Linezolid Glenmark 600 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Linezolid Glenmark 600 mg film-coated tablets EFG

Read the entire 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. Do not give it to others, even if they have the same symptoms as you, because it could harm them.

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

Contents of the leaflet

1. What Linezolid Glenmark is and what it is used for

2. What you need to know before taking Linezolid Glenmark

3. How to take Linezolid Glenmark

4. Possible side effects

5. How to store Linezolid Glenmark

6. Contents of the pack and other information

1. What Linezolid Glenmark is and what it is used for

Linezolid is an antibiotic belonging to the oxazolidinone group. It works by preventing the growth of certain bacteria (germs) that cause infections. It is used to treat pneumonia and certain skin or subcutaneous tissue infections. Your doctor will have decided whether linezolid is appropriate for treating your infection.

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

It is important that you follow your doctor's instructions regarding dosage, administration, and duration of treatment.

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

2. What you need to know before taking Linezolid Glenmark

Do not take Linezolid Glenmark:

• 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, isocarboxazid, selegiline, moclobemide). These medicines are usually used to treat depression or Parkinson's disease.
• if you are breastfeeding. This medicine is excreted in breast milk and could affect your baby.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting linezolid:

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 may need to monitor your general health and blood pressure before and during treatment, or may choose a different treatment more appropriate for you. Ask your doctor if you are unsure whether 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 hyperactive thyroid (hyperthyroidism)?
• Do you have a tumour of the adrenal glands (pheochromocytoma) or carcinoid syndrome (caused by tumours in the hormonal system, presenting symptoms such as diarrhea, skin flushing, wheezing)?
• Do you suffer from manic depression, schizophrenia, mental confusion, or other mental disorders?
• Do you have a history of hyponatremia (low sodium levels in the blood), or are you taking medicines that reduce sodium levels in the blood, such as certain diuretics like hydrochlorothiazide?
• Are you taking opioids?

Using certain medicines, including antidepressants and opioids, together with linezolid may cause serotonin syndrome, a potentially life-threatening condition (see section 2 “Other medicines and Linezolid Glenmark” and section 4).

Take special care with Linezolid

Inform your doctor before taking linezolid if:

• you are elderly,

• you bruise easily or bleed excessively,

• 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 a reduction in your visual field,

• loss of sensation in your arms or legs, or tingling or prickling sensations in your arms or legs,

• diarrhea may occur while taking or after taking antibiotics, including linezolid. If diarrhea becomes severe, persists for a long time, or if you notice blood or mucus in your stools, stop taking linezolid immediately and consult your doctor. In this situation, do not take medicines that stop or reduce intestinal movements,

• nausea or repeated 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 (breakdown of muscle tissue), which can lead to kidney damage,

• malaise and dizziness with muscle weakness, headache, confusion, and memory impairment, which may indicate hyponatremia (low sodium levels in the blood).

Other medicines and Linezolid Glenmark

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Linezolid may sometimes interact with certain medicines and cause adverse effects such as changes in blood pressure, body temperature, or heart rate.

• Tell 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 the previous section 2 “Do not take Linezolid Glenmark”): monoamine oxidase inhibitors (MAOIs, such as phenelzine, isocarboxazid, selegiline, moclobemide). These medicines are usually used to treat depression or Parkinson's disease.

Also inform your doctor if you are taking the following medicines. 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 choose a different treatment more suitable for you:

• decongestants for colds or flu remedies containing pseudoephedrine or phenylpropanolamine,
• certain medicines for asthma such as salbutamol, terbutaline, fenoterol,
• certain antidepressants called tricyclics or SSRIs (selective serotonin reuptake inhibitors). There are many medicines in this group, including amitriptyline, citalopram, clomipramine, dosulepin, doxepin, fluoxetine, fluvoxamine, imipramine, lofepramine, paroxetine, 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 or 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 Glenmark with food and drink

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

Avoid eating excessive amounts of cheese, yeast extracts, or soybean seed extracts (e.g., soy sauce), and avoid alcoholic beverages, especially draught beer and wine. This is because this medicine may react with a naturally occurring substance called tyramine found 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 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 medicine.

