Prospecto: Information for the User

Linezolid Demo 2 mg/ml, Solution for Infusion EFG

Read this prospect carefully before you receive this medicine because it contains important information for you.

• Keep this prospect, 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 and should not be given to others, even if they have the same symptoms as you, as it may harm them.

• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospect. See section 4.

1.What is Linezolid Demo and how is it used

2.What you need to know before being treated with Linezolid Demo

3.How to administer Linezolid Demo

4.Possible adverse effects

5.Storage of Linezolid Demo

6.Package contents and additional information

Linezolidis an antibiotic from 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 iflinezolidis suitable for treating your infection.

Do not administer LinezolidDemoif:

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Linezolid Demo.

Linezolid may not be suitable for you if you respondyesto any of the following questions. In that case, inform your doctor, as they 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 or not you are taking medication for it?
• 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, flushing, shortness of breath)?
• Do you suffer from manic depression, schizophrenia, confusion, or other mental health problems?
• Do you have a history of hyponatremia (low sodium levels in the blood) or are taking medications that reduce sodium levels in the blood, such as certain diuretics like hydrochlorothiazide?
• Are you taking opioids?

The use of certain medications, including antidepressants and opioids, in combination with Linezolid Demo may cause serotonin syndrome, a potentially life-threatening condition (see section 2 "Other medications and Linezolid Demo" and section 4).

Be especially careful withLinezolidDemo

Inform your doctor before using this medication if:

• You are an elderly patient
• You bleed easily and bruise easily
• You have anemia (low red blood cell levels)
• 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:

• Visual problems such as blurred vision, changes in color vision, difficulty seeing clearly, or if you notice a reduction in your field of vision.
• Loss of sensation in your arms or legs or a feeling of tingling or burning in your arms or legs.
• Dyspepsia may occur while taking or after taking antibiotics, including linezolid. If diarrhea becomes intense, lasts a long time, or if you notice that your stools contain blood or mucus, stop taking this medication immediately and consult your doctor. In this situation, do not take medications that stop or reduce intestinal movements.
• Recurring nausea or vomiting, abdominal pain, or hyperventilation
• Discomfort and dizziness with muscle weakness, headache, confusion, and memory deterioration that may indicate hyponatremia (low sodium levels in the blood).

LinezolidDemoand other medications

There is a risk thatlinezolidmay interact with certain medications 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 taken recently any other medication.

Inform your doctor if you are taking or have taken in the last 2 weeksthe following medications, asyou should not uselinezolidif you are still taking or if you have taken them recently (see section 2 "Do not use Linezolid Demo").

• Monamine oxidase inhibitors (MAOIs, such as phenelzine, isocarboxazid, selegiline, moclobemide). These medications are often used to treat Parkinson's disease.

Also inform your doctor if you are taking the following medications. Your doctor may decide to treat you withlinezolid,but they 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.

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

LinezolidDemowith food, drinks, and alcohol

• You can takelinezolidbefore, during, or after meals.
• Avoid eating large amounts of strong cheesecurd, yeast extracts, or soybean extracts (such as soy sauce) and beer or wine. The reason is that linezolid may react with a natural substance called tyramine present in some foods. This interaction may cause an increase in your blood pressure.
• If you experience a headache after eating or drinking, inform your doctor, pharmacist, or nurse immediately.

Pregnancy, breastfeeding, and fertility

The effect oflinezolidon pregnant women is unknown. Therefore, pregnant women should not uselinezolid, unless advised by their doctor. If you are pregnantor breastfeeding, if you think you may be pregnant, or if you are trying to become pregnant, consult your doctor or pharmacist before using this medication.

You should not breastfeed while takinglinezolidbecause this medication passes into the milk and could affect your baby.

Driving and operating machinery

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

LinezolidDemocontainsglucose and sodium

Linezolid Demosolutioncontains 13.7 g of glucose per 300 ml dose, which should be taken into account in patients with diabetes mellitus.

