LINEZOLID SANDOZ 600 mg FILM-COATED TABLETS

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

Do not take Linezolid Sandoz if:

• you are allergic to linezolid or any of the other ingredients of this medicine (listed in section 6),
• you are taking or have taken in the last 2 weeks certain medicines called monoamine oxidase inhibitors (MAOIs such as phenelzine, isocarboxazid, selegiline, moclobemide). These medicines are usually used to treat depression or Parkinson's disease,
• you are breastfeeding. This medicine passes into breast milk and could affect the baby.

Warnings and precautions

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

Linezolid may not be suitable for you if you answer yesto any of the following questions. In that case, inform your doctor, as he/she will need to monitor your overall health and blood pressure before and during treatment, or may decide that another treatment is better for you.

Ask your doctor if you are unsure whether any of these categories apply to your case.

• Do you have high blood pressure, whether treated or not?.
• Have you been diagnosed with hyperthyroidism?.
• Do you have a tumor of the adrenal glands (pheochromocytoma) or carcinoid syndrome (caused by tumors in the hormonal system that present with symptoms of diarrhea, skin flushing, wheezing)?.
• Do you suffer from manic depression, schizophrenic disorder, mental confusion, or other mental problems?.
• Do you have a history of hyponatremia (low sodium levels in the blood) or are you taking medications that reduce sodium levels in the blood, such as certain diuretics like hydrochlorothiazide?.
• Are you taking opioids?.
• Are you taking any of the following medications?.
• • decongestant remedies for colds containing pseudoephedrine or phenylpropanolamine,
  • certain asthma medications like salbutamol, terbutaline, fenoterol,
  • certain antidepressants called tricyclics or SSRIs (selective serotonin reuptake inhibitors) such as amitriptyline, citalopram, clomipramine, dosulepin, doxepin, fluoxetine, fluvoxamine, imipramine, lofepramine, paroxetine, or sertraline,
  • medications used to treat migraines like sumatriptan or zolmitriptan,
  • medications for treating severe allergic reactions like adrenaline (epinephrine),
  • medications that increase blood pressure like noradrenaline (norepinephrine), dopamine, and dobutamine,
  • medications used to treat moderate or severe pain,
  • opioids like pethidine, buprenorphine,
  • medications used to treat anxiety disorders like buspirone,
  • a antibiotic called rifampicin.

Be careful with Linezolid Sandoz

Consult your doctor, pharmacist, or nurse before starting to take this medicine if:

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

Inform your doctor immediately if during treatment you experience:

• vision problems such as blurred vision, changes in color vision, difficulty seeing clearly, or if you notice your field of vision is reduced,
• loss of sensitivity in your arms or legs or a tingling or burning sensation in your arms or legs,
• diarrhea can occur while taking or after taking antibiotics, including linezolid. If diarrhea becomes severe, lasts a long time, or if you notice that your stools contain blood or mucus, you should stop taking linezolid immediately and consult your doctor. In this situation, do not take medications that stop or reduce intestinal movements,
• repeated nausea or vomiting, abdominal pain, or hyperventilation,
• unexpected muscle pain, sensitivity, or weakness and/or dark urine. These can be signs of a serious condition called rhabdomyolysis (muscle breakdown), which can cause kidney damage,
• discomfort and dizziness with muscle weakness, headache, confusion, and memory impairment that may indicate hyponatremia (low sodium levels in the blood).

Children and adolescents

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

Other medicines and Linezolid Sandoz

There is a risk that linezolid may interact with certain medications and produce side effects such as changes in blood pressure, body temperature, or heart rate.

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.

Tell your doctor if you are taking or have been takingin the last 2 weeksthe following medications, as you must not takelinezolid if you are still taking them or have taken them recently (see also section 2 above “Do not take Linezolid Sandoz”):

• monoamine oxidase inhibitors (MAOIs, such as phenelzine, isocarboxazid, selegiline, moclobemide).

These medications are usually used to treat depression or Parkinson's disease.

Also, inform your doctor if you are taking the following medications. Your doctor may decide to treat you with linezolid, but will need to assess your overall health and blood pressure before and during treatment. In other cases, your doctor may decide that another treatment is better for you.

• Decongestant remedies for colds containing pseudoephedrine or phenylpropanolamine,
• certain asthma medications like salbutamol, terbutaline, fenoterol,
• certain antidepressants called tricyclics or SSRIs (selective serotonin reuptake inhibitors), including amitriptyline, citalopram, clomipramine, dosulepin, doxepin, fluoxetine, fluvoxamine, imipramine, lofepramine, paroxetine, or sertraline,
• medications used to treat migraines like sumatriptan or zolmitriptan,
• medications for treating severe allergic reactions like adrenaline (epinephrine),
• medications that increase blood pressure like noradrenaline (norepinephrine), dopamine, and dobutamine,
• medications used to treat moderate or severe pain,
• opioids like pethidine, buprenorphine,
• medications used to treat anxiety disorders like buspirone,
• medications that prevent blood clotting like warfarin,
• a antibiotic called rifampicin.

Taking Linezolid Sandoz with food, drinks, and alcohol

• You can take linezolid before, during, or after meals.
• Avoid eating excessive amounts of mature cheese, yeast extracts, or soybean extracts, for example, soy sauce, and alcoholic beverages, especially draft beer and wine. The reason is that this medication can react with a substance called tyramine that is naturally present in some foods. This interaction can cause an increase in your blood pressure.
• If you start experiencing headaches after eating or drinking, inform your doctor, pharmacist, or nurse immediately.

See also section 3 “How to take Linezolid Sandoz” for more information.

Pregnancy, breastfeeding, and fertility

The effect of linezolid on pregnant women is unknown. Therefore, pregnant women should not take linezolid unless advised by their doctor.

If you are pregnant or breastfeeding, 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 breastfeed while taking linezolid because this medicine passes into breast milk and could affect your baby.

Driving and using machines

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

Linezolid Sandoz contains sodium

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

3. How to take Linezolid Sandoz

Adults

Follow exactly the administration instructions of this medicine as described in this leaflet or as directed by your doctor, pharmacist, or nurse. If you are unsure, consult your doctor, pharmacist, or nurse again.

The recommended dose for adultsis one tablet(600 mg of linezolid) twice a day(every 12 hours).

The normal treatment duration is 10 to 14 days, but it can be extended up to 28 days.

The safety and efficacy of this medicine have not been established for treatment periods longer than 28 days. Your doctor will decide the duration of your treatment.

While taking linezolid, your doctor will perform regular blood tests to monitor your blood count.

If you take linezolid for more than 28 days, your doctor must monitor your vision.

Use in children and adolescents

Linezolid is not normally used in children or adolescents (under 18 years of age).

Method of administration

Swallow the tablet whole with a glass of water.

You can take this medicine before, during, or after meals.

If you are on a dialysis program, you should take linezolid after each session.

If you take more Linezolid Sandoz than you should

Inform your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Linezolid Sandoz

Take the missed tablet as soon as you remember.

Take the next tablet 12 hours later and continue taking the tablets every 12 hours.

Do not take a double dose to make up for the missed dose.

If you stop taking Linezolid Sandoz

It is essential to continue taking linezolid unless your doctor tells you to stop the treatment.

If your initial symptoms return when you stop your treatment, inform your doctor or pharmacist immediately.

If you have any further questions on 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 all people suffer from them.

Report immediately to your doctor, pharmacist, or nurseif you notice any of the following adverse effects while being treated with linezolid:

The most serious adverse effects of linezolid (whose frequency is in parentheses) are:

• 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. Skin reactions such as a purple elevated rash due to inflammation of the 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 (unknown), difficulty seeing clearly (unknown), or if you notice that your field of vision is reduced (rare),
• severe diarrhea that contains blood and/or mucus (antibiotic-associated colitis, including pseudomembranous colitis), which in rare circumstances could lead to life-threatening complications (uncommon),
• repeated nausea or vomiting, abdominal pain, or rapid breathing (rare),
• cases of epileptic seizures or convulsions have been reported (uncommon),
• serotonin syndrome (unknown), you should inform your doctor if you experience agitation, confusion, delirium, stiffness, tremor, discoordination, convulsions, rapid heartbeat, severe respiratory problems, and diarrhea (suggestive of serotonin syndrome), while also being treated with antidepressants called ISRSs and opioids (e.g., buprenorphine) (see section 2),
• unexplained bleeding or bruising, which may be due to an alteration in the number of certain blood cells that can affect blood coagulation or produce anemia (frequent),
• reduction in the number of blood cells that can affect the ability to fight infections (uncommon). Some signs of infection include: fever (frequent), sore throat (uncommon), mouth ulcers (uncommon), and fatigue (uncommon),
• rhabdomyolysis (uncommon): signs and symptoms include unexplained muscle pain, sensitivity, or weakness, and/or dark urine. These can be signs of a serious condition called rhabdomyolysis (muscle breakdown), which can cause kidney damage,
• pancreatitis (uncommon),
• convulsions (uncommon),
• transient ischemic attacks (temporary alteration of blood flow that causes short-term symptoms such as vision loss, weakness in arms and legs, difficulty speaking, and loss of consciousness),
• "Ringing" in the ears (tinnitus) (uncommon),

Cases of numbness, tingling, or blurred vision have been reported in patients who have taken linezolid for more than 28 days. If you experience difficulties with your vision, consult your doctor as soon as possible.

Otheradverse effects include:

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

• fungal infections, especially in the vagina or mouth,
• headache,
• metallic taste,
• diarrhea, nausea, or vomiting,
• alteration of some blood test results, including protein, salt, or enzyme tests that measure liver, kidney, or blood sugar function,
• difficulty sleeping,
• increased blood pressure,
• anemia (reduction in the number of red blood cells),
• dizziness,
• abdominal pain, localized or generalized,
• constipation,
• indigestion,
• localized pain,
• reduction in platelet count,

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

• vaginal or genital inflammation in women,
• tingling or numbness sensation,
• swelling, discomfort, changes in tongue color,
• dry mouth,
• need to urinate more frequently,
• chills,
• feeling of thirst,
• increased sweating,
• hyponatremia (low sodium levels in the blood),
• kidney failure,
• abdominal swelling,
• increased creatinine,
• stomach pain,
• changes in heart rhythm (e.g., increased heart rate),
• decrease in blood cell count,
• weakness and/or sensory changes.

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

• change in tooth surface color, which disappears with professional dental cleaning procedures.

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

• alopecia (hair loss).

Reporting of Adverse Effects

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

5. Storage of Linezolid Sandoz

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging and blister after CAD/EXP. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be thrown away through wastewater or household waste. Ask your pharmacist how to dispose of packaging and medicines that are no longer needed. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Linezolid Sandoz

• The active ingredient is linezolid. Each film-coated tablet contains 600 mg of linezolid.
• The other ingredients are microcrystalline cellulose, anhydrous colloidal silica, sodium carboxymethylcellulose type A, hydroxypropylcellulose, and magnesium stearate in the core; hypromellose (E464), titanium dioxide (E171), and macrogol (E1521) in the film coating.

Appearance of the Product and Package Contents

Linezolid Sandoz 600 mg film-coated tablets are white to off-white, biconvex, oval-shaped tablets, 18.8 mm in length, 9.9 mm in width, and 6.4 mm in thickness, with "LZ600" engraved on one side and smooth on the other side.

Linezolid Sandoz 600 mg film-coated tablets are available in blister packs containing:

10, 10 (10 x 1), 20, 28, 30, 50, 60, or 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

S.C. Sandoz S.R.L

Str. Livezeni nr. 7ª,

RO-540472 Targu-Mures

Romania

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee, 1,

39179 Barleben

Germany

or

Lek Pharmaceuticals d.d.

Verovškova 57,

1526 Ljubljana

Slovenia

Date of the Last Revision of this Prospectus:January 2025

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/