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Package leaflet: Information for the user

ZYVOX®

film-coated tablets for use in Adults

Linezolid

_Pharmacia

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, pharmacist or nurse.

-    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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Zyvox is and what it is used for

2.    What you need to know before you take Zyvox

3.    How to take Zyvox

4.    Possible side effects

5.    How to store Zyvox

6.    Contents of the pack and other information

1.    What Zyvox is and what it is used for

Zyvox 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 Zyvox is suitable to treat your infection.

2.    What you need to know before you take Zyvox

Do not take Zyvox:

•    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 Zyvox passes into breast milk and could affect the baby.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Zyvox.

Zyvox 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?

•    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, 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

-    an antibiotic called rifampicin Take special care with Zyvox

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

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 Zyvox. If this becomes severe or persistent or you notice that your stool contains blood or mucus, you should stop taking Zyvox 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 Zyvox

There is a risk that Zyvox 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 Zyvox must not be taken if you are already taking these medicines or have taken them recently (see also Section 2 above ‘Do not take Zyvox’).

•    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 Zyvox, 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.

Please tell your doctor, pharmacist or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Zyvox with food, drink and alcohol

•    You can take Zyvox 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 Zyvox 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, pharmacist or nurse immediately.

Pregnancy, breast-feeding and fertility

The effect of Zyvox in pregnant women is not known. Therefore, it should not be taken in pregnancy unless advised by your doctor. If you are pregnant or breastfeeding, 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 Zyvox because it passes into breast milk and could affect the baby.

Driving and using machines

Zyvox 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 Zyvox

Adults

Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. Check with your doctor, 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 Zyvox 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 Zyvox, your doctor should perform regular blood tests to monitor your blood count.

Your doctor should monitor your eyesight if you take Zyvox for more than 28 days.    PAA077157

Use in children and adolescents

Zyvox is not normally used to treat children and adolescents (under 18 years old).

If you take more Zyvox than you should

Tell your doctor or pharmacist immediately.

If you forget to take Zyvox

Take the forgotten tablet as soon as you remember. Take the next film-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 film-coated tablet.

If you stop taking Zyvox

Unless your doctor instructs you to stop treatment, it is important to continue taking Zyvox.

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, 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 Zyvox:

•    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 Zyvox.

•    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 life-threatening.

•    recurrent nausea or vomiting, abdominal pain or rapid breathing.

•    rits or seizures have been reported with Zyvox. You should let your doctor know if you experience agitation, confusion, delirium, rigidity, tremor, incoordination and seizure while also taking antidepressants known as SSRIs (see section 2).

Numbness, tingling or blurred vision have been reported by patients who have been given Zyvox 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

•    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

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

•    Blurred vision

•    “Ringing” in the ears (tinnitus)

•    Inflammation of the veins (IV only)

•    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)

Rare (may affect up to 1 in 1,000 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):

•    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, rapid breathing)

•    Severe skin disorders

•    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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom

Yellow Card Scheme website: www.mhra.gov.uk/yellowcard

Malta

ADR Reporting

Website: www.medicinesauthoritv.gov.mt/adrportal

5. How to store Zyvox

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 pack or the 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 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 Zyvox contains

-    The active substance in this medicine is called linezolid. Each film-coated tablet contains 600 mg linezolid

-    The other ingredients are maize starch (corn derived), microcrystalline cellulose (E460), hydroxypropylcellulose (E463), sodium starch glycollate type A and magnesium stearate (E572). The film coating contains opadry, white, YS-1-18202-A(e) comprising: hypromellose (E464), titanium dioxide (E171), macrogol 400 and carnauba wax (E903).

What Zyvox looks like and contents of the pack

Zyvox 600 mg film-coated tablets are white, oval-shaped and debossed with “ZYV” on one side and “600” on the other. Zyvox film-coated tablets are available in blister strips of 10 tablets packaged in a box.

Each box contains either 10, 20, 30, 50, 60 or 100 film-coated tablets. Also in white, HDPE bottle with a polypropylene screw cap containing either 10, 14, 20, 24, 30, 50, 60 or 100 (for hospital use only) film-coated tablets. Not all pack sizes may be marketed.

The Marketing Authorisation Holder

The Marketing Authorisation Holder is Pharmacia Limited, Sandwich, Kent, CT13 9NJ, UK

Manufacturer

Pfizer Manufacturing Deutschland GmbH, Betriebsstatte Freiburg, Mooswaldallee 1, D-79090 Freiburg, Germany.

This medicinal product is authorised in the Member States of the EEA under the following names:

Austria

Belgium

Cyprus

Czech Republic

Denmark

Estonia

Finland

France

Germany

Greece

Iceland

Ireland

Italy

Latvia

Lithuania

Luxembourg

Malta

Netherlands

Norway

Poland

Portugal

Slovakia

Slovenia

Spain

Sweden

United Kingdom

This leaflet was last revised in 07/2016

Ref: ZY 14_0

PAA077157