ZYVOX 600MG FILM COATED TABLETS
Active substance(s): LINEZOLID
ZYVOX® 600 mg
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
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
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
• 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 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
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?
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
• problems with your vision such as blurred vision,
changes in colour vision, difficulty in seeing detail or if
your field of vision becomes restricted.
• 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
• recurrent nausea or vomiting, abdominal pain or rapid
Other medicines and Zyvox
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 or pharmacist if you are taking or have
recently taken any other medicines.
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’).
Mock up 3941.indd 1
• 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,
• 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
• Medicines used to treat moderate to severe pain,
such as pethidine.
• Medicines used to treat anxiety disorders, such as
• Medicines that stop blood clotting, such as warfarin.
• An antibiotic called rifampicin.
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
• If you develop a throbbing headache after eating or
drinking, tell your doctor, pharmacist or nurse
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
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
Zyvox for more than 28 days.
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
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
Mock up 3941
treatment with Zyvox:
The serious side effects (with frequency in brackets) of
• Severe skin disorder (not known), swelling
particularly around the face and neck (not known),
wheezing and/or difficulty breathing (not known).
This may be the sign of an allergic reaction and it
may be necessary for you to stop taking Zyvox.
Skin reactions such as red sore skin and flaking
(dermatitis) (uncommon), rash (common), itching
• Problems with your vision such as blurred vision
(uncommon), changes in colour vision (not known),
difficulty in seeing detail (not known) or if your field
of vision becomes restricted (rare).
• 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 (rare).
• Recurrent nausea or vomiting, abdominal pain or
rapid breathing (not known).
• Fits or seizures (uncommon) 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)
• 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
• Changes in numbers of certain cells in the blood
which may affect your ability to fight infection
(common) some signs of infection include: any fever
(common), sore throat (uncommon), mouth ulcers
(uncommon) and tiredness (uncommon).
• Inflammation of the pancreas (uncommon).
• Convulsions (uncommon).
• 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
• “Ringing” in the ears (tinnitus) (uncommon).
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”
• 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
• Difficulty in sleeping
• Increased blood pressure
• Anaemia (low red blood cell)
• Localised or general abdominal pain
• Localised pain
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
• Inflammation of the veins (IV only)
• Swollen, sore, or discoloured tongue
• A need to urinate more often
• Feeling thirsty
• Increased sweating
• Changes in proteins, salts or enzymes in the blood
which measure kidney or liver function
• Hyponatraemia (low blood sodium levels)
• Kidney failure
• Reduction in platelets
• Abdominal bloating
• Injection site pain
• Increase in creatinine
• Stomach pain
• Changes in heart rate (e.g. increase rate)
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
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 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, ovalshaped 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
Not all pack sizes may be marketed.
The Marketing Authorisation Holder
Pharmacia Limited, Sandwich, Kent, CT13 9NJ, UK
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:
This leaflet was last revised in 08/2017
Ref: ZY 15_1
Rare (may affect up to 1 in 1,000 people):
• 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
• Alopecia (hair loss)
• 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 or
pharmacist. 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
Yellow Card Scheme website:
Mock up 3941.indd 2
Mock up 3941
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.