This medication contains 114 mg of sodium (main component of table salt/for cooking) in each 300 ml dose. This is equivalent to 5.7% of the maximum daily sodium intake recommended for an adult.

Adults

Follow exactly the administration instructions contained in this leaflet or those indicated by your doctor, pharmacist, or nurse. If in doubt, ask your doctor, pharmacist, or nurse.

This medication will be administered to you by a doctor or other healthcare professional through an infusion (by perfusion within a vein). The recommended dose for adults (18 years or older) is 300 ml (600 mg of linezolid) twice a day administered directly into the bloodstream (intravenously), through an infusion over a period of 30 to 120 minutes.

If you are on dialysis, you will be administered linezolid after each session.

The usual duration of treatment is 10-14 days, but it may 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 being treated with linezolid, your doctor will perform periodic blood tests to monitor your blood count.

If you are treated with linezolid for more than 28 days, your doctor should monitor your vision.

Use in children and adolescents

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

If you are administered more Linezolid Demo than you should

If you think you may have been administered more linezolid than you should, inform your doctor or nurse 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 administered.

If you forgot to use Linezolid Demo

As this medication is administered under close supervision, it is very unlikely that a dose will be forgotten. If you think you may have forgotten to administer a treatment dose, inform your doctor or nurse immediately.You cannot be given a double dose to compensate for missed doses.

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

Inform your doctor, pharmacist, or nurseimmediately if you notice any of the following side effects while takinglinezolid:

The most severe side effects of Linezolid Demo (frequency in parentheses) are:

• Severe skin reactions (rare), swelling particularly around the face and neck (rare), shortness of breath 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 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 vision (unknown), difficulty seeing clearly (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 circumstances may lead to complications that can be life-threatening (rare).
• Repeated nausea or vomiting, abdominal pain, or rapid breathing (rare).
• There have been reported cases of seizures or convulsions (rare) in patients takinglinezolid.
• Serotonin syndrome (unknown) should inform your doctor if you experience agitation, confusion, delirium, rigidity, tremors, ataxia, rapid heartbeats, severe respiratory problems, and diarrhea (suggestive of serotonin syndrome) while also taking antidepressants called ISRS or opioids (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).
• Pancreatitis (rare).
• Seizures (rare).
• Transient ischemic attacks. (Temporary alteration of blood flow to the brain causing short-term symptoms such as loss of vision, weakness in arms and legs, difficulty speaking, and loss of consciousness) (rare).
• Tinnitus (ringing in the ears) (rare).

There have been reported cases of numbness, tingling, or blurred vision in patients who have takenlinezolidfor more than 28 days. If you experience difficulty with your vision, consult your doctor as soon as possible.

Other side effects include:

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

• Fungal infections, especially in the vagina or mouth
• Headache
• Metalllic taste
• Diarrhea, nausea, or vomiting
• Alteration of some blood test results, including those resulting from tests of proteins, salts, or enzymes that measure liver, kidney, or blood sugar function
• Difficulty sleeping
• Increased blood pressure
• Anemia (low 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 1,000 people):

• Change in the color of the tooth surface, which disappears with professional dental cleaning procedures

Also, the following side effects have been reported.

Unknown frequency(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, pharmacist, or nurse, even if it is not listed in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: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 indicated on the label and carton boxafter “CAD”. The expiration date refers to the last day of that month.

No special storage conditions are required.

Keep the bottle in the outer packaging to protect it from light.

After opening: from a microbiological point of view, unless the opening method excludes the risk of bacterial contamination, the product should be used immediately, otherwise the storage times and conditions will be the responsibility of the user.

Do not useif visible particles are present in the solution or if it is not transparent.

Do not dispose of any medication through wastewater or household waste. Ask your pharmacist how to dispose of unused medications. These measures will help protect the environment.

What it containsLinezolidDemo

• The active substance is linezolid. Each millilitre of solution contains 2 mg of linezolid. Each 300 ml infusion bottle contains 600 mg of linezolid.
• The other components are glucose monohydrate (a type of sugar, see section 2), sodium citrate (E331, see section 2), citric acid monohydrate, hydrochloric acid (5N) (E507) or sodium hydroxide (5N) (E524) and water for injection preparations.

Appearance of the medicinal product and contents of the primary packLinezolidDemo

Linezolid Demo is a transparent, colourless to yellowish infusion solution.

It is presented in cartons containing 300 ml polypropylene bottles.

It is presented in packs of 1, 2, 5, 10, 20 or 25 bottles.

Not all pack sizes may be marketed.

Marketing authorisation holder and responsible person

Demo S.A., Pharmaceutical Industry

21st km National Road Athens-Lamia,

14568 Krioneri, Attiki,

Greece

Further information on this medicinal product can be obtained from the local representative of the marketing authorisation holder:

Local representative:

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

This medicinal productisauthorised in the member states of theEuropeanEconomicEspacewiththe following names:

Last update of the summary of product characteristics:June2024

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

This information is intended solely for healthcare professionals

LinezolidDemo2 mg/ml solución para perfusión EFG

IMPORTANT:

Consult the Summary of Product Characteristics (SmPC) before prescribing.

Linezolid is not active against infections caused by Gram-negative pathogenic microorganisms. Concomitant treatment with antibiotics against Gram-negative microorganisms should be initiated if there is certainty or suspicion of co-infection with Gram-negative pathogenic microorganisms.

Description

Single-use plastic bottles made of polypropylene, ready for use, with a moulded plastic cap, a type II rubber stopper and a easy-open ring or a double-port closure with elastomeric inserts. The bottle contains 300 ml of solution and is presented in a carton. Each carton contains 1 bottle.

Single-use plastic bottles made of polypropylene, ready for use, with a moulded plastic cap, a type II rubber stopper and a easy-open ring or a double-port closure with elastomeric inserts.

Each bottle is presented inside a metallised plastic sleeve. The bottle contains 300 ml of solution and is presented in a carton. Each carton contains 2, 5, 10, 20 or 25 bottles.

The 300 ml bottle is available in packs of 1, 2, 5, 10, 20 and 25 bottles.

Not all pack sizes may be marketed.

• LinezolidDemois a transparent, colourless to yellowish infusion solution. Othercomponents are: glucose monohydrate, sodium citrate (E331), citric acid monohydrate, hydrochloric acid (5N) (E507) or sodium hydroxide (5N) (E524) and water for injection preparations.

Dosage and administration

Linezolid should only be initiated in a hospital setting and after evaluation by a specialist doctor, such as a microbiologist or an infectious diseases specialist.

Patients who start treatment with the parenteral formulation can switch to any of the oral presentations when clinically indicated. In this case, no dose adjustment is required, as the oral bioavailability of linezolid is approximately 100%.

The infusion solution should be administered over a period of 30 to 120 minutes.

The recommended dose of linezolid should be administered intravenously twice a day.

Recommended duration and dosage for adults:

The duration of treatment depends on the microorganism, the site of infection, the severity and the patient's clinical response.

The recommendations for the duration of treatment listed below reflect those used in clinical trials. For some types of infection, it may be advisable to prescribe shorter treatments, although this has not been evaluated in clinical trials.

The maximum duration of treatment is 28 days. The safety and efficacy of linezolid have not been established when administered for periods longer than 28 days.

Infections associated with concurrent bacteremiado not require an increase in the recommended dose or the duration of treatment. The recommended doses for the infusion solution are as follows:

Pediatric population:

The safety and efficacy of linezolid have not been established in childrenunder18 years.The available data are described in sections 4.8, 5.1 and 5.2 of the Summary of Product Characteristics, however, no dosage recommendation can be made.

Geriatric population:No dose adjustment is required.

Renal impairment:No dose adjustment is required.

Severe renal impairment (i.e. CLCR<30

Since approximately 30% of the linezolid dose is eliminated during 3 hours of haemodialysis, linezolid should be administered after dialysis in patients receiving this treatment. The main metabolites of linezolid are eliminated in part by haemodialysis, but the concentrations of their metabolites are considerably higher after dialysis than in patients with normal renal function or mild to moderate renal impairment. Therefore, linezolid should be used with special caution in patients with severe renal impairment undergoing dialysis and only if the expected benefit outweighs the potential risk.

Until now, there is no experience with the administration of linezolid in patients undergoing continuous ambulatory peritoneal dialysis (CAPD) or alternative treatments for renal impairment (other than haemodialysis).

Follow the same changes as in the SmPC

Severe hepatic impairment:Patients with mild to moderate hepatic impairment (Child-Pugh class A or B): no dose adjustment is required.

Severe hepatic impairment (Child-Pugh class C):As linezolid is metabolised by a non-enzymatic process, it is expected that impaired liver function will not significantly affect its metabolism, and therefore no dose adjustment is recommended. However, there are insufficient clinical data and linezolid should only be used in these patients if the expected benefit outweighs the theoretical risk.

Contraindications

Hypersensitivity to linezolid or to any of the excipients.

Linezolid should not be used in patients taking monoamine oxidase inhibitors (MAOIs) or within two weeks of taking such medication.

Unless there are facilities available for close monitoring and control of blood pressure, linezolid should not be administered to patients with the following underlying conditions or who are being treated with the following medications:

• Patients with uncontrolled hypertension, phaeochromocytoma, carcinoid syndrome, thyrotoxicosis, bipolar disorder, affective disorders, acute confusional state.

• Patients taking any of the following medications: selective serotonin reuptake inhibitors, tricyclic antidepressants, 5-HT1 receptor agonists (triptans), direct or indirect sympathomimetics (including bronchodilators, pseudoephedrine and phenylpropanolamine), vasopressors (e.g. adrenaline/epinephrine, noradrenaline/norepinephrine), dopaminergic drugs (e.g. dopamine, dobutamine), pethidine or buspirone.

Discontinue breastfeeding before and during treatment with linezolid (see section 4.6 of the SmPC).

Special warnings and precautions for use

Myelosuppression

Myelosuppression (including anaemia, leucopenia, pancytopenia and thrombocytopenia) has been reported in patients treated with linezolid. In patients in whom follow-up was performed, it was seen that after discontinuation of treatment, the affected haematological parameters returned to pre-treatment levels. The risk of these effects appears to be associated with the duration of treatment. Elderly patients treated with linezolid may be at a higher risk of experiencing haematological disorders than younger patients. Thrombocytopenia may occur more frequently in patients with severe renal impairment, whether or not they are undergoing dialysis, and in patients with moderate to severe hepatic impairment.

Close monitoring of the full blood count is recommended in patients who: have pre-existing anaemia, granulocytopenia or thrombocytopenia; are receiving concomitant medication that may decrease haemoglobin levels, reduce the count or affect the count or function of platelets; have severe renal impairment or moderate to severe hepatic impairment; or who are receiving more than 10-14 days of treatment. Linezolid should only be administered to these patients if it is possible to closely monitor haemoglobin levels, blood counts and platelet counts.

If significant myelosuppression occurs during treatment with linezolid, treatment should be discontinued, unless continuation of treatment is considered absolutely necessary, in which case, close monitoring of haematological parameters and implementation of appropriate therapeutic measures should be performed.

It is also recommended to perform a complete blood count (including haemoglobin, platelets, absolute leucocyte count and formula) in patients receiving linezolid, regardless of their baseline haematology.

In compassionate use studies, a higher incidence of severe anaemia was reported in patients treated with linezolid for periods longer than the recommended maximum duration of 28 days. These patients require more frequent blood transfusions. Cases of anaemia requiring blood transfusion have also been reported during post-marketing experience, with a higher number of cases in patients who received linezolid for more than 28 days.

Severe sideroblastic anaemia has been reported during post-marketing experience. In cases where the onset is known, the majority of patients were treated for more than 28 days. Most patients recovered partially or totally after discontinuation of linezolid treatment, with or without treatment for anaemia.

