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Linezolid 600 mg Film-coated Tablets

Discontinued
Active Ingredient:
linezolid
Company:  
Glenmark Pharmaceuticals Europe Ltd See contact details
ATC code: 
J01XX08
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About Medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine.
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Last updated on emc: 03 Jun 2021

Below is a text only representation of the Patient Information Leaflet (ePIL).

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on {phone} 0800 198 5000. The product code(s) for this leaflet is: PL 25258/0155 .

Linezolid 600 mg Film-coated Tablets

Package leaflet: Information for the user

Linezolid 600 mg 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 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 Linezolid 600 mg Film-coated Tablets are and what they are used for
2. What you need to know before you take Linezolid 600 mg Film-coated Tablets
3. How to take Linezolid 600 mg Film-coated Tablets
4. Possible side effects
5. How to store Linezolid 600 mg Film-coated Tablets
6. Contents of the pack and other information

1. What Linezolid 600 mg Film-coated Tablets are and what they are 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 600 mg Film-coated Tablets is suitable to treat your infection.

2. What you need to know before you take Linezolid 600 mg Film-coated Tablets
Do not take Linezolid 600 mg Film-coated Tablets:
  • if you are allergic to linezolid or 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 it passes into breast milk and could affect the baby.

Warnings and precautions

Talk to your doctor or pharmacist before taking Linezolid.

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, whether or not you are taking medicines for this?
  • 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?

Take special care with Linezolid

Talk to your doctor or pharmacist before taking Linezolid 600 mg Film-coated Tablets 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 have dialysis
  • have diarrhoea.

Tell your doctor immediately if you suffer from any of the following during treatment (see also section 4):

  • 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 Linezolid tablets 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 600 mg Film-coated Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

There is a risk that Linezolid tablets 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 600 mg Film-coated Tablets must not be taken if you are already taking these medicines or have taken them recently (see Section 2 above ‘Do not take Linezolid 600mg film-coated tablets):

  • 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 600 mg Film-coated Tablets, 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, citalopram, 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.
  • An antibiotic called rifampicin

Linezolid 600 mg Film-coated Tablets with food, drink and alcohol

You can take Linezolid tablets 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 your blood pressure.

If you develop a throbbing headache after eating or drinking, tell your doctor or pharmacist or nurse immediately.

Pregnancy, breast-feeding and fertility

The effect of Linezolid 600 mg Film-coated Tablets in pregnant women is not known. Therefore it should not be taken in pregnancy unless advised by your doctor. If you are pregnant or breast feeding, 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 tablets because it passes into breast milk and could affect the baby.

Driving and using machines

Linezolid tablets 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 600 mg Film-coated Tablets contains lactose

This product contains lactose monohydrate. If you have been told that you have an intolerance to some sugars contact your doctor or pharmacist before taking this medicine.

3. How to take Linezolid 600 mg Film-coated Tablets
Adults

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

The recommended dose is one film-coated tablet (600 mg linezolid) twice daily (every twelve hours). Swallow the film-coated tablet whole with some water.

If you are on kidney dialysis, you should take Linezolid tablets 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 tablets, your doctor should perform regular blood tests to monitor your blood count. Your doctor should monitor your eyesight if you take Linezolid tablets for more than 28 days.

Children and adolescents

Linezolid tablets are not normally used to treat for children and adolescents (under 18 years old).

If you take more Linezolid 600 mg Film-coated Tablets than you should

Tell your doctor or pharmacist immediately.

If you forget to take Linezolid 600 mg Film-coated Tablets

Take the forgotten tablet as soon as you remember. Take the next fim-coated tablet 12 hours after this and continue taking your film-coated tablets every 12 hours. Do not take a double dose to make up for a forgotten dose.

If you stop taking Linezolid 600 mg Film-coated Tablets

Unless your doctor instructs you to stop treatment, it is important to continue taking Linezolid tablets. 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 or nurse.

