Linezolid Aurovitas Spain 600 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Linezolid Aurovitas Spain 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 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 reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Linezolid Aurovitas Spain is and what it is used for

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

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

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

Do not store or reuse this medicine. If you have any antibiotic left over after completing treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste.

It is used to treat pneumonia and certain skin or soft tissue infections. Your doctor will have decided whether this medicine is appropriate for treating your infection.

2. What you need to know before starting to take Linezolid Aurovitas Spain

Do not take Linezolid Aurovitas Spain

• 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 medicines known as monoamine oxidase inhibitors (MAOIs, such as phenelzine, isocarboxazide, selegiline, moclobemide). These medicines are usually used to treat depression or Parkinson's disease.
• if you are breastfeeding. This medicine passes into breast milk and could affect the baby.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to take Linezolid Aurovitas Spain.

Linezolid may not be suitable for you if you answer yes to any of the following questions. In such cases, inform your doctor, as they 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 you.

• You have high blood pressure, whether or not you are taking medication for it.
• You have been diagnosed with hyperactive thyroid (hyperthyroidism).
• You have a tumor of the adrenal glands (pheochromocytoma) or carcinoid syndrome (caused by tumors in the hormonal system, presenting symptoms such as diarrhea, skin flushing, and wheezing).
• You suffer from manic depression, schizophrenia, confusion, or other mental disorders.
• You have a history of hyponatremia (low sodium levels in the blood) or take medicines that reduce sodium levels in the blood, e.g., certain diuretics such as hydrochlorothiazide.
• You are taking any opioid.

Using certain medicines, including antidepressants and opioids, together with linezolid may cause serotonin syndrome, a potentially life-threatening condition (see “Other medicines and Linezolid Aurovitas Spain”).

Take special care with Linezolid Aurovitas Spain

Inform your doctor before taking this medicine if:

• you are elderly.
• you bruise easily or bleed easily.
• 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 a reduction in your visual field.
• loss of sensation in arms or legs, or a tingling or burning sensation in your arms or legs.
• Diarrhea may occur while taking or after stopping antibiotics, including linezolid. If diarrhea becomes severe, persists for a long time, or if you notice blood or mucus in your stools, stop taking this medicine immediately and consult your doctor. In this situation, do not take medicines that stop or reduce intestinal movements.
• repeated nausea or 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.
• dizziness and malaise with muscle weakness, headache, confusion, and memory impairment, which may indicate hyponatremia (low sodium levels in the blood).

Other medicines and Linezolid Aurovitas Spain

Tell your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

Sometimes, linezolid can interact with certain medicines and cause adverse effects such as changes in blood pressure, body temperature, or heart rate.

Inform your doctor if you are taking or have taken within the last 2 weeks the following medicines, as you must not take linezolid if you are still taking them or have recently taken them (see also section 2 above “Do not take Linezolid Aurovitas Spain”):

• Monoamine oxidase inhibitors (MAOIs, such as phenelzine, isocarboxazide, selegiline, moclobemide). These medicines are commonly used to treat Parkinson's disease.

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

• Cold decongestants containing pseudoephedrine or phenylpropanolamine.
• Certain asthma medications such as salbutamol, terbutaline, fenoterol.
• Certain antidepressants called tricyclics or SSRIs (selective serotonin reuptake inhibitors). There are many medicines in this group, including amitriptiline, citalopram, clomipramine, dosulepin, doxepin, fluoxetine, fluvoxamine, imipramine, lofepramine, paroxetine, or sertraline.
• Medicines used to treat migraines, such as sumatriptan or zolmitriptan.
• Medicines used to treat sudden severe allergic reactions, such as adrenaline (epinephrine).
• Medicines that increase blood pressure, such as noradrenaline (norepinephrine), dopamine, and dobutamine.
• Opioids (e.g., meperidine), used to treat moderate to severe pain.
• Medicines used to treat anxiety disorders, such as buspirone.
• Medicines that prevent blood clotting, such as warfarin.
• An antibiotic called rifampicin.

Taking Linezolid Aurovitas Spain with food, drinks, and alcohol

• You may take this medicine before, during, or after meals.
• Avoid eating excessive amounts of cheese, yeast extracts, soybean seed extracts (e.g., soy sauce), and alcoholic beverages, especially draught beer and wine. This is because this medicine can react with a substance called tyramine, naturally present in some foods. This interaction may cause an increase in your blood pressure.
• If you develop a headache after eating or drinking, inform your doctor, pharmacist, or nurse immediately.

Pregnancy, breastfeeding, and fertility

The effect of linezolid in pregnant women is unknown. Therefore, pregnant women should not take this medicine unless advised by their 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 medicine.

You must not breastfeed while taking linezolid, as 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 operate machinery. Remember that if you do not feel well, your ability to drive or use machines may be impaired.

Linezolid Aurovitas Spain contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Linezolid Aurovitas Spain contains sodium

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

3. How to take Linezolid Aurovitas Spain

Adults

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one film-coated tablet (600 mg) twice daily (every 12 hours). Swallow the film-coated tablet whole with some water.

If you are on a dialysis regimen, you should take this medicine after each dialysis session.

The usual duration of treatment is 10–14 days, but may 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 you are taking this medicine, your doctor will perform periodic blood tests to monitor your blood count.

If you take this medicine for more than 28 days, your doctor will need to monitor your vision.

Use in children and adolescents

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

If you take more Linezolid Aurovitas Spain than you should

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

If you forget to take Linezolid Aurovitas Spain

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

If you stop taking Linezolid Aurovitas Spain

It is important that you only stop your treatment if instructed to do so by your doctor.

If your initial symptoms return after stopping treatment, inform your doctor or pharmacist immediately.

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

4. Possible adverse effects

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

Tell your doctor, pharmacist, or nurse immediately if you notice any of the following adverse effects while taking linezolid:

Serious adverse effects of linezolid (frequency in parentheses) include:

• 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 may need to be stopped. Skin reactions such as raised purple rash due to inflammation of blood vessels (rare), red, sore, 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 clearly (frequency not known), or a reduction in your field of vision (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 (rare).
• Seizures or convulsions have been reported (uncommon) in patients receiving linezolid.
• 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 taking antidepressants called SSRIs or opioids (see section 2).
• 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 the number of certain blood cells that may affect the ability to fight infections (uncommon). Some signs of infection include: fever (common), sore throat (uncommon), mouth ulcers (uncommon), and fatigue (uncommon).
• Rhabdomyolysis (rare): signs and symptoms include 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.
• Inflammation of the pancreas (uncommon).
• Convulsions (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, slowed speech, and loss of consciousness) (uncommon).
• 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 vision problems, consult your doctor as soon as possible.

Other adverse effects include:

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

• Fungal infections, especially in the vagina or mouth.
• Headache.
• Metallic taste.
• Diarrhoea, vomiting, nausea.
• Changes in certain blood test results, including tests for proteins, salts, or enzymes measuring liver or kidney function, or blood sugar levels.
• Difficulty sleeping.
• Increased blood pressure.
• Anaemia (reduction in the number of red blood cells).
• Dizziness.
• Localised or generalised abdominal pain.
• Constipation.
• Indigestion.
• Localised pain.
• Decreased platelet count.

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

• Inflammation of the vagina or female genital area.
• Tingling or numbness sensations.
• Swelling, discomfort, changes in tongue colour.
• Dry mouth.
• Need to urinate more frequently.
• Chills.
• Feeling of thirst.
• Increased sweating.
• Hyponatraemia (low sodium levels in blood).
• Hypoglycaemia (low blood sugar levels).
• Kidney failure.
• Abdominal swelling.
• Increased creatinine.
• Stomach pain.
• Changes in heart rhythm (e.g., increased heart rate).
• Decreased blood cell count.
• Weakness and/or sensory changes.

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

• Change in tooth surface colour, which resolves with professional dental cleaning procedures.
• Change in tongue surface colour to black, with a hairy appearance.

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 adverse effect, talk to 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: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Linezolid Aurovitas Spain

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

Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date is 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 empty containers and unused medicines at the SIGRE collection point in your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Linezolid Aurovitas Spain

• The active substance is linezolid. Each film-coated tablet contains 600 mg of linezolid.
• The other components are:

Tablet core contains: poloxamer 407, sodium carboxymethylstarch (type A) (derived from potato starch), povidone K30, colloidal anhydrous silica, microcrystalline cellulose, lactose monohydrate, talc and magnesium stearate.

Coating contains: hypromellose, polyethylene glycol 400 (macrogol) and titanium dioxide (E171).

Appearance of the product and contents of the container

Linezolid Aurovitas Spain 600 mg film-coated tablets are white, oval-shaped, biconvex tablets.

Linezolid Aurovitas Spain tablets are available in PA/AL/PVC-Aluminum or PVC/PE/PVDC-Aluminum blister strips containing 10, 20, 30, 50 or 60 film-coated tablets.

Linezolid Aurovitas Spain tablets are also available in HDPE bottles containing 10, 14, 20, 24, 30, 50 or 60 film-coated tablets, with a child-resistant screw cap.

Linezolid Aurovitas Spain tablets are also available in HDPE bottles containing 100 film-coated tablets (for hospital use only).

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

Pharmathen International S.A.

Sapes Industrial Park Block 5

69300 Rodopi

Greece

Or

Pharmathen S.A.

6, Dervenakion str.

15351 Pallini, Attiki

Greece

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

Date of the latest review of this leaflet: April 2026

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