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Package leaflet: Information for the user
Celecoxib 100 mg capsules, hard Celecoxib 200 mg capsules, hard
Celecoxib
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 signs of illness 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 is and what it is used for
2. What you need to know before you take Celecoxib
3. How to take Celecoxib
4. Possible side effects
5. How to store Celecoxib
6. Contents of the pack and other information
1. What Celecoxib is and what it is used for
Celecoxib is used for the relief of signs and symptoms of rheumatoid arthritis, osteoarthritis and ankylosing spondylitis in adults.
Celecoxib belongs to a group of medicines called non-steroidal antiinflammatory drugs (NSAID), and specifically a sub-group known as (COX-2) inhibitors. Your body makes prostaglandins that may cause pain and inflammation. In conditions such as rheumatoid arthritis and osteoarthritis your body makes more of these. Celecoxib acts by reducing the production of prostaglandins, thereby reducing the pain and inflammation.
2. What you need to know before you take Celecoxib Do not take Celecoxib
• 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 “sulphonamides” (e.g. some antibiotics used to treat infections)
• if you currently have an ulcer in your stomach or intestines, or bleeding in your stomach or intestines
• if as a result of taking acetylsalicylic acid or any other anti-inflammatory and pain-relieving medicine (NSAID) you have had asthma, nose polyps, severe nose congestion, or an allergic reaction such as an itchy skin rash, swelling of the face, lips, tongue or throat, breathing difficulties or wheezing
• if you are pregnant. If you can become pregnant during ongoing treatment you should discuss methods of contraception 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 disease of the intestines such as ulcerative colitis or Crohn's disease
• if you have heart failure, established ischaemic heart disease, or cerebrovascular disease, e.g. you have been diagnosed with a heart attack, stroke, or transient ischaemic attack (temporary reduction of blood flow
to the brain; also known as “mini-stroke”), angina, or blockages of blood vessels to the heart or brain
• if you have or have had problems with your blood circulation (peripheral arterial disease) or if you have had surgery on the arteries of your legs
Warnings and precautions
Talk to your doctor or pharmacist before taking Celecoxib.
• if you have previously had an ulcer or bleeding in your stomach or intestines. (Do not take Celecoxib if you currently have an ulcer or bleeding in your stomach or intestine)
• if you are taking acetylsalicylic acid (even at low dose for heart protective purposes)
• if you use medicines to reduce blood clotting (e.g. warfarin/ warfarin like anticoagulants or novel oral anti-clotting medicines, e.g. apixaban)
• if you use medicines called corticosteroids (e.g. prednisone)
• if you are using Celecoxib at the same time as other non-acetylsalicylic NSAIDs such as ibuprofen or diclofenac. The use of these medicines together should be avoided
• if you smoke, have diabetes, raised blood pressure or raised cholesterol
• if your heart, liver or kidneys are not working well your doctor may want to keep a regular check on you
• if you have fluid retention (such as swollen ankles and feet)
• if you are dehydrated, for instance due to sickness, diarrhoea or the use of diuretics (used to treat excess fluid in the body)
• if you have had a serious allergic reaction or a serious skin reaction to any medicines
• if you feel ill due to an infection or think you have an infection, as Celecoxib may mask a fever or other signs of infection and inflammation
• if you are over 65 years of age your doctor may want to monitor you regularly
• the consumption of alcohol and NSAIDs may increase the risk of gastrointestinal problems
As with other NSAIDs (e.g. ibuprofen or diclofenac) this medicine may lead to an increase in blood pressure, and so your doctor may ask to monitor your blood pressure on a regular basis.
Some cases of severe liver reactions, including severe liver inflammation, liver damage, liver failure (some with fatal outcome or requiring liver transplant), have been reported with celecoxib. Of the cases that reported time to onset, most severe liver reactions occurred within one month of start of treatment.
Celecoxib may make it more difficult to become pregnant. You should inform your doctor if you are planning to become pregnant or if you have problems to become pregnant (see section on “Pregnancy, breast-feeding and fertility”).
Other medicines and Celecoxib
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines:
• Ciclosporin and tacrolimus (used for immune system suppression e.g. after transplants)
Celecoxib can be taken with low dose acetylsalicylic acid (75 mg or less daily). Ask your doctor for advice before taking both medicines together.
Pregnancy, breast-feeding 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 must not be used by women who are pregnant or can become pregnant (i.e. women of child bearing potential who are not using adequate contraception) during ongoing treatment. If you become pregnant during treatment with Celecoxib you should discontinue the treatment and contact your doctor for alternative treatment.
