Prospect: information for the patient

Celecoxib TecniGen 200 mg hard capsules EFG

Read this prospect carefully before starting to take this medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only to you, and you should not give it 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, pharmacist, or nurse, even if they are not listed in this prospect.

5Storage of Celecoxib TecniGen

6.Contents of the package and additional information

Celecoxib TecniGen contains celecoxib as the active ingredient.

Celecoxib TecniGen is indicated to relieve the symptoms and signs ofrheumatoid arthritis, osteoarthritis, and ankylosing spondylitis.

Celecoxib TecniGen belongs to a class of medications known as nonsteroidal anti-inflammatory drugs (NSAIDs), and specifically to 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. Celecoxib TecniGen acts by reducing the production of prostaglandins, thereby reducing pain and inflammation.

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

Do not take Celecoxib TecniGen

Inform your doctor if any of the following circumstances affect 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 any 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 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 ischemic heart disease, or cerebrovascular disease, for example, you have been diagnosed with a heart attack, stroke, or transient ischemic attack (temporary decrease in blood flow to the brain; also known as “mini-stroke”), angina pectoris, or obstruction of the blood vessels that supply the heart or brain
• if you have or have had circulation problems (peripheral arterial disease) or if you have been operated on to clear 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 hemorrhage. (Do not take Celecoxib TecniGen if 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 Celecoxib TecniGen 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 (such as swollen feet or ankles)
• if you are dehydrated, for example, due to an illness 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 TecniGen can 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 can perform regular checks.

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 onset was reported, most of the severe liver reactions occurred inthe 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 difficulty becoming pregnant (see 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 taken recently, 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 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 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 an adequate contraceptive method) during treatment. If you become pregnant during treatment with Celecoxib TecniGen, you should discontinue 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 operating machinery

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

Celecoxib TecniGen contains 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.

Celecoxib TecniGen contains sodium

This medication contains less than 1 mmol of sodium (23 mg) 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 the action of Celecoxib TecniGen 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 Celecoxib TecniGen for longer than necessary to control your symptoms.

Celecoxib TecniGen must be swallowed whole with a glass of water.The capsules are taken orally at any time of the 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 starting 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).

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

Patients over 65 years, 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:Celecoxib TecniGen is only for adults, it is not indicated for 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 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 Celecoxib TecniGen

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 the treatment with Celecoxib TecniGen

Stopping treatment with Celecoxib TecniGen abruptly may cause a worsening of symptoms. Do not stop taking Celecoxib TecniGen 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, pharmacist, or nurse.

Like all medications, Celecoxib TecniGen may 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 treatment with Celecoxib TecniGen and inform your doctor immediately if you experience any of the following side effects:

• 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 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, dark urine, pale stools, easy bruising, or itching)

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), 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

Rare side effects (may affect up to 1 in 100 patients):-Stroke*

• Heart failure, palpitations (perception of heartbeats), tachycardia (rapid heart rate)
• Worsening of high blood pressure
• Abnormalities in liver function tests
• Abnormalities in kidney function tests
• Anemia (changes in red blood cells that may cause fatigue and difficulty breathing)
• Anxiety, depression, fatigue, numbness, tingling
• High potassium levels in blood test results (may cause nausea, fatigue, muscle weakness, or palpitations)
• Blurred or altered vision, tinnitus (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)

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

• Stomach ulcers (bleeding), throat ulcers, or intestinal ulcers; or intestinal rupture (may cause stomach pain, fever, nausea, vomiting, intestinal obstruction), dark or black stools, throat inflammation (may cause difficulty swallowing), pancreatitis (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)
• Muscle coordination difficulties
• 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 (red, swollen area with numerous small pustules)

Liver failure, severe liver damage, and severe liver inflammation (sometimes with fatal outcome or requiring liver transplant). Symptoms may include nausea, diarrhea, jaundice, dark urine, pale stools, easy bruising, or itching

• Renal problems (possible kidney failure, kidney inflammation)
• Pulmonary embolism (blood clots in the lungs' blood vessels). Symptoms may include sudden difficulty breathing, acute chest pain, or collapse (obstruction of the pulmonary blood 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 inflammation (may cause fever, pain, or purplish spots on the skin)
• Obstruction of an artery or vein 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, easy bruising, frequent nosebleeds, or increased risk of infections)
• Chest pain
• Altered sense of taste
• Decoloration of the skin (petechiae), muscle pain and weakness, joint pain
• Menstrual disorders
• Headache, flushing
• Low sodium levels in blood test results (may cause loss of appetite, headache, nausea, muscle cramps, or 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):

• Cardiovascular 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 generally 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 (lung 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

Nocturia (excessive nighttime urination), hematuria (bleeding from the vagina), 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 strong vaginal bleeding, chest pain
• High sodium levels in blood test results

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

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

Do not use this medication 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.

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 point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Celecoxib TecniGen

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

Appearance of the product and content of the container

Celecoxib TecniGen 200 mg capsules are hard, white capsules.

Celecoxib TecniGen 200 mg is presented in blister-type containers with 20 and 30 hard capsules.

Only some container sizes may be commercially marketed.

Holder of the marketing authorizationTecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3rd floor.

28108 Alcobendas (Madrid) SPAIN

Responsible for manufacturing

This medicine is authorized in the member states of the European Economic Area with the following names:

Portugal: Celecoxib Atrolif

Italy: Celecoxib Pentafarma, 200 mg, rigid capsule

Spain: Celecoxib TecniGen 200 mg hard capsules EFG.

Revision date of this leaflet:November 2021

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/