Linezolid Krka 600 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Linezolid Krka 600mg film-coated tablets EFG

Read the entire 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, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

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

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as flu or the common cold.

It is important that you follow your doctor's instructions regarding dosage, dosing interval, and duration of treatment.

Do not keep or reuse this medicine. If you have any antibiotic left over after finishing your treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines via wastewater or household waste.

Linezolid is used to treat pneumonia and certain skin or subcutaneous infections. Your doctor will decide whether linezolid is appropriate for treating your infection.

2. What you need to know before taking Linezolid Krka

Do not take Linezolid Krka:

• if you are allergic to linezolid or to any of the other ingredients of this medicine (listed in section 6).
• if you are taking or have taken within the last 2 weeks any medicine belonging to the class of monoamine oxidase inhibitors (MAOIs, 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 infant.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking 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, who will need to examine your general health and blood pressure before and during treatment, and decide whether there is a better treatment option for you. Ask your doctor if you are unsure whether these categories apply to you.

• Do you have high blood pressure, whether or not you are taking medication for it?
• Have you been diagnosed with overactive thyroid (hyperthyroidism)?
• Do you have a tumor of the adrenal glands (pheochromocytoma) or carcinoid syndrome (caused by tumors of the hormonal system, with symptoms such as diarrhea, skin flushing, wheezing)?
• Do you suffer from manic depression, schizoaffective disorders, mental confusion, or other mental health problems?
• Do you have a history of hyponatremia (low sodium levels in the blood), 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).

Take special care when taking Linezolid Krka

Talk to your doctor before starting Linezolid Krka if you:

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

Tell your doctor immediately if during treatment you experience:

• vision problems such as blurred vision, changes in color vision, difficulty seeing fine details, or narrowing of your field of vision.
• loss of sensation in your arms or legs, or tingling or itching sensations in your arms or legs.
• diarrhea, which may occur if you are taking or have taken antibiotics, including Linezolid Krka. If diarrhea becomes severe or persistent, or if you notice blood or mucus in your stools, you must stop treatment with Linezolid Krka immediately and consult your doctor. In such a situation, you should not take medicines that inhibit or slow intestinal movements.
• nausea or repeated vomiting, abdominal pain, or rapid breathing.
• unexplained muscle pain, tenderness, or weakness, and/or dark urine. These may be signs of a serious condition called rhabdomyolysis (muscle breakdown), which can lead to kidney damage.
• malaise and dizziness with muscle weakness, headache, confusion, and memory impairment, which may indicate hyponatremia (low sodium levels in the blood).

Children and adolescents

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

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, body temperature, or heart rate.

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

Tell your doctor if you are taking or have taken within the last 2 weeks the following medicines, as Linezolid Krka must not be taken if you are already taking these medicines or have taken them recently (see also section 2, "Do not take Linezolid Krka 600 mg"):

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

Also inform your doctor if you are taking the following medicines. Your doctor may still decide to prescribe Linezolid Krka, but will need to assess 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 suited for you.

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

Taking Linezolid Krka with food, drinks, and alcohol

• You may take Linezolid Krka 600 mg before, during, or after meals.
• Avoid eating large amounts of aged cheese, yeast extracts, or soy extracts (such as soy sauce), and avoid alcoholic beverages, especially draught beer and wine. The reason is that Linezolid Krka may react with a substance called tyramine present in certain 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

The effects of Linezolid Krka in pregnant women are unknown. Therefore, it should not be taken during pregnancy unless advised by your doctor. If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

You must not breastfeed while taking Linezolid Krka, as it passes into breast milk and may affect the infant.

Driving and using machines

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

Linezolid Krka contains sodium

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

3. How to take Linezolid Krka

Follow exactly the instructions for use provided in this leaflet or those given by your doctor, pharmacist, or nurse. If in doubt, consult your doctor or pharmacist again. The recommended dose is one film-coated tablet (600 mg of Linezolid) twice daily (every 12 hours). Swallow the film-coated tablet whole with a little water.

If you are undergoing dialysis, you should take Linezolid Krka after each dialysis session.

A typical treatment course lasts from 10 to 14 days, but may extend up to 28 days. The safety and efficacy of this medicine have not been established for periods longer than 28 days. Your doctor will decide the duration of treatment.

During treatment with Linezolid Krka, your doctor should perform periodic blood tests to monitor your blood count.

Your doctor should monitor your vision if you are taking Linezolid Krka for more than 28 days.

Use in children and adolescents

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

If you take more Linezolid Krka than you should

Inform your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist or call the Poison Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Linezolid Krka

Take the missed tablet as soon as you remember. Then take your next film-coated tablet 12 hours after that, and continue taking your tablets every 12 hours. Do not take a double dose to make up for the missed film-coated tablet.