Breast-feeding
Celecoxib must not be used during breast-feeding.
Fertility
NSAIDs, including Celecoxib, may make it more difficult to become pregnant. You should tell your doctor if you are planning to become pregnant or if you have problems becoming pregnant.
Driving and using machines
You should be aware of how you react to Celecoxib before you drive or operate machinery. If you feel dizzy or drowsy after taking Celecoxib, do not drive or operate machinery until these effects wear off.
Celecoxib contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Celecoxib
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Your doctor will tell you what dose you should take. As the risk of side effects associated with heart problems may increase with dose and duration of use, it is important that you use the lowest dose that controls your pain and you should not take Celecoxib for longer than necessary to control symptoms.
Contact your doctor within two weeks of starting treatment if you do not experience any benefit.
The recommended dose:
For osteoarthritis the recommended dose is 200 mg each day, increased by your doctor to a maximum of 400 mg, if needed.
The dose is usually:
• One 200 mg capsule once a day; or
• One 100 mg capsule twice a day.
For rheumatoid arthritis the recommended dose is 200 mg each day (taken in two divided doses), increased by your doctor to a maximum of 400 mg (taken in two divided doses), if needed.
The dose is usually:
• One 100 mg capsule twice a day.
For Celecoxib 200 mg only:
If the dose you are prescribed cannot be achieved with this strength of medicinal product, other strengths of this medicinal product are available to achieve the dose. Please consult your doctor.
For ankylosing spondylitis the recommended dose is 200 mg each day, increased by your doctor to a maximum of 400 mg, if needed.
The dose is usually:
• One 200 mg capsule once a day; or
• One 100 mg capsule twice a day.
Maximum daily dose is 400 mg per day
Kidney or liver problems: make sure your doctor knows if you have liver or kidney problems as you may need a lower dose.
The elderly, especially those with a weight less than 50 kg: if you are over 65 years of age and especially if you weigh less than 50 kg, your doctor may want to monitor you more closely.
Use in children: Celecoxib is for adults only, it is not for use in children.
Method of administration
Celecoxib is for oral use. It should be swallowed whole with a drink of water.
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 each day.
If you have difficulty swallowing capsules: The entire capsule contents can be sprinkled onto a spoonful of semi-solid food (such as cool or room temperature applesauce, rice gruel, yogurt or mashed banana) and swallowed immediately with a drink approximately 240 ml of water.
To open the capsule, hold upright to contain the granules at the bottom then gently squeeze the top and twist to remove, taking care not to spill the contents. Do not chew or crush the granules.
If you take more Celecoxib than you should
You should not take more capsules than your doctor tells you to. If you take too many capsules contact your doctor, pharmacist or hospital and take your medicine with you.
If you forget to take Celecoxib
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 dose.
If you stop taking Celecoxib:
Suddenly stopping your treatment with Celecoxib may lead to your symptoms getting worse.
Do not stop taking Celecoxib unless your doctor tells you to. Your doctor may tell you to reduce the dose over a few days before stopping completely.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can have side-effects, although not everybody gets them.
The side effects listed below were observed in arthritis patients who took celecoxib. Side effects marked with an asterisk (1) are listed below at the higher frequencies that occurred in patients who took celecoxib to prevent colon polyps. Patients in these studies took at high doses and for a long duration.
If any of the following happen, stop taking Celecoxib and tell 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 pain in the chest
or
Belgium:
Finland:
Germany:
The Netherlands:
Portugal:
Spain:
Sweden:
The United Kingdom:
This leaflet was last revised in 02/2016.
Celecoxib AB 100 mg/200 mg harde capsules / gelules / Hartkapseln
Celecoxib Orion 100 mg/200 mg kovat kapselit Celecoxib Aurobindo 100 mg/200 mg Hartkapseln Celecoxib Aurobindo 100 mg/200 mg, harde capsules Celecoxib Aurovitas
Celecoxib Aurobindo 200 mg capsulas duras EFG Celecoxib Orion 100 mg/200 mg kapslar, harda Celecoxib 100 mg/200 mg capsules, hard
- severe stomach pain or any sign of bleeding in the stomach or intestines, such as passing black or bloodstained stools, or vomiting blood.
- a skin reaction such as rash, blistering or peeling of the skin
- liver failure (symptoms may include nausea (feeling sick), diarrhoea, jaundice (your skin or the whites of your eyes look yellow).
