Prospect: information for the user

Celecoxib Vir-Pharma 200 mg hard capsules EFG

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

• Keep this prospect, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you, and you should not give it to others who 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 prospect. See section 4.

Celecoxib belongs to a class of medications known as nonsteroidal anti-inflammatory drugs (NSAIDs), and 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. Celecoxib acts by reducing the production of prostaglandins, thereby reducing pain and inflammation.

Celecoxib Vir-Pharma is indicated in adults to alleviate the symptoms ofrheumatoid arthritis, osteoarthritis, and ankylosing spondylitis.

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 take Celecoxib Vir-Pharma

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

• if you areallergic to celecoxib or any of the other componentsof this medication (listed in section 6).
• if you have had anyallergic reactionto any medication in the group called “sulfonamides” (e.g., some are antibiotics used to treat infections).
• if you havecurrentlyanulcerorbleedingin your stomach or intestines.
• 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 asevere allergic reactionsuch as skin rash with itching, facial swelling, lip, tongue, or throat swelling, difficulty breathing, or wheezing.
• if you arepregnant. If you can become pregnant during treatment, discuss contraceptive methods with your doctor.
• if you arebreastfeeding your child.
• if you have aserious liver disease.
• if you have aserious kidney disease.
• if you haveinflammatory bowel diseasesuch asulcerative colitisorCrohn's disease.
• if you haveheart failure, diagnosed coronary artery disease, orstroke, 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 “mini-stroke”), angina, or obstruction of the heart or brain blood vessels.
• if you have or have hadcirculatory problems(peripheral artery disease) or if you have beenoperatedon the arteries of your legs.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Celecoxib Vir-Pharma:

• if you have previously had astomach ulceror bleeding in your stomach or intestines (Do not take Celecoxib Vir-Pharmaif you currently have a stomach ulcer or bleeding in your stomach or intestines).
• if you are takingacetylsalicylic acid(even at low doses as a heart protector).
• if you are taking antiplatelet therapies
• if you are receivingmedications to reduce blood clotting(e.g., warfarin,

anticoagulant analogs of warfarin or new oral anticoagulants, e.g., apixaban)

• if you are receiving medications called corticosteroids (e.g., prednisone)
• if you are taking Celecoxib Vir-Pharma at the same time as othernon-acetylsalicylic acid NSAIDssuch as ibuprofen or diclofenac. You should avoid using these medications together.
• if you are asmoker, have diabetes, high blood pressure, or high cholesterol.
• if yourheart, liver, or kidneys do notfunction well, your doctor may want to monitor you regularly.
• if you havefluid retention(e.g., swollen feet or ankles).
• if you aredehydrated, 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 experienced asevere allergic reactionor a severe skin reaction to any medication.
• if you feel unwell due to aninfectionor think you have an infection, as taking Celecoxib Vir-Pharma may mask fever or other signs of infection and inflammation.
• if you areover 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 othernonsteroidal anti-inflammatory drugs(e.g., ibuprofen or diclofenac), this medication may increase your blood pressure, so your doctor may perform regular checks.

Some cases ofsevere liver damagehave been reported with celecoxib, including severe liver inflammation, liver damage, and liver failure (some with fatal outcome or requiring liver transplant).Most of the severe liver damage cases occurred in the first month of treatment.

Celecoxib Vir-Pharma may make it difficult to becomepregnant. You should inform your doctor if you plan to become pregnant or if you have difficulty becoming pregnant (see Pregnancy and breastfeeding).

Use of Celecoxib Vir-Pharma with other medications

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

• Dextromethorphan(used to treat cough).
• ACE inhibitorsangiotensin 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).
• Warfarinor otherwarfarin analogs(agents that reduce blood clotting). Including newer medications such as apixaban
• Lithium(used to treat certain types of depression).
• Other medicationsused 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).
• Ciclosporinandtacrolimus(used to treat immunosuppression, e.g., after transplants).

Celecoxib Vir-Pharma can be taken with low doses ofacetylsalicylic acid(75 mg daily or less). Consult your doctor before taking both medications together.

Pregnancy and 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

Celecoxib Vir-pharma 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 Vir-Pharma, discontinue treatment and contact your doctor for alternative treatment.

Breastfeeding

Celecoxib Vir-Pharma should not be used during breastfeeding.

Fertility

NSAIDs, including Celecoxib Vir-Pharma, 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 Vir-Pharma before driving or operating machinery. If you feel dizzy or drowsy after taking Celecoxib Vir-Pharma, do not drive or operate machinery until these effects pass.

Celecoxib Vir-Pharma contains lactose

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

Celecoxib Vir-Pharma contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per capsule; that is, it 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 Vir-Pharma 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 Vir-Pharma for longer than necessary to control symptoms.

Administration form:

Celecoxib Vir-Pharma must be administered orally.The capsules can be taken at any time of the day, with or without food. However, try to take each dose of Celecoxib Vir-Pharma 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.

The recommended dose is:

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

The usual dose is:

• 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 recommended initial dose of 200 mg (administered in two doses of 100 mg per day) is not possible with this medication. Please consult your doctor.

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 usual dose is:

• one 200 mg capsule once a day.

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

Patients over 65 years old, especially those weighing 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 Vir-Pharma is only for adults, it is not indicated for children.

If you take more Celecoxib Vir-Pharma than you should

You should not take more capsules than indicated by your doctor. If you take more Celecoxib Vir-Pharma 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 Vir-Pharma

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 Vir-Pharma

Stopping treatment with Celecoxib Vir-Pharmamay cause a worsening of symptoms. Do not stop taking this medication 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 or pharmacist.

Like all medications, this medication may 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 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 side effects, discontinue treatment with Celecoxib Vir-Pharma and inform your doctor immediately:

If you have:

• 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 peeling of the skin.
• liver insufficiency [the symptoms may include nausea (feeling of discomfort), diarrhea, jaundice (your skin or the white of your eyes appears yellow)].

Very common (may affect more than 1 in 10 patients)

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

Common (may affect up to 1 in 10 patients)

• Myocardial infarction*
• 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 of the paranasal sinuses), nasal congestion 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*
• Worsening of existing allergies
• Headache
• Nausea (feeling of discomfort)
• Joint pain
• Accidental injury

Uncommon (may affect up to 1 in 100 patients)

• Stroke*
• Heart failure, palpitations (perception of heartbeats), tachycardia (rapid heart rate)
• Abnormalities in liver function tests
• Abnormalities in kidney function tests
• Anemia (changes in red blood cells that may cause fatigue and difficulty breathing)
• Anxiety, depression, fatigue, numbness, tingling
• High potassium levels in blood test results [may cause nausea (feeling 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
• Rash with itching and elevation (urticarial hives)
• Eye inflammation
• Difficulty breathing
• Decoloration of the skin (cardenales)
• Chest pain (generalized pain not related to the heart)
• Facial swelling

Rare (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, intestinal inflammation, pancreatitis (may cause stomach pain)
• Low sodium levels in blood (a condition known as hyponatremia)
• Decreased white blood cell count (which helps protect the body from infections) or platelet count (increases the risk of bleeding and cardenales)
• Difficulty in muscle coordination of movements
• Confusion, altered sense of 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
• Stomach or intestinal hemorrhage (may cause stools or vomit with blood), intestinal or colon inflammation,
• Severe liver inflammation (hepatitis). Symptoms may include nausea (feeling of discomfort), diarrhea, jaundice (yellow discoloration of the skin and eyes), dark urine, pale stools, easy bleeding, itching, or chills
• Acute kidney failure
• Menstrual disorders
• Swelling in the face, lips, mouth, tongue, or throat, or difficulty swallowing

Muy rare: (may affect up to 1 in 10,000 patients):

• Brain hemorrhage that causes death.
• Severe allergic reactions (including potential anaphylactic shock) Severe skin alterations such as Stevens-Johnson syndrome, exfoliative dermatitis, and toxic epidermal necrolysis (may cause rash, blistering, or peeling of the skin) and acute generalized pustular psoriasis (symptoms include redness of the skin with swollen areas and numerous small pustules).
• A late-onset allergic reaction with possible symptoms such as rashes, 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)].
• Liver insufficiency, liver damage, and severe liver inflammation (fulminant hepatitis) (sometimes with fatal outcome or requiring liver transplant). Symptoms may include nausea (feeling of discomfort), diarrhea, jaundice (yellow discoloration 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 yellow 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)
• Meningitis (inflammation of the membrane surrounding the brain and spinal cord).
• Worsening of epilepsy (seizures possibly more frequent and/or severe).
• Vascular inflammation (may cause fever, pain, and purple spots on the skin).
• Obstruction of an artery or vein in the eye that leads to partial or complete loss of vision,
• Decreased red and white blood cell count and platelet count (may cause fatigue, easy bleeding, frequent nosebleeds, and increased risk of infections).
• Altered sense of smell.
• Muscle pain and weakness
• Ageusia (loss of taste)

Frequency not known (cannot be estimated from available data):

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

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 non-arthritis-related diseases or other arthritic conditions were:

Common (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, gas)
• Kidney stones (which may cause stomach or back pain, blood in the urine), difficulty urinating
• Weight gain

Uncommon (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 difficulty breathing).
• Gastrointestinal problems: stomach infection (which may cause 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 that cause vision disturbance or blurred vision, vertigo due to inner ear problems, ulcers, inflammation, or bleeding of the gums, mouth ulcers.
• Excessive nighttime urination, heavy menstrual bleeding, 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 very heavy vaginal bleeding, chest pain.
• High 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:http://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 blister pack and on the packaging, after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Celecoxib Vir-Pharma

The active ingredient is celecoxib.

Each hard capsule contains 200 mg of celecoxib.

The other components (excipients) are: the granule contains lactose monohydrate, povidone, croscarmelose sodium, laurilsulfate of sodium, magnesium stearate (E572) (The capsule coating contains gelatin (E441), titanium dioxide (E171), iron oxide yellow (E172). The printing ink contains shellac lacquer (E904), propylene glycol (E1520) and iron oxide yellow (E-172).

Appearance of the product and content of the container

Hard, opaque, white capsules. The body contains a yellow band with the text “C9OX-200” in white.

Celecoxib Vir-Pharma may be presented in containers of 1, 10, 20, 30, 40, 50, 60 or 100 hard capsules.

Only some container sizes may be commercially available.

Marketing Authorization Holder

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Polígono Industrial URTINSA II

28923 Alcorcón (Madrid)

Spain

Responsible for manufacturing

Synthon BV

Microweg 22

6545 CM, Nijmegen

Netherlands

or

Synthon Hispania S.L

Castelló, 1

Polígono Las Salinas

08830 Sant Boi de Llobregat

Spain

or

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Polígono Industrial URTINSA II

28923 Alcorcón (Madrid)

Spain

or

G.L. Pharma GmbH

Schlossplatz 1,

8502 Lannach,

Austria

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

NetherlandsLicebril 200 mg, capsules, hard

Spain Celecoxib Vir-Pharma 200 mg hard capsules EFG

Last review date of this leaflet: July 2023

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