Package Insert: Patient Information

Linezolid Sandoz 600 mg Film-Coated Tablets

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed only for you, and you should 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 package insert. See section 4.

6. Contents of the pack and additional information

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

It is used for the treatment of pneumonia and certain skin or subcutaneous tissue infections. Your doctor will have decided if Linezolid Sandoz is suitable for treating your infection.

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 any medicine 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 yes to any of the following questions. In that case, tell your doctor, as he/she will need to monitor your general 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 or not you are taking medicines to treat it?
• Have you been diagnosed with hyperthyroidism?
• Do you have a tumour of the adrenal glands (pheochromocytoma) or carcinoid syndrome (caused by tumours in the hormonal system that present with symptoms of diarrhoea, flushing of the skin, wheezing)?
• Do you have manic depression, schizophrenia, confusion or other mental problems?
• Have you had 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?
• Are you taking any of the following medicines?
• • Decongestants for colds that contain pseudoephedrine or phenylpropanolamine,
  • Medicines to treat asthma such as salbutamol, terbutaline, fenoterol,
  • Tricyclic antidepressants or SSRI (selective serotonin reuptake inhibitors) such as amitriptyline, citalopram, clomipramine, dosulepina, doxepin, fluoxetine, fluvoxamine, imipramine, lofepramine, paroxetine or sertraline,
  • Medicines used to treat migraines such as sumatriptan or zolmitriptan,
  • Medicines to treat severe allergic reactions such as adrenaline (epinephrine),
  • Medicines that increase blood pressure such as noradrenaline (norepinephrine), dopamine and dobutamine,
  • Medicines used to treat moderate or severe pain, such as pethidine, buprenorphine,
  • Medicines used to treat anxiety disorders such as buspirone,
  • An antibiotic called rifampicin.

Be especially 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 a lot,
• You have anaemia (low red blood cell count),
• You are prone to infections,
• You have a history of convulsions,
• You have liver or kidney problems, especially if you are on dialysis,
• You have diarrhoea.

Inform your doctor immediately if during treatment you experience:

• Visual problems such as blurred vision, changes in colour vision, difficulty seeing clearly, or if you notice that your field of vision is reduced,
• Loss of sensation in your arms or legs, or a feeling of numbness or tingling in your arms or legs,
• Diarrhoea while taking or after taking antibiotics, including linezolid. If the diarrhoea becomes severe, lasts a long time, or if you notice that your stools contain blood or mucus, stop taking linezolid immediately and consult your doctor. In this situation, do not take medicines that stop or reduce bowel movements,
• Recurring nausea or vomiting, abdominal pain, or hyperventilation,
• Unexpected muscle pain, sensitivity or weakness, and dark urine. These may 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 deterioration that may indicate hyponatremia (low sodium levels in the blood).

Children and adolescents

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

Other medicines and Linezolid Sandoz

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

Inform your doctor or pharmacist if you are taking or have recently taken any other medicine.

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

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

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

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

• Decongestants for colds that contain pseudoephedrine or phenylpropanolamine,
• Some medicines to treat asthma such as salbutamol, terbutaline, fenoterol,
• Certain antidepressants called tricyclics or SSRIs (selective serotonin reuptake inhibitors). There are many types of these medicines, including amitriptyline, citalopram, clomipramine, dosulepina, doxepin, fluoxetine, fluvoxamine, imipramine, lofepramine, paroxetine or sertraline,
• Medicines used to treat migraines such as sumatriptan or zolmitriptan,
• Medicines to treat severe allergic reactions such as adrenaline (epinephrine),
• Medicines that increase blood pressure such as noradrenaline (norepinephrine), dopamine and dobutamine,
• Medicines used to treat moderate or severe pain,
• Opioids, such as pethidine, buprenorphine,
• Medicines used to treat anxiety disorders such as buspirone,
• Medicines that prevent blood clotting such as warfarin,
• An antibiotic called rifampicin.

