600 mg film-coated tablets
linezolid
What Linezolid Accord is and what it is used for
Linezolid is an antibiotic in a group called oxazolidinones that prevent the growth of certain bacteria that cause infection. It is used to treat pneumonia and certain skin and soft tissue infections. Your doctor will decide if Linezolid Accord is suitable for treating your infection.
Linezolid contained in Linezolid Accord 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 using Linezolid Accord
Do not use Linezolid Accord
- if you are allergic (hypersensitive) 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 medicine called monoamine oxidase inhibitors (MAOIs, such as phenelzine, isocarboxazide, selegiline , moclobemide) in the last 2 weeks . These drugs can be used to treat depression or Parkinson’s disease
- if you are breast-feeding. This is because the drug passes into breast milk and can affect the baby.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before taking Linezolid Accord.
Linezolid Accord may not be suitable for you if you answer yes to any of the questions below. In this case, tell your doctor because he/she needs to check 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 not sure if the following questions apply to you.
- Do you have high blood pressure , regardless of whether you are taking any medicine for it?
- How was your diagnosis of 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, schizoaffective disorder (schizophrenia with changing mood), confusion or other mental problems?
- Are you taking any of the following medicines?
- decongestants used in colds and containing pseudoephedrine or phenylpropanolamine
- certain drugs used to treat asthma , e.g. salbutamol , terbutaline , fenoterol
- certain medicines used to treat depression called tricyclic antidepressants or SSRIs (selective serotonin reuptake inhibitors). There are many such drugs, e.g. amitriptyline, citalopram , clomipramine, dosulepin, doxepine, fluoxetine , fluvoxamine, imipramine, lofepramine, paroxetine and sertraline .
- drugs used to treat migraines , e.g. sumatriptan and zolmitriptan
- drugs used to treat sudden, severe allergic reactions, e.g. adrenaline
- drugs that raise blood pressure , e.g. norepinephrine , dopamine and dobutamine
- drugs used to treat moderate to severe pain, e.g. pethidine
- drugs used to treat anxiety disorders, e.g. buspiron
- an antibiotic called rifampicin.
Take special care with Linezolid Accord
- Talk to your doctor before taking Linezolid Accord 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 problems or kidney problems, especially if you are undergoing dialysis
- have diarrhea.
Tell a doctor immediately if you experience any of the following during treatment:
- problems with vision, e.g. blurred vision, abnormal color vision, decreased visual acuity or limitations of field of view et
- decreased sensitivity in arms or legs, or ant crawls or tingling in arms or legs
- You may get diarrhea while taking or after taking antibiotics , including Linezolid Accord. If the diarrhea becomes severe or persistent or if you find that your stools contain blood or mucus, stop taking Linezolid Accord immediately and contact a doctor. In this situation, do not take any medication that may stop or slow bowel movements
- recurrent nausea or vomiting, abdominal pain (abdominal pain) or rapid breathing.
Other medicines and Linezolid Accord
There is a risk that Linezolid Accord will sometimes affect or be affected by 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 Accord must not be taken if you are already taking or have recently taken these medicines (see also section 2 above, “Do not take Linezolid Accord”)
- monoamine oxidase inhibitors (MAOIs, for example 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 Accord, but you will need to check your general health and blood pressure before and during treatment. Otherwise, your doctor may decide that another treatment is more appropriate for you.
- decongestants used in colds and containing pseudoephedrine or phenylpropanolamine
- certain drugs used to treat asthma , e.g. salbutamol , terbutaline , fenoterol
- certain medicines used to treat depression called tricyclic antidepressants or SSRIs (selective serotonin reuptake inhibitors). There are many such drugs, e.g. amitriptyline, citalopram , clomipramine, dosulepin, doxepine, fluoxetine , fluvoxamine, imipramine, lofepramine, paroxetine and sertraline .
- drugs used to treat migraines , e.g. sumatriptan and zolmitriptan
- drugs used to treat sudden, severe allergic reactions, e.g. adrenaline
- drugs that raise blood pressure , e.g. norepinephrine , dopamine and dobutamine
- drugs used to treat moderate to severe pain, e.g. pethidine
- drugs used to treat anxiety disorders, e.g. buspiron
- drugs that prevent the formation of blood clots, e.g. warfarin .
Tell your doctor, pharmacist, or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Linezolid Accord with food, drink and alcohol
- You can take Linezolid Accord either before, during or after a meal.
- Avoid eating large amounts of aged cheese, yeast extract, or soybean extract (eg soy sauce) and avoid drinking alcohol, especially draft beer and wine. This is because this medicine can react with a substance called tyramine which is found naturally in certain foods and can lead to high blood pressure .
- Tell your doctor, pharmacist or nurse immediately if you experience a throbbing headache after eating or drinking
Pregnancy, breastfeeding and fertility
The effect of this drug on pregnant women is unknown. Therefore, it should not be used during pregnancy except after a special prescription 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 taking this medicine.
You should not breastfeed while taking Linezolid Accord as it passes into breast milk and may affect the baby.
