Prospect: information for the patient

Celecoxib Stada 200 mg hard capsules EFG

Read this prospect carefully before starting to take this medicine, 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 or pharmacist.
• This medicine has been prescribed for you and should not be given 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 or pharmacist, even if they are not listed in this prospect. See section 4.

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

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

3.How to take Celecoxib Stada

4.Possible adverse effects

5.Storage of Celecoxib Stada

6.Contents of the package and additional information

Celecoxib is indicatedinadultsto relieve the symptoms and signs ofrheumatoid arthritis,ofosteoarthritis, and ofankylosing spondylitis.

Celecoxib 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. Your body produces prostaglandins that can cause pain and inflammation. In conditions such as rheumatoid arthritis or osteoarthritis, your body produces them in greater quantities. Celecoxib acts by reducing the production of prostaglandins, thereby reducing pain and inflammation.

The medication will start to take effect a few hours after taking the first dose, but you may not experience a complete effect until several days have passed.

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 Stada

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

• 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 antibiotics used to treat infections).
• if you currently have a stomach ulcer or intestinal ulcer or stomach or intestinal bleeding.
• if you have had any of the following symptoms as a result of taking acetylsalicylic acid or any other anti-inflammatory and pain-relieving 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, discuss the use of contraceptive methods with your doctor.
• if you are breastfeeding your child.
• 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 coronary artery disease, or cerebrovascular disease, for example, if 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 obstruction of the blood vessels to the heart or brain.
• if you have or have had circulatory problems (peripheral arterial disease) or if you have been operated on on the arteries of your legs.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Celecoxib Stada:

• if you have previously had a stomach ulcer or intestinal bleeding(Do not take celecoxibif you currently have a stomach ulcer or intestinal bleeding).
• if you are taking acetylsalicylic acid (even at low doses as a heart protector).
• if you are taking antiplatelet therapies.

• if you are receiving medications to reduce blood clotting (e.g., warfarin/anticoagulant analogs of warfarin or new oral anticoagulants, e.g., apixaban).
• if you are receiving medications called corticosteroids (e.g., prednisone).

• if you are taking celecoxib at the same time as other non-acetylsalicylic acid anti-inflammatory drugs 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 do not function 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 celecoxib can mask fever and 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 AINEs may increase the risk of experiencing gastrointestinal problems.

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

There have been reported cases of severe liver reactions with celecoxib, including severe liver inflammation, liver damage, and liver insufficiency (some with fatal outcome or requiring liver transplant).Of the cases in which the onset was specified, most severe liver reactions occurred in 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 have difficulty becoming pregnant (see Pregnancy and breastfeeding).

Other medications and Celecoxib Stada

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

• Dextromethorphan (used to treat cough).
• ACE inhibitors, angiotensin II receptor antagonists, beta-blockers, and diuretics(medications used to treat hypertension and heart failure).
• Fluconazole and rifampicin (used to treat infections caused by bacteria and fungi).
• Warfarinor other warfarin analogs(agents that reduce blood clotting), including newer medications such as apixaban.
• 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 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

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.

Pregnancy

Celecoxib 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, you should discontinue treatment and contact your doctor for alternative treatment.

Breastfeeding

Celecoxib should not be used 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.

Driving and operating machinery

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

Celecoxib Stada contains lactose and sodium

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

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.If you think or believe that the action of celecoxib is too strong or too 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 for longer than necessary to control your symptoms.

Administration Form

Celecoxib must be administered orally.The capsules are taken at any time of the day, with or without food. However, try to take each dose of celecoxib 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:

The recommended dose for the treatment ofosteoarthritisis 200 mg per day, if necessary, your doctor mayincrease itup to a maximum of 400 mg.

The usual dose is:

• One 200 mg capsule once a day.

The usual dose for the treatment ofrheumatoid arthritisis 200 mg per day (in two doses), if necessary, your doctor mayincrease itup to a maximum of 400 mg (in two doses).

The usual dose is:

• One 100 mg capsule twice a day.

Ifyoucannotachievewiththismedicationtheprescribeddose,there areothermedicationswiththedoseof100mgofcelecoxib.Consult your doctor.

The usual dose for the treatment ofankylosing spondylitisis 200 mg per day, if necessary, your doctor may increase it up to a maximum of 400 mg.

The usual dose is:

• One 200 mg capsule once a day.

Maximum Daily Dose

You should not take more than 400 mg per day (two celecoxib 200 mg capsules).

Patients with kidney or liver problems: make sure your doctor knows if you have kidney or liver problems since you may need a lower dose.

Older patients, 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 for children.

If you take more Celecoxib Stada than you should

You should not take more capsules than indicated by your doctor. If you take more celecoxib 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 Toxicology Poison Control Service. Telephone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Celecoxib Stada

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 Celecoxib Stada

Stopping treatment abruptly with celecoxibmay cause a worsening of symptoms. Do not stop taking celecoxibunless 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 or pharmacist.

Like all medications, this medication 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 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. Patients included in these studies took celecoxib at high doses and for a prolonged period of time.

If you experience any of the following side effects, discontinue treatment with celecoxib and inform your doctor immediately:

If you have:

• 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 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 white of your eyes appears yellow)).

Very common side effects: may affect more than one in 10 people

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

Common side effects: may affect up to 1 in 10 people

• 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 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)
• Joint pain
• Worsening of existing allergies.
• Accidental injury

Rare side effects: may affect up to 1 in 1,000 people

• Ulcers (bleeding) in the stomach, throat, or intestines; or intestinal rupture (may cause stomach pain, fever, nausea, vomiting, intestinal obstruction), dark or black stools, pancreatitis (may cause stomach pain), esophagitis (inflammation of the esophagus).
• Low sodium levels in the blood (a condition known as hyponatremia).
• 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.
• Feeling of confusion, alterations in taste.
• Increased sensitivity to light.
• Loss of hair.
• Alucinations.
• Eye hemorrhage.
• Acute reaction that may lead to pulmonary inflammation.
• Irregular heart rhythm.
• Rubefaction.
• Coagulation of blood in the pulmonary vessels. Symptoms may include sudden difficulty breathing, acute chest pain, or collapse.
• Stomach or intestinal hemorrhage (may cause stools or vomit with blood), intestinal or colon inflammation.
• Severe liver inflammation (hepatitis). Symptoms may include nausea, diarrhea, jaundice (yellow discoloration of the skin and eyes), dark urine, pale stools, easy bleeding, itching, or chills.
• Acute kidney failure.
• Menstrual disorders.
• Swelling in the face, lips, mouth, tongue, or throat, or difficulty swallowing.

Very rare side effects: may affect up to 1 in 10,000 people

• Severe allergic reactions (including potentially fatal anaphylactic shock).
• Severe skin alterations such as Stevens-Johnson syndrome, exfoliative dermatitis, and toxic epidermal necrolysis (may cause rash, blistering, or peeling of the skin) and acute generalized pustular psoriasis(symptoms include skin redness with swollen areas and numerous small pustules).
• Delayed allergic reaction with possible symptoms such as rash, facial swelling, fever, swollen lymph nodes, and abnormalities in clinical test results (e.g., liver, blood cells (eosinophilia, a type of increased blood cell count)).
• Cerebral hemorrhage leading to death.
• Meningitis (inflammation of the membrane surrounding the brain and spinal cord).
• Severe liver failure, liver damage, and severe liver inflammation (hepatitis fulminant) (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 bleeding, itching, or chills.
• Liver problems (such as cholestasis and cholestatic hepatitis, which may be accompanied by symptoms such as pale stools, nausea, and yellow discoloration of the skin or eyes).
• Kidney inflammation and other kidney problems (such as nephrotic syndrome and minimal change disease, which may be accompanied by symptoms such as fluid retention (edema), foamy urine, fatigue, and loss of appetite).
• Worsening of epilepsy (convulsions possibly more frequent and/or severe).
• Obstruction of an artery or vein in the eye leading to partial or complete loss of vision.
• Inflammation of blood vessels (may cause fever, pain, and purple spots on the skin).
• Decreased white blood cell count and platelet count (may cause fatigue, easy bleeding, frequent nasal bleeding, and increased risk of infections).
• Muscle pain and weakness.
• Alteration of taste.
• Loss of taste.

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

• Decreased female fertility, which is normally reversible if medication is discontinued

The side effects reported in clinical trials in which celecoxib was administered at a dose of 400 mg 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 people

• 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 people

• Deep vein thrombosis (blood clotting usually in the leg, which may cause pain, swelling, or redness of the calf or problems 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 that cause 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 very heavy vaginal bleeding, chest pain.
• Elevated sodium levels in blood test results.

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of the medication.

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

Do not use this medication after the expiration date that appears on the packaging 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 bedisposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Celecoxib Stada Composition

The active ingredient is celecoxib.

Each hard capsule contains 200 mg of celecoxib.

The other components (excipients) are: lactose monohydrate, croscarmellose sodium, povidone K30, sodium lauryl sulfate, magnesium stearate, titanium dioxide (E-171), gelatin, yellow iron oxide (E172).

Product Appearance and Packaging Contents

Celecoxib Stada is presented in the form of hard capsules.

Thecapsulesarehard gelatin capsules with a white body and a yellow cap,filledwitha white or almost white crystalline powder.

The capsules are presented in PVC-Al or PVC/PVdC-Al blisters.

Celecoxib Stada may be presented in packaging of 10, 20, 30, 40, 50, 60, 80, 90, 100, 120, 150, 160, 180 hard capsules

Only some packaging sizes may be commercially available.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern(Barcelona)

Spain

[email protected]

Responsible Manufacturer

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

or

Centrafarm Services B.V.

Van de Reijtstraat 31-E

4814 NE Breda

Netherlands

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

Bélgica:Celecoxib EG 100 mg capsules, hard

Celecoxib EG 200 mg capsules, hard

BulgariaDEFINAX 200 mg capsules

República ChecaCelecoxib Stada 200 mg tvrdé tobolky

AlemaniaCelecoxib Stada 200 mg Hartkapseln

DinamarcaCelecoxib Stada

EspañaCelecoxib Stada 200 mg cápsulas duras EFG

FinlandiaCelecoxib Stada 200 mg kapseli, kova

FranciaCELECOXIB EG 200 mg, gélule

IslandiaCelecoxib STADA 200 mg hart hylki

LuxemburgoCelecoxib EG 200 mg gélules

HolandaCelecoxib CF 200 mg, capsules, hard

PortugalCelecoxib Ciclum

SueciaCelecoxib Stada 200 mg kapsel, hård

Last review date of this leaflet: July 2021

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