LINEZOLID 600 MG FILM-COATED TABLETS

Active substance: LINEZOLID

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Linezolid 600mg film-coated tablets
Linezolid
Read all of this leaflet carefully before you start taking this medicine
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 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.
In this leaflet:
1.
What Linezolid is and what it is used for
2.
Before you take Linezolid
3.
How to take Linezolid
4.
Possible side effects
5.
How to store Linezolid
6.
Further 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.

BEFORE YOU TAKE LINEZOLID

Do not take Linezolid if you are:
 allergic (hypersensitive) to linezolid or any of the other ingredients of this medicine
 taking or have taken within the last 2 weeks any medicines known as monoamine oxidase
inhibitors (MAOIs for example phenelzine, isocarboxazid, selegiline, moclobemide). These may
be used to treat depression or Parkinson’s disease.
 you are breast-feeding. This is because it passes into breast milk and could affect the baby.
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
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-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
 are prone to getting infections
 have a history of seizures
 have liver problems or kidney problems particularly if you have 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.
 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 over breathing
Taking other medicines
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
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.
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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.
Taking 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 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 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.
3.

HOW TO TAKE LINEZOLID

Adults
Always take Linezolid tablets as your doctor has told you. If you are unsure ask your doctor or
pharmacist. 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.
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.
Children
Linezolid is not normally used to treat children and adolescents (under 18 years old).
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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
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 Linezolid 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.
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 very rare circumstances may develop into
complications that are life-threatening.
recurrent nausea or vomiting, abdominal pain or over 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
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 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
Uncommon side-effects (likely to occur in less than 1 in 100 people):
 Inflammation of the vagina or genital area in women
 Changes in numbers of certain cells in the blood which may affect your ability to fight infection
 Difficulty in sleeping
 Dizziness, sensations such as tingling or feeling numb
 Blurred vision
 “Ringing” in the ears (tinnitus)
 Increased blood pressure, inflammation of the veins
 Indigestion, stomach pain, constipation
 Dry or sore mouth , swollen, sore, or discoloured tongue
 Skin rash
 A need to urinate more often
 Fever or chills, aches and pains
 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.
 Reduction in the numbers of cells in the blood which fight against infection.
Rare side-effects (likely to occur in less than 1 in 1000 people):
 Changes in heart rate (e.g. increased rate)
 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),
 Kidney failure
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, overbreathing)
 Severe skin disorders
 Convulsions
 Superficial tooth discolouration, removable with professional dental cleaning (manual descaling)
 Alopecia (hair loss)
 Hyponatraemia (low blood sodium levels)
 Changes in colour vision, difficulty in seeing detail or if your field of vision becomes restricted
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.
5.

HOW TO STORE LINEZOLID

Keep out of the reach and sight of children.
There are no special storage conditions.
Do not use your tablets after the expiry date which is stated on the pack. The expiry date refers to the last
day of that month.

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Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help us to protect the environment.
6.

FURTHER INFORMATION

What Linezolid film-coated tablet contains
-The active substance in this medicine is called linezolid. Each tablet contains 600 mg linezolid
-The other ingredients are microcrystalline cellulose (E460), maize starch, sodium starch glycollate
(type A), hydroxpropylcellulose (E463) and magnesium stearate (E572). The film coating contains
macrogol 400, hypromellose (E464), titanium dioxide (E171) and carnauba wax (E903). The printing ink
contains red iron oxide (E172).
What Linezolid film- coated tablets looks like and contents of the pack
Linezolid 600 mg film-coated tablets are white, oval-shaped and marked “LINEZOLID 600 mg” in
red ink. Linezolid tablets are available as blister strips of 10 tablets packed in a box.
Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation Holder
Pfizer Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom
Manufacturer
Pfizer Manufacturing Belgium NV, Rijksweg 12, B-2870 Puurs, Belgium
Pfizer Service Company BVBA, Hoge Wei 10, 1930 Zaventum, Belgium
This medicinal product is authorised in the Member States of the EEA under the following names:
Belgium

Linezolid Pfizer

Luxembourg

Linezolid Pfizer

Finland

Linezolid Pfizer

United Kingdom Linezolid
This leaflet was last revised in (09/2013)

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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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