Patient Information Leaflet

CelecoxibMABO200 mg Hard Capsules EFG

Read this leaflet carefully before you start taking this medicine. 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 give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet.

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

2.What you need to know before you start taking Celecoxib MABO

3.How to take Celecoxib MABO

4.Possible side effects

5Storage of Celecoxib MABO

6.Contents of the pack and additional information

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

CelecoxibMABOcontains celecoxib as the active ingredient andbelongs to a class of medications known as nonsteroidal anti-inflammatory drugs (NSAIDs), specifically the subgroup known as 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.CelecoxibMABOacts by reducing the production of prostaglandins, thereby reducing pain and inflammation.

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

Do not take CelecoxibMABO

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

• 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 “sulfamidas” (e.g.: some are antibiotics used to treat infections)
• if you currently have a stomach or intestinal ulcer or hemorrhage
• 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 itchy skin rash, 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
• 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 problems such as: 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 blood vessels that irrigate the heart or brain
• if you have or have had circulation problems (peripheral arterial disease) or if you have been operated on the arteries of your legs

Warnings and precautions

Consult your doctor or pharmacist before starting to takeCelecoxibMABO

• if you have previously had a stomach or intestinal ulcer or hemorrhage. (Do not take CelecoxibMABOif you currently have a stomach or intestinal ulcer or hemorrhage).
• if you are taking acetylsalicylic acid (even at low doses as a heart protector)
• if you are receiving medications to reduce blood clotting (e.g.: warfarin)
• if you are taking CelecoxibMABOat 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 CelecoxibMABOmay mask fever or other signs of infection and inflammation
• if you are over 65 years old, your doctor may want to monitor you regularly

Like other anti-inflammatory medications (e.g.: ibuprofen or diclofenac), this medication may increase your blood pressure, so your doctor will be able to monitor it periodically.

During treatment with celecoxib, some cases of severe liver reactions have been reported, including severe liver inflammation, liver damage, and liver failure (some with fatal outcome or requiring liver transplant).Of the cases in which the timing of the event was specified, most severe liver reactions occurred in the first month of treatment.

CelecoxibMABOmay 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 Pregnancy and breastfeeding).

Taking CelecoxibMABOwith other medications

Some medications may modify the effect of other medications.Inform your doctor or pharmacist that you aretaking, havetakenrecentlyor may need to take any other medication:

• Dextromethorphan (used to treat cough)
• ACE inhibitors or angiotensin II receptor antagonists (medicationsused to treat hypertension and heart failure)
• Diuretics (used to eliminate excess fluid from the body)
• Fluconazole and rifampicin (used to treat infections caused by bacteria and fungi)
• Warfarin or other oral anticoagulants (agents that reduce blood clotting)
• 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)

CelecoxibMABOcan 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, consultyour doctor or pharmacist before using this medication

CelecoxibMABOshould not be used by pregnant women or women who may become pregnant (i.e.: women of childbearing age and not using an adequate contraceptive method) during treatment. If you become pregnant during treatment with CelecoxibMABO, you should discontinue treatment and contact your doctor for alternative treatment.

CelecoxibMABOshould not be taken during breastfeeding.

Driving and operating machinery

You should know how you react to CelecoxibMABObefore driving or operating machinery. If you feel dizzy or drowsy after taking CelecoxibMABO, do not drive or operate machinery until these effects pass.

CelecoxibMABOcontains lactose

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

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

If you think or believe that the action of CelecoxibMABOis 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 CelecoxibMABOfor longer than necessary to control symptoms.

Contact your doctor if, after two weeks of starting treatment, you do not experience an improvement.

Recommended dose:

CelecoxibMABOis available in hard capsules of 200 mg. Depending on the medication prescribed by your doctor, the recommended dose is:

For the treatment of arthritis

The usual dose is 200 mg per day, which can be taken as:

• 1 capsule of 200 mgonce a day

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

• 1 capsule of 200 mgtwice 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 recommended dose of 100 mgtwice

a daycannot be administered with this medication. There are other

medications with a concentration of 100 mg of celecoxib).

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 dayor 2 capsules of 200 mgonce a day.

Maximum daily dose:

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

Problems with the kidneys or liver:Make sure your doctor knows if you have problems with the liver or kidneys, as you may need a lower dose.

Patients over 65 years old, especially those with a weight of 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:CelecoxibMABOis only for adults, not for children.

Administration form:

This medication is taken orally.

The capsules should be swallowed whole with a glass of water, and can be taken at any time of the day, with or without food. However, try to take each dose of CelecoxibMABOat the same time every day.

If you take more CelecoxibMABOthan you should

You should not take more capsules than indicated by your doctor. If you take more capsules 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 taken.

If you forgot to take CelecoxibMABO

If you forgot 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 CelecoxibMABO

Stopping treatment with CelecoxibMABOabruptly may cause a worsening of symptoms. Do not stop taking CelecoxibMABOunless 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 medications, CelecoxibMABOmay cause side effects, although not everyone will experience them.

