100 mg, 200 mg hard capsules 
celecoxib

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

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 
6. Contents of the packaging and other information 

What Celecoxib Sandoz is and what it is used for

Celecoxib Sandoz contains the active substance celecoxib and belongs to a group of medicines called non-steroidal anti-inflammatory drugs ( NSAIDs ), and more specifically to the subgroup cyclooxygenase -2 inhibitors (COX ‑ 2 ‑ inhibitors). These work by reducing the amount of prostaglandins . Prostaglandins are substances produced by the body. Some prostaglandins cause pain and inflammation , while others help protect the lining of the stomach. Celecoxib Sandoz reduces the production of prostaglandins that cause pain and inflammation and not those that protect the stomach.

Celecoxib Sandoz is used in adults to reduce pain and relieve swelling of tissue in degenerative joint disease ( osteoarthritis ), inflammatory rheumatic joint disease ( rheumatoid arthritis ) and in certain types of inflammation between the vertebrae ( pelvospondylitis ).

You can expect the medicine to start working within a few hours of taking the first dose , but it may take several days before it takes full effect.

Celecoxib contained in Celecoxib Sandoz may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist or other healthcare professional if you have any further questions and always follow their instructions.

What you need to know before you take Celecoxib Sandoz

Do not take Celecoxib Sandoz:

  • if you are allergic to celecoxib or any of the other ingredients of this medicine (listed in section 6)
  • if you have had an allergic reaction to a group of medicines called ‘sulfonamides’ (eg some antibiotics used to treat infections )
  • if you currently have ulcers in the stomach or duodenum or bleeding in the stomach or intestines
  • if you have suffered from asthma , nasal polyps, severe nasal congestion or an allergic reaction , e.g. itchy rash, swelling of the face, lips, tongue or throat, difficulty breathing or wheezing after taking acetylsalicylic acid or any other anti-inflammatory and analgesic medicine ( NSAIDs , eg ibuprofen , including COX-2inhibitors)
  • if you have severe liver disease
  • if you have severe kidney disease
  • if you are pregnant or if you may become pregnant (if it is possible that you may become pregnant during treatment, you should discuss appropriate contraception with your doctor)
  • if you are breast-feeding
  • if you have an inflammatory bowel disease, e.g. ulcerative colitis or Crohn’s disease
  • if you have heart failure or known ischemic heart disease or disease of the blood vessels of the brain , e.g. if you have been diagnosed with a heart attack, stroke , temporary decrease in blood flow to the brain (also known as a “mini-stroke”), angina or narrowing of the blood vessels to the heart or brain
  • if you have or have had problems with blood circulation ( peripheral vascular disease) or if you have had surgery on the blood vessels in your legs.

If you think any of the above apply to you, talk to your doctor or pharmacist.

Warnings and cautions

Talk to your doctor or pharmacist before taking Celecoxib Sandoz if you:

  • have heart, liver or kidney problems, your doctor may want to check you regularly
  • is dehydrated due to vomiting, diarrhea or the use of diuretics (to treat fluid retention in the body)
  • have edema (fluid accumulation in the body, eg swollen ankles and feet)
  • previously had ulcers in the stomach or duodenum or bleeding in the stomach or intestines
  • feeling sick due to an infection , or suspecting you have an infection , as Celecoxib Sandoz may mask a fever or other signs of infection and inflammation
  • smoking, having diabetes , high blood pressure or high cholesterol
  • have had a severe allergic reaction or a severe skin reaction to any medicine
  • is over 65 years old; your doctor will check you regularly.

Like other NSAIDs (eg ibuprofen or diclofenac ), this medicine may cause high blood pressure , and your doctor may ask you to have your blood pressure checked regularly.

Some cases of severe hepatic reactions have been reported following the use of celecoxib, e.g. severe hepatitis, liver damage, liver failure (some cases with fatal outcome, or requiring liver transplantation). In cases where the time to onset of symptoms was reported, most severe liver reactions were seen within one month of starting treatment.

Celecoxib Sandoz can make it harder to get pregnant. You should tell your doctor if you are planning to become pregnant or if you are having difficulty getting pregnant (see the section on Pregnancy, breast-feeding and fertility ).

Children and young people

Celecoxib Sandoz is for adults only. It should not be used in children.

Other medicines and Celecoxib Sandoz

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

This is especially true if you are taking any of the following medicines:

  • blood thinners, e.g. cougarin-type warfarin / blood thinners or newer oral anticoagulants such as apixaban, dabigatran or rivaroxaban
  • drugs called corticosteroid s (such as prednisone)
  • if you are taking medicines that reduce the formation of platelets , e.g. acetylsalicylic acid  (ASA) (see below)
  • acetylsalicylic acid (even in low doses to protect the heart) or other non-steroidal anti-inflammatory drugs (eg ibuprofen or diclofenac ). You should avoid taking celecoxib and other anti-inflammatory drugs besides acetylsalicylic acid at the same time.Celecoxib Sandoz can be taken with a low dose of acetylsalicylic acid (75 mg or less per day). Ask your doctor for advice before taking these medicines at the same time.
  • ACE inhibitors , medicines to treat heart problems
  • angiotensin II receptor inhibitors, medicines to treat heart problems
  • beta-blockers , medicines to treat high blood pressure and heart failure
  • barbiturate s , medicines to treat epilepsy / seizures or sleep problems
  • carbamazepine , a medicine used to treat epilepsy / seizures or certain forms of pain or depression
  • citalopram , imipramine , antidepressants, or lithium (used to treat manic phases of bipolar disorder (a type of depression))
  • other drugs to treat depression (tricyclic agents and selective serotonin reuptake inhibitors ( SSRIs -preparat))
  • ciclosporin or tacrolimus , medicines to prevent transplant rejection in patients undergoing a transplant
  • dextromethorphan , a medicine used in certain cough mixtures
  • diazepam , a drug used to treat sleep problems or anxiety
  • diuretics , a drug used to treat high blood pressure , heart failure or excess fluid in the body
  • fluconazole , a medicine used to treat fungal infections
  • methotrexate , a medicine used to treat rheumatoid arthritis , psoriasis or leukemia
  • rifampicin , a medicine used to treat bacterial infections
  • drugs to treat psychosis s and schizophrenia ( antipsychotic )
  • medicines to treat sleep disorders, high blood pressure or organ-related heartbeats ( antiarrhythmics )

Ask your doctor if you are not sure which of these medicines you are taking.

Celecoxib with alcohol

Alcohol consumption is not recommended during treatment with Celecoxib Sandoz, as it may increase the risk of gastrointestinal problems.

Pregnancy, breastfeeding and fertility

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

  • You must not use Celecoxib Sandoz if you are pregnant or may become pregnant during treatment (ie women of childbearing potential not using adequate contraception).
  • If you become pregnant while taking Celecoxib Sandoz , stop taking it immediately and contact your doctor.
  • Do not take this medicine if you are breast-feeding.
  • NSAIDs including Celecoxib Sandoz can make it harder to get pregnant. You should tell your doctor if you are planning to become pregnant or if you are having difficulty getting pregnant.

Driving and using machines

You may feel dizzy or drowsy after taking Celecoxib Sandoz. If this happens, do not drive or use machines until these effects subside.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and / or side effects . Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Celecoxib Sandoz contains lactose (a sugar)

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Celecoxib Sandoz contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per capsule, ie essentially ‘sodium-free’.

How to take Celecoxib Sandoz

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

As the risk of heart side effects may increase with high doses and long-term treatment, it is important that you take the lowest dose to keep your pain under control and not use this medicine for longer than you need to keep your symptoms under control.

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

The recommended dose is:

In degenerative joint disease ( osteoarthritis ), the recommended dose is 200 mg daily, which the doctor may increase to a maximum of 400 mg if necessary.

Usual dose is:

  • one 200 mg capsule once a day or
  • one capsule of 100 mg twice a day.

In inflammatory rheumatic arthritis ( rheumatoid arthritis ), the recommended dose is 200 mg daily, which the doctor may increase to a maximum of 400 mg if necessary.

Usual dose is:

  • one capsule of 100 mg twice a day.

In certain types of inflammation between the vertebrae ( pelvic spondylitis ), the recommended dose is 200 mg daily, which the doctor may increase to a maximum of 400 mg if necessary.

Usual dose is:

  • one 200 mg capsule once a day or
  • one capsule of 100 mg twice a day.

Do not take more than 400 mg daily in any treatment indication.

Older

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

Kidney or liver problems

If you have kidney or liver problems, tell your doctor as you may need to take a lower dose .

Use

Celecoxib Sandoz is for oral use (should be swallowed).

Take the capsule (s):

  • swallow them whole with a glass of water
  • preferably at the same time each day
  • with or without food.

If you have difficulty swallowing capsules: All the contents of the capsule can be sprinkled on a teaspoon of semi-solid food (eg cold or room temperature apple puree, rice gruel, yoghurt or mashed banana) and swallowed immediately with a glass of water.

Open the capsule by holding it upright so that the granules collect at the bottom. Then gently squeeze the upper part and remove it with a twisting motion. Be careful not to spill any of the contents. Granules must not be chewed or crushed.

If you forget to take Celecoxib Sandoz

It is important that you take your medication every day. If you forget to take one or more doses , take them as soon as you remember and then continue with the usual dose .

Do not take a double dose to make up for a forgotten dose .

If you stop taking Celecoxib Sandoz

Always consult a doctor before stopping this medicine. Even if you are feeling well, your doctor may decide that you need to continue taking this medicine.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects , although not everybody gets them.

