Celecoxib Sandoz 200 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Celecoxib Sandoz 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Celecoxib Sandoz is and what it is used for
2. What you need to know before you take Celecoxib Sandoz
3. How to take Celecoxib Sandoz
4. Possible side effects
5. How to store Celecoxib Sandoz

Pack contents and other information

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

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

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

The medicine will start to work several 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 Sandoz

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

Do not take Celecoxib Sandoz

Inform your doctor if any of the following circumstances 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 previously 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,
• 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, 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 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 a "mini-stroke"), angina pectoris, or blockage of blood vessels to the heart or brain,
• if you have or have had circulatory problems (peripheral arterial disease) or have undergone surgery on the arteries in your legs.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Celecoxib Sandoz if:

• you have previously had a stomach or intestinal ulcer or bleeding (Do not take Celecoxib Sandoz if you currently have a stomach or intestinal ulcer or bleeding),
• you smoke, have diabetes, high blood pressure, or high cholesterol,
• you have heart, liver, or kidney problems; your doctor may want to monitor you regularly,
• you have fluid retention (such as swollen feet or ankles),
• 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),
• you have previously experienced a severe allergic reaction or a serious skin reaction to any medicine,
• you feel unwell due to an infection or suspect you have an infection, as taking celecoxib may mask fever or other signs of infection and inflammation,
• you are over 65 years old; your doctor will want to monitor you regularly.

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

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). Among cases where the onset was reported, 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, breastfeeding and fertility").

Children and adolescents

Celecoxib Sandoz is for adults only. It is not intended for use in children and adolescents under 18 years of age.

Taking Celecoxib Sandoz with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine:

• dextromethorphan (used to treat cough),
• ACE inhibitors, angiotensin II receptor antagonists, beta-blockers, and diuretics (used to treat hypertension and heart failure),
• fluconazole and rifampicin (used to treat infections caused by bacteria and fungi),
• medicines to reduce blood clots, e.g., warfarin or other coumarin-type anticoagulants (including newer anticoagulants such as apixaban, dabigatran, or rivaroxaban),
• corticosteroid medicines (e.g., prednisone),
• antiplatelet therapies, e.g., acetylsalicylic acid (see below),
• acetylsalicylic acid (even at low doses for heart protection). Celecoxib may be taken with a low dose of acetylsalicylic acid (75 mg or less daily). Ask your doctor for advice before taking this medicine,
• other non-steroidal anti-inflammatory drugs (NSAIDs), e.g., ibuprofen or diclofenac. You should avoid taking celecoxib concomitantly with other NSAIDs,
• lithium (used to treat certain types of depression),
• other medicines used to treat depression such as citalopram, imipramine, sleep disorders, high blood pressure, or irregular heartbeat,
• diazepam, a medicine used to treat insomnia or anxiety,
• neuroleptics (used to treat certain mental disorders),
• methotrexate (used in rheumatoid arthritis, psoriasis, and leukemia),
• carbamazepine (used to treat seizures/epilepsy/convulsions and certain types of pain or depression),
• barbiturates (used to treat seizures/epilepsy/convulsions and certain sleep disorders),
• cyclosporine and tacrolimus (used for immunosuppression, e.g., after organ transplants).

Taking Celecoxib Sandoz with alcohol

Alcohol consumption is not recommended while taking celecoxib, as it may increase gastrointestinal problems.

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 should 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 to discuss alternative treatment.

• Breastfeeding

Celecoxib should not be used during breastfeeding.

• Fertility

NSAIDs, including celecoxib, may impair fertility. 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 be aware of 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 Sandoz contains lactose

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

Celecoxib Sandoz contains sodium

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

3. How to take Celecoxib Sandoz

Follow exactly the instructions for using this medicine given by your doctor or pharmacist. Consult your doctor or pharmacist if you have any doubts.

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 that you use the lowest effective dose that controls your pain and that you do not take Celecoxib Sandoz longer than necessary to control your symptoms.

Method of administration

Celecoxib is 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 every day.

If you have difficulty swallowing the capsules: you may sprinkle the entire contents of the capsule onto a level teaspoon of soft food (such as applesauce, rice, yogurt, or mashed banana, cold or at room temperature) and swallow it immediately with a glass of water of approximately 240 ml.

To open the capsule, hold it vertically to keep the granules at the bottom, then press the top and twist it off, taking care not to spill the contents. Do not chew or crush the granules.

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

Recommended dose:

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 dose is usually:

• one 200 mg capsule once daily, or
• one 100 mg capsule twice daily.

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

The dose is usually:

• one 100 mg capsule twice daily.

The dose of 100 mg twice daily cannot be achieved with Celecoxib Sandoz 200 mg hard capsules. Please consult your doctor.

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

The dose is usually:

• one 200 mg capsule once daily, or
• one 100 mg capsule twice daily.

Do not take more than 400 mg per day for any therapeutic use.

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

If you are over 65 years of age, and especially if you weigh less than 50 kg, your doctor may wish to monitor you more closely.

Use in children and adolescents

Celecoxib Sandoz is for adults only and is not indicated in children and adolescents under 18 years of age.

If you take more Celecoxib Sandoz than you should

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

If you have taken more Celecoxib Sandoz than you should, contact your doctor, pharmacist, or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount used.

If you forget to take Celecoxib Sandoz

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 Sandoz

Stopping treatment with celecoxib abruptly may cause worsening of symptoms. Do not stop taking Celecoxib Sandoz unless instructed by your doctor. Your doctor will advise you to gradually reduce the dose over a few 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 experiences 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 CelecoxibSandoz 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 CelecoxibSandoz 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, blood-stained stools, or blood in vomit,
• a skin reaction such as rash, blisters or peeling of the skin,
• liver failure, symptoms of which may include nausea (feeling unwell), diarrhea, jaundice (your skin or the whites of your eyes appear yellow).

