Celecoxib Viatris 200 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Celecoxib Viatris 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, pharmacist, or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Celecoxib Viatris is and what it is used for

Celecoxib Viatris is indicated in adults for the relief of the signs and symptoms of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis.

Celecoxib Viatris belongs to a class 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, which can cause pain and inflammation. In conditions such as rheumatoid arthritis or osteoarthritis, your body produces higher levels of these prostaglandins. Celecoxib Viatris works by reducing the production of prostaglandins, thereby decreasing pain and inflammation.

You should expect the medicine to start working within a few hours after taking the first dose, although a full effect may not be felt for several days.

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

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

Do not take Celecoxib Viatris:

Inform 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 previously had an allergic reaction to any medicine in the group called "sulfonamides", such as certain 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 after taking acetylsalicylic acid (aspirin) or any other non-steroidal anti-inflammatory and analgesic drug (NSAID): asthma, nasal polyps, severe nasal congestion or rhinorrhea, or allergic symptoms such as itchy rash, swelling of the face, lips, tongue or throat, difficulty breathing or wheezing.
• If you are pregnant. If you could 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 in blood flow to the brain; also known as "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 if you have undergone surgery on the arteries in your legs.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Celecoxib Viatris:

• If you have previously had an ulcer or bleeding in your stomach or intestines (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 such as for cardioprotection).
• If you are taking antiplatelet treatments.
• If you are taking medicines to reduce blood clotting (e.g.: warfarin or anticoagulant medicines such as warfarin or newer oral anticoagulants, for example, apixaban, dabigatran, rivaroxaban).
• If you are taking corticosteroid medicines (e.g., prednisone).
• If you are taking celecoxib at the same time as other non-acetylsalicylic NSAIDs 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 are not functioning properly, 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 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 severe skin reaction to any medicine.
• If you feel unwell due to an infection or suspect 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.
• 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 your blood pressure, so your doctor may periodically monitor your blood pressure.

Serious liver reactions have been reported with celecoxib, including severe hepatitis, liver damage, and liver failure (some fatal or requiring liver transplantation). Among cases where the onset was reported, most serious liver reactions occurred within the first month of treatment (see section 4, Possible side effects).

Serious skin reactions associated with celecoxib treatment have been reported. Stop using celecoxib and contact your doctor immediately if you notice any of the symptoms of serious skin reactions described in section 4, 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 for adults only and is not indicated for use in children and adolescents.

Other medicines and Celecoxib Viatris

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

• Dextromethorphan (used to treat cough).
• ACE inhibitors, angiotensin II receptor antagonists, beta-blockers, and diuretics (medicines used to treat hypertension and heart failure).
• Diuretics (used to remove excess fluid from the body).
• 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 agents 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 organ transplants).

Celecoxib may be taken with low-dose acetylsalicylic acid (aspirin, 75 mg daily or less). Seek advice from your doctor before taking both medicines 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 medicine.

Pregnancy

Celecoxib must 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

Celecoxib must 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 experiencing difficulties becoming pregnant.

Driving and using machines

You should be aware of 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 have passed.

Celecoxib Viatris contains lactose

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

Celecoxib Viatris contains sodium

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

3. How to take Celecoxib Viatris

Follow exactly the instructions your doctor has given you for taking this medicine. 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 effective dose that controls your pain and not to take celecoxib for longer than necessary to control symptoms.

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

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 daily, or
• one 100 mg capsule twice daily.

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 daily.

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 daily, or
• one 100 mg capsule twice daily.

Kidney or liver problems: make sure your doctor knows if you have liver or kidney problems, as you may require a lower dose.

Elderly patients over 65 years, especially those weighing less than 50 kg: your doctor may wish to monitor you more closely if you are over 65 years of age, particularly 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 intended for adults only and is not indicated for use in children and adolescents.

Method of administration

Celecoxib Viatris should be taken orally. Swallow the capsules whole with a glass of water. The capsules may be taken at any time of day, with or without food. However, try to take each dose at the same time every day.

If you take more Celecoxib Viatris than you should

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

You may also call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Celecoxib 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 taking Celecoxib Viatris

Stopping treatment with celecoxib abruptly may cause worsening of symptoms. Do not stop taking this medicine unless instructed by your doctor.