Unbalanced mortality in a clinical trial in patients with Gram-positive catheter-related infections

In an open-label study in severely ill patients with catheter-related infections caused by Gram-positive microorganisms, an excess of mortality was observed in patients treated with linezolid compared with those treated with vancomycin/dicloxacillin/oxacillin [78/363 (21.5%) vs 58/363 (16.0%)]. The main factor influencing the mortality rate was the baseline status of infections caused exclusively by Gram-positive microorganisms (odds ratio 0.96; 95% CI: 0.58-1.59), but it was significantly higher (p= 0.0162) in the linezolid group for patients infected with any other microorganism or in whom no microorganism was isolated at baseline (odds ratio 2.48; 95% CI: 1.38-4.46). The greatest imbalance occurred during treatment and within 7 days after discontinuation of the study drug in the linezolid group. In the linezolid group, more patients acquired Gram-negative infections during the study and died from Gram-negative infections and polymicrobial infections. Therefore, linezolid should only be used in patients with complicated skin and soft tissue infections in whom there is suspicion or certainty of co-infection with Gram-negative microorganisms if there are no other treatment options available. In these circumstances, concomitant treatment with antibiotics against Gram-negative microorganisms should be initiated.

Diarrhea and antibiotic-associated colitis

With the use of almost all antibiotics, including linezolid, cases of antibiotic-associated diarrhea and antibiotic-associated colitis, including pseudomembranous colitis and Clostridium difficile-associated diarrhea, have been reported, whose severity can range from mild diarrhea to fatal colitis. Therefore, it is essential to consider this diagnosis in patients who develop severe diarrhea during or after treatment with linezolid. If suspected or confirmed antibiotic-associated diarrhea or antibiotic-associated colitis, treatment with the antibacterial agents, including linezolid, should be discontinued and appropriate therapeutic measures should be implemented immediately. In this situation, medications that inhibit peristalsis are contraindicated.

Lactic acidosis

Cases of lactic acidosis have been reported with the use of linezolid. Patients who develop signs or symptoms of metabolic acidosis, including recurrent nausea or vomiting, abdominal pain, low bicarbonate levels or hyperventilation while being treated with linezolid should receive immediate medical attention. If lactic acidosis occurs, the benefits of continuing treatment with linezolid should be weighed against the potential risks.

Mitochondrial dysfunction

Linezolid inhibits mitochondrial protein synthesis. As a result of this inhibition, adverse events such as lactic acidosis, anaemia and neuropathy (optic and peripheral) may occur, which are more frequent when the duration of treatment is longer than 28 days.

Serotonin syndrome

Spontaneous reports of serotonin syndrome associated with concomitant administration of linezolid and serotoninergic agents, including antidepressants such as selective serotonin reuptake inhibitors (SSRIs) and opioids, have been reported. Therefore, concomitant administration of linezolid and serotoninergic agents is contraindicated, except when the concomitant administration of linezolid and serotoninergic agents is absolutely necessary (see section 4.3 of the SmPC). In these cases, patients should be closely monitored for signs and symptoms of serotonin syndrome, such as cognitive dysfunction, hyperpyrexia, hyperreflexia and ataxia. If signs or symptoms occur, consideration should be given to discontinuing one or both agents; if the serotoninergic agent is discontinued, symptoms may resolve.

Hypontremia and SIADH

Hypontremia and/or syndrome of inappropriate antidiuretic hormone secretion (SIADH) have been observed in some patients treated with linezolid.Regular monitoring of serum sodium levels is recommended in patients at risk of hypontremia, such as elderly patients or patients taking medications that may reduce serum sodium levels (e.g. thiazide diuretics such as hydrochlorothiazide).

Optic and peripheral neuropathy

Cases of peripheral neuropathy, as well as optic neuropathy and optic neuritis, which may progress to loss of vision in patients treated with linezolid, have been reported; these cases have occurred mainly in patients treated for periods longer than the recommended maximum duration of 28 days.

