LINEZOLID GLENMARK 600 mg FILM-COATED TABLETS

2. What you need to know before taking Linezolid Glenmark

Do not take Linezolid Glenmark:

• if you are allergic to linezolid or any of the other components of this medication (listed in section 6).
• if you are taking or have taken in the last 2 weeks any medication known as 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 is excreted in breast milk and may 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 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 choose another treatment that is better for you. Ask your doctor if you are unsure if any of these categories apply to you:

• 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, skin flushing, and wheezing)?
• Do you suffer from manic depression, schizophrenic disorder, confusion, or other mental problems?
• Do you take opioids?

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

Be careful with Linezolid

Inform your doctor before taking linezolid if:

• 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 occur during treatment:

• vision 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 numbness or tingling in your arms or legs,
• diarrhea can occur 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 linezolid 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.

Other medications and Linezolid Glenmark

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

Linezolid may interact with certain medications and produce side effects such as changes in blood pressure, body temperature, or heart rate.

• Tell your doctor if you are taking or have takenin the last 2 weeksthe following medications, as you should not take linezolidif you are still taking them or have taken them recently (see also section 2 above "Do not take Linezolid Glenmark"): monoamine oxidase inhibitors (MAOIs, such as phenelzine, isocarboxazid, selegiline, moclobemide). These medications are usually used to treat depression or 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 overall health and blood pressure before and during treatment. In other cases, your doctor may choose another treatment that is better for you:

• decongestants for cold or flu preparationsthat contain pseudoephedrine or phenylpropanolamine,
• certain asthma medicationssuch as salbutamol, terbutaline, fenoterol,
• certain antidepressantscalled 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, sertraline,
• medications used to treat migrainessuch as sumatriptan or zolmitriptan,
• medications for treating severe allergic reactionssuch as adrenaline (epinephrine).
• medications that increase blood pressure, such as noradrenaline (norepinephrine), dopamine, and dobutamine,
• opioids (e.g., 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.

A antibiotic called rifampicin.

Taking Linezolid Glenmark with food and drinks

You can take linezolid before, during, or after meals.

Avoid eating excessive amounts of cheese, yeast extracts, or soybean extracts (e.g., soy sauce) and alcoholic beverages, especially 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 not known. Therefore, pregnant women should not use linezolid 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 taking this medication.

You should not breastfeed while taking linezolid because this medication passes into breast milk and may 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 do not feel well, your ability to drive or use machines may be affected.

Linezolid Glenmark contains lactose

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

3. How to take Linezolid Glenmark

Adults

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor, pharmacist, or nurse again.

The recommended dose is one tablet (600 mg of linezolid) twice a day (every 12 hours). The film-coated tablet should be swallowed whole with water.

If you are on a dialysis program, you will be given linezolid after each session.

The normal treatment duration 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 for treatment periods longer than 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 will need to monitor your vision.

Use in children and adolescents

The use of these tablets is not recommended in children and adolescents (under 18 years of age).

If you take more Linezolid Glenmark 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 forget to take Linezolid Glenmark

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 Glenmark

It is essential that you only stop your treatment if your doctor advises you to do so. If you stop your treatment and your initial symptoms return, 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 everyone will experience them.

Tell your doctor, nurse, or pharmacist immediatelyif you notice any of the following side effects while taking Linezolid Glenmark:

The serious side effects (with frequency in parentheses) of Linezolid are:

• severe skin reactions (unknown) swelling, particularly around the face and neck (unknown), wheezing, and difficulty breathing (unknown). This may be a sign of an allergic reaction, and treatment may need to be discontinued. Skin reactions such as red and scaly skin (dermatitis) (uncommon), rash (common), and itching (common).
• vision problems such as blurred vision (uncommon), changes in color perception (unknown), difficulty seeing clearly (unknown), or if you notice a reduction in your field of vision (rare).
• severe diarrhea that contains blood and/or mucus (antibiotic-associated colitis, including pseudomembranous colitis), which in rare circumstances can lead to life-threatening complications (rare).
• repeated nausea or vomiting, abdominal pain, or rapid breathing (unknown).
• seizures or convulsions (uncommon) have been reported in patients taking linezolid.
• Serotonin syndrome (unknown): you should inform your doctor if you experience agitation, confusion, delirium, rigidity, tremor, uncoordination, rapid heartbeat, severe respiratory problems, and diarrhea (suggestive of serotonin syndrome) while 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 cells in the blood that can affect blood clotting or cause anemia (common).
• changes in the number of certain cells in the blood that can affect your ability to fight an infection (common), some signs of infection include: any fever (common), sore throat (uncommon), mouth ulcers (uncommon), and fatigue (uncommon).
• pancreatitis (uncommon).
• seizures (uncommon).
• transient ischemic attacks (temporary alteration of blood flow to the brain that causes short-term symptoms, such as loss of vision, weakness in the legs and arms, difficulty speaking, and loss of consciousness) (uncommon).
• "ringing" in the ears (tinnitus) (uncommon).
• numbness, tingling, or blurred vision have been reported by patients who have taken these tablets for more than 28 days. If you experience difficulties with your vision, you should consult your doctor as soon as possible.

Other side effects include:

Common side effects(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 liver, kidney function tests, or blood sugar levels

• Difficulty sleeping
• Increased blood pressure
• Anemia (reduction in the number of red blood cells)
• Dizziness
• Abdominal pain, localized or generalized
• Constipation
• Indigestion
• Localized pain

Uncommon side effects(may affect up to 1 in 100 people)

• Vaginal or genital inflammation in women
• Feeling of numbness or tingling
• Inflammation of the veins (only IV)
• Painful, swollen, or discolored tongue
• Need to urinate more frequently
• Chills

• Feeling of thirst
• Increased sweating
• Alteration in blood proteins, salts, or enzymes that measure liver or kidney function
• Hyponatremia (low sodium levels in the blood)
• Kidney failure
• Reduced platelet count
• Abdominal swelling
• Pain at the injection site
• Increased creatinine
• Stomach pain
• Changes in heart rhythm (e.g., increased heart rate)

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

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

The following side effects have also been reported, but their frequency is not known(frequency cannot be estimated from available data)

• Alopecia (hair loss)
• Decreased blood cell count
• Weakness and/or sensory changes

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Linezolid Glenmark

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

Do not use this medication after the expiration date stated on the packaging 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 the drain or in the trash. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Container Content and Additional Information

Composition of Linezolid Glenmark

• The active ingredient is linezolid.
• The other components are lactose monohydrate, povidone, sodium croscarmellose, magnesium stearate, hypromellose, titanium dioxide, and macrogol.

Appearance of the Product and Container Content

Linezolid Glenmark 600 mg film-coated tablets are white or almost white, oval, biconvex tablets marked with "G" on one side and "469" on the other side.

The tablets are available in blister packs containing 10, 20, and 30 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Manufacturer:

Glenmark Pharmaceuticals s.r.o.

Fibichova 143

566 17 Vysoké Mýto

Czech Republic

Further information about this medicinal product can be obtained from the local representative of the Marketing Authorization Holder:

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7th floor

28045 Madrid

Spain

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:July 2023.

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/).