Zyvoxid 20 mg Suspension

The active ingredient (linezolid) is an antibiotic that stops the growth of certain types of bacteria (germs) that cause infections. ZYVOXID is used to treat pneumonia and some infections in the skin or under the skin. Your doctor will decide if ZYVOXID is suitable to treat your infection.

Do not take ZYVOXID:

• if you are hypersensitive (allergic) to linezolid or any of the other ingredients of ZYVOXID (listed in section 6).
• if you are taking or have taken within the last 2 weeks any medicines known as monoamine oxidase inhibitors (for example phenelzine, isocarboxazid). These medicines may be used to treat depression or Parkinson’s disease.
• if you are pregnant or breastfeeding.

ZYVOXID 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 another treatment is better for you. Ask your doctor:

• if you have high blood pressure
• if you been diagnosed with an overactive thyroid gland
• if you have a tumour of the adrenal glands (phaeochromocytoma)
• if you are taking a decongestant, cold or flu remedies containing pseudoephedrine or phenylpropanolamine
• if you are taking medicines used to raise blood pressure (e.g. epinephrine, norepinephrine)
• if you are taking medicines used to treat certain psychiatric or mental conditions and Parkinson’s disease (e.g. dopamine, dobutamine)

Your doctor will monitor you for signs and symptoms of serotonin syndrome.

ZYVOXID will not be given to you:

• if you are taking antidepressants known as tricyclics or SSRIs (selective serotonin reuptake inhibitors) or you have carcinoid syndrome (caused by tumours of the hormone system with symptoms of diarrhoea, flushing of the skin and wheezing)
• if you are taking medicines used to treat migraine (triptans)
• if you are taking medicines used to treat moderate to severe pain, such as meperidine
• if you are taking medicines used to treat anxiety disorders such as buspirone

Warnings and precautions

Take special care with ZYVOXID:

• if you bruise and bleed easily
• if you are anaemic (lack of iron in the blood / decreased numbers of red blood cells)
• if you take medicines that may decrease your haemoglobin levels
• if you take ZYVOXID for more than 2 weeks
• if you have diarrhoea as ZYVOXID leads to an overgrowth of a bacteria called C. difficile in the colon
• if you have problems with your vision such as blurred vision, changes in colour vision, difficulty in seeing detail or if your field of vision becomes restricted
• if you have recurrent nausea or vomiting, abdominal pain or over-breathing (lactic acidosis)
• if you have convulsions or a history of seizures
• if you suffer from a life-threatening infection like suffering from infections that need a catheter in the large vein and are placed in the intensive care units
• if you have liver problems or kidney problems particularly if you have dialysis

Your doctor will monitor your vision if you are taking ZYVOXID for more than 3 months or even if you report problems with your vision regardless the length of therapy. You may develop diarrhoea while taking or after taking ZYVOXID. If this becomes severe or persistent or you notice that your stool contains blood or mucous, you should stop taking ZYVOXID immediately and consult your doctor. In this situation, you should not take medicines that stop or slow bowel movement. You should let your doctor know if you experience agitation (feeling of being worried or upset), confusion (feeling that you cannot decide what to do), delirium (confused state/extreme excitement or happiness), rigidity (stiffness), tremor (shake), incoordination (unable to control muscle movements) and seizure while also taking antidepressants known as SSRI’s.

Do not share medicines prescribed for you with any other person. Always take ZYVOXID granules for suspension exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Your doctor will decide how ZYVOXID is given to you and what dose will be given. Your doctor will decide on the duration of your treatment.

Adults and adolescents (12 years and older): The usual dose is 400 mg to 600 mg orally every 12 hours depending on the type of infection.

Children (birth through to 11 years): The usual dose is 10 mg/kg orally every 8 hours depending on the type of infection. If you are on kidney dialysis, you should take ZYVOXID after dialysis. While you are taking ZYVOXID, your doctor should perform regular blood tests to monitor your blood count. Your doctor should monitor your eyesight if you take ZYVOXID for more than 28 days.

