Linezolid Polpharma

Package Leaflet: Information for the User

Linezolid Polpharma, 600 mg, Film-Coated Tablets

Linezolid

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• -Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Linezolid Polpharma and what is it used for
• 2. Important information before taking Linezolid Polpharma
• 3. How to take Linezolid Polpharma
• 4. Possible side effects
• 5. How to store Linezolid Polpharma
• 6. Contents of the pack and other information

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

Linezolid Polpharma is an antibiotic belonging to the group of oxazolidinones. Its action involves inhibiting the growth of certain bacteria (microorganisms) that cause infections.
Linezolid Polpharma is used in adults to treat pneumonia and certain skin or soft tissue infections. The doctor will decide if linezolid is suitable for treating a specific infection in the patient.

2. Important information before taking Linezolid Polpharma

When not to take Linezolid Polpharma

• If the patient is allergic to linezolid or any of the other ingredients of this medicine (listed in section 6).
• If the patient is currently taking or has taken in the last 2 weeks any of the medicines called monoamine oxidase inhibitors (MAOIs, e.g., phenelzine, isocarboxazid, selegiline, moclobemide). These medicines are used to treat depression or Parkinson's disease.
• If the patient is breastfeeding. Linezolid passes into breast milk and may harm the baby.

Warnings and precautions

Before starting to take Linezolid Polpharma, the patient should discuss it with their doctor or pharmacist.
If the patient answers “yes”to any of the following questions, it means that Linezolid Polpharma may not be suitable for them.
In such a situation, the patient should tell their doctor, who may decide to perform general and blood pressure tests before and during treatment, or decide to use another, more suitable treatment.
In case of any doubts whether the patient is affected by the situations described below, they should ask their doctor.

• Does the patient have high blood pressure?
• Has the patient been diagnosed with hyperthyroidism?
• Does the patient have a pheochromocytoma (a tumor of the adrenal gland) or carcinoid syndrome (caused by a tumor of the hormonal system, with symptoms such as diarrhea, hot flashes, wheezing)?
• Does the patient have: manic depression, schizoaffective disorders, disorientation or other mental disorders?
• Is the patient taking any opioid medicines?
• Is the patient taking any of the following medicines:
• medicines that reduce nasal congestion, used in colds and flu, containing pseudoephedrine or phenylpropanolamine,
• certain medicines used to treat asthma, e.g., salbutamol, terbutaline, fenoterol,
• certain antidepressant medicines, known as tricyclic antidepressants or selective serotonin reuptake inhibitors (SSRIs), e.g., amitriptyline, cipramil, clomipramine, dosulepin, doxepin, fluoxetine, fluvoxamine, imipramine, lofepramine, paroxetine, sertraline,
• medicines used to treat migraines, e.g., sumatriptan and zolmitriptan,
• medicines used to treat sudden, severe allergic reactions, e.g., adrenaline (epinephrine),
• medicines that increase blood pressure, e.g., noradrenaline (norepinephrine), dopamine, and dobutamine,
• opioids, e.g., pethidine - used to treat moderate or severe pain,
• medicines used to treat anxiety disorders, e.g., buspirone,
• the antibiotic rifampicin.

If the patient has any of the following conditions, they should inform their doctor before starting to take this medicine:

• tendency to bruise or bleed,
• anemia (low red blood cell count),
• prone to infections,
• history of seizures,
• liver or kidney problems, especially if the patient is on dialysis,
• diarrhea.

The patient should immediately inform their doctor if they experience any of the following during treatment:

• vision disturbances, such as blurred vision, changes in color vision, difficulty seeing details, or narrowing of the field of vision;
• loss of sensation or tingling or prickling in the hands or feet;
• diarrhea, which may occur during or after the use of antibiotics, including Linezolid Polpharma; if the diarrhea is severe or persistent or if there is blood or mucus in the stool, the patient should stop taking Linezolid Polpharma and contact their doctor; in such a situation, the patient should not take medicines that slow down bowel movements;
• recurring nausea or vomiting, abdominal pain, or increased respiratory rate.

Taking some medicines, including antidepressants and opioids, with Linezolid Polpharma may lead to the occurrence of serotonin syndrome - a potentially life-threatening condition (see section 2 "Linezolid Polpharma and other medicines" and section 4).

