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BIXOCEL 200 MG CAPSULES HARD

Active substance(s): CELECOXIB

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Bixocel 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 4.4.
What is in this leaflet
1.
2.
3.
4.
5.
6.

1.

What Bixocel is and what it is used for
What you need to know before you take Bixocel
How to take Bixocel
Possible side effects
How to store Bixocel
Contents of the pack and other information

What Bixocel is and what it is used for
Bixocel is used for the relief of signs and symptoms of rheumatoid arthritis, osteoarthritis and
ankylosing spondylitis in adults.
Celecoxib belongs to a group of medicinal products called nonsteroidal anti-inflammatory 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 Bixocel
You have been prescribed this medicine by your doctor. The following information will help you get the
best results with this medicine. If you have any further questions please ask your doctor or pharmacist.
Do not take Bixocel:
Tell your doctor if any of the following are true for you as patients with these conditions should not
take celecoxib.
 if you are allergic (hypersensitive) 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.

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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 Bixocel.
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 Bixocel
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 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 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.
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 and
breast-feeding).
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Other medicines and Bixocel
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)

Celecoxib can be taken with low dose acetylsalicylic acid (75mg or less daily). Ask your doctor for
advice before taking both medicines together.
Tell your doctor or pharmacist if you are taking, or have recently taken any of the medicines listed
above or any other medicines.
Bixocel with food and drink
Food and drink do not influence the effect of Bixocel.
Pregnancy, breast-feeding and fertility
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.
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 must not be used during breast-feeding.
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.
Bixocel contains lactose
Bixocel 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.

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3.

How to take Bixocel
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if
you are not sure. If you think or feel that the effect of celecoxib 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 celecoxib for longer than necessary to control symptoms.
Celecoxib 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.
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 (taken in two divided doses), increased by
your doctor to a maximum of 400 mg (taken in two divided doses), if needed.
Bixocel 200 mg:
 The dose of 200 mg (taken as one 100 mg capsule twice a day) cannot be achieved with Bixocel 200
mg capsules, hard. Please consult your doctor.
For ankylosing spondylitis 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.
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.
You should not take more than 400 mg per day.
If you take more Bixocel 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.

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If you forget to take Bixocel
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 Bixocel
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 cause side effects, although not everybody gets them.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not
listed in this leaflet.
The side effects listed below were observed in arthritis patients who took Bixocel. Side effects
marked with an asterisk (*) are listed below at the higher frequencies that occurred in patients who
took celecoxib to prevent colon polyps. Patients in these studies took celecoxib at high doses and for
a long duration.
If any of the following happen, stop taking Bixocel 100 mg capsules, hard 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)).
Very common side effects (may affect more than 1 in 10 people)
 High blood pressure*
Common side effects (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*

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Worsening of existing allergies

Uncommon side effects (may affect up to 1 in 100 people)
 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 side effects (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 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
 Elevation of liver enzymes
Not known side effects (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
exenthematous 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).
 Liver failure , liver damage and severe liver inflammation (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
 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

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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)
Ageusia (loss of taste)

In clinical studies not associated with arthritis or other arthritic conditions, where Bixocel 100 mg
capsules, hard was taken at doses of 400mg per day for up to 3 years, the following additional side
effects have been observed:
Common side effects (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, elevated levels of blood creatinine (indicates kidney failure) • Weight gain
• Benign prostatic hyperplasia (enlargement of the prostate)
Uncommon side effects (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 • Allergic dermatitis (allergic skin reaction)

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

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Do not use this medicine after the expiry date which is stated on the blister and carton after ‘EXP’. The
first two digits indicate the month and the last four digits indicate the year. The expiry date refers to the
last day of that month.
This medicinal product medicine does not require any special storage conditions.
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 Bixocel contains
The active substance is celecoxib. Each capsule contains 200 mg celecoxib.
The other ingredients are lactose monohydrate, povidone, croscarmellose sodium, sodium lauryl sulphate,
magnesium stearate (E572) (granulate); gelatin (E441), titanium dioxide (E171), iron oxide yellow (E172)
(capsule), The printing ink components are Shellac (E904), Propylene glycol (E1520) and iron oxide
yellow (E172).
What Bixocel looks like and contents of the pack
Opaque, white, hard gelatin capsule. The body contains a yellow band and white text “C9OX-200”.
Bixocel is contained in packs of 1, 10, 20, 30, 40, 50, 60 and 100 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Synthon BV
Microweg 22
6545 CM, Nijmegen
The Netherlands
Manufacturer(s):
Synthon BV
Microweg 22
6545 CM, Nijmegen
The Netherlands
Synthon Hispania S.L.
Castelló, 1,
08830 Sant Boi de Llobregat,
Spain

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This medicinal product is authorised in the Member States of the EEA under the following names:

NL
CZ
DE
ES
FR
PT
RO

Bixocel 200 mg, capsules hard
Letabex 200 mg tvrdá tobolka
Celecox-HEXAL 200 mg Hartkapseln
Celecoxib Almus 200 mg cápsulas duras EFG
Celecoxib Sandoz 200 mg, gélule
Celecoxib Sandoz
Calidem 200 mg capsule

This leaflet was last revised in: 08/2014

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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.

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