Your doctor will tell you how long your treatment with ZYVOXID will last. Do not stop treatment early. If you have the impression that the effect of ZYVOXID is too strong or too weak, tell your doctor or pharmacist.

If you take more ZYVOXID than you should: In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. If you or somebody else takes too much oral liquid, tell your doctor or pharmacist immediately.

If you forget to take ZYVOXID Granules for suspension: Take the forgotten oral liquid as soon as you remember. Take the next dose 12 hours after this and continue taking the medicine every 12 hours. Do not take a double dose to make up for forgotten individual doses.

If you stop taking ZYVOXID: Unless your doctor instructs you to stop treatment, it is important to continue taking ZYVOXID. If you stop and your original symptoms come back tell your doctor or pharmacist immediately.

ZYVOXID can have side effects. Not all side effects reported for ZYVOXID are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking ZYVOXID, please consult your health care provider for advice.

If any of the following happens, stop taking ZYVOXID and tell your doctor immediately or go to the casualty department at your nearest hospital:

• skin reactions such as red sore skin and flaking (dermatitis), rash, itching, or swelling, particularly around the face and neck called angioedema. This may be the sign of an anaphylactic allergic reaction and it may be necessary for you to stop taking ZYVOXID
• severe diarrhoea containing blood and/or mucus (antibiotic associated colitis including pseudomembranous colitis), which may develop into complications that are life-threatening
• recurrent nausea or vomiting, abdominal pain
• over-breathing
• seizures

These are all very serious side effects. If you have them, you may have had a serious reaction to ZYVOXID. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following:

Frequent side effects

• fungal infections especially vaginal or oral “thrush”
• headache
• metallic taste in the mouth or alteration in taste
• stomach pain
• pain and cramps in the stomach or bloating due to gas
• diarrhoea, nausea or vomiting
• increased number of certain compounds (bilirubin, AST, ALT) in the blood that are high during liver damage
• increased number of enzymes (LDH, alkaline phosphatase, urea and creatinine, BUN, creatine kinase, lipase, amylase) that are high during certain diseases or organ damage
• increase in blood sugar (non-fasting)
• decrease in protein, albumin, sodium, calcium
• changes in the level of potassium or bicarbonate
• increased neutrophils or eosinophils
• decreased red blood cell count
• increased or decreased platelets

Less frequent side effects

• change in the number of certain types of blood cells
• increase in a type of enzyme called serum creatine phosphokinase
• high blood sugar
• dizziness, sensations such as tingling or feeling numb
• a reduced sense of touch
• difficulty in sleeping
• problems with your vision such as blurred vision, changes in colour vision, difficulty in seeing detail or if your field of vision becomes restricted
• ringing in the ears (tinnitus)
• increased blood pressure
• low blood pressure
• constipation
• dry or sore mouth
• indigestion
• stomach diseases
• feeling tired or thirsty
• inflammation of the pancreas (nausea, vomiting, fever/chills and abdominal (belly) pain)
• infection of the skin
• increased sweating
• skin rash and itching
• inflammation of the vagina or genital area in women
• a need to urinate more often
• fever or chills, aches and pains, fatigue or tiredness
• increased creatinine, sodium and calcium

Other side effects

• 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
• build-up of lactic acid in the body
• convulsions
• damage to the nerve causing weakness, numbness and pain, usually in your hands and feet
• swollen, sore, or discoloured tongue
• superficial tooth discolouration, removable with professional dental cleaning (manual descaling)
• severe skin disorders like toxic epidermal necrolysis and Stevens-Johnson syndrome which results in painful blisters and peeling of the skin

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects: If you get side effects, talk to your doctor or pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reactions Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of ZYVOXID.

Store all medicines out of reach of children. Store at room temperature at or below 25 °C. Keep the bottle tightly closed and in the outer carton to protect from light. Do not use after the expiry date printed on the carton. Your suspension can be stored for three weeks at room temperature at or below 25 °C and should be used within 21 days. Before use, gently turn the bottle upside down a few times. Do not shake. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).