600 mg film-coated tablets
linezolid
What Linezolid Sandoz is and what it is used for
Linezolid Sandoz is an antibiotic from oxazolidinonklassen that prevents the growth of certain bacteria ( pathogenic s) causing the infection s. Linezolid Sandoz is used to treating pneumonia and certain skin and soft tissue infections. Your doctor will decide if Linezolid Sandoz is the right treatment for your infection.
Linezolid contained in Linezolid Sandoz may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you take Linezolid Sandoz
Do not take Linezolid Sandoz:
- if you are allergic to linezolid or any of the other ingredients of this medicine (listed in section 6).
- if you are taking or if you have used any monoamine oxidase inhibitors in the past 2 weeks (MAO inhibitors such as phenelzine, isocarboxazide, selegiline , moclobemide). These drugs can be used, among other things, to treat depression or Parkinson’s disease .
- if you are breast-feeding, as it passes into the breast milk and may affect the baby.
Linezolid Sandoz may not be used if you answer yes to any of the following questions. If so, 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 appropriate for you.
Discuss with your doctor if you are unsure if any of the following questions apply to you
- Do you have high blood pressure ?
- Have you been diagnosed with an overactive thyroid gland ?
- 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, skin redness, problems with wheezing when breathing)?
- Do you suffer from manic depression, schizophrenia with a changing mood, confusion or other mental problems?
- Are you taking any of the following medicines?
- decongestants used in colds, containing pseudoephedrine or phenylpropanolamine
- drugs used to treat asthma, such as salbutamol , terbutaline , fenoterol
- antidepressant drugs such as tricyclic or SSRIs (selective serotonin reuptake inhibitors) e.g. amitriptyline, citalopram , clomipramine, dosulepin, doxepine, fluoxetine , fluvoxamine, imipramine, lofepramine, paroxetine , sertraline
- drugs used to treat migraines , such as sumatriptan and zolmitriptan
- drugs used to treat sudden, severe allergic reactions such as adrenaline ( epinephrine )
- medicines that increase your blood pressure such as norepinephrine ( norepinephrine ), dopamine and dobutamine
- drugs used to treat moderate to severe pain conditions such as pethidine
- drugs used to treat anxiety disorders such as buspirone
- an antibiotic called rifampicin.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before taking Linezolid Sandoz if you
- easily bruises and begins to bleed
- have anemia
- is susceptible to infection you
- have previously had seizures
- have liver or kidney problems and especially if you get dialysis
- have diarrhea.
Tell your doctor immediately if you suffer from ongoing treatment
- problems with vision, such as blurred vision, altered color vision, impaired visual acuity, or visual field limitations .
- diarrhea. You may develop diarrhea while you are taking or after taking antibiotics , including Linezolid Sandoz. If the diarrhea becomes severe or persistent or if you find that your stools contain blood or mucus, you should immediately stop your treatment with Linezolid Sandoz and contact your doctor. In this situation, do not take any medication that may stop or slow bowel movements.
- recurrent nausea or vomiting, abdominal pain or shortness of breath.
While you are taking Linezolid Sandoz, your doctor will perform regular blood tests to check your blood count.
Your doctor should check your vision if you are taking Linezolid Sandoz for more than 28 days.
Children and young people
Linezolid Sandoz is not normally used to treat children and adolescents (under 18 years of age).
Other medicines and Linezolid Sandoz
There is a risk that Linezolid Sandoz will interact with certain other medicines and cause side effects such as changes in blood pressure, body temperature, or heart rate.
Tell your doctor if you are taking or have taken any of the following medicines in the last two weeks as Linezolid Sandoz should not be used if you are already taking or have recently used them (see also section 2 “Do not take Linezolid Sandoz”):
- monoamine oxidase inhibitors (eg phenelzine, isocarboxazide, 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 Linezolid Sandoz but need 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 which contain pseudoephedrine or phenylpropanolamine
- Some drugs used to treat asthma such as salbutamol , terbutaline , phenoterol
- certain antidepressant drugs known as tricyclics or SSRIs (selective serotonin reuptake inhibitors). There are many such drugs as amitriptyline, citalopram , clomipramine, dosulepin, doxepin, fluoxetine , fluvoxamine, imipramine, lofepramine, paroxetine , sertraline
- drugs used to treat migraines , such as sumatriptan and zolmitriptan
- drugs used to treat sudden, severe allergic reactions, such as adrenaline ( epinephrine )
- medicines that raise your blood pressure , such as norepinephrine ( norepinephrine ), dopamine and dobutamine
- drugs used to treat moderate to severe pain conditions such as pethidine
- drugs used to treat anxiety disorders such as buspirone
- drugs that prevent the formation of blood clots, such as warfarin .
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Linezolid Sandoz with food, drink and alcohol
- 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 this drug can react with a substance, tyramine, which is found naturally in certain foods and it can increase blood pressure .
- Tell your doctor or pharmacist immediately if you experience throbbing headaches after eating or drinking.
See also section 3 “Method of administration” for further information.