Linezolid Polpharma and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Linezolid Polpharma may sometimes interact with some medicines, which can cause side effects, such as changes in blood pressure, temperature, or heart rate.
If the patient has taken any of the following medicines in the last 2 weeks, they should tell their doctor, as it is contraindicatedto take Linezolid Polpharma (see also section 2 "When not to take Linezolid Polpharma").

• Monoamine oxidase inhibitors (MAOIs, e.g., phenelzine, isocarboxazid, selegiline, moclobemide). These medicines are used to treat depression or Parkinson's disease.

The patient should also inform their doctor if they are taking any of the following medicines. The doctor may decide to continue with Linezolid Polpharma, but will need to monitor the patient's general health and blood pressure before and during treatment.
Otherwise, the doctor may decide that another treatment is best for the patient.

• Medicines that reduce nasal congestion, used in colds and flu, containing pseudoephedrine or phenylpropanolamine.
• Certain medicines used to treat asthma, e.g., salbutamol, terbutaline, fenoterol.
• Certain antidepressant medicines, known as tricyclic antidepressants or selective serotonin reuptake inhibitors (SSRIs). There are many such medicines, including amitriptyline, cipramil, clomipramine, dosulepin, doxepin, fluoxetine, fluvoxamine, imipramine, lofepramine, paroxetine, sertraline.
• Medicines used to treat migraines, e.g., sumatriptan and zolmitriptan.
• Medicines used to treat sudden, severe allergic reactions, e.g., adrenaline (epinephrine).
• Medicines that increase blood pressure, e.g., noradrenaline (norepinephrine), dopamine, and dobutamine.
• Opioids, e.g., pethidine - used to treat moderate or severe pain.
• Medicines used to treat anxiety disorders, e.g., buspirone.
• Anticoagulant medicines, e.g., warfarin.

Linezolid Polpharma with food, drink, and alcohol

• The patient should avoid consuming large amounts of mature cheese, yeast extracts, or soy products (e.g., soy sauce) and drinking alcohol, especially draft beer and wine. This medicine may react with a substance called tyramine, which occurs naturally in some foods, causing an increase in blood pressure.
• If the patient experiences a throbbing headache after eating or drinking, they should immediately tell their doctor or pharmacist.

Pregnancy, breastfeeding, and fertility

The effect of Linezolid Polpharma in pregnant women is not known. Therefore, this medicine should not be taken during pregnancy, unless prescribed by a doctor.
If the patient is pregnant, thinks they may be pregnant, or plans to have a baby, they should consult their doctor before taking this medicine.
The patient should not breastfeed while taking Linezolid Polpharma, as it passes into breast milk and may affect the baby.

Driving and using machines

Linezolid Polpharma may cause dizziness or vision disturbances. If such symptoms occur, the patient should not drive or operate any machines. The patient should remember that feeling unwell can affect their ability to drive and use machines.

The medicine contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially 'sodium-free'.

3. How to take Linezolid Polpharma

Adults

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
The usual dose of Linezolid Polpharma is 1 tablet (600 mg of linezolid) taken twice a day (every 12 hours).
The tablet should be swallowed whole, with a small amount of water.
The tablet can be taken before, during, or after a meal.
Patients on dialysis should take Linezolid Polpharma after dialysis.
Treatment usually lasts from 10 to 14 days, but may last up to 28 days. The efficacy and safety of using this medicine for more than 28 days have not been established. The doctor will decide how long the treatment should last.
During treatment with Linezolid Polpharma, the doctor will prescribe regular blood tests to monitor the patient's blood count.
If the patient takes Linezolid Polpharma for more than 28 days, the doctor should prescribe an eye examination.

Use in children and adolescents

Linezolid Polpharma is not recommended for use in children and adolescents (under 18 years of age).

Taking more than the recommended dose of Linezolid Polpharma

The patient should immediately tell their doctor or pharmacist.

Missing a dose of Linezolid Polpharma

The patient should take the missed tablet as soon as possible. The next tablet of Linezolid Polpharma should be taken 12 hours later, and the patient should continue taking the medicine every 12 hours. The patient should not take a double dose to make up for the missed tablet.

Stopping treatment with Linezolid Polpharma

It is important to continue taking Linezolid Polpharma unless the doctor advises the patient to stop.
If the patient stops taking the medicine and the initial symptoms of the disease return, they should immediately tell their doctor or pharmacist.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Linezolid Polpharma can cause side effects, although not everybody gets them.
If any of the following side effects occur during treatment, the patient should immediatelytell their doctor or pharmacist:

• skin reactions, such as redness, pain, or peeling of the skin (dermatitis), rash, itching, or swelling, especially on the face and neck; these may be symptoms of an allergic reaction and may require stopping the use of Linezolid Polpharma;
• vision problems, such as changes in visual acuity, changes in color vision, difficulty seeing details, or narrowing of the field of vision;
• severe diarrhea with blood and/or mucus (enteritis, including pseudomembranous colitis associated with antibiotic use), which can very rarely lead to life-threatening complications;
• recurring nausea or vomiting, abdominal pain, or increased respiratory rate;
• seizures or convulsions have been reported during treatment;
• serotonin syndrome (frequency not known) - if the patient experiences excessive stimulation, confusion, sweating, hallucinations, involuntary movements, shivering, and tremors, they should tell their doctor (see section 2).

In patients taking this medicine for more than 28 days, numbness, tingling, or blurred vision have been reported. If the patient experiences vision disturbances, they should contact their doctor as soon as possible.

Other side effects

Common(occurring in less than 1 in 10 people):

• fungal infections, especially vaginal or "thrush" in the mouth
• headache
• metallic taste in the mouth
• diarrhea, nausea, or vomiting
• changes in the results of some blood tests, including kidney or liver function tests or increased blood sugar levels
• bleeding or bruising of unknown cause, which may be due to changes in the number of certain blood cells, affecting blood clotting and leading to anemia
• difficulty sleeping
• increased blood pressure
• anemia (low red blood cell count)
• changes in the number of certain blood cells, which may affect the ability to fight infections
• rash
• itching
• dizziness
• localized or general abdominal pain
• constipation
• indigestion
• localized pain
• fever.

Uncommon(occurring in less than 1 in 100 people):

• vaginal or genital area inflammation in women
• tingling and numbness
• blurred vision
• "ringing" in the ears (tinnitus)
• phlebitis
• dryness or pain in the mouth, swelling, irritation, or discoloration of the tongue
• need to urinate more often
• chills
• feeling tired or thirsty
• pancreatitis
• increased sweating
• changes in blood protein and salt levels or enzyme activity indicating kidney or liver function
• seizures
• low sodium levels in the blood
• kidney failure
• decreased number of certain blood platelets
• abdominal bloating
• transient ischemic attacks (temporary disruptions in blood flow to the brain, causing short-term symptoms such as loss of vision, weakness in the arms and legs, speech problems, and loss of consciousness)
• dermatitis
• increased creatinine levels
• abdominal pain
• changes in heart rate (e.g., accelerated heart rate).

Rare(occurring in less than 1 in 1000 people):

• limited field of vision
• superficial tooth discoloration, removable by professional dental cleaning (manual removal of tartar).

The following side effects have also been reported (frequency not known):

• serotonin syndrome (symptoms include rapid heart rate, disorientation, excessive sweating, hallucinations, involuntary movements, shivering, and tremors)
• lactic acidosis (symptoms include recurring nausea and vomiting, abdominal pain, and increased respiratory rate)
• severe skin reactions
• sideroblastic anemia (a type of anemia - low red blood cell count)
• hair loss (alopecia)
• color vision disturbances or difficulty seeing details
• decreased blood cell count
• weakness and/or sensory disturbances.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Linezolid Polpharma

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Linezolid Polpharma contains

• The active substance of this medicine is linezolid. Each tablet contains 600 mg of linezolid.
• The other ingredients are: sodium carboxymethylcellulose (Type A), microcrystalline cellulose PH 101, microcrystalline cellulose PH 102, povidone K30, sodium dihydrogen citrate powder (Type F0100), magnesium stearate. The coating contains: hypromellose, microcrystalline cellulose, macrogol stearate 40 (Type I), titanium dioxide (E171).

What Linezolid Polpharma looks like and contents of the pack

Linezolid Polpharma, 600 mg, are white, elongated, biconvex, film-coated tablets.
The tablets are available in blisters containing 10 tablets, packed in a cardboard box.
Each pack contains 10 film-coated tablets.

Marketing authorization holder and manufacturer

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański
Phone: +48 22 364 61 01
Date of last revision of the leaflet:February 2024