Very common: may affect more than 1 in 10 people:
• High blood pressure, including worsening of existing high blood pressure *
Common: may affect up to 1 in 10 people:
• Heart attack*
• Fluid build up with swollen ankles, legs and/or hands
• Urinary infections
• Shortness of breath*, sinusitis (sinus inflammation, sinus infection, blocked or painful sinuses), blocked or runny nose, sore throat, coughs, colds, flu-like symptoms
• Dizziness, difficulty sleeping
• Vomiting*, stomach ache, diarrhoea, indigestion, wind
• Rash, itching
• Muscle stiffness
• Difficulty swallowing*
• Headache
• Nausea (feeling sick)
• Painful joints
• Worsening of existing allergies
• Accidental injury
Uncommon: may affect up to 1 in 100 people:
• Stroke*
• Heart failure, palpitations (awareness of heart beat), fast heart rate
• Abnormalities in liver-related blood tests
• Abnormalities in kidney-related blood tests
• Anaemia (changes in red blood cells that can cause fatigue and breathlessness)
• Anxiety, depression, tiredness, drowsiness, tingling sensations (pins and needles)
• High levels of potassium in blood test results (can cause nausea (feeling sick), fatigue, muscle weakness or palpitations)
• Impaired or blurred vision, ringing in the ears, mouth pain and sores, difficulty hearing*
• Constipation, burping, stomach inflammation (indigestion, stomach ache or vomiting), worsening of inflammation of the stomach or intestine.
• Leg cramps
• Raised itchy rash (hives)
• Eye Inflammation
• Difficulty breathing
• Skin discolouration (bruising)
• Chest pain (generalised pain not related to the heart)
• Face swelling
Rare: may affect up to 1 in 1,000 people:
• Ulcers (bleeding) in the stomach, gullet or intestines; or rupture of the intestine (can cause stomach ache, fever, nausea, vomiting, intestinal blockage), dark or black stools, inflammation of the pancreas (can lead to stomach pain) inflammation of the gullet (oesophagus)
• Low levels of sodium in the blood (a condition known as hyponatraemia)
• Reduced number of white blood cells (which help protect the body from infection) and blood platelets (increased chance of bleeding or bruising)
• Difficulty coordinating muscular movements
• Feeling confused, changes in the way things taste
• Increased sensitivity to light
• Loss of hair
• Hallucinations
• Bleeding in the eye
• Acute reaction that may lead to lung inflammation
• Irregular heartbeat
• Flushing
• Blood clot in the blood vessels in the lungs. Symptoms may include sudden breathlessness, sharp pains when you breathe or collapse
• Bleeding of the stomach or intestines (can lead to bloody stools or vomiting), inflammation of the intestine or colon.
• Severe liver inflammation (hepatitis). Symptoms may include nausea (feeling sick), diarrhoea, jaundice (yellow discolouration of the skin or eyes), dark urine, pale stools, bleeding easily, itching or chills
• Acute kidney failure
• Menstrual disturbances
• Swelling of the face, lips, mouth, tongue or throat, or difficulty swallowing
Very rare: may affect up to 1 in 10000 people
• Serious allergic reactions (including potentially fatal anaphylactic shock)
• Serious skin conditions such as Stevens-Johnson syndrome, exfoliative dermatitis and toxic epidermal necrolysis (can cause rash, blistering or peeling of the skin) and acute generalised exenthematous pustulosis (symptoms include the skin becoming red with swollen areas covered in numerous small pustules)
• A delayed allergic reaction with possible symptoms such as rash, swelling of the face, fever, swollen glands, and abnormal test results (e.g., liver, blood cell (eosinophilia, a type of raised white blood cell count)
• Bleeding within the brain causing death
• 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 transplant). Symptoms may include nausea (feeling sick), diarrhoea, jaundice (yellow discolouration of the skin or eyes), dark urine, pale stools, bleeding easily, itching or chills
• Liver problems (such as cholestasis and cholestatic hepatitis, which may may be accompanied by symptoms such as discoloured stools, nausea and yellowing of the skin or 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 (oedema), foamy urine, fatigue and a loss of appetite)
• Worsening of epilepsy (possible more frequent and/or severe seizures)
• Blockage of an artery or vein in the eye leading to partial or complete loss of vision,
• Inflamed blood vessels (can cause fever, aches, purple blotches on the skin)
