Linezolid Krka

Leaflet accompanying the packaging: patient information

Linezolid Krka, 600 mg, film-coated tablets

Linezolid

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Linezolid Krka and what is it used for
• 2. Important information before taking Linezolid Krka
• 3. How to take Linezolid Krka
• 4. Possible side effects
• 5. How to store Linezolid Krka
• 6. Contents of the packaging and other information

1. What is Linezolid Krka and what is it used for

Linezolid Krka is an antibiotic, belonging to the class of antibiotics - oxazolidinones, which works by stopping the growth of certain bacteria that cause infections. This medicine is used to treat pneumonia, some skin and soft tissue infections. The doctor will decide if Linezolid Krka is suitable for treating a specific infection.

2. Important information before taking Linezolid Krka

When not to take Linezolid Krka

• if the patient is allergic to linezolid or any of the other ingredients of this medicine (listed in section 6);
• if the patient is currently taking or has taken in the last 2 weeks monoamine oxidase inhibitors (MAOIs, e.g., phenelzine, isocarboxazid, selegiline, moclobemide). These medicines are used to treat depression or Parkinson's disease;
• during breastfeeding, as linezolid passes into breast milk and may harm the baby.

Warnings and precautions

Before starting treatment with Linezolid Krka, the patient should talk to their doctor, pharmacist, or nurse. Linezolid Krka may not be suitable for the patient if they answer "yes" to any of the following questions. In such a case, the patient should discuss this with their doctor, as it may be necessary to check their overall health and blood pressure before and during treatment. The doctor may also decide to prescribe a different medicine.

• Does the patient have high blood pressure, or are they taking medicines for it?
• Has the patient been diagnosed with hyperthyroidism?
• Does the patient have a pheochromocytoma (a tumor of the adrenal gland) or carcinoid syndrome (a condition caused by tumors in the hormonal system, characterized by symptoms such as diarrhea, flushing, and wheezing)?

in the blood, or is the patient taking medicines that lower sodium levels in the blood, such as certain diuretics (also known as "water pills"), e.g., hydrochlorothiazide?

• Is the patient taking any opioid medicines?
• Does the patient have a history of bipolar disorder, schizoaffective disorder, confusion, or other mental disorders?

When to exercise caution when taking Linezolid Krka

The patient should inform their doctor before taking Linezolid Krka if they:

• are elderly,
• have a tendency to bruise or bleed,
• have anemia (low red blood cell count),
• are prone to infections,
• have a history of seizures,
• have liver or kidney problems, especially if they are on dialysis,
• have diarrhea.

The patient should immediately tell their doctor if they experience:

• vision problems, such as blurred vision, changes in color vision, difficulty seeing details, or narrowing of the visual field,
• loss of sensation in their hands or feet or a feeling of tingling or numbness in their hands and feet,
• diarrhea during or after taking antibiotics, including Linezolid Krka; if the diarrhea is severe, persistent, or contains blood or mucus, the patient should stop taking Linezolid Krka and contact their doctor; in such cases, the patient should not take medicines that slow down bowel movements,
• recurring nausea or vomiting, abdominal pain, or rapid breathing,
• unexplained muscle pain, tenderness, or weakness and (or) dark urine color. These may be symptoms of a serious condition called rhabdomyolysis (muscle breakdown), which can lead to kidney damage.
• nausea and feeling unwell, including muscle weakness, headache, confusion, and memory problems, which may indicate hyponatremia (low sodium levels in the blood).

Children and adolescents

Linezolid Krka is not usually used to treat children and adolescents (under 18 years of age).

Linezolid Krka and other medicines

There is a risk of interactions between Linezolid Krka and other medicines. These interactions can lead to side effects, such as changes in blood pressure, body temperature, or heart rate. The patient should tell their doctor about all medicines they are taking or have recently taken, as well as any medicines they plan to take.

The patient should inform their doctor about taking the following medicines:

currently or in the last 2 weeks, as Linezolid Krka should not be taken during or after recent treatment with these medicines (see also section 2 above: "When not to take Linezolid Krka"):

• monoamine oxidase inhibitors (MAOIs: e.g., phenelzine, isocarboxazid, selegiline, moclobemide); these medicines are used to treat depression or Parkinson's disease.