Possible adverse effects

Very common: may affect more than 1 in 10 people

• increased blood pressure, including worsening of pre-existing high blood pressure*.

Common: 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 sinuses, sinus blockage or pain), stuffy or runny nose, sore throat, cough, cold, flu-like symptoms,
• dizziness, difficulty sleeping,
• nausea (feeling unwell),
• vomiting*, stomach pain, diarrhea, indigestion, gas,
• difficulty swallowing*,
• rash, itching,
• muscle stiffness,
• headache,
• joint pain,
• worsening of existing allergies,
• accidental injury.

Uncommon: may affect up to 1 in 100 people

• stroke*,
• heart failure, 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, drowsiness, tingling sensation,
• elevated levels of potassium in the blood which may cause abnormal heart rhythm or muscle weakness,
• blurred or altered vision, 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,
• itchy raised rash (urticarial wheals),
• eye inflammation,
• difficulty breathing,
• skin discoloration (bruising),
• chest pain (generalized pain not related to the heart),
• swelling of the face.

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

• bleeding from the stomach and intestines (may lead to bloody stools or vomiting), inflammation of the intestine or colon,
• (bleeding) ulcers in the throat, stomach or intestines; or rupture of the intestine (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) which may cause tiredness and confusion, muscle spasms, seizures and coma,
• decrease in the number of white blood cells (which help protect the body from infections) and platelets (increased risk of bleeding and bruising),
• difficulty in muscular coordination of movements,
• feeling confused, taste disturbances,
• increased sensitivity to light,
• hair loss,
• hallucinations,
• bleeding in the eye,
• acute reaction that may lead to lung inflammation,
• irregular heartbeat,
• flushing,
• blood clots in blood vessels of the lungs. Symptoms may include difficulty breathing, sharp pain when breathing or collapse,
• severe liver inflammation (hepatitis). Symptoms may include nausea (feeling unwell), diarrhea, jaundice (yellowing of the skin or eyes), darkening of the urine, pale stools, easy bleeding, itching or chills,
• acute kidney failure,
• menstrual disorders,
• swelling of the face, lips, mouth, tongue or throat, or difficulty swallowing.

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

• severe allergic reaction (including potentially life-threatening anaphylactic shock),
• serious skin diseases such as Stevens-Johnson syndrome, exfoliative dermatitis and toxic epidermal necrolysis (may cause rash, blisters or peeling of the skin), and acute generalized exanthematous pustulosis (symptoms include red skin discoloration with swelling of areas covered with numerous small pustules),
• a delayed allergic reaction with possible symptoms such as rashes, facial swelling, fever, swollen glands and abnormalities in clinical test results, e.g.: liver or blood cells (eosinophilia, a type of increase in blood cell count),
• bleeding inside the brain, including fatal cases,
• meningitis (inflammation of the membrane around 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), darkened 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 yellowing of the skin and 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 water retention (edema), foamy urine, fatigue and loss of appetite,
• seizures and 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: cannot be estimated from the available data

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

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

Common: 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 the urine), difficulty urinating, elevated creatinine levels in blood (indicating kidney failure),
• weight gain.

Uncommon: may affect up to 1 in 100 people

• deep vein thrombosis (blood clotting 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),
• lower limb fracture,
• herpes, skin infection, eczema (dry, itchy rash), pneumonia (chest infection with possible symptoms such as cough, fever, difficulty breathing),
• floaters in the eye causing visual disturbance or blurred vision, conjunctival bleeding, vertigo due to inner ear problems, ulcers, inflammation or bleeding of the gums, mouth ulcers,
• excessive urination at night, hemorrhoid/anal bleeding, frequent bowel movements,
• fatty lumps in the skin or other locations, ganglion cyst (non-painful swelling in or around joints or tendons, in the hand or foot), difficulty speaking, abnormal or very heavy vaginal bleeding, chest pain,
• elevated sodium levels 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 via 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 Sandoz

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

Do not use this medicine after the expiry date stated on the packaging, following “EXP”. The first two digits indicate the month and the last four digits the year. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Celecoxib Sandoz

• The active substance is celecoxib. Each hard capsule contains 200 mg of celecoxib.
• The other components (excipients) are: lactose monohydrate, povidone (E 1201), sodium croscarmellose (E 468), sodium lauryl sulfate (E 487), magnesium stearate (E 572), gelatin (E 441), titanium dioxide (E 171), yellow iron oxide (E 172).

Components of the printing ink: shellac glaze (E 904), propylene glycol (E 1520), concentrated ammonia solution (E 527), and yellow iron oxide (E 172).

Appearance of the product and contents of the container

White, opaque hard gelatin capsules. The capsule body has a yellow band and is printed with "C9OX-200" in white.

The capsules are presented in ALU/PVC blisters packed in cardboard boxes.

Pack sizes:

Blister: 1, 20, 30, 40, 60 hard capsules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Parque Norte Business Park

Roble Building

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Synthon Hispania S.L.

Castelló, 1,

08830 Sant Boi de Llobregat,

Spain

or

Synthon BV

Microweg 22

6545 CM, Nijmegen

The Netherlands

or

Lek Pharmaceuticals d.d.

Verovskova, 57

1526 Ljubljana

Slovenia

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

The Netherlands: Celecoxib Sandoz 200 mg, capsules hard

Italy: Celecoxib Sandoz

Date of the most recent review of this leaflet: January 2021

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/