CELEBREX 200MG HARD CAPSULES

Active substance: CELECOXIB

View full screen / Print PDF » Download PDF ⇩

Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER
Celebrex® 200mg Hard Capsule
celecoxib
This product will be referred to as Celebrex throughout this leaflet.
This product is available in multiple strengths and all strengths will be
referred to throughout this leaflet
Read all of this leaflet carefully before you start taking this
medicine
 Keep this leaflet. You may need to read it again
 If you have any further questions, please ask your doctor or pharmacist
 This medicine has been prescribed for you. Do not pass it on to others.
It may harm them, even if their symptoms are the same as yours
 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
In this leaflet:
1. What Celebrex is and what it is used for
2. Before you take Celebrex
3. How to take Celebrex
4. Possible side effects
5. How to store Celebrex
6. Further information
1.

WHAT CELEBREX IS AND WHAT IT IS USED FOR

Celebrex is used for the relief of signs and symptoms of rheumatoid
arthritis, osteoarthritis and ankylosing spondylitis.
Celebrex belongs to a group of medicinal products called nonsteroidal antiinflammatory drugs (NSAID), and specifically a sub-group known as (COX2) 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. Celebrex acts by reducing the production
of prostaglandins, thereby reducing the pain and inflammation.
2.

Taking other medicines
Some medicines can affect the way other medicines work. Please tell your
doctor or pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription:
 Dextromethorphan (used to treat coughs)
 ACE inhibitors or angiotensin II antagonists (used for high blood
pressure and heart failure)
 Diuretics (used to treat excess fluid in the body)
 Fluconazole and rifampicin (used to treat fungal and bacterial
 infections)
 Warfarin or other oral anticoagulants (“blood-thinning” agents that
reduce blood clotting)
 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)
 Ciclosporin and tacrolimus (used for immune system suppression
e.g. after transplants)

BEFORE YOU TAKE CELEBREX

You have been prescribed Celebrex by your doctor. The following
information will help you get the best results with Celebrex. If you have any
further questions please ask your doctor or pharmacist.
Do not take Celebrex
Tell your doctor if any of the following are true for you as patients with
these conditions should not take Celebrex.
 if you are allergic (hypersensitive) to celecoxib or any of the other
ingredients of Celebrex
 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
Take special care with Celebrex
Check with your doctor if any of the following applies to you:
 if you have previously had an ulcer or bleeding in your stomach or
intestines. (Do not take Celebrex 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)
 if you are using Celebrex 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
Celebrex may mask a fever or other signs of infection and
 inflammation
 if you are over 65 years of age your doctor may want to keep a
regular check on you
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.
Celebrex 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 and breast-feeding).

Celebrex can be taken with low dose acetylsalicylic acid (75mg or less
daily). Ask your doctor for advice before taking both medicines
together.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Celebrex 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 Celebrex you should discontinue the
treatment and contact your doctor for alternative treatment. Celebrex must
not be used during breast-feeding.
Driving and using machines
You should be aware of how you react to Celebrex before you drive or
operate machinery. If you feel dizzy or drowsy after taking Celebrex, do not
drive or operate machinery until these effects wear off.
Important information about some of the ingredients of Celebrex
Celebrex contains lactose (a type of sugar). 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 CELEBREX

Always take Celebrex exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are unsure. If you think or feel
that the effect of Celebrex is too strong or too weak, talk to your doctor or
pharmacist.
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 Celebrex for longer than necessary to control
symptoms.
Celebrex 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 Celebrex at the same time each day.
Contact your doctor within two weeks of starting treatment if you do not
experience any benefit.
For osteoarthritis the usual 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 usual dose is 200 mg each day,
increased by your doctor to a maximum of 400 mg, if needed.
The dose is usually:
■ one 100 mg capsule twice a day.
For ankylosing spondylitis the usual dose is 200 mg each day,
increased by your doctor to a maximum of 400mg, if needed.
The dose is usually:
■ one 200 mg capsule once a day; or
■ one 100 mg capsule twice a 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.
Children: Celebrex is for adults only, it is not for use in children.
You should not take more than 400 mg per day.

If you take more Celebrex 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 Celebrex:
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 doses.
If you stop taking Celebrex:
Suddenly stopping your treatment with Celebrex may lead to your
symptoms getting worse. Do not stop taking Celebrex 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 product, ask your doctor
or pharmacist.

