100 mg and 200 mg capsules, hard
celecoxib
What Celecoxib Krka is and what it is used for
Celecoxib Krka is used in adults for the relief of symptoms in the treatment of chronic rheumatoid arthritis, osteoarthritis, and pelvic pondylitis .
Celecoxib Krka belongs to a group of medicines called non-steroidal anti-inflammatory drugs ( NSAIDs ), and more specifically to the subgroup inhibitors of cyclooxygenase -2 ( COX-2 inhibitors). Your body produces prostaglandins that can cause pain and inflammation and in conditions such as rheumatoid arthritis and osteoarthritis, your body produces more of them. Celecoxib Krka works by reducing the production of prostaglandins and thus reducing pain and inflammation.
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 Krka 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.
2. What you need to know before you use Celecoxib Krka
Do not use Celecoxib Krka
You have been prescribed Celecoxib Krka by your doctor. The following information will help you get the best results from your treatment. If you have any further questions, ask your doctor or pharmacist.
Do not take Celecoxib Krka
Tell your doctor if any of the following apply to you as patients with these conditions should not take Celecoxib Krka.
- 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, for example, if you have had a heart attack, stroke, temporarily reduced blood flow to the brain (also known as “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 or pharmacist before taking Celecoxib Krka:
- if you have previously had ulcers or bleeding in the stomach or intestines( Do not take Celecoxib Krka if you currently have ulcers or bleeding in the stomach or intestines)
- if you are taking medicines that reduce the formation of platelets
- 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 / warfarin-like anticoagulants or new oral blood thinners, eg apixaban)
- if you are taking medicines called corticosteroids (eg prednisone)
- if you are taking Celecoxib Krka 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, for example, 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 may have an infection , as Celecoxib Krka may mask a fever or other signs of infection and inflammation
- if you are over 65, your doctor will check you regularly
- Intake of alcohol and NSAIDs may increase the risk of gastrointestinal upset
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 Krka 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 ).
Other medicines and Celecoxib Krka
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, angiotensin II antagonists, beta-blockers, and diuretics (used to treat high blood pressure and heart failure )
- Fluconazole and rifampicin (used to treat fungal and bacterial infections)
- Warfarin or other warfarin-like medicines (blood thinners that reduce blood clotting) including newer medicines like apixaban
- 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 Krka 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.
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.
Pregnancy
Celecoxib Krka 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 Krka, you should stop treatment and contact your doctor for other treatment.
Breast-feeding
Celecoxib Krka must not be used during breast-feeding.
Fertility
NSAIDs, including Celecoxib Krka, can make it harder to get pregnant. Tell your doctor if you are planning to become pregnant or have problems getting pregnant.
Driving and using machines
You should know how you react to Celecoxib Krka before driving or using machines. If you feel dizzy or drowsy after taking Celecoxib Krka, 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 increased 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 Krka 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 sodium (23 mg) per capsule, ie essentially ‘ sodium-free’. is next to “sodium-free”.
How to use Celecoxib Krka
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure. If you have the impression that the effect of Celecoxib Krka is too strong or too weak, talk to your doctor or pharmacist.
Your doctor will tell you which dose to take. As the risk of heart side effects may increase with high doses and long-term treatment, it is important that you do not take higher doses or use Celecoxib Krka for longer than you need to control your symptoms.
Celecoxib Krka should be swallowed whole with some water. Your dose can be taken at any time of the day, with or without food, but try to take each dose at the same time of day.
Contact your doctor if you do not experience any improvement after two weeks of treatment.
The recommended dose is:
In osteoarthritis , the recommended 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 recommended 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 capsule of 100 mg twice a day.
For pelvic pondylitis , the recommended 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.
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.
Use in children: Celecoxib Krka is for adults only and should not be used in children.
Maximum daily dose:
You should not take more than 400 mg daily (4 capsules Celecoxib Krka 100 mg or 2 capsules Celecoxib Krka 200 mg).
If you forget to use Celecoxib Krka
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 Krka
If you suddenly stop taking Celecoxib Krka, your symptoms may get worse. Do not stop taking Celecoxib Krka 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.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
The side effects listed below have been observed in patients with osteoarthritis who have used Celecoxib Krka. Adverse reactions marked with an asterisk (*) are indicated with the higher frequency seen in patients who used Celecoxib Krka to prevent colon polyps. These patients took Celecoxib Krka in high doses and for a long time.
