Celecoxib Stada 200 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Celecoxib Stada 200 mg hard capsules EFG

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

• • Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you and you should not give it to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if such adverse effects are not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Celecoxib is indicated in adults for the relief of the signs and symptoms of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis.

Celecoxib 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 that can cause pain and inflammation. In conditions such as rheumatoid arthritis or osteoarthritis, your body produces them in higher amounts. Celecoxib works by reducing the production of prostaglandins, thereby decreasing pain and inflammation.

The medicine will begin to work a few hours after taking the first dose, but you may not experience the full effect until several days have passed.

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

Your doctor has prescribed you celecoxib. The following information will help you get the best results with celecoxib. If you have any further 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:

• if you are allergic to celecoxib or to any of the other ingredients of this medicine (listed in section 6).
• if you have had an allergic reaction to any medicine in the group called "sulfonamides" (e.g., some antibiotics used to treat infections).
• if you currently have a stomach or intestinal ulcer or bleeding from the stomach or intestine.
• if you have previously experienced any of the following symptoms after taking acetylsalicylic acid or any other anti-inflammatory drugs and painkillers: 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 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 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, or blockage of blood vessels to the heart or brain.
• if you have or have had circulation problems (peripheral arterial disease) or if you have had surgery on the arteries in your legs.

Warnings and precautions

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

• if you have previously had an ulcer or bleeding in your stomach or intestine (Do not take celecoxib if you currently have an ulcer or bleeding in your stomach or intestine).

• if you are taking acetylsalicylic acid (even at low doses such as for heart protection).

• if you are taking antiplatelet therapies.

• if you are taking medicines to reduce blood clotting (e.g., warfarin/warfarin analogues or newer oral anticoagulants, e.g., apixaban).

• if you are taking corticosteroids (e.g., prednisone).

• if you are taking celecoxib at the same time as other non-acetylsalicylic acid NSAIDs such as ibuprofen or diclofenac. The combined use of these medicines should be avoided.

• if you are a smoker, have diabetes, high blood pressure, or high cholesterol.

• if your heart, liver, or kidneys are not working 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 an illness with vomiting or diarrhea, or due to the use of diuretics (used to treat excess fluid in the body).

• if you have had a serious allergic reaction or a serious skin reaction to any medicine.

• if you feel unwell due to an infection or think you have an infection, as taking celecoxib may mask fever or other signs of infection and inflammation.

• if you are over 65 years old, your doctor will want to monitor you regularly.

• Alcohol consumption and NSAIDs can increase the risk of gastrointestinal problems.

Like other anti-inflammatory drugs (e.g., ibuprofen or diclofenac), this medicine may increase your blood pressure, so your doctor may monitor it periodically.

Some cases of serious liver reactions have been reported with celecoxib, including severe hepatitis, liver damage, and liver failure (some fatal or requiring liver transplantation). In cases where the onset was specified, most serious 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 need to use any other medicines.

• Dextromethorphan (used to treat cough).
• ACE inhibitors, angiotensin II receptor antagonists, beta-blockers, and diuretics (medicines used to treat hypertension and heart failure).
• Fluconazole and rifampicin (used to treat infections caused by bacteria and fungi).
• Warfarin or other warfarin analogues (agents that reduce blood clot formation), including newer agents such as apixaban.
• 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 transplants).

Celecoxib can 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

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

Pregnancy

Celecoxib 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 taking celecoxib, you must stop treatment and contact your doctor for an alternative treatment.

Breastfeeding

Celecoxib must 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 experiencing difficulty becoming pregnant.

Driving and using machines

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 have passed.

Celecoxib Stada contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him 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

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. If you think or believe that the effect of celecoxib 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 you should not take celecoxib for longer than necessary to control your symptoms.

Method of administration

Celecoxib is for oral use. The capsules may 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 you do not experience improvement within two weeks after starting treatment.

The recommended dose is:

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

The usual dose is:

• One 200 mg capsule once daily.

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

The usual dose is:

• One 100 mg capsule twice daily.

If you cannot achieve the prescribed dose with this medicine, other celecoxib-containing products with a 100 mg dose are available. Please consult your doctor.

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

The usual dose is:

• One 200 mg capsule once daily.

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 require a lower dose.

Elderly patients, 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 is for adults only and is not indicated for use in children.

If you take more Celecoxib Stada than you should

Do not take more capsules than prescribed by your doctor. If you take more celecoxib than instructed, contact your doctor, pharmacist, or hospital immediately and bring the medicine with you.

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or the Toxicology Information Service immediately. Phone: 91 562 04 20, and state the name of 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

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

If you have any further 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 everyone will experience them.