You must not breastfeed while taking linezolid, as this medicine passes into breast milk and may affect your baby.

Driving and using machines

Linezolid may cause dizziness or vision problems. If this occurs, do not drive or operate machinery. Remember that if you do not feel well, your ability to drive or operate machinery may be impaired.

Linezolid Glenmark contains lactose

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

Linezolid Glenmark contains sodium

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

3. How to take Linezolid Glenmark

Adults

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

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

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

The usual duration of treatment is 10 to 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 linezolid, your doctor will periodically perform blood tests to monitor your blood count. If you take linezolid for more than 28 days, your doctor should 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Linezolid Glenmark

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

If you stop taking Linezolid Glenmark

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, pharmacist, or nurse.

4. Possible adverse effects

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

Tell your doctor, nurse or pharmacist immediately if you notice any of the following adverse effects while being treated with Lizenolid Glenmark:

Serious adverse effects (with frequency in parentheses) of Linezolid are:

• severe skin reactions (uncommon), swelling particularly around the face and neck (uncommon), wheezing and difficulty breathing (rare). These may be signs of an allergic reaction and treatment may need to be stopped. Skin reactions such as raised purple rash due to inflammation of blood vessels (rare), red and scaly skin (dermatitis) (uncommon), rash (common) and itching (common).

• vision problems (uncommon), such as blurred vision (uncommon), changes in color perception (not known), difficulty seeing clearly (not known), or if you notice a reduction in your visual field (rare).

• severe diarrhoea containing blood and/or mucus (antibiotic-associated colitis including pseudomembranous colitis), which in rare cases could lead to complications that may become life-threatening (uncommon).

• repeated nausea or vomiting, abdominal pain or rapid breathing (rare).

• cases of epileptic seizures or convulsions (uncommon) have been reported in patients treated with lizenolid.

• Serotonin syndrome (not known): you must inform your doctor if you experience agitation, confusion, delirium, stiffness, tremor, lack of coordination, convulsions, rapid heartbeat, severe breathing problems and diarrhoea (suggestive of serotonin syndrome) while also being treated with 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 that may affect blood clotting or cause anaemia (common).

• changes in the number of certain blood cells that may affect your ability to fight infection (common); some signs of infection include: any fever (common), sore throat (uncommon), mouth ulcers (uncommon), and tiredness (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 (breakdown of muscle tissue), which can cause kidney damage.

• inflammation of the pancreas (uncommon).

• seizures (uncommon).

• transient ischaemic attacks (temporary disruption 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) (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 any problems with your vision, you should consult your doctor as soon as possible.

Other adverse effects include:

Common adverse effects (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, kidney function or blood sugar levels

• difficulty sleeping

• increased blood pressure

• anaemia (reduction in the number of red blood cells)

• dizziness

• localized or generalized abdominal pain

• constipation

• indigestion

• localized pain

• reduction in the number of platelets

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

• inflammation of the vagina or female genital area

• tingling or numbness sensation

• painful, swollen or discoloured tongue

• dry mouth

• need to urinate more frequently

• chills

• sensation of thirst

• increased sweating

• hyponatraemia (low sodium levels in 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 adverse effects (may affect up to 1 in 1,000 people)

• change in the colour of the tooth surface, which disappears with professional dental cleaning procedures

The following adverse effects have also been reported with unknown frequency (frequency cannot be estimated from the 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 can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Linezolid Glenmark

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of any unused medicine and its packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Linezolid Glenmark

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

Appearance of the product and contents of the pack

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.

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

Only certain 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

For further information about this medicinal product, you may contact 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 European Economic Area member states under the following names:

Date of the last revision of this leaflet: November 2025.

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