Zivoxid

Package Leaflet: Information for the Patient

Zyvoxid, 600 mg, Film-Coated Tablets

Linezolid

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package leaflet, as 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Zyvoxid and what is it 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 is Zyvoxid and what is it used for

Zyvoxid is an antibiotic belonging to the group of oxazolidinones. Its action involves inhibiting the growth of certain bacteria that cause infections.
Zyvoxid is used to treat pneumonia, complicated skin and soft tissue infections.
Your doctor will decide if Zyvoxid is suitable for treating your specific infection.

2. Important information before taking Zyvoxid

When not to take Zyvoxid

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

Warnings and precautions

If you answer "yes" to any of the following questions, it means that Zyvoxid may not be suitable for you.
In such a situation, tell your doctor, who may decide to perform a general examination and blood pressure check before and during treatment, or decide to use a different treatment.

• Do you have high blood pressure?
• Do you have an overactive thyroid gland?
• Do you have a tumor of the adrenal gland (pheochromocytoma) or carcinoid syndrome (caused by a tumor of the hormonal system with symptoms such as diarrhea, flushing, wheezing)?
• Do you have bipolar disorder, schizoaffective disorder (a disorder in which symptoms of schizophrenia and affective disorders, such as depression or mania, occur at the same time), confusion, or other mental disorders?
• Have you had hyponatremia (low sodium levels in the blood) or are you taking medicines that lower sodium levels in the blood, such as certain diuretics (also called "water pills"), such as hydrochlorothiazide?
• Are you taking any opioid medicines?

Taking Zyvoxid with certain other medicines may cause side effects, such as changes in blood pressure, temperature, or heart rate.

Interactions with other medicines

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Taking Zyvoxid with other medicines may cause side effects, such as changes in blood pressure, temperature, or heart rate.

Before taking Zyvoxid, discuss with your doctor if you are taking or have taken in the last 2 weeks any of the following medicines (see "When not to take Zyvoxid"), as their use is contraindicated:

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

Also, tell your doctor if you are taking any of the medicines listed above in "Warnings and precautions". In such a case, your doctor may decide to use Zyvoxid, but before starting treatment, you should have a general examination and blood pressure check, which will be repeated throughout the treatment period. In some cases, your doctor may decide to use a different treatment.

Taking Zyvoxid with food and drink

• Zyvoxid can be taken before, during, or after a meal.
• During treatment, you should limit your consumption of foods such as mature cheeses, yeast extracts, soy products (e.g., soy sauce), and alcoholic beverages, especially beer and wine. These products contain tyramine, which can react with Zyvoxid and cause an increase in blood pressure.
• If you experience a throbbing headache after eating or drinking, tell your doctor.

Pregnancy and breastfeeding

The action of Zyvoxid in pregnant women is not known, so it should only be used on the explicit advice of a doctor. If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
Do not take Zyvoxid while breastfeeding. The medicine passes into human milk and may harm your baby.

Driving and using machines

Zyvoxid may cause dizziness and vision disturbances. Do not drive or operate any machines in this case. Remember that feeling unwell can affect your ability to drive or operate machines.

Zyvoxid contains sodium

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

3. How to take Zyvoxid

Always take this medicine 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, ask your doctor or pharmacist.
The usual dose of Zyvoxid for adults (18 years and older) is one 600 mg tablet taken twice a day (every 12 hours). Swallow the tablet whole with a small amount of water.
Patients on dialysis should take Zyvoxid after dialysis.
Zyvoxid is usually taken for 10 to 14 days, but no longer than 28 days. The safety and efficacy of using Zyvoxid for more than 28 days have not been established.
Your doctor will decide the duration of treatment.
During treatment with Zyvoxid, your doctor will recommend regular blood tests to monitor your blood cell count.
If you take Zyvoxid for more than 28 days, you should have an eye examination.

Use in children and adolescents

Zyvoxid should not be used in children and adolescents under 18 years of age.

Overdose

Immediately consult your doctor or pharmacist.

Missed dose

Take the missed tablet as soon as possible. Take the next tablet at the next scheduled time (12 hours later) and continue taking the medicine every 12 hours. Do not take a double dose to make up for a missed dose.

Stopping treatment

Take Zyvoxid for as long as your doctor tells you. If you stop taking Zyvoxid and your symptoms come back, tell your doctor immediately.
If you have any further questions on the use of this medicine, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following side effects, tell your doctor, nurse, or pharmacist immediately:

• severe skin reactions, such as redness, skin peeling (dermatitis), rash, itching, or swelling, especially on the face and neck (not very common), wheezing, and (or) difficulty breathing (rare); these may be signs of an allergic reaction, and in such cases, it may be necessary to stop taking Zyvoxid. Skin reactions, such as a purple, raised rash caused by inflammation of blood vessels (rare)

Visual disturbances (not very common), such as changes in visual acuity, changes in color vision, blurred vision, or narrowing of the visual field;

• severe diarrhea, especially diarrhea with blood and (or) mucus; this may be a sign of pseudomembranous colitis, a rare but potentially life-threatening condition that can occur after antibiotic treatment (not very common);
• recurring nausea or vomiting, abdominal pain, or increased respiratory rate (rare);
• seizures;
• serotonin syndrome (frequency not known) if you experience excessive stimulation, confusion, hallucinations, stiffness, tremors, lack of coordination, seizures, rapid heart rate, serious breathing problems, and diarrhea (suggesting serotonin syndrome) while taking Zyvoxid with selective serotonin reuptake inhibitors or opioids, tell your doctor (see section 2);
• changes in the number of certain blood cells, which can affect your ability to fight infections (not very common);
• rhabdomyolysis (rare): objective and subjective symptoms include unexplained muscle pain, tenderness, or weakness and (or) dark urine. These may be signs of a serious condition called rhabdomyolysis (muscle breakdown), which can lead to kidney damage.

Numbness, tingling, or changes in visual acuity were reported by patients who took Zyvoxid for more than 28 days. If you experience a worsening of vision, you should contact your doctor immediately.

Other side effects

Common(may affect up to 1 in 10 people):

• fungal infections, especially candidiasis (mainly of the vagina and mouth);
• headache;
• metallic taste in the mouth;
• diarrhea, nausea, or vomiting;
• changes in blood morphology or laboratory test results, including those measuring proteins, salts, or enzymes used to assess kidney, liver, or blood sugar parameters;
• decreased platelet count;
• bleeding, bruising, or unexplained bleeding, which may be caused by changes in the blood system that can affect blood clotting and lead to anemia;
• sleep disturbances (insomnia);
• increased blood pressure;
• anemia (decreased red blood cell count);
• skin rash;
• itching;
• dizziness;
• local or general abdominal pain;
• constipation;
• indigestion;
• local pain;
• fever.

Uncommon(may affect up to 1 in 100 people):

• vaginal or genital infections in women;
• sensory disturbances, such as numbness, tingling, or prickling;
• blurred vision;
• "ringing" in the ears (tinnitus);
• dryness or pain in the mouth, swelling, irritation, or discoloration of the tongue;
• need to urinate frequently;
• chills;
• feeling tired or thirsty;
• pancreatitis;
• increased sweating;
• seizures;
• hyponatremia (low sodium levels in the blood);
• kidney failure;
• abdominal bloating;
• transient ischemic attacks (temporary disturbances of blood flow to the brain, causing short-term symptoms such as loss of vision, weakness of limbs, slurred speech, loss of consciousness);
• skin inflammation;
• increased creatinine levels in the blood;
• stomach pain;
• changes in heart rate (e.g., rapid rhythm);
• changes in the number of certain blood cells, which can affect your ability to fight infections;
• decreased number of all types of blood cells;
• weakness and (or) sensory changes.

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

• narrowing of the visual field;
• superficial discoloration of teeth that can be removed by dental cleaning (manual removal of tartar);
• lactic acidosis (recurring nausea and vomiting, abdominal pain, increased respiratory rate);
• sideroblastic anemia (a type of anemia).

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

• serotonin syndrome (rapid heart rate, confusion, excessive sweating, hallucinations, involuntary movements, shivering, tremors);
• hair loss;
• color vision disturbances or difficulty seeing details.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder or its representative.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Zyvoxid

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 packaging after EXP.
The expiry date refers to the last day of that month.
Store in a temperature not exceeding 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help 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.
• The other ingredients are: cornstarch, microcrystalline cellulose (intra-granular), microcrystalline cellulose (extra-granular), hydroxypropylcellulose (intra-granular), hydroxypropylcellulose (binding solution), sodium carboxymethylcellulose (type A) (see section 2 "Zyvoxid contains sodium"), magnesium stearate. The coating contains: 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" engraved on one side and "600" on the other side.
Packaging: PVC/Aluminum blister pack containing 10 film-coated tablets, in a cardboard box.

Marketing authorization 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
To obtain more detailed information on this medicine, contact the local representative of the marketing authorization holder:
Pfizer Polska Sp. z o.o.
phone: 22 335 61 00

Date of last revision of the package leaflet: 09/2024

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