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ZYVOX 600MG FILM COATED TABLETS

Active substance(s): LINEZOLID

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Package leaflet: Information for the user

ZYVOX® 600 mg
film-coated tablets
for use in Adults
Linezolid

• loss of sensitivity in your arms or legs or a sensation
of tingling or pricking in your arms or legs.
• you may develop diarrhoea while taking or after taking
antibiotics, including Zyvox. If this becomes severe or
persistent or you notice that your stool contains blood
or mucus, you should stop taking Zyvox immediately
and consult your doctor. In this situation, you should
not take medicines that stop or slow bowel
movement.
• recurrent nausea or vomiting, abdominal pain or rapid
breathing.
Other medicines and Zyvox

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,
pharmacist or nurse.
– 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,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Zyvox is and what it is used for
2. What you need to know before you take Zyvox
3. How to take Zyvox
4. Possible side effects
5. How to store Zyvox
6. Contents of the pack and other information

1. What Zyvox is and what it is
used for
Zyvox is an antibiotic of the oxazolidinones group that
works by stopping the growth of certain bacteria (germs)
that cause infections. It is used to treat pneumonia and
some infections in the skin or under the skin. Your doctor
will have decided if Zyvox is suitable to treat your infection.

2. What you need to know before
you take Zyvox
Do not take Zyvox:
• if you are allergic to linezolid or any of the other
ingredients of this medicine (listed in section 6).
• if you are taking or have taken within the last 2 weeks
any medicines known as monoamine oxidase inhibitors.
(MAOIs: for example phenelzine, isocarboxazid,
selegiline, moclobemide). These medications may be
used to treat depression or Parkinson’s disease.
• if you are breast-feeding. This is because Zyvox
passes into breast milk and could affect the baby.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking
Zyvox.
Zyvox may not be suitable for you if you answer yes to
any of the following questions. In this case tell your doctor
as he/she will need to check your general health and
your blood pressure before and during your treatment or
may decide that another treatment is better for you.
Ask your doctor if you are not sure whether these
categories apply to you.
• Do you have high blood pressure, whether or not you
are taking medicines for this?
• Have you been diagnosed with an overactive thyroid?
• Do you have a tumour of the adrenal glands
(phaeochromocytoma) or carcinoid syndrome (caused
by tumours of the hormone system with symptoms of
diarrhoea, flushing of the skin, wheezing)?
• Do you suffer from manic depression, schizoaffective
disorder, mental confusion or other mental problems?
• Are you taking any of the following medicines?
– decongestant, cold or flu remedies containing
pseudoephedrine or phenylpropanolamine
– medicines used to treat asthma such as salbutamol,
terbutaline, fenoterol
– antidepressants known as tricyclics or SSRIs
(selective serotonin reuptake inhibitors) for example
amitriptyline, citalopram, clomipramine, dosulepin,
doxepin, fluoxetine, fluvoxamine, imipramine,
lofepramine, paroxetine, sertraline
– medicines used to treat migraine such as
sumatriptan and zolmitriptan
– medicines used to treat sudden, severe allergic
reactions such as adrenaline (epinephrine)
– medicines which increase your blood pressure,
such as noradrenaline (norepinephrine), dopamine
and dobutamine
– medicines used to treat moderate to severe pain,
such as pethidine
– medicines used to treat anxiety disorders, such as
buspirone
– an antibiotic called rifampicin
Take special care with Zyvox
Tell your doctor before you take this medicine if you:
• bruise and bleed easily
• are anaemic (have low red blood cells)
• are prone to getting infections
• have a history of seizures
• have liver problems or kidney problems particularly if
you are on dialysis
• have diarrhoea
Tell your doctor immediately if during treatment you
suffer from:
• problems with your vision such as blurred vision,
changes in colour vision, difficulty in seeing detail or if
your field of vision becomes restricted.

