CELECOXIB VIATRIS 200 mg HARD CAPSULES

2. What you need to know before you take Celecoxib Viatris

Your doctor has prescribed celecoxib for you. 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:

Tell your doctor if any of the following circumstances apply 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 any medicine of the group called "sulfonamides" such as some antibiotics used to treat infections or diuretics.
• If you currentlyhave a stomach or intestinal ulcer or bleeding, or bleeding in the stomach or intestines.
• If you have previously experienced any of the following symptoms after taking acetylsalicylic acid (aspirin) or any other anti-inflammatory and analgesic medicine (NSAID): asthma, nasal polyps, severe nasal congestion, or allergic symptoms such as skin rash with itching, swelling of the face, lips, tongue, or throat, difficulty breathing, or wheezing.
• If you are pregnant. If you may become pregnant during 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 the blood vessels to the heart or brain.
• If you have had 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 takingCelecoxib Viatris:

• If you have previouslyhad a stomach or intestinal ulcer or bleeding (do not takecelecoxibif you currentlyhave a stomach or intestinal ulcer or bleeding).
• If you are taking acetylsalicylic acid (aspirin; even at low doses as a cardiac protector).
• If you are taking antiplatelet treatments.
• If you are receiving medicines to reduce blood clotting (e.g., warfarin or anticoagulant medicines such as warfarin or new oral anticoagulants, e.g., apixaban, dabigatran, rivaroxaban).
• If you are taking corticosteroids (e.g., prednisone).
• If you are taking celecoxib at the same time as other non-acetylsalicylic NSAIDs 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 (e.g., swollen feet or ankles).
• If you are dehydrated, e.g., due to a disease 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 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 signs of infection and inflammation.
• If you are over 65 years old, your doctor will monitor you regularly.
• 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 your blood pressure, so your doctor may perform periodic blood pressure checks.

Some cases of severe liver reactions have 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 it was reported when the event started, most severe liver reactions occurred within the first month of treatment (see Possible side effects).

Celecoxib may make it more 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).

Children and adolescents

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

Other medicines and Celecoxib Viatris

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, and beta-blockers, and diuretics (medicines used to treat high blood pressure and heart failure).
• Diuretics (used to eliminate excess fluid from the body).
• Fluconazole and rifampicin (used to treat bacterial and fungal infections).
• Warfarin or other warfarin analogs (agents that reduce blood clot formation), 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.
• Neuroleptics (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).

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

Celecoxib 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, you should stop treatment and contact your doctor for alternative treatment.

Breastfeeding

Celecoxib should not be used during breastfeeding.

Fertility

NSAIDs, including celecoxib, may make it more 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 celecoxib before driving or using machinery. If you feel dizzy or drowsy after taking celecoxib, do not drive or use machinery until these effects have passed.

Celecoxib Viatris contains lactose

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

Celecoxib Viatris contains sodium

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

3. How to take Celecoxib Viatris

Take this medicine exactly as your doctor has told you. If you are not sure, ask 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 celecoxib for longer than necessary to control the symptoms.

Method of administration

Celecoxib Viatris should be taken orally.The capsules can be taken at any time of day, with or without food. However, try to take each dose of this medicine at the same time each day.

If you have difficulty swallowing the capsules, you can sprinkle the entire contents of the capsule onto 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:

For osteoarthritis,the recommended dose is 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 or
• one 100 mg capsule twice a day.

For rheumatoid arthritis,the recommended dose is 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.

For ankylosing spondylitis,the recommended dose is 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 or
• one 100 mg capsule twice a 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, 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 of celecoxib per day.

Use in children and adolescents

Celecoxib Viatris is only for adults; it is not indicated in children and adolescents.

.

If you take moreCelecoxib Viatristhan you should

If you accidentally take too much medicine, talk to your doctor or pharmacist or contact the nearest hospital emergency department for advice.

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

If you forget to takeCelecoxib Viatris

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 takingCelecoxib Viatris

Suddenly stopping treatment with celecoxib 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 product, 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 tookcelecoxib. The adverse effects marked with an asterisk (*) occurred in patients who tookcelecoxibfor the prevention of colon polyps. The patients included in these studies tookcelecoxibat high doses and for a prolonged period.

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 or bloody stools, or blood in vomit.
• A skin reaction such as rash, blistering, or peeling of the skin.
• Liver failure. Symptoms may include nausea (feeling of discomfort), diarrhea, jaundice (yellow discoloration of the skin and eyes).

Other Adverse 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:

• Heart attack*.
• Fluid retention with swelling of ankles, legs, and/or hands.
• Urinary tract infection.

