600 mg film-coated tablets
linezolid
What Zyvoxid is and what it is used for
Zyvoxid is an antibiotic from the oxazolidinone class that prevents the growth of certain bacteria ( pathogens ) that cause infection. Zyvoxid is used to treat pneumonia and certain skin and soft tissue infections. Your doctor will decide if Zyvoxid is a suitable treatment for your infection.
What you need to know before using Zyvoxid
Do not use Zyvoxid
- if you are allergic to linezolid or any of the other ingredients of this medicine (listed in section 6).
- if you use or if you have used in the last 2 weeks any monoamine oxidase inhibitor (MAO inhibitor: for example phenelzine, isocarboxazid, selegiline, moclobemide). These drugs can be used, among other things, to treat depression or Parkinson’s disease.
- if you are breastfeeding, as Zyvoxid passes into breast milk and may affect the baby.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Zyvoxid.
Zyvoxid should possibly not be used if you answer yes to any of the questions below. If this is the case, inform your doctor who may need to review your general health including your blood pressure before and during treatment, and possibly decide that another treatment is more suitable for you.
Discuss with your doctor if you are unsure if any of the questions below apply to you.
- Do you have high blood pressure, regardless of whether you take any medicine for it?
- Have you been diagnosed with an overactive thyroid?
- Do you have a tumor on the adrenal gland ( pheochromocytoma ) or carcinoid syndrome (caused by a tumor in the hormonal system with symptoms such as diarrhea, flushing, and problems with wheezing when breathing)?
- Do you suffer from manic depression, schizophrenia with mood swings, confusional states, or other mental problems?
- Have you previously had hyponatremia (low sodium levels in the blood) or are you taking medicines that lower sodium levels in the blood, e.g. certain diuretics (also known as diuretics) such as hydrochlorothiazide?
- Do you use opioids?
The use of certain medicines, including antidepressants and opioids, together with Zyvoxid can lead to serotonin syndrome, a potentially life-threatening condition (see section 2 “Other medicines and Zyvoxid” and section 4).
Be especially careful with Zyvoxid
Tell your doctor before starting treatment with this medicine if you
- is an elderly person
- bruises easily and starts bleeding
- have anemia (low number of red blood cells )
- is susceptible to infection
- previously had seizures
- have liver or kidney problems and above all, if you are on dialysis
- have diarrhea.
Tell your doctor immediately if during ongoing treatment you experience the:
- vision problems, such as blurred vision, altered color vision, reduced visual acuity, or limitations in the field of vision, etc.
- loss of feeling in the arms or legs, or tingling or crawling in the arms or legs.
- diarrhea. You may develop diarrhea while taking or after taking antibiotics, including Zyvoxid. If diarrhea becomes severe or persistent, or if you find that your stool contains blood or mucus, stop taking Zyvoxid immediately and contact your doctor. In this situation, you should not take any medicine that can stop or prolong bowel movements.
- recurrent nausea or vomiting, abdominal pain, or faster breathing.
- nausea and not feeling well with muscle weakness, headache, confusion, and forgetfulness. It may indicate hyponatremia (low sodium levels in the blood).
Other medicines and Zyvoxid
There is a risk that Zyvoxid sometimes interacts with certain other medicines and causes side 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 in the last two weeks have taken any of the following medicines as Zyvoxid must not be used if you are already taking or have recently taken them (see also section 2 “Do not take Zyvoxid”).
- monoamine oxidase inhibitors (eg phenelzine, isocarboxazid, selegiline, moclobemide). These drugs can be used to treat depression or Parkinson’s disease.
Also, tell your doctor if you are taking any of the following medicines. Your doctor may still decide to give you Zyvoxid but needs to check your general health and blood pressure before starting treatment and continuously during treatment. Your doctor may also decide to give you another, more appropriate treatment.