Pregnancy and breastfeeding
The effect of Linezolid Sandoz in pregnant women is unknown. Therefore, it should not be used during pregnancy except after a special prescription by a doctor.
If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
You should not breastfeed while using Linezolid Sandoz as the medicine passes into breast milk and may affect the baby.
Driving and using machines
Linezolid Sandoz may make you feel dizzy or have problems with your vision. If this happens, do not drive or use machines. Remember that if you do not feel well, 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 sharpened 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. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Linezolid Sandoz contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per film-coated tablet, ie essentially ‘sodium-free’.
How to take Linezolid Sandoz
Adults
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose for adults is one tablet (600 mg linezolid) twice daily (every 12 hours).
The usual duration of treatment is 10 to 14 days but can be up to 28 days.
The safety and efficacy of this medicine have not been established during treatment over 28 days. Your doctor will decide how long you should be treated.
Method of administration
Swallow the tablet whole with a little water.
You can take Linezolid Sandoz either before, during, or after a meal.
If you are undergoing kidney dialysis, take Linezolid Sandoz after dialysis.
Use for children and adolescents
Linezolid Sandoz is not normally used to treat children and adolescents (under 18 years of age).
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 these side effects during treatment with Linezolid Sandoz:
- skin reactions such as sore, redness and scaly skin ( dermatitis ), rash, itching or swelling, especially on the face and neck. This may be a sign of an allergic reaction and it may be necessary for you to stop taking Linezolid Sandoz.
- problems with vision such as blurred vision, altered color vision, difficulty seeing details or if you experience that the field of vision becomes limited.
- severe diarrhea with blood and / or mucus (antibiotic-associated colitis including pseudomembranous colitis ), which in very rare cases can develop into life-threatening complications.
- recurrent nausea or vomiting, abdominal pain or shortness of breath.
- Seizures have been reported with Linezolid Sandoz.You should contact your doctor immediately if you experience anxiety, confusion , confusion, stiffness, tremors, difficulty coordinating your movements or have seizures if you are also taking antidepressant drugs known as SSRIs (see section 2).
Numbness, tingling, or blurred vision have been reported in patients treated with Linezolid Sandoz 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 people) :
- 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 showing your kidney or liver function or blood sugar level
- unexplained bleeding or bruising, which may be due to changes in the number of certain blood cells which may affect the blood’s ability to clot (coagulate) or lead to anemia ( anemia ).
Uncommon (may affect up to 1 in 100 people):
- inflammation of the vagina or abdomen in women
- changes in the number of certain blood cell s, which can affect your ability to fight infection s
- difficulty sleeping
- dizziness, various sensations such as ant crawling and numbness
- dimsyn
- ringing in the ears ( tinnitus )
- increased blood pressure , inflammation of veins
- indigestion, stomach pain, constipation
- dry mouth or soreness in the mouth, swollen, sore or discolored tongue
- rash
- increased urination frequency
- fever or chills, pain and aches
- feeling tired, increased thirst
- inflammation of the pancreas
- increased sweating
- effects on blood test results such as protein levels, salts or enzymes used as a measure of kidney or liver function.
Rare (may affect up to 1 in 1,000 people):
- effect on heart rate (faster heart rate)
- transient ischemic attacks (temporary disturbances in the blood flow through the brain causing short, transient symptoms such as loss of vision, weakness in the legs and arms, slurred speech and unconsciousness)
- kidney failure .
Has been reported (occurs in the unknown number of users):
- serotonergic syndrome (with symptoms of rapid heartbeat, confusion, abnormal sweating, hallucinations, involuntary movements, chills and tremors)
- lactic acidosis (with symptoms of recurrent nausea and vomiting, abdominal pain and faster breathing)
- severe skin reactions
- cramps
- superficial tooth discoloration, which can be removed with professional tooth cleaning (manual removal)
- hair loss
- hyponatremia (low levels of sodium in the blood)
- altered color vision, difficulty seeing details or limited field of vision .
How to store Linezolid Sandoz
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. or EXP. The expiration date is the last day of the specified month.
No special storage instructions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is linezolid. Each film-coated tablet contains 600 mg linezolid.
- The other ingredients are microcrystalline cellulose, anhydrous colloidal silica, sodium starch glycolate type A, hydroxypropylcellulose, magnesium stearate in the tablet core; hypromellose (E464), titanium dioxide (E171) and macrogol (E1521) in the film coating.
What the medicine looks like and contents of the pack
Linezolid Sandoz 600 mg film-coated tablet is a white to off-white, biconvex oval film-coated tablet, 18.8 mm long, 9.9 mm wide, and 6.4 mm thick with “LZ600” embossed on one side and smooth on the other side.
Linezolid Sandoz 600 mg film-coated tablets are supplied in blister packs containing:
10, 10 (10 x 1), 20, 28, 30, 50, 60, 100 film-coated tablets
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Holder of marketing authorization
Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Manufacturer
SC Sandoz, SRL, Str. Livezeni nr. 7A, RO-540472 Targu-Mures, Romania
or
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany
or
Lek Pharmaceuticals dd, Verovškova 57, 1526 Ljubljana, Slovenia