If any of the following occur, stop taking Celecoxib Krka and contact a 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, such as 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):
- High blood pressure including an increase in already high blood pressure *
Common (may affect up to 1 in 10 people):
- Myocardial infarction*
- Accumulation of fluid 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 *
- Headache
- Nausea
- Joint pain
- Worsening of existing allergies you
- Damage in the event of an accident
Uncommon (may affect up to 1 in 100 people):
- Stroke*
- Heart failure, palpitations, rapid heartbeat
- 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, and crawling
- Increased 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, inflammation of the stomach (digestive problems, stomach pain, or vomiting), worsening inflammation of the stomach or intestines.
- Leg cramps
- Elevated, itchy rash ( hives )
- Eye inflammation
- Breathing difficulties
- Discolored skin (bruises)
- Chest pain (general pain not related to the heart)
- Facial swelling
Rare (may affect up to 1 in 1,000 people):
- Ulcers (bleeding) in the stomach, esophagus or intestine, or ruptured intestine (may cause abdominal pain, fever, nausea, vomiting, intestinal obstruction), dark or black stools, inflammation of the pancreas (may cause abdominal pain), inflammation of the esophagus ( esophagitis )
- Decreased amount of sodium in the blood (a condition known as hyponatremia )
- Reduced 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 light sensitivity
- Hair loss
- Hallucinations
- Bleeding in the eye
- The acute reaction that can lead to pneumonia
- Irregular heartbeats
- Pastures
- Blood clots in the blood vessels of the lungs. Symptoms may include sudden shortness of breath, sharp pain when breathing, or collapse
- Bleeding in the stomach or intestines (may lead to bloody stools or vomiting), intestinal inflammation
- 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
- Acute renal failure
- Menstrual disorders
- Swelling of the face, lips, mouth, tongue or throat, wheezing or difficulty swallowing
Very rare (may affect up to 1 in 10,000 people):
- Severe skin reactions (including anaphylactic shock, which may be life-threatening)
- Severe skin conditions such as Stevens-Johnson syndrome , exfoliative dermatitis and toxic epidermal necrolysis (which may cause a rash, blistering or flaking of the skin) and acute 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 ))
- Cerebral hemorrhage, which can be life-threatening
- Meningitis ( inflammation of the meninges)
- Liver failure, liver damage, and severe liver inflammation ( fulminant hepatitis ) (some cases with fatal outcome 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
- Liver problems (eg cholestasis and cholestatic hepatitis, which may be accompanied by symptoms such as discolored stools, nausea, and yellowing of the skin or eyes)
- Kidney inflammation and other kidney problems (eg nephrotic syndrome and minimal change disease that may be accompanied by symptoms such as fluid retention ( edema ), frothy urine, fatigue, and loss of appetite)
- Impaired epilepsy (possibly increased number of seizures and/or increased severity)
- Partial or complete vision loss, caused by blockage of a blood vessel in the eye
- Inflammation of the blood vessels (may cause fever, aches, dark purple spots on the skin)
- Deficiency of all blood cells (may cause fatigue, increased tendency to get bruises, frequent nosebleeds, and increased risk of infection)
- Muscle aches and weakness
- Impaired sense of smell
- Loss of taste
No known frequency (occurrence cannot be calculated from the available data):
- Decreased fertility in women, which is usually transient at the end of treatment
In clinical trials of conditions other than osteoarthritis or joint pain, which Celecoxib Krka was the dose you about 400 mg daily for up to 3 years, the following additional adverse reactions are observed:
Common (may affect up to 1 in 10 people):
- Angina (chest pain)
- Irritable bowel syndrome (may include abdominal pain, diarrhea, digestive problems, flatulence)
- Kidney stones (may cause pain in the abdomen or back, 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 can 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 Krka
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
- The active substance is celecoxib. Each 100 mg hard capsule contains 100 mg of celecoxib. Each 200 mg hard capsule contains 200 mg of celecoxib.
- The other ingredients (excipients) in 100 mg hard capsules are lactose monohydrate, povidone K30, croscarmellose sodium, sodium lauryl sulfate, magnesium stearate (E470b) in the capsule, and gelatin and titanium dioxide (E171) in the capsule shell.
- The other ingredients (excipients) in 200 mg hard capsules are lactose monohydrate, povidone K30, croscarmellose sodium, sodium lauryl sulfate, magnesium stearate (E470b) in the capsule and gelatin, titanium dioxide (E171), and yellow iron oxide (E172) in the capsule shell.
What the medicine looks like and the contents of the pack
100 mg hard capsule is white, 15.4 mm-16.2 mm long. The capsule contains white or almost white granules.
200 mg hard capsule is a brownish yellow, 18.9 mm-19.7 mm long. The capsule contains white or almost white granules.
100 mg and 200 mg capsules are available in pack sizes of 10, 20, 30, 40, 50, 60, 90, or 100 blister capsules.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
KRKA Sverige AB, Göta Ark 175, 118 72 Stockholm,
Manufacturer
KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany