Dilizolen

Package leaflet: Information for the user

Dilizolen, 2 mg/ml, infusion solution
Linezolid
Please read the entire leaflet carefully before use, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents:

1. What Dilizolen is and what it is 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 pack and other information

1. What Dilizolen is and what it is used for

Dilizolen is an antibiotic belonging to the oxazolidinone group, which works by inhibiting
the growth of certain types of bacteria (microorganisms) that cause infections. It is used to treat
pneumonia and certain skin and soft tissue infections (tissues located beneath the skin). Your doctor will decide
whether Dilizolen is appropriate for treating your specific infection.

2. Important information before using Dilizolen

When not to use Dilizolen:

• if the patient is allergic to linezolid or to 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 in the treatment of 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, discuss this with your doctor, pharmacist or nurse.
Dilizolen may not be the right medicine for a patient who answers yes to any of the questions listed below.
In such a case, inform your doctor, who will examine the patient's general health and blood pressure before starting treatment and monitor them during treatment, or may decide to use another, more suitable treatment.
If in doubt whether any of the following situations apply to the patient, consult a doctor.

• Does the patient have high blood pressure and is therefore taking medication or not?
• Has hyperthyroidism been diagnosed in the patient?
• Does the patient have a tumour of the adrenal gland (pheochromocytoma) or carcinoid syndrome (caused by tumours of the hormonal system, with diarrhoea, flushing, wheezing)?
• Does the patient have depression with periods of mania, schizoaffective disