600 mg film-coated tablets
linezolid
What Linezolid Glenmark is and what it is used for
Linezolid 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 Glenmark is suitable for treating your infection.
Linezolid contained in Linezolid Glenmark 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 taking Linezolid Glenmark
Do not take Linezolid Glenmark:
- 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 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 or pharmacist before taking Linezolid Glenmark.
Linezolid 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 suitable for you. Ask your doctor if you are not sure 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?
- 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?
Take special care with Linezolid Glenmark
Talk to your doctor or pharmacist before taking Linezolid Glenmark if you:
- easily bruises and begins to bleed
- have anemia (low number of red blood cells )
- is susceptible to infection you
- have previously had seizures
- have liver problems or kidney problems, especially if you are undergoing dialysis
- have diarrhea.
Tell your doctor immediately if you experience any of the following during treatment (see also section 4):
- problems with vision, e.g. blurred vision, abnormal color vision, decreased visual acuity or limitations of field of view et
- loss of sensation in arms or legs or tingling or ant crawling in arms or legs.
- diarrhea. You may develop diarrhea while taking or after taking antibiotics , including Linezolid Glenmark. If the diarrhea becomes severe or persistent or if you find that your stools contain blood or mucus, stop taking Linezolid Glenmark 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 faster breathing.
Other medicines and Linezolid Glenmark
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
There is a risk that Linezolid Glenmark 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 Glenmark should not be used if you are already taking or have recently used them (see also section 2 “Do not take Linezolid Glenmark”).
- 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 Glenmark, 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
- Some drugs used to treat asthma such as salbutamol , terbutaline , phenoterol
- 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
- drug that raises blood pressure , et , 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 .
- an antibiotic called rifampicin
Linezolid Glenmark with food, drink and alcohol
You can take Linezolid Glenmark 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 Linezolid Glenmark can react with a substance called tyramine, which is found naturally in certain foods. This interaction may increase 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 Linezolid Glenmark in pregnant women is unknown. Therefore, it should not be taken 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 Glenmark as it passes into breast milk and may affect the baby.
Driving and using machines
Linezolid Glenmark 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 can 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 Glenmark contains lactose
The product contains lactose monohydrates. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to take Linezolid Glenmark
Adults
Always take these tablets according to the package leaflet or your doctor, pharmacist, or nurse’s instructions. If you are not sure, talk to your doctor, pharmacist, or nurse.
The usual dose is one film-coated tablet (600 mg linezolid) twice daily (every 12 hours). Swallow the film-coated tablet whole with water.
If you are undergoing kidney dialysis, you should take Linezolid Glenmark 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 Glenmark, your doctor will take regular blood tests to check your blood count. Your doctor will check your vision if you take the tablets for more than 28 days.
Use for children and adolescents
Linezolid Glenmark is not normally used for treatment in 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 Glenmark:
The most serious adverse reactions (with frequency in brackets) during treatment with Linezolid Glenmark are:
- severe skin reactions (frequency not known), swelling mainly of the face and neck (frequency not known), wheezing and / or difficulty breathing (frequency not known). This may be a sign of an allergic reaction and it may be necessary for you to stop taking these tablets. Skin reactions such as sore, red and scaly skin ( dermatitis ) (uncommon), rash (common), itching (common).
- problems with vision, e.g. blurred vision (uncommon), altered color vision (frequency is not known), difficulty seeing details (frequency is not known) or visual field limitations (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 (stomach pain) or faster breathing
- Seizures (less common) have been reported with Linezolid Glenmark. 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) (frequency not known)
- 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 causing short, transient symptoms such as loss of vision, weakness in the legs and arms, slurred speech and unconsciousness) (uncommon)
- ringing in the ears ( tinnitus ) (uncommon)
- Numbness, tingling or blurred vision have been reported in patients treated with Linezolid Glenmark for more than 28 days. Contact your doctor immediately if you experience vision problems.
Another adverse s comprises:
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
- difficulty sleeping
- high blood pressure
- anemia (low red blood cell count )
- dizziness
- localized or general abdominal pain (abdominal pain)
- constipation
- indigestion
- localized pain
Uncommon (may affect up to 1 in 100 people):
- inflammation of the vagina or abdomen in women
- sensations such as numbness and ant crawling
- inflammation of the veins ( intravenous administration only )
- swollen, tender or discolored tongue
- need to urinate more often
- overindulge
- increased thirst
- increased sweating
- changes in proteins , salts or enzymes in the blood that measure kidney function or liver function
- hyponatremia (low levels of sodium in the blood)
- renal failure (renal impairment)
- decreased platelet count
- gas in the stomach
- injection site pain
- elevated creatinine
- abdominal pain
- changes in heart rate (eg faster heart rate).
Rare (may affect up to 1 in 1,000 people):
- superficial tooth discoloration, which can be removed with professional tooth cleaning (manual removal).
The following side effects have also been reported not known (frequency can not be calculated from the available data):
- alopecia (hair loss)
- reduced number of blood cell s
- weakness and / or changes in sensation
How to store Linezolid Glenmark
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. The expiration date is the last day of the specified month.
No special storage instructions.
Do not use this medicine if the tablets are discolored.
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
- The other ingredients are lactose monohydrate , povidone, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide and macrogol.
What the medicine looks like and contents of the pack
Linezolid Glenmark 600 mg film-coated tablets are white to off-white, oval, biconvex film-coated tablets with “G” debossed on one side and “469” on the other side.
The tablets are available in blister packs containing 10, 20, and 30 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Glenmark Arzneimittel GmbH
Industriestr. 31
82194 Gröbenzell
Germany
Manufacturer
Glenmark Pharmaceuticals Europe Limited,
Building 2, Croxley Green Business Park Croxley Green
WD 18 8YA UK
Glenmark Pharmaceuticals sro,
Fibichova 143, 566 17 Vysoké Mytó,
Czech Republic
Glenmark Arzneimittel GmbH
Industriestr. 31
82194 Gröbenzell
Germany