100 mg & 200 mg capsule, hard 
celecoxib

Read all of this leaflet carefully before you start taking 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 may harm them, even if they show symptoms 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 4.4.

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

What Celecoxib Stada is and what it is used for

Celecoxib Stada is used for relieving symptoms in the treatment of chronicrheumatoid arthritis, osteoarthritis, and pelvic pondylitis ( inflammation of the joints of the spine) in adults.

Celecoxib Stada belongs to a group of medicines called non-steroidal anti-inflammatory drugs ( NSAIDs ), and more specifically to the subgroup COX-2inhibitors. Your body produces prostaglandins that can cause pain and inflammationand in conditions such as rheumatoid arthritis and osteoarthritis , your body produces more of them. Celecoxib Stada works by reducing the production of prostaglandins and thus reducing pain and inflammation .

Celecoxib contained in Celecoxib Stada 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 use Celecoxib Stada

Do not use Celecoxib Stada

  • 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 or bleeding in the stomach / intestines
  • if you have had asthma , nasal polyps, severe nasal congestion, or an allergic reaction such as itchy skin 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 ( NSAID )
  • if you are pregnant. If you are likely to become pregnant during treatment, you should discuss appropriate contraceptive methods with your doctor
  • if you are breast-feeding
  • if you have severe liver disease
  • if you have severe kidney disease
  • if you have an inflammatory bowel disease, such as 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 had 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

Warnings and cautions

Talk to your doctor before taking Celecoxib Stada:

  • if you have previously had ulcers or bleeding in the stomach or intestines
  • (Do not take Celecoxib Stada if you currently have ulcers or bleeding in the stomach or intestines)
  • if you are taking acetylsalicylic acid (even at low doses in order to protect your heart)
  • if you are taking medicines to reduce blood clots (eg warfarin )
  • if you are taking Celecoxib Stada at the same time as other NSAIDs (besides acetylsalicylic acid ), such as ibuprofen or diclofenac. Concomitant use of these drugs should be avoided
  • if you smoke, have diabetes , high blood pressure or high cholesterol
  • If your heart, liver or kidneys are not working properly, your doctor may want to check you regularly
  • if you have fluid retention in your body (such as swollen ankles and feet)
  • if you are dehydrated, e.g. due to vomiting, diarrhea, or if you are taking diuretics(to treat fluid retention in the body)
  • if you have had a severe allergic reaction or a severe skin reaction to any medicine
  • if you have an infection , or suspect you have an infection , as Celecoxib Stada may mask a fever or other signs of infection and inflammation
  • If you are over 65, your doctor may want to check you regularly

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

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

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

Other medicines and Celecoxib Stada

Some medicines may affect the way some other medicines work. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines:

  • Dextromethorphan (used to treat cough)
  • ACE inhibitors or angiotensin II antagonists (used to treat high blood pressure and heart failure )
  • Diuretics ( diuretics used to store fluid in the body)
  • Fluconazole and rifampicin (used to treat fungal and bacterial infections)
  • Warfarin or other blood-thinning drugs that reduce blood clotting
  • Lithium (used to treat certain types of depression)
  • Other medicines for depression, sleep disorders, high blood pressure or irregular heartbeat
  • Neuroleptics (used to treat certain mental illnesses)
  • Methotrexate (used to treat rheumatic joint disease, psoriasis and leukemia )
  • Carbamazepine (used to treat epilepsy / seizures and certain forms of pain or depression)
  • Barbiturates (used to treat epilepsy / seizures and certain sleep disorders)
  • Ciclosporin and tacrolimus (used to suppress the immune system, eg after transplants)

Celecoxib Stada can be taken with a low dose of acetylsalicylic acid . Ask your doctor for advice before taking these medicines at the same time.

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.

Celecoxib Stada must not be used by women who are pregnant or may become pregnant during treatment (ie women of childbearing potential not using adequate contraception). If you become pregnant during treatment with Celecoxib Stada, you should stop treatment and contact your doctor for other treatment.

Celecoxib Stada may make it more difficult to get pregnant (see section Warnings and precautions).

Celecoxib Stada must not be used during breast-feeding.

Driving and using machines

You should know how to react to Celecoxib Stada before driving or using machines. If you feel dizzy or drowsy after taking Celecoxib Stada, do not drive or use machines until these effects have subsided.

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 Stada contains lactose and sodium

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

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

3. How to use Celecoxib Stada

Always take this medicine exactly as your doctor 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 do not take a higher dose or use Celecoxib Stada for longer than you need to control your symptoms.

