ZYVOXID 600 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

ZYVOXID 600 mg film-coated tablets

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 further information

1. What is Zyvoxid and what is it used for

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

Antibiotics are used to treat bacterial infections and will not work for viral infections such as the common cold or flu.

It is important that you follow the instructions regarding the dose, the taking, and the duration of the treatment as indicated by your doctor.

Do not keep or reuse this medicine. If you have leftover antibiotic after finishing the 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 medicine (listed in section 6).
• you are taking or have taken in the last 2 weeks certain medicines called monoamine oxidase inhibitors (MAOIs, such as phenelzine, isocarboxazid, 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 your baby.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting treatment with Zyvoxid.

Zyvoxid may not be suitable for you if you answer yesto any of the following questions. In this case, tell 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 not sure if any of these categories apply to your case.

• Do you have high blood pressure, are you taking or not taking medicines 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 cause symptoms such as diarrhea, skin flushing, and wheezing)?
• Do you suffer from manic depression, schizophrenic disorder, 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, such as hydrochlorothiazide?
• Do you take opioids?

The use of certain medicines, including antidepressants and opioids, together with Zyvoxid may cause adverse effects such as changes in blood pressure, body temperature, or heart rate.

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.

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

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

Also, inform your doctor if you are taking 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 other cases, your doctor may decide that another treatment is better for you.

• Decongestant remedies for colds containing pseudoephedrine or phenylpropanolamine.
• Certain medicines for treating asthma, such as salbutamol, terbutaline, fenoterol.
• Certain antidepressants called tricyclics or SSRIs (selective serotonin reuptake inhibitors). There are many medicines of this type, including amitriptyline, 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 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 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 may 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 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 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 sodium

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

3. How to take Zyvoxid

Adults

Always take this medicine exactly as described in this leaflet or as directed by your doctor, pharmacist, or nurse. If you are not sure, ask your doctor, pharmacist, or nurse.

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

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 medicine have not been established for treatment periods longer than 28 days. Your doctor will decide the duration of your treatment.

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

If you take Zyvoxid for more than 28 days, your doctor should 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, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Zyvoxid

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

If you stop taking Zyvoxid

It is important that you only stop your treatment if your doctor tells you to.

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 medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

The most serious side effects of Zyvoxid (whose frequency is between parentheses) are:

• Severe skin reactions (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 stopping treatment with Zyvoxid. Skin reactions such as a purple raised 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 (not known), difficulty seeing details (not known), or if you notice that your field of vision is reduced (rare).
• Severe diarrhea that contains blood and/or mucus (antibiotic-associated colitis, including pseudomembranous colitis), which in rare circumstances may lead to life-threatening complications (uncommon).
• Repeated nausea or vomiting, abdominal pain, or rapid breathing (rare).
• There have been reports of seizures or convulsions (uncommon).
• Serotonin syndrome (unknown) should be indicated to your doctor if you experience agitation, confusion, delirium, rigidity, tremor, uncoordinated movements, convulsions, rapid heartbeat, severe respiratory problems, and diarrhea (suggestive of serotonin syndrome) while also being treated with antidepressants called SSRIs and opioids (see section 2).
• Bleeding or bruising without explanation, which may be due to an alteration in the number of certain blood cells that can affect blood clotting or cause 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 (rare). These can be signs of a serious condition called rhabdomyolysis (muscle breakdown), which can cause kidney damage.
• Pancreatitis (uncommon).
• Seizures (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 difficulties with your vision, consult your doctor as soon as possible.

Other side 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.
• Abdominal pain, localized or generalized.
• Constipation.
• Indigestion.
• Localized pain.
• Decreased platelet count.

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

• Vaginal or genital inflammation in women.
• 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 the blood).
• Kidney failure.
• Abdominal swelling.
• Increased creatinine.
• Stomach pain.
• Changes in heart rhythm (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 color, which disappears with professional dental cleaning procedures.

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

• Alopecia (hair loss).

Reporting of side effects

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

5. Storing 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 which is stated on the carton or blister after "EXP". The expiry date is the last day of the month stated. This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package Contents and Additional Information

Zyvoxid Composition

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

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

Appearance and Packaging of Zyvoxid

Zyvoxid 600 mg film-coated tablets are white, oval, 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, 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 containing 10, 14, 20, 24, 30, 50, 60, or 100 film-coated tablets (for hospital use only).

Only some 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 Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of the Last Revision of this Leaflet:

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