Package Insert: Information for the Patient

Celecoxib Viatris200 mg Hard EFG Capsules

Read this package insert carefully before starting to take this medication, 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, pharmacist, or nurse.
• This medication has been prescribed only for you and should not be given 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, pharmacist, or nurse even if they are not listed in this package insert. See section 4.

1. What isCelecoxib Viatrisand how is it used

2. What you need to know before starting to takeCelecoxib Viatris

3. How to takeCelecoxib Viatris

4. Possible adverse effects

5. Storage ofCelecoxib Viatris

6. Contents of the package and additional information

Celecoxib Viatrisis indicated in adults to relieve the symptoms and signs ofrheumatoid arthritis, osteoarthritis, and ankylosing spondylitis.

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

You should wait for your medication to take effect a few hours after taking the first dose, but it may take several days to experience a complete effect.

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

Do not takeCelecoxib Viatris:

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 (including those in section 6).
• If you have had any allergic reaction to a medication in the group called “sulfonamides” such as some antibiotics used to treat infections or diuretics.
• If you currently have a stomach or intestinal ulcer or bleeding, or bleeding in the stomach or intestines.
• If you have previously experienced any of the following symptoms as a result of taking acetylsalicylic acid (aspirin) or any other nonsteroidal anti-inflammatory drug (NSAID): asthma, nasal polyps, severe nasal congestion or rhinorrhea, or allergic symptoms such as skin rash with itching, facial swelling, lip, tongue, or throat swelling, 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 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 been diagnosed with 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 had surgery on the arteries of your legs.

Warnings and precautions

Consult your doctor or pharmacist before starting to takeCelecoxib Viatris:

• If you have previously had a stomach or intestinal ulcer or bleeding (do not take celecoxib if you currently have a stomach or intestinal ulcer or bleeding).
• If you are taking acetylsalicylic acid (aspirin), even at low doses as a heart protector.
• If you are taking antiplatelet medications.
• If you are receiving medications to reduce blood clotting (e.g., warfarin or anticoagulants such as warfarin or new oral anticoagulants, for example, apixaban, dabigatran, rivaroxaban).
• If you are taking corticosteroids (e.g., prednisone).
• If you are taking celecoxib at the same time as other non-acetylsalicylic acid NSAIDs such as ibuprofen or diclofenac. You should avoid the use of 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 feet or ankles).
• 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 can mask fever or other signs of infection and inflammation.
• If you are over 65 years old, your doctor will monitor you regularly.
• The consumption of alcohol and NSAIDs can increase the risk of gastrointestinal problems.

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

Some cases of severe liver reactions with celecoxib have been reported, including severe liver inflammation, liver damage, and liver failure (some with fatal outcome or requiring liver transplant). Of the cases in which the onset of the event was reported, most severe liver reactions occurred in the first month of treatment (see Possible side effects).

Celecoxib 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 Pregnancy and breastfeeding).

Children and adolescents

Celecoxib is only for adults and is not indicated for children and adolescents.

Other medications and Celecoxib Viatris

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, and beta-blockers, and diuretics (medications used to treat hypertension and heart failure).
• Diuretics (used to eliminate excess fluid from the body).
• 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 some types of depression).
• Other medications used to treat depression, sleep disorders, high blood pressure, or irregular heartbeat.
• Neuroleptics (used to treat some mental disorders).
• Methotrexate (used in rheumatoid arthritis, psoriasis, and leukemia).
• Carbamazepine (used to treat epilepsy/convulsions and some types of pain or depression).
• Barbiturates (used to treat epilepsy/convulsions and some sleep disorders).
• Ciclosporin and tacrolimus (used to treat immunosuppression, for example, after transplants).

Celecoxib can be taken with low doses of acetylsalicylic acid (aspirin, 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

Celecoxib 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

Celecoxib 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 to celecoxib before driving or operating machinery. If you feel dizzy or drowsy after taking celecoxib, do not drive or operate machinery until these effects pass.

Celecoxib Viatris contains lactose

Celecoxib 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 Viatris contains sodium

Each capsule contains less than 1 mmol of sodium (23 mg); this 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 ofcelecoxibis 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 takecelecoxibfor longer than necessary to control symptoms.

Administration Form

Celecoxib Viatris must be administered orally.The capsules are taken at any time of the day, with or without food. However, try to take each dose of this medication 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, cold or at room temperature) and swallow it immediately with a glass of water approximately 240ml.

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:

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

The dose is usually

• one capsule of 200mg once a day or
• one capsule of 100mg twice a day.

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

The dose is usually:

• one capsule of 100mg twice a day.

For ankylosing spondylitis,the recommended dose is 200mg per day; if necessary, your doctor may increase it up to a maximum of 400mg.

The dose is usually:

• one capsule of 200mg once a day or
• one capsule of 100mg twice a day.

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

Patients over 65 years, especially those with a weight under 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 of celecoxib per day.

Use in children and adolescents

Celecoxib Viatrisis only for adults, not indicated for children and adolescents.

.

If you take moreCelecoxib Viatris than you should

If you accidentally take too much medication, inform your doctor or pharmacist or contact the nearest hospital emergency service for advice.

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 Viatris

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 the treatment withCelecoxib Viatris

The abrupt interruption of treatment withcelecoxibmay cause a worsening of symptoms.Do not stop taking this medication unless your doctor tells you to.

Your doctor may indicate that you reduce the dose for a few days before completely interrupting treatment.

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.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:

If you have:

• A hypersensitivity reaction such as skin rash, facial swelling, wheezing, or difficulty breathing.
• Cardiovascular problems such as chest pain.
• Severe stomach pain or any sign of bleeding in the stomach or intestines, such as dark or bloody stools, or blood in the vomit.
• A skin reaction such as rash, blistering, or peeling of the skin.
• Acute liver failure. Symptoms may include nausea (feeling unwell), diarrhea, jaundice (yellowing of the skin and eyes).

Other side effects

Very common: may affect more than 1 in 10 people:

• Hypertension, including worsening of existing hypertension*.

Common: may affect up to 1 in 10 people:may affect up to 1 in 10 people:

• 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 (urge to vomit).
• Joint pain.
• Worsening of existing allergies.
• Accidental injury.

Uncommon: may affect up to 1 in 100 people:may affect up to 1 in 100 people:

• 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 can cause fatigue and difficulty breathing).
• Anxiety, depression, fatigue, numbness, tingling.
• High potassium levels in blood test results (may cause nausea (feeling unwell), 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 rash (hives).
• Eye inflammation (conjunctivitis).
• 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 people:

• 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), esophageal inflammation.
• Decreased white blood cell count (may cause increased risk of infections) and platelet count.
• Low sodium levels in the blood (a condition known as hyponatremia).
• Difficulty in coordinating muscle movements.
• Confusion, hallucinations, altered taste.
• Increased sensitivity to light.
• Hair loss.
• Hallucinations.
• Eye hemorrhage.
• Acute reaction that may lead to pulmonary inflammation.
• Irregular heart rhythm.
• Rubefaction.
• Thromboembolism in the lungs. Symptoms may include sudden difficulty breathing, sharp chest pain, or collapse.
• Gastrointestinal hemorrhage (may cause bloody stools or vomit), intestinal or colonic inflammation.
• Severe liver inflammation (hepatitis). Symptoms may include nausea (feeling unwell), diarrhea, jaundice (yellowing of the skin and eyes), dark urine, pale stools, easy bruising, itching, or chills.
• Acute kidney failure.

• Menstrual disorders.
• Swelling in the face, lips, mouth, tongue, or jaw, or difficulty swallowing.

Very rare: may affect up to 1 in 10,000 people:

• Severe allergic reactions (including potential anaphylactic shock that can be fatal).
• 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 and red areas with numerous small pustules).
• A late-onset 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 that causes death.
• Meningitis (inflammation of the membrane surrounding the brain and spinal cord).
• Acute liver failure, liver damage, and severe liver inflammation (hepatitis fulminant) (sometimes with fatal outcome or requiring liver transplant). Symptoms may include nausea (feeling unwell), diarrhea, jaundice (yellowing of the skin and eyes), dark urine, pale stools, easy bruising, itching, or chills.
• Liver problems (such as cholestasis and cholestatic hepatitis, which may be accompanied by symptoms such as discolored stools, nausea, and yellowish discoloration 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).
• Worsening of epilepsy (seizures that may be more frequent and/or severe).
• Obstruction of an artery or vein in the eye that leads to partial or complete loss of vision.
• Inflammation of blood vessels (may cause fever, pain, and purple spots on the skin).
• Decreased red blood cell, white blood cell, and platelet count (may cause fatigue, easy bruising, frequent nosebleeds, and increased risk of infections).
• Muscle pain and weakness.
• Altered sense of smell.
• Loss of taste.

Frequency not known: cannot be estimated from available data:

• Decreased fertility in women, which is normally reversible upon discontinuing the medication.

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

Common: may affect up to 1 in 10 people:may affect up to 1 in 10 people:

• Cardiovascular problems: angina pectoris (chest pain).
• Gastrointestinal problems: irritable bowel syndrome (may include stomach pain, diarrhea, indigestion, and gas).
• Kidney stones (which may cause stomach pain or back pain, blood in urine), difficulty urinating.
• Weight gain.

Uncommon: may affect up to 1 in 100 people:may affect up to 1 in 100 people:

• Deep vein thrombosis (blood clots usually 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 zoster, skin infection, eczema (dry, itchy rash), pneumonia (lung 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 leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use: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 packaging, bottle, and blister pack, 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 containers 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 containers and medications you no longer need. By doing so, you will help protect the environment.

Composition ofCelecoxib Viatris

• The active ingredient is celecoxib.
• Each hard capsule contains 200 mg of celecoxib.
• The other components (excipients) are: sodium laurilsulfate, povidone K29-32, lactose monohydrate, croscarmellose sodium, magnesium stearate, anhydrous colloidal silica.
• The capsule coating contains:

Titanium dioxide (E-171), gelatin, iron oxide black (E-172), iron oxide red (E-172), iron oxide yellow (E-172).

• The printing ink contains shellac lacquer, iron oxide black (E-172), and propylene glycol.

Appearance of the product and contents of the package

Celecoxib Viatrisis presented in the form of hard capsules.

The capsules are hard gelatin, with a light brown opaque head and a white opaque body, filled with white to almost white powder. On the head and body of the capsule, the inscription "Mylan" over "CE 200" is in black.

This medication may be presented in blisters containing 10, 20, 30, 50, 60, and 100 capsules, single-dose blisters of 30 and 60 capsules, or in bottles of 500 capsules.

Only some package sizes may be commercially available.

Marketing authorization holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible for manufacturing

McDermott Laboratories Ltd. T/A Gerard Laboratories

35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13

Ireland

Mylan Hungary Kft

H-2900 Komárom Mylan útca 1

Hungary

Further information about this medication can be obtained by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medication is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

GermanyCelecoxib Mylan 200 mg Hartkapseln

SpainCelecoxib Viatris 200 mg hard capsules EFG

FranceCELECOXIB Viatris 200 mg, gélule

NetherlandsCelecoxib Mylan 200 mg, capsules, hard

ItalyCelecoxib Mylan

PortugalSedrivalex

United KingdomCelecoxib 200 mg Capsules, hard

(Northern Ireland)

Last review date of this leaflet: April 2022

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