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LINEZOLID 100MG/ 5ML GRANULES FOR ORAL SUSPENSION

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PACKAGE LEAFLET: INFORMATION FOR THE USER
LINEZOLID 100mg/5ml granules for oral suspension
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 stool 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.
Medicines used to treat anxiety disorders, such as buspirone.
Medicines that stop blood clotting, such as warfarin.

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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 and breast-feeding
The effect of Linezolid in pregnant women is not known. Therefore it should not be taken in pregnancy
unless advised by your doctor. Tell your doctor if you are pregnant, think you may be pregnant or are trying
to become pregnant.
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.
Important information about some of the ingredients in Linezolid
Aspartame
Aspartame, a sweetening agent, is partly converted into phenylalanine in the body. This may be harmful for
people with phenylketonuria.
Sucrose, sorbitol and fructose
Sucrose and fructose are sugars. 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 Linezolid
Always take Linezolid as your doctor has told you. If you are unsure ask your doctor or pharmacist.
Linezolid comes as granules which will be made up by the pharmacist to make a suspension for you to take.
Adults
The usual dose of Linezolid 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.
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If you are on kidney dialysis, you should take Linezolid 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 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).
If you take more Linezolid than you should
Tell your doctor or pharmacist immediately.
If you forget to take Linezolid
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 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.
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:
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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
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. increase 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, over breathing)
 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 sight and reach of children.
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Keep the bottle in the outer carton in order to protect from light.
Do not use the suspension 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.
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 granules for oral suspension contain



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.
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.

What Linezolid looks like and contents of the pack
Linezolid 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
The Marketing Authorisation Holder is Pharmacia Limited, Sandwich, Kent, CT13 9NJ, UK and the
manufacturer is Pfizer Manufacturing Belgium NV, Rijksweg 12, B-2870 Puurs, Belgium.
Company contact address: Medical Information Department, Pfizer Limited, Walton Oaks, Dorking Road,
Tadworth, Surrey KT20 7NS. Telephone: 01304 616 161.
This leaflet was last revised in 07/2013.
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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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