CELECOXIB NORMON 200 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Celecoxib Normon 200 mg Hard Capsules EFG

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

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

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

Celecoxib Normon belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), specifically to the subgroup known as selective cyclooxygenase-2 (COX-2) inhibitors. Your body produces prostaglandins that can cause pain and inflammation. In conditions such as rheumatoid arthritis or osteoarthritis, your body produces them in larger quantities. Celecoxib Normon works by reducing the production of prostaglandins, thus reducing pain and inflammation.

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

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

2. What you need to know before you take Celecoxib Normon

Your doctor has prescribed Celecoxib Normon for you. The following information will help you get better results with Celecoxib Normon. If you have any other questions, please ask your doctor or pharmacist.

Do not take Celecoxib Normon

Tell your doctor if any of the following applies to you, as patients with these conditions should not take Celecoxib Normon:

• if you are allergic to celecoxib or any of the other ingredients of this medicine (listed in section 6).
• if you have 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
• if you have previously experienced any of the following symptoms after taking acetylsalicylic acid or any other anti-inflammatory medicine: asthma, nasal polyps, severe nasal congestion, or allergic symptoms such as skin rash with itching, swelling of the face, lips, tongue, or throat, 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
• 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 a "mini-stroke"), angina pectoris, or obstruction of the blood vessels that supply the heart or brain
• if you have or have had blood circulation problems (peripheral arterial disease) or if you have had surgery on the arteries in your legs.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Celecoxib Normon:

• if you have previously had a stomach or intestinal ulcer or bleeding (do not take Celecoxib Normon if you currently have a stomach or intestinal ulcer or bleeding)
• if you are taking acetylsalicylic acid (even at low doses as a heart protector)
• if you are taking antiplatelet therapies
• if you are taking medicines to reduce blood clotting (e.g., warfarin/anticoagulants analogous to warfarin or new oral anticoagulants, e.g., apixaban)
• if you are taking medicines called corticosteroids (e.g., prednisone)
• if you are taking Celecoxib Normon at the same time as other non-acetylsalicylic 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 work well, 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, 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 medicine
• if you feel unwell due to an infection or think you have an infection, as taking Celecoxib Normon may mask fever or other signs of infection and inflammation
• if you are over 65 years old, your doctor will want to monitor you regularly, as the consumption of alcohol and NSAIDs can increase the risk of gastrointestinal problems
• As with other anti-inflammatory medicines (e.g., ibuprofen or diclofenac), this medicine may increase your blood pressure, so your doctor may perform periodic blood pressure checks

Some cases of severe liver reactions have been reported with celecoxib, including

severe liver inflammation, liver damage, liver failure (some with a fatal outcome or requiring liver transplantation). Of the cases where the start of the event was specified, most severe liver reactions occurred within the first month of treatment.

Celecoxib Normon may make it more difficult to become pregnant. You should inform your doctor if you plan to become pregnant or if you are having difficulty becoming pregnant (see section Pregnancy, breastfeeding.

Using Celecoxib Normon with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines:

.

• Dextromethorphan (used to treat coughs).
• 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 bacterial and fungal infections).
• Warfarin or other warfarin-like medicines (agents that reduce blood clot formation), including newer medicines such as apixaban.
• Lithium (used to treat some types of depression).
• Other medicines used to treat depression, sleep disorders, high blood pressure, or irregular heartbeat.
• Antipsychotics (used to treat some mental disorders).
• Methotrexate (used in rheumatoid arthritis, psoriasis, and leukemia).
• Carbamazepine (used to treat epilepsy/seizures and some forms of pain or depression).
• Barbiturates (used to treat epilepsy/seizures and some sleep disorders).
• Ciclosporin and tacrolimus (used to suppress the immune system, e.g., after transplants).

Celecoxib Normon can be taken with low doses of acetylsalicylic acid (75 mg daily or less). Ask your doctor for advice 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 Normon should not be used by pregnant women or women who may become pregnant (i.e., women of childbearing potential who do not use adequate contraception) during treatment. If you become pregnant during treatment with Celecoxib Normon, you should stop treatment and contact your doctor for alternative treatment.

Breastfeeding

Celecoxib Normon should not be used during breastfeeding.

Fertility

NSAIDs, including Celecoxib Normon, may make it more 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 using machines

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

Celecoxib Normon contains lactose

This medicine contains lactose (a type of sugar). If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Celecoxib Normon contains sodium

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

3. How to take Celecoxib Normon

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again. If you think the effect of Celecoxib Normon is too strong or too weak, talk to your doctor or pharmacist.

Your doctor will tell you what dose to take. Since the risk of side effects associated with heart problems may increase with the dose and duration of treatment, it is important that you use the lowest dose that controls your pain and do not take Celecoxib Normon for longer than necessary to control the symptoms.

Method of administration:

Celecoxib Normon should be taken orally.The capsules can be taken at any time of the day, with or without food. However, try to take each dose of Celecoxib Normon at the same time each day.

If you have difficulty swallowing the capsules: you can sprinkle the entire contents of the capsule onto a level teaspoon of some semi-solid food (such as apple sauce, rice, yogurt, or mashed banana at cold or room temperature) and swallow it immediately with a glass of water of approximately 240 ml.

To open the capsule, hold it in a vertical position to keep the granules at the bottom; then, press the top and twist it to remove it, being careful not to spill the contents. Do not chew or crush the granules.

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

The recommended doseis:

The recommended dose for the treatment of osteoarthritisis 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 a day

The recommended dose for the treatment of rheumatoid arthritisis 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 a day

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 a day

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

Patient 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, especially if you weigh less than 50 kg

Do not take more than 400 mg per day

Use in children:Celecoxib Normon is for adults only; it is not indicated in children.