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

In osteoarthritis, the usual dose is 200 mg daily, which can be increased to a maximum of 400 mg if your doctor deems it necessary.

The usual dose is:

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

In chronic rheumatoid arthritis , the usual dose is 200 mg daily (divided into two doses ), which can be increased to a maximum of 400 mg (divided into two doses ) if your doctor deems it necessary.

The usual dose is:

  • one capsule of 100 mg twice a day.

If the dose one you have been prescribed cannot be achieved with this strength of the medicine, other strengths of this medicine are available to achieve the dose one. Consult your doctor.

In pelvospondylitis, the usual dose is 200 mg daily, which can be increased to a maximum of 400 mg if your doctor deems it necessary.

The usual dose is:

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

Maximum daily dose:

You should not take more than 400 mg daily (four Celecoxib Stada 100 mg capsules or two Celecoxib Stada 200 mg capsules).

Kidney or liver failure : if you have kidney or liver failure, tell your doctor as you may need to take a lower dose .

Elderly people, especially those weighing less than 50 kg : If you are over 65, and especially if you weigh less than 50 kg, your doctor may want to check you more closely.

Method of administration

Celecoxib Stada should be swallowed whole with some water. The capsules can be taken at any time of the day, with or without food, but try to take each dose of Celecoxib Stada at the same time each day.

Use for children and adolescents

Celecoxib Stada is for adults only and should not be used in children.

If you forget to use Celecoxib Stada

If you forget to take your dose , take it as soon as you remember. Do not take a double dose to make up for a forgotten dose .

If you stop using Celecoxib Stada

If you suddenly stop taking Celecoxib Stada, your symptoms may get worse. Do not stop taking Celecoxib Stada unless your doctor tells you to. Your doctor may ask you to reduce your dose for a few days before stopping treatment altogether.

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 osteoarthritis using celecoxib. Adverse reactions marked with an asterisk (*) are indicated with the higher frequency seen in patients using celecoxib to prevent colon polyps. These patients took celecoxib in high doses and for a long time.

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

If you experience:

  • 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 signs of bleeding in the stomach or intestines, e.g. black or blood – stained stools or vomiting with blood in
  • 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)).

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

Common (may affect up to 1 in 10 people):

  • myocardial infarction*
  • fluid accumulation in the body that can cause swelling in the ankles, legs and / or hands
  • urinary tract infection
  • difficulty breathing *, sinusitis, nasal congestion or runny nose, sore throat, cough, cold, flu-like symptoms
  • dizziness, difficulty sleeping 
  • vomiting *, stomach pain, diarrhea, digestive problems, flatulence
  • rash, itching
  • muscle tension
  • difficulty swallowing *
  • deterioration of existing allergies .

Uncommon (may affect up to 1 in 100 people):

  • stroke*
  • heart failure, palpitations, rapid heartbeat
  • increase in already high blood pressure
  • changes in liver values ​​during blood tests
  • changes in kidney values ​​during blood tests
  • anemia (decreased number of red blood cells, which can cause weakness and shortness of breath)
  • anxiety, depression, fatigue, drowsiness, ant crawling
  • increased amount of potassium in the blood (may cause nausea, fatigue, muscle weakness or palpitations)
  • impaired vision or blurred vision, tinnitus , soreness in the mouth, cold sores, hearing loss *
  • constipation, belching, gastritis (indigestion, stomach pain or vomiting), worsening inflammation of the stomach or intestines.
  • leg cramps
  • raised, itchy rash ( hives ).

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

  • ulcers (bleeding) in the stomach, esophagus and intestines, ruptured intestines (may cause abdominal pain, fever, nausea, vomiting, intestinal obstruction), dark or black stools, inflammation of the esophagus (may cause difficulty swallowing), inflammation of the pancreas (may cause abdominal pain) 
  • decreased white blood cell count (which helps protect the body against infection ) and platelets (increased risk of bleeding or bruising)
  • difficulty coordinating muscle movements
  • confusion, taste changes
  • increased photosensitivity
  • hair loss.

