LINEZOLID KRKA 600 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Linezolid Krka 600 mg Film-Coated Tablets EFG

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

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

Linezolid is an antibiotic of 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 the flu or the common cold.

It is essential that you follow the instructions regarding dosage, administration interval, and treatment duration as indicated by your doctor.

Do not store or reuse this medication. If you have any leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not throw away medications down the drain or in the trash.

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

2. What you need to know before you take Linezolid Krka

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 monoamine oxidase inhibitor (MAOI) medication (e.g., phenelzine, isocarboxazid, selegiline, moclobemide). You may have been prescribed these medications 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, who will need to examine your overall health and blood pressure before and during treatment and 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 medication to treat it?
• Have you been diagnosed with hyperthyroidism?
• Do you have a tumor of the adrenal glands (pheochromocytoma) or carcinoid syndrome (caused by tumors of the hormonal system with symptoms of diarrhea, skin flushing, wheezing)?
• Do you suffer from manic depression, schizoaffective disorders, mental confusion, or other mental problems?
• Do you have a history of hyponatremia (low sodium levels in the blood) or take medications that reduce sodium levels in the blood, such as certain diuretics like hydrochlorothiazide?
• Do you take opioids?

The use of certain medications, including antidepressants and opioids, along with linezolid, may cause adverse reactions, such as changes in blood pressure, temperature, or heart rate.

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

Tell your doctor if you are taking or have taken in the last 2 weeksthe following medications, as Linezolid Krka must notbe taken if you are already taking these medications 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 medications to treat depression or Parkinson's disease.

Also, inform your doctor if you are taking the following medications. Your doctor may still decide to prescribe Linezolid Krka, but needs to examine your overall 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.

• nasal decongestants or cold medications containing pseudoephedrine or phenylpropanolamine,
• certain medications for 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,
• medications for migraine, such as sumatriptan and zolmitriptan,
• medications for severe and sudden allergic reactions, such as adrenaline (epinephrine),
• medications that increase blood pressure, such as noradrenaline (norepinephrine), dopamine, and dobutamine,
• opioids, for example, pethidine, to treat moderate or severe pain,
• medications for anxiety disorders, such as buspirone,
• medications that prevent blood clotting, such as warfarin.
• a antibiotic called rifampicin.

Taking Linezolid Krka with food, drinks, and alcohol

• You can take Linezolid Krka 600 mg before, during, or after meals.
• Avoid taking large amounts of mature cheese, yeast extracts, or soy extracts (such as soy sauce) and alcoholic beverages, especially draft beer and wine. The reason is that Linezolid Krka may react with a substance called tyramine that is present in some foods. This interaction can 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 on pregnant women are not known. 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 plan to become pregnant, consult your doctor or pharmacist before using this medication.

You should not breastfeed if you are taking Linezolid Krka, as it passes into breast milk and may affect the baby.

Driving and using machines

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

Linezolid Krka contains sodium

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

3. How to take Linezolid Krka

Follow exactly the administration instructions of this medication contained in this leaflet or as indicated by your doctor, pharmacist, or nurse. In case of doubt, consult your doctor or pharmacist again. The recommended dose is one 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 should take Linezolid Krka after each treatment.

A normal treatment period usually lasts from 10 to 14 days, but can be up to 28 days. The safety and efficacy of this medication for periods longer than 28 days have not been established. 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 take 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, consult your doctor or pharmacist or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Linezolid Krka

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

If you stop taking Linezolid Krka

Unless your doctor tells you to stop treatment, it is essential that you 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 on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The most serious side effects (whose frequency is between parentheses) are:

Inform your doctor, pharmacist, or nurse immediatelyif you experience any of these side 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). This may be a sign of an allergic reaction and may require discontinuation of treatment with Linezolid Krka. Skin reactions such as a purple elevated rash due to inflammation of blood vessels (rare), red, painful, and scaly skin (dermatitis) (uncommon), skin rash (frequent), itching (frequent).
• Vision problems (uncommon) such as blurred vision (uncommon), changes in color perception (not known), difficulty seeing details (not known), or if you notice a reduction in your field of vision (rare).
• Severe diarrhea that contains blood and/or mucus (antibiotic-associated colitis, including pseudomembranous colitis), which in rare circumstances may lead to life-threatening complications (uncommon).
• Repeated nausea or vomiting, abdominal pain, or rapid breathing (not known).
• Seizures or convulsions (uncommon) have been reported in patients treated with Linezolid Krka.
• Serotonin syndrome (not known), you should inform your doctor if you experience agitation, confusion, delirium, rigidity, tremor, uncoordination, convulsions, rapid heartbeat, severe respiratory problems, and diarrhea (suggestive of serotonin syndrome) while also being treated with antidepressants called SSRIs or opioids (see section 2).
• Pancreatitis (uncommon).
• 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 blood cell counts that can affect the ability to fight infections (frequent). Some signs of infection include: fever (frequent), sore throat (uncommon), mouth ulcers (uncommon), and fatigue (uncommon).
• Muscle pain without apparent cause, sensitivity, or weakness, and/or dark urine (rare). These can be signs of a serious condition called rhabdomyolysis (muscle breakdown), which can cause kidney damage.
• Seizures (uncommon).
• Transient ischemic attacks (temporary alteration of blood flow to the brain that causes short-term symptoms such as loss of vision, 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 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
• Metallic taste in the mouth
• Diarrhea, nausea, or vomiting
• Changes in some blood test results, including those that measure proteins, salts, or enzymes that measure kidney or liver function or blood glucose concentration
• Difficulty sleeping
• Increased blood pressure
• Anemia (low red blood cell count)
• Dizziness
• Abdominal pain, localized or generalized
• Constipation
• Indigestion
• Localized pain
• Decreased platelet count

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

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

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

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

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

• Alopecia (hair loss)

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible that they are not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Linezolid Krka

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

Do not use this medication after the expiration date stated on the blister pack and carton after EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medication in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Packaging Contents and Additional Information

Composition of Linezolid Krka

• The active substance is linezolid. Each film-coated tablet contains 600 mg of linezolid.
• The other ingredients (excipients) are microcrystalline cellulose, corn starch, sodium carboxymethyl starch (Type A) (derived from corn 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 and Packaging of the Product

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 Authorization Holder and Manufacturer

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

8501 Novo mesto, Slovenia

You can request more information about this medicinal product by contacting the local representative of the marketing authorization 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 authorized 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 medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.es/).