Your doctor may advise you to gradually reduce the dose over a few days before completely stopping treatment.

If you have any further 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 everyone will experience them.

The adverse effects listed 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. The patients included in these studies received 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 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 unwell), diarrhea, jaundice (yellowing 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.

• 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 of wanting to vomit).

• Painful joints.

• Worsening of existing allergies.

• Accidental injury.

Uncommon: may affect up to 1 in 100 people:

• Stroke*.
• Heart failure, palpitations (awareness of heartbeat), rapid heartbeat.
• Abnormal blood test results related to the liver.
• Abnormal blood test results related to the kidney.
• Anemia (changes in red blood cells that 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, difficulty hearing*.
• Constipation, belching, stomach inflammation (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: may affect up to 1 in 1,000 people:

• (Bleeding) ulcers in the stomach, throat or intestines; or intestinal perforation (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).

• 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 concentration in the blood (a condition known as hyponatremia).

• Difficulty with muscular coordination of movements.

• Feeling confused, hallucinations, taste disturbances.

• Increased sensitivity to light.

• Hair loss.

• Eye bleeding.

• 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 bloody 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: may affect up to 1 in 10,000 people:

• Severe allergic reactions (including potentially life-threatening anaphylactic shock).
• Severe skin disorders 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 red skin with swollen, red areas and numerous small pustules).
• A delayed allergic reaction with possible symptoms such as rashes, facial swelling, 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).
• 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).
• 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 blood cells, white blood cells and platelets (may cause tiredness, easy 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:

• Decreased fertility in women, which is usually reversible upon stopping the medicine.

• Other serious skin conditions, such as drug-induced fixed eruption (a distinctive skin allergic reaction that typically recurs in the same location(s) upon re-exposure to the drug and may present as round or oval-shaped patches of redness and swelling of the skin, blisters (urticaria) and itching) and generalized bullous fixed drug eruption (which may cause generalized skin reactions).

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

Common: may affect up to 1 in 10 people:

• Heart problems: angina (chest pain).
• Stomach problems: irritable bowel syndrome (may include stomach pain, diarrhea, indigestion and gas).
• Kidney stones (may 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 may cause pain, swelling or redness of the calf or breathing problems).
• Stomach problems: stomach infection (may cause irritation or ulcers in the stomach and intestine).
• Fracture of lower limbs.
• Shingles, skin infection, eczema (dry, itchy rash), pneumonia (infection in the chest [possible cough, fever, difficulty breathing]).
• Eye floaters causing visual disturbance or blurred vision, vertigo due to inner ear problems, ulcers, inflammation or bleeding of the gums, mouth ulcers.
• Excessive urination at night, hemorrhoid/anal bleeding, frequent bowel movements.
• Fatty lumps in the skin or other sites, ganglion cyst (non-painful swelling in joints or tendons or around them, 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 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 via 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 Viatris

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

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

This medicine does not require any special storage conditions.

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

6. Contents of the pack and other information

Composition of Celecoxib Viatris

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

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

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

Nature and contents of the container

Celecoxib Viatris is available as hard capsules.

The capsules are made of hard gelatin, with an opaque light brown cap and an opaque white body, filled with white to almost white powder. The imprint "MYLAN" on "CE 200" in black appears on both the cap and the body of the capsule.

This medicine may be supplied in blisters containing 10, 20, 30, 50, 60 and 100 capsules, in unit-dose blisters of 30 and 60 capsules, or in bottles of 500 capsules.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer

Mylan Hungary Kft
H-2900 Komárom Mylan útca 1
Hungary

For further information about this medicine, contact 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 European Economic Area (EEA) Member States and in the United Kingdom (Northern Ireland) under the following names:

Germany: Celecoxib Mylan 200 mg Hard Capsules
Spain: Celecoxib Viatis 200 mg hard capsules EFG
France: CELECOXIB Viatris 200 mg, capsule
Italy: Celecoxib Mylan
United Kingdom: Celecoxib 200 mg Capsules, hard (Northern Ireland)

Date of the most recent revision of this leaflet: November 2025

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