Has been reported (occurs in unknown number of users):

  • cerebral hemorrhage, which can be life-threatening
  • severe allergic reactions (including anaphylactic shock , which may be life-threatening) which may cause skin rash, swelling of the face, lips, mouth, tongue or throat, wheezing or difficulty breathing; difficulty swallowing
  • bleeding in the stomach or intestines (may cause bloody stools or vomiting), intestinal inflammation, nausea
  • severe skin side effects such as Stevens-Johnson syndrome, exfoliative dermatitisand toxic epidermal necrolysis (which may cause a rash, blistering, or scaling of the skin), and acute skin rash-like generalized pustulosis (red, swollen area 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 (eg in liver tests and blood cell tests ( eosinophilia, a type of increased amount of white blood cells ))
  • liver failure, liver damage and severe hepatitis (some cases fatal or requiring liver transplantation). Symptoms may include nausea, diarrhea, jaundice (yellowing of the skin or eyes), dark urine, pale stools, increased tendency to bleed, itching or chills
  • kidney problems ( kidney failure , kidney inflammation)
  • blood clots in the blood vessels of the lungs. Symptoms may include sudden shortness of breath, sharp pain when breathing or collapse
  • irregular heartbeats
  • meningitis
  • hallucinations
  • worsening epilepsy (possibly increased number of seizures and / or increased severity)
  • inflammation of the blood vessels (may cause fever, aches, dark purple spots on the skin)
  • partial or complete loss of vision, caused by blockage of a blood vessel in the eye, inflammation of the conjunctiva of the eye , eye bleeding
  • deficiency of all blood cells (may cause fatigue, increase the tendency to get bruises, frequent nosebleeds and increased risk of infection)
  • chest pain
  • impaired sense of smell
  • discolored skin (bruising), muscle aches and weakness, joint pain
  • menstrual disorders
  • headache, hot flashes
  • decreased amount of sodium in the blood (may cause loss of appetite, headache, nausea, muscle cramps, and weakness).

In addition, in clinical trials of conditions other than osteoarthritis or joint problems, in which celecoxib was taken in doses of 400 mg daily for up to 3 years, the following adverse reactions have been observed:

Common (may affect up to 1 in 10 people):

  • angina (chest pain),
  • gastrointestinal problems: irritated colon (may include abdominal pain, diarrhea, digestive problems, flatulence)
  • kidney stones (may cause abdominal or back pain, blood in the urine), urinary incontinence
  • weight gain.

Uncommon (may affect up to 1 in 100 people):

  • deep vein thrombosis (blood clot, usually in the legs, which may cause pain, swelling or redness in the calf or difficulty breathing)
  • stomach infection (which can cause irritation and ulcers in the stomach and intestines)
  • fracture of forearm / lower leg
  • shingles , skin infection, eczema (dry itchy rash), pneumonia (cough, fever, difficulty breathing)
  • visual impairment caused by small spots in the visual field , dizziness caused by problems in the inner ear, tender, inflamed or bleeding gums, cold sores
  • need to urinate frequently at night, bleeding from hemorrhoids , upset bowel
  • lumps of fat in the subcutaneous tissue, ganglion (harmless swelling of the wrist and ankle tendons), speech difficulties, abdominal bleeding, tenderness in the breasts
  • the increased amount of 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 Stada

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 blister and carton after EXP. The expiration date is the last day of the specified month.

Do not store above 30 ° 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

The active substance is celecoxib

Celecoxib Stada 100 mg

Each hard capsule contains 100 mg of celecoxib.

Celecoxib Stada 200 mg

Each hard capsule contains 200 mg celecoxib.

Other ingredients are:

Lactose monohydrate , croscarmellose sodium, povidone K 30, sodium laurilsulfate, magnesium stearate, titanium dioxide (E171), gelatin.

Celecoxib Stada capsule 100 mg: Indigo carmine (E132)

Celecoxib Stada capsule 200 mg: Yellow iron oxide (E172)

What the medicine looks like and the contents of the pack

Celecoxib Stada is available as hard capsules.

Celecoxib Stada 100 mg: white hard gelatin capsules with a blue cap filled with a white or almost white crystalline powder.

Celecoxib Stada 200 mg: white hard gelatin capsules with a yellow cap filled with a white or almost white crystalline powder.

The capsules are packaged in PVC-Aluminum or PVC / PCdC-aluminum blister.

Pack sizes: 10, 20, 30, 40, 50, 60, 80, 90, 100, 120, 150, 160, 180.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Other manufacturers

Centrafarm Services BV

New Donk 9

4879 AC Etten Leur

Netherlands

Contact the representative of the marketing authorization holder to find out more about this medicine:

STADA Nordic ApS

Marielundvej 46 A

2730 Herlev

Denmark

Muhammad Nadeem

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