Label: Information for the User

ZYVOXID 600 mg Film-Coated Tablets

Linezolid

Read this label carefully before you start taking this medicine,because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this label. See section 4.

1.What is Zyvoxid and what it is used for

2.What you need to know before starting to use Zyvoxid

3.How to use Zyvoxid

4.Possible side effects

5.Storage of Zyvoxid

6.Contents of the pack and additional information

Zyvoxid is an antibiotic belonging to the oxazolidinones group that acts by preventing the growth of certain bacteria (germs) that cause infections.

It is used for the treatment of pneumonia and certain skin or subcutaneous tissue infections. Your doctor will have decided if Zyvoxid is suitable for treating your infection.

Do not take Zyvoxid if:

• You are allergic to linezolid or any of the other ingredients in this medication (listed in section6).
• You are taking or have taken in the last 2weeks any medication called monoamine oxidase inhibitors (MAOIs such as phenelzine, isocarboxazid, selegiline, moclobemide). These medications are usually used to treat depression or Parkinson's disease.
• You are breastfeeding. Zyvoxid passes into the milk and may affect the baby.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Zyvoxid.

Zyvoxid may not be suitable for you if you respondyesto any of the following questions. In that case, inform your doctor, as they will need to monitor your overall health and blood pressure before and during treatment or may decide that another treatment is better for you.

Ask your doctor if you are unsure whether any of these categories apply to your case.

• Do you have high blood pressure, whether or not you are taking medication for it?
• Have you been diagnosed with hyperthyroidism?
• Do you have a tumor of the adrenal glands (pheochromocytoma) or carcinoid syndrome (caused by tumors in the hormonal system that present with symptoms of diarrhea, skin flushing, shortness of breath)?
• Do you have manic depression, schizophrenia, confusion, or other mental health problems?
• Have you had low sodium levels in your blood (hyponatremia) or are you taking medications that reduce sodium levels in the blood, such as certain diuretics like hydrochlorothiazide?
• Are you taking opioids?

The use of certain medications, including antidepressants and opioids, with Zyvoxid may cause serotonin syndrome, a potentially life-threatening condition (see section2 “Other medications and Zyvoxid” and section4).

Be especially careful with Zyvoxid:

Inform your doctor before taking this medication if:

• You are an elderly patient.
• You bleed or bruise easily.
• You have anemia (low red blood cell count).
• You are prone to infections.
• You have a history of seizures.
• You have liver or kidney problems, especially if you are on dialysis.
• You have diarrhea.

Inform your doctor immediately if during treatment you experience:

• Visual problems such as blurred vision, changes in color vision, difficulty seeing clearly, or if you notice a reduction in your visual field.
• Loss of sensation in your arms or legs or a feeling of tingling or burning in your arms or legs.
• Dysentery may occur while taking or after taking antibiotics, including linezolid. If diarrhea becomes intense, lasts a long time, or if you notice that your stools contain blood or mucus, stop taking Zyvoxid immediately and consult your doctor. In this situation, do not take medications that stop or reduce intestinal movements.
• Recurring nausea or vomiting, abdominal pain, or rapid breathing.
• Muscle pain without apparent cause, sensitivity, or weakness, and/or dark urine. These may be signs of a serious condition called rhabdomyolysis (muscle degradation), which can cause kidney damage.
• Discomfort and dizziness with muscle weakness, headache, confusion, and memory deterioration that may indicate hyponatremia (low sodium levels in the blood).

Use of Zyvoxid with other medications

Zyvoxid may interact with certain medications and produce adverse effects such as changes in blood pressure, body temperature, or heart rate.

Inform your doctor or pharmacist if you are taking or have recently taken any other medication.

Inform your doctor if you are taking or have taken in the last 2 weeks the following medications, as you should not take Zyvoxid if you are still taking them or if you have taken them recently (see also section2 above “Do not take Zyvoxid”):

• Monoamine oxidase inhibitors (MAOIs, such as phenelzine, isocarboxazid, selegiline, moclobemide). These medications are usually used to treat depression or Parkinson's disease.

Also inform your doctor if you are taking the following medications. Your doctor may decide to treat you with Zyvoxid, but they will need to assess your overall health and blood pressure before and during treatment. In other cases, your doctor may decide that another treatment is better for you.

• Decongestants for colds that contain pseudoephedrine or phenylpropanolamine.
• Certain medications for asthma such as salbutamol, terbutaline, fenoterol.
• Certain antidepressants called tricyclics or SSRIs (selective serotonin reuptake inhibitors). There are many medications of this type, including amitriptyline, citalopram, clomipramine, dosulepina, doxepin, fluoxetine, fluvoxamine, imipramine, lofepramine, paroxetine, or sertraline.
• Medications used to treat migraines such as sumatriptan or zolmitriptan.
• Medications used to treat severe allergic reactions such as adrenaline (epinephrine).
• Medications that increase blood pressure such as noradrenaline (norepinephrine), dopamine, and dobutamine.
• Opioids (such as pethidine) used to treat severe pain.
• Medications used to treat anxiety disorders such as buspirone.
• Medications that prevent blood clotting such as warfarin.
• An antibiotic called rifampicin.

Taking Zyvoxid with food, drinks, and alcohol

• You can take Zyvoxid before, during, or after meals.
• Avoid eating large amounts of cheese, yeast extracts, or soybean extracts (such as soy sauce) and alcoholic beverages, especially barrel beer and wine. The reason is that Zyvoxid may react with a substance called tyramine that is naturally present in some foods. This interaction may cause an increase in your blood pressure.
• If you start with a headache after eating or drinking, inform your doctor, pharmacist, or nurse immediately.

Pregnancy, breastfeeding, and fertility

The effect of Zyvoxid on pregnant women is unknown. Therefore, pregnant women should not use Zyvoxid, unless their doctor advises them to.If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

You should not breastfeed while taking Zyvoxid because this medication passes into the milk and may affect your baby.

Driving and operating machinery

Zyvoxid may cause dizziness or visual problems. If this happens, do not drive or operate machinery. Remember that if you do not feel well, you may be affected in your ability to drive or operate machinery.

Zyvoxid contains sodium

Zyvoxid contains less than 1mmol of sodium (23mg) per 600mg tablet; this is, essentially “sodium-free”.

Adults

Always follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor, pharmacist, or nurse. If in doubt, ask your doctor, pharmacist, or nurse.

The recommended dose is one film-coated tablet (600 mg of linezolid) twice a day (every 12 hours). Swallow the film-coated tablet whole with a little water.

If you are on dialysis, take Zyvoxid after each session.

The normal treatment duration is 10-14 days, but it may be extended up to 28 days. The safety and efficacy of this medication have not been established in treatment periods exceeding 28 days. Your doctor will decide on the duration of your treatment.

While taking Zyvoxid, your doctor will perform periodic blood tests to monitor your blood count.

If you take Zyvoxid for more than 28 days, your doctor will monitor your vision.

Use in children and adolescents

Zyvoxid is not usually used in children or adolescents (under 18 years old).

If you take more Zyvoxid than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, telephone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Zyvoxid

Take the missed tablet as soon as you remember. Take the next film-coated tablet 12 hours later and continue taking the film-coated tablets every 12 hours.Do not take a double dose to make up for the missed dose.

If you interrupt treatment with Zyvoxid

It is essential that you only interrupt your treatment if your doctor instructs you to do so.

If your initial symptoms return after interrupting your treatment, inform your doctor or pharmacist immediately.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.personas los sufran.

Inform your doctor, nurse or pharmacist immediately if you notice any of the following side effects while taking Zyvoxid:si nota cualquiera de los siguientes efectos adversos mientras está en tratamiento con Zyvoxid:

The most serious side effects of Zyvoxid (frequency in parentheses) are:

• Severe skin changes (rare), swelling, particularly around the face and neck (rare), wheezing and/or difficulty breathing (rare). This may be a sign of an allergic reaction and may require discontinuation of Zyvoxid treatment. Skin reactions such as purple elevated rash due to inflammation of blood vessels (rare), red, painful and scaly skin (dermatitis) (rare), skin rash (frequent), itching (frequent).
• Vison problems (rare) such as blurred vision (rare), changes in color perception (unknown), difficulty seeing details (unknown) or if you notice a reduction in your field of vision (rare).
• Severe diarrhea containing blood and/or mucus (antibiotic-associated colitis including pseudomembranous colitis), which in rare cases may lead to complications that can be life-threatening (rare).
• Repeated nausea or vomiting, abdominal pain or rapid breathing (rare).
• Seizures or convulsions (rare) have been reported.
• Serotonin syndrome (unknown) should inform your doctor if you experience agitation, confusion, delirium, rigidity, tremors, discoordination, seizures, rapid heartbeats, severe respiratory problems, and diarrhea (suggestive of serotonin syndrome) while also taking antidepressants called ISRSs and opioids (see section2).
• Unexplained bleeding or bruising, which may be due to a change in the number of certain blood cells that can affect blood clotting or produce anemia (frequent).
• Reduction in the number of white blood cells that can affect the ability to fight infections (rare). Some signs of infection include: fever (frequent), sore throat (rare), mouth ulcers (rare), and fatigue (rare).
• Muscle pain without apparent cause, sensitivity or weakness and/or dark urine (rare)This may be a sign of a serious condition called rhabdomyolysis (muscle degradation), which can cause kidney damage.
• Pancreatitis (rare).
• Convulsions (rare).
• Transient ischemic attacks (temporary disruption of blood flow to the brain causing symptoms for a short time such as loss of vision, weakness in arms and legs, difficulty speaking, and loss of consciousness) (rare).
• Tinnitus (ringing in the ears) (rare).

Cases of numbness, tingling or blurred vision have been reported in patients who have taken Zyvoxid for more than 28días. If you experience vision difficulties, consult your doctor as soon as possible.

Other side effects include:

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

• Fungal infections, especially in the vagina or mouth.
• Headache.
• Metalllic taste.
• Diarrhea, vomiting, nausea.
• Alteration of some blood test results, including protein, salt or enzyme tests that measure liver, kidney or blood sugar function.
• Difficulty sleeping.
• Increased blood pressure.
• Anemia (reduction in the number of red blood cells).
• Dizziness.
• Localized or generalized abdominal pain.
• Constipation.
• Indigestion.
• Localized pain.
• Reduction in platelet count.

Rare (may affect up to 1 in 1000people):

• Change in the color of the tooth surface, which disappears with professional dental cleaning procedures.

Also, the following side effects have been reported (unknown: the frequency cannot be estimated from the available data):

• Alopecia (hair loss).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use https://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packaging or blister after«CAD». The expiration date is the last day of the month indicated. This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Composition of Zyvoxid

-The active ingredient is linezolid. Each film-coated tablet contains 600mg of linezolid.

-The other components are: maize starch, microcrystalline cellulose (E460), hydroxypropyl cellulose (E463), sodium carboxymethyl starch (type A) (derived from potato starch) (see section2 “Zyvoxid contains sodium”), and magnesium stearate (E572). Thefilm coatingcontains: hypromellose (E464), titanium dioxide (E171), macrogol 400, and carnauba wax (E903).

Appearance of the product and contents of the Zyvoxid package

Zyvoxid 600mg film-coated tablets are white, oval-shaped, engraved with “ZYV” on one side and “600” on the other.

The film-coated tablets of Zyvoxid are available in blister strips of 10 tablets that are presented in a carton. Each carton contains 10, 20, 30, 50, 60, or 100 film-coated tablets. The tablets, also white, are available in HDPE bottles with a polypropylene screw cap with 10, 14, 20, 24, 30, 50, 60, or 100 film-coated tablets (only for hospital use).

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Pfizer, S.L.

Avda. Europa, 20B.

Parque Empresarial La Moraleja.

28108, Alcobendas. Madrid

Spain.

Responsible manufacturer

Pfizer Manufacturing Deutschland GmbH

Mooswaldallee 1

79108 Freiburg Im Breisgau.

Germany

.

This medicine is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Last review date of this leaflet:

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/