- decongestants containing pseudoephedrine or phenylpropanolamine
- certain medicines used to treat asthma such as salbutamol, terbutaline, fenoterol
- certain antidepressants are known as tricyclics or SSRIs (selective serotonin reuptake inhibitors). There are many such drugs such as amitriptyline, citalopram, clomipramine, dosulepin, doxepin, fluoxetine, fluvoxamine, imipramine, lofepramine, paroxetine, sertraline
- medicines used to treat migraines, such as sumatriptan and zolmitriptan
- medicines used to treat sudden, severe allergic reactions, such as adrenaline
- medicines that raise your blood pressure, such as norepinephrine, dopamine, and dobutamine
- opioids such as pethidine – used to treat moderate to severe pain conditions
- medicines used to treat anxiety disorders such as buspirone
- medicines that prevent the formation of blood clots, such as warfarin.
- an antibiotic called rifampicin
Zyvoxid with food, drink, and alcohol
- You can take Zyvoxid either before, during, or after a meal.
- Avoid large amounts of aged cheese, yeast extract, or soybean extract (such as soy sauce), and avoid drinking alcohol (especially draft beer and wine). This is because Zyvoxid can react with a substance, tyramine, which is found naturally in certain foods. This interaction can increase blood pressure et.
- Tell your doctor, pharmacist, or nurse immediately if you experience a pounding headache after eating or drinking.
Pregnancy, breastfeeding, and fertility
The effect of Zyvoxid on pregnant women is unknown. Therefore, Zyvoxid should not be used during pregnancy unless specifically prescribed by a 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 using this medicine.
You should not breastfeed while using Zyvoxid as the medicine passes into breast milk and may affect the baby.
Driving ability and use of machinery
Zyvoxid may make you feel dizzy or experience problems with your vision. If this happens, do not drive or use machines. Remember that if you are unwell, your ability to drive and use machines may be affected.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Zyvoxid contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 600 mg tablet, i.e. it is almost “sodium-free”.
How to use Zyvoxid
Adults
Always use this medicine according to what is written in this leaflet or according to the instructions of the doctor, pharmacist, or nurse. Consult a doctor, pharmacist, or nurse if you are unsure. The recommended dose is one tablet (600 mg linezolid) twice daily (every 12 hours). Swallow the tablet whole with water.
If you are undergoing kidney dialysis, Zyvoxid should be taken after the dialysis treatment.
The usual duration of treatment is 10 to 14 days but can be up to 28 days. The safety and effectiveness of this drug have not been established when used for more than 28 days. Your doctor will decide how long you will be treated.
While you are taking Zyvoxid, your doctor will carry out regular blood tests to check your blood count.
Your doctor should check your vision if you receive Zyvoxid for more than 28 days.
Use for children and adolescents
Zyvoxid is not normally used for treatment in children and adolescents (under 18 years of age).
If you have used too much Zyvoxid
If you have ingested too much medicine or if, for example, a child accidentally ingested the medicine
immediately contact a doctor or hospital for an assessment of the risk and advice. Alternatively, contact a pharmacist immediately.
If you forget to use Zyvoxid
Take the forgotten tablet as soon as you remember. Take the next tablet 12 hours after this and then continue to take your tablets every 12 hours. Do not take a double dose to make up for a missed tablet.
If you stop using Zyvoxid
You must continue to take Zyvoxid unless your doctor tells you to stop treatment.
Tell your doctor or pharmacist immediately if you stop treatment and the return of your original symptoms.
If you have any further questions about this medicine, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor, nurse, or pharmacist immediately if you experience any of the following side effects during treatment with Zyvoxid.
The most serious side effects (with frequency in brackets) during treatment with Zyvoxid are:
- Severe skin reactions (uncommon), swelling especially of the face and neck (uncommon), wheezing, and/or difficulty breathing (rare). This may be a sign of an allergic reaction and it may be necessary for you to stop treatment with Zyvoxid. Skin reactions such as a raised, purple rash due to inflammation of the blood vessels (rare), tender redness and scaly skin ( dermatitis ) (uncommon), rash (common), and itching (common).
- Problems with your vision (uncommon) such as blurred vision (uncommon), change in color vision (reported), difficulty seeing details (reported), or if you feel that your field of vision is becoming restricted (rare).