• Difficult 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*.
• Headache.
• Nausea (feeling of vomiting).
• Painful joints.
• Worsening of existing allergies.
• Accidental injury.

Uncommon: may affect up to 1 in 100 people:

• Stroke*.
• Heart failure, palpitations (perception of heartbeat), accelerated 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, fatigue, muscle weakness, or palpitations).
• Blurred or altered vision, ringing in the ears, mouth 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).
• Ocular inflammation (conjunctivitis).
• 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 people:

• 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, pancreatic inflammation (can cause stomach pain).
• Decrease in the number of white blood cells (which help protect the body from infections) and platelets (increased risk of bleeding and bruising).
• Low sodium levels in the blood (a condition known as hyponatremia).
• Difficulty in muscular coordination of movements.
• Feeling of confusion, hallucinations, taste disturbances.
• Increased sensitivity to light.
• Hair loss.
• Hallucinations.
• Ocular hemorrhage.
• Acute reaction that can lead to pulmonary inflammation.
• Irregular heartbeat.
• Flush.
• Blood clots in the blood vessels of the lungs. Symptoms may include sudden difficulty breathing, sharp chest pain, or collapse.
• Gastrointestinal bleeding (can cause bloody stools or vomit), intestinal or colon inflammation.
• Severe liver inflammation (hepatitis). Symptoms may include nausea, diarrhea, jaundice, 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 people:

• 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 acute generalized exanthematous pustulosis (symptoms include redness of the skin with swollen and red areas with 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]).
• Bleeding in the brain that causes death.
• Meningitis (inflammation of the membrane surrounding the brain and spinal cord).
• Liver failure, liver damage, and severe liver inflammation (fulminant hepatitis) (sometimes with fatal outcome or requiring liver transplant). Symptoms may include nausea, diarrhea, jaundice, 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, which may be accompanied by symptoms such as fluid retention, foamy urine, fatigue, and loss of appetite).
• Worsening of epilepsy (possibly more frequent and/or severe seizures).
• Obstruction of an artery or vein in the eye that leads to partial or complete loss of vision.
• Vasculitis (can cause fever, pain, purple spots on the skin).
• Decrease in the number of red blood cells, white blood cells, and platelets (can cause fatigue, ease of bruising, frequent nosebleeds, and increased risk of infections).
• Muscle pain and weakness.
• Disturbance of the sense of smell.
• Loss of taste.

Frequency not known: cannot be estimated from available data:

• Decrease in female fertility, which is normally reversible upon discontinuation of the medicine.

Adverse effects reported in clinical trials in whichcelecoxibwas administered at a dose of 400 mg per day for a period of up to 3 years, in patients with diseases unrelated to arthritis or other arthritic conditions, were:

Common: may affect up to 1 in 10 people:

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

Uncommon: may affect up to 1 in 100 people:

• Deep vein thrombosis (blood clots usually in the leg, which can cause pain, swelling, or redness of the calf or breathing problems).
• Stomach problems: stomach infection (which can cause irritation or ulcers in the stomach and intestine).
• Fracture of lower limbs.
• Herpes zoster, skin infection, eczema (dry rash with itching), pneumonia (infection in the chest [possibility of cough, fever, difficulty breathing]).
• Floaters in the eye that cause vision disturbance or blurred vision, vertigo due to problems in the inner ear, ulcers, inflammation, or bleeding of the gums, mouth ulcers.
• Excessive urination at night, bleeding from hemorrhoids, frequent bowel movement.
• Fat lumps on the skin or other areas, ganglion cyst (painless inflammation in the joints or tendons or around them, in the hand or foot) difficulty speaking, abnormal or heavy vaginal bleeding, chest pain.
• High levels of sodium in blood test results.

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

5. Storage of Celecoxib Viatris

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

Do not use this medicine after the expiration date stated on the carton, bottle, and blister, after EXP. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Deposit the containers 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 containers and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Celecoxib Viatris

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

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

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

Appearance of the product and package contents

Celecoxib Viatris is 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. The head and body of the capsule are marked with the inscription Mylan over CE 200 in black.

This medicine 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 pack sizes may be marketed.

Marketing authorization holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer

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

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Germany Celecoxib Mylan 200 mg Hartkapseln

Spain Celecoxib Viatris 200 mg hard capsules EFG

France CELECOXIB Viatris 200 mg, gélule

Netherlands Celecoxib Mylan 200 mg, capsules, hard

Italy Celecoxib Mylan

Portugal Sedrivalex

United Kingdom Celecoxib 200 mg Capsules, hard

(Northern Ireland)

Date of the last revision of this leaflet: April 2022

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