Zyvoxid 600 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

ZYVOXID 600 mg film-coated tablets

Linezolid

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, 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 other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Zyvoxid is and what it is used for
2. What you need to know 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 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 influenza or the common cold.

It is important that you follow your doctor's instructions regarding dosage, administration, and duration of treatment.

Do not store or reuse this medicine. If you have any antibiotic left over after completing your treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines by flushing them down the sink or in the household waste.

It is used to treat pneumonia and certain skin or subcutaneous tissue infections. Your doctor will have decided whether Zyvoxid is appropriate for treating your infection.

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

Do not take Zyvoxid if:

• you are allergic to linezolid or to any of the other components of this medicine (listed in section 6).
• you are taking or have taken within the last 2 weeks any medicines known as monoamine oxidase inhibitors (MAOIs, such as phenelzine, isocarboxazide, selegiline, moclobemide). These medicines are usually used to treat depression or Parkinson's disease.
• you are breastfeeding. Zyvoxid passes into breast milk and could affect the baby.

Warnings and precautions

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

Zyvoxid may not be suitable for you if you answer yes to any of the following questions. In such cases, inform your doctor, as they will need to monitor your general health and blood pressure before and during treatment, or may decide that another treatment is more appropriate for you.

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

• Do you have high blood pressure, whether or not you are taking medication for it?
• Have you been diagnosed with hyperactive thyroid?
• Do you have a tumor of the adrenal glands (pheochromocytoma) or carcinoid syndrome (caused by tumors in the hormonal system, presenting symptoms such as diarrhea, skin flushing, wheezing)?
• Do you suffer from manic depression, schizophrenia, confusion, or other mental disorders?
• 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?

Using certain medicines, including antidepressants and opioids, together with Zyvoxid may lead to serotonin syndrome, a potentially life-threatening condition (see section 2 “Other medicines and Zyvoxid” and section 4).

Take special care with Zyvoxid:

Inform your doctor before taking this medicine if:

• You are elderly.
• You bruise easily or bleed excessively.
• 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 any of the following occur during treatment:

• Vision 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 arms or legs, or a tingling or burning sensation in arms or legs.
• Diarrhea may occur while taking or after stopping antibiotics, including linezolid. If diarrhea becomes severe, persists for a long time, or if you notice blood or mucus in your stools, stop taking Zyvoxid immediately and consult your doctor. In this situation, do not take medications that slow or reduce intestinal movements.
• Repeated nausea or vomiting, abdominal pain, or rapid breathing.
• Muscle pain without apparent cause, 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.
• Malaise and dizziness with muscle weakness, headache, confusion, and memory impairment, which may indicate hyponatremia (low sodium levels in the blood).

Use of Zyvoxid with other medicines

Zyvoxid may sometimes interact with certain medicines and cause 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 taken any of the following medicines within the last 2 weeks, as you must not take Zyvoxid if you are still taking them or have recently taken them (see also section 2 above, “Do not take Zyvoxid”):

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

Also inform your doctor if you are taking any of the following medicines. Your doctor may decide to treat you with Zyvoxid, but will need to assess your general condition and blood pressure before and during treatment. In some cases, your doctor may decide that another treatment is more suitable for you.

• Cold decongestants containing pseudoephedrine or phenylpropanolamine.
• Certain asthma medications such as salbutamol, terbutaline, or fenoterol.
• Certain antidepressants called tricyclics or SSRIs (selective serotonin reuptake inhibitors). There are many medicines of this type, including amitriptiline, citalopram, clomipramine, dosulepin, doxepin, fluoxetine, fluvoxamine, imipramine, lofepramine, paroxetine, or sertraline.
• Medicines used to treat migraines such as sumatriptan or zolmitriptan.
• Medicines used to treat sudden severe allergic reactions such as adrenaline (epinephrine).
• Medicines that increase blood pressure such as noradrenaline (norepinephrine), dopamine, and dobutamine.
• Opioids (e.g., pethidine) used to treat 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 may take Zyvoxid before, during, or after meals.
• Avoid eating excessive amounts of cheese, yeast extracts, soybean seed extracts (e.g., soy sauce), or drinking alcoholic beverages, especially draught beer and wine. The reason is that Zyvoxid can react with a substance called tyramine, which occurs naturally in some foods. This interaction may cause an increase in your blood pressure.
• If you develop a headache after eating or drinking, inform your doctor, pharmacist, or nurse immediately.

Pregnancy, breastfeeding, and fertility

The effect of Zyvoxid in 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

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

Driving and using machines

Zyvoxid may cause dizziness or vision problems. If this occurs, do not drive or operate machinery. Remember that your ability to drive or operate machinery may be impaired if you do not feel well.

Zyvoxid contains sodium

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

3. How to take Zyvoxid

Adults

Always follow exactly the instructions for taking this medicine provided in this leaflet, or those given by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.

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

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

The usual duration of treatment is 10–14 days, but may be extended up to 28 days. The safety and efficacy of this medicine have not been established for treatment periods longer than 28 days. Your doctor will decide the duration of your treatment.