- Severe diarrhea containing blood and/or mucus (antibiotic-associated colitis including pseudomembranous colitis ), which may rarely develop into life-threatening complications (less common).
- Recurrent nausea or vomiting, stomach pain, or faster breathing (rare).
- Seizures (less common) have been reported with Zyvoxid.
- Serotonergic syndrome (has been reported): You should contact your doctor immediately if you experience restlessness, confusion, confusion, stiffness, tremors, difficulty coordinating your movements, seizures, faster heart rate, severe breathing difficulties, and diarrhea (signs of serotonin syndrome) if you at the same time also taking antidepressants known as SSRIs or opioids (see section 2).
- Unexplained bleeding or bruising may be due to changes in the number of certain blood cells may affect the ability of the blood to clot (coagulate) or lead to anemia ( common ).
- Changes in the number of certain blood cells can affect your ability to fight infection (less common). Signs of infection include fever (common), sore throat (less common), mouth sores (less common), and fatigue (less common).
- Inflammation of the pancreas (less common).
- Cramps (less common).
- Transient ischemic attacks (temporary disturbances in blood flow through the brain causing short, transient symptoms such as loss of vision, weakness in the legs and arms, slurred speech, and unconsciousness) (uncommon).
- Tinnitus ( less common).
Numbness, tingling, or blurred vision have been reported in patients treated with Zyvoxid for more than 28 days. Contact your doctor immediately if you experience vision problems.
Other side effects include:
Common (may affect up to 1 in 10 users):
- fungal infections, especially in the vagina or oral cavity
- headache
- metallic taste in the mouth
- diarrhea, nausea, or vomiting
- change in certain blood test results, including those that measure protein levels, salts, or enzymes, which show your kidney or liver function or blood sugar level
- sleep difficulties
- increased blood pressure
- anemia (low number of red blood cells )
- dizziness
- localized or generalized abdominal pain
- constipation
- indigestion
- localized pain
- decreased number of blood platelets.
Uncommon (may affect up to 1 in 100 users):
- inflammation of the vagina or vagina in women
- sensations such as numbness and tingling
- swollen, tender, or discolored tongue
- dry mouth
- increased frequency of urination
- overindulge
- increased thirst
- increased sweating
- hyponatremia (low levels of sodium in the blood)
- kidney failure
- gas in the stomach
- elevated creatinine
- stomach ache
- impact on heart rhythm (e.g. faster heart rate)
- reduced number of blood cells
- weakness and/or sensory changes.
Rare (may affect up to 1 in 1,000 users):
- superficial tooth discoloration, which can be removed manually with professional teeth cleaning.
Has been reported (occurring in an unknown number of users):
- hair loss.
How Zyvoxid should be stored
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the package or blister pack. The expiration date is the last day of the specified month. This medicine has no special storage instructions.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist
Contents of the packaging and other information
Contents declaration
- The active substance is linezolid. One tablet contains 600 mg of linezolid.
- Other ingredients are corn starch (from corn), microcrystalline cellulose (E460), hydroxypropyl cellulose (E463), sodium starch glycolate type A (see section 2, “Zyvoxide contains sodium”), and magnesium stearate (E572). The film coating contains hypromellose (E464), titanium dioxide (E171), macrogol 400, and carnauba wax (E903).
Appearance and package sizes of the medicine
Zyvoxid 600 mg tablets are white, oval, and debossed with “ZYV” on one side and “600” on the other side.
Zyvoxid tablets are supplied in blister packs of 10 tablets packed in a carton. Each box contains either 10, 20, 30, 50, 60, or 100 tablets. The tablets are also supplied in a white HDPE jar with a polypropylene screw cap containing either 10, 14, 20, 24, 30, 50, 60, or 100 (hospital use only) tablets.
Not all pack sizes may be marketed.
Pfizer AB
191 90 Sollentuna
Phone: 08/550 520 00
Manufacturer
Pfizer Service Company, BVBA, Hoge Wei 10, 1930 Zaventem, Belgium
or
Pfizer Manufacturing Deutschland GmbH, Betriebsstätte Freiburg, Mooswaldallee 1, D-79090 Freiburg,
Germany