CELECOXIB TECNIGEN 200 mg HARD CAPSULES

2. What you need to know before taking Celecoxib TecniGen

Your doctor has prescribed Celecoxib TecniGen to you. The following information will help you get the best results with Celecoxib TecniGen. If you have any other questions, please ask your doctor or pharmacist.

Do not take Celecoxib TecniGen

Tell your doctor if any of the following circumstances apply to you, as patients with these conditions should not take Celecoxib TecniGen:

• if you are allergic to celecoxib or any of the other components of this medication (listed in section 6)
• if you have had an allergic reaction to any medication in the group called "sulfonamides"

(e.g., some are 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 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, 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 problems such as: 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 that supply the heart or brain
• if you have or have had blood 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 TecniGen

• if you have previously had a stomach or intestinal ulcer or bleeding. (Do not take Celecoxib TecniGenif 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 medications to reduce blood clotting (e.g., warfarin)
• if you are taking Celecoxib TecniGen at the same time as other non-acetylsalicylic NSAIDs such as ibuprofen or diclofenac. The combined use of these medications should be avoided
• if you are a smoker, have diabetes, high blood pressure, or high cholesterol
• if your heart, liver, or kidneys do not function 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 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 medication
• if you feel unwell due to an infection or think you have an infection, as taking Celecoxib TecniGen may mask fever or other signs of infection and inflammation - if you are over 65 years old, your doctor may want to monitor you regularly.

As with other anti-inflammatory medications (e.g., ibuprofen or diclofenac), this medication may increase your blood pressure, so your doctor may want to monitor it periodically.

During treatment with celecoxib, some cases of severe liver reactions have been reported, 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 TecniGen may make it difficult to become pregnant. You should inform your doctor if you plan to become pregnant or if you have problems becoming pregnant (see section Pregnancy and Breastfeeding).

Taking Celecoxib TecniGen with Other Medications

Some medications may modify the effect of other medications. Inform your doctor or pharmacist that you are taking, have recently taken, or may need to take any other medication:

• Dextromethorphan (used to treat cough)
• ACE inhibitors or angiotensin II receptor antagonists (medications used to treat hypertension and heart failure)
• Diuretics (used to eliminate excess fluid from the body)
• Fluconazole and rifampicin (used to treat bacterial and fungal infections)
• Warfarin or other oral anticoagulants (agents that reduce blood clot formation)
• 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/seizures and certain types of pain or depression)
• Barbiturates (used to treat epilepsy/seizures and certain sleep disorders)
• Cyclosporine and tacrolimus (used to suppress the immune system, e.g., after transplants).

Celecoxib TecniGen can be taken with low doses of acetylsalicylic acid (75 mg daily or less). Ask your doctor for advice before taking both medications together.

Pregnancy, Breastfeeding, and Fertility

Celecoxib TecniGen should not be used by pregnant women or women who may become pregnant (i.e., women of childbearing age who do not use adequate contraception) during treatment. If you become pregnant during treatment with Celecoxib TecniGen, you should stop treatment and contact your doctor for alternative treatment.

Celecoxib TecniGen should not be taken during breastfeeding.

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.

Driving and Using Machines

You should know how you react to Celecoxib TecniGen before driving or using machinery. If you feel dizzy or drowsy after taking Celecoxib TecniGen, do not drive or operate machinery until these effects have passed.

Celecoxib TecniGen Contains Lactose

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

Celecoxib TecniGen Contains Sodium

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

3. How to Take Celecoxib TecniGen

Follow the administration instructions for this medication exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

If you think or believe that the effect of Celecoxib TecniGen is too strong or too weak, inform your doctor or pharmacist.

Your doctor will indicate the dose you should take. Since the risk of side 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 you should not take Celecoxib TecniGen for longer than necessary to control the symptoms.

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

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 usual dose is 200 mg per day (1 capsule once a day), if necessary, your doctor may increase the dose up to a maximum of 400 mg (1 capsule 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), if necessary, your doctor may increase the dose up to a maximum of 400 mg (1 capsule twice a day).

For the Treatment of Ankylosing Spondylitis

The recommended dose is 200 mg per day (1 capsule once a day), if necessary, your doctor may increase the dose up to a maximum of 400 mg (2 capsules once a day or 1 capsule twice a day).

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

Patient 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, especially if you weigh less than 50 kg.

Use in Children:Celecoxib TecniGen is for adults only, it is not indicated in children.

Do not take more than 400 mg of celecoxib per day.

If You Take More Celecoxib TecniGen Than You Should

Do not take more capsules than indicated by your doctor. If you take more capsules than indicated, 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 Toxicology Information Service (telephone 91 562 04 20), indicating the medication and the amount taken.

If You Forget to Take Celecoxib TecniGen

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 TecniGen

Sudden cessation of treatment with Celecoxib TecniGen may cause a worsening of symptoms. Do not stop taking Celecoxib TecniGen unless your doctor tells you to. Your doctor will indicate that you should decrease the dose for a few days before stopping treatment completely.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

4. Possible Side Effects

Like all medications, Celecoxib TecniGen can cause side effects, although not all people experience them.

The following side effects were observed in patients with arthritis taking celecoxib. The side effects marked with an asterisk (*) occurred in patients taking celecoxib for the prevention of colon polyps and have been classified according to the highest frequency of occurrence. The patients included in these studies took celecoxib at high doses and for a prolonged period.

