• 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.

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

• 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.

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?

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.

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

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.

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.

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.

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.

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.

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

Tell your doctor or pharmacist immediately.

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.

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.

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.

• The active substance is linezolid
• The other ingredients are Lactose monohydrate, Povidone, Croscarmellose sodium,
  Magnesium stearate, Hypromellose, Titanium dioxide and Macrogol.

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.