indicated by your doctor. If you take too many capsules, contact your doctor, pharmacist, or hospital and bring the medication with you so the doctor can see what you are taking.

If You Forget to Take Celecoxib Kern Pharma

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

If You Stop Taking Celecoxib Kern Pharma

Do not stop taking Celecoxib Kern Pharma unless your doctor tells you to.

If you have any other questions about the use of this medication, 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.

The following adverse effects have been observed in patients with arthritis who took Celecoxib Kern Pharma. The adverse effects marked with an asterisk (*)are listed below at the highest frequencies that have occurred in patients who tookCelecoxib Kern Pharmato prevent colon polyps. The patients in these studies tookCelecoxib Kern Pharmain high doses and for a prolonged period.

Stop taking Celecoxib Kern Pharma 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 intestine, such as dark or bloody stools, or blood in vomit.
• skin reactions such as rash, blisters or peeling of the skin.
• liver failure (symptoms may include nausea (feeling of discomfort), diarrhea, jaundice (yellowing of the skin or eyes)).

Very common: may affect more than 1 in 10 patients

• Increased blood pressure, including worsening of existing hypertension*.

Common: may affect up to 1 in 10 patients

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

Uncommon: may affect up to 1 in 100 patients

• Stroke*
• Heart failure, palpitations (perception of heartbeat), rapid heartbeat
• Abnormalities in blood tests related to the liver
• Abnormalities in 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 (feeling of discomfort), fatigue, muscle weakness or palpitations)
• Blurred or altered vision, ringing in the ears, mouth pain and ulcers, difficulty hearing*
• Constipation, belching, stomach inflammation (indigestion, stomach pain or vomiting), worsening of stomach or intestinal inflammation
• Leg cramps
• Rash with itching and relief (urticarial habon)
• Eye inflammation
• Difficulty breathing
• Discoloration of the skin (bruises)
• Chest pain (generalized pain not related to the heart)
• Swelling of the face

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

• Ulcers (bleeding) in the stomach, throat or intestines; or intestinal rupture (can cause stomach pain, fever, nausea, vomiting, intestinal obstruction), dark or black stools, pancreatic inflammation (can lead to stomach pain), throat inflammation (esophagus)
• Low sodium levels in the blood (a disease known as hyponatremia)
• Decreased number of white blood cells or platelets (increases the possibility of bleeding and bruising)
• Difficulty in 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
• Flush
• Blood clots in the blood vessels of the lungs. Symptoms may include sudden difficulty breathing, sharp chest pain or collapse
• Stomach or intestinal bleeding (can lead to bloody stools or vomit), intestinal or colon inflammation
• Severe liver inflammation (hepatitis). Symptoms may include nausea (feeling of discomfort), diarrhea, jaundice (yellowing of the skin and eyes), dark urine, pale stools, ease of bleeding, itching or chills
• Acute kidney failure
• Menstrual disorders
• Swelling in the face, lips, mouth, tongue or throat, wheezing or difficulty swallowing

Very rare: 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, blistering 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-onset allergic reaction with possible symptoms such as rash, swelling of the face, fever, swollen glands and abnormalities in clinical test results (e.g. liver, blood cells (eosinophilia, a type of increase in white 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 (feeling of discomfort), diarrhea, jaundice (yellowing of the skin and eyes), dark urine, pale stools, ease of bleeding, itching or chills
• 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 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 (possibly more frequent and/or severe seizures)
• Obstruction of an artery or vein in the eye that leads to partial or complete loss of vision
• Inflammation of the blood vessels (can cause fever, pain, purple spots on the skin)
• Reduction in the number of red blood cells, white blood cells and platelets (can cause fatigue, ease of bruising, frequent nosebleeds and increased risk of infections)
• Muscle pain and weakness
• Alteration of the sense of smell
• Loss of the sense of taste

Frequency not known: cannot be estimated from the available data

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

In clinical trials not related to arthritis or other arthritic conditions, in which celecoxib was taken at a dose of 400 mg per day for a maximum of 3 years, the following adverse effects were observed:

Common: may affect up to 1 in 10 patients

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

Uncommon: may affect up to 1 in 100 patients

• Deep vein thrombosis (blood clotting usually 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 intestine)
• Fracture of lower limbs
• Herpes, skin infection, eczema (dry rash with itching), pneumonia (chest infection (possibility of cough, fever, difficulty breathing))
• Flies in the eye that cause vision disturbance or blurred vision, vertigo due to problems in the inner ear, ulcers, inflammation or bleeding of the gums, ulcers in the mouth
• Excessive urination at night, bleeding from hemorrhoids, frequent bowel movements
• Fat lumps on the skin or other areas, ganglion cyst (painless 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 levels of sodium in blood test results

Reporting of adverse effects

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

5. Storage of Celecoxib Kern Pharma

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

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

This medicine does not require any special storage conditions. Store in the original package to protect it from light and moisture.

Medicines should not be thrown down the drain or into the trash. Deposit the packages and medicines that you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packages and medicines that you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Celecoxib Kern Pharma

The active ingredient is celecoxib.

Celecoxib Kern Pharma 200 mg: Each hard capsule contains 200 mg of celecoxib.

The other components (excipients) are:

Capsule core: lactose monohydrate, low-substitution hydroxypropylcellulose, type A crospovidone, povidone K29/32, sodium lauryl sulfate, magnesium stearate.

Capsule shell: gelatin and titanium dioxide (E171)

The 200 mg capsules also contain black iron oxide (E172).

Appearance of Celecoxib Kern Pharma and package contents

Celecoxib Kern Pharma 200 mg hard capsules are size "2" (approximately 17.8 mm ± 0.4 mm), contain white or off-white powder, and have a gray opaque cap and body.

The capsules are packaged in PVC/PVDC/ALU blisters.

Celecoxib Kern Pharma is available in packages of 10, 20, 30, 40, 50, 60 and 100 hard capsules.

Not all package sizes may be marketed.

Marketing authorization holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Manufacturer

Laboratorios LICONSA S.A.

Av. De Miralcampo 7

19200 Azuqueca de Henares

Guadalajara

SPAIN

This medicine is authorized in the Member States of the European Economic Area under the following names:

DE

Celecoxib Liconsa 200 mg Hartkapseln

ES

Celecoxib Kern Pharma 200 mg hard capsules EFG

Date of the last revision of this prospectus: March 2019