LINEZOLID AUROVITAS SPAIN 600 mg FILM-COATED TABLETS

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

Do not take Linezolid Aurovitas Spain

• if you are allergic to linezolid or any of the other ingredients of this medication (included in section 6).
• if 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 usually used to treat depression or Parkinson's disease.
• if you are breastfeeding. This medication passes into breast milk and could affect your 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 answer yesto 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 not sure if any of these categories apply to your case.

• You have high blood pressure, whether or not you are taking medications 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 cause symptoms such as diarrhea, skin flushing, wheezing).
• You suffer from manic depression, schizophrenic disorder, mental confusion, or other mental problems.
• You have a history of hyponatremia (low sodium levels in the blood) or take medications that decrease sodium levels in the blood, e.g., certain diuretics, such as hydrochlorothiazide.
• You take any opioid.

The use of certain medications, including antidepressants and opioids, along with linezolid may cause a serotonin syndrome, a potentially life-threatening disease (see "Other medications and Linezolid Aurovitas Spain").

Be especially careful with Linezolid Aurovitas Spain

Inform your doctor before taking this medication 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 the following appear during treatment:

• vision problems such as blurred vision, changes in color vision, difficulty seeing clearly, or if you notice that your field of vision is reduced.
• loss of sensation in the arms or legs or a sensation of tingling or burning in your arms or legs.
• diarrhea 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, you should stop taking this medication 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 rapid breathing.
• a feeling of dizziness and discomfort with muscle weakness, headache, confusion, and memory impairment, which may be indicative of hyponatremia (low sodium levels in the blood).

Other medications and Linezolid Aurovitas Spain

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

Occasionally, linezolid may interact with certain medications 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 medications, as you 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 medications are usually used to treat 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 general condition 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 that contain pseudoephedrine or phenylpropanolamine.
• Certain medications for treating asthma, such as salbutamol, terbutaline, fenoterol.
• Certain antidepressants called tricyclics or SSRIs (selective serotonin reuptake inhibitors). There are many medications of this type, including amitriptyline, citalopram, clomipramine, dosulepin, doxepin, fluoxetine, fluvoxamine, imipramine, lofepramine, paroxetine, or sertraline.
• Medications used to treat migraines, such as sumatriptan or zolmitriptan.
• Medications for treating severe allergic reactions, such as adrenaline (epinephrine).
• Medications that increase blood pressure, such as noradrenaline (norepinephrine), dopamine, and dobutamine.
• Opioids (e.g., pethidine), used to treat moderate to severe pain.
• Medications used to treat anxiety disorders, such as buspirone.
• Medications that prevent blood clotting, such as warfarin.
• An antibiotic called rifampicin.

Taking Linezolid Aurovitas Spain with food, drinks, and alcohol

• You can take this medication before, during, or after meals.
• Avoid eating excessive amounts of cheese, yeast extracts, or soybean extracts (e.g., 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.

Pregnancy, breastfeeding, and fertility

The effect of linezolid on pregnant women is unknown. Therefore, pregnant women should not take this medication 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 medication.

Do not breastfeed while taking linezolid because this medication 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 are not feeling well, your ability to drive or use machines may be affected.

Linezolid Aurovitas Spain contains lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medication.

Linezolid Aurovitas Spain contains sodium

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

3. How to take Linezolid Aurovitas Spain

Adults

Follow the instructions for administration of this medication contained in this leaflet or as 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). You should swallow the film-coated tablet whole with a little water.

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

The normal treatment duration is 10-14 days, but it may be extended up to 28 days. The safety and efficacy of this medication have not been established for treatment periods longer than 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 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Linezolid Aurovitas Spain

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 missed doses.

If you stop taking Linezolid Aurovitas Spain

It is essential that you only stop your treatment if your doctor indicates it.

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everybody gets 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 (whose frequency is between 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 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 may lead to life-threatening complications (uncommon).
• Repeated nausea or vomiting, abdominal pain, or rapid breathing (rare).
• Seizures or convulsions (uncommon) have been reported in patients treated with linezolid.
• Serotonin syndrome (unknown): you should inform your doctor if you experience agitation, confusion, delirium, rigidity, tremor, uncoordination, convulsions, rapid heartbeat, severe respiratory problems, and diarrhea (suggestive of serotonin syndrome) while also being treated with antidepressants called SSRIs or opioids (see section 2).
• Bleeding or unexplained bruising, which may be due to an alteration 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 (uncommon). Some signs of infection include: fever (frequent), sore throat (uncommon), mouth ulcers (uncommon), and fatigue (uncommon).
• Pancreatitis (uncommon).
• Convulsions (uncommon).
• 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, slowed speech, and loss of consciousness) (uncommon).
• "Ringing" in the ears (tinnitus) (uncommon).

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.
• Metallic taste.
• Diarrhea, vomiting, nausea.
• 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.
• Decreased platelet count.

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

• Vaginal or genital inflammation in women.
• A sensation like tingling or numbness.
• Swelling, discomfort, color changes of the tongue.
• 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 side effects have also been reported (unknown: frequency cannot be estimated from available data):

• Alopecia (hair loss).

Reporting of side effects

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

5. Storage of Linezolid Aurovitas Spain

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the box and on the blister after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Linezolid Aurovitas Spain

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

The tablet core contains: poloxamer 407, sodium carboxymethyl starch (type A) (derived from potato starch), povidone K30, colloidal anhydrous 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 Package Contents

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 blister strips 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 screw cap.

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

Only some package 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 Last Revision of this Leaflet: March 2025

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