CELECOXIB CINFA 200 mg HARD CAPSULES

2. What you need to know before you take celecoxib cinfa

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

Do not take celecoxib cinfa

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 in the group called "sulfonamides" (e.g. some antibiotics used to treat infections)
• if you currently have a stomach or intestinal ulcer or bleeding
• if you have previously experienced any of the following symptoms after taking acetylsalicylic acid or any other anti-inflammatory medicine: 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 can 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 or 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 starting to take celecoxib cinfa

• if you have previously had a stomach or intestinal ulcer or bleeding. (Do not take celecoxibif you currently have a stomach or intestinal ulcer or bleeding).
• if you are taking acetylsalicylic acid (even at low doses as a heart protector)
• if you are taking antiplatelet therapies
• if you are taking medicines to reduce blood clotting (e.g. warfarin/anticoagulants analogous to warfarin or new oral anticoagulants, e.g. apixaban)
• 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 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 (such as swollen feet or ankles)
• if you are dehydrated, for example, 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 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

As with other anti-inflammatory medicines (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 in which it was reported when the event started, most severe liver reactions occurred within 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 are having difficulty becoming pregnant (see section Pregnancy and breastfeeding).

Other medicines and celecoxib cinfa

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, beta-blockers, and diuretics (medicines used to treat high blood pressure and heart failure)
• Fluconazole and rifampicin (used to treat bacterial and fungal infections)
• Warfarin or other warfarin-like anticoagulants (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
• Antipsychotics (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)
• Cyclosporin and tacrolimus (used to suppress the immune system, e.g. after transplants).

Celecoxib can be taken with low doses of acetylsalicylic acid (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 contraceptive methods) 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 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 (see section Pregnancy and breastfeeding).

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 operate machinery until these effects have passed.

celecoxib cinfa contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

celecoxib cinfa contains sodium

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

3. How to take celecoxib cinfa

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist again.

If you think or feel that the action of celecoxib is too strong or too weak, tell 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 should be taken orally.The capsules can be taken at any time of the day, with or without food. However, try to take each dose of celecoxib at the same time each day.

If you have difficulty swallowing the capsules: you can sprinkle the entire contents of the capsule into 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 the treatment of osteoarthritis

The recommended dose is 200 mg per day:

• 1 capsule of 200 mg once a day

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

• 1 capsule of 200 mg twice a day

For the treatment of rheumatoid arthritis

The initial recommended dose is 200 mg per day:

• 1 capsule of 100 mg twice a day(this initial recommended dose of 100 mg twice a day cannot be administered with this medicine. Please consult your doctor).

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

• 1 capsule of 200 mg twice a day

For the treatment of ankylosing spondylitis

The initial recommended dose is 200 mg per day:

• 1 capsule of 200 mg once a day

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

• 1 capsule of 200 mg twice a dayor 2 capsules of 200 mg once 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, as 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, it is not indicated in children.

If you take more celecoxib cinfa than you should

Do not take more capsules than your doctor has told you. If you take more celecoxib than you should, consult your doctor, pharmacist, or hospital immediately and take the medicine with you.

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

If you forget to take celecoxib cinfa

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 cinfa

Sudden stopping of treatment with celecoxib may cause worsening of symptoms. Do not stop taking celecoxib unless your doctor tells you to. Your doctor will tell you to reduce the dose for a few days before stopping treatment completely.

If you have any further questions on 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 all people suffer from them.

The adverse effects mentioned 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 and have been classified taking into account the highest frequency of occurrence. The patients included in these studies took celecoxib at high doses and for a prolonged period.

If you experience any of the following adverse effects, discontinue 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 urine or stools stained with blood, or blood in 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 adverse effects (may affect more than 1 in 10 patients):

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

Common adverse effects (may affect up to 1 in 10 patients):

• Heart attack*
• 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), 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 discomfort)
• Pain in the joints
• Worsening of existing allergies
• Accidental injury

Uncommon adverse effects (may affect up to 1 in 100 patients):

• Stroke*
• Heart failure, palpitations (perception of heartbeat), rapid 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 pain or 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 wheal)
• Eye inflammation
• Difficulty breathing
• Discoloration of the skin (bruises)
• Chest pain (generalized pain not related to the heart)
• Swelling of the face

Rare adverse effects (may affect up to 1 in 1,000 patients):

• 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, pancreatitis (can cause stomach pain), esophagitis (inflammation of the esophagus)
• Low sodium levels in the blood (a disease known as hyponatremia)
• Decreased number of white blood cells and platelets in the blood (increases the risk of bleeding and bruising)
• Difficulty in muscular coordination of movements
• Feeling of confusion, taste disturbances
• Increased sensitivity to light
• Hair loss
• Hallucinations

• Eye bleeding
• Acute reaction that can lead to lung inflammation
• Irregular heartbeat
• Flush
• Blood clots in the blood vessels of the lungs. Symptoms may include sudden difficulty breathing, sharp chest pain, or collapse
• Bleeding in the stomach or intestine (can cause bloody stools or vomit), inflammation of the intestine or colon
• Severe liver inflammation (hepatitis). Symptoms may include nausea, diarrhea, jaundice (yellow discoloration of the skin and eyes), dark urine, pale stools, easy bruising, or itching
• Acute kidney failure
• Menstrual disorders
• Swelling in the face, lips, mouth, tongue, or throat, or difficulty swallowing

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

• 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 areas and numerous small pustules)
• A late-onset 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 (yellow discoloration of the skin and eyes), dark urine, pale stools, easy bruising, or itching

oscurecida, heces pálidas, facilidad para tener hemorragias, picor o escalofríos

• 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 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 leading to partial or complete loss of vision
• Inflammation of blood vessels (can cause fever, pain, purple spots on the skin)
• Decreased number of red and white blood cells and platelets (can cause fatigue, easy bruising, frequent nosebleeds, and increased risk of infections)
• Muscle pain and weakness
• Taste disturbance
• Loss of taste

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

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

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

Common adverse effects (may affect up to 1 in 10 patients):

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

Uncommon adverse effects (may affect up to 1 in 100 patients):

• 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 (can cause irritation or ulcers in the stomach and intestine)
• Fracture of lower limbs
• Herpes, skin infection, eczema (dry rash with itching), pneumonia (chest infection, 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 movements
• 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 that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of celecoxib cinfa

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

Do not use this medicine after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines that you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of celecoxib cinfa

• The active ingredient is celecoxib. Each hard capsule contains 200 mg of celecoxib.
• The other ingredients (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, black iron oxide (E-172), propylene glycol, concentrated ammonia solution, and potassium hydroxide.

Appearance of the product and package contents

Celecoxib cinfa are hard capsules with a white body and the inscription “200 mg” and a yellow cap with the inscription “A001”. The contents of the capsule are a white to off-white granulate.

They are presented in PVC/PVDC/Aluminum blisters. Each package contains 20, 30, or 100 hard capsules.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

or

Ferrer Internacional, S.A.

Joan Buscallà, 1-9

08190 Sant Cugat del Vallés (Barcelona)

Date of the last revision of this prospectus: November 2021

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/

You can access detailed and updated information about this medicine by scanning the QR code included in the prospectus and packaging with your mobile phone (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 to: https://cima.aemps.es/cima/dochtml/p/78565/P_78565.html