Celecoxib Kern Pharma 200 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Celecoxib Kern Pharma 200 mg hard capsules EFG

Celecoxib

Read the entire leaflet carefully before you start taking this medicine, because 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, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Celecoxib Kern Pharma is and what it is used for

Celecoxib Kern Pharma is indicated to relieve the signs and symptoms of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis in adults.

Celecoxib Kern Pharma belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs), specifically to the subgroup known as selective 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 increased amounts of these substances. Celecoxib Kern Pharma works by reducing the production of prostaglandins and therefore decreases pain and inflammation.

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

Do not take Celecoxib Kern Pharma

• if you are allergic to celecoxib or to any of the other ingredients of this medicine (listed in section 6).

• if you have had an allergic reaction to the group of medicines known as "sulfonamides" (e.g., certain antibiotics used to treat infections).

• if you currently have a stomach or intestinal ulcer or gastrointestinal bleeding.

• if, after taking acetylsalicylic acid or any other non-steroidal anti-inflammatory and pain-relieving drug (NSAID), you have previously experienced asthma, nasal polyps, severe nasal congestion, or an allergic reaction such as skin rash, swelling of the face, lips, tongue or throat, breathing difficulties 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 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 in blood flow to the brain, also known as a "mini-stroke"), angina pectoris, or blockage of blood vessels supplying the heart or brain.

• if you have or have had circulation problems (peripheral arterial disease) or have had surgery on the arteries in your legs.

Warnings and precautions

Talk to your doctor or pharmacist before taking Celecoxib Kern Pharma:

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

(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 for cardioprotection).
• if you are taking drugs that reduce blood clotting (e.g., warfarin/anticoagulants such as warfarin or newer anticoagulant drugs such as apixaban).

if you are taking corticosteroid medicines (such as prednisone)

• if you are taking Celecoxib Kern Pharma at the same time as other non-acetylsalicylic acid 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 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 use of diuretics (medicines used to treat excess fluid in the body).
• if you have previously had a serious allergic reaction or a severe skin reaction to any medicine.
• if you feel unwell due to an infection or suspect 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 of age, your doctor will want to monitor you regularly.
• alcohol consumption and NSAIDs can increase the risk of gastrointestinal problems.

This medicine may increase blood pressure, so your doctor may monitor your blood pressure periodically.

Serious liver reactions, including severe hepatitis, liver damage, and liver failure (some fatal or requiring liver transplantation), have been reported during treatment with celecoxib. Among cases where the onset time was specified, most serious hepatic reactions occurred within the first month of treatment.

Other medicines and Celecoxib Kern Pharma

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

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

Celecoxib Kern Pharma may be used concomitantly with low-dose acetylsalicylic acid (75 mg or less per day). Consult your doctor or pharmacist before starting 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 Kern Pharma must not be used by pregnant women or women who may become pregnant (i.e., women of childbearing potential who are not using adequate contraceptive methods) during treatment. If you become pregnant while taking Celecoxib Kern Pharma, stop treatment immediately and contact your doctor to discuss alternative treatment.

Breastfeeding

Celecoxib Kern Pharma must 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 are having difficulty conceiving.

Driving and use of machines

You should be aware of 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 have passed.

Celecoxib Kern Pharma contains lactose and sodium

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

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

3. How to take Celecoxib Kern Pharma

Follow exactly the administration instructions given by your doctor for this medicine. If in 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 daily, or
• One 100 mg capsule twice daily

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 daily

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 daily, or
• One 100 mg capsule twice daily

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

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

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

Patients over 65 years of age, especially those weighing less than 50 kg: if you are over 65 years old, and particularly if you weigh less than 50 kg, your doctor may wish 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 intended for adults only and is not indicated for use in children.

Method of administration

Celecoxib Kern Pharma is for oral use.

The capsules can be taken at any time of day, with or without food. However, 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 may be sprinkled onto a spoonful of semisolid food (such as applesauce, rice pudding, yogurt, or mashed banana at room temperature or cold) and swallowed immediately with a drink (approximately 240 ml or a glass of water).

To open the capsule, hold it vertically to keep the powder at the bottom, then gently squeeze the top and twist it off, taking care not to spill the contents.

If you take more Celecoxib Kern Pharma than you should

Do not take more capsules than prescribed by your doctor. If you take too many capsules, contact your doctor, pharmacist, or hospital immediately, and bring the medicine with you so the doctor can see what you have taken.