Patients should be advised to report any visual symptoms, such as changes in visual acuity, changes in colour vision, blurred vision or visual field defects. In such cases, visual function should be evaluated as soon as possible and an ophthalmologist should be consulted if necessary. Regular monitoring of visual function should be performed in any patient treated with linezolid for a period longer than 28 days.

The continuation of treatment with linezolid in patients who have experienced optic or peripheral neuropathy should be evaluated against the potential risks.

A higher risk of neuropathy may exist when linezolid is used in patients who are currently taking or have recently taken antimycobacterial medication for the treatment of tuberculosis.

Seizures

Cases of seizures have been reported in patients treated with linezolid. In most cases, a history of seizures or risk factors for seizures was reported. Patients should be advised to report any history of seizures.

Inhibitors of monoamine oxidase

Linezolid is a reversible and non-selective inhibitor of monoamine oxidase (MAO); however, it does not exert any antidepressant effect at the doses used for antibacterial treatment. There is limited data on the pharmacological interactions and safety of linezolid in patients receiving linezolid and underlying conditions or concomitant treatment with medications that increase this risk. Therefore, linezolid should not be used in these circumstances, unless close observation and monitoring of the patient are possible.

Use with foods rich in tyramine

Patients should be advised not to consume large amounts of foods rich in tyramine (see section 4.5).

Overinfection

The effects of linezolid treatment on normal flora have not been evaluated in clinical trials. Occasionally, the use of antibiotics may lead to the overgrowth of non-susceptible microorganisms. Approximately 3% of patients who received linezolid at the recommended doses during clinical trials presented with candidiasis associated with treatment. In cases of overinfection during treatment, appropriate measures should be taken.

Special populations

Linezolid should be used with caution in patients with severe renal impairment, and only if the expected benefit outweighs the potential risk.

Linezolid should only be used in patients with severe hepatic impairment if the expected benefit outweighs the potential risk.

Effects on fertility

In studies in adult male rats with linezolid exposure levels similar to those expected in humans, a reversible decrease in fertility and abnormal sperm morphology were observed. The potential effects of linezolid on human male reproductive system are unknown.

Clinical studies

The safety and efficacy of linezolid have not been established when administered for periods longer than 28 days.

Clinical trials did not include patients with diabetic foot lesions, pressure ulcers, ischaemic lesions, severe burns or gangrene. Therefore, there is limited experience with the use of linezolid in the treatment of these conditions.

Warnings about excipients

Glucose

This medicinal productcontains 13.7 gof glucose in 300 ml, which should be taken into account in the treatment of patients with diabetes mellitus or other conditions associated with glucose intolerance.

Sodium

This medicinal productcontains 114 mg of sodium per 300 ml dose,equivalent to 5.7% of the maximum daily intake of 2 g of sodium recommended by the WHO for an adult.

Linezolid Demo may be prepared for administration with solutions containing sodium (see section 6.6), and this should be considered in relation to the total sodium intake from all sources administered to the patient.

Interactions

Inhibitors of monoamine oxidase

Linezolid is a reversible and non-selective inhibitor of monoamine oxidase (MAO). The data on pharmacological interactions and safety of linezolid administered to patients receiving concomitant treatment with medications that increase the risk of MAO inhibition are limited. Therefore, linezolid should not be used in these circumstances, unless close observation and monitoring of the patient are possible.

Potential interactions that increase blood pressure

Linezolid increased the hypotensive effect produced by pseudoephedrine and phenylpropanolamine in healthy normotensive volunteers. Simultaneous administration of linezolid with pseudoephedrine or phenylpropanolamine produced mean increases in systolic blood pressure of approximately 30-40 mmHg, compared with the 11-15 mmHg produced by linezolid alone, the 14-18 mmHg produced by pseudoephedrine or phenylpropanolamine alone, and the 8-11 mmHg produced by placebo. No similar studies have been performed in hypertensive patients. It is recommended that if linezolid is administered with medications with vasopressor effects (including dopaminergic agents), the doses of these medications should be titrated carefully to achieve the desired response.

Potential serotoninergic interactions

In healthy volunteers, the potential pharmacological interaction of linezolid with dextromethorphan was studied. Two doses of 20 mg of dextromethorphan were administered with a 4-hour interval, with or without linezolid. In healthy volunteers who received linezolid and dextromethorphan, no effects of serotonin syndrome (confusion, delirium, restlessness, tremor, diaphoresis, hyperpyrexia) were observed.

During post-marketing experience: a case of a patient experiencing symptoms similar to those of serotonin syndrome, during the use of linezolid and dextromethorphan, which resolved after discontinuation of both treatments.

Spontaneous reports of serotonin syndrome have been reported during the concomitant use of linezolid with serotoninergic agents, including antidepressants such as selective serotonin reuptake inhibitors (SSRIs) and opioids (see section 4.3 of the SmPC). Therefore, concomitant administration of linezolid and serotoninergic agents is contraindicated, except when the concomitant administration of linezolid and serotoninergic agents is absolutely necessary.

Use with foods rich in tyramine

No significant pressor response was observed in volunteers who received linezolid and less than 100 mg of tyramine. This suggests that only excessive consumption of foods or beverages high in tyramine (e.g. aged cheese, yeast extracts, non-distilled alcoholic beverages and fermented soy products such as soy sauce) is necessary to be avoided.

Medications metabolized through the cytochrome P450

Linezolid is not metabolized in a detectable manner by the cytochrome P450 (CYP) enzyme system or inhibits any of the clinically significant human CYP isoforms (1A2, 2C9, 2C19, 2D6, 2E1 and 3A4). Similarly, linezolid does not induce CYP450 enzymes in rats. Therefore, no pharmacological interactions induced by CYP450 with linezolid are expected.

Rifampicin

The effect of rifampicin on the pharmacokinetics of linezolid was studied in 16 healthy male volunteers who received 600 mg of linezolid twice a day for 2.5 days, with and without 600 mg of rifampicin once a day for 8 days. Rifampicin reduced the Cmax and AUC of linezolid by a mean of 21% [90% CI, 15, 27] and 32% [90% CI, 27, 37], respectively. The mechanism of this interaction and its clinical relevance are unknown.

Warfarin

The simultaneous administration of warfarin and linezolid in a steady-state condition produced a 10% mean maximum decrease in INR (International Normalised Ratio) and a 5% decrease in AUC of INR. The data from patients who have received warfarin and linezolid are insufficient to evaluate the clinical relevance, if any, of these findings.

Fertility, pregnancy and lactation

Pregnancy

The available data on the use of linezolid in pregnant womenare limited. Animal studies have shown reproductive toxicity. There is a potential risk in humans.

Linezolid should not be used during pregnancy, except when clearly necessary. That is, only if the potential benefit outweighs the possible risk.

Lactation

The available data in animals suggest that linezolid and its metabolites may pass into breast milk, and therefore breastfeeding should be discontinued before and during treatment.

Fertility

Studies in animals have shown a decrease in fertility.

Effects on ability to drive and use machines

Patients should be advised that they may experience dizziness or visual symptoms while receiving linezolid, and they should be advised not to drive or operate machinery if any of these symptoms occur.

Adverse reactions

The following table lists all adverse reactions of this medicinal product and their frequencies based on all causality data from clinical trials in which more than 6,000 adult patients received the recommended doses of linezolid for a maximum of 28 days.

The most frequently reported adverse reactions were diarrhoea (8.9%), nausea (6.9%), vomiting (4.3%) and headache (4.2%).

The most frequently reported adverse reactions related to the drug that led to treatment discontinuation were headache, diarrhoea, nausea and vomiting. Approximately 3% of patients discontinued treatment due to an adverse reaction related to the drug.

The following adverse reactions have been reported during post-marketing experience and are included in the table in the category of “Unknown frequency”, as the frequency cannot be estimated from the available data.

The following adverse reactions have been observed and reported during treatment with linezolid with the following frequencies: Very common (≥ 1/10), common (≥1/100 to <1

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