Prospecto : Information for the User

ZYVOXID 100mg/5 ml Granulated Suspension for Oral Use

Linezolid

Read this prospect carefully before starting to take this medication,because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only to you, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospect. See section 4.

1.What is Zyvoxid and for what it is used

2.What you need to knowbefore starting totake Zyvoxid

3.How to take Zyvoxid

4.Possible adverse effects

5.Storage of Zyvoxid

6. Contents of the package and additional information

Zyvoxid is an antibiotic from 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 medicine (listed in section 6).
• You are taking or have taken in the last 2 weeks any medicine called monoamine oxidase inhibitors (MAOIs such as, for example, phenelzine, isocarboxazid, selegiline, moclobemide). These medicines 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 take Zyvoxid.

Zyvoxid may not be suitable for you if you respondyesto any of the following questions. In that case, inform your doctor, as he/she will need to monitor your general 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 medicines to treat it?
• Have you been diagnosed with hyperthyroidism?
• Do you have a tumour of the adrenal glands (pheochromocytoma) or carcinoid syndrome (caused by tumours in the hormonal system that present with symptoms of diarrhoea, flushing of the skin, 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 medicines that reduce sodium levels in the blood, such as certain diuretics like hydrochlorothiazide?
• Are you taking opioids?

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

Be especially careful with Zyvoxid:

Inform your doctor before taking this medicine if:

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

Inform your doctor immediately if during treatment you experience:

• Visual problems such as blurred vision, changes in colour vision, difficulty seeing clearly or if you notice that your field of vision is reduced.
• Loss of sensation in your arms or legs or a feeling of tingling or burning in your arms or legs.
• Diarhoea while taking or after taking antibiotics, including linezolid. If the diarrhoea becomes severe, 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 medicines 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 medicines

In some cases, Zyvoxid may interact with certain medicines 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 medicine.

Inform your doctor if you are taking or have been taking in the last 2 weeksthe following medicines, asyou must nottake Zyvoxid if you are still taking them or if you have recently taken them (see also section 2 above “Do not take Zyvoxid”):

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

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

• Cold remedies containing pseudoephedrine or phenylpropanolamine.
• Certain medicines for asthma such as salbutamol, terbutaline, fenoterol.
• Certain antidepressants called tricyclics or SSRIs (selective serotonin reuptake inhibitors). There are many types of these medicines, including amitriptyline, citalopram, clomipramine, dosulepin, doxepin, fluoxetine, fluvoxamine, imipramine, lofepramine, paroxetine, or sertraline.
• Medicines used to treat migraines such as sumatriptan or zolmitriptan.
• Medicines for severe allergic reactions such as adrenaline (epinephrine).
• Medicines that increase blood pressure, such as noradrenaline (norepinephrine), dopamine, and dobutamine.
• Opioids (such as pethidine) used to treat moderate to severe pain.
• Medicines used to treat anxiety disorders such as buspirone.
• Medicines 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 draught 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 advised by their doctor. If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medicine.

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

Driving and operating machines

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

Zyvoxid contains:

Aspartame

The suspension of this medicine contains 210mg of aspartame in each dose equivalent to 35mg/5ml. 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 correctly.

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

The suspension of Zyvoxid contains no more than 100.8mg of fructose in each dose equivalent to 16.8mg/5ml and contains no more than 262.8mg of sorbitol in each dose equivalent to 43.8mg/5ml. 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 is unable to break down fructose, consult your doctor before taking this medicine.

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

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

Sodium

The suspension of Zyvoxid contains 68.43mg of sodium (main component of table salt) equivalent to 11.4mg 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 on low-sodium diets.

Benzoate of sodium

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

Zyvoxid contains Alcohol (ethanol)

When prepared as a suspension, this medicine contains no more than 6mg of alcohol (ethanol) in each dose equivalent to 1mg/5ml (0.02p/v). The amount of alcohol in each dose is equivalent to less than 0.15ml of beer or 0.06ml of wine.

The small amount of alcohol contained in this medicine has no perceptible effect..

Adults

Always follow exactly the medication administration instructions contained in this leaflet or those given by your doctor, pharmacist, or nurse. If in doubt, 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 must be taken.

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

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

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

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

Use in children and adolescents

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

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, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Zyvoxid

Take the dose you forgot as soon as you remember. Take the next dose 12hours later and continue taking the medication every 12hours.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 tells you to.

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.

Inform your doctor, nurse or pharmacist immediatelyif you notice any of the following side effects while taking Zyvoxid:

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

• Severe skin changes (rare), swelling, particularly around the face and neck (rare), shortness of breath and/or difficulty breathing (rare). This may be a sign of an allergic reaction and treatment with Zyvoxid may need to be discontinued. Skin reactions such as purple raised rash due to inflammation of blood vessels (rare), red, painful and scaly skin (dermatitis) (rare), skin rash (frequent), itching (frequent).
• Visual 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 have been reported (rare).
• Serotonin syndrome (unknown) should inform your doctor if you experience agitation, confusion, delirium, rigidity, tremors, discoordination, convulsions, rapid heart rate, severe respiratory problems, and diarrhea (suggestive of serotonin syndrome) while also taking 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 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). These may be signs 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 that causes 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 28days. If you experience vision difficulties, consult your doctor as soon as possible.

Other side effects include:

Frequent (can affect up to1 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.
• Abdominal pain localized or generalized.
• Constipation.
• Indigestion.
• Localized pain.
• Reduction in the number of platelets.

Rare (can affect up to1 in 10,000people):

• Change in the color of the surface of the teeth, 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 Usehttps://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.

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

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

Shelf life of the reconstituted suspension: 21 days. Discard any unused solution. Note the date of reconstitution on the outer packaging.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of unused packaging and medication. This will help protect the environment.

Composition of Zyvoxid

• The active ingredient is linezolid. After reconstitution, each 5ml of suspension contains 100mg of linezolid.
• The other components are sucrose, mannitol (E421), microcrystalline cellulose (E460), sodium carboxymethylcellulose (E466), aspartame (E951), anhydrous colloidal silica (E551), sodium citrate (E331), xanthan gum (E415), sodium benzoate (E211), anhydrous citric acid (E330), sodium chloride, ethanol, and sweeteners (fructose, maltodextrin [derived from corn], monoammonium glycyrrhizinate, and sorbitol). The flavoringsare orange flavor, peppermint flavor, vanilla flavor, and orange cream flavor (see section2 “Zyvoxidcontains aspartame; sucrose, sorbitol, mannitol, and fructose; sodium; sodium benzoate, and alcohol (ethanol)”.

Appearance of the product and contents of the Zyvoxid oral suspension packaging

Zyvoxid oral suspension granules are presented in brown bottles with a white to yellow-orange powder/granules, 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 container with a 2.5/5ml measuring spoon.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

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

Parque Empresarial La Moraleja.

28108, Alcobendas,

Madrid, Spain

Manufacturer responsible

Pfizer Service Company, BV.

Hoge Wei, 10.

1930, Zaventem.

Belgium.

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

Last revision date of this leaflet: June 2024

For detailed and updated information on this medicinal product, please consult the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.

This information is intended solely for healthcare professionals:

Instructions for preparing the oral suspension:

Linezolid is supplied as granules that must be prepared exclusively by a healthcare professional.

Remove the granules and reconstitute using 123ml of water in two approximately equal portions to obtain 150ml 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 Zyvoxid oral suspension is six 5ml scoops (600mg of linezolid) twice a day (every 12hours).

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

See section3 above“How to use Zyvoxid”.