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LINEZOLID 600 MG FILM-COATED TABLETS

Active substance(s): LINEZOLID

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Version 7
18-11-2015 10:15
Holger Clas +49 6172 686 6161

Linezolid 600mg
film-coated tablets
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
1. What Linezolid is and what it is used for
2. What you need to know before you take Linezolid
3. How to take Linezolid
4. Possible side effects
5. How to store Linezolid
6. Contents of the pack and other information
1. What Linezolid is and what it is used for
Linezolid 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
Linezolid is suitable to treat your infection.

2. What you need to know before you take
Linezolid
Do not take Linezolid
• 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
Linezolid passes into breast milk and could
affect the baby.
Warnings and precautions
Linezolid 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 Linezolid
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 prickling in your arms or
legs.
• You may develop diarrhoea while taking or
after taking antibiotics, including Linezolid. If
this becomes severe or persistent or you notice
that your stools contains blood or mucus, you
should stop taking Linezolid 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 Linezolid
There is a risk that Linezolid 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 Linezolid must not be taken if you are already
taking these medicines or have taken them
recently. (See also Section 2 above ‘Do not take
Linezolid’.
• 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 Linezolid, 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

Linezolid

Linezolid 600mg
film-coated tablets

xxxx

Package leaflet: Information for the user

Package leaflet:
Information for the user

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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.
Linezolid with food and drink
• You can take Linezolid 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 Linezolid may
react with a substance called tyramine which is
naturally present in some foods. This interaction
may cause an increase in blood pressure.
• If you develop a throbbing headache after eating
or drinking, tell your doctor or pharmacist
immediately.
Pregnancy, breast-feeding and fertility
The effect of Linezolid 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 Linezolid
because it passes into breast milk and could affect
the baby.
Driving and using machines
Linezolid 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.
Linezolid contains lactose. If you have been told
by your doctor that you have an intolerance to
some sugars, contact your doctor before taking this
medicinal product.
3. How to take Linezolid
Adults
Always take this medicine exactly as your doctor
has told you. Check with your doctor or pharmacist
if you are not sure. The usual dose is one tablet
(600mg linezolid) twice daily (every twelve hours).
Swallow the tablet whole with some water.
If you are on kidney dialysis, you should take
Linezolid after 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 Linezolid, your doctor should
perform regular blood tests to monitor your blood
count.
Your doctor should monitor your eyesight if you
take Linezolid for more than 28 days.
Use in children
Linezolid is not normally used to treat children and
adolescents (under 18 years old).
If you take more Linezolid than you should
Tell your doctor or pharmacist immediately.
If you forget to take Linezolid
Take the forgotten tablet as soon as you remember.
Take the next tablet 12 hours after this and
continue taking your tablets every 12 hours. Do
not take twice as many tablets to make up for a
missing a dose.
If you stop taking Linezolid
Unless your doctor instructs you to stop treatment,
it is important to continue taking Linezolid.
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
product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause sideeffects, although not everybody gets them.
Tell your doctor, nurse or pharmacist
immediately if you notice any of these side effects
during your treatment with Linezolid:
• 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 Linezolid.
• 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
Linezolid. 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).
Numbness, tingling or blurred vision have been
reported by patients who have been given
Linezolid 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
• Local or generalised 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
• Change in proteins, salts or enzymes in the
blood which measure kidney or liver function
• Convulsions
• Hyponatraemia (low 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 or
pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at: 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 Linezolid
Keep this medicine out of the sight and reach of
children.
Store below 30ºC.
Do not use this medicine after the expiry date
which is stated on the pack. The expiry date refers
to the last day of that month.
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 Linezolid contains
- The active substance in this medicine is called
linezolid. Each tablet contains 600 mg linezolid
- The other ingredients are lactose monohydrate,
hypromellose (E464), polacrilin potassium,
magnesium stearate (E572) and silica
colloidal anhydrous. The film coating contains
hypromellose (E464), titanium dioxide (E171),
macrogol and carnauba wax (E903).
What Linezolid Film-coated tablets looks like
and contents of the pack
Linezolid 600 mg Film-Coated Tablets are white to
off white, oval shaped tablets debossed with “I” on
one side and “22” on the other side.
Linezolid tablets are available in pack sizes of 1,
10, 20, 30, 50, 60, 100 film-coated tablets. Not
all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Hetero Europe S.L.
Viladecans Business Park – Edificio Brasil
Catalunya 83-85
08840 Viladecans (Barcelona)
Spain
Pharmadox HeaIthcare Ltd.
KW20A Kordin Industrial Park, Paola, PLA 3000
Malta
This medicinal product is authorised in the Member
States of the EEA under the following names:
The Netherlands
Germany
Spain

Linezolid Hetero 600 mg,
filmomhulde tabletten
Linezolid Hetero 600 mg
Filmtabletten
Linezolid Accordpharma
600 mg comprimidos
recubiertos con película EFG

This leaflet was last approved in 11/2015

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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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