The adverse reactions listed below have been observed in patients with arthritis taking celecoxib. Adverse reactions marked with an asterisk (*) are listed below with the higher frequency seen in patients taking celecoxib to prevent colon polyps. Patients in these studies took celecoxib in high doses and for a long time.

If any of the following occur, stop taking Celecoxib Sandoz and contact your doctor immediately :

  • an allergic reaction such as a rash, swelling of the face, wheezing or difficulty breathing
  • heart problems such as chest pain
  • severe stomach pain or signs of bleeding in the stomach or intestines, e.g. black or blood-stained stools or vomiting with blood
  • a skin reaction such as rash, blistering or flaking
  • liver failure (symptoms may include nausea, diarrhea, jaundice (your skin or whites of the eyes look yellowish)).

Possible side effects:

Very common (may affect more than 1 user in 10)

  • high blood pressure , including worsening of already high blood pressure *

Common (may affect up to 1 in 10 people)

  • sinusitis ( sinusitis )
  • upper respiratory tract infection
  • urinary tract infection
  • deterioration of existing allergy s
  • difficulty sleeping, dizziness
  • muscle stiffness
  • headache
  • myocardial infarction*
  • cough
  • breathing difficulties *
  • sore throat
  • runny nose or nasal congestion, sneezing
  • magont
  • diarrhea
  • indigestion
  • weather voltage
  • nausea
  • vomiting *
  • difficulty swallowing *
  • rash, itching
  • joint pain
  • fluid accumulation in the body that can cause swelling in the ankles, legs and / or hands
  • flu-like symptoms
  • accident

Uncommon (may affect up to 1 in 100 people)

  • decreased number of red blood cells that can make the skin pale and you become weak or short of breath
  • increased amount of potassium in the blood which can lead to muscle weakness, muscle twitching or irregular heartbeat
  • anxiety, depression, fatigue
  • stroke*
  • tingling or numbness ( paresthesia ), drowsiness
  • blurred vision, eye inflammation ( conjunctivitis )
  • earring, hearing loss *
  • heart failure
  • rapid heartbeat or palpitations
  • difficulty breathing ( bronchospasm )
  • constipation, belching, inflammation of the stomach, worsening inflammation of the stomach or intestines
  • soreness in the mouth, cold sores
  • changes in liver values, increase in liver enzymes in the blood, e.g. AST and ALAT
  • raised, itchy rash (hives)
  • discoloration of the skin (bruises)
  • leg cramps
  • changes in renal values ​​during blood tests: increase in creatinine and urea nitrogen in the blood
  • facial swelling
  • chest pain (general pain unrelated to the heart)

Rare (may affect up to 1 in 1,000 people)

  • reduced number of white blood cells , which help protect the body against infection ( leukopenia )
  • decreased platelet count , which increases the risk of bleeding or bruising
  • confusion
  • hallucinations
  • difficulty controlling movements ( ataxia )
  • taste changes
  • eye bleeding
  • irregular heartbeats
  • blood clot in the blood vessels of the lungs. Symptoms may include sudden shortness of breath, sharp pain when breathing or collapse
  • acute reaction that can lead to pneumonia
  • hemorrhage
  • bleeding in the stomach or intestines (may lead to blood in the stool or bloody vomiting), intestinal inflammation
  • ulcer (bleeding) in the esophagus, stomach or intestines or ruptured intestine (may cause abdominal pain, fever, nausea, vomiting, intestinal obstruction)
  • inflammation of the esophagus that can cause difficulty swallowing ( esophagitis )
  • dark or black stools
  • inflammation of the pancreas that causes severe pain in the abdomen and back
  • serious liver inflammation ( hepatitis ). Symptoms may include nausea, diarrhea, jaundice (yellowing of the skin or eyes), dark urine, pale stools, increased tendency to bleed, itching or chills
  • swelling of the face, lips, mouth, tongue or throat or difficulty swallowing
  • hair loss
  • increased photosensitivity
  • acute renal failure
  • decreased amount of sodium in the blood which can cause fatigue, confusion, muscle cramps, seizures and coma
  • menstrual disorders

