CELECOXIB STADA 200 mg HARD CAPSULES

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

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

Do not take Celecoxib Stada

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

Warnings and Precautions

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

Do not take celecoxibif you currently have a stomach or intestinal ulcer or bleeding).

• Consumption of alcohol and NSAIDs can increase the risk of gastrointestinal problems.

As with other anti-inflammatory drugs (e.g. ibuprofen or diclofenac), this medicine may increase your blood pressure, so your doctor may perform periodic blood pressure checks.

Some cases of severe liver reactions have been reported with celecoxib, including severe liver inflammation, liver damage, liver failure (some with a fatal outcome or requiring liver transplantation). Of the cases in which it was specified when the event started, most severe liver reactions occurred within the first month of treatment.

Celecoxib may make it more difficult to become pregnant. You should inform your doctor if you plan to become pregnant or if you are having difficulty becoming pregnant (see section Pregnancy and Breastfeeding).

Other Medicines and Celecoxib Stada

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

• Dextromethorphan (used to treat coughs).
• ACE inhibitors, angiotensin II receptor antagonists, beta-blockers, and diuretics (medicines used to treat high blood pressure and heart failure).
• Fluconazole and rifampicin (used to treat bacterial and fungal infections).
• Warfarin or other warfarin-like anticoagulants (agents that reduce blood clot formation), including newer medicines such as apixaban.
• Lithium (used to treat some types of depression).
• Other medicines 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/seizures and some forms of pain or depression).
• Barbiturates (used to treat epilepsy/seizures and some sleep disorders).
• Cyclosporine and tacrolimus (used for immune system suppression, 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 medicines together.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

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

Breastfeeding

Celecoxib should not be used during breastfeeding.

Fertility

NSAIDs, including celecoxib, may make it more 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 Using Machines

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

Celecoxib Stada Contains Lactose and Sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

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

3. How to Take Celecoxib Stada

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist. If you think the effect of celecoxib is too strong or too weak, talk to your doctor or pharmacist.

Your doctor will tell you what dose to take. Since the risk of side effects associated with heart problems may increase with the dose and duration of treatment, it is important that you use the lowest dose that controls your pain and do not take celecoxib for longer than necessary to control your symptoms.

Method of Administration

Celecoxib should be taken orally.The capsules can be taken at any time of day, with or without food. However, try to take each dose of celecoxib at the same time each day.

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

The recommended dose is:

The recommended dose for the treatment of osteoarthritisis 200 mg per day; if necessary, your doctor may increase it to a maximum of 400 mg.

The dose is usually:

• One 200 mg capsule once a day.

The usual dose for the treatment of rheumatoid arthritisis 200 mg per day (in two divided doses); if necessary, your doctor may increase it to a maximum of 400 mg (in two divided doses).

The dose is usually:

• One 100 mg capsule twice a day.

If you cannot achieve the prescribed dose with this medicine, there are other medicines available with a dose of 100 mg of celecoxib. Consult your doctor.

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

The dose is usually:

• One 200 mg capsule once a day.

Maximum Daily Dose

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

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

Elderly 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 for adults only; it is not indicated in children.

If you take more Celecoxib Stada than you should

Do not take more capsules than your doctor has told you. If you take more celecoxib than you should, contact your doctor, pharmacist, or hospital immediately and take the medicine with you.

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or the Toxicological Poison Control Service immediately. Telephone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Celecoxib Stada

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 Stada

Sudden stopping of treatment with celecoxib may cause worsening of symptoms. Do not stop taking celecoxib unless your doctor tells you to. Your doctor will tell you to reduce the dose over a few days before stopping treatment completely.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

The adverse effects mentioned below were observed in patients with arthritis who took celecoxib. The effects marked with an asterisk (*) occurred in patients who took celecoxibfor the prevention of colon polyps and have been classified taking into account the highest frequency of occurrence. The patients included in these studies took celecoxibat high doses and for a prolonged period.

If you experience any of the following adverse effects, discontinue treatment with celecoxiband inform your doctor immediately:

If you have:

• 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 vomit.
• A skin reaction such as rash, blisters or peeling of the skin.
• Liver failure (symptoms may include nausea, diarrhea, jaundice, dark urine, pale stools, ease of bruising, or chills).

Very frequent adverse effects: may affect more than 1 in 10 people

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

Frequent adverse effects: may affect up to 1 in 10 people

• Heart attack*.
• Fluid retention with swelling of ankles, legs and/or hands.
• Urinary tract infection.
• Difficult 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*.
• Headache
• Nausea (feeling of discomfort)
• Pain in the joints
• Worsening of existing allergies.
• Accidental injury

