DILIZOLEN 2 mg /Ml Solution

Contents of the leaflet

1. Leaflet accompanying the packaging: information for the user
2. Dilizolen, 2 mg/ml, solution for infusion
   1. You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
3. What is Dilizolen and what is it used for
4. Important information before using Dilizolen
   1. When not to use Dilizolen:
   2. Warnings and precautions
   3. Precautions during treatment with Dilizolen
   4. Dilizolen and other medicines
   5. The patient should inform their doctor if they are taking or have taken any of the following medicines within the last 2 weeks
   6. Dilizolen with food, drink, and alcohol
   7. Pregnancy, breastfeeding, and fertility
   8. Driving and using machines
   9. Dilizolen contains glucose and sodium.
   10. Glucose
   11. Sodium
5. How to use Dilizolen
   1. Adults
   2. Use in children and adolescents
   3. Using a higher dose of Dilizolen than recommended
   4. Missing a dose of Dilizolen
6. Possible side effects
   1. Other side effects include:
   2. Common (may affect up to 1 in 10 people):
   3. Not very common (may affect up to 1 in 100 people):
   4. Rare (may affect up to 1 in 1000 people):
   5. The following side effects have also been reported (frequency not known: frequency cannot be estimated from the available data):
   6. Reporting side effects
7. How to store Dilizolen
8. Contents of the packaging and other information
   1. What Dilizolen contains
   2. What Dilizolen looks like and what the packaging contains
   3. Marketing authorization holder
   4. Manufacturer (responsible for batch release)
   5. For more information about this medicine, the patient should contact their local representative of the marketing authorization holder:

Leaflet accompanying the packaging: information for the user

Dilizolen, 2 mg/ml, solution for infusion

Linezolid

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor, pharmacist, or nurse.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Dilizolen and what is it used for
• 2. Important information before using Dilizolen
• 3. How to use Dilizolen
• 4. Possible side effects
• 5. How to store Dilizolen
• 6. Contents of the packaging and other information

1. What is Dilizolen and what is it used for

Dilizolen is an antibiotic belonging to the group of oxazolidinones, which works by inhibiting the growth of certain types of bacteria (microorganisms) that cause infections. It is used to treat pneumonia and some skin and soft tissue infections (located under the skin). The doctor will decide if Dilizolen is suitable for treating a specific infection.

2. Important information before using Dilizolen

When not to use Dilizolen:

• 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 within the last 2 weeks a medicine from a group called monoamine oxidase inhibitors (e.g., phenelzine, isocarboxazid, selegiline, moclobemide). These medicines may be used to treat depression or Parkinson's disease;
• if the patient is breastfeeding. Dilizolen passes into breast milk and may affect the baby.

Warnings and precautions

Before starting treatment with Dilizolen, the patient should discuss it with their doctor, pharmacist, or nurse. Dilizolen may not be the right medicine for patients who answer "yes" to any of the following questions. In such cases, the patient should inform their doctor, who will examine their overall health and blood pressure before starting treatment and will monitor them during treatment or may decide to use another, more suitable treatment. If in doubt, the patient should consult their doctor.

• Does the patient have high blood pressure and is taking medication for it or not?
• Has the patient been diagnosed with hyperthyroidism?
• Does the patient have a adrenal tumor (pheochromocytoma) or carcinoid syndrome (caused by hormonal tumors, with diarrhea, hot flashes, wheezing)?
• Does the patient have depression with manic episodes, schizoaffective disorders, disorientation, or other mental disorders?
• Is the patient taking any opioid medicines? Using certain medicines, including antidepressants and opioids, with Dilizolen may lead to the development of serotonin syndrome, a potentially life-threatening condition (see section 2 "Dilizolen and other medicines" and section 4).
• Has the patient had hyponatremia (low sodium levels in the blood) or is taking medicines that lower sodium levels in the blood, such as certain diuretics (also called "water pills"), such as hydrochlorothiazide?

Precautions during treatment with Dilizolen

Before starting treatment with this medicine, the patient should discuss it with their doctor if they:

• are elderly
• have a tendency to bruise and bleed
• have anemia (low red blood cell count)
• have a tendency to develop infections
• have had seizures in the past
• have liver or kidney problems, especially if they are on dialysis
• have diarrhea

The patient should immediately inform their doctor if, during treatment:

• they experience vision disturbances, such as blurred vision, changes in color perception, difficulty seeing details, or narrowing of the visual field,
• they experience loss of sensation in their hands and feet or a feeling of numbness and tingling in their hands and feet,
• they experience diarrhea during or after antibiotic treatment, including Dilizolen. If it is severe or persistent or if the patient notices blood or mucus in their stool, they should stop taking Dilizolen and consult their doctor immediately. In such cases, the patient should not take medicines that slow down or stop bowel movements.
• they experience recurring nausea or vomiting, abdominal pain, or increased respiratory rate.
• they experience unexplained muscle pain, tenderness, or weakness and (or) dark urine color. These may be symptoms of a serious condition called rhabdomyolysis (muscle breakdown), which can lead to kidney damage.
• they experience nausea and malaise, including muscle weakness, headache, confusion, and memory disorders, which may indicate hyponatremia (low sodium levels in the blood).

Dilizolen and other medicines

Concomitant use of Dilizolen with certain other medicines may cause side effects, such as changes in blood pressure, body temperature, or heart rate. The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken.

The patient should inform their doctor if they are taking or have taken any of the following medicines within the last 2 weeks

because Dilizolen should not be taken if the patient is already taking these medicines or has taken them recently (see also section 2 above "When not to use Dilizolen").

• monoamine oxidase inhibitors (e.g., phenelzine, isocarboxazid, selegiline, moclobemide). These medicines may be 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 prescribe Dilizolen, but before starting treatment, the doctor will perform a general examination and blood pressure check, which will be repeated throughout the treatment period. In other cases, the doctor will decide to use another, more suitable treatment.

• medicines that reduce nasal congestion, used in colds or flu, containing pseudoephedrine or phenylpropanolamine,
• certain medicines used to treat asthma, such as salbutamol, terbutaline, fenoterol,
• certain antidepressant medicines from the group of tricyclic antidepressants or selective serotonin reuptake inhibitors (SSRI). There are many such medicines, including amitriptyline,

citalopram, clomipramine, dosulepin, doxepin, fluoxetine, fluvoxamine, imipramine, lofepramine, paroxetine, sertralina,

• medicines used to treat migraines, such as sumatriptan, zolmitriptan,
• medicines used to treat sudden, severe allergic reactions, such as adrenaline,
• medicines that increase blood pressure, such as noradrenaline, dopamine, and dobutamine,
• opioids, e.g., pethidine, used to treat moderate to severe pain,
• medicines used to treat anxiety disorders, such as buspirone,
• anticoagulant medicines, such as warfarin,
• the antibiotic rifampicin,

Dilizolen with food, drink, and alcohol

• Dilizolen can be taken before, during, or after a meal.
• The patient should avoid consuming large amounts of mature cheese, yeast extracts, or soy products, such as soy sauce, and alcoholic beverages, especially beer and wine. Dilizolen may interact with a substance called tyramine, which occurs naturally in these foods. This interaction may increase blood pressure.
• If the patient experiences a throbbing headache after eating or drinking, they should immediately inform their doctor, pharmacist, or nurse.

Pregnancy, breastfeeding, and fertility

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

Driving and using machines

Dilizolen may cause dizziness and vision disturbances. If these symptoms occur, the patient should not drive or operate any machines. The patient should remember that feeling unwell affects their ability to drive and use machines.

Dilizolen contains glucose and sodium.

Glucose

1 ml of Dilizolen solution contains 45.7 mg of glucose (13.7 g of glucose in one infusion bag). The patient should inform their doctor or nurse if they have diabetes.

Sodium

1 ml of Dilizolen solution contains 0.38 mg of sodium (114 mg of sodium in one infusion bag). The patient should inform their doctor or nurse if they are on a low-sodium diet.

3. How to use Dilizolen

Adults

This medicine should always be used exactly as prescribed by the doctor, pharmacist, or nurse. If in doubt, the patient should consult their doctor, pharmacist, or nurse. The medicine will be administered as an intravenous infusion by a doctor or medical staff. The recommended dose for adults (18 years and older) is 300 ml of solution (600 mg of linezolid) twice a day, administered directly into the bloodstream as an intravenous infusion lasting from 30 to 120 minutes. If the patient is on dialysis, Dilizolen is administered after dialysis. The treatment cycle usually lasts from 10 to 14 days, but may last up to 28 days. The safety and efficacy of this medicine have not been established for use longer than 28 days. The doctor will decide on the duration of treatment. During treatment with Dilizolen, the doctor will order regular blood tests to monitor the patient's blood morphology. If Dilizolen is used for more than 28 days, the doctor will order an eye examination.

Use in children and adolescents

Dilizolen is not usually recommended for children and adolescents (under 18 years of age).

Using a higher dose of Dilizolen than recommended

If the patient is concerned that they have received too high a dose of Dilizolen, they should immediately inform their doctor or nurse.

Missing a dose of Dilizolen

Since the medicine will be administered under close medical supervision, missing a dose is unlikely. However, if the patient suspects that they have missed a dose, they should immediately inform their doctor or nurse. The patient should not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, Dilizolen can cause side effects, although not everybody gets them. The patient should immediately inform their doctor, nurse, or pharmacistif they experience any of the following side effects during treatment with Dilizolen: Severe side effects that may occur with Dilizolen (frequency in parentheses) include:

• severe skin reactions (not very common), swelling, especially in the face and neck (not very common), wheezing, and (or) shortness of breath (rare). These may be symptoms of an allergic reaction, and it may be necessary to stop using Dilizolen. Skin reactions, such as a raised, purple rash caused by vasculitis (rare), redness, skin peeling (skin inflammation) (not very common), rash (common), itching (common).
• vision disturbances (not very common), such as blurred vision (not very common), changes in color perception (unknown frequency), difficulty seeing details (unknown frequency), or narrowing of the visual field (rare).
• severe diarrhea with blood and (or) mucus in the stool (antibiotic-associated colitis, including pseudomembranous colitis), which may rarely be life-threatening (not very common).
• recurring nausea or vomiting, abdominal pain, or increased respiratory rate (rare).
• seizures or convulsions (not very common) have been reported during treatment with Dilizolen.
• serotonin syndrome (unknown frequency): the patient should inform their doctor if they experience symptoms such as agitation, disorientation, hallucinations, stiffness, tremors, coordination disorders, and convulsions, rapid heartbeat, severe breathing difficulties, and diarrhea when taking antidepressant medicines from the SSRI group (selective serotonin reuptake inhibitors) or opioids (see section 2).
• bleeding or bruising of unknown cause, which may be caused by changes in the number of certain blood cells, affecting blood clotting or leading to anemia (common).
• changes in the number of certain blood cells, which may affect the patient's ability to fight infections (not very common), some symptoms of infection include fever (common), sore throat (not very common), oral ulcers (not very common), and fatigue (not very common).
• rhabdomyolysis (rare): objective and subjective symptoms include unexplained muscle pain, tenderness, or weakness and (or) dark urine color. These may be symptoms of a serious condition called rhabdomyolysis (muscle breakdown), which can lead to kidney damage.
• pancreatitis (not very common).
• seizures (not very common).
• transient ischemic attacks (transient cerebral ischemic attacks, causing short-term symptoms such as vision loss, limb weakness, slurred speech, and loss of consciousness) (not very common).
• "ringing" in the ears (tinnitus) (not very common).

In patients taking Dilizolen 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 include:

Common (may affect up to 1 in 10 people):

• fungal infections, especially vaginal candidiasis or oral thrush
• headache
• metallic taste in the mouth
• diarrhea, nausea, or vomiting
• sleep disturbances
• increased blood pressure
• anemia (low red blood cell count)
• dizziness
• local or generalized abdominal pain
• constipation
• digestive disorders (indigestion)
• local pain
• decreased platelet count

Not very common (may affect up to 1 in 100 people):

• vaginal or vulvar inflammation in women
• feeling of numbness or tingling
• swelling, pain, or discoloration of the tongue
• dryness of the oral mucosa
• pain at the infusion site (intravenous infusion)
• phlebitis (including at the infusion site)
• frequent urination
• chills
• feeling of thirst
• increased sweating
• hyponatremia (low sodium levels in the blood)
• kidney problems
• bloating
• pain at the injection site
• increased creatinine levels
• abdominal pain
• changes in heart rate (e.g., increased heart rate)
• decreased blood cell count
• weakness and (or) sensory disturbances

Rare (may affect up to 1 in 1000 people):

• surface tooth discoloration, which can be removed by a dental cleaning procedure (manual removal of tartar)

The following side effects have also been reported (frequency not known: frequency cannot be estimated from the available data):

• hair loss (alopecia)

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw; tel.: +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 representative of the marketing authorization holder. By reporting side effects, more information can be collected on the safety of this medicine.

5. How to store Dilizolen

Hospital staff will ensure that the Dilizolen solution is not used after the expiry date printed on the infusion bag and that it is administered to the patient immediately after opening the packaging. Hospital staff will also visually inspect the solution before use and will only use a clear solution without solid particles. They will also ensure that the solution is stored properly in a cardboard box and outer foil to protect it from light and keep it out of sight and reach of children until it is needed. After opening: For microbiological reasons, the medicine should be used immediately, unless the opening method excludes the risk of microbiological contamination. If the medicine is not used immediately, the user is responsible for the storage time and conditions. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Dilizolen contains

• The active substance is linezolid. 1 ml of solution contains 2 mg of linezolid.
• The other ingredients are glucose monohydrate, sodium citrate, anhydrous citric acid, hydrochloric acid, sodium hydroxide, and water for injections.

What Dilizolen looks like and what the packaging contains

Dilizolen is available as a clear solution packaged in single infusion bags made of polyethylene, containing 300 ml (600 mg of linezolid) of solution. The bags are packaged in cardboard boxes, one or ten bags per box. Not all pack sizes may be marketed.

Marketing authorization holder

Glenmark Pharmaceuticals s.r.o., Hvězdova 1716/2b, 140 78 Prague 4, Czech Republic

Manufacturer (responsible for batch release)

Zakłady Farmaceutyczne Polpharma S.A., ul. Pelpińska 19, 83-200 Starogard Gdański, Poland

For more information about this medicine, the patient should contact their local representative of the marketing authorization holder:

Glenmark Pharmaceuticals Sp. z o.o., ul. Dziekońskiego 3, 00-728 Warsaw, Email: [email protected], Date of last revision of the leaflet:March 2025