 Liver failure, liver damage and severe liver inflammation (sometimes










4.

POSSIBLE SIDE EFFECTS

Like all medicines, Celebrex can have side-effects, although not
everybody gets them.
If any of the side effects get serious, or if you notice any side effects not
listed in this leaflet, tell your doctor or pharmacist.
The side effects listed below were observed in arthritis patients who
took Celebrex. Side effects marked with an asterisk (*) are listed below
at the higher frequencies that occurred in patients who took Celebrex
to prevent colon polyps. Patients in these studies took Celebrex at
high doses and for a long duration.










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
Kidney problems (possible kidney failure, inflammation of the
kidneys)
Blood clot in the blood vessels in the lungs. Symptoms may include
sudden breathlessness, sharp pains when you breathe or collapse
Irregular heartbeat
Meningitis (inflammation of the membrane around the brain and spinal
cord)
Hallucinations
Worsening of epilepsy (possible more frequent and/or severe
seizures)
Inflamed blood vessels (can cause fever, aches, purple blotches on the
skin)
Blockage of an artery or vein in the eye leading to partial or
complete loss of vision, inflammation of the conjunctiva, bleeding in the
eye
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)
Chest pain
Impaired sense of smell
Skin discolouration (bruising), muscle pain and weakness, painful joints
Menstrual disturbances
Headache, flushing
Low levels of sodium in blood test results (can cause loss of appetite,
headache, nausea (feeling sick), muscle cramps and weakness)

If any of the following happen, stop taking Celebrex 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
 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).

In clinical studies not associated with Arthritis or other arthritic
conditions, where Celebrex was taken at doses of 400mg per day for
up to 3 years, the following additional side effects have been
observed:

Very common: affects more than 1 user in 10:

Uncommon: affects 1 to 10 users in 1,000:
 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

 High blood pressure*
Common: affects 1 to 10 users in 100:
 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*
 Worsening of existing allergies
Uncommon: affects 1 to 10 users in 1,000:
 Stroke*
 Heart failure, palpitations (awareness of heart beat), fast heart rate
 Worsening of existing high blood pressure
 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)
Rare: affects 1 to 10 users in 10,000:
 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 gullet (can cause
difficulty in swallowing), inflammation of the pancreas (can lead to
 stomach pain)
 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
Not known: frequency cannot be estimated from the available data:
 Bleeding within the brain causing death
 Serious allergic reactions (including potentially fatal anaphylactic shock)
which can cause skin rash, swelling of the face, lips, mouth, tongue or
throat, wheezing or difficulty breathing; difficulty swallowing
 Bleeding of the stomach or intestines (can lead to bloody stools or
vomiting), inflammation of the intestine or colon, nausea (feeling sick)
 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 exanthematous pustulosis
(red swollen area with 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))

Common: affects 1 to 10 users in 100:
 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

If any of the side effects get serious, or if you notice any side effects not
listed in this leaflet, tell your doctor or pharmacist.
5.







6.

How to store Celebrex
Keep out of the sight and reach of children.
Do not store Celebrex above 30°C.
Do not use Celebrex after the expiry date stated on the blister and
carton. The expiry date refers to the last day of that month.
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.
Further Information

What Celebrex contains
 The active substance is celecoxib.
 Each hard capsule contains 200mg of the active ingredient celecoxib.
 Each capsule also contains the following ingredients: gelatine, lactose
monohydrate, sodium lauryl sulphate, povidone K-30, croscarmellose
sodium, sorbitan monolaurate, shellac, propylene glycol, magnesium
stearate, titanium dioxide (E171) and yellow ferric oxide (E172).
This product 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.
What Celebrex looks like and contents of the pack
Celebrex are opaque, white hard capsules with two gold bands marked
‘7767’ and ‘200’. They are available in blister packs of 20 or 30 capsules.
Manufacturer:
This product is manufactured by Pfizer Manufacturing Deutschland GmbH,
D-89257 Illertissen, Germany. Procured from within the EU. Repackaged by
the Parallel Import Product Licence holder:
G Pharma Ltd, Dakota Avenue, Salford M50 2PU.
PL 16369/1076

Celebrex 200mg Hard Capsules

POM

22/07/2014
Celebrex® is a trade mark of Pfizer.

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web2)