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

If you take Zyvoxid for longer than 28 days, your doctor should monitor your vision.

Use in children and adolescents

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

If you take more Zyvoxid than you should

In case of overdose or accidental ingestion, immediately consult your doctor or pharmacist or call the Toxicology Information Service at telephone number 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 after the missed dose, then continue taking the film-coated tablets every 12 hours. Do not take a double dose to make up for the forgotten dose.

If you stop taking Zyvoxid

It is important that you interrupt your treatment only if instructed to do so by your doctor.

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Tell your doctor, nurse, or pharmacist immediately if you notice any of the following adverse effects while being treated with Zyvoxid:

The most serious adverse effects of Zyvoxid (with their frequency in parentheses) are:

• Severe skin reactions (uncommon), swelling particularly around the face and neck (uncommon), wheezing and/or difficulty breathing (rare). These may be signs of an allergic reaction, and treatment with Zyvoxid may need to be stopped. Skin reactions such as raised purple rash due to inflammation of blood vessels (rare), red, sore, and scaly skin (dermatitis) (uncommon), skin rash (common), itching (common).
• Vision problems (uncommon), such as blurred vision (uncommon), changes in color perception (frequency not known), difficulty seeing fine details (frequency not known), or if you notice a reduction in your visual field (rare).
• Severe diarrhea containing blood and/or mucus (antibiotic-associated colitis including pseudomembranous colitis), which in rare cases may lead to complications that could become life-threatening (uncommon).
• Repeated nausea or vomiting, abdominal pain, or rapid breathing (rare).
• Cases of epileptic seizures or convulsions have been reported (uncommon).
• Serotonin syndrome (frequency not known): inform your doctor if you experience agitation, confusion, delirium, muscle rigidity, tremor, lack of coordination, seizures, rapid heartbeat, severe breathing problems, and diarrhea (suggestive of serotonin syndrome) while also being treated with antidepressants called SSRIs and opioids (see section 2).
• Unexplained bleeding or bruising, which may be due to changes in the number of certain blood cells that can affect blood clotting or cause anemia (common).
• Reduction in the number of blood cells that may affect the ability to fight infections (uncommon). Some signs of infection include: fever (common), sore throat (uncommon), mouth ulcers (uncommon), and fatigue (uncommon).
• Muscle pain without apparent cause, tenderness or weakness, and/or dark urine (rare). These may be signs of a serious condition called rhabdomyolysis (muscle breakdown), which can lead to kidney damage.
• Inflammation of the pancreas (uncommon).
• Seizures (uncommon).
• Transient ischemic attacks (temporary disruption of blood flow to the brain causing short-term symptoms such as loss of vision, weakness in arms and legs, difficulty speaking, and loss of consciousness) (uncommon).
• Ringing in the ears (tinnitus) (uncommon).

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

Other adverse effects include:

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

• Fungal infections, especially in the vagina or mouth.
• Headache.
• Metallic taste.
• Diarrhea, vomiting, nausea.
• Changes in certain blood test results, including tests for proteins, salts, or enzymes measuring liver or kidney function, or blood sugar levels.
• 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.

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

• Inflammation of the vagina or female genital area.
• Tingling or numbness sensations.
• Swelling, discomfort, changes in tongue color.
• Dry mouth.
• Need to urinate more frequently.
• Chills.
• Feeling thirsty.
• Increased sweating.
• Hyponatremia (low sodium levels in blood).
• Kidney failure.
• Abdominal swelling.
• Increased creatinine.
• Stomach pain.
• Changes in heart rhythm (e.g., increased heart rate).
• Decrease in blood cell counts.
• Weakness and/or sensory changes.

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

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

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

• Alopecia (hair loss).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Zyvoxid

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

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the container or blister after "EXP". The expiry date refers to the last day of the month indicated. This medicine does not require special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Zyvoxid

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

-The other components are: corn starch, microcrystalline cellulose (E460), hydroxypropylcellulose (E463), sodium carboxymethylstarch (type A) (derived from potato starch) (see section 2 “Zyvoxid contains sodium”), and magnesium stearate (E572). The film coating contains: hypromellose (E464), titanium dioxide (E171), macrogol 400, and carnauba wax (E903).

Appearance of Zyvoxid and contents of the pack

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

Zyvoxid film-coated tablets are available in 10-tablet blisters packed in cartons. Each carton contains 10, 20, 30, 50, 60, or 100 film-coated tablets. The white tablets are also available in HDPE bottles with a polypropylene screw cap containing 10, 14, 20, 24, 30, 50, 60, or 100 film-coated tablets (for hospital use only).

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Pfizer, S.L.

Avda. Europa, 20B.

Parque Empresarial La Moraleja.

28108, Alcobendas. Madrid

Spain.

Manufacturer

Pfizer Manufacturing Deutschland GmbH

Mooswaldallee 1

79108 Freiburg Im Breisgau.

Germany

This medicinal product is authorized in the European Economic Area Member States and in the United Kingdom (Northern Ireland) under the following names:

Date of the most recent review of this leaflet:

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