CELECOXIB PENSA 200 mg HARD CAPSULES

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

This medicine is indicated in adults to relieve the signs and symptoms of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis.

Celecoxib belongs to a class of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), and more 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 works by reducing the production of prostaglandins, thus reducing pain and inflammation.

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 pensa

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

Do not takeCelecoxib pensa

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

• 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 the group of medicines 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 anti-inflammatory and analgesic drug (NSAIDs), you have experienced asthma, nasal polyps, severe nasal congestion, or an allergic reaction such as skin rash, face, 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 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 of blood flow to the brain; also known as a “mini-stroke”), angina pectoris, or obstruction of blood vessels to the heart or brain
• if you have or have had blood circulation problems (peripheral arterial disease) or if you have undergone surgery on 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 or bleeding

(Do not takethis medicineif 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 take medicines to reduce blood coagulation (e.g. warfarin/warfarin-like anticoagulants 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. The concomitant 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 ankles and feet)
• if you are dehydrated, for example, as a result of 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 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 can increase the risk of gastrointestinal problems

As with other anti-inflammatory drugs (e.g. ibuprofen or diclofenac), this medicine may increase blood pressure, and your doctor may perform periodic blood pressure checks.

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

This medicine 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 (see section Pregnancy and breastfeeding).

Other medicines and Celecoxib pensa

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

• Dextromethorphan (used to treat cough)
• ACE inhibitors, angiotensin II receptor antagonists, beta-blockers, and diuretics (medicines used to treat hypertension and heart failure)
• Fluconazole and rifampicin (used to treat bacterial and fungal infections)
• Warfarin or other warfarin-like anticoagulants (blood clot formation reducing agents), 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 for immune system suppression, e.g. after transplants)

This medicine 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

This medicine should not be used during pregnancy or in women who may become pregnant (i.e. women of childbearing potential who do not use adequate contraceptive methods) during treatment. If you become pregnant during treatment with celecoxib, you should stop treatment and contact your doctor for alternative treatment.

Breastfeeding

This medicine 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 using machines

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

Celecoxib pensa contains lactose and sodium

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

Each capsule contains less than 1 mmol of sodium(23 mg), i.e. it is essentially “sodium-free”.

3. How to take Celecoxib pensa

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist. If you think the effect of celecoxib 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 this medicine for longer than necessary to control the symptoms.

The recommended dose is:

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 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 once a day.

Do not take more than 400 mg per 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 old, especially those weighing less than 50 kg:if you are over 65 years old and weigh less than 50 kg, your doctor may want to monitor you more closely.

Use in children:

Celecoxib pensa is only for adults; it is not indicated in children.

Method of administration

This medicine 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 at the same time every day.

If you have difficulty swallowing the capsules: you can sprinkle the entire contents of the capsule onto a level teaspoon of soft 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 squeeze 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.

If you take more Celecoxib pensa than you should:

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

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or poison control center immediately (telephone: 91 562 04 20), stating the medicine and the amount taken.

If you forget to takeCelecoxib pensa:

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 pensa:

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

If you have any further questions on 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 all people suffer from them.

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

If you experience any of the following adverse effects, discontinue treatment withcelecoxiband 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, or dark urine)

Other Adverse Effects:

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

• Increased 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 infection
• Difficult breathing*, sinusitis, 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
• Joint pain
• Worsening of existing allergies
• Accidental injury

Uncommon Adverse Effects: may affect up to 1 in 100 patients:

• Stroke*

• Heart failure, palpitations, rapid heartbeat
• Abnormal liver blood tests
• Abnormal kidney blood tests
• Anemia
• Anxiety, depression, fatigue, numbness, tingling
• High potassium levels in blood tests
• Blurred or altered vision, ringing in the ears, mouth ulcers, difficulty hearing*
• Constipation, belching, stomach inflammation, worsening of stomach or intestinal inflammation
• Leg cramps
• Itchy rash with relief
• Eye inflammation
• Difficulty breathing
• Skin discoloration
• Chest pain
• Facial swelling

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

• Bleeding ulcers in the stomach, throat, or intestines; or intestinal rupture
• Low sodium levels in the blood
• Decreased white blood cell count and platelets
• Muscle coordination difficulties
• Confusion, taste disturbances
• Increased sensitivity to light
• Hair loss
• Hallucinations
• Eye bleeding
• Acute reaction that can lead to lung inflammation
• Irregular heartbeat
• Flushed skin
• Blood clots in the lungs
• Gastrointestinal bleeding or inflammation
• Severe liver inflammation
• Kidney problems
• Worsening of epilepsy
• Blockage of an artery or vein in the eye
• Blood vessel inflammation
• Decreased red and white blood cell count and platelets
• Muscle pain and weakness
• Taste disturbance
• Loss of taste

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, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis
• Delayed allergic reaction with possible symptoms such as rash, facial swelling, fever, swollen glands, and abnormal clinical test results
• Cerebral hemorrhage
• Meningitis
• Liver failure, liver damage, and severe liver inflammation
• Liver problems such as cholestasis and cholestatic hepatitis
• Kidney problems such as nephrotic syndrome and minimal change disease
• Worsening of epilepsy
• Blockage of an artery or vein in the eye
• Blood vessel inflammation
• Decreased red and white blood cell count and platelets
• Muscle pain and weakness
• Taste disturbance
• Loss of taste

Adverse Effects of Unknown Frequency: frequency cannot be estimated from 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 up to 3 years, in patients with diseases unrelated to arthritis or other arthritic conditions, were:

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

• Cardiac problems: angina pectoris
• Gastrointestinal problems: irritable bowel syndrome
• Kidney stones, difficulty urinating
• Weight gain

Uncommon Adverse Effects: may affect up to 1 in 100 patients:

• Deep vein thrombosis
• Gastrointestinal problems: stomach infection
• Fracture of lower limbs
• Herpes, skin infection, eczema, pneumonia
• Eye problems, vertigo, mouth ulcers, gum inflammation or bleeding
• Nocturia, hemorrhoids, frequent bowel movements
• Fat deposits in the skin or other areas, ganglion cyst, difficulty speaking, abnormal or heavy vaginal bleeding, chest pain
• High sodium levels in blood tests

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 pensa

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

Do not use this medicine after the expiration date that appears on the blister pack and carton after CAD.

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

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and unused medicines in the SIGRE collection point at the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofCelecoxib pensa

• The active ingredient is celecoxib.

Each hard capsule contains 200 mg of celecoxib.

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

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

Product Appearance and Package Contents

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

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

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

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 under the following names:

Italy: Celecoxib Pensa Pharma 200 mg hard capsules

Spain: Celecoxib pensa 200 mg hard capsules EFG

Date of the last revision of this prospectus:May 2024

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