The patient should also inform their doctor if they are taking any of the following medicines. The doctor may still prescribe Linezolid Krka, but it will be necessary to monitor the patient's overall health and blood pressure before and during treatment. In other cases, the doctor may decide that a different medicine would be more suitable for the patient.

• Decongestant medicines used for colds or flu that contain pseudoephedrine or phenylpropanolamine.
• Certain asthma medicines, e.g., salbutamol, terbutaline, fenoterol.
• Tricyclic antidepressants or SSRIs (selective serotonin reuptake inhibitors). Many medicines belong to these groups, e.g., amitriptyline, citalopram, clomipramine, dosulepin, doxepin, fluoxetine, fluvoxamine, imipramine, lofepramine, paroxetine, sertraline.
• Migraine medicines, e.g., sumatriptan and zolmitriptan.
• Medicines used to treat severe allergic reactions, e.g., adrenaline (epinephrine).
• Medicines that increase blood pressure, e.g., noradrenaline (norepinephrine), dopamine, and dobutamine.
• Opioids, e.g., pethidine, used to treat moderate to severe pain.
• Medicines used to treat anxiety disorders, e.g., buspirone.
• Anticoagulant medicines, e.g., warfarin.
• The antibiotic rifampicin.

Linezolid Krka with food, drink, and alcohol

• Linezolid Krka can be taken with or without food.
• During treatment, the patient should limit their consumption of foods that contain tyramine, such as mature cheeses, yeast extracts, soy products (e.g., soy sauce), and alcoholic beverages, especially beer and wine. These products interact with Linezolid Krka, which may cause an increase in blood pressure.
• If the patient experiences a throbbing headache after eating or drinking, they should immediately talk to their doctor, pharmacist, or nurse.

Pregnancy, breastfeeding, and fertility

The effects of linezolid in pregnant women are unknown. Therefore, unless the doctor advises otherwise, Linezolid Krka should not be taken during pregnancy. If the patient is pregnant, breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine. During treatment with Linezolid Krka, the patient should not breastfeed, as the medicine passes into breast milk and may harm the baby.

Driving and using machines

Linezolid Krka may cause dizziness or vision disturbances. In such cases, the patient should not drive or operate machines. The patient should remember that feeling unwell can affect their ability to drive and use machines.

Linezolid Krka contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Linezolid Krka

This medicine should always be taken exactly as described in this patient leaflet or as advised by the doctor, pharmacist, or nurse. If the patient has any doubts, they should consult their doctor or pharmacist. The usual dose is one tablet (600 mg of linezolid) twice a day (every 12 hours). The tablet should be swallowed whole, with a glass of water. In patients undergoing dialysis, Linezolid Krka should be taken after dialysis. Treatment usually lasts from 10 to 14 days but may last up to 28 days. The effectiveness and safety of using this medicine for periods longer than 28 days have not been established. The doctor will decide on the necessary treatment duration. During treatment with Linezolid Krka, the doctor will recommend regular blood tests to monitor the patient's blood count.

Use in children and adolescents

Linezolid Krka is not usually used to treat children and adolescents (under 18 years of age).

Taking more than the recommended dose of Linezolid Krka

The patient should immediately inform their doctor or pharmacist.

Missing a dose of Linezolid Krka

If the patient misses a tablet, they should take it as soon as possible. The next tablet should be taken after 12 hours, and subsequent tablets should be taken every 12 hours. The patient should not take a double dose to make up for a missed tablet.

Stopping treatment with Linezolid Krka

Linezolid Krka should be taken for as long as the doctor advises. If the patient stops taking the medicine and their original symptoms return, they should immediately inform their doctor or pharmacist. If the patient has any further doubts about taking this medicine, they should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Linezolid Krka can cause side effects, although not everybody gets them. Serious side effects of Linezolid Krka (with frequency in parentheses) include:

• severe skin reactions (not very common), swelling, especially in the face and neck (not very common), wheezing, and (or) difficulty breathing (rare). These may be symptoms of an allergic reaction, and it may be necessary to stop taking Linezolid Krka. Skin reactions, such as: a raised, purple rash caused by inflammation of blood vessels (rare), redness and peeling of the skin (skin inflammation) (not very common), rash (common), itching (common)
• vision disturbances (not very common), such as blurred vision (not very common), changes in color perception (frequency unknown), difficulty seeing details (frequency unknown), or narrowing of the visual field (rare)
• severe diarrhea with blood and (or) mucus in the stool (antibiotic-associated colitis, including pseudomembranous colitis), which can rarely lead to life-threatening complications (not very common)
• recurring nausea or vomiting, abdominal pain, or rapid breathing (rare)
• seizures (not very common) have been reported during treatment with Linezolid Krka.
• serotonin syndrome (frequency unknown). The patient should inform their doctor if they experience symptoms such as agitation, confusion, hallucinations, stiffness, tremors, coordination problems, seizures, rapid heart rate, serious breathing problems, and diarrhea (suggesting serotonin syndrome) (see section 2).

pancreatitis (not very common)

• bleeding or bruising of unknown cause, which may be due to changes in blood cell count, affecting blood clotting or leading to anemia (common)
• changes in the number of certain blood cells, which may affect the patient's ability to fight infections (not very common); symptoms of infection include: fever (common), sore throat (not very common), mouth ulcers (not very common), fatigue (not very common)
• rhabdomyolysis (rare): objective and subjective symptoms include unexplained muscle pain, tenderness, or weakness and (or) dark urine color. These may be signs of a serious condition called rhabdomyolysis (muscle breakdown), which can lead to kidney damage.
• seizures (not very common)
• transient ischemic attacks (temporary disturbances of blood flow to the brain, causing short-term symptoms such as loss of vision, weakness of limbs, slurred speech, loss of consciousness) (not very common)
• "ringing" in the ears (tinnitus) (not very common).

In patients who have taken Linezolid Krka for more than 28 days, numbness, tingling, or blurred vision have been reported. If the patient experiences vision disturbances, they should immediately contact their doctor.

Additional side effects include:

Common side effects(may affect up to 1 in 10 people):

• fungal infections, especially vaginal or oral thrush
• headache
• metallic taste in the mouth
• diarrhea, nausea, or vomiting
• changes in some blood test results, including those measuring proteins, salts, or enzymes, used to assess kidney or liver function, or blood sugar levels
• sleep disturbances
• increased blood pressure
• anemia (low red blood cell count)
• dizziness
• local or generalized abdominal pain
• constipation
• indigestion (dyspepsia)
• local pain
• decreased platelet count

Uncommon side effects(may affect up to 1 in 100 people):

• vaginal or genital thrush in women
• feeling of numbness or tingling
• swelling, pain, or discoloration of the tongue
• dry mouth,
• frequent urination
• chills
• increased thirst
• increased sweating
• hyponatremia (low sodium levels in the blood)
• kidney problems
• bloating
• increased creatinine levels
• abdominal pain
• changes in heart rate (e.g., increased heart rate)
• decreased count of all blood cell types
• weakness and (or) changes in sensation

Rare side effects(may affect up to 1 in 1000 people):

• surface discoloration of teeth, which can be removed by a dental cleaning procedure (scaling)

Other side effects have also been reported(frequency unknown: frequency cannot be estimated from the available data):

• hair loss (alopecia)

If any side effect gets worse or if the patient experiences any side effects not listed in this leaflet, they should inform their doctor or pharmacist.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, the patient can help provide more information on the safety of this medicine.

5. How to store Linezolid Krka

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month stated. There are no special precautions for storage. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Linezolid Krka contains

• The active substance is linezolid. Each film-coated tablet contains 600 mg of linezolid.
• The other ingredients are microcrystalline cellulose, cornstarch, sodium carboxymethylcellulose, type A, hydroxypropylcellulose, magnesium stearate in the tablet core, and hypromellose 3 cP, titanium dioxide (E 171), macrogol 6000, and talc in the tablet coating. See section 2 "Linezolid Krka contains sodium".

What Linezolid Krka looks like and contents of the pack

White to almost white, oval, slightly biconvex film-coated tablets; tablet dimensions: 18 mm x 9 mm. Packaging: 10, 20, and 30 film-coated tablets in blisters, in a cardboard box. Not all pack sizes may be marketed.

Marketing authorization holder

KRKA, d. d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d. d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

This medicine is authorized in the Member States of the European Economic Area under the following names:

For more information about this medicine, the patient should contact their local representative of the marketing authorization holder: KRKA-POLSKA Sp. z o.o., ul. Równoległa 5, 02-235 Warsaw, tel. 22 57 37 500.

Date of last revision of the leaflet: 30.05.2025