600 mg film-coated tablets
linezolid
What Linezolid Krka is and what it is used for
Linezolid Krka is an antibiotic from oxazolidinonklassen that prevents the growth of certain bacteria ( pathogenic s) causing the infection s. Linezolid Krka is used to treat pneumonia and certain skin and soft tissue infections. Your doctor will decide if Linezolid Krka is an appropriate treatment for your infection .
Linezolid contained in Linezolid Krka 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 Krka
Do not use Linezolid Krka
- 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, among other things, to treat depression or Parkinson’s disease .
- if you are breast-feeding, as Linezolid Krka passes into breast milk and may affect your baby.
Warnings and cautions
Talk to your doctor or pharmacist before taking Linezolid Krka.
Linezolid Krka may not be suitable for you if you answer yes to any of the following questions. If so, inform your doctor who may need to review your general health and 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, 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
- drugs used to treat depression, such as tricyclic antidepressants 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
- drugs that raise blood pressure , such as norepinephrine , dopamine and dobutamine
- drugs used to treat moderate to severe pain, such as pethidine
- drugs used to treat anxiety disorders, such as buspirone
- an antibiotic called rifampicin
Take special care with Linezolid Krka
Tell your doctor before taking 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 are undergoing dialysis
- have diarrhea
Tell your doctor immediately if you experience:
- problems with vision, such as blurred vision, altered color vision, impaired visual acuity or visual field limitations.
- loss of sensation in arms or legs or tingling or ant crawling in arms or legs.
- diarrhea. You may develop diarrhea while you are taking or after taking antibiotics , including Linezolid Krka. 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 Krka 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 (abdominal pain) or rapid breathing.
Children and young people
Linezolid Krka is not normally used to treat children or adolescents (under 18 years of age).
Other medicines and Linezolid Krka
There is a risk that Linezolid Krka 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 Krka must not be used if you are already taking or have recently taken them (see also section 2 “Do not use Linezolid Krka”).
- 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 Krka but need to check your general health and blood pressure before and during treatment. Your doctor may also decide to give you another more appropriate treatment.
- decongestants used in colds and containing pseudoephedrine or phenylpropanolamine
- Some drugs used to treat asthma , such as salbutamol , terbutaline , fenoterol
- certain drugs used to treat depression, such as tricyclic antidepressants 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, 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.
Tell your doctor or pharmacist if you are taking / using, have recently taken / used or might take / use any other medicines, including medicines obtained without a prescription.
Linezolid Krka with food, drink and alcohol
- You can take Linezolid Krka either before, during or after a meal.
- Avoid eating 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 Krka can react with a substance called tyramine, which is found naturally in certain foods, and can increase blood pressure .
- Tell your doctor or pharmacist immediately if you experience throbbing headaches after eating or drinking.
Pregnancy, breastfeeding and fertility
The effect of Linezolid Krka in pregnant women is unknown. Therefore, linezolid Krka not be used during pregnancy unless specifically prescribed by a doctor. If you are pregnant or breast-feeding, 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 breast-feed while using Linezolid Krka as the medicine passes into breast milk and may affect the baby.
Driving and using machines
Linezolid Krka 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 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 Krka contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’.
How to use Linezolid Krka
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The usual 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 Krka 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 during treatment over 28 days. Your doctor will decide how long you should be treated.
While you are taking Linezolid Krka, your doctor should perform regular blood tests to check your blood count.
Your doctor should check your vision if you are taking Linezolid Krka for more than 28 days.
Use for children and adolescents
Linezolid Krka 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.
The serious side effects (with frequency in brackets) of Linezolid Krka are:
Tell your doctor, nurse or pharmacist immediately if you experience any of these side effects during treatment with Linezolid Krka:
- 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 Krka. Skin reactions such as sore, redness and scaly skin ( dermatitis ) (uncommon side effects ), rash (common side effects ), itching (common side effects ).
- Problems with your vision such as blurred vision (less common side effects ), altered color vision (have been reported), difficulty seeing details (have been reported) or if you experience limited visual field (rare side effects ).
- Severe diarrhea containing blood and / or mucus (antibiotic-associated colitis including pseudomembranous colitis ), which in rare cases can develop into life-threatening complications (rare side effects ).
- Recurrent nausea or vomiting, abdominal pain or faster breathing (has been reported).
- Seizures (less common side effects ) have been reported with Linezolid Krka. 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 side effect s).
- Changes in the number of certain blood cells which may affect your ability to fight infections (common side effects ). Signs of infection may include fever (common side effects ), sore throat (less common side effects ), cold sores (less common side effects ) and fatigue (less common side effects ).
- Inflammation of the pancreas (less common side effects ).
- Seizures (less common side effects ).
- 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 side effects ).
- Ringing in the ears ( tinnitus ) (uncommon adverse s).
Numbness, tingling or blurred vision have been reported by patients treated with Linezolid Krka for more than 28 days. Contact your doctor immediately if you experience vision problems.
Other side effects include:
Common side effects are (may affect up to 1 in 10):
- 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 function or liver function or blood sugar level
- difficulty sleeping
- increased blood pressure
- anemia (low red blood cell count )
- dizziness
- localized or general abdominal pain (abdominal pain)
- constipation
- indigestion
- localized pain
Less common side effects are (may affect up to 1 in 100):
- inflammation of the vagina or abdomen in women
- sensations such as numbness and ant crawling
- inflammation of veins
- dry mouth or cold sores, swollen, sore or discolored by tongue
- increased need to urinate
- overindulge
- feeling tired, increased thirst
- increased sweating
- effects on blood test results such as protein levels, salts or enzymes used as a measure of 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
- magont
- effect on heart rate (faster heart rate)
Rare side effects are (may affect up to 1 in 1000):
- superficial tooth discoloration, which can be removed with professional tooth cleaning (manual removal)
Has been reported (occurs in an unknown number of users):
- hair loss
- reduced number of blood cell s
- weakness and / or changes in sensation
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How to store Linezolid Krka
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.
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, maize starch, sodium starch glycolate (type A), hydroxypropylcellulose (type EF), magnesium stearate in the tablet core and hypromellose (3 mPa.s), titanium dioxide (E171), macrogol 6000 and talc in the film coating.
See section 2 “Linezolid Krka contains sodium”.
What the medicine looks like and contents of the pack
White to an off-white, oval, slightly biconvex film-coated tablet. Dimensions of the tablet: 18 x 9 mm.
Linezolid Krka is available in blister packs containing 10, 20, 30 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Manufacturer
KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany