CELECOXIB VIR-PHARMA 200 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Celecoxib Vir-Pharma 200 mg Hard Capsules EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Celecoxib Vir-Pharma and what is it used for

Celecoxib belongs to a group 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 acts by reducing the production of prostaglandins, thus reducing pain and inflammation.

Celecoxib Vir-Pharma is indicated in adults to relieve the signs and symptoms of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis.

The medicine 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.

2. What you need to know before you take Celecoxib Vir-Pharma

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

Do not take Celecoxib Vir-Pharma

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

• if you are allergic to celecoxib or any of the other ingredientsof this medicine (listed in section 6).
• if you have had an allergic reactionto any medicine in the group called "sulfonamides" (e.g. some antibiotics used to treat infections).
• if you currently have a stomach or intestinal ulcer or bleeding.
• if you have previously experienced any of the following symptoms after taking acetylsalicylic acid or any other anti-inflammatory medicine: asthma, nasal polyps, severe nasal congestion, or an allergic reactionsuch as a skin rash with itching, swelling of the face, lips, tongue, or throat, 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 breast-feeding.
• if you have severe liver disease.
• if you have severe kidney disease.
• if you have inflammatory bowel diseasesuch as ulcerative colitisor Crohn's disease.
• if you have heart failure, diagnosed ischemic heart disease, or stroke, 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 obstruction of the blood vessels to the heart or brain.
• if you have or have had blood circulation problems(peripheral arterial disease) or if you have had surgery on the arteries in your legs.

Warnings and precautions

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

• if you have previously had a stomach or intestinal ulcer or bleeding(do not take Celecoxib Vir-Pharmaif you currently have a stomach or intestinal ulcer or bleeding).
• if you are taking acetylsalicylic acid(even at low doses, such as for heart protection).
• if you are taking antiplatelet therapies
• if you are receiving medicines to reduce blood clotting(e.g. warfarin, warfarin-like anticoagulants, or new oral anticoagulants, e.g. apixaban)

if you are receiving medicines called corticosteroids (e.g. prednisone)

• if you are taking Celecoxib Vir-Pharma at the same time as other non-acetylsalicylic NSAIDssuch as ibuprofen or diclofenac. The use of these medicines together should be avoided.
• if you are a smoker, have diabetes, high blood pressure, or high cholesterol.
• if your heart, liver, or kidneys are not working well, your doctor may want to monitor you regularly.
• if you have fluid retention(such as swollen feet or ankles).
• if you are dehydrated, for example, due to an illness with vomiting, diarrhea, or due to the use of diuretics (used to treat excess fluid in the body).
• if you have had a severe allergic reactionor a severe skin reaction to any medicine.
• if you feel unwell due to an infectionor think you have an infection, as taking Celecoxib Vir-Pharma may mask fever or other signs of infection and 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.

Like other non-steroidal anti-inflammatory drugs(e.g. ibuprofen or diclofenac), this medicine may increase your blood pressure, so your doctor may perform periodic blood pressure checks.

Some cases of severe liver reactionshave been reported with celecoxib, including severe liver inflammation, liver damage, liver failure (some with a fatal outcome or requiring liver transplantation). Of the cases where the start of the event was reported, most severe liver reactions occurred within the first month of treatment.

Celecoxib Vir-Pharma may make it more difficult to become pregnant. You should inform your doctor if you plan to become pregnant or if you are having trouble becoming pregnant (see section Pregnancy and breast-feeding).

Using Celecoxib Vir-Pharma with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, such as:

• 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 bacterial and fungal infections).
• Warfarinor other warfarin-like medicines(agents that reduce blood clot formation), including newer medicines such as apixaban
• Lithium(used to treat some types of depression).
• Other medicinesused 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 types of pain or depression).
• Barbiturates(used to treat epilepsy/seizures and some sleep disorders).
• Ciclosporin and tacrolimus(used to suppress the immune system, e.g. after transplants).

Celecoxib Vir-Pharma 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 and breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Celecoxib Vir-pharma should not be used by pregnant women or women who may become pregnant (i.e. women of childbearing potential who do not use adequate contraception) during treatment. If you become pregnant during treatment with Celecoxib Vir-Pharma, you should stop treatment and contact your doctor for alternative treatment.

Breast-feeding

Celecoxib Vir-Pharma should not be used during breast-feeding.

Fertility

NSAIDs, including Celecoxib Vir-Pharma, may make it more difficult to become pregnant. You should inform your doctor if you plan to become pregnant or if you are having trouble becoming pregnant.

Driving and using machines

You should know how you react to Celecoxib Vir-Pharma before driving or using machines. If you feel dizzy or drowsy after taking Celecoxib Vir-Pharma, do not drive or operate machinery until these effects have passed.

Celecoxib Vir-Pharma contains lactose

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

Celecoxib Vir-Pharma contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per capsule; this is essentially "sodium-free".

3. How to take Celecoxib Vir-Pharma

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again. If you think the effect of Celecoxib Vir-Pharma is too strong or too weak, tell 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 to use the lowest dose that controls your pain and you should not take Celecoxib Vir-Pharma for longer than necessary to control the symptoms.

Method of administration:

Celecoxib Vir-Pharma 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 Vir-Pharma at the same time every day.

If you have difficulty swallowing the capsules: you can sprinkle the entire contents of the capsule into a level teaspoon of some semi-solid food (such as apple sauce, rice, yogurt, or mashed banana, cold or at room temperature) and swallow it immediately with a glass of water of 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.

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

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.

Patients with kidney or liver problems:make sure your doctor knows if you have liver or kidney problems, as 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, especially if you weigh less than 50 kg.

Do not take more than 400 mg per day

Use in children

Celecoxib Vir-Pharma is only for adults; it is not indicated in children.

If you take more Celecoxib Vir-Pharma than you should

Do not take more capsules than your doctor has told you. If you take more Celecoxib Vir-Pharma than you should, consult your doctor, pharmacist, or hospital immediately and take the medicine with you.

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

If you forget to take Celecoxib Vir-Pharma

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 Vir-Pharma

Suddenly stopping treatment with Celecoxib Vir-Pharma may cause your symptoms to worsen. Do not stop taking this medicine unless your doctor tells you to. Your doctor will tell you to reduce the dose over a few days before stopping treatment completely.

If you have any other questions about 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.

If you experience any of the following adverse effects, discontinue treatment with Celecoxib Vir-Pharma 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 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 (feeling of discomfort), diarrhea, jaundice (your skin or the whites of your eyes appear 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)

• Heart attack*
• 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), 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*
• 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 heartbeat), rapid heartbeat
• Abnormalities in blood tests related to the liver
• Abnormalities in blood tests related to the kidneys
• Anemia (changes in red blood cells that can cause fatigue and difficulty breathing)
• Anxiety, depression, fatigue, numbness, tingling sensation
• High levels of potassium in blood test results [can cause nausea (feeling of discomfort), fatigue, muscle weakness or palpitations]
• Blurred or altered vision, 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 relief (urticarial habon)
• Eye inflammation
• Difficulty breathing
• Discoloration of the skin (bruises)
• Chest pain (generalized pain not related to the heart)
• Swelling of the face

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

• Ulcers (bleeding) in the stomach, throat or intestines; or rupture of the intestine (can cause stomach pain, fever, nausea, vomiting, intestinal obstruction), dark or black stools, pancreatitis (can cause stomach pain), esophagitis (inflammation of the esophagus)
• Low sodium levels in the blood (a disease known as hyponatremia)
• Decreased number of white blood cells or platelets (increases the risk of bleeding and bruising)
• Difficulty in muscular coordination of movements
• Feeling of confusion, taste disturbances
• Increased sensitivity to light
• Hair loss
• Hallucinations
• Eye bleeding
• Acute reaction that can lead to lung inflammation
• Irregular heartbeat
• Redness
• Blood clots in the blood vessels of the lungs. Symptoms may include sudden difficulty breathing, sharp chest pain or collapse
• Bleeding in the stomach or intestine (can cause stools or vomit with blood), inflammation of the intestine or colon,
• Severe liver inflammation (hepatitis). Symptoms may include nausea (feeling of discomfort), diarrhea, jaundice (yellow discoloration of the skin and eyes), dark urine, pale stools, ease of bleeding, itching or chills
• Acute kidney failure
• Menstrual disorders
• Swelling in the face, lips, mouth, tongue or throat, or difficulty swallowing

Very Rare (may affect up to 1 in 10,000 patients)

• Bleeding in the brain that causes death.
• Severe allergic reactions (including potentially fatal anaphylactic shock) Severe skin disorders such as Stevens-Johnson syndrome, exfoliative dermatitis and toxic epidermal necrolysis (can cause rash, blistering or peeling of the skin) and generalized acute pustular exanthema (symptoms include redness of the skin with swollen areas and numerous small pustules).
• A late allergic reaction with possible symptoms such as rash, swelling of the face, fever, swollen glands and abnormalities in clinical test results [e.g. liver, blood cells (eosinophilia, a type of increase in blood cell count)].
• Liver failure, 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, ease of bleeding, itching or chills
• Liver problems (such as cholestasis and cholestatic hepatitis, which may be accompanied by symptoms such as discolored stools, nausea and yellowing of the skin or eyes)
• Kidney inflammation and other kidney problems (such as nephrotic syndrome and minimal change disease that 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 (possibly more frequent and/or severe seizures).
• Inflammation of blood vessels (can cause fever, pain, purple spots on the skin).
• Obstruction of an artery or vein in the eye that leads to partial or complete loss of vision,
• Reduction in the number of red and white blood cells and platelets (can cause fatigue, ease of bruising, frequent nosebleeds and increased risk of infections).
• Alteration of the sense of smell.
• Muscle pain and weakness
• Ageusia (loss of taste)

Frequency Not Known (cannot be estimated from available data)

• Decrease in female fertility, which is normally reversible if the medication is discontinued.

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 does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: http://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Celecoxib Vir-Pharma

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.

This medicine does not require special storage conditions.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Celecoxib Vir-Pharma Composition

The active ingredient is celecoxib.

Each hard capsule contains 200 mg of celecoxib.

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

Product Appearance and Package Contents

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

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

Only some package sizes may be marketed.

Marketing Authorization Holder

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Polígono Industrial URTINSA II

28923 Alcorcón (Madrid)

Spain

Manufacturer

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:

Netherlands Licebril 200 mg, capsules, hard

Spain Celecoxib Vir-Pharma 200 mg hard capsules EFG

Date of the last revision of this prospectus: July 2023

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