Celecoxib sandoz 200 mg capsulas duras efg

Label:Information for the User

Celecoxib Sandoz200 mg Hard EFG Capsules

Read this label carefully before starting to take this medication as it contains important information for you.

• Keep this label as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, and you should not give it 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 label. See section 4.

Contents of the package and additional information

Celecoxib Sandozis indicated in adults to relieve the symptoms and signs ofrheumatoid arthritis, osteoarthritis, and ankylosing spondylitis.

Celecoxib Sandozcontains the active ingredient celecoxib. Celecoxibbelongs to a class of medications known as nonsteroidal anti-inflammatory drugs (NSAIDs), specifically 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 Sandoz 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 prescribedcelecoxib. The following information will help you get better results with this medication. If you have any other questions, please ask your doctor or pharmacist.

Do not take Celecoxib Sandoz

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

• if you areallergic to celecoxib or any of the other componentsof this medication (listed in section 6),
• if you have had anyallergic reactionto any medication in the group called “sulfonamides” (e.g., some are antibiotics used to treat infections),
• if you havecurrentlyanulcerorbleedingin your stomach or intestine,
• if you have previously experienced any of the following symptoms as a result of taking acetylsalicylic acid or any other anti-inflammatory medication:asthma, nasal polyps, severe nasal congestion, or allergic symptomssuch as skin rash with itching, facial swelling, lip, tongue, or throat swelling, difficulty breathing, or wheezing,
• if you arepregnant. If you can become pregnant during treatment, you should discuss contraceptive methods with your doctor,
• if you arebreastfeeding your child,
• if you have aserious liver disease,
• if you have aserious kidney disease,
• if you haveinflammatory bowel diseasesuch asulcerative colitisorCrohn's disease,
• if you haveheart failure, diagnosed coronary artery 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 obstruction of blood vessels to the heart or brain,
• if you have or have hadcirculatory problems(peripheral arterial disease) or if you have beenoperatedon the arteries of your legs.

Warnings and precautions

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

• you have previously had anulceror bleeding in your stomach or intestine (Do not take Celecoxib Sandozif you currently have an ulceror bleeding in your stomach or intestine),
• 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 havefluid retention(such as swollen feet or ankles),
• you aredehydrated, for example, due to a disease with vomiting, diarrhea, or the use of diuretics (used to treat excess fluid in the body),
• you have had asevere allergic reactionor a severe skin reaction to any medication,
• you feel unwell due to aninfectionor think you have an infection, as taking celecoxib may mask fever or other signs of infection and inflammation,
• you are over65 years old, your doctor will want to monitor you regularly.

Like otherNSAIDs(e.g., ibuprofen or diclofenac), this medication may increase your blood pressure, so your doctor may perform regular checks.

There have beenreportedcases ofsevere liver damagewith celecoxib, including severe liver inflammation, liver damage, and liver failure (some with fatal outcome or requiring liver transplant).Of the cases in which the onset was reported, most severe liver damage occurred in the first month of treatment.

Celecoxib may make it difficult to becomepregnant. You should inform your doctor if you plan to become pregnant or if you have difficulty becoming pregnant (see section"Pregnancy, breastfeeding, and fertility").

Children and adolescents

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

Taking Celecoxib Sandoz with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to useany other medication:

• Dextromethorphan(used to treat cough),
• inhibitors of the ECA, angiotensin II receptor antagonists, beta-blockers, and diuretics(used to treat hypertension and heart failure),
• fluconazoleandrifampicin(used to treat infections caused by bacteria and fungi),
• medications to reduce blood clots, e.g. warfarin or other anticoagulants of the coumarin type (the newer anticoagulants such as apixaban, dabigatran, or rivaroxaban,
• medications called corticosteroids (e.g. prednisone),
• antiplatelet therapies, e.g. acetylsalicylic acid (see below),
• acetylsalicylic acid (even at low doses to protect the heart). Celecoxib can be taken with a low dose of acetylsalicylic acid (75 mg or less daily).Ask your doctor for advicebefore taking this medication,
• other nonsteroidal anti-inflammatory drugs (NSAIDs), e.g. ibuprofen or diclofenac. You should avoid taking celecoxib concomitantly with other NSAIDs,
• lithium(used to treat some types of depression),
• other medicationsused to treat depression such as citalopram, imipramine, sleep disorders, high blood pressure, or irregular heartbeat,
• diazepam, a medication used to treat insomnia or anxiety,
• neuroleptics(used to treat some mental disorders),
• methotrexate(used in rheumatoid arthritis, psoriasis, and leukemia),
• carbamazepine(used to treat seizures/epilepsy/convulsions and some forms of pain or depression),
• barbiturates(used to treat seizures/epilepsy/convulsions and some sleep disorders),
• ciclosporinandtacrolimus(used to treat immunosuppression, e.g. after transplants).

Taking Celecoxib Sandoz with alcohol

It is not recommended to consume alcohol while taking celecoxib, as this may increase gastrointestinal problems.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or 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 Sandoz contains lactose

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

Celecoxib Sandoz contains sodium

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. Consult your doctor or pharmacist if you have any doubts.

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 Sandoz for longer than necessary to control your symptoms.

Administration Method

Celecoxibis taken orally.

The capsules can be 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.

If you have difficulty swallowing the capsules: you can spread the entire content of the capsule on a teaspoon of some semi-solid food (such as apple sauce, rice, yogurt, or mashed banana, cold or at room temperature) and swallow it immediately with a glass of water approximately 240 ml.

To open the capsule, hold it in a vertical position to keep the granules at the bottom, then press the top and turn it to extract it, being careful not to spill the content.Do not chew or crush the granules.

