Prospect: Information for the Patient

Linezolid Glenmark 600 mg Film-Coated Tablets EFG

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.

-This medicine has been prescribed only for you, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

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

1.What is Linezolid Glenmarkand for what it is used

2.What you need to know before starting to take Linezolid Glenmark

3.How to take Linezolid Glenmark

4.Possible adverse effects

1. Storage of Linezolid Glenmark

6.Contents of the package and additional information

Linezolid is an antibiotic belonging to 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 linezolid is suitable for treating your infection.

Do not take Linezolid Glenmark:

• 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 is excreted in milk and could 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 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 choose another treatment better 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 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, wheezing)?
• Do you have manic depression, schizophrenia, confusion or other mental problems?
• Are you taking opioids?

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

Be especially careful with Linezolid

Inform your doctor before taking linezolid if:

• you bruise easily and bleed a lot,
• you have anemia (you have low levels of red blood cells in your blood),
• 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 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 linezolid 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 or rapid breathing.

Other medicines and Linezolid Glenmark

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

Occasionally, 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 takenin the last 2 weeksthe following medicines, as you should not take linezolid if you are still taking them or if you 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 medicines are usually used to treat depression or 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 choose another treatment better for you:

• decongestants for colds or flu preparations containing pseudoephedrine or phenylpropanolamine,
• some medicines for treating asthma such as salbutamol, terbutaline, fenoterol,
• certainantidepressantscalled tricyclics or SSRIs (selective serotonin reuptake inhibitors). There are many types of these medicines, including amitriptyline, citalopram, clomipramine, dosulepin, doxepin, fluoxetine, fluvoxamine, imipramine, lofepramine, paroxetine, sertraline,
• medicines used to treatmigrainessuch as sumatriptan or zolmitriptan,
• medicines for treatingsevere allergic reactionssuch as adrenaline (epinephrine).
• medicines that increaseblood pressure, such as noradrenaline (norepinephrine), dopamine and dobutamine,
• opioids (such as pethidine) used to treatmoderate or severe pain,
• medicines used to treatanxiety disorders, such as buspirone,
• medicines that preventblood clotting, such as warfarin.

An antibiotic called rifampicin.

Taking Linezolid Glenmark with food and drink

You can take linezolid before, during or after meals.

Avoid eating large amounts of cheese, yeast extracts or soybean extracts (such as soy sauce) and alcoholic beverages, especially barrel 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, breastfeeding and fertility

There is no known effect of linezolid on pregnant women. Therefore, pregnant women should not use linezolid, 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 taking this medicine.

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

Driving and operating machinery

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

Linezolid Glenmark contains lactose

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

Adults

Follow exactly the administration instructions for this medication 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 dialysis, linezolid will be administered 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 in treatment periods exceeding 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 should monitor your vision.

Use in children and adolescents

This medication is not recommended for use in children and adolescents (under 18 years old).

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 forgot to take Linezolid Glenmark

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

If you interrupt treatment with Linezolid Glenmark

It is essential that you only interrupt your treatment if your doctor instructs you to do so. 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, nurse or pharmacist immediatelyif you notice any of the following side effects while taking Linezolid Glenmark:

Severe side effects (frequency in parentheses) of Linezolid are:

• Severe skin reactions (unknown) 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 (infrequent), rash (frequent) and itching (frequent).
• Visual problems such as blurred vision (infrequent), changes in color perception (unknown), difficulty seeing clearly (unknown) or if you notice that your field of vision is reduced (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).
• Repeated nausea or vomiting, abdominal pain or rapid breathing (unknown).
• Seizures or convulsions have been reported in patients taking linezolid (infrequent).
• Serotonin syndrome (unknown): Inform your doctor if you experience agitation, confusion, delirium, rigidity, tremor, uncoordinated movements, 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 changes in the number of certain blood cells that can affect blood clotting or cause anemia (frequent).
• Changes in the number of certain blood cells that can affect your ability to fight an infection (frequent), some signs of infection include: any fever (frequent), sore throat (rare), mouth ulcers (infrequent) and fatigue (infrequent).
• Pancreatitis (infrequent).
• Seizures (infrequent).
• Transient ischemic attacks (temporary disruption of blood flow to the brain causing symptoms such as loss of vision, weakness in the legs and arms, difficulty speaking and loss of consciousness) (infrequent).
• "Buzzing" in the ears (tinnitus) (infrequent).
• Numbness, tingling or blurred vision have been reported by patients who have taken these tablets for more than 28 days. If you experience difficulty with your vision, consult your doctor as soon as possible.

Other side effects include:

Frequent side effects(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 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

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

• Vaginal or genital area inflammation in women
• Sensation of numbness or tingling
• Vein inflammation (only IV)
• Sore, swollen or discolored tongue
• Increased frequency of urination
• Chills

• Thirst
• Increased sweating
• Alteration in proteins, salts or enzymes in the blood that measure liver or kidney function
• Hyponatremia (low sodium levels in the blood)
• Renal failure
• Reduction in 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 the color of the surface of the teeth, which disappears with professional dental cleaning procedures

The following unknown side effects have also been reported(frequency cannot be estimated from available data)

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

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 the Spanish System for the Vigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears 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 drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Linezolid Glenmark

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

Appearance of the product and contents of the package

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

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

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Responsible manufacturer:

Glenmark Pharmaceuticals s.r.o.

Fibichova 143

566 17 Vysoké Mýto

Czech Republic

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Viso Farmacéutica, S.L.U.

c/ Retama 7, 7ª Planta

28045 Madrid

Spain

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

Last review date of this leaflet:July 2023.

More detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).