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There is a risk that Zyvox may sometimes interact with
certain other medicines to cause side effects such as
changes in blood pressure, temperature or heart rate.
Tell your doctor if you are taking or have taken within
the last 2 weeks the following medicines as Zyvox
must not be taken if you are already taking these
medicines or have taken them recently (see also Section
2 above ‘Do not take Zyvox’).
• monoamine oxidase inhibitors (MAOIs; for example
phenelzine, isocarboxazid, selegiline, moclobemide).
These may be used to treat depression or Parkinson’s
disease.
Also tell your doctor if you are taking the following
medicines. Your doctor may still decide to give you
Zyvox, but will need to check your general health and
your blood pressure before and during your treatment.
In other cases, your doctor may decide that another
treatment is better for you.
• Decongestant cold or flu remedies containing
pseudoephedrine or phenylpropanolamine.
• Some medicines used to treat asthma such as
salbutamol, terbutaline, fenoterol.
• Certain antidepressants known as tricyclics or SSRIs
(selective serotonin reuptake inhibitors). There are
many of these, including amitriptyline, citalopram,
clomipramine, dosulepin, doxepin, fluoxetine,
fluvoxamine, imipramine, lofepramine, paroxetine,
sertraline.
• Medicines used to treat migraine such as sumatriptan
and zolmitriptan.
• Medicines used to treat sudden, severe allergic
reactions such as adrenaline (epinephrine).
• Medicines which increase your blood pressure, such
as noradrenaline (norepinephrine), dopamine and
dobutamine.
• Medicines used to treat moderate to severe pain, such
as pethidine.
• Medicines used to treat anxiety disorders, such as
buspirone.
• Medicines that stop blood clotting, such as warfarin.
Please tell your doctor, pharmacist or nurse if you are
taking or have recently taken any other medicines,
including medicines obtained without a prescription.
Zyvox with food, drink and alcohol
• You can take Zyvox either before, during or after a
meal.
• Avoid eating large amounts of mature cheese, yeast
extracts, or soya bean extracts e.g. soy sauce and
drinking alcohol, especially draught beers and wine.
This is because Zyvox may react with a substance
called tyramine which is naturally present in some
foods. This interaction may cause an increase in your
blood pressure.
• If you develop a throbbing headache after eating or
drinking, tell your doctor, pharmacist or nurse
immediately.
Pregnancy, breast-feeding and fertility
The effect of Zyvox in pregnant women is not known.
Therefore, it should not be taken in pregnancy unless
advised by your doctor. If you are pregnant or breastfeeding, think you may be pregnant or are planning to
have a baby, ask your doctor or pharmacist for advice
before taking this medicine.
You should not breast-feed when taking Zyvox because
it passes into breast milk and could affect the baby.
Driving and using machines
Zyvox may make you feel dizzy or experience problems
with your vision. If this happens, do not drive or operate
any machinery. Remember that if you are unwell your
ability to drive or operate machinery may be affected.

3. How to take Zyvox
Adults
Always take this medicine exactly as described in this
leaflet or as your doctor, pharmacist or nurse has told
you. Check with your doctor, pharmacist or nurse if you
are not sure.
The recommended dose is one film-coated tablet
(600 mg linezolid) twice daily (every twelve hours).
Swallow the film-coated tablet whole with some water.
If you are on kidney dialysis, you should take Zyvox after
your dialysis treatment.
A course of treatment usually lasts 10 to 14 days, but
can last up to 28 days. The safety and effectiveness of
this medicine have not been established for treatment
periods longer than 28 days. Your doctor will decide
how long you should be treated.
While you are taking Zyvox, your doctor should perform
regular blood tests to monitor your blood count.
Your doctor should monitor your eyesight if you take
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Use in children and adolescents
Zyvox is not normally used to treat children and
adolescents (under 18 years old).
If you take more Zyvox than you should
Tell your doctor or pharmacist immediately.
If you forget to take Zyvox
Take the forgotten tablet as soon as you remember.
Take the next film-coated tablet 12 hours after this and
continue taking your film-coated tablets every 12 hours.
Do not take a double dose to make up for a forgotten
film-coated tablet.
If you stop taking Zyvox
Unless your doctor instructs you to stop treatment, it is
important to continue taking Zyvox.
If you stop and your original symptoms come back tell
your doctor or pharmacist immediately.
If you have any further questions on the use of this
medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Tell your doctor, nurse or pharmacist immediately if
you notice any of these side effects during your
treatment with Zyvox:
• skin reactions such as red sore skin and flaking
(dermatitis), rash, itching, or swelling, particularly
around the face and neck. This may be the sign of an
allergic reaction and it may be necessary for you to
stop taking Zyvox.
• problems with your vision such as blurred vision,
changes in colour vision, difficulty in seeing detail or if
your field of vision becomes restricted.
• severe diarrhoea containing blood and/or mucus
(antibiotic associated colitis including
pseudomembranous colitis), which in rare
circumstances may develop into complications that
are life-threatening.
• recurrent nausea or vomiting, abdominal pain or rapid
breathing.
• fits or seizures have been reported with Zyvox. You
should let your doctor know if you experience
agitation, confusion, delirium, rigidity, tremor,
incoordination and seizure while also taking
antidepressants known as SSRIs (see section 2).
Numbness, tingling or blurred vision have been
reported by patients who have been given Zyvox for
more than 28 days. If you experience difficulties with
your vision you should consult your doctor as soon
as possible.
Other side effects include:
Common (may affect up to 1 in 10 people):
• Fungal infections especially vaginal or oral “thrush”
• Headache
• Metallic taste in the mouth
• Diarrhoea, nausea or vomiting
• Changes in some blood test results including those
measuring your kidney or liver function or blood sugar
levels
• Unexplained bleeding or bruising, which may be
due to changes in the numbers of certain cells in the
blood which may affect blood clotting or lead to
anaemia
• Difficulty in sleeping
• Increased blood pressure
• Anaemia (low red blood cell)
• Changes in numbers of certain cells in the blood
which may affect your ability to fight infection
• Skin rash
• Itching skin
• Dizziness
• Localised or general abdominal pain
• Constipation
• Indigestion
• Localised pain
• Fever
Uncommon (may affect up to 1 in 100 people):
• Inflammation of the vagina or genital area in women
• Sensations such as tingling or feeling numb
• Blurred vision
• “Ringing” in the ears (tinnitus)
• Inflammation of the veins (IV only)
• Dry or sore mouth, swollen, sore, or discoloured
tongue
• A need to urinate more often
• Chills
• Feeling tired or thirsty
• Inflammation of the pancreas
• Increased sweating
• Changes in proteins, salts or enzymes in the blood
which measure kidney or liver function
• Convulsions
• Hyponatraemia (low blood sodium levels)
• Kidney failure
• Reduction in platelets
• Abdominal bloating
• Transient ischaemic attacks (temporary disturbance
of blood flow to the brain causing short term
symptoms such as loss of vision, leg and arm
weakness, slurring of speech and loss of
consciousness)
• Injection site pain
• Inflammation of the skin
• Increase in creatinine
• Stomach pain
• Changes in heart rate (e.g. increase rate)

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Rare (may affect up to 1 in 1,000 people):
• Restricted field of vision
• Superficial tooth discolouration, removable with
professional dental cleaning (manual descaling)
The following side effects have also been reported
(Not known: frequency cannot be estimated from the
available data):
• Serotonin syndrome (symptoms include fast heart
rate, confusion, abnormal sweating, hallucinations,
involuntary movements chills and shivering)
• Lactic acidosis (symptoms include recurrent nausea
and vomiting, abdominal pain, rapid breathing)
• Severe skin disorders
• Sideroblastic anaemia (a type of anaemia (low red
blood cells))
• Alopecia (hair loss)
• Changes in colour vision or difficulty in seeing detail
• Decrease of the blood cell count
• Weakness and/or sensory changes
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
(see details below). By reporting side effects you can help
provide more information on the safety of this medicine.
United Kingdom
Yellow Card Scheme website:
www.mhra.gov.uk/yellowcard
Malta
ADR Reporting
Website: www.medicinesauthority.gov.mt/adrportal

5. How to store Zyvox
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 pack or the blister after ‘EXP’. The expiry
date refers to the last day of that month. This medicinal
product 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 Zyvox contains
– The active substance in this medicine is called linezolid.
Each film-coated tablet contains 600 mg linezolid
– The other ingredients are maize starch (corn derived),
microcrystalline cellulose (E460), hydroxypropylcellulose
(E463), sodium starch glycollate type A and
magnesium stearate (E572). The film coating contains
opadry, white, YS-1-18202-A(e) comprising:
hypromellose (E464), titanium dioxide (E171),
macrogol 400 and carnauba wax (E903).
What Zyvox looks like and contents of the pack
Zyvox 600 mg film-coated tablets are white, oval-shaped
and debossed with “ZYV” on one side and “600” on the
other. Zyvox film-coated tablets are available in blister
strips of 10 tablets packaged in a box.
Each box contains either 10, 20, 30, 50, 60 or 100 filmcoated tablets. Also in white, HDPE bottle with a
polypropylene screw cap containing either 10, 14, 20, 24,
30, 50, 60 or 100 (for hospital use only) film-coated tablets.
Not all pack sizes may be marketed.
The Marketing Authorisation Holder
The Marketing Authorisation Holder is Pharmacia
Limited, Sandwich, Kent, CT13 9NJ, UK
Manufacturer
Pfizer Manufacturing Deutschland GmbH, Betriebsstätte
Freiburg, Mooswaldallee 1, D-79090 Freiburg, Germany.
This medicinal product is authorised in the Member
States of the EEA under the following names:
Austria
Belgium
Cyprus
Czech Republic
Denmark
Estonia
Finland
France
Germany
Greece
Iceland
Ireland
Italy
Latvia
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Slovakia
Slovenia
Spain
Sweden
United Kingdom

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This leaflet was last revised in 07/2016
Ref: ZY 14_0

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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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