Skip to Content

ZYVOX 100 MG/ 5 ML GRANULES FOR ORAL SUSPENSION

Active substance(s): LINEZOLID

View full screen / Print PDF » Download PDF ⇩
Transcript
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 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 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.

What is in this leaflet:

Linezolid

1. What Zyvox is and what it
is used for
FPO 128 - 10 MIL

FPO 128 - 10 MIL
Linezolid

ZYVOX 100 mg/5 ml
granules for oral
suspension

ZYVOX 100 mg/5 ml
granules for oral
suspension

GLUE PANEL

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

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:

GLUE PANEL

• if you are allergic (hypersensitive)
to linezolid or any of the other
ingredients of this medicine.
• 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

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?
• 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,
cipramil, 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.
• 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

Time/Date:

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

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, cipramil,
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 or pharmacist
if you are taking or have recently
taken any other medicines, including
medicines obtained without a
prescription.

Zyvox with food and drink

• 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



Project No.



13015

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,
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.

Important information about
some of the ingredients in Zyvox
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

Sucrose and fructose are sugars.
Sorbitol and mannitol are sugar
alcohols. 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 (8.5mg per 5ml). 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
your doctor has told you. Check with
your doctor or pharmacist if you are
not sure.
Zyvox comes as granules which will be
made up by the pharmacist to make a
suspension for you to take.
The usual dose of Zyvox suspension
is six 5ml spoonfuls (600mg linezolid)
twice daily (every 12 hours).
Before using, gently turn the bottle
upside down a few times. DO NOT
SHAKE.

rev. 08JUN11

Artwork Number

Description

14367500

Zyvox Granules for Oral Suspension

Dimensions

Use in children

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 twice as much medicine to
make up for missing a 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.

4. Possible side effects

Like all medicines, Zyvox 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 SSRI’s (see section 2).

C. Connelly
D. Huff

Rev

1

GA

UK/Ireland

SKU No.

PD2352 Rev 2

Item

F482068008/F482068058 Insert

Colors:

EDITOR’S COPY
Black

Mgr M. Wolpert

Country

Drawing No.

20” x 10” (2.5” x 1.0625” folded)

Additional Info:

GA

Pregnancy, breast-feeding and
fertility

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.

14367500.indd 1 6/24/15 12:52 PM



GS

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 or pharmacist immediately.

GS: DATE:

Dieline
PR

GS / ART REV (LCA)

GS / ART REV (FA)

CHANGES

CHANGES

CHANGES

OK

OK

OK

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 side effects
(likely to occur in less than 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 side effects
(likely to occur in less than 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
• 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)

Rare side effects
(likely to occur in less than 1 in
1000 people):

• Restricted field of vision
• Superficial tooth discolouration,
removable with professional dental
cleaning (manual descaling)

The following side effects have
also been reported
(frequency not known):

• 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
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.

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
label. The expiry date refers to the last
day of the month.
Any remaining 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 us to protect the
environment.

6. Contents of the pack and
other information
What Zyvox granules for oral
suspension contains

• The active substance is linezolid.
Each bottle contains 66 g of granules
providing 150 ml of suspension when
reconstituted with 123 ml water by
the pharmacist or health care
professional. Each 5ml of suspension
contains 100mg 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,
monoammonium glycyrrhizinate,
sorbitol). Flavourings are orange,
orange cream, peppermint and
vanilla.

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
Denmark Zyvoxid
Estonia Zyvoxid
Finland Zyvoxid
France Zyvoxid
Germany Zyvoxid
Greece Zyvoxid
Iceland Zyvoxid
Ireland Zyvox
Italy Zyvoxid

Latvia Zyvoxid
Lithuania Zyvoxid
Luxembourg Zyvoxid
Malta Zyvox
Netherlands Zyvoxid
Norway Zyvoxid
Poland Zyvoxid
Portugal Zyvoxid
Slovakia Zyvoxid
Slovenia Zyvoxid
Spain Zyvoxid
Sweden Zyvoxid
United Kingdom Zyvox

This leaflet was last revised in
IE: MM/YYYY
UK: 06/2015.
Ref: ZY 13_0
14367500

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 providing an orange-flavoured
liquid (suspension) when made up
with water. Each bottle is packaged in
a carton with a 2.5ml/5ml measuring
spoon.

Marketing Authorisation Holder
and Manufacturer
United Kingdom
The Marketing Authorisation Holder is
Pharmacia Limited, Sandwich, Kent,
CT13 9NJ, UK and the manufacturer is
Pfizer Service Company BVBA, Hoge
Wei 10, 1930 Zaventem, Belgium.

Company contact address:

Medical Information Department, Pfizer
Limited, Walton Oaks, Dorking Road,
Tadworth, Surrey KT20 7NS.
Telephone: 01304 616 161.
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
and the manufacturer is Pfizer Service
Company BVBA, Hoge Wei 10, 1930
Zaventem, Belgium.

14367500.indd 2 6/24/15 12:52 PM

NO COPY AREA

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