Package Leaflet: Information for the User

Celecoxib Cinfa 200 mg Hard Capsules EFG

Read this 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 or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours. It may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

1.What is celecoxib cinfa and what it is used for

2.What you need to know before taking celecoxib cinfa

3.How to take celecoxib cinfa

4.Possible side effects

5Storage of celecoxib cinfa

6.Contents of the pack and additional information

celecoxib cinfa is indicated in adults to relieve the symptoms and signs ofrheumatoid arthritis, osteoarthritis, and ankylosing spondylitis.

celecoxib cinfabelongs to a class of medications known as nonsteroidal anti-inflammatory drugs (NSAIDs), and specifically to the subgroup known as 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 greater quantities. celecoxib cinfa acts by reducing the production of prostaglandins, thereby reducing pain and inflammation.

The medication 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.

Your doctor has prescribedcelecoxib. The following information will help you get better results withcelecoxib. If you have any other questions, please ask your doctor or pharmacist.

Do not take celecoxib cinfa

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 thismedication (listed in section 6)
• if you have had any allergic reaction to any medication in the group called “sulfonamides” (e.g. some antibiotics used to treat infections)
• if you havecurrentlyan ulcer or bleeding in your stomach or intestine
• 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, or obstruction of the heart or brain blood vessels
• if you have or have had circulatory problems (peripheral arterial disease) or if you have been operated on to remove the arteries in your legs

Warnings and precautions

Consult your doctor or pharmacist before starting to take celecoxib cinfa

• if you havepreviouslyhad an ulcer or bleeding in your stomach or intestine. (Do not take celecoxibif you currently have an ulcer or bleeding in your stomach or intestine).
• if you are taking acetylsalicylic acid (even at low doses as a cardioprotective agent)
• 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 corticosteroids (e.g. prednisone)
• if you are taking celecoxib at the same time as other non-acetylsalicylic acid anti-inflammatory drugs 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, e.g. 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 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 monitor it regularly.

Some cases of severe liver reactions have been reported with celecoxib, 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.

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 section Pregnancy and breastfeeding).

Other medications and celecoxib cinfa

Inform your doctor or pharmacist if you aretaking, havetakenrecentlyor may need to take any other medication.

• Dextromethorphan (used to treat cough)
• ACE inhibitors, angiotensin II receptor antagonists, beta-blockers, and diuretics (medicationsused 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 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, e.g. after transplants)

Celecoxibcan be taken with low doses of acetylsalicylic acid (75 mg daily or less). Please 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, consultyour 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 taken 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 cinfa contains lactose

This medication containslactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Celecoxib cinfa contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per capsule; it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.This medication should be taken exactly as directed by your doctor or pharmacist.In case of doubt, consult your doctor or pharmacist again.

If you think or believe that the action of celecoxib is too strong or too 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 celecoxib for longer than necessary to control your symptoms.

Administration Form:

Celecoxib should be administered orally.The capsules are taken at any time of the day, with or without food. However, try to take each dose of celecoxib 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 at room temperature) 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.

The recommended dose is:

For the treatment of osteoarthritis

The recommended dose is 200 mg per day:

• 1 capsule of 200 mgonce a day

If necessary, your doctor may increase the dose up to a maximum of 400 mg:

• 1 capsule of 200 mgtwice a day

For the treatment of rheumatoid arthritis

The initial recommended dose is 200 mg per day:

• 1capsuleof100mgtwice a day

If necessary, your doctor may increase the dose up to a maximum of 400 mg:

• 1 capsule of 200 mgtwice a day

For the treatment of ankylosing spondylitis

The initial recommended dose is 200 mg per day:

• 1 capsule of 200 mgonce a day

If necessary, your doctor may increase the dose up to a maximum of 400 mg:

• 1 capsule of 200 mgtwice a dayor2 capsules of 200 mgonce a day.

Maximum Daily Dose::

You should not take more than 400 mg of celecoxib per day.

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

Use in children

Celecoxib is only for adults, not indicated for children.

If you take more celecoxib than you should

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

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 forget to take celecoxib

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 treatment with celecoxib

Stopping treatment with celecoxib abruptly may cause a worsening of symptoms. Do not stop taking celecoxib unless your doctor tells you to. Your doctor will indicate that you should reduce the dose over a few days before stopping treatment completely.

