Zyvoxid

Package leaflet: Information for the patient

Zyvoxid, 600 mg, film-coated tablets
Linezolidum
Please read carefully all the information in this leaflet before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Table of contents of the leaflet

1. What Zyvoxid is and what it is used for
2. Important information before taking Zyvoxid
3. How to take Zyvoxid
4. Possible side effects
5. How to store Zyvoxid
6. Contents of the pack and other information

1. What Zyvoxid is and what it is used for

Zyvoxid is an antibiotic belonging to the oxazolidinone group. It works by
inhibiting the growth of certain bacteria that cause infections.
Zyvoxid is used to treat pneumonia and complicated skin and soft tissue infections.
Your doctor will decide whether Zyvoxid is appropriate for treating the specific infection.

2. Important information before using Zyvoxid

When not to use Zyvoxid

• if the patient is allergic to linezolid or any of the other ingredients of this medicine (listed in section 6);
• if the patient is currently taking or has taken within the last 2 weeks a medicine from a group called monoamine oxidase inhibitors (e.g. phenelzine, isocarboxazid, selegiline, moclobemide); these medicines are used in the treatment of depression or Parkinson's disease;
• if the patient is breastfeeding; the medicine passes into human milk and may harm the infant.

Warnings and precautions
If the patient answers "yes" to any of the following questions, this may mean that Zyvoxid is not suitable for them.
In such a case, the patient should inform their doctor, who may decide to perform a general examination and blood pressure measurement before and during treatment, or may choose to prescribe a different, more suitable treatment.
If there are any doubts regarding the conditions described below, the patient should consult their doctor.

• Does the patient have high blood pressure?
• Does the patient have hyperthyroidism?
• Does the patient have a tumour of the adrenal gland (pheochromocytoma) or carcinoid syndrome (caused by a tumour of the endocrine system, with symptoms such as diarrhoea, flushing, wheezing)?
• Does the patient have bipolar disorder, schizoaffective disorders (conditions in which symptoms typical of both schizophrenia and affective disorders, i.e. depression or mania, occur simultaneously), disorientation, or other psychiatric disorders?
• Has the patient previously experienced hyponatraemia (low sodium levels in the blood), or is the patient taking medicines that reduce sodium levels in the blood, such as certain diuretics (also known as "water tablets"), e.g. hydrochlorothiazide?
• Is the patient taking any opioid medicines?

Concomitant use of certain medicines, including antidepressants and opioids, with Zyvoxid may lead to serotonin syndrome — a potentially life-threatening condition (see section 2 "Zyvoxid with other medicines" and section 4).

• Is the patient taking any of the following medicines:
  • medicines reducing nasal or sinus congestion used in colds or flu, containing pseudoephedrine or phenylpropanolamine;
  • medicines used to treat asthma, e.g. salbutamol, terbutaline, fenoterol;
  • antidepressants known as tricyclic antidepressants or serotonin reuptake inhibitors, e.g. amitriptyline, citalopram, clomipramine, dosulepin, doxepin, fluoxetine, fluvoxamine, imipramine, lofepramine, paroxetine, sertraline;
  • medicines used to treat migraine, e.g. sumatriptan and zolmitriptan;
  • medicines used to treat severe allergic reactions, e.g. adrenaline (epinephrine);
  • medicines that increase blood pressure, e.g. noradrenaline (norepinephrine), dopamine, dobutamine;
  • opioids, e.g. pethidine - used to treat moderate to severe pain;
  • anxiolytics, e.g. buspirone;
  • anticoagulants, e.g. warfarin;
  • medicines containing the antibiotic rifampicin.

Before starting treatment with Zyvoxid, discuss this with the doctor or pharmacist.
If the patient has any of the risk factors listed below, they should inform their doctor before starting this medicine:

• advanced age,
• tendency to bruising and bleeding,
• anaemia (reduced number of red blood cells),
• tendency to infections,
• seizures (in the past),
• liver or kidney dysfunction, particularly in dialysed patients,
• diarrhoea.

The patient should inform their doctor immediately if, during treatment with Zyvoxid, they experience:

• worsening of vision, such as changes in visual acuity, changes in colour vision, blurred vision, or visual field defects;
• loss of sensation in hands and feet, or tingling or prickling sensations in hands and feet;
• diarrhoea occurring during or after antibiotic treatment, including Zyvoxid; if severe or persistent diarrhoea occurs, or if blood or mucus is visible in the stool, the patient should stop taking Zyvoxid and consult a doctor; in such cases, medicines that inhibit or stimulate intestinal motility should not be taken;
• recurring nausea or vomiting, abdominal pain, or increased breathing rate;
• unexplained muscle pain, tenderness, or weakness and (or) darkening of urine. These may be symptoms of a serious condition called rhabdomyolysis (muscle breakdown), which may lead to kidney damage;
• nausea and general malaise, including muscle weakness, headache, confusion, and memory disturbances, which may indicate hyponatraemia (low sodium levels in the blood).

