Package Insert: Information for the Patient

Celecoxib Kern Pharma 200 mg Hard Capsules EFG

Celecoxib

Read this entire package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Celecoxib Kern Pharma is indicated to relieve the symptoms and signs ofrheumatoid arthritis, osteoarthritisandankylosing spondylitisin adults.

Celecoxib Kern Pharma belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs), specifically the subgroup known as cyclooxygenase-2 (COX-2) inhibitors. The body produces substances called prostaglandins that can cause pain and inflammation. In conditions such as rheumatoid arthritis and osteoarthritis, the body produces a greater amount. Celecoxib Kern Pharma acts by reducing the production of these substances and, therefore, decreases pain and inflammation.

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 nonsteroidal anti-inflammatory drug (NSAID), you have experienced asthma, nasal polyps, severe nasal congestion, or an allergic reaction such as skin rash, facial swelling, lip, tongue, or throat swelling, 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 a severe liver disease.
• if you have a severe kidney disease.
• if you have an inflammatory intestinal disease such as ulcerative colitis or Crohn's disease.
• if you have heart failure, a diagnosed ischemic heart disease, or cerebrovascular disease, for example, if you have been diagnosed with a heart attack, stroke, or transient ischemic attack (temporary reduction of blood flow to the brain, also known as “mini-stroke”), angina pectoris, or obstruction of the blood vessels that supply the heart or brain.
• if you have or have had peripheral artery 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 Kern Pharma:

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

(do not take Celecoxib Kern Pharma if 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 blood thinners (e.g., warfarin or anticoagulants like warfarin or new anticoagulants like apixaban).

if you are taking medications called corticosteroids (such as prednisone)

• if you are taking Celecoxib Kern Pharma at the same time as other NSAIDs, such as ibuprofen or diclofenac. The use of these medications together should be avoided.
• if you are a smoker, have diabetes, have 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 (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 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 may increase the risk of gastrointestinal problems

This medication may increase blood pressure, and your doctor may monitor this periodically.

During treatment with celecoxib, some cases of severe liver reactions, such as severe liver inflammation, liver damage, and liver failure (some with fatal consequences or requiring liver transplantation) have been reported.Most of the 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 taken recently, or may need to take any other medication:

• dextromethorphan (medication for cough);
• ACE inhibitors, angiotensin II receptor antagonists, beta-blockers, and diuretics (medications used to treat hypertension and heart failure);
• fluconazole and rifampicin (medications for fungal or bacterial infections)
• warfarin or other medications like warfarin, including new medications like apixaban (agents that reduce blood clotting);
• lithium (medication for depression)
• some medications for depression, sleep disorders, high blood pressure, or cardiac arrhythmias
• neuroleptics (medications for mental disorders)
• methotrexate (medication for rheumatoid arthritis, psoriasis, and leukemia)
• carbamazepine (medication for epilepsy/convulsions and some types of pain or depression)
• barbiturates (medications for epilepsy/convulsions and some sleep disorders)
• ciclosporin 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 together.

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 this 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 difficulty becoming pregnant.

Driving and operating machinery

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

Celecoxib Kern Pharma contains lactose and sodium

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

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

Follow exactly the administration instructions indicated by your doctor for this medication. 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
• Two 100 mg capsules per 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:

• Two 100 mg capsules per 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
• Two 100 mg capsules per day

Since the risk of adverse effects associated with cardiac problems increases with the dose and duration of treatment, it is essential to take the lowest dose to control pain and not use Celecoxib Kern Pharma for longer than necessary to control symptoms.

Do not take more than 400 mg of celecoxib per day.

Renal or liver problems:Make sure your doctor knows that you have kidney or liver problems, as you will need a lower dose.

Patients over 65 years, 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 only for adults and is notindicated for children.

Administration form

Celecoxib Kern Pharma is for oral use.

Capsules can be taken at any time of the day, with or without food. However, try to take all Celecoxib Kern Pharma doses 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 room temperature) and swallowed immediately with a drink (approximately 240 ml or a glass of water).

To open the capsule, hold it upright 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 that 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 compensate for the missed doses.

If you interrupt treatment with Celecoxib Kern Pharma

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

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

Just like all medications,this medicationcan cause side effects, although not everyone will experience them.

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

Stop taking Celecoxib Kern Pharma and immediately inform your doctor 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 or bloody stools, or blood in the vomit.

-skin reactions such as rash, blisters or skin peeling.

