Package Leaflet: Information for the User

Linezolid Aurovitas Spain 600 mg Film-Coated Tablets

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

-Keep this leaflet, as 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. Do 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 leaflet. See section 4.

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

2.What you need to know before you start taking Linezolid Aurovitas Spain

3.How to take Linezolid Aurovitas Spain

4.Possible side effects

5.Storage of Linezolid Aurovitas Spain

6.Contents of the pack and additional information

Linezolid is 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 if this medication is suitable for treating your infection.

Do not take Linezolid Aurovitas Spain

-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 medicine called monoamine oxidase inhibitors (MAOIs, such as phenelzine, isocarboxazid, selegiline, moclobemide). These medicines are usually used to treat depression or Parkinson's disease.

-if you are breastfeeding. This medicine passes into the milk and could affect the baby.

Warnings and precautions

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

Linezolid may not be suitable for you if you answeryesto any of the following questions. In that case, inform 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.

•You have high blood pressure, whether or not you are taking medicines to treat it.

•You have been diagnosed with hyperthyroidism.

•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 of the skin, wheezing).

•You have manic depression, schizophrenia, confusion or other mental problems.

•You have a history of hyponatremia (low sodium levels in the blood) or are taking medicines that lower sodium levels in the blood, e.g., some diuretics, such as hydrochlorothiazide.

•You are taking an opioid.

The use of certain medicines, including antidepressants and opioids, together with linezolid may cause a serotonin syndrome, a potentially fatal disease (see “Other medicines and Linezolid Aurovitas Spain”).

Be particularly careful withLinezolid Aurovitas Spain

Inform your doctor before taking this medicine if:

-you are elderly.

-you bleed easily and have petechiae.

-you have anemia(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 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 that your field of vision is reduced.

-numbness or tingling in your arms or legs.

-diarrhea 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, stop taking this medicine immediately and consult your doctor. In this situation, do not take medicines that stop or slow down bowel movements.

-repeated nausea or vomiting, abdominal pain orrapid breathing.

-feeling dizzy and unwell with muscle weakness, headache, confusion, and memory deterioration, which may be indicative of hyponatremia (low sodium levels in the blood).

Other medicines andLinezolid Aurovitas Spain

Inform your doctor or pharmacist if you are using, have used recentlyor may need to use any other medicine.

In some cases, linezolid may interact with certain medicines and produce adverse effects such as changes in blood pressure, body temperature, or heart rate.

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

•monoamine oxidase inhibitors (MAOIs, such as phenelzine, isocarboxazid, selegiline, moclobemide). These medicines are usually used to treat 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.

•decongestant medicines for colds that contain pseudoephedrine or phenylpropanolamine.

•some medicines for asthma, such as salbutamol, terbutaline, fenoterol.

•some antidepressants called tricyclics or SSRIs (selective serotonin reuptake inhibitors). There are many medicines of this type, including amitriptyline, citalopram, clomipramine, dosulepin, doxepin, fluoxetine, fluvoxamine, imipramine, lofepramine, paroxetine, or sertraline.

•medicines used to treat migraines, such as sumatriptan or zolmitriptan.

•medicines for severe allergic reactions, such as adrenaline (epinephrine).

•medicines that increase blood pressure, such as noradrenaline (norepinephrine), dopamine, and dobutamine.

•opioids (e.g., pethidine), used to treat moderate to severe pain.

•medicines used to treat anxiety disorders, such as buspirone.

•medicines that prevent blood clotting, such as warfarin.

•a type of antibiotic called rifampicin.

Taking Linezolid Aurovitas Spain with food, drink and alcohol

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

•Avoid eating large amounts of cheese, yeast extracts or soybean extracts (e.g., soy sauce) and alcoholic beverages, especially draught beer and wine. The reason is that this medicine may react with a substance called tyramine that is naturally 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.

Pregnancy,breastfeedingand fertility

The effect of linezolid on 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 intend to become pregnant, consult your doctor or pharmacist before using this medicine.

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

Driving and operating machines

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

Linezolid Aurovitas Spain contains lactose

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

Linezolid Aurovitas Spain contains sodium

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

Adults

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

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

If you are on dialysis, take this medication after each session.

The normal duration of treatment is 10-14 days, but it may be extended 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 this medication, your doctor will perform periodic blood tests to monitor your blood count.

If you take this medication for more than 28 days, your doctor should monitor your vision.

Use in children and adolescents

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

If you take more Linezolid Aurovitas Spain than you should

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 Aurovitas Spain

Take the tablet you forgot as soon as you remember. Take the next film-coated tablet 12 hours later and continue taking the film-coated tablets every 12 hours.

If you interrupt treatment with Linezolid Aurovitas Spain

It is essential that you only interrupt your treatment if your doctor instructs you to.

If your initial symptoms return after interrupting your 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 serious side effects of linezolid (frequency in parentheses) are:

-Severe skin changes(rare),swelling, particularly 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).

-Visual problems(rare),such as blurred vision (rare), changes in color perception (unknown), difficulty seeing clearly (unknown), or if you notice a reduction in your field of vision (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).

-Recurring nausea or vomiting, abdominal pain, or rapid breathing (rare).

-Seizures or convulsions have been reported in patients taking linezolid (rare).

-Serotonin syndrome(unknown): Inform your doctor if you experience agitation, confusion, delirium, rigidity, tremor, ataxia, seizures, rapid heart rate, severe respiratory problems, and diarrhea (suggestive of serotonin syndrome)while also taking antidepressants called ISRSs or opioids (see section 2).

-Unexplained bleeding or bruising, which may be due to a change in the number of certain blood cells that can affect blood clotting or produce anemia (frequent).

-Changes in the number of some 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 the legs and arms, slurred speech, and loss of consciousness) (rare).

-“Tinnitus” (ringing in the ears) (rare).

There have been reports of numbness, tingling, or blurred vision in patients who have taken linezolid for more than 28 days. If you experience vision difficulties, 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, vomiting, nausea.

-Alteration of some blood test results, including results of protein, salt, or enzyme tests that measure liver, kidney function, or blood sugar levels.

-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 1,000 people):

-Vaginal or genital area inflammation in women.

-Sensation of numbness or tingling.

-Swelling, discomfort, changes in tongue color.

-Dry mouth.

-Increased need to urinate.

-Chills.

-Thirst.

-Increased sweating.

-Hyponatremia (low sodium levels in the blood).

-Renal failure.

-Abdominal swelling.

-Increased creatinine levels.

-Abdominal 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 the color of the tooth surface, which disappears with professional dental cleaning procedures.

Also, the following side effects have been reported (unknown: 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 theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano: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 usethis medicationafter the expiration date that appears onthe box and on the blister pack after CAD.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 through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection pointat the pharmacy. Ask your pharmacisthow to dispose ofpackaging and medications that you no longerneed.By doing so, you will help protect the environment.

Composition of Linezolid Aurovitas Spain

-The active ingredient is linezolid. Each film-coated tablet contains 600 mg of linezolid.

-The other components are:

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

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

Appearance of the product and contents of the package

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

Linezolid Aurovitas Spain tablets are available in PA/ALL/PVC-Aluminum or PVC/PE/PVDC-Aluminum blisters with 10, 20, 30, 50, or 60 film-coated tablets.

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

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

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible for manufacturing

Pharmathen International S.A.

Sapes Industrial Park Block 5

69300 Rodopi

Greece

Or

Pharmathen S.A.

6, Dervenakion str.

15351 Pallini, Attiki

Greece

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: March 2025

More 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).