Leaflet: information for the user

Linezolid Krka 600mg film-coated tablets

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

Linezolid is an antibiotic belonging to the oxazolidinones group that acts by preventing the growth of certain types of bacteria (germs) that cause infections.

Linezolid is used to treat pneumonia and some skin or subcutaneous infections. Your doctor will decide if linezolid is suitable for treating your infection.

Do not take 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 have taken in the last 2 weeks any medicine belonging to the class of monoamine oxidase inhibitors (MAOI, e.g., phenelzine, isocarboxazid, selegiline, moclobemide). You may have been prescribed these medicines to treat depression or Parkinson's disease.
• if you are breastfeeding. The reason is that linezolid passes into breast milk and may affect the baby.

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to take Linezolid Krka.

Linezolid Krka may not be suitable for you, if you answer yes to any of the following questions. In this case, inform your doctor that you will need a general health check and blood pressure check before and during treatment and they will decide if there is a better treatment for you.
Ask your doctor if you are unsure if these categories apply to you.

• Do you have high blood pressure, whether or not you are taking medicines to treat it?
• Have you been diagnosed with hyperthyroidism?
• Do you have a tumor of the adrenal glands (pheochromocytoma) or carcinoid syndrome (caused by hormonal system tumors with symptoms of diarrhea, flushing of the skin, wheezing)?
• Do you suffer from manic depression, schizoaffective disorders, confusion or other mental problems?
• Have you had low sodium levels in your blood (hyponatremia) or are you taking medicines that reduce sodium levels in the blood, such as certain diuretics like hydrochlorothiazide?
• Are you taking opioids?

The use of certain medicines, including antidepressants and opioids, together with linezolid may cause serotonin syndrome, a potentially life-threatening condition (see section 2 “Other medicines and Linezolid Krka” and section 4).

Be especially careful when taking Linezolid Krka

Consult your doctor before starting to take Linezolid Krka if you:

• are an elderly person,
• have bruises and bleed easily,
• have anemia (low red blood cell count),
• are prone to infections,
• have a history of epileptic seizures,
• have liver or kidney problems, especially if you are on dialysis,
• have diarrhea.

Inform your doctorimmediatelyif during treatment you experience:

• visual problems such as blurred vision, changes in color vision, difficulty seeing in detail or narrowing of your field of vision,
• loss of sensation in your arms or legs or a feeling of pins and needles in your arms or legs,
• diarrhea if you are taking or have taken antibiotics, including Linezolid Krka. If this becomes severe or persistent or you notice that your stools contain blood or mucus,stop taking Linezolid Krka immediately and consult your doctor. In this situation, do not take medicines that inhibit or slow down intestinal movements,
• repeated nausea or vomiting, abdominal pain or rapid breathing,
• feeling unwell and dizzy with muscle weakness, headache, confusion and memory deterioration that may indicate low sodium levels in the blood.

Children and adolescents

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

Other medicines and Linezolid Krka

There is a risk that Linezolid Krka may sometimes interact with other medicines causing adverse reactions, such as changes in blood pressure, temperature or heart rate.

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

Inform your doctor if you are taking or have taken in the last 2 weeksthe following medicines, as Linezolid Krkamust notbe taken if you are already taking these medicines or have taken them recently (see also in section 2, "Do not take Linezolid Krka 600 mg "):

• monoamine oxidase inhibitors (MAOI, e.g., phenelzine, isocarboxazid, selegiline, moclobemide). You may have been prescribed these medicines to treat depression or Parkinson's disease.

Inform your doctor also if you are taking the following medicines. Your doctor may still decide to prescribe Linezolid Krka, but they will need to examine your general health and blood pressure before and during treatment. In other cases, your doctor may decide to prescribe a different treatment that is better for you.

• decongestants or cold medicines containing pseudoephedrine or phenylpropanolamine,
• some medicines to treat asthma, such as salbutamol, terbutaline, fenoterol,
• certain antidepressants such as tricyclics or SSRIs (selective serotonin reuptake inhibitors). There are many of these, such as amitriptyline, citalopram, clomipramine, dosulepin, doxepin, fluoxetine, fluvoxamine, imipramine, lofepramine, paroxetine, sertraline,
• medicines to treat migraines, such as sumatriptan and zolmitriptan,
• medicines to treat severe and sudden allergic reactions, such as adrenaline (epinephrine),
• medicines that increase blood pressure, such as noradrenaline (norepinephrine), dopamine and dobutamine,
• opioids, such as peridin, to treat moderate or severe pain,
• medicines to treat anxiety disorders, such as buspirone,
• medicines that prevent blood clotting, such as warfarin.
• a type of antibiotic called rifampicin.

Taking Linezolid Krka with food, drink and alcohol

• You can take Linezolid Krka 600 mg before, during or after meals.
• Avoid taking large amounts of strong cheese, yeast extracts or soya extracts (such as soy sauce) and alcoholic drinks, especially barrel beer and wine. The reason is that Linezolid Krka may react with a substance called tyramine that is present in some foods. This interaction may cause an increase in your blood pressure.
• If you develop a throbbing headache after eating or drinking,inform your doctor, pharmacist or nurse immediately.

Pregnancy, breastfeeding and fertility

There is no known effect of Linezolid Krka on pregnant women. Therefore, it should not be taken during pregnancy, unless your doctor advises you to. If you are pregnant or breastfeeding, or think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medicine.

Do not breastfeed while taking Linezolid Krka as it passes into breast milk and may affect the baby.

Driving and operating machines

Linezolid Krka may cause dizziness or visual problems. If this happens, do not drive or operate machines. Remember that if you feel unwell, your ability to drive or operate machines may be impaired.

Linezolid Krka contains sodium

This medicine contains less than 1 mmolof sodium (23 mg) per tablet; this is essentially “sodium-free”.

Follow exactly the administration instructions for this medication contained in this leaflet or those indicated by your doctor, pharmacist, or nurse. In case of doubt, consult your doctor or pharmacist again. The recommended dose is a film-coated tablet (600 mg of Linezolid) twice a day (every 12 hours). Swallow the film-coated tablet whole with a little water.

If you are on dialysis, you must take Linezolid Krka after each treatment.

A typical treatment period usually lasts from 10 to 14 days, but it may reach 28 days. The safety and efficacy of this medication have not been established for periods longer than 28 days. Your doctor will decide the duration of treatment.

Your doctor must perform blood tests periodically during treatment with Linezolid Krka to monitor your hemogram.

Your doctor must check your vision if you take Linezolid Krka for more than 28 days.

Use in children and adolescents

Linezolid Krka is not usually used for the treatment of children and adolescents (under 18 years).

If you take more Linezolid Krka than you should

Inform your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Linezolid Krka

Take the tablet you forgot as soon as you remember. Take the next film-coated tablet 12 hours after this one and continue taking your tablets every 12 hours.Do not take a double dose to compensate for the missed tablet.

If you interrupt treatment with Linezolid Krka

Unless your doctor tells you to stop treatment, it is essential to continue taking Linezolid Krka. If you stop treatment and your original symptoms return,inform your doctor or pharmacist immediately..

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The most serious side effects (frequency in parentheses) are:

Inform your doctor, pharmacist, or nurse immediatelyif you experience any of the following side effects during treatment with Linezolid Krka 600 mg:

• Severe skin changes (rare), swelling, particularly around the face and neck (rare), wheezing and/or difficulty breathing (rare). This may be a sign of an allergic reaction and may require discontinuation of Linezolid Krka treatment. Skin reactions such as purple elevated rash due to inflammation of blood vessels (rare), red, painful, and scaly skin (dermatitis) (rare), skin rash (frequent), itching (frequent).
• Visual problems (rare) such as blurred vision (rare), changes in color perception (unknown), difficulty seeing in detail (unknown), or if you notice a reduction in your visual field (rare).
• Severe diarrhea containing blood and/or mucus (antibiotic-associated colitis including pseudomembranous colitis), which in rare cases may lead to complications that can be life-threatening (rare).
• Repeated nausea or vomiting, abdominal pain, or rapid breathing (unknown).
• There have been reported cases of seizures or convulsions (rare) in patients treated with Linezolid Krka.
• Serotonin syndrome (unknown), inform your doctor if you experience agitation, confusion, delirium, rigidity, tremors, discoordination, convulsions, rapid heartbeat, severe respiratory problems, and diarrhea (suggestive of serotonin syndrome) while also being treated with antidepressants called ISRS or opioids (see section 2).
• Pancreatitis (rare).
• Unexplained bleeding or bruising, which may be due to an alteration in the number of certain blood cells that can affect blood clotting or produce anemia (frequent).
• Changes in the number of blood cells that can affect the ability to fight infections (frequent). Some signs of infection include: fever (frequent), sore throat (rare), mouth ulcers (rare), and fatigue (rare).
• Convulsions (rare).
• Transient ischemic attacks (temporary alteration of blood flow to the brain causing symptoms such as loss of vision, weakness in arms and legs, difficulty speaking, and loss of consciousness) (rare).
• “Tinnitus” (ringing in the ears) (rare).

Entumecimiento, hormigueo o visión borrosa have been reported in patients treated with Linezolid Krka for more than 28 days. If you experience vision difficulties, consult your doctor as soon as possible.

Other side effects include:

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

• Fungal infections, especially vaginal or oral candidiasis
• Headache
• Metalllic taste in the mouth
• Diarhea, nausea, or vomiting
• Changes in some blood test results, including those that measure proteins, salts, or enzymes that measure renal or hepatic function or blood glucose concentration
• Difficulty falling asleep
• Increased blood pressure
• Anemia (low red blood cell count)
• Dizziness
• Localized or general abdominal pain
• Constipation
• Indigestion
• Localized pain
• Platelet reduction

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

• Vaginal or genital area inflammation in women
• Sensation of numbness or tingling
• Swollen, painful, or discolored tongue
• Dry mouth
• Very frequent urination
• Chills
• Thirst
• Increased sweating
• Hyponatremia (low potassium levels in blood)
• Renal failure
• Abdominal distension
• Increased creatinine
• Stomach pain
• Changes in heart rate (e.g., increased frequency)
• Decreased blood cell count
• Weakness and/or sensory changes

Rare side effects (may affect up to 1 in 1,000 people):

• Change in the surface color of the teeth, which can be removed with a professional dental cleaning (manual removal of dental plaque)

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

• Alopecia (hair loss)

If any of the side effects become severe, or if you notice any side effect not listed in this prospectus, please contact your doctor or pharmacist.

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the blister pack and on the carton box after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Linezolid Krka

• The active ingredient is linezolid. Each film-coated tablet contains 600 mg of linezolid.
• The other components (excipients) are, microcrystalline cellulose, maize starch, carboxymethylstarch sodium (Type A) (derived from maize starch), hydroxypropylcellulose (Type EF), magnesium stearate in the tablet core, hypromellose, titanium dioxide (E171), macrogol 6000, and talc, in the coating.

See section 2 “Linezolid Krka contains sodium”

Appearance of the product and contents of the pack

White or almost white, oval, slightly biconvex film-coated tablet. Dimensions 18 x 9 mm.

Linezolid Krka 600 mg is presented in blisters containing 10, 20, and 30 film-coated tablets.

Holder of the marketing authorization and responsible for manufacturing

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

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura, 10, 28108, Alcobendas, Madrid, Spain

Responsible for manufacturing

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

or

TAD Pharma GmbH Heinz-Lohmann-Straße 5 27472 Cuxhaven Germany

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

Last revision date of this leaflet: June 2023.

The detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.es).