ZYVOXID 100 mg/5 ml ORAL SUSPENSION GRANULES

Introduction

Package Leaflet: Information for the User

ZYVOXID 100mg/5 ml granules for oral suspension

Linezolid

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.

Contents of the pack and other information:

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

1. What is Zyvoxid and what is it used for

Zyvoxid is an antibiotic of the oxazolidinone group that works by preventing the growth of certain bacteria (germs) that cause infections.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as flu or the common cold.

It is essential that you follow the instructions regarding dosage, administration, and duration of treatment as indicated by your doctor.

Do not store or reuse this medication. If you have any leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not throw away medicines via wastewater or household waste.

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.

2. What you need to know before you take Zyvoxid

Do not take Zyvoxid if:

• You are allergic to linezolid or any of the other ingredients of this medication (listed in section 6).
• You are taking or have taken in the last 2 weeks any monoamine oxidase inhibitor (MAOI) medications (such as phenelzine, isocarboxazid, selegiline, moclobemide). These medications are usually used to treat depression or Parkinson's disease.
• You are breastfeeding. Zyvoxid passes into breast milk and may affect your baby.

Warnings and precautions

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

Zyvoxid may not be suitable for you if you answer yesto any of the following questions. In this case, inform your doctor, as he/she 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 medications to treat 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, wheezing)?
• Do you suffer from bipolar disorder, schizophrenia, confusion, or other mental problems?
• Do you have a history of hyponatremia (low sodium levels in the blood) 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, along with Zyvoxid, may cause serotonin syndrome, a potentially life-threatening condition (see section 2 "Other medicines and Zyvoxid" and section 4).

Be careful with Zyvoxid:

Inform your doctor before taking this medication if:

• You are an elderly patient.
• You bruise easily and bleed.
• 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:

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

Taking Zyvoxid with other medicines

Occasionally, 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 weeksthe following medications, as you must nottake Zyvoxid if you are still taking them or have taken them recently (see also section 2 above "Do not take Zyvoxid"):

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

Also, inform your doctor if you are taking the following medications. Your doctor may decide to treat you with Zyvoxid, but 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.

• Decongestant remedies for colds containing pseudoephedrine or phenylpropanolamine.
• Certain medications for treating 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, dosulepin, doxepin, fluoxetine, fluvoxamine, imipramine, lofepramine, paroxetine, or sertraline.
• Medications used to treat migraines such as sumatriptan or zolmitriptan.
• Medications for treating severe allergic reactions such as adrenaline (epinephrine).
• Medications that increase blood pressure, such as noradrenaline (norepinephrine), dopamine, and dobutamine.
• Opioids (e.g., pethidine) used to treat moderate to 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 excessive amounts of cheese, yeast extracts, or soybean extracts (e.g., soy sauce) and alcoholic beverages, especially draft beer and wine. The reason is that Zyvoxid can react with a substance called tyramine that is naturally present in some foods. This interaction can cause an increase in your blood pressure.
• If you start experiencing headaches 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 advised by their 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 medication.

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

Driving and using machines

Zyvoxid may cause dizziness or vision problems. If this happens, do not drive or use machines. Remember that if you do not feel well, your ability to drive or use machines may be affected.

Zyvoxid contains:

Aspartame

The suspension of this medication contains 210 mg of aspartame in each dose equivalent to 35 mg/5 ml. Aspartame contains a source of phenylalanine. Phenylalanine may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it properly.

Sucrose and fructose (sugars), mannitol, and sorbitol (sugar alcohols)

The suspension of Zyvoxid does not contain more than 100.8 mg of fructose in each dose equivalent to 16.8 mg/5 ml and does not contain more than 262.8 mg of sorbitol in each dose equivalent to 43.8 mg/5 ml. Sorbitol is a source of fructose.

If your doctor has told you that you (or your child) have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot break down fructose, consult your doctor before taking this medication.

The oral suspension may cause tooth decay due to its fructose and sucrose content.

The oral suspension may have a mild laxative effect due to its mannitol and sorbitol content.

Sodium

The suspension of Zyvoxid contains 68.43 mg of sodium (main component of table salt) which is equivalent to 11.4 mg per 5 ml. The amount of sodium per dose is equivalent to 3.4% of the maximum daily recommended intake for an adult, which should be taken into account in patients with low-sodium diets.

Sodium benzoate

When prepared as a suspension, this medication contains 60 mg of sodium benzoate in each dose equivalent to 10 mg/5 ml. Sodium benzoate may increase the levels of a substance called bilirubin and may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).

Zyvoxid contains Alcohol (ethanol)

When prepared as a suspension, this medication does not contain more than 6 mg of alcohol (ethanol) in each dose which is equivalent to 1 mg/5 ml (0.02% v/v). The amount of alcohol in each dose is equivalent to less than 0.15 ml of beer or 0.06 ml of wine.

The small amount of alcohol in this medication does not produce any noticeable effect.

3. How to take Zyvoxid

Adults

Always take this medication exactly as described in this leaflet or as directed by your doctor, pharmacist, or nurse. If you are unsure, ask your doctor, pharmacist, or nurse.

Zyvoxid is presented in the form of granules, which must be reconstituted exclusively by a healthcare professional to prepare the suspension that you should take.

The recommended dose of Zyvoxid suspension is 6 teaspoons of 5 ml (600 mg of linezolid) twice a day (every 12 hours).

Before each use, gently invert the bottle several times. DO NOT SHAKE.

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

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

Use in children and adolescents

Zyvoxid is not normally used in children or adolescents (under 18 years of age).

If you take more Zyvoxid than you should

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

If you forget to take Zyvoxid

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

If you stop taking Zyvoxid

It is essential that you only stop your treatment if your doctor advises you to do so.

If your initial symptoms return when you stop your treatment, inform your doctor or pharmacist immediately.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Report immediately to your doctor, nurse, or pharmacistif you notice any of the following adverse effects while being treated with Zyvoxid:

The most serious adverse effects of Zyvoxid (whose frequency is in parentheses) are:

• Severe skin disorders (uncommon), swelling particularly around the face and neck (uncommon), wheezing and/or difficulty breathing (rare). This may be a sign of an allergic reaction and may require discontinuation of treatment with Zyvoxid. Skin reactions such as a purplish elevated rash due to inflammation of blood vessels (rare), red, painful, and scaly skin (dermatitis) (uncommon), skin rash (frequent), itching (frequent).
• Vision problems (uncommon), such as blurred vision (uncommon), changes in color perception (unknown), difficulty seeing details (unknown), or if you notice that your field of vision is reduced (rare).
• Severe diarrhea containing blood and/or mucus (antibiotic-associated colitis including pseudomembranous colitis), which in rare circumstances could lead to life-threatening complications (uncommon).
• Repeated nausea or vomiting, abdominal pain, or rapid breathing (rare).
• There have been reports of epileptic seizures or convulsions (uncommon).
• Serotonin syndrome (unknown) should indicate to your doctor if you experience agitation, confusion, delirium, stiffness, tremor, uncoordination, convulsions, rapid heartbeat, severe respiratory problems, and diarrhea (suggestive of serotonin syndrome) while also being treated with antidepressants called ISRSs or opioids (see section 2).
• Unexplained bleeding or bruising, which may be due to an alteration in the number of certain blood cells that can affect blood coagulation or produce anemia (frequent).
• Reduction in the number of blood cells that can affect the ability to fight infections (uncommon). Some signs of infection include: fever (frequent), sore throat (uncommon), mouth ulcers (uncommon), and fatigue (uncommon).
• Muscle pain without apparent cause, sensitivity, or weakness, and/or dark urine (uncommon). These may be signs of a serious condition called rhabdomyolysis (muscle degradation), which can cause kidney damage.
• Pancreatitis (uncommon).
• Convulsions (uncommon).
• Transient ischemic attacks (temporary alteration of blood flow to the brain that causes short-term symptoms such as vision loss, weakness in arms and legs, difficulty speaking, and loss of consciousness) (uncommon).
• "Ringing" in the ears (tinnitus) (uncommon).