Taking Linezolid Sandoz with food, drinks and alcohol

• You can take linezolid before, during or after meals.
• Avoid eating large amounts of strong cheese, yeast extracts or soya bean extracts, for example soy sauce, and alcoholic drinks, especially draught beer and wine. The reason is that this medicine may react with a natural substance called tyramine that is present in some foods. This interaction may cause an increase in your blood pressure.
• If you start with a headache after eating or drinking, inform your doctor, pharmacist or nurse immediately.

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

Pregnancy, lactation 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 become pregnant, consult your doctor or pharmacist before using this medicine.

You should not breastfeed while taking linezolid because this medicine passes into breast milk and could affect your baby.

Driving and operating machines

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

Linezolid Sandoz contains sodium

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

Adults

Follow exactly the administration instructions for this medication described in this leaflet or indicated by your doctor, pharmacist, or nurse.In case of doubt, consult your doctor, pharmacist, or nurse again.

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

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

The safety and efficacy of this medication have not been established in treatment periods exceeding 28 days. Your doctor will decide the duration of your treatment.

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

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

Use in childrenand adolescents

Linezolid is not usually used in children or adolescents (under 18 years old).

Administration form

Swallow the tablet whole with a glass of water.

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

If you are on dialysis, 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot 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 compensate for the missed dose.

If you interrupt the treatment with Linezolid Sandoz

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

If your initial symptoms return after interrupting treatment, 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.

Inform your doctor, pharmacist, or nurse immediatelyif you notice any of the following side effects while taking linezolid:

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

• severe skin reactions (rare), particularly swelling 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 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),
• vision problems (rare), such as blurred vision (rare), changes in color perception (unknown), difficulty seeing clearly (unknown), or if you notice a decrease 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 (rare),
• cases of seizures or convulsions (rare),
• serotonin syndrome (unknown), inform your doctor if you experience agitation, confusion, delirium, rigidity, tremors, ataxia, convulsions, rapid heartbeats, severe respiratory problems, and diarrhea (suggestive of serotonin syndrome), while also taking 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 clotting or produce anemia (frequent),
• reduction in the number of white blood cells that can affect the ability to fight infections (rare). Some signs of infection include: fever (frequent), sore throat (rare), mouth ulcers (rare), and fatigue (rare),
• rhabdomyolysis (rare): signs and symptoms include unexplained muscle pain, sensitivity, or weakness, and/or dark urine. These may be signs of a serious condition called rhabdomyolysis (muscle degradation), which can cause kidney damage,
• pancreatitis (rare),
• convulsions (rare),
• transient ischemic attacks (temporary alteration in blood flow causing short-term symptoms such as loss of vision, weakness in arms and legs, difficulty speaking, and loss of consciousness),
• “Tinnitus” in the ears (rare),

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

Otherside 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 those measuring liver, kidney, or blood sugar function,
• difficulty sleeping,
• increased blood pressure,
• anemia (reduction in red blood cell count),
• dizziness,
• localized or generalized abdominal pain,
• constipation,
• indigestion,
• localized pain,
• reduction in platelet count,

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

• vaginal or genital area inflammation in women,
• tingling or numbness,
• swelling, discomfort, changes in tongue color,
• dry mouth,
• increased urination frequency,
• chills,
• thirst,
• increased sweating,
• hyponatremia (low sodium levels in blood),
• renal failure,
• abdominal swelling,
• increased creatinine levels,
• 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 side effects have also been reported (frequency unknown, the frequency cannot be estimated from available data):

• alopecia (hair loss).

Reporting of side effects

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

Keepthis medicationout of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and the blister pack after CAD/EXP. 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 the drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of Linezolid Sandoz

• The active ingredient is linezolid.Each film-coated tablet contains 600 mg of linezolid.
• The other components 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 content of the container

Linezolid Sandoz 600 mg film-coated tablets are white to off-white, biconvex, oval-shaped, 18.8 mm long, 9.9 mm wide, and 6.4 mm thick film-coated tablets with the mark “LZ600” engraved on one side and smooth on the other side.

Linezolid Sandoz 600 mg film-coated tablets are available in blisters in containers containing:

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

Only some container sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing

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

Last review date of this leaflet:January 2025

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