The side effects listed below were observed in patients with arthritis who took celecoxib. The side effects marked with an asterisk (*) occurred in patients who took 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.

Stop taking CelecoxibMABOand inform your doctor immediately if you experience any of the following side effects:

• 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 with blood, or blood in the vomit.
• A skin reaction such as rash, blisters, or skin peeling.
• Liver failure (symptoms may include nausea, diarrhea, jaundice, or yellowing of the skin or eyes).

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

• Increased 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 infection
• Difficulty breathing*, sinusitis (inflammation and infection of the paranasal sinuses, obstruction or pain of the paranasal sinuses), nasal congestion or discharge, sore throat, cough, cold, flu-like symptoms
• Dizziness, difficulty sleeping
• Vomiting*, stomach pain, diarrhea, indigestion, gas
• Rash, itching
• Muscle stiffness
• Difficulty swallowing*
• Worsening of existing allergies

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, inflammation of the esophagus (may cause difficulty swallowing), inflammation of the pancreas (may cause stomach pain)
• 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 sense of taste
• Increased sensitivity to light
• Hair loss

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

• Cerebral hemorrhage leading to death
• Severe allergic reactions (including potential anaphylactic shock) that may cause skin rash, facial swelling, lips, mouth, tongue, or throat, wheezing, or difficulty breathing; difficulty swallowing
• Gastrointestinal hemorrhage (may cause stools or vomit with blood), intestinal or colon inflammation, nausea
• Severe skin alterations such as Stevens-Johnson syndrome, exfoliative dermatitis, and toxic epidermal necrolysis (may cause rash, blistering, or skin peeling) and acute generalized pustular psoriasis (swollen and red area with numerous small pustules)
• Liver failure, severe liver damage, and liver inflammation (sometimes with fatal outcome or requiring liver transplant). Symptoms may include nausea, diarrhea, jaundice, dark urine, pale stools, easy bleeding, itching, or chills
• Renal problems (possible renal insufficiency, kidney inflammation)
• Pulmonary embolism (blood clots in the pulmonary arteries). Symptoms may include sudden difficulty breathing, acute chest pain, or collapse (obstruction of the pulmonary vessels)
• Irregular heart rhythm
• Meningitis (inflammation of the membrane surrounding the brain and spinal cord)
• Hallucinations
• Worsening of epilepsy (seizures possibly more frequent and/or severe)
• Arterial or venous obstruction in the eye leading to partial or complete vision loss, conjunctival inflammation, hemorrhage
• Decreased red and white blood cell count and platelet count (may cause fatigue, frequent nosebleeds, easy bleeding, and increased risk of infections)
• Chest pain
• Altered sense of taste
• Decoloration of the skin (petechiae), muscle pain and weakness, joint pain
• M menstrual disorders
• Headache, flushing
• Low sodium levels in blood test results (may cause loss of appetite, headache, nausea, cramps, and muscle weakness)

The side effects observed in clinical trials in which celecoxib was administered at a dose of 400mg per day for more than 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 clotting usually in the leg, which may cause pain, swelling, or redness of the calf or difficulty breathing)
• Gastrointestinal problems: stomach infection (which may cause stomach 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 vision 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 severe vaginal bleeding, chest pain
• High sodium levels in blood test results

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish 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.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe blister pack and on the boxafter CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition ofCelecoxib MABO

• The active ingredient is celecoxib.Each hard capsulecontains 200 mg of celecoxib.
• The other components (excipients) are: lactose monohydrate, sodium lauryl sulfate, povidone K-29/32, croscarmellose sodium, magnesium stearate.
• The capsule coating contains: gelatin, sodium lauryl sulfate, titanium dioxide (E171), yellow iron oxide (E172), water.
• The ink contains: black iron oxide (E172), shellac-NF-E904, anhydrous ethanol, isopropanol,butanol, propylene glycol, concentrated ammonium solution, potassium hydroxide, and purified water

Appearance of the product and content of the container

Celecoxib MABO is presented in the form of hard capsules.

White capsules with the inscription 200 mg and yellow caps with the inscription A001.

The capsules are presented in Aluminio/PVC-PVDC blisters.

Celecoxib MABO may be presented in containers of 30 and 100 hard capsules.

Only some sizes of containers may be commercially available.

Marketing authorization holder

MABO-FARMA S.A.

Calle Rejas 2, 1st floor

28821 Coslada

Madrid

Spain

Responsible for manufacturing

Ferrer Internacional, S.A.

Joan Buscallà, 1-9

08173 Sant Cugat del Vallés (Barcelona)

Spain

or

Laboratorios Cinfa S.A.

Ctra. Olaz-Chipi, 10.

Poligono Industrial Areta - Huarte - Navarra

31620 – Spain

Last review date of this leaflet: May 2021

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http: //www.aemps.gob.es/