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

Recommended Dose

The recommended dose is:

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

The dose is usually:

-one 200 mg capsule once a day or

-two 100 mg capsules per day.

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

The dose is usually:

- two 100 mg capsules per day.

The dose of 100 mg twice a day 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 can be increased by your doctor up to a maximum of 400 mg, if necessary.

The dose is usually:

• one 200 mg capsule once a day or
• two 100 mg capsules per day.

Do not take more than 400 mg per dayin all therapeutic uses.

Problems in the kidney or liver

Make sure your doctor knows if you have problems in the liver or kidney since you may need a lower dose.

Older patients

SIf you are over 65 years old and especially if you weigh less than 50 kg, your doctor may want to monitor you more closely.

Use in children and adolescents

Celecoxib Sandoz is only for adults, it is not indicated in children and adolescents under 18 years old.

If you take more CelecoxibSandozthan 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.

If you have taken more Celecoxib Sandoz than you should, consult your doctor, pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If you forgot to take CelecoxibSandoz

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 the treatment with CelecoxibSandoz

Stopping treatment abruptly with celecoxib may cause a worsening of symptoms. Do not stop taking Celecoxib Sandoz unless 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 taking celecoxib. The side effects marked with an asterisk (*) occurred in patients taking Celecoxib Sandoz 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 Sandoz and inform your doctor immediately:

If you have:

• an allergic 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 (feeling unwell), diarrhea, jaundice (your skin or the white of your eyes appears yellow).

Possible side effects

Very common:mayaffect more than 1 in 10 people

• increase in 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 paranasal sinuses, obstruction or pain of the paranasal sinuses), stuffy nose 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.

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

• bleeding of the stomach and intestines (may lead to bloody stools or vomiting), inflammation of the intestine or colon,
• ulcers (bleeding) 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 esophagus,
• low sodium levels in the blood (a condition known as hyponatremia) that may cause fatigue and confusion, muscle spasms, convulsions and coma,
• decrease in the number of white blood cells and platelets (may cause fatigue, frequent nosebleeds, increased risk of infections),
• difficulty in coordinating muscle movements,
• feeling of confusion, altered sense of taste,
• increased sensitivity to light,
• hair loss,
• hallucinations,
• bleeding in the eye,
• acute reaction that may lead to pulmonary inflammation,
• irregular heart rhythm,
• rubefaction,
• blood clots in the pulmonary vessels. Symptoms may include difficulty breathing, sharp pains when breathing or collapse,
• severe liver inflammation (hepatitis). Symptoms may include nausea (feeling unwell), diarrhea, jaundice (yellow discoloration of the skin or eyes), dark urine, pale stools, easy bleeding, itching or chills,
• acute renal 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 potential 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 pustular psoriasis (symptoms include red skin discoloration with swelling of areas covered with numerous small pustules),
• late-onset allergic reaction with possible symptoms such as rash, facial swelling, fever, swollen lymph nodes and abnormalities in clinical test results, e.g. liver or blood cells (eosinophilia, a type of increase in blood cell count),
• bleeding in the brain, including fatal cases,
• meningitis (inflammation of the membrane surrounding the brain and spinal cord),
• liver failure, liver damage and severe liver inflammation (hepatitis fulminant) (sometimes with fatal outcome or requiring liver transplant). Symptoms may include nausea (feeling unwell), 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 dark stools, nausea and yellow discoloration of the skin and eyes),
• kidney inflammation 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 (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, purple spots on the skin),
• decrease in the number of red and white blood cells and platelets (may cause fatigue, frequent nosebleeds, increased risk of infections),
• muscle pain and weakness,
• alteration of the sense of taste,
• loss of taste.

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

• Decreased fertility in women, 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:may affect up to 1 in 10 people

• cardiovascular problems: angina (chest pain),
• gastrointestinal problems: irritable bowel syndrome (may include abdominal pain, diarrhea, indigestion and gas),
• kidney stones (may cause stomach or back pain, blood in the urine), difficulty urinating, elevated creatinine levels in the blood (indicates renal insufficiency),
• weight gain.

Rare: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 (may cause stomach irritation or ulcers in the stomach and intestine),
• lower limb fractures,
• herpes, skin infection, eczema (dry, itchy rash), pneumonia (infection in the chest with possible symptoms such as cough, fever, difficulty breathing),
• flies in the eye that cause vision disturbance or blurred vision, conjunctival bleeding, vertigo due to inner ear problems, ulcers, inflammation or bleeding of the gums, mouth ulcers,
• excessive nocturia, hemorrhoids, frequent bowel movements.
• fat 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 the Vigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keepthis medicationout of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging, after “CAD”. The first two digits indicate the month and the last four digits indicate the year. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and unused medications at the SIGRE point of the pharmacy.In case of doubt, ask your pharmacisthow to dispose ofthepackaging and themedications that you do notneed.By doing so, you will help protect the environment.

Celecoxib CompositionSandoz

• The active ingredient is celecoxib. Each hard capsule contains 200 mg of celecoxib.
• The other components (excipients) are: lactose monohydrate, povidone (E 1201), croscarmellose sodium (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 lacquer (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 package

Hard gelatin capsules, white and opaque. The capsule body contains a yellow band and is printed “C9OX-200” in white.

The capsules are presented in ALU/PVC blisters in carton boxes.

Package sizes:

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

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible manufacturer

Synthon Hispania S.L.

Castelló, 1,

08830 Sant Boi de Llobregat,

Spain

or

Synthon BV

Microweg 22

6545 CM, Nijmegen

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 with the following names:

Netherlands:Celecoxib Sandoz 200 mg, hard capsules

Italy:Celecoxib Sandoz

Last review date of this leaflet: January 2021

For detailed information on this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/