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 missed doses.

If you stop taking Celecoxib Kern Pharma

Do not stop taking Celecoxib Kern Pharma unless instructed by your doctor.

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.

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

Stop taking Celecoxib Kern Pharma and immediately inform your doctor if you experience:

• 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 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 unwell), diarrhea, jaundice (skin or whites of the eyes appear yellow)).

Very common: may affect more than 1 in 10 patients

• Increased blood pressure, including worsening of pre-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 sinuses, sinus blockage or pain), stuffy 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 unwell)
• Joint pain
• Worsening of existing allergies
• Accidental injury

Uncommon: may affect up to 1 in 100 patients

• 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
• Anemia (changes in red blood cells which may cause fatigue and difficulty breathing)
• Anxiety, depression, fatigue, numbness, tingling sensation
• Elevated potassium levels 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, difficulty hearing*
• Constipation, belching, stomach inflammation (indigestion, stomach pain or vomiting), worsening of stomach or intestinal inflammation
• Leg cramps
• Itchy, raised rash (urticarial rash)
• Eye inflammation
• Difficulty breathing
• Skin discoloration (bruising)
• 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 perforation (may cause stomach pain, fever, nausea, vomiting, intestinal obstruction), dark or black stools, pancreatitis (may cause stomach pain), inflammation of the throat (esophagus)
• Low levels of sodium in the blood (a condition known as hyponatremia)
• Decrease in the number of white blood cells (which help protect the body from infections) or 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 bleeding
• 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 pain when breathing or collapse
• Stomach or intestinal bleeding (may result in bloody stools or vomit), inflammation of the intestine or colon
• Severe liver inflammation (hepatitis). Symptoms may include nausea (feeling unwell), diarrhea, jaundice (yellowing of the skin and eyes), dark urine, pale stools, easy bleeding, itching or chills
• Acute kidney failure
• Menstrual disorders
• Swelling of 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 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 generalized exanthematous pustulosis (symptoms include reddening of the skin with swollen areas and numerous small pustules)
• Delayed-onset allergic reaction with possible symptoms such as rash, facial swelling, fever, swollen glands and abnormal clinical test results (e.g., liver, blood cells (eosinophilia, a type of increase in white blood cell count))
• Bleeding in the brain 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), 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 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 (edema), 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 vision loss
• Inflammation of blood vessels (may cause fever, pain, purple spots on the skin)
• Reduction in the number of red blood cells, white blood cells and platelets (may cause fatigue, easy bruising, frequent nosebleeds and increased risk of infections)
• Muscle pain and weakness
• Impaired sense of smell
• Loss of taste

Frequency not known: cannot be estimated from available data

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

In clinical trials unrelated to arthritis or other arthritic conditions, where celecoxib was taken at doses of 400 mg per day for up to 3 years, the following adverse effects were observed:

Common: may affect up to 1 in 10 patients

• Heart problems: angina (chest pain);
• Stomach problems: irritable bowel syndrome (may include stomach pain, diarrhea, indigestion, gas)
• Kidney stones (may lead to stomach or back pain, blood in 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 breathing problems)
• Stomach problems: stomach infection (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, hemorrhoid/anal bleeding, frequent bowel movements
• Fatty lumps in the skin or other areas, ganglion cyst (painless swelling in or around joints or tendons, in hand or foot), difficulty speaking, abnormal or heavy vaginal bleeding, chest pain
• Elevated sodium levels 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 not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide 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 expiry date stated on the blister pack or cardboard container. The expiry date refers to the last day of the month indicated.

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

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

6. Contents of the pack and other information

Composition of Celecoxib Kern Pharma

The active substance 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-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 black iron oxide (E172).

Appearance of Celecoxib Kern Pharma and contents of the pack

Celecoxib Kern Pharma 200 mg hard capsules are size “2” (approximately 17.8 mm ± 0.4 mm), contain white to off-white powder, and have an opaque grey cap and body.

The capsules are packaged in blisters made of polyvinyl chloride (PVC)/polyvinylidene chloride (PVDC)/aluminum (ALU).

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

Only some pack sizes may be commercially available.

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 medicinal product is authorized in the Member States of the European Economic Area under the following names:

DE

Celecoxib Liconsa 200 mg Hard Capsules

ES

Celecoxib Kern Pharma 200 mg hard capsules EFG

Date of the most recent revision of this leaflet: March 2019