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

  • decreased number of red and white blood cells and platelets (may lead to fatigue, increased tendency to get bruises, frequent nosebleeds and increased risk of infection)
  • severe allergic reactions including possible fatal anaphylactic shock
  • bleeding in the brain (including death)
  • inflammation of the membrane around the brain and spinal cord that is not caused by infection (aseptic meningitis )
  • seizures or worsening of epilepsy (possibly increased number of seizures and / or increased severity)
  • lost sense of taste
  • lost sense of smell
  • blockage of an artery or vein in the eye leading to complete or partial loss of vision
  • inflammation in a blood vessel that can lead to fever, pain or dark purple spots on the skin
  • hepatic failure, liver damage, severe hepatitis ( fulminant hepatitis ) (sometimes fatal or requiring liver transplant). Symptoms may include nausea, diarrhea, jaundice (yellowing of the skin or eyes), dark urine, pale stools, increased tendency to bleed, itching or chillsIn cases where the time to onset of symptoms was reported, most severe liver reactions were seen within one month of starting treatment.
  • liver problems such as cholestasis and cholestatic hepatitis , which may be accompanied by symptoms such as discolored stools, nausea and yellow skin or yellow eyes
  • severe skin side effects such as Stevens-Johnson syndrome , exfoliative dermatitisand toxic epidermal necrolysis (which may cause rash, blistering or flaking of the skin and acute generalized exanthematous pustulosis (symptoms which cause the skin to become red with swollen areas covered with many small blisters)
  • a delayed allergic reaction with possible symptoms such as rash, swelling of the face, fever, swollen glands and abnormal test results, e.g. in liver and blood cell tests ( eosinophilia , a type of increased white blood cell count ). This reaction is called drug-induced rash with eosinophilia and systemic symptoms (DRESS) or hypersensitivity syndrome.
  • muscle inflammation with pain and weakness
  • inflammation of the kidneys and other kidney problems (eg nephrotic syndromeand minimal change disease, which may be accompanied by symptoms such as fluid in the body ( edema ), frothy urine, fatigue and decreased appetite)

Has been reported (occurs in unknown number of users)

  • reduced fertility in women, which usually declines when treatment is stopped.

In addition, the following unknown adverse reactions occurred in a polyp prevention study in which patients took 400 mg celecoxib daily:

  • Common (may affect up to 1 in 10 people): chest pain (angina), irritable bowel syndrome (may include abdominal pain, diarrhea, indigestion, flatulence), kidney stones (may cause abdominal or back pain, blood in the urine), increase in creatinine in the blood, benign prostatic hyperplasia with difficulty urinating, weight gain
  • Uncommon (may affect up to 1 in 100 people): stomach infection, which can cause irritation and ulcers in the stomach and intestines (Helicobacter infection), shingles , superficial inflammation of the skin (erysipelas), pneumonia(bronchopneumonia – breast infection [possible cough, fever , difficulty breathing]), infection of the inner ear, gingivitis, lumps of fat in the skin or elsewhere (lipoma), spots in the visual field that lead to blurred vision or impaired vision, conjunctival hemorrhage, deep vein thrombosis (blood clot usually in the legs that can cause pain, swelling or redness of the calf or difficulty breathing), voice problems (speech difficulties), bleeding fromhemorrhoids , frequent bowel movements, cold sores, allergic dermatitis , ganglion cyst (harmless swelling of the wrist and ankle tendons), need to urinate frequently at night, abnormal or very heavy bleeding from the abdomen, soreness in the breasts, lower leg fracture, increased sodium in the blood.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Celecoxib Sandoz

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

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiration date is the last day of the specified month.

Do not store above 25 ° C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

Celecoxib Sandoz 100 mg hard capsules:

  • The active substance is celecoxib. One hard capsule contains 100 mg celecoxib

Celecoxib Sandoz 200 mg hard capsules:

  • The active substance is celecoxib. One hard capsule contains 200 mg of celecoxib
  • Other ingredients are:Capsule content Celecoxib Sandoz 100 mg and 200 mg hard capsules:Carrageenan (E407), sodium lauryl sulphate , lactose monohydrate , microcrystalline cellulose (E460), magnesium stearate (E470b), anhydrous colloidal silica (E551), talc (E553b)
    Capsule cover Celecoxib Sandoz 100 mg hard capsules:Gelatin (E441), titanium dioxide (E171), indigo carmine (E132)
    Capsule cover Celecoxib Sandoz 200 mg hard capsules:Gelatin (E441), titanium dioxide (E171), iron oxide, red (E172), iron oxide, yellow (E172)

What the medicine looks like and contents of the pack

Celecoxib Sandoz 100 mg hard capsules:

The capsules (17.7-18.3 mm long) have a white lower part and a blue upper part, containing white to yellowish pellets.

Celecoxib Sandoz 200 mg hard capsules:

The capsules (19.1-19.7 mm long) have a white lower part and an orange upper part, containing white to yellowish pellets.

Celecoxib Sandoz hard capsules are packaged in PVC / TE / PVDC / Alu foil blisters. The carton contains 10, 20, 30, 50, 60, 90 or 100 hard capsules.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark

Manufacturer

Lek Pharmaceuticals dd, Verovškova ulica 57,1526 Ljubljana, Slovenia

or

Lek SA, ul Domaniewska 50 C 02-672 Warsaw, Poland

or

Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, Saxony-Anhalt, 39179 Barleben, Germany

Muhammad Nadeem

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