Celecoxib Tecnigen 200 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Celecoxib TecniGen 200 mg hard capsules EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet.

Leaflet contents:

1. What Celecoxib TecniGen is and what it is used for
2. What you need to know before taking Celecoxib TecniGen
3. How to take Celecoxib TecniGen
4. Possible side effects
5. How to store Celecoxib TecniGen
6. Contents of the pack and other information

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

Celecoxib TecniGen contains celecoxib as the active substance.

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

Celecoxib TecniGen belongs to a class of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs), and specifically to the subgroup known as selective cyclooxygenase-2 (COX-2) inhibitors. Your body produces prostaglandins which can cause pain and inflammation. In conditions such as rheumatoid arthritis or osteoarthritis, your body produces them in higher amounts. Celecoxib TecniGen works by reducing the production of prostaglandins, thereby decreasing pain and inflammation.

2. What you need to know before starting to take Celecoxib TecniGen

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

Do not take Celecoxib TecniGen

Inform 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 to any of the other ingredients of this medicine (listed in section 6)
• if you have previously had an allergic reaction to any medicine in the group called "sulfonamides"

(e.g.: some of these 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 after taking acetylsalicylic acid or any other anti-inflammatory drug: asthma, nasal polyps, severe nasal congestion, or allergic symptoms such as itchy rash, swelling of the face, lips, tongue or throat, difficulty breathing or wheezing
• if you are pregnant. If you could 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 in blood flow to the brain; also known as "mini-stroke"), angina pectoris, or blockage of the blood vessels supplying the heart or brain
• if you have or have had problems with blood circulation (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 TecniGen if you currently have a stomach or intestinal ulcer or bleeding).
• if you are taking acetylsalicylic acid (even low-dose, such as for heart protection)
• if you are taking medications to reduce blood clotting (e.g., warfarin)
• if you are taking Celecoxib TecniGen together with other non-acetylated NSAIDs such as ibuprofen or diclofenac. The combined use of these medicines should be avoided
• if you are a smoker, or have diabetes, high blood pressure, or high cholesterol
• if your heart, liver, or kidneys do not function properly, your doctor may wish 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 or diarrhea, or due to the use of diuretics (used to treat excess fluid in the body)
• if you have previously experienced a severe allergic reaction or a serious skin reaction to any medication
• if you feel unwell due to an infection or suspect you have an infection, as taking Celecoxib TecniGen may mask fever or other signs of infection and inflammation—if you are over 65 years of age, your doctor may wish to monitor you regularly.

Like other anti-inflammatory medicines (e.g., ibuprofen or diclofenac), this medicine may increase your blood pressure, so your doctor may carry out periodic monitoring.

Serious liver-related reactions, including severe hepatitis, liver damage, and liver failure (some cases fatal or requiring liver transplantation), have been reported during treatment with celecoxib. Among the cases where the onset time was reported, most serious hepatic reactions occurred within the first month of treatment.

Celecoxib TecniGen may make it more difficult to become pregnant. You should inform your doctor if you are planning to become pregnant or if you have difficulty becoming pregnant (see section Pregnancy and breastfeeding).

Taking Celecoxib TecniGen with other medicines

Some medicines may alter the effect of other medicines. Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines:

• Dextromethorphan (used to treat cough)
• ACE inhibitors or angiotensin II receptor antagonists (medicines used to treat high blood pressure and heart failure)
• Diuretics (used to remove 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 clot formation)
• Lithium (used to treat certain types of depression)
• Other medicines 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 for immunosuppression, e.g., after organ transplants).

Celecoxib TecniGen may be taken with low-dose acetylsalicylic acid (75 mg daily or less). Ask your doctor for advice before taking both medicines together.

Pregnancy, breastfeeding, and fertility

Celecoxib TecniGen must not be used by pregnant women or women who may become pregnant (i.e., women of childbearing potential who are not using an adequate contraceptive method) during treatment. If you become pregnant while being treated with Celecoxib TecniGen, you must discontinue treatment and contact your doctor for an alternative treatment.

Celecoxib TecniGen must not be taken during breastfeeding.

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

You should be aware of 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 have subsided.

Celecoxib TecniGen contains lactose

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

Celecoxib TecniGen contains sodium

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

3. How to take Celecoxib TecniGen

Follow exactly the instructions for use of this medicine given 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 tell you the dose you should take. Since the risk of adverse effects related to heart problems may increase with dose and duration of treatment, it is important to use the lowest dose that controls your pain and not to take Celecoxib TecniGen for longer than necessary to control symptoms.

Celecoxib TecniGen must 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 each day.

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

The recommended dose is:

For the treatment of osteoarthritis

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

For the treatment of rheumatoid arthritis

The recommended initial dose is 200 mg per day (1 capsule of 100 mg twice daily). If necessary, your doctor may increase the dose up to a maximum of 400 mg (1 capsule twice daily).

For the treatment of ankylosing spondylitis

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

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

Patients aged 65 years and older, especially those weighing less than 50 kg: your doctor may wish to monitor you more closely if you are over 65 years of age, particularly if you weigh less than 50 kg.

Use in children: Celecoxib TecniGen is for adults only and is not indicated for use 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 prescribed, consult your doctor, pharmacist, or hospital immediately, and bring the medicine with you.

In case of overdose or accidental ingestion, contact 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 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 missed doses.

If you interrupt treatment with Celecoxib TecniGen

Suddenly stopping treatment with Celecoxib TecniGen may cause your symptoms to worsen. Do not stop taking Celecoxib TecniGen unless your doctor tells you to. Your doctor will advise you to gradually reduce the dose over several days before completely stopping treatment.

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

4. Possible adverse effects

Like all medicines, Celecoxib TecniGen may cause adverse effects, although not everyone will experience them.