4. Possible side effects

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 600 mg Film-coated Tablets:

The serious side effects (with frequency in brackets) of Linezolid tablets are:

  • Severe skin disorder (not known), swelling, particularly around the face and neck (not known), wheezing and/or difficulty breathing (not known). This may be the sign of an allergic reaction and it may be necessary for you to stop taking these tablets. Skin reactions such as red sore skin and flaking (dermatitis) (uncommon), rash (common), itching (common).
  • problems with your vision such as blurred vision (uncommon), changes in colour vision (not known), difficulty in seeing detail (not known) or if your field of vision becomes restricted (rare).
  • 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 (rare).
  • recurrent nausea or vomiting, abdominal pain or rapid breathing (not known).
  • fits or seizures (uncommon) have been reported with Linezolid 600 mg Film-coated Tablets. 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) (not known).
  • 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 (common).
  • Changes in numbers of certain cells in the blood which may affect your ability to fight infection (common) some signs of infection include: any fever (common), sore throat (uncommon), mouth ulcers (uncommon) and tiredness (uncommon).
  • Inflammation of the pancreas (uncommon).
  • Convulsions (uncommon).
  • 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) (uncommon).
  • "Ringing" in the ears (tinnitus) (uncommon).
  • numbness, tingling or blurred vision have been reported by patients who have been given Linezolid tablets 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 (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
  • Difficulty in sleeping
  • Increased blood pressure
  • Anaemia (low red blood cell)
  • Dizziness
  • Localised or general abdominal pain
  • Constipation
  • Indigestion
  • Localised pain

Uncommon (may affect up to 1 in 100 people)

  • Inflammation of the vagina or genital area in women
  • Sensations such as tingling or feeling numb
  • Inflammation of the veins (IV only)
  • sore, swollen or discoloured tongue
  • A need to urinate more often
  • Chills
  • Feeling thirsty
  • Increased sweating
  • Changes in proteins, salts or enzymes in the blood which measure kidney or liver function.
  • Hyponatraemia (low blood sodium levels)
  • Kidney failure
  • Reduction in platelets
  • Abdominal bloating
  • Injection site pain
  • Increase in creatinine
  • Stomach pain
  • Changes in heart rate (e.g. increase rate)

Rare (may affect up to1 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 not known (frequency cannot be estimated from the available data):

  • Alopecia (hair loss)
  • 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 Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in Google play or Apple App store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Linezolid 600 mg Film-coated Tablets

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Do not use this medicine if you notice the tablets are discolured.

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 Linezolid 600 mg Film-coated Tablets contains
  • The active substance is linezolid
  • The other ingredients are Lactose monohydrate, Povidone, Croscarmellose sodium,
    Magnesium stearate, Hypromellose, Titanium dioxide and Macrogol.

What Linezolid 600 mg Film-coated Tablets looks like and contents of the pack

Linezolid 600 mg Film-coated Tablets 600 mg Film-coated Tablets are white to off-white, oval, biconvex, film-coated tablets with “G” debossed on one side and “469” on the other.

The tablets are available in blister packs containing 10, 20 and 30 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Glenmark Pharmaceuticals Europe Limited
Laxmi House
2 B Draycott Avenue
Kenton
Middlesex
HA3 0BU
United Kingdom

Manufacturers
Glenmark Pharmaceuticals Europe Limited.
Building 2
Croxley Green Business Park
Croxley Green
Hertfordshire
WD 18 8YA
United Kingdom

Glenmark Pharmaceuticals s.r.o.
Fibichova 143
566 17 Vysoke Myto
Czech Republic

Glenmark Arzneimittel GmbH
Industriestr. 31
Gröbenzell
82194
Germany

This leaflet was last revised in 07/2019.

Glenmark Pharmaceuticals Europe Ltd
Company image
Address
Building 2, Croxley Park, Watford, WD18 8YA
Telephone
+44 (0)1923 202 950
Fax
+44 (0)1923 251137
Medical Information Direct Line
0800 458 0383
Stock Availability
+44 (0)1923 202 950