If you stop taking Linezolid Krka

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

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

4. Possible adverse effects

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

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

Contact your doctor, pharmacist, or nurse immediately if you experience any of the following adverse effects during treatment with Linezolid Krka 600 mg:

• Severe skin reactions (uncommon), swelling particularly around the face and neck (uncommon), wheezing and/or difficulty breathing (rare). These may be signs of an allergic reaction, and treatment with Linezolid Krka may need to be discontinued. Skin reactions such as raised purple rash due to inflammation of blood vessels (rare), red, sore, and scaly skin (dermatitis) (uncommon), skin rash (common), itching (common).
• Vision problems (uncommon), such as blurred vision (uncommon), changes in color perception (frequency not known), difficulty seeing fine details (frequency not known), or reduced visual field (rare).
• Severe diarrhoea containing blood and/or mucus (antibiotic-associated colitis including pseudomembranous colitis), which in rare cases may lead to complications that could be life-threatening (uncommon).
• Repeated nausea or vomiting, abdominal pain, or rapid breathing (frequency not known).
• Cases of epileptic seizures or convulsions (uncommon) have been reported in patients receiving Linezolid Krka.
• Serotonin syndrome (frequency not known). Inform your doctor if you experience agitation, confusion, delirium, muscle rigidity, tremor, lack of coordination, convulsions, rapid heartbeat, severe breathing problems, or diarrhoea (suggestive of serotonin syndrome), especially if you are also being treated with antidepressants called SSRIs or opioids (see section 2).
• Inflammation of the pancreas (uncommon).
• Unexplained bleeding or bruising, which may be due to changes in the number of certain blood cells affecting blood clotting or causing anaemia (common).
• Changes in blood cell counts that may affect the ability to fight infections (common). Some signs of infection include: fever (common), sore throat (uncommon), mouth ulcers (uncommon), and fatigue (uncommon).
• Muscle pain without apparent cause, tenderness or weakness, and/or dark urine (rare). These may be signs of a serious condition called rhabdomyolysis (muscle breakdown), which may lead to kidney damage.
• Seizures (uncommon).
• Transient ischaemic attacks (temporary disruption of blood flow to the brain causing short-term symptoms such as vision loss, weakness in arms and legs, difficulty speaking, and loss of consciousness) (uncommon).
• Ringing in the ears (tinnitus) (uncommon).

Numbness, tingling, or blurred vision have been reported in patients treated with Linezolid Krka for more than 28 days. If you experience vision problems, consult your doctor as soon as possible.

Other adverse effects include:

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

• Fungal infections, especially vaginal or oral candidiasis
• Headache
• Metallic taste in the mouth
• Diarrhoea, nausea, or vomiting
• Changes in certain blood test results, including those measuring proteins, salts, or enzymes indicating kidney or liver function, or blood glucose concentration
• Difficulty sleeping
• Increased blood pressure
• Anaemia (low red blood cell count)
• Dizziness
• Localized or generalized abdominal pain
• Constipation
• Indigestion
• Localized pain
• Reduced platelet count

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

• Vaginal or genital area inflammation in women
• Tingling or numbness sensation
• Swollen, painful, or discolored tongue
• Dry mouth
• Frequent need to urinate
• Chills
• Feeling thirsty
• Increased sweating
• Hyponatremia (low sodium levels in blood)
• Kidney failure
• Abdominal distension
• Increased creatinine
• Stomach pain
• Changes in heart rate (e.g., increased heart rate)
• Decreased blood cell counts
• Weakness and/or sensory changes

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

• Change in tooth surface coloration, which can be removed with professional dental cleaning (manual removal of dental calculus)

The following adverse effects have also been reported (frequency not known – cannot be estimated from available data):

• Alopecia (hair loss)

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

Reporting of adverse effects:

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Linezolid Krka

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

Do not use this medicine after the expiry date stated on the blister and cardboard box after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point in your pharmacy. If you are unsure how to dispose of unused medicines or their packaging, ask your pharmacist. This will help protect the environment.

6. Contents of the pack and other information

Composition of Linezolid Krka

• The active substance is linezolid. Each film-coated tablet contains 600 mg of linezolid.
• The other components (excipients) are microcrystalline cellulose, maize starch, sodium carboxymethylstarch (Type A) (derived from maize starch), hydroxypropylcellulose (Type EF), magnesium stearate in the tablet core; and 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 available in blisters containing 10, 20 and 30 film-coated tablets.

Marketing Authorisation Holder and Manufacturer

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

You can request further information about this medicinal product by contacting the local representative of the Marketing Authorisation Holder:

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

Manufacturer

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

or

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

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Date of the last revision of this leaflet: May 2025

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