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

Other adverse effects include:

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

• Fungal infections, especially in the vagina or mouth.
• Headache.
• Metallic 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.
• Reduced platelet count.

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

• Inflammation of the vagina or genital area of the woman.
• Feeling of tingling or numbness.
• Swelling, discomfort, color changes of the tongue.
• Dry mouth.
• Need to urinate more frequently.
• Chills.
• Feeling of thirst.
• Increased sweating.
• Hyponatremia (low sodium levels in blood).
• Kidney failure.
• Abdominal swelling.
• Increased creatinine.

• Stomach pain.
• Changes in heart rate (e.g., increased heart rate).
• Decrease in blood cell count.
• Weakness and/or sensory changes.

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

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

The following adverse effects have also been reported (unknown: frequency cannot be estimated from available data):

• Alopecia (hair loss).

Reporting of Adverse Effects

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

5. Storage of Zyvoxid

Keep this medicine out of sight and reach of children.

Store the bottle in the outer packaging to protect it from light.

Do not use this medicine after the expiration date that appears on the packaging after "CAD". The expiration date is the last day of the month indicated.

Validity period of the reconstituted suspension: 21 days. Discard unused solution. Record the reconstitution date on the outer packaging.

Medicines should not be thrown away through wastewater or household waste. Ask your pharmacist how to dispose of packaging and medicines that are no longer needed. This will help protect the environment.

6. Package Contents and Additional Information

Zyvoxid Composition

• The active ingredient is linezolid. After reconstitution, each 5 ml of suspension contains 100 mg of linezolid.
• The other components are sucrose, mannitol (E421), microcrystalline cellulose (E460), sodium carboxymethylcellulose (E551), aspartame (E951), colloidal anhydrous silica (E446), sodium citrate (E331), xanthan gum (E415), sodium benzoate (E211), anhydrous citric acid (E330), sodium chloride, ethanol, and sweeteners (fructose, maltodextrin [derived from corn], glycyrrhizinate monoammonium, and sorbitol). The flavorings are orange flavor, mint flavor, vanilla flavor, and orange cream flavor (see section 2 "Zyvoxid contains aspartame; sucrose, sorbitol, mannitol, and fructose; sodium; sodium benzoate; and alcohol [ethanol]").

Appearance of the Product and Package Contents of Zyvoxid Granules for Oral Suspension

Zyvoxid granules for oral suspension are presented in brown-colored bottles with a white to yellow-orange granule/powder, which may contain white to yellow-orange or yellow-orange-brown lumps. When reconstituted with water, a reconstituted liquid with an orange flavor (suspension) of white to yellow-orange color is obtained. Each bottle is supplied in a cardboard box with a 2.5/5 ml measuring spoon.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Pfizer, S.L. Avda. Europa, 20B.

Parque Empresarial La Moraleja.

28108, Alcobendas,

Madrid, Spain

Manufacturer

Pfizer Service Company, BV.

Hoge Wei, 10.

1930, Zaventem.

Belgium.

This medicine has been authorized in EU Member States under the following names:

Date of the Last Revision of this Prospectus: June 2024

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.

This information is intended only for healthcare professionals:

Instructions for preparing the oral suspension:

Linezolid comes in the form of granules that must be prepared exclusively by a healthcare professional.

Remove the granules and reconstitute using 123 ml of water in two approximately equal aliquots to obtain 150 ml of oral suspension. The suspension must be shaken vigorously between each addition of water. The appearance after reconstitution is a white to yellow-orange suspension.

Before use, gently invert the bottle several times. DO NOT SHAKE.

The usual dose of the Zyvoxid suspension is six 5-ml spoons (600 mg of linezolid) twice a day (every 12 hours).

The disposal of unused medicine and all materials that have come into contact with it will be carried out in accordance with local regulations.

See also section 3 above "How to use Zyvoxid".