Uncommon adverse effects: may affect up to 1 in 100 people

• Stroke*.
• Heart failure, palpitations (perception of heartbeat), accelerated heartbeat.
• Abnormalities in blood tests related to the liver.
• Abnormalities in blood tests related to the kidneys.
• Anemia (changes in red blood cells that can cause fatigue and difficulty breathing).
• Anxiety, depression, fatigue, numbness, 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 or ulcers, difficulty hearing*.
• Constipation, belching, stomach inflammation (indigestion, stomach pain or vomiting), worsening of stomach or intestinal inflammation.
• Leg cramps.
• Rash with itching and relief (urticarial habon).
• Eye inflammation
• Difficulty breathing
• Discoloration of the skin (bruises)
• Chest pain (generalized pain not related to the heart)
• Swelling of the face

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

• Ulcers (bleeding) in the stomach, throat or intestines; or rupture of the intestine (can cause stomach pain, fever, nausea, vomiting, intestinal obstruction), dark or black stools, pancreatitis (can cause stomach pain), esophagitis (inflammation of the esophagus).
• Low sodium levels in the blood (a disease known as hyponatremia).
• Decreased number of white blood cells and platelets (increases the possibility of bleeding and bruising).
• Difficulty in muscular coordination of movements.
• Feeling of confusion, alterations in taste.
• Increased sensitivity to light.
• Hair loss.
• Hallucinations.
• Eye bleeding.
• Acute reaction that can lead to lung inflammation.
• Irregular heartbeat.
• Redness of the skin.
• Blood clots in the blood vessels of the lungs. Symptoms may include sudden difficulty breathing, sharp chest pain, or collapse.
• Gastrointestinal bleeding or intestinal inflammation (can cause stools or vomit with blood), colon inflammation.
• Severe liver inflammation (hepatitis). Symptoms may include nausea, diarrhea, jaundice, dark urine, pale stools, ease of bruising, or chills.
• Acute kidney failure.
• Menstrual disorders.
• Swelling in the face, lips, mouth, tongue, or throat, or difficulty swallowing.

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

• Severe allergic reactions (including potentially fatal anaphylactic shock).
• Severe skin disorders such as Stevens-Johnson syndrome, exfoliative dermatitis, and toxic epidermal necrolysis (can cause rash, blistering, or peeling of the skin) and generalized acute pustular exanthema (symptoms include redness of the skin with swollen areas and numerous small pustules).
• A delayed allergic reaction with possible symptoms such as rash, swelling of the face, fever, swollen glands, and abnormalities in clinical test results (e.g., liver, blood cells (eosinophilia, a type of increase in blood cell count)).
• Bleeding in the brain that causes death.
• Meningitis (inflammation of the membrane surrounding the brain and spinal cord).
• Liver failure, liver damage, and severe liver inflammation (fulminant hepatitis) (sometimes with fatal outcome or requiring liver transplantation). Symptoms may include nausea, diarrhea, jaundice, dark urine, pale stools, ease of bruising, or chills.
• Liver problems (such as cholestasis and cholestatic hepatitis, which may be accompanied by symptoms such as discolored stools, nausea, and yellowing 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, foamy urine, fatigue, and loss of appetite).
• Worsening of epilepsy (possibly more frequent and/or severe seizures).
• Obstruction of an artery or vein in the eye that leads to partial or complete loss of vision.
• Inflammation of blood vessels (can cause fever, pain, purple spots on the skin).
• 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).
• Muscle pain and weakness.
• Alteration of taste.
• Loss of taste.

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

• Decreased fertility in women, which is normally reversible if the medication is discontinued

Adverse effects reported in clinical trials in which celecoxib was administered at doses of 400 mg per day for more than 3 years, in patients with diseases unrelated to arthritis or other arthritic conditions, were:

Frequent adverse effects: may affect up to 1 in 10 people

• 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 people

• Deep vein thrombosis (blood clotting generally 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 rash with itching), pneumonia (chest infection (possibility of cough, fever, difficulty breathing)).
• Floaters in the eye that cause vision disturbance or blurred vision, vertigo 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 heavy vaginal bleeding, chest pain.
• High levels of sodium in blood test results.

Reporting of adverse effects:

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

5. Storage of Celecoxib Stada

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

Do not use this medicine 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 above 30°C.

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

6. Package Contents and Additional Information

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 Package Contents

Celecoxib Stada is presented in the form of hard capsules.

The capsules are hard gelatin with a white body and a yellow cap, filled with a white or almost white crystalline powder.

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

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

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratory STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

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

Belgium: Celecoxib EG 100 mg capsules, hard

Celecoxib EG 200 mg capsules, hard

Bulgaria DEFINAX 200 mg capsules

Czech Republic Celecoxib Stada 200 mg tvrdé tobolky

Germany Celecoxib Stada 200 mg Hartkapseln

Denmark Celecoxib Stada

Spain Celecoxib Stada 200 mg cápsulas duras EFG

Finland Celecoxib Stada 200 mg kapseli, kova

France CELECOXIB EG 200 mg, gélule

Iceland Celecoxib STADA 200 mg hart hylki

Luxembourg Celecoxib EG 200 mg gélules

Netherlands Celecoxib CF 200 mg, capsules, hard

Portugal Celecoxib Ciclum

Sweden Celecoxib Stada 200 mg kapsel, hård

Date of the last revision of this leaflet: July 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/).