Prospecto: information for the user

Celecoxib NORMON200 mg hard capsules EFG

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed only for you, and you must not give it to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are not listed in this prospect. See section 4.

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

2. What you need to know before starting to take Celecoxib NORMON

3. How to take Celecoxib NORMON

4. Possible adverse effects

5. Storage of Celecoxib NORMON

6. Contents of the pack and additional information

CelecoxibNormonbelongs to a class of medications known as nonsteroidal anti-inflammatory drugs (NSAIDs),specifically to the subgroup known as cyclooxygenase-2 (COX-2) inhibitors. The body produces prostaglandins that can cause pain and inflammation. In conditions such as rheumatoid arthritis or osteoarthritis, the body produces them in greater quantities. CelecoxibNormonacts by reducing the production of prostaglandins, thereby reducing pain and inflammation.

CelecoxibNormonis indicatedinadultsfor relieving the symptoms ofrheumatoid arthritis,osteoarthritis, and ankylosing spondylitis

The medication will begin to take effect a few hours after taking the first dose, but it may take several days to experience a complete effect.

Your doctor has prescribed Celecoxib Normon. 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

Inform your doctor if any of the following circumstances affect you, as patients with these conditions should not take Celecoxib Normon:

• if you are allergic tolcelecoxib or any of the other components of this medication (listed in section 6).
• if you have had any allergic reaction to any medication in the group called “sulfamidas” (e.g., some antibiotics used to treat infections)
• if you havecurrentlyan ulcer or bleeding in your stomach or intestine
• if you have previously experienced any of the following symptoms as a result of taking acetylsalicylic acid or any other anti-inflammatory medication: asthma, nasal polyps, severe nasal congestion, or allergic symptoms such as skin rash with itching, facial swelling, lip, tongue, or throat swelling, 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 your child
• 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 decrease in blood flow to the brain; also known as “mini-stroke”), angina pectoris,or obstruction of blood vesselsthatirrigate the heart orthebrain
• if you have or have had problems with blood circulation (peripheral arterial disease) or if you have been operated on your leg arteries.

Warnings and precautions

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

• if you have hadpreviouslyan ulcer or bleeding in your stomach or intestine (Do not take Celecoxib Normonif you currently have an ulcer or bleeding in your stomach or intestine)
• if you are taking acetylsalicylic acid (even at low doses as a heart protector)
• if you are taking antiplatelet therapies!
• if you are receiving medications to reduce blood clotting (e.g., warfarin/anticoagulant analogs or new oral anticoagulants, e.g., apixaban)
• if you are receiving corticosteroids (e.g., prednisone)
• if you are taking Celecoxib Normonat the same time as other non-acetylsalicylic acid anti-inflammatory medications such as ibuprofen or diclofenac. You should avoid using these medications together
• if you are a smoker, have diabetes, 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 (e.g., swollen feet or ankles)
• if you are dehydrated, e.g., due to a disease 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 medication
• if you feel unwell due to an infection or think you have an infection, as taking Celecoxib Normonmay mask fever or other signs of infection and inflammation
• if you are over 65 years old, your doctor will want to monitor you regularlyThe consumption of alcohol and NSAIDs may increase the risk of gastrointestinal problems
• Like other anti-inflammatory medications (e.g., ibuprofen or diclofenac), this medication may increase your blood pressure, so your doctor may perform regular checks

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

severe liver inflammation, liver damage, liver failure (some with fatal outcome or requiring liver transplant).Of the cases in which it was specified when the event started, most severe liver reactions occurred in the first month of treatment.

Celecoxib Normonmay make it difficult to become pregnant. You should inform your doctor if you plan to become pregnant or if you have difficulty becoming pregnant (see Pregnancy, lactation section).

Use of Celecoxib Normonwith other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication:

.

• Dextromethorphan (used to treat cough)
• ACE inhibitors or angiotensin II receptor antagonists, beta-blockers, and diuretics (medications used to treat hypertension and heart failure)
• Fluconazole and rifampicin (used to treat infections caused by bacteria and fungi)
• Warfarin or other warfarin analogs (agents that reduce blood clotting), including newer medications such as apixaban
• Lithium (used to treat some types of depression)
• Other medications used to treat depression, sleep disorders, high blood pressure, or irregular heartbeat
• Neuroleptics (used to treat some mental disorders)
• Methotrexate (used in rheumatoid arthritis, psoriasis, and leukemia)
• Carbamazepine (used to treat epilepsy/convulsions and some forms of pain or depression)
• Barbiturates (used to treat epilepsy/convulsions and some sleep disorders)
• Ciclosporin and tacrolimus (used to treat immunosuppression, e.g., after transplants)

Celecoxib Normoncan be taken with low doses of acetylsalicylic acid (75 mg daily or less). Consult your doctor before taking both medications together.

Pregnancy, lactation, 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 medication

Pregnancy

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

Lactation

Celecoxib Normonshould not be usedduring breastfeeding.

Fertility

NSAIDs, including Celecoxib Normon, may make it 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 operating machinery

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

Celecoxib Normoncontains lactose

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

Celecoxib contains sodium

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. If you think or believe that the action of Celecoxib Normon is too strong or weak, inform your doctor or pharmacist.

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

Administration form:

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

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

To open the capsule, hold it in a vertical position to keep the granules at the bottom; then,

press the top and turn it to extract it, being careful not to spill the content.Do not chew or crush the granules.

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

Therecommendeddoseis:

The recommended dosefor the treatment of osteoarthritisis 200 mg per day, if your doctor may increase it up to a maximum of 400 mg.

The dose is usually:

• one capsule of 200 mgonce a day

The recommended dose for the treatment of rheumatoid arthritisis 200 mg per day, if your doctor may increase it up to a maximum of 400 mg:

The dose is usually:

• one capsule of 100 mg twice a day

The recommended dose for the treatment of ankylosing spondylitis

is 200 mg per day, if your doctor may increase it up to a maximum of 400 mg.

The dose is usually:

• one capsule of 200 mgonce a day

Problemsin the kidney or liver:make sure your doctor knows if you have problems in the liver or kidney since you may need a lower dose.

Patients over 65 years, especially those with a weight of less than 50 kg:Your doctor may want to monitor you more closely if you are over 65 years old and especially if you weigh less than 50 kg.

You should not take more than 400 mg per day.

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

If you take more Celecoxib Normonthan you should

You should not take more capsules than indicated by your doctor. If you take more capsules than you have been told, consult your doctor, pharmacist, or hospital immediately and bring the medication with you.

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

If you forgot to take Celecoxib Normon

If you forgot to take a capsule, take it as soon as you remember. Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with Celecoxib Normon

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

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

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

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

If you experience any of the following side effects, discontinue treatment with Celecoxib Normon and immediately inform your doctor if you have :

• an allergic reaction such as skin rash, facial swelling, sneezing, 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 with blood, or blood in the vomit.
• a skin reaction such as rash, blisters, or skin peeling.
• liver insufficiency (symptoms may include nausea, diarrhea, jaundice (yellowing of the skin or eyes)).

Frequent side effects(may affect more than 1 in 10 patients):

• Increased blood pressure, including worsening of existing high blood pressure.

Common side effects(may affect up to 1 in 10 patients):

• Myocardial infarction*
• Fluid retention with swelling of the ankles, legs, and/or hands
• Urinary tract infections
• Respiratory difficulty*, sinusitis (inflammation and infection of the paranasal sinuses, obstruction or pain of the paranasal sinuses), nasal congestion or discharge, sore throat, cough, cold, flu-like symptoms
• Dizziness, difficulty sleeping
• Vomiting*, stomach pain, diarrhea, indigestion, gas
• Rash, itching
• Muscle stiffness
• Difficulty swallowing*
• Headache
• Nausea (sensation of discomfort)
• Joint pain
• Worsening of existing allergies
• Accidental injury

Rare side effects(may affect up to 1 in 1,000 patients):