Stop treatment with Celecoxib TecniGen and inform your doctor immediately if you experience any of the following side effects:

• 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 the vomit.
• A skin reaction such as rash, blisters, or peeling of the skin.
• Liver failure (symptoms may include nausea, diarrhea, jaundice (your skin or the whites of your eyes appear yellow).

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):

• 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 in 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*
• Worsening of existing allergies

Adverse effects that are uncommon (may affect up to 1 in 100 patients):

• Heart failure, palpitations (perception of heartbeat), accelerated heartbeat
• Worsening of high blood pressure
• Anomalies in blood tests related to the liver
• Anomalies in blood tests related to the kidneys
• Anemia (changes in red blood cells that can cause fatigue and difficulty breathing)
• Anxiety, depression, fatigue, drowsiness, 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 and ulcers, difficulty hearing*
• Constipation, belching, stomach inflammation (indigestion, stomach pain, or vomiting), worsening of stomach or intestinal inflammation
• Leg cramps
• Itchy and relieving rash (urticarial habon)

Adverse effects that are rare (may affect up to 1 in 1,000 patients):

• Ulcers (bleeding) in the stomach, throat, or intestines; or intestinal rupture (can cause stomach pain, fever, nausea, vomiting, intestinal obstruction), dark or black stools, throat inflammation (can cause difficulty swallowing), pancreatic inflammation (can lead to stomach pain)
• Decrease in the number of white blood cells and platelets (increases the possibility of bleeding and bruising)
• Difficulty in muscular movement coordination
• Feeling of confusion, taste alterations
• Increased sensitivity to light
• Hair loss

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

• Bleeding in the brain that causes death
• Severe allergic reactions (including potentially fatal anaphylactic shock) that can cause skin rash, swelling in the face, lips, mouth, tongue, or throat, wheezing, or difficulty breathing; difficulty swallowing
• Stomach or intestinal bleeding (can lead to bloody stools or vomiting), intestinal or colon inflammation, nausea (feeling of discomfort)
• 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 (red and swollen area with numerous small pustules)

Liver failure, liver damage, and severe liver inflammation (sometimes with fatal outcome or requiring liver transplant). Symptoms may include nausea (feeling of discomfort), diarrhea, jaundice (yellow discoloration of the skin and eyes), dark urine, pale stools, ease of bleeding, itching, or chills

• Kidney problems (possible kidney failure, kidney inflammation)
• Blood clots in the blood vessels of the lungs. Symptoms may include sudden difficulty breathing, sharp chest pain, or collapse (circulatory obstruction of the pulmonary vessels)
• Irregular heart rhythm
• Meningitis (inflammation of the membrane surrounding the brain and spinal cord) - Hallucinations
• Worsening of epilepsy (possibly more frequent and/or severe seizures)
• Inflammation of blood vessels (can cause fever, pain, purple spots on the skin)
• Obstruction of an artery or vein in the eye that leads to partial or complete loss of vision, conjunctival inflammation, eye bleeding
• Reduction in the number of red and white blood cells and platelets (can cause fatigue, ease of bruising, frequent nosebleeds, and increased risk of infections)
• Chest pain
• Alteration of taste
• Discoloration of the skin (bruises), muscle pain and weakness, joint pain
• Menstrual disorders
• Headache, flushing
• Low sodium levels in blood test results (can cause loss of appetite, headache, nausea, cramps, and muscle weakness)

The adverse effects observed in clinical trials in which Celecoxib was administered at a dose of 400mg per day for more than 3 years, in patients who had 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, and 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 clotting 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 intestines)
• Fracture of lower limbs
• Herpes, skin infection, eczema (dry itchy rash), pneumonia (chest infection, possibility of cough, fever, difficulty breathing)
• Flying flies in the eye that cause vision disorder or blurred vision, dizziness 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 movement

• 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 very heavy vaginal bleeding, chest pain
• High sodium levels in blood test results

If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects that do not appear in this prospectus.

5. Conservation of Celecoxib TecniGen

Keep this medicine out of sight and reach of children.

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

Do not store at a temperature above 30°C.

Medicines should not be thrown down the drain or into the trash. Deposit the containers and medicines you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Celecoxib TecniGen composition

• The active ingredient is celecoxib. Each capsule contains 200 mg of celecoxib.
• The other components (excipients) are: lactose monohydrate, sodium croscarmellose, povidone K30, sodium lauryl sulfate, magnesium stearate. The capsule shell contains gelatin, titanium dioxide (E-171), and indigo carmine (E-132)

Product appearance and package contents

Celecoxib TecniGen 200 mg capsules are hard white capsules.

Celecoxib TecniGen 200 mg is available in blister packs of 20 and 30 hard capsules.

Only some package sizes may be marketed.

Marketing authorization holderTecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D.

28108 Alcobendas (Madrid) SPAIN

Manufacturer

This medicine is authorized in the Member States of the European Economic Area under the following names:

Portugal: Celecoxib Atrolif

Italy: Celecoxib Pentafarma, 200 mg, hard capsules

Spain: Celecoxib TecniGen 200 mg hard capsules EFG.

Date of the last revision of this prospectus:November 2021

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