If you take more Celecoxib Normon than you should

Do not take more capsules than your doctor has told you. If you take more capsules than you should, consult your doctor, pharmacist, or hospital immediately and take the medicine with you.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medicine and the amount taken.

If you forget to take Celecoxib Normon

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

If you stop taking Celecoxib Normon

Stopping treatment with Celecoxib Normon abruptly may cause your symptoms to worsen. Do not stop taking Celecoxib Normon unless your doctor tells you to. Your doctor will tell you to reduce the dose over a few days before stopping treatment completely.

If you have any other questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible Adverse Effects

Like all medicines, Celecoxib Normon can cause adverse effects, although not all people suffer from them.

The adverse effects mentioned below were observed in patients with arthritis who were taking celecoxib. The adverse effects marked with an asterisk (*) occurred in patients who were taking celecoxib for the prevention of colon polyps and have been classified according to the highest frequency of occurrence. The patients included in these studies took celecoxib at high doses and for a prolonged period.

If you experience any of the following adverse effects, discontinue treatment with Celecoxib Normon 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 or stools stained with blood, or blood in vomit.
• a skin reaction such as rash, blisters, or peeling of the skin.
• liver failure (symptoms may include nausea, diarrhea, jaundice (yellowing of the skin or eyes)).

Very Common Adverse Effects(may affect more than 1 in 10 patients):

• Increase in blood pressure, including worsening of existing high blood pressure.

Common Adverse Effects(may affect up to 1 in 10 patients):

• Heart attack*
• Fluid retention with swelling of ankles, legs, and/or hands
• Urinary tract infections
• Difficulty breathing*, sinusitis (inflammation and infection of the paranasal sinuses, obstruction or pain in 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 Adverse Effects(may affect up to 1 in 100 patients):

• Stroke*
• Heart failure, palpitations (perception of heartbeat), rapid heartbeat
• Abnormal liver function tests
• Abnormal kidney function tests
• Anemia (changes in red blood cells that can cause fatigue and difficulty breathing)
• Anxiety, depression, fatigue, numbness, tingling sensation
• Elevated potassium levels in blood test results (can cause nausea, fatigue, muscle weakness, or palpitations)
• Blurred or altered vision, ringing in the ears, mouth ulcers, difficulty hearing*
• Constipation, belching, stomach inflammation (indigestion, stomach pain, or vomiting), worsening of stomach or intestinal inflammation
• Leg cramps
• Itchy rash with relief (urticarial wheal)
• Eye inflammation
• Difficulty breathing
• Skin discoloration (bruises)
• Chest pain (generalized pain not related to the heart)
• Swelling of the face

Rare Adverse Effects(may affect up to 1 in 1,000 patients):

• Ulcers (bleeding) in the stomach, throat, or intestines; or rupture of the intestine (can cause stomach pain, fever, nausea, vomiting, intestinal obstruction), dark or black stools, pancreatic inflammation (can cause stomach pain) esophageal inflammation
• Low sodium levels in the blood (a condition known as hyponatremia)
• Decreased number of white blood cells and platelets (increases the risk 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
• Flushing
• 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 cause stools or vomit with blood), intestinal or colon inflammation
• Severe liver inflammation (hepatitis). Symptoms may include nausea, diarrhea, jaundice (yellowing of the skin and eyes), dark urine, pale stools, ease of bruising, itching, or chills
• Acute kidney failure
• Menstrual disorders
• Swelling in 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 fatal anaphylactic shock)
• Severe skin reactions such as Stevens-Johnson syndrome, exfoliative dermatitis, and toxic epidermal necrolysis (can cause rash, blistering, or peeling of the skin) and acute generalized exanthematous pustulosis (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 blood cell count)]
• Brain bleeding 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, diarrhea, jaundice (yellowing of the skin and eyes), dark urine, pale stools, ease of bruising, 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 problems (such as nephrotic syndrome and minimal change disease, which may be accompanied by symptoms such as fluid retention, 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 blood vessels (can cause fever, pain, purple spots on the skin)
• Reduction in the number of red and white blood cells and platelets (can cause fatigue, ease of bruising, frequent nosebleeds, and increased risk of infections)
• Muscle pain and weakness
• Alteration of taste
• Loss of taste

Adverse Effects of Unknown Frequency(their frequency cannot be estimated from the available data):

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

Adverse Effects Reported in Clinical Trials in Which Celecoxib Was Administered

at a Dose of 400 mg per Day for More Than 3 Years, in Patients with Diseases Unrelated to Arthritis or Other Arthritic Conditions:

Common Adverse Effects(may affect up to 1 in 10 patients):

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

Uncommon Adverse Effects(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 intestines)
• 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, dizziness due to problems in the inner ear, ulcers, inflammation, or bleeding of the gums, mouth ulcers
• 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 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 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 Normon

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

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

Store below 30°C.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Celecoxib Normon

The active ingredient is celecoxib. Each capsule contains 200 mg of celecoxib.

The other components (excipients) are: lactose monohydrate, sodium lauryl sulfate, povidone, sodium croscarmellose, anhydrous colloidal silica, and magnesium stearate. The capsule is composed of gelatin, titanium dioxide (E-171), and yellow iron oxide (E-172).

Appearance of the Product and Package Contents

Celecoxib Normon are hard capsules with a yellow cap and a white body.

They are available in packages containing 30 hard capsules.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the Last Revision of this Prospectus: July 2024

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

You can access detailed information about this medicine by scanning the QR code included in the prospectus and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/78687/P_78687.html