• A reduction in the number of red and white blood cells and platelets (may cause tiredness, easy bruising, frequent nose bleeds and increased risk of infections)
• Muscle pain and weakness
• Impaired sense of smell
• Loss of taste
Not known: frequency cannot be estimated from the available data:
• Decreased fertility in females, which is usually reversible on discontinuation of the medicine
In clinical studies not associated with Arthritis or other arthritic conditions, where celecoxib was taken at doses of 400 mg per day for up to 3 years, the following additional side effects have been observed:
Common: may affect up to 1 in 10 people:
• Heart problems: angina (chest pain)
• Stomach problems: irritable bowel syndrome (can include stomach ache, diarrhoea, indigestion, wind)
• Kidney stones (which may lead to stomach or back pain, blood in urine), difficulty passing urine
• Weight gain
Uncommon: may affect up to 1 in 100 people:
• Deep vein thrombosis (blood clot usually in the leg, which may cause pain, swelling or redness of the calf or breathing problems)
• Stomach problems: stomach infection (which can cause irritation and ulcers of the stomach and intestines),
• Lower limb fracture
• Shingles, skin infection, eczema (dry itchy rash), pneumonia (chest infection (possible cough, fever, difficulty breathing))
• Floaters in the eye causing blurred or impaired vision, vertigo due to inner ear troubles, sore, inflamed or bleeding gums, mouth sores
• Excessive urination at night, bleeding from piles/ haemorrhoids, frequent bowel movements
• Fatty lumps in skin or elsewhere, ganglion cyst (harmless swellings on or around joints and tendons in the hand or foot), difficulty speaking, abnormal or very heavy bleeding from the vagina, breast pain
• High levels of sodium in blood test results
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Celecoxib
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 label, carton or bottle after EXP. The expiry date refers to the last day of that month.
Store below 30°C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Celecoxib contains
- The active substance is celecoxib.
Each hard, capsule contains 100 mg celecoxib.
Each hard, capsule contains 200 mg celecoxib.
- The other ingredients are:
Capsule contents: Lactose monohydrate, hydroxypropyl cellulose, crospovidone (Type B)(E1202), sodium lauril sulfate(E487), povidone (K-30) (E1201), sodium stearyl fumarate.
Capsule shell: Titanium dioxide (E171), gelatin (E441).
Printing ink: Shellac (E904), indigo carmine aluminium lake (E132) (100 mg only), yellow iron oxide (E172) (200 mg only).
What Celecoxib looks like and contents of the pack
Capsule, hard.
Celecoxib 100 mg capsules, hard
White cap/White body, Size '4' hard gelatin capsule filled with white to off-white granular powder imprinted with 'Y' on cap and '100' on body with blue ink.
Celecoxib 200 mg capsules, hard
White cap/White body, Size '2' hard gelatin capsule filled with white to off-white granular powder imprinted with 'Y' on cap and '200' on body with gold ink.
Celecoxib capsules are available in clear PVC Aluminium foil blister pack and white opaque HDPE bottle pack with polypropylene closure.
Pack sizes:
Blister packs: 10, 20, 30, 50, 60, 90 and 100 capsules HDPE packs:
100 mg: 60, 100, 250 and 500 capsules.
200 mg: 30, 100, 250 and 500 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Milpharm Limited
Ares Block, Odyssey Business Park West End Road Ruislip HA4 6QD United Kingdom
Manufacturer
APL Swift Services (Malta) Limited HF26, Hal Far Industrial Estate, Hal Far Birzebbugia, BBG 3000 Malta
Milpharm Limited
Ares Block, Odyssey Business Park West End Road Ruislip HA4 6QD United Kingdom
This medicinal product is authorized in the Member States of the EEA under the following names:
Dextromethorphan (used to treat coughs)
• ACE inhibitors or angiotensin II antagonists, beta blockers and diuretics (used for high blood pressure and heart failure)
• Fluconazole and rifampicin (used to treat fungal and bacterial infections)
• Warfarin or warfarin like medicines (“blood-thinning” agents that reduce blood clotting) including newer medicines like apixaban
• Lithium (used to treat some types of depression)
• Other medicines to treat depression, sleep disorders, high blood pressure or an irregular heartbeat
• Neuroleptics (used to treat some mental disorders)
• Methotrexate (used to treat rheumatoid arthritis, psoriasis and leukaemia)
• Carbamazepine (used to treat epilepsy/seizures and some forms of pain or depression)
• Barbiturates (used to treat epilepsy/seizures and some sleep disorders)