Information for the User: Package Insert

Celecoxib pensa 200 mg Hard Capsules EFG

Read this entire package insert carefully before taking this medicine, 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 medicine has been prescribed for you only, and you should not give it to others even if they 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.

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

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

3.How to take Celecoxib pensa

4.Possible side effects

5.Storage of Celecoxib pensa

6.Contents of the pack and additional information

This medication is indicated for adults to relieve the symptoms and signs ofrheumatoid arthritis, osteoarthritis, and ankylosing spondylitis.

Celecoxibbelongs to a class of medications known as nonsteroidal anti-inflammatory drugs (NSAIDs), specifically to the subgroup known as selective 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.Celecoxibacts by reducing the production of prostaglandins, thereby reducing pain and inflammation.

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

Your doctor has prescribed this medication for you. The following information will help you get the best results from this medication. If you have any other questions, please ask your doctor or pharmacist..

Do not takeCelecoxib if you think

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

• 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 known as “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, 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 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 coronary artery disease, or cerebrovascular disease, for example, if you have had a heart attack, stroke, or transient ischemic attack (temporary decrease in blood flow to the brain; also known as “mini-stroke”), angina, or obstruction of the heart or brain blood vessels
• if you have or have had peripheral artery disease or if you have been operated on to clear the arteries in your legs.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Celecoxib pensa

• if you have previously had a stomach or intestinal ulcer

(Do not takethis medicationif you currently have a stomach or intestinal ulcer).

• if you are taking acetylsalicylic acid (even at low doses as a heart protector)
• if you are taking antiplatelet therapies
• if you are taking medications to reduce blood clotting (e.g., warfarin/anticoagulant analogs or new oral anticoagulants, e.g., apixaban)
• if you are taking corticosteroids (e.g., prednisone)
• if you are taking celecoxib at the same time as other NSAIDs that do not contain acetylsalicylic acid, 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 ankles and feet)
• if you are dehydrated, for example, 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 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

Like other anti-inflammatory medications (e.g., ibuprofen or diclofenac), this medication may increase blood pressure, and your doctor may perform regular checks on this.

Some cases of severe liver reactions have been reported, including severe liver inflammation, liver damage, and liver failure (some with fatal consequences or requiring liver transplant).Of the cases that specified the time of onset, these severe liver reactions occurred during the first month of treatment.

This medication may 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 section Pregnancy and breastfeeding).

Other medications and Celecoxib pensa

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

• Dextromethorphan (used to treat cough)
• ACE inhibitors, angiotensin II receptor antagonists, beta-blockers, and diuretics (medications used to treat high blood pressure 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 certain types of depression)
• Other medications used to treat depression, sleep disorders, high blood pressure, or irregular heartbeat
• Neuroleptics (used to treat certain mental disorders)
• Methotrexate (used in rheumatoid arthritis, psoriasis, and leukemia)
• Carbamazepine (used to treat epilepsy/convulsions and certain types of pain or depression)
• Barbiturates (used to treat epilepsy/convulsions and certain sleep disorders)
• Ciclosporin and tacrolimus (used to suppress the immune system, e.g., after transplants)

This medication can be taken with low doses of acetylsalicylic acid (75 mg daily or less). Consult your doctor before taking both medications 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 medication.

Pregnancy

This medication should 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, you should discontinue treatment and contact your doctor for alternative treatment.

Breastfeeding

This medication should not be used during breastfeeding.

Fertility

NSAIDs, including celecoxib, 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 tothis medicationbefore driving or operating machinery. If you feel dizzy or drowsy after taking celecoxib, do not drive or operate machinery until these effects pass.

Celecoxib pensa contains lactose and sodium

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

This medication contains less than 1 mmol ofsodium(23 mg), which is essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.If you think or believe that the action of celecoxib is too strong or too 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 this medication for longer than necessary to control your symptoms.

Recommended dose:

The recommended dosefor 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 dosefor 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:

• two 100 mg capsules per day

The recommended dosefor the treatment of ankylosing spondylitisis 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 per day.

Do not take more than 400mg per day.

Problems with the kidneys or liver:make sure your doctor knows if you have problems with the liver or kidneys since you may need a lower dose.

Patients over 65 years, especially those weighing less than 50 kg:if you are over 65 years old and weigh less than50 kg, your doctor may want to monitor you more closely.

Use in children:

Celecoxib pensa is only for adults,it is not indicated for children.

Administration form

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

If you have difficulty swallowing the capsules: you can spread the entire contents 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 water 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 turn it to extract it, being careful not to spill the contents.Do not chew or crush the granules.

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

If you take more Celecoxib pensa than you should:

You should not take more capsules than indicated by your doctor.If you take more celecoxib 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 ingested.

If you forgot to takeCelecoxib pensa:

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 treatment with Celecoxib pensa:

Stopping treatment abruptly with this medication may worsen your symptoms. Do not stop taking this medication unless your doctor tells you to. Your doctor may instruct you to reduce the dose for a few days before stopping treatment completely.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The side effects listed 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 and inform your doctor immediately:celecoxibe informe a su médico inmediatamente:

Si tiene:

• 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 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)).

Other side effects:

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 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), 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 100 patients:

• Stroke*

• Heart failure, palpitations (perception of heartbeats), tachycardia (rapid heart rate)
• Abnormalities in liver-related blood tests
• Abnormalities in kidney-related blood tests
• 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 (sensation of discomfort), 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 hives (hives with itching and raised lesions)
• Eye inflammation
• Difficulty breathing
• Decoloration of the skin (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, esophagus or intestines; or intestinal rupture (may cause stomach pain, fever, nausea, vomiting, intestinal obstruction), dark or black stools, pancreatitis inflammation (may cause stomach pain), esophageal 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 cardenales)
• Difficulty in coordinating muscle movements
• Confusion, altered taste
• Increased sensitivity to light
• Hair loss
• Hallucinations
• Eye hemorrhage
• Acute reaction that may lead to pulmonary inflammation
• Irregular heart rhythm
• Rubefaction
• Thrombi in the pulmonary blood vessels. Symptoms may include sudden difficulty breathing, acute 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 (sensation of discomfort), 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, or difficulty swallowing

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

• Severe allergic reactions (including potential 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)
• Delayed 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)]
• Cerebral hemorrhage leading to 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 (sensation of discomfort), 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 (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, purple spots on the skin)
• Decreased red and white blood cell count and platelet count (may cause fatigue, easy bleeding, 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 female fertility, which is normally reversible if medication is discontinued

The side effects reported in clinical trials in which celecoxib was administered at a dose of 400 mg per day for a period of up to 3 years in patients with diseases unrelated to arthritis or other arthritic conditions were:

Frequent side effects: may 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 stomach or back pain, blood in the urine), difficulty urinating
• Weight gain

Rare side effects: may affect up to 1 in 100 patients:

• Deep vein thrombosis (blood clots generally 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 [chest infection (possibility of cough, fever, difficulty breathing)]
• Flies in the eye causing visual disturbance or blurred vision, vertigo due to inner ear problems, ulcers, inflammation or bleeding of the gums, mouth ulcers
• Excessive nighttime urination, vaginal bleeding or hemorrhoids, 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 severe vaginal bleeding, chest pain
• Elevated sodium levels in blood test results

Reporting of side effects:

If you experienceany type of side effect, consult your doctor or pharmacist, even if it ispossibleside effects that do not appear in this prospectus.Also, you can report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine

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 and on the box after CAD.

The expiration date is the last day of the month indicated.

Do not store at a temperature above30°C.

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

Composition ofCelecoxib pensa

• The active ingredient is celecoxib.

Each hard capsule contains 200 mg of celecoxib.

• The other components are: sodium lauryl sulfate, povidone, lactose monohydrate, sodium croscarmellose, magnesium stearate.

The capsule coating contains: titanium dioxide (E171), gelatin

Appearance of the product and contents of the packaging

Hard gelatin capsules, size 0, opaque, white body and cap, containing a white or almost white homogeneous powder free of particles.

Blister packs available in packaging sizes of 20 or 30 hard capsules.

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible manufacturer:

Laboratorios Alter S.A.

C/ Mateo Inurria, 30.

28036 - Madrid

Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Italy: Celecoxib Pensa Pharma 200 mg rigid capsule

Spain: Celecoxib pensa 200 mg hard capsules EFG

Revision date of this leaflet:May 2024

Further detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es