The adverse effects listed below were observed in patients with arthritis who were taking celecoxib. The adverse 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 of time.

Stop treatment with Celecoxib TecniGen and inform your doctor immediately if you experience any of the following adverse 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, blood in the stool, or blood in vomit.
• A skin reaction such as rash, blisters, or skin peeling.
• Liver failure (symptoms may include nausea (feeling unwell), diarrhea, jaundice (yellowing of the skin or whites of the eyes)).

Very common adverse effects (may affect more than 1 in 10 people):

• Increased blood pressure*.

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

• Heart attack*
• Fluid retention with swelling of ankles, legs and/or hands
• Urinary tract infection
• Difficulty breathing*, sinusitis (inflammation and infection of the paranasal sinuses, sinus blockage or pain), nasal congestion or runny nose, sore throat, cough, common cold, flu-like symptoms
• Dizziness, difficulty sleeping
• Vomiting*, stomach pain, diarrhea, indigestion, flatulence
• Rash, itching
• Muscle stiffness
• Difficulty swallowing*
• Worsening of existing allergies

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

• Stroke*
• Heart failure, palpitations (awareness of heartbeat), accelerated heartbeat
• Worsening of high blood pressure
• Abnormal blood test results related to the liver
• Abnormal blood test results related to the kidney
• Anemia (changes in red blood cells that may cause fatigue and difficulty breathing)
• Anxiety, depression, fatigue, numbness, tingling sensation
• Elevated potassium levels in blood test results (may cause nausea (feeling unwell), fatigue, muscle weakness, or palpitations)
• Blurred or altered vision, ringing in the ears, mouth pain and ulcers, hearing difficulty*
• Constipation, belching, stomach inflammation (indigestion, stomach pain, or vomiting), worsening of stomach or intestinal inflammation
• Leg cramps
• Itchy, raised rash (urticarial rash)

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

• Bleeding ulcers in the stomach, throat, or intestines; or intestinal perforation (may cause stomach pain, fever, nausea, vomiting, intestinal obstruction), dark or black stools, throat inflammation (may cause difficulty swallowing), pancreatitis (may lead to stomach pain)
• Decrease in white blood cell count (cells that help protect the body from infections) and platelets (increased risk of bleeding and bruising)
• Difficulty with muscular coordination of movements
• Confusion, taste disturbances
• Increased sensitivity to light
• Hair loss

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

• Brain hemorrhage leading to death
• Severe allergic reactions (including potentially life-threatening anaphylactic shock) which may cause skin rash, swelling of the face, lips, mouth, tongue, or throat, wheezing or difficulty breathing; difficulty swallowing
• Stomach or intestinal bleeding (may result in bloody stools or vomit), inflammation of the intestine or colon, nausea (feeling unwell)
• Serious skin reactions such as Stevens-Johnson syndrome, exfoliative dermatitis, and toxic epidermal necrolysis (may cause rash, blistering, or skin peeling), and acute generalized exanthematous pustulosis (swollen and red area with numerous small pustules)
• Liver failure, liver damage, and severe liver inflammation (sometimes fatal or requiring liver transplantation). Symptoms may include nausea (feeling unwell), diarrhea, jaundice (yellowing of the skin and eyes), dark urine, pale stools, easy bleeding, itching, or chills
• Kidney problems (possible kidney failure, kidney inflammation)
• Blood clots in blood vessels of the lungs. Symptoms may include sudden breathing difficulty, sharp pain when breathing, or collapse (circulatory blockage of pulmonary pathways)
• Irregular heartbeat
• 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 (may cause fever, pain, purple spots on the skin)
• Blockage of an artery or vein in the eye leading to partial or complete vision loss, conjunctivitis, eye hemorrhage
• Reduction in red and white blood cells and platelets (may cause fatigue, easy bruising, frequent nosebleeds, and increased risk of infections)
• Chest pain
• Taste disturbance
• Skin discoloration (bruising), muscle pain and weakness, joint pain
• Menstrual disorders
• Headache, flushing
• Low sodium levels in blood test results (may cause loss of appetite, headache, nausea (feeling unwell), muscle cramps, and weakness)

Adverse effects observed in clinical trials where Celecoxib was administered at a dose of 400 mg daily for more than 3 years in patients with diseases not related to Arthritis or other arthritic conditions were:

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

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

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

• Deep vein thrombosis (blood clot usually in the leg, which may cause calf pain, swelling, or redness, or breathing problems)
• Stomach problems: stomach infection (may cause irritation or ulcers in the stomach and intestine)
• Fracture of lower limbs
• Herpes, skin infection, eczema (dry, itchy rash), pneumonia (chest infection (possible cough, fever, difficulty breathing))
• Eye floaters causing visual disturbance or blurred vision, vertigo due to inner ear problems, gum ulcers, inflammation or bleeding, mouth ulcers
• Excessive urination at night, hemorrhoid bleeding, frequent bowel movements
• Fatty lumps in the skin or other areas, ganglion cyst (non-painful swelling in or around joints or tendons, in hand or foot), difficulty speaking, abnormal or very heavy vaginal bleeding, chest pain
• Elevated sodium levels in blood test results

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

5. Storage of Celecoxib TecniGen

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

Do not use this medicine after the expiry date stated on the blister and outer carton following EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point located at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and additional information

Composition of Celecoxib TecniGen

• The active substance 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 indigotine (indigo carmine) (E-132).

Appearance of the product and contents of the pack

Celecoxib TecniGen 200 mg capsules are hard capsules of white color.

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

Only some pack sizes may be marketed.

Marketing Authorization Holder Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D.

28108 Alcobendas (Madrid) SPAIN

Manufacturer

This medicine is authorized in the European Economic Area member states 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 most recent review of this leaflet: November 2021

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