• Stroke*
• Heart failure, palpitations (perception of heartbeats), tachycardia (rapid heart rate)
• Abnormal liver function test results
• Abnormal kidney function test results
• Anemia (changes in red blood cells that may cause fatigue and difficulty breathing)
• Anxiety, depression, fatigue, numbness, tingling
• Elevated potassium levels in blood test results (may cause nausea, fatigue, muscle weakness, or palpitations)
• Blurred or altered vision, tinnitus (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
• Urticarial rash (hives)
• Eye inflammation
• Difficulty breathing
• Skin discoloration (cardenales)
• Chest pain (generalized pain not related to the heart)
• Facial swelling

Very rare side effects(may affect up to 1 in 10,000 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, intestinal inflammation
• Low sodium levels in the blood (a condition known as hyponatremia)
• Decreased white blood cell count (which helps protect the body from infections) and platelet count (increases the risk of bleeding and petechiae)
• 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
• Blood clots in the pulmonary vessels. Symptoms may include sudden difficulty breathing, sharp chest pain, or collapse
• Gastrointestinal or intestinal hemorrhage (may 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, easy bruising, itching, or chills
• Acute kidney failure
• Menstrual disorders
• Facial, lip, mouth, tongue, or throat swelling, or difficulty swallowing

Very rare side effects: may affect up to 1 in 10,000 patients:

• -Severe allergic reactions (including potential anaphylactic shock that can be fatal)
• -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)
• -Late-onset allergic reaction with possible symptoms such as rash, facial swelling, fever, swollen lymph nodes, and abnormal laboratory test results [e.g., liver, blood cells (eosinophilia, a type of increased white blood cell count)]
• -Cerebral hemorrhage that causes death
• -Meningitis (inflammation of the membrane surrounding the brain and spinal cord)
• -Severe liver insufficiency, liver damage, and severe liver inflammation (hepatitis fulminans) (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 bruising, itching, or chills
• -Liver problems (such as cholestasis and cholestatic hepatitis, which may be accompanied by symptoms such as pale stools, nausea, and yellowish discoloration 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 (seizures possibly more frequent and/or severe)
• -Obstruction of an artery or vein in the eye leading to partial or complete loss of vision
• -Vascular inflammation (may cause fever, pain, and purplish discoloration of the skin)
• -Decreased red and white blood cell count and platelet count (may cause fatigue, easy bruising, frequent nosebleeds, and increased risk of infections)
• -Muscle pain and weakness
• -Altered sense of taste
• -Loss of taste

Side effects of unknown frequency(their frequency cannot be estimated from available data):

- Decreased fertility in women, which is usually reversible if medication is discontinued

Notified side effectsin 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,were:

Frequent side effectsmay affect up to 1 in 10 patients:

• Cardiac problems: angina pectoris (chest pain)
• Gastrointestinal problems: irritable bowel syndrome (may include abdominal pain, diarrhea, indigestion, and gas)
• Kidney stones (which may cause abdominal or back pain, blood in the urine), difficulty urinating
• Weight gain

Rare side effectsmay affect up to 1 in 10,000 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 irritation or ulcers in the stomach and intestines)
• Fracture of lower limbs
• Herpes, skin infection, eczema (dry, itchy rash), pneumonia (lung infection, possibility of cough, fever, difficulty breathing)
• Flies in the eye that cause visual disturbance or blurred vision, vertigo due to inner ear problems, ulcers, inflammation, or bleeding of the gums, mouth ulcers
• Nocturia (excessive nighttime urination), heavy menstrual bleeding, frequent bowel movements
• Lipomas (fatty tumors) in the skin or other areas, ganglion cysts (non-painful inflammation in the joints or tendons or around them, in the hand or foot), difficulty speaking, abnormal vaginal bleeding, chest pain
• Elevated 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 packaging after CAD. The expiration date is the last day of the month indicated.

Store below 30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

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 contents of the packaging

Celecoxib Normonarehard capsules with a yellow cap and a white body.

They are presented in containers holding 30 hard capsules.

.

Holder of the marketing authorization and responsible manufacturer

Laboratorios Normon, S.A.

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

Date of the last review of this leaflet: July 2024

The detailed information on this medication is available onthe website ofthe Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/