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

If you experience any of the following adverse effects, stop treatment with celecoxib and 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 blood-stained stools, or blood in vomit.
• A skin reaction such as rash, blisters or peeling of the skin.
• Liver failure (symptoms may include nausea (feeling unwell), diarrhea, jaundice (your skin or the whites of your eyes appear yellow)).

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

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

Common 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.
• Difficulty breathing*, sinusitis (inflammation and infection of the paranasal sinuses, sinus blockage or pain), stuffy 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 unwell).
• Joint pain.
• Worsening of existing allergies.
• Accidental injury.

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

• Stroke*.
• Heart failure, palpitations (awareness of heartbeat), rapid heartbeat.
• Abnormalities in blood tests related to the liver.
• Abnormalities in blood tests related to the kidney.
• Anemia (changes in red blood cells which may cause fatigue and difficulty breathing).
• Anxiety, depression, tiredness, numbness, tingling sensation.
• High levels of potassium 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, burping, inflammation of the stomach (indigestion, stomach pain or vomiting), worsening of inflammation of the stomach or intestine.
• Leg cramps.
• Itchy, raised rash (urticarial wheal).
• Eye inflammation.
• Difficulty breathing.
• Skin discoloration (bruising).
• 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 intestinal rupture (may cause stomach pain, fever, nausea, vomiting, intestinal obstruction), dark or black stools, inflammation of the pancreas (may cause stomach pain), inflammation of the throat (esophagus).
• Low levels of sodium in the blood (a condition known as hyponatremia).
• Decrease in the number of white blood cells (which help protect the body from infections) and platelets (increased risk of bleeding and bruising).
• Difficulty with muscular coordination of movements.
• Feeling confused, taste disturbances.
• Increased sensitivity to light.
• Hair loss.
• Hallucinations.
• Eye bleeding.
• Acute reaction that may lead to lung inflammation.
• Irregular heartbeat.
• Flushing.
• Blood clots in blood vessels of the lungs. Symptoms may include sudden shortness of breath, sharp pain when breathing, or collapse.
• Bleeding from the stomach or intestine (may result in bloody stools or vomit), inflammation of the intestine or colon.
• Severe liver inflammation (hepatitis). Symptoms may include nausea (feeling unwell), diarrhea, jaundice (yellowing of the skin and eyes), dark urine, pale stools, easy bruising or bleeding, itching, or chills.
• Acute kidney failure.
• Menstrual disorders.
• Swelling of 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 life-threatening anaphylactic shock).
• Severe skin reactions such as Stevens-Johnson syndrome, exfoliative dermatitis and toxic epidermal necrolysis (may cause rash, blistering or peeling of the skin), and acute generalized exanthematous pustulosis (symptoms include reddening of the skin with swollen areas and numerous small pustules).
• A delayed allergic reaction with possible symptoms such as rashes, 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 leading to death.
• Meningitis (inflammation of the membrane surrounding the brain and spinal cord).
• Liver failure, liver damage and severe liver inflammation (fulminant hepatitis) (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 bruising or bleeding, itching, or chills.
• Liver problems (such as cholestasis and cholestatic hepatitis, which may be accompanied by symptoms such as pale stools, nausea, and yellowing of the skin or eyes).
• Inflammation of the kidneys 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 (possibly more frequent and/or severe seizures).
• Blockage of an artery or vein in the eye leading to partial or complete loss of vision.
• Inflammation of blood vessels (may cause fever, pain, purple spots on the skin).
• Reduction in the number of red and white blood cells and platelets (may cause tiredness, easy bruising, frequent nosebleeds, and increased risk of infections).
• Muscle pain and weakness.
• Disturbance of taste sensation.
• Loss of taste.

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

• Decreased fertility in women, which is usually reversible if the medicine is discontinued.

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

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

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

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

• Deep vein thrombosis (blood clot usually in the leg, which may cause pain, swelling or redness in the calf or breathing problems).
• Stomach problems: stomach infection (which may cause irritation or ulcers in the stomach and intestine).
• Fracture of lower limbs.
• Herpes, skin infection, eczema (dry, itchy rash), pneumonia (chest infection with 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 sites, ganglion cyst (non-painful swelling in joints or tendons or around them, in hand or foot), difficulty speaking, abnormal or very heavy vaginal bleeding, chest pain.
• High levels of sodium in blood test results.

Reporting of adverse effects:

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

5. Storage of Celecoxib Stada

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Celecoxib Stada

The active substance is celecoxib.

Each hard capsule contains 200 mg of celecoxib.

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

Appearance of the product and contents of the pack

Celecoxib Stada is presented in the form of hard capsules.

The capsules are hard gelatin capsules 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 available in pack sizes of 10, 20, 30, 40, 50, 60, 80, 90, 100, 120, 150, 160, 180 hard capsules.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorio 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 medicinal product is authorised in the European Economic Area member states 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 hard capsules 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 most recent revision of this leaflet: July 2021

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