If you have any other doubts about the use of thismedication, ask your doctororpharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The side effects mentioned 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 and have been classified based on the highest frequency of occurrence. 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 immediately inform your doctor if you have:

• A hypersensitivity 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, diarrhea, jaundice, dark urine, pale stools, easy bruising, or itching).

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 1,000 patients):

• Ulcers (bleeding) in the stomach, esophagus, or intestines; or intestinal rupture (may cause stomach pain, fever, nausea, vomiting, intestinal obstruction), dark or black stools, pancreatitis (may cause stomach pain), esophagitis (inflammation of the esophagus)
• Low sodium levels in the blood (a condition known as hyponatremia)
• Decreased white blood cell count (which helps protect the body from infections) and platelet count (increases the risk of bleeding and petechiae)
• Difficulty in coordinating muscle movements
• Confusion, altered taste
• Increased sensitivity to light
• Hair loss
• Alucinations

• Eye hemorrhage
• Acute reaction that may lead to pulmonary inflammation
• Irregular heart rhythm
• Rubefaction
• Coagulation of blood in the pulmonary vessels. Symptoms may include sudden difficulty breathing, acute 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, diarrhea, jaundice, dark urine, pale stools, easy bruising, itching, or chills
• Acute kidney failure
• Menstrual disorders
• Swelling in the face, lips, mouth, tongue, or throat, or difficulty swallowing

Very rare side effects (may affect up to 1 in 10,000 patients):

• Severe allergic reactions (including potentially fatal anaphylactic shock)
• 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 skin redness with swollen areas and 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 leading to death
• Meningitis (inflammation of the membrane surrounding the brain and spinal cord)
• Severe liver failure, liver damage, and severe liver inflammation (hepatitis fulminans) (sometimes with fatal outcome or requiring liver transplant). Symptoms may include nausea, diarrhea, jaundice, 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 pale stools, nausea, and yellow discoloration 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 (convulsions possibly more frequent and/or severe)
• Obstruction of an artery or vein in the eye leading to partial or complete loss of vision
• Inflammation of blood vessels (may cause fever, pain, and purple spots on the skin)
• Decreased red and white blood cell count and platelet count (may cause fatigue, easy bruising, frequent nosebleeds, and increased risk of infections)
• Muscle pain and weakness
• Altered sense of taste
• Loss of taste

Side effects of unknown frequency (cannot be estimated from available data):

• Decreased fertility in women, which is normally reversible if medication is discontinued

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 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, 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 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, skin infection, eczema (dry, itchy rash), pneumonia (chest infection, possibility of cough, fever, difficulty breathing)
• Flies in the eye causing visual 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 Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe packagingafter 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 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.

Celecoxib Cinfa Composition

• The active ingredient is celecoxib. Each hard capsule contains 200 mg of celecoxib.
• The other components (excipients) are:lactose monohydrate, sodium lauryl sulfate, povidone K-29/32, sodium croscarmellose, and magnesium stearate.The capsule contains:gelatin,yellow iron oxide (E-172), quinoline yellow (E-104),titanium dioxide (E-171)and sodium lauryl sulfate.The printing ink contains:shellac lacquer, iron oxide black (E-172), propylene glycol, concentrated ammonium solution, and potassium hydroxide.

Appearance of the Product and Contents of the Package

Celecoxib Cinfa are hard capsules with a white body, with the inscription “200 mg” and a yellow cap

with the inscription “A001”.The capsule contents are a white to off-white granulate.

It is presented inPVC/PVDC/Aluminum blisters. Each package contains20, 30, or 100 hard capsules.

Only some package sizes may be commercially available.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra)- Spain

Responsible Manufacturer

Laboratorios Cinfa, S.A

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

or

Ferrer Internacional, S.A.

Joan Buscallà, 1-9

08190 Sant Cugat del Vallés (Barcelona)

Last Review Date of this Leaflet: November 2021

For detailed information about this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http: //www.aemps.gob.es/

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/78565/P_78565.html

QR code link to:https://cima.aemps.es/cima/dochtml/p/78565/P_78565.html