Celecoxib Pensa 200 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Celecoxib pensa 200 mg hard capsules EFG

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 must 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 reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Celecoxib pensa is and what it is 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 known as non-steroidal anti-inflammatory drugs (NSAIDs), and more specifically to the subgroup known as selective cyclooxygenase-2 (COX-2) inhibitors. Your body produces prostaglandins which can cause pain and inflammation. In conditions such as rheumatoid arthritis or osteoarthritis, your body produces them in higher amounts. Celecoxib works by reducing the production of prostaglandins, thereby decreasing pain and inflammation.

The medicine will start to work several hours after taking the first dose, but a full effect may not be felt until several days have passed.

2. What you need to know before taking Celecoxib pensa

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

Do not take Celecoxib pensa

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

• 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., some antibiotics used to treat infections)
• if you currently have a stomach or intestinal ulcer or bleeding
• if taking acetylsalicylic acid or any other anti-inflammatory and painkiller medicine (NSAIDs) has caused you to experience asthma, nasal polyps, severe nasal congestion, or an allergic reaction such as skin rash, swelling of the face, lips, tongue or throat, difficulty breathing or wheezing
• if you are pregnant. If you could 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 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 to 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 pensa

• if you have previously had an ulcer or bleeding in your stomach or intestine

(Do not takethis medicine if you currently have an ulcer or bleeding in your stomach or intestine).

• if you are taking acetylsalicylic acid (even at low doses such as for heart protection)
• if you are taking antiplatelet therapies
• if you take medicines to reduce blood clotting (e.g., warfarin/warfarin analogues or new oral anticoagulants, e.g., apixaban)
• if you are receiving medicines called 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 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, for example, due to an illness with vomiting or diarrhea, or due to the use of diuretics (used to treat excess fluid in the body)
• if you have had a severe allergic reaction or a serious skin reaction to any medicine
• if you feel unwell due to an infection or think you may 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
• alcohol consumption and NSAIDs may increase the risk of gastrointestinal problems

Like other anti-inflammatory medicines (e.g., ibuprofen or diclofenac), this medicine may increase blood pressure, so your doctor may carry out periodic monitoring.

Serious liver reactions have been reported, including severe hepatitis, liver damage, and liver failure (some of which were fatal or required liver transplantation). Among cases where onset was specified, these serious liver reactions occurred during the first month of treatment.

This medicine may make it harder 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 medicines and Celecoxib pensa

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

• Dextromethorphan (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 (used to treat infections caused by bacteria and fungi)
• Warfarin or other warfarin analogues (agents that reduce blood clot formation), including newer medicines such as apixaban
• Lithium (used to treat certain types of depression)
• Other medicines 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/seizures and certain types of pain or depression)
• Barbiturates (used to treat epilepsy/seizures and certain sleep disorders)
• Cyclosporine and tacrolimus (used for immunosuppression, e.g., after transplants)

This medicine may be taken with low-dose 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 become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

This medicine should not be used by pregnant women or women who may become pregnant (i.e., women of childbearing potential who are not using an adequate contraceptive method) during treatment. If you become pregnant while taking celecoxib, you must 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 harder to become pregnant. You should inform your doctor if you plan to become pregnant or if you are experiencing difficulty becoming pregnant.

Driving and using machines

You should be aware of how you react to this medicine before driving or operating 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 lactose (a type of sugar). If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

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

3. How to take Celecoxib pensa

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again. If you think or believe that the effect of celecoxib is too strong or too weak, inform your doctor or pharmacist.

Your doctor will determine the dose you should take. Since the risk of adverse effects related to heart problems may increase with dose and duration of treatment, it is important to use the lowest dose that controls your pain and you should not take this medicine longer than necessary to control symptoms.

The recommended dose is:

The recommended dose for the treatment of osteoarthritis is 200 mg per day; if necessary, your doctor may increase it up to a maximum of 400 mg.

The usual dosing regimen is:

• one 200 mg capsule once daily.

The recommended dose for the treatment of rheumatoid arthritis is 200 mg per day; if necessary, your doctor may increase it up to a maximum of 400 mg.

The usual dosing regimen is:

• one 100 mg capsule twice daily.

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 usual dosing regimen is:

• one 200 mg capsule once daily.

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 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 weigh less than 50 kg, your doctor may wish to monitor you more closely.

Use in children:

Celecoxib pensa is for adults only and is not indicated for use in children.

Method of administration

This medicine is for oral use. The capsules may be taken at any time of day, with or without food. However, try to take each dose of celecoxib at the same time each day.

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

To open the capsule, hold it vertically to keep the granules at the bottom; then squeeze the top and twist it off, taking care not to spill the contents. Do not chew or crush the granules.

Contact your doctor if you do not experience improvement within two weeks after starting treatment.

If you take more Celecoxib pensa than you should:

Do not take more capsules than prescribed by your doctor. If you take more celecoxib than prescribed, contact your doctor, pharmacist, or hospital immediately and bring the medicine with you.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, stating the name of the medicine and the amount ingested.

If you forget to take Celecoxib 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 discontinue treatment with Celecoxib, consider the following:

Suddenly stopping treatment with this medicine may cause your symptoms to worsen. Do not stop taking this medicine unless instructed by your doctor. Your doctor may advise you to gradually reduce the dose over several days before completely stopping treatment.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

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

The adverse effects listed below were observed in patients with arthritis who were taking celecoxib. The adverse effects marked with an asterisk (*) occurred in patients 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 of time.

If you experience any of the following adverse effects, stop treatment with celecoxib 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 blood-stained stools, or blood in vomit
• a skin reaction such as rash, blistering or peeling of the skin
• liver failure (symptoms may include nausea (feeling unwell), diarrhea, jaundice (your skin or the whites of your eyes appear yellow)).

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
• 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 adverse effects: may affect up to 1 in 100 patients:

• Stroke*

• Heart failure, palpitations (awareness of heartbeat), rapid heartbeat

• Abnormalities in blood tests related to the liver

• Abnormalities in blood tests related to the kidney

• Anemia (changes in red blood cells which may cause fatigue and difficulty breathing)

• Anxiety, depression, tiredness, numbness, tingling sensation

• Elevated levels of potassium 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, hearing difficulty*

• Constipation, belching, inflammation of the stomach (indigestion, stomach pain or vomiting), worsening of stomach or intestinal inflammation

• Leg cramps

• Itchy, raised rash (urticarial wheals)

• Eye inflammation

• Difficulty breathing

• Skin discoloration (bruising)

• 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 intestinal rupture (may cause stomach pain, fever, nausea, vomiting, intestinal obstruction), dark or black stools, inflammation of the pancreas (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) and platelets (increased risk of bleeding and bruising)
• Difficulty in muscular coordination of movements
• Feeling confused, taste disturbances
• Increased sensitivity to light
• Hair loss
• Hallucinations
• Eye hemorrhage
• Acute reaction that may lead to lung inflammation
• Irregular heartbeat
• Flushing
• Blood clots in the blood vessels of the lungs. Symptoms may include sudden shortness of breath, sharp pain when breathing, or collapse
• Bleeding from the stomach or intestines (may result in blood in 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, or difficulty swallowing

Very rare adverse effects: 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)
• A delayed allergic reaction with possible symptoms such as rashes, swelling of the face, fever, swollen glands and abnormalities in clinical test results [e.g.: liver, blood cells (eosinophilia, a type of increased blood cell count)]
• Bleeding in the brain causing 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)
• Inflammation of the kidneys 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 and white blood cells and platelets (may cause fatigue, easy bruising, frequent nosebleeds and increased risk of infections)
• Muscle pain and weakness
• Disturbance of taste sensation
• Loss of taste

Adverse effects with unknown frequency: frequency cannot be estimated from the available data:

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

Adverse effects reported in clinical trials in which celecoxib was administered at a dose of 400 mg daily for up to 3 years, in patients with conditions unrelated to arthritis or other arthritic conditions, were:

Common adverse effects: may affect up to 1 in 10 patients:

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

Uncommon adverse effects: may affect up to 1 in 100 patients:

• Deep vein thrombosis (blood clots usually in the leg, which may cause pain, swelling or redness in 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)]
• Floaters in the eye causing visual disturbance or blurred vision, vertigo due to inner ear problems, gum ulcers, inflammation or bleeding, mouth ulcers
• Excessive urination at night, hemorrhoid/anal bleeding, frequent bowel movements
• Fatty lumps in the skin or other areas, ganglion cyst (non-painful swelling in or around joints or tendons, usually in the hand or foot), difficulty speaking, abnormal or very heavy vaginal bleeding, chest pain
• Elevated levels of sodium in blood test results

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through 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 pensa

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the blister and on the carton after EXP.

The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Celecoxib pensa

• The active substance is celecoxib.

Each hard capsule contains 200 mg of celecoxib.

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

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

Appearance of the product and contents of the pack

Hard gelatin capsules size 0, opaque, with body and cap both white in colour, containing a homogeneous white or almost white powder free from particles.

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

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

Italy: Celecoxib Pensa Pharma 200 mg capsule rigide

Spain: Celecoxib pensa 200 mg hard capsules EFG

Date of the most recent review of this leaflet: May 2024

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