-liver failure (symptoms may include nausea, 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
• Difficulty 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 heartbeats), tachycardia (rapid heart rate)
• Abnormalities in liver function tests
• Abnormalities in kidney function tests
• Anemia (changes in red blood cells that can cause fatigue and difficulty breathing)
• Anxiety, depression, fatigue, numbness, tingling
• High potassium levels in blood test results (may cause nausea, 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 elevation (urticarial hives)
• Eye inflammation
• Difficulty breathing
• Decoloration of the skin (cardenales)
• Chest pain (generalized pain not related to the heart)
• Facial swelling

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

• Ulcers (bleeding) in the stomach, throat or intestines; or intestinal rupture (may cause stomach pain, fever, nausea, vomiting, intestinal obstruction), dark or black stools, stomach or intestinal inflammation
• Low sodium levels in blood (a condition known as hyponatremia)
• Decreased white blood cell count or platelet count (may cause increased risk of bleeding and cardenales)
• Difficulty in muscle coordination of movements
• Sensation of confusion, altered taste
• Increased sensitivity to light
• Hair loss
• Hallucinations
• Eye hemorrhage
• Acute reaction that may lead to pulmonary inflammation
• Irregular heart rhythm
• Rubefaction
• Clots in the pulmonary blood vessels. Symptoms may include sudden difficulty breathing, acute chest pain or collapse
• Stomach or intestinal hemorrhage (may cause bloody stools or vomit), intestinal or colon inflammation
• Severe liver inflammation (hepatitis). Symptoms may include nausea, diarrhea, jaundice (yellowing of the skin and eyes), dark urine, pale stools, easy bleeding, itching or chills
• Acute kidney failure
• Menstrual disorders
• Facial, lip, mouth, tongue or throat swelling, 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 alterations such as Stevens-Johnson syndrome, exfoliative dermatitis and toxic epidermal necrolysis (may cause rash, blistering or skin peeling) 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 that causes death
• Meningitis (inflammation of the membrane surrounding the brain and spinal cord)
• Severe liver failure, liver damage and severe liver inflammation (hepatitis fulminant) (sometimes with fatal outcome or requiring liver transplant). Symptoms may include nausea, diarrhea, jaundice (yellowing of the skin and eyes), dark urine, pale stools, easy 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 (convulsions possibly more frequent and/or severe)
• Obstruction of an artery or vein in the eye that leads to partial or complete loss of vision
• Inflammation of blood vessels (may cause fever, pain, purple spots on the skin)
• Decreased white blood cell, red blood cell and platelet count (may cause fatigue, easy bleeding, frequent nosebleeds and increased risk of infections)
• Muscle pain and weakness
• Altered sense of smell
• Loss of sense of taste

Frequency not known: cannot be estimated from available data

• Decreased fertility in women, which is usually reversible if medication is stopped

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 side effects were observed:

Common: may affect up to 1 in 10 patients

• Cardiovascular problems: angina (chest pain);
• Gastrointestinal problems: irritable bowel syndrome (may include stomach pain, diarrhea, indigestion, gas)
• Kidney stones (which may cause 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 may cause pain, swelling or redness of the calf or problems breathing)
• Gastrointestinal problems: stomach infection (which may cause stomach irritation or ulcers in the stomach and intestines)
• Lower limb fractures
• Herpes, skin infection, eczema (dry, itchy rash), pneumonia (lung infection (possibility of cough, fever, difficulty breathing))
• Flies in the eye that cause vision disturbance or blurred vision, vertigo due to inner ear problems, ulcers, inflammation or bleeding of the gums, mouth ulcers
• Excessive nighttime urination, heavy menstrual bleeding, 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 effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

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

This medication does not require any special storage conditions.Store inthe original packaging to protect it from light and moisture.

Medications should not be disposed of through drains or in the trash. Deposit the 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 the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Celecoxib Kern Pharma

The active ingredient is celecoxib.

CelecoxibKern Pharma200 mg: Each hard capsule contains 200 mg of celecoxib.

The other components (excipients) are:

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

Capsule coating:gelatin and titanium dioxide (E171)

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

Appearance of Celecoxib Kern Pharma and content of the container

CelecoxibKern Pharma200 mg hard capsules are size “2” (approximately 17.8 mm ± 0.4 mm), contain white to off-white powder, and have a gray opaque cap and body.

The capsules are packaged inblister packs of polyvinyl chloride (PVC)/polyvinylidene chloride (PVDC)/aluminum (ALU).

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

Only some container sizes may be commercially marketed.

Marketing authorization holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Responsible for manufacturing

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 with the following names:

DE

Celecoxib Liconsa 200 mg Hartkapseln

ES

Celecoxib Kern Pharma 200 mg hard capsules EFG

Last review date of this leaflet: March 2019