Driving and using machines
Linezolid Accord may make you feel dizzy or have vision problems. 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 Accord contains soy lecithin
Do not use this medicine if you are allergic to soy.
How to use Linezolid Accord
Adults
Always take this medicine exactly according to the instructions in this leaflet or as your doctor, pharmacist, or nurse. If you are not sure, talk to your doctor, pharmacist, or nurse. 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, you should take linezolid after dialysis treatment.
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 with treatment for more than 28 days. Your doctor will decide how long you should receive treatment.
While you are taking Linezolid Accord, your doctor should take regular blood tests to check your blood count. Your doctor should check your vision if you are taking Linezolid Accord for more than 28 days.
Use for children and adolescents
Linezolid Accord 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 Accord:
- skin reactions, e.g. 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 Accord
- problems with vision, e.g. blurred vision, changes in color vision, difficulty seeing details or limitations of vision et
- severe diarrhea containing blood and / or mucus (antibiotic-associated colitis including pseudomembranous colitis ), which in rare cases can develop into life-threatening complications
- recurrent nausea or vomiting, abdominal pain (abdominal pain) or rapid breathing
- Seizures have been reported with linezolid. You should contact a doctor immediately if you experience anxiety, confusion, confusion with hallucinations, stiffness, tremors, coordination problems and seizures if you are also taking antidepressant medicines called SSRIs (see section 2).
Numbness, tingling, or blurred vision have been reported in patients receiving linezolid for more than 28 days. If you have vision problems, contact your doctor as soon as possible.
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
- changes in certain blood test results, including tests that show your kidney function or liver function or blood sugar level
- unexplained bleeding or bruising that 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 (low red blood cell count )
- difficulty sleeping
- high blood pressure
- anemia (low red blood cell count )
- changes in the number of certain blood cell s, which may affect your ability to fight infection s
- rash
- skin itching
- dizziness
- localized or general abdominal pain (abdominal pain)
- constipation
- indigestion
- localized pain
- fever.
Uncommon (may affect up to 1 in 100 people):
- inflammation of the vagina or abdomen in women
- sensations such as numbness and ant crawling
- dimsyn
- ringing in the ears ( tinnitus )
- inflammation of the veins ( intravenous use only )
- dry mouth or cold sores, swollen, sore or discolored tongue
- need to urinate more often
- overindulge
- feeling tired, increased thirst
- inflammation of the pancreas
- increased sweating
- changes in proteins , salts or enzymes in the blood that measure kidney function or liver function
- seizures
- hyponatremia (low levels of sodium in the blood)
- renal failure (renal impairment)
- decreased platelet count
- gas in the stomach
- transient ischemic attacks (temporary disturbances in the blood flow to the brain causing short, transient symptoms such as loss of vision, weakness in the legs and arms, slurred speech and unconsciousness)
- injection site pain
- inflammation of the skin
- elevated creatinine
- abdominal pain
- changes in heart rate (eg faster heart rate).
Rare (may affect up to 1 in 1,000 people):
- limited field of view
- superficial tooth discoloration, which can be removed with professional tooth cleaning (manual removal).
The following side effects have also been reported ( may occur in an unknown number of users):
- serotonin syndrome (symptoms include rapid heartbeat, confusion, abnormal sweating, hallucinations, involuntary movements, chills and tremors)
- lactic acidosis (symptoms include recurrent nausea and vomiting, abdominal pain (abdominal pain) and rapid breathing)
- severe skin reactions
- sideroblastic anemia (a type of anemia: low red blood cell count )
- alopecia (hair loss)
- altered color vision or difficulty seeing details
- reduced number of blood cell s
- weakness and / or changes in sensation
How to store Linezolid Accord
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 or can after EXP, or on the blister after EXP. The expiration date is the last day of the specified month.
This medicine has no special storage instructions.
Canned tablets should be used within 90 days after first opening the jar.
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. One tablet contains 600 mg linezolid
- The other ingredients are microcrystalline cellulose, hydroxypropylcellulose ‑ L, sodium starch glycolate (type A) and magnesium stearate. The film coating contains polyvinyl alcohol, partially hydrolyzed, titanium dioxide (E171), talc, lecithin (soy) and xanthan gum.
What the medicine looks like and contents of the pack
Linezolid Accord 600 mg film-coated tablets are white to off-white, oval, biconvex film-coated tablets debossed with “EQ1” on one side and smooth on the other.
The tablets are in blisters packaged in a carton or jar.
Jars have a white child-resistant polypropylene closure (with wadding with induction closure) and are desiccant.
One carton of blister contains 1, 10, 20, 30, 50, 60 or 100 film-coated tablets.
One jar contains 10, 30, or 100 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Accord Healthcare BV
Winthontlaan 200
3526 VK Utrecht
Netherlands
Manufacturer
Accord Healthcare Limited
Sage House, 319 Pinner Road, North Harrow, Middlesex HA1 4HF, UK
Accord Healthcare BV
Winthontlaan 200
3526 kV Utrecht
Netherlands
Accord Healthcare Polska Sp.z oo,
ul. Lutomierska 50,95-200 Pabianice, Poland