600 mg film-coated tablets
linezolid
What Linezolid Teva is and what it is used for
Linezolid Teva is an antibiotic from oxazolidinonklassen that prevents the growth of certain bacteria that cause infection you. It is used to treat pneumonia and certain skin and soft tissue infections. Your doctor will decide if Linezolid Teva is the right treatment for your infection.
Linezolid contained in Linezolid Teva 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 Teva
Do not take Linezolid Teva:
- 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 taken any monoamine oxidase inhibitors in the last 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 Linezolid Teva passes into breast milk and may affect your baby.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before taking Linezolid Teva.
Linezolid Teva 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 , regardless of whether you are taking any medicine for it?
- 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?
Take special care with Linezolid Teva
Tell your doctor before starting treatment with this medicine if you:
- easily bruises and begins to bleed
- have anemia (low red blood cell count )
- 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 experience:
- vision problems such as blurred vision, abnormal color vision, loss of visual acuity or limitations of field of view et
- loss of sensation in the arms and legs or a feeling of tingling or stinging in the arms and legs
- diarrhea. You may develop diarrhea while you are taking or after taking antibiotics , including Linezolid Teva. If the diarrhea becomes severe or persistent or if you find that your stools contain blood or mucus, stop your treatment with Linezolid Teva immediately 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 faster breathing.
Children and young people
Linezolid Teva is not normally used to treat children and adolescents (under 18 years of age).
Other medicines and Linezolid Teva
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
There is a risk that Linezolid Teva will sometimes 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 Teva must not be taken if you are taking or have recently taken them (see also section 2, “Do not take Linezolid Teva”):
- monoamine oxidase inhibitors ( MAOIs , eg phenelzine, isocarboxazide, selegiline , moclobemide). These drugs can be used, among other things, 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 Teva 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
- drugs that raise your blood pressure , such as 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
- an antibiotic called rifampicin.
Linezolid Teva with food, drink and alcohol
- You can take Linezolid Teva 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 Linezolid Teva can react with a substance, tyramine, which is found naturally in certain foods. This interaction may increase blood pressure .
- Tell your doctor or pharmacist immediately if you experience throbbing headaches after eating or drinking.
Pregnancy, breastfeeding and fertility
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 taking this medicine.
The effect of Linezolid Teva in pregnant women is unknown. Therefore Linezolid Teva not be taken during pregnancy unless specifically prescribed by a doctor.
You should not breastfeed while using Linezolid Teva as the medicine passes into breast milk and may affect the baby.
Driving and using machines
Linezolid Teva can 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 Teva contains
Linezolid Teva contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Linezolid Teva contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per film-coated tablet, ie it is essentially ‘sodium-free’.
How to take Linezolid Teva
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Adults
The recommended dose is one film-coated tablet (600 mg linezolid) twice daily (every 12 hours). Swallow the film-coated tablet whole with water.
The tablet has a breaking notch. The notch is only for you to be able to divide the tablet if you have difficulty swallowing it whole.
If you are undergoing kidney dialysis, Linezolid Teva should be taken after dialysis treatment.
The recommended 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 for more than 28 days. Your doctor will decide how long you should be treated.
While you are taking Linezolid Teva, your doctor will perform regular blood tests to check your blood count.
Your doctor should check your vision if you are taking Linezolid Teva for more than 28 days.
Use for children and adolescents
Linezolid Teva 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.
Very common: affects more than 1 user in 10
Common: affects up to 1 in 10 people
Uncommon: affects up to 1 in 100 people
Rare: affects up to 1 in 1,000 people
Very rare: affects up to 1 in 10,000 people
No known frequency: frequency can not be calculated from available data
Tell your doctor, nurse, or pharmacist immediately if you experience any of these side effects during treatment with Linezolid Teva:
The most serious adverse reactions (with frequency in brackets) during treatment with Linezolid Teva are:
- severe skin reactions (have been reported), swelling mainly of the face and neck (have been reported), wheezing and / or difficulty breathing (have been reported). This may be a sign of an allergic reaction and it may be necessary for you to stop taking Linezolid Teva. Skin reactions such as sore, red and scaly skin ( dermatitis ) (uncommon), rash (common), itching (common).
- problems with your vision such as blurred vision (uncommon), altered color vision (reported), difficulty seeing details (reported) or if you experience limited vision (rare).
- severe diarrhea containing blood and / or mucus (antibiotic-associated colitis including pseudomembranous colitis ), which in rare cases can develop into life-threatening complications (rare).
- recurrent nausea or vomiting, abdominal pain or faster breathing (has been reported).
- Seizures (uncommon) have been reported with Linezolid Teva. 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) (reported).
- unexplained bleeding or bruising may be due to changes in the number of certain blood cell s which can affect the blood’s ability to clot (clot) or lead to anemia ( anemia ) (common).
- changes in the number of certain blood cells which may affect your ability to fight infection (common). Signs of infection include: fever (common), sore throat (uncommon), cold sores (uncommon) and feeling tired (uncommon).
- inflammation of the pancreas (less common).
- cramps (less common).
- transient ischemic attacks (temporary disturbances in the blood flow through the brain which cause short, transient symptoms such as loss of vision, weakness in the legs and arms, slurred speech and unconsciousness) (less common).
- ringing in the ears ( tinnitus ) (less common).
- Numbness, tingling or blurred vision have been reported in patients treated with Linezolid Teva for more than 28 days. Contact your doctor immediately if you experience vision problems.
Other side effects include:
Usual:
- fungal infections mainly 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
- difficulty sleeping
- increased blood pressure
- anemia (low red blood cell count )
- dizziness
- localized or general abdominal pain
- constipation
- indigestion
- localized pain.
Uncommon:
- inflammation of the vagina or abdomen in women
- various sensations such as numbness and ant crawling
- inflammation of veins ( intravenous administration only )
- swollen, tender or discolored tongue
- increased urination frequency
- overindulge
- increased thirst
- increased sweating
- effects on blood test results such as protein levels, salts or enzymes used as a measure of kidney or liver function
- hyponatremia (low levels of sodium in the blood)
- kidney failure
- decreased platelet count
- gas in the stomach
- injection site pain ( intravenous administration only )
- elevated creatinine
- magont
- effects on heart rate (eg faster heart rate).
Rare side effects:
- superficial tooth discoloration, which can be removed with professional tooth cleaning (manual removal).
The following side effects have also been reported:
- alopecia (hair loss)
- reduced number of blood cell s
- weakness and / or sensory changes.
How to store Linezolid Teva
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 blister and the carton. 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 lactose monohydrate , spray-dried lactose monohydrate , maize starch, crospovidone (E1202), hydroxypropylcellulose (E463), croscarmellose sodium (E468), magnesium stearate (E470b), hypromellose 2910 5cand (E461) and E42.
What the medicine looks like and contents of the pack
- White, film-coated, capsule-shaped tablet, marked with “600” on one side. The other side has a break notch.
- Available pack sizes for blisters: 10, 10×1, 20, 20×1, 28, 30, 60, 90 and 100 film-coated tablets and hospital packs of 50×1 film-coated tablets. Not all pack sizes may be marketed.