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ZYVOX 100 MG/ 5 ML GRANULES FOR ORAL SUSPENSION

Active substance(s): LINEZOLID / LINEZOLID / LINEZOLID

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Package leaflet: Information for the user

ZYVOX® 100 mg/5 ml

granules for oral suspension

Linezolid
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?

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.
• 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.

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.
• An antibiotic called rifampicin.

Zyvox with food, drink and alcohol



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’).
• monoamine oxidase inhibitors (MAOIs:
for example phenelzine, isocarboxazid,
selegiline, moclobemide). These may be



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 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.
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.

Zyvox contains
Aspartame
Aspartame, a sweetening agent, is partly
converted into phenylalanine in the body. This
may be harmful for people with phenylketonuria.
Sucrose, sorbitol, mannitol and fructose
This medicine contains sucrose, mannitol,
sorbitol and fructose. If you have been told
that you have an intolerance to some sugars
contact your doctor before taking this medicine.
Sucrose and fructose may also be harmful to
the teeth.
Sodium
When made up into a suspension this medicine
contains 51 mg of sodium per dose (8.5 mg per
5 ml). This should be taken into consideration if
you are on a controlled sodium diet.
Ethanol
This medicinal product contains small amounts
of ethanol (alcohol), less than 100 mg per 5 ml
dose.

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.
Zyvox comes as granules which will be made
up exclusively by a healthcare professional to
make a suspension for you to take.
The recommended dose of Zyvox suspension is
six 5 ml spoonfuls (600 mg linezolid) twice daily
(every 12 hours).
Before using, gently turn the bottle upside down
a few times. DO NOT SHAKE.
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 dose of medicine as soon
as you remember. Take the next dose 12 hours

after this and continue taking the medicine
every 12 hours. Do not take a double dose to
make up for a forgotten dose.

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:
The serious side effects (with frequency in
brackets) of Zyvox are:
• 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
(common).
• 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) (not known).
• 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 (common).
• 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 consciousness)
(uncommon).
• “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”
• 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
• Difficulty in sleeping
• Increased blood pressure
• Anaemia (low red blood cell)
• Dizziness
• Localised or general abdominal pain
• Constipation
• Indigestion
• 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
• Chills
• 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)
Rare (may affect up to 1 in 1000 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 available data):
• 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,
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
Ireland
HPRA Pharmacovigilance,
Earlsfort Terrace, IRL–Dublin 2;
Tel: +353 1 6764971;
Fax: +353 1 6762517.
Website: www.hpra.ie;
E-mail: medsafety@hpra.ie

5. How to store Zyvox
Keep this medicine out of the sight and reach of
children.
Keep the bottle in the outer carton in order to
protect from light.
Do not use this medicine after the expiry date
which is stated on the carton after ‘EXP’. The
expiry date refers to the last day of that month.
Any remaining, unused suspension should be
discarded within 21 days of reconstitution.
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 is linezolid. After
reconstitution each 5 ml of suspension
contains 100 mg linezolid.
The other ingredients are sucrose,
mannitol, microcrystalline cellulose (E460),
carboxymethylcellulose sodium (E466),
aspartame, anhydrous colloidal silica
(E551), sodium citrate, xanthan gum,
sodium benzoate, citric acid anhydrous,
sodium chloride, sweeteners (fructose,
maltodextrin (corn derived), monoammonium
glycyrrhizinate, sorbitol). Flavourings are
orange flavour, peppermint flavour, vanilla
flavour and orange cream flavour.

What Zyvox looks like and contents of
the pack

Zyvox granules for oral suspension are supplied
in a brown bottle containing white to light
yellow orange flavoured granules which may
contain lumps providing a white to yellow
orange‑flavoured liquid (suspension) when
made up with water. Each bottle is packaged in
a carton with a 2.5 ml/5 ml measuring spoon.

The Marketing Authorisation Holder
United Kingdom
The Marketing Authorisation Holder is Pharmacia
Limited, Sandwich, Kent, CT13 9NJ, UK
Ireland
The Marketing Authorisation Holder is Pfizer
Healthcare Ireland, 9 Riverwalk, National Digital
Park, City West Business Campus, Dublin 24,
Ireland: Telephone: 1800 633 363

Manufacturer
Pfizer Service Company BVBA, Hoge Wei 10,
1930 Zaventem, Belgium.
This medicinal product is authorised in the
Member States of the EEA under the following
names:
Austria
Zyvoxid
Belgium
Zyvoxid
Cyprus
Zyvoxid
Czech Republic
Zyvoxid
Zyvoxid
Denmark
Estonia
Zyvoxid
Finland
Zyvoxid
France
Zyvoxid
Germany
Zyvoxid
Zyvoxid
Greece
Iceland
Zyvoxid
Ireland
Zyvox
Italy
Zyvoxid
Latvia
Zyvoxid
Zyvoxid
Lithuania
Luxembourg
Zyvoxid
Malta
Zyvox
Netherlands
Zyvoxid
Norway
Zyvoxid
Zyvoxid
Poland
Portugal
Zyvoxid
Slovakia
Zyvoxid
Slovenia
Zyvoxid
Spain
Zyvoxid
Zyvoxid
Sweden
United Kingdom
Zyvox
This leaflet was last revised in
IE: MM/YYYY
UK: 09/2016
Ref: ZY 14_1

14401000

The following information is intended for
healthcare professionals only:
Instructions for preparation of the oral
suspension:
Linezolid comes as granules which will be made
up exclusively by a healthcare professional.
Loosen the granules and reconstitute using
123 ml water in two approximately equal
aliquots to produce 150 ml oral suspension.
The suspension should be vigorously
shaken between each addition of water. The
appearance after reconstitution is a white to
yellow-orange suspension.
Before using, gently turn the the bottle upside
down a few times. DO NOT SHAKE.
The usual dose of Zyvox suspension is six 5 ml
spoonfuls (600 mg linezolid) twice daily (every
12 hours).
Any unused medicinal product or waste material
should be disposed of in accordance with local
requirements.
See also Section 3 above ‘How to take Zyvox’.

Expand Transcript

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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