Zyvoxid with other medicines
Inform the doctor about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Concomitant use of Zyvoxid with other medicines may cause adverse effects, such as changes in blood pressure, body temperature, or heart rate.
Inform the doctor if the patient is taking or has taken within the last 2 weeks
any of the following medicines (see section "When not to use Zyvoxid"), as Zyvoxid treatment is contraindicated in such cases:

• monoamine oxidase inhibitors (e.g. phenelzine, isocarboxazid, selegiline, moclobemide). These medicines are used in the treatment of depression or Parkinson's disease.

The patient should also inform the doctor if they are taking any of the medicines listed above in the section "Warnings and precautions". In such cases, the doctor may decide to proceed with Zyvoxid treatment, but the patient should undergo a general examination and blood pressure measurement before starting treatment, which should be repeated throughout the treatment period. In some cases, the doctor may decide to use an alternative treatment.

Taking Zyvoxid with food and drink

• Zyvoxid may be taken before, during, or after meals.
• During treatment, consumption of foods such as mature cheeses, yeast extracts, soy products (e.g. soy sauce), and alcoholic beverages, especially draught beer and wine, should be limited. These products contain tyramine, which may interact with Zyvoxid, leading to increased blood pressure.
• If the patient experiences a throbbing headache after eating or drinking, they should inform their doctor.

Pregnancy and breastfeeding
The effects of Zyvoxid in pregnant women are unknown; therefore, it should be used only on strict medical advice. If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
Zyvoxid should not be used during breastfeeding. The medicine passes into human milk and may harm the infant.

Driving and operating machinery
Zyvoxid may cause dizziness and visual disturbances. The patient should not drive or operate machinery. It should be remembered that general malaise may affect the ability to drive and operate machinery.

Zyvoxid contains sodium
Zyvoxid contains less than 1 mmol (23 mg) of sodium per 600 mg tablet, meaning the medicine is considered "sodium-free".

3. How to take Zyvoxid

This medicine should always be taken exactly as your doctor has told you. If you are not sure, ask
your doctor or pharmacist.
Adults
Zyvoxid should always be taken exactly as your doctor has told you. If you are not sure, contact your
doctor or pharmacist.
The usual dose of Zyvoxid in adults (18 years and older) is 1 tablet (600 mg linezolid) taken twice a
day (every 12 hours). Swallow the tablet whole with a small amount of water.
For patients undergoing dialysis, Zyvoxid should be administered after completion of dialysis.
Zyvoxid is usually given for 10 to 14 days, but not longer than 28 days. The safety and efficacy of
Zyvoxid administered for longer than 28 days have not been established. The decision on the duration
of treatment will be made by your doctor.
While taking Zyvoxid, your doctor will recommend regular blood tests to monitor blood-forming
system function.
If Zyvoxid is used for longer than 28 days, an eye examination should be performed.
Use in children and adolescents
Zyvoxid must not be used in children and adolescents under 18 years of age.
Taking more Zyvoxid than prescribed
Seek immediate advice from your doctor or pharmacist.
If you forget to take Zyvoxid
Take the missed tablet as soon as possible. Then take the next tablet 12 hours after the missed dose
and continue taking the medicine every 12 hours. Do not take a double dose to make up for a
missed dose.
Stopping Zyvoxid
Continue taking Zyvoxid for as long as your doctor tells you to.
If symptoms return after stopping Zyvoxid, inform your doctor immediately.
If you have any further questions about the use of this medicine, talk to your doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the adverse reactions listed below occur, you should immediately
inform your doctor, nurse or pharmacist:

• severe skin reactions, e.g. redness, peeling of the skin (dermatitis), rash, itching or swelling, particularly around the face and neck (not common), wheezing and (or) difficulty breathing (rare); these may be symptoms of an allergic reaction and in such a case, discontinuation of Zyvoxid treatment may be necessary. Skin reactions such as raised, purple rash caused by inflammation of blood vessels (rare)

• vision problems (not common), manifesting as changes in visual acuity, changes in colour vision, blurred vision or narrowing of the visual field;

• severe diarrhoea, particularly diarrhoea with blood and (or) mucus; this may be a sign of pseudomembranous colitis, which may occur after antibiotic treatment and in rare cases may be life-threatening (not common);

• recurrent nausea or vomiting, abdominal pain or increased breathing rate (rare);

• seizures;

• serotonin syndrome (frequency unknown): if the patient experiences excessive agitation, confusion, hallucinations, stiffness, tremor, lack of coordination, seizures, rapid heartbeat, severe breathing problems and diarrhoea (suggesting serotonin syndrome) while taking serotonin reuptake inhibitors or opioids concurrently, inform the doctor (see section 2);

• changes in the number of certain blood cells, which may affect the ability to fight infections (not common);

• rhabdomyolysis (rare): subjective and objective symptoms include unexplained muscle pain, tenderness or weakness and (or) darkly coloured urine. These may be signs of a serious condition called rhabdomyolysis (muscle breakdown), which may lead to kidney damage.

Numbness, tingling, and changes in visual acuity have been reported by patients who received Zyvoxid for longer than 28 days. If a patient experiences worsening of vision, they should contact their doctor immediately.

Other adverse reactions
Common (may occur in up to 1 in 10 people):

• fungal infections, especially candidiasis (mainly of the vagina and oral cavity);
• headache;
• metallic taste in the mouth;
• diarrhoea, nausea or vomiting;
• changes in blood morphology or blood test results, including those measuring proteins, salts or enzymes used to assess kidney, liver function or blood glucose levels;
• reduced platelet count;
• bleeding, development of unexplained bruising, which may be due to changes in the blood system affecting blood coagulation and potentially leading to anaemia;
• sleep disturbances (insomnia);
• increased blood pressure;
• anaemia (reduced number of red blood cells);
• skin rash;
• skin itching;
• dizziness;
• local or general abdominal pain;
• constipation;
• indigestion;
• local pain;
• fever.

Not common (may occur in up to 1 in 100 people):

• inflammation of the vagina or genital area in women;
• sensory disturbances such as loss of sensation, tingling or numbness;
• blurred vision;
• ringing in the ears (tinnitus);
• dryness or pain in the mouth, swelling, irritation or discolouration of the tongue;
• increased need to urinate;
• chills;
• feeling of fatigue or thirst;
• pancreatitis;
• increased sweating;
• seizures;
• hyponatraemia (reduced sodium levels in the blood);
• hypoglycaemia (reduced blood glucose levels);
• kidney failure;
• abdominal bloating;
• transient ischaemic attacks (transient disturbances in blood supply to the brain causing temporary symptoms such as loss of vision, limb weakness, slurred speech, loss of consciousness);
• skin inflammation;
• increased blood creatinine levels;
• stomach pain;
• changes in heart rate (e.g. increased rhythm);
• changes in the number of certain blood cells, which may affect the ability to fight infections;
• reduction in all types of blood cells;
• weakness and (or) sensory changes.

Rare (may occur in up to 1 in 1,000 people):

• narrowing of the visual field;
• superficial tooth discolouration, removable by dental cleaning (manual removal of tartar);
• lactic acidosis (recurrent nausea and vomiting, abdominal pain, increased breathing rate);
• sideroblastic anaemia [a type of anaemia (reduced number of red blood cells)];
• black discolouration of the surface of the tongue, giving it a "hairy" appearance.

Frequency not known (cannot be estimated from available data):

• serotonin syndrome (increased heart rate, disorientation, profuse sweating, hallucinations, involuntary movements, chills, tremors);
• hair loss;
• disturbances in colour vision or difficulty perceiving details.

Reporting of adverse reactions
If any symptoms of adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder or its representative.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store the medicine Zyvoxid

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following: EXP.
The expiry date refers to the last day of the stated month.
Store at a temperature not exceeding 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Proper disposal helps protect the environment.

6. Contents of the pack and other information

What Zyvoxid contains

• The active substance is linezolid. Each tablet contains 600 mg of linezolid.
• Other components of the medicine are: corn starch, microcrystalline cellulose (intragranular), microcrystalline cellulose (extragranular), hydroxypropylcellulose (intragranular), hydroxypropylcellulose (binding solution), sodium carboxymethyl starch (type A) (see section 2 "Zyvoxid contains sodium"), magnesium stearate. Coating ingredients: Carnauba wax, Opadry White YS-1-18202-A (hydroxypropylmethylcellulose, titanium dioxide, polyethylene glycol).

What Zyvoxid looks like and contents of the pack
White or almost white, oval tablets, with "ZYV" debossed on one side and "600" on the other side.
Pack: PVC/aluminum foil blister containing 10 coated tablets, in a cardboard box.

Marketing Authorisation Holder
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium

Manufacturer
Pfizer Manufacturing Deutschland GmbH
Mooswaldallee 1
79108 Freiburg im Breisgau
Germany

For more detailed information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Pfizer Polska Sp. z o.o.
tel. 22 335 61 00

Comprehensive and up-to-date information about this product can be obtained by scanning the QR code located on the outer packaging using a mobile device. The same information is also available at the URL: https://www.pfizer.pl/ulotka-zyvoxidtabletki and on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products http://www.urpl.gov.pl.