Package Insert: Information for the User

Artilog 200 mg Hard Capsules

celecoxib

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed 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 or pharmacist even if they are not listed in this package insert. See section 4.

1.What Artilog is and for what it is used

2. What you need to know before starting to take Artilog

3. How to take Artilog

4. Possible adverse effects

5. Storage of Artilog

6. Contents of the pack and additional information

Artilog 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. Artilog acts by reducing the production of prostaglandins, thereby reducing pain and inflammation.

Artilog is indicated in adults to alleviate the symptoms ofrheumatoid arthritis, osteoarthritis, andankylosing spondylitis.

The medication will begin 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 Artilog. The following information will help you get better results with Artilog. If you have any other questions, please ask your doctor or pharmacist.

Do not take Artilog

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

• if you are allergic to celecoxib or any of the other components of this medication (including those listed in section 6)
• if you have had any allergic reaction to a medication in the group called “sulfonamides” (e.g. some antibiotics used to treat infections)

• if you havecurrentlyan ulcer or bleeding in 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 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, 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 obstruction of the blood vessels to the heart or brain
• if you have or have had circulatory problems (peripheral arterial disease) or if you have been operated on on the arteries of your legs

Warnings and precautions

Consult your doctor or pharmacist before starting to take Artilog:

• if you have hadpreviouslyan ulcer or bleeding in your stomach or intestines (Do not take Artilogif you currently have an ulcer or bleeding in your stomach or intestines)
• if you are taking acetylsalicylic acid (even at low doses as a heart protector)
• if you are taking antiplatelet therapies
• if you are receiving medications to reduce blood clotting (e.g. warfarin/anticoagulant analogs or new oral anticoagulants, e.g. apixaban)
• if you are receiving medications called corticosteroids (e.g. prednisone)
• if you are taking Artilog at the same time as other non-acetylsalicylic acid anti-inflammatory medications such as ibuprofen or diclofenac. You should avoid using 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 Artilog can 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 anti-inflammatory medications (e.g. ibuprofen or diclofenac), this medication can increase your blood pressure, so your doctor will be able to perform regular checks on it.

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).Most of the severe liver reactions occurred in the first month of treatment.

Artilog 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 section Pregnancy and breastfeeding).

Use of Artilog with other medications

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

• dextromethorphan (used to treat cough)
• ACE inhibitors, angiotensin 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)
• warfarin or other warfarin analogs (agents that reduce blood clotting), including newer medications such as apixaban
• lithium (used to treat certain types of depression)
• other medications 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/convulsions and certain types of pain or depression)
• barbiturates (used to treat epilepsy/convulsions and certain sleep disorders)
• ciclosporin and tacrolimus (used to treat immunosuppression, e.g. after transplants)

Artilog can be taken with low doses of acetylsalicylic acid (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

Artilog 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 Artilog, you should discontinue treatment and contact your doctor for alternative treatment.

Breastfeeding

Artilog should not be used during breastfeeding.

Fertility

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

Artilog contains lactose

This medication containslactose(a type of sugar). If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

Artilog contains sodium

This medication contains less than 23 mg ofsodium(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 Artilog's action 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 Artilog for longer than necessary to control symptoms.

Administration Form

Artilog 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 Artilog 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 cold or room temperature mashed banana) 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.

Recommended Dose

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

The usual dose is:

• one capsule of 200mg once a day.

The recommended dosefor the treatment of rheumatoid arthritisis 200mg per day (administered in two doses), if necessary, your doctor may increase it up to a maximum of 400mg.

The usual dose is:

-one capsule of 100mg twice a day

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

The usual dose is:

• one capsule of 200mg once a day.

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

Patients over 65 years old, especially those weighing less than 50kg:your doctor may want to monitor you more closely if you are over 65years old and especially if you weigh less than50kg.

You should not take more than 400mg per day.

Use in children

Artilog is only for adults, it is not indicated for children.

If you take more Artilog than you should

You should not take more capsules than indicated by your doctor. If you take more Artilog than you have been told, consult your doctor, pharmacist, or hospital immediately and bring the medication with you.

If you forget to take Artilog

If you forget 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 with Artilog

Stopping treatment with Artilog abruptly may cause a worsening of symptoms. Do not stop taking Artilog 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 Artilog. The side effects marked with an asterisk (*) occurred in patients taking Artilog for the prevention of colon polyps and have been classified based on the highest frequency of occurrence. Patients included in these studies took Artilog at high doses and for a prolonged period of time.

If you experience any of the following side effects, discontinue treatment with Artilog 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 stained with blood, or blood in the 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 white of your eyes appears yellow)].

Very common side effects: may affect more than 1 in 10 patients:

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

Common side effects: 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*
• Headache
• Nausea (feeling of discomfort)
• Joint pain
• Worsening of existing allergies
• Accidental injury

Rare side effects: may affect up to 1 in 100 patients:

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

Very rare side effects: may affect up to 1 in 10,000 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, stomach or intestinal inflammation (may cause pain in the stomach), esophageal inflammation
• Low sodium levels in the blood (a condition known as hyponatremia)
• Decreased white blood cell and platelet counts (may cause fatigue, frequent nosebleeds, and increased risk of infections)
• Difficulty in coordinating muscle movements
• Confusion, altered taste
• Increased sensitivity to light
• Hair loss
• Hallucinations
• Eye hemorrhage
• Acute reaction that may lead to pulmonary inflammation
• Irregular heart rhythm
• Rubefaction
• Clots in the blood vessels of the lungs. Symptoms may include sudden difficulty breathing, sharp 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

Side effects of unknown frequency: their frequency 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 Artilog 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 side effects: 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, and gas)
• Kidney stones (which may cause stomach or back pain, blood in the urine), difficulty urinating
• Weight gain

Rare side effects: 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 problems breathing)
• Gastrointestinal problems: stomach infection (which may cause irritation or ulcers in the stomach and intestines)
• Fracture of lower limbs
• 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 urination at night, 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
• Elevated sodium levels in blood test results

Reporting of side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is apossibleside effect that does not appear in this prospectus.You can also report them directly through theSpanish System for the Pharmacovigilance of Medicinal Products for Human Use: https://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 usethis medicationafter the expiration date that appears onthe blister pack and on the packaging.The expiration date is the last day of the month indicated.

Do not store at a temperature above30°C.

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

Composition of Artilog

The active ingredient iscelecoxib.

Each capsule contains 200 mg of celecoxib.

The other components (excipients) are:

Lactose monohydrate, sodium lauryl sulfate, povidone, croscarmellose sodium, magnesium stearate. The capsule coating contains gelatin, titanium dioxide (E-171), sodium lauryl sulfate, and sorbitan monolaurate. The printing ink contains shellac, propylene glycol, and iron oxide (E-172).

Appearance of the product and contents of the package

Artilog is presented in the form of capsules.

The capsules are opaque, white, with two golden bands and bear the marks “7767”and “200”.

The capsules are presented in a PVC/aluminum transparent or opaque blister.

Artilog may be presented in packaging of 2, 5, 6, 10, 20, 30, 40, 50, 60, 100, 10x10, 10x30, 10x50, 1x50 unit dose, 1x100 unit dose, and 5x(10x10).

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible for manufacturing

Klocke Verpackungs-Service GmbH

Max-Becker-Str. 6

76356 Weingarten (Baden)

Germany

or

Pfizer Manufacturing Deutschland GmbH

Mooswaldallee 1?

79108 Freiburg Im Breisgau?

Germany?

or

Mylan Hungary Kft.

Mylan utca 1

Komárom, 2900

Hungary

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

Viatris Pharmaceuticals, S.L.U.

Calle General Aranaz, 86

28027 Madrid

Spain

This medicinal product is authorized in the Member States of the European Economic Area with the following names:

Last review date of this leaflet: April 2021

Other sources of information

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