Skip to Content

LINEZOLID 600MG FILM COATED TABLETS

Active substance(s): LINEZOLID

View full screen / Print PDF » Download PDF ⇩
Transcript
10 mm

50 mm

10 mm

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

1. What this medicine is and what it is used for
The name of this medicine is Linezolid 600mg film-coated tablets,
which contains Linezolid as an active ingredient. 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 this medicine
Do not take this medicine:
• if you are allergic to linezolid or to 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 this medicine passes into
breast milk and could affect the baby.

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 linezolid. If this becomes severe or persistent or you notice
that your stools contains blood or mucus, you should stop taking this
medicine 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.
Children and adolescents
This medicine is not normally used to treat children and adolescents
(under 18 years old).
Other medicines and Linezolid
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines, including medicines obtained without a
prescription.
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.

SAME SIZE ARTWORK
Front

Linezolid 600mg tablets 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 this medicine may react with a
substance called tyramine which is naturally present in some foods to
cause an increase in your 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 this medicine because it
passes into breast milk and could affect the baby.
Driving and using machines
This medicine 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.
This medicine contains lactose
If you have been told by your doctor that you have an intolerance to
some sugars, contact your doctor before taking this medicine.

3. How to take this medicine

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 this medicine’).
• monoamine oxidase inhibitors (MAOIs; for example phenelzine,
isocarboxazid, selegiline, moclobemide). These may be used to
treat depression or Parkinson’s disease.

Always take this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.

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.

Severe renal impairment
If you are on kidney dialysis, you should take this medicine after
dialysis treatment.

10 mm

Warnings and precautions
This medicine 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

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

• 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.
280 mm

LINEZOLID 600MG
FILM-COATED TABLETS

- 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

270 mm

The recommended dose is
Adults
The usual dose is one tablet (600mg linezolid) twice daily (every
twelve hours).

IXXXXXX

Package leaflet: Information for the patient

10 mm

50 mm

10 mm

Duration of 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.
Follow-up during treatment with this medicine
While you are taking this medicine, your doctor should perform regular
blood tests to monitor your blood count.
Your doctor should monitor your eyesight if you take this medicine for
more than 28 days.
If you take more of this medicine than you should
If you have taken too much of this medicine, or if someone else
accidentally takes your tablets, contact a doctor or hospital for advice
immediately.
If you forget to take this medicine
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 a double dose to make up for the forgotten dose.
If you stop taking this medicine
Do not stop taking this medicine unless your doctor tells you to. 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 or pharmacist.

4. Possible side effects

Rare side effects (may affect up to 1 in 1,000 people)
• Restricted field of vision
• Superficial tooth discolouration, removable with professional dental
cleaning (manual descaling)
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)

10 mm

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 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.
• serious illness with blistering of the skin, mouth, eyes and genitals.
These may be symptoms of Stevens-Johnson Syndrome.
• 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 lifethreatening.
• 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

Uncommon side effects (may affect up to 1 in 10 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)

SAME SIZE ARTWORK
270 x 280 mm
Back

270 mm

• Lactic acidosis (symptoms include recurrent nausea and vomiting,
abdominal pain, rapid breathing)
• 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 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 this medicine
• Keep this medicine out of the sight and reach of children.
• This medicinal product does not require any special storage
conditions. For HDPE bottles: Use within 30 days of first opening.
• Do not use this medicine after the expiry date which is stated on the
label after EXP. 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 protect the environment.

6. Contents of the pack and other information
What this medicine contains
• The active substance is linezolid. Each film-coated tablet contains
600 mg of linezolid.
• The other ingredients are lactose monohydrate, hydroxypropyl
cellulose, maize starch, sodium starch glycolate, magnesium
stearate. The tablet coat contains titanium dioxide (E171),
hypromellose, macrogol 400, carnauba wax.
What this medicine looks like and contents of the pack
• These tablets are white to off white, oval shaped, bevel edged,
biconvex film coated tablets debossed with ‘H’ on one side and ‘L8’
on the other side.
• This medicine is available in blister packs of 10, 20, 30, 50, 60
tablets and HDPE bottles of 10, 14, 20, 24, 30, 50, 60 or 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Name and address: Bristol Laboratories Ltd,
Unit 3, Canalside, Northbridge Road,
Berkhamsted, Hertfordshire,
HP4 1EG, United Kingdom
Telephone:
0044 (0)1442 200922
Fax:
0044 (0)1442 873717
Email:
info@bristol-labs.co.uk
Linezolid 600mg Film-Coated Tablets; PL 17907/0525
This leaflet was last revised in December 2015
To request a copy of this leaflet in Braille, large print or audio format,
contact the licence holder at the address (or telephone, fax, email)
above.

V5 08-12-15 D0

280 mm

Route and method of administration
For oral use.
Swallow the tablet whole with some water.

experience difficulties with your vision you should consult your doctor
as soon as possible.
Other side effects include:
Common side effects (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

IXXXXX

Use in children
This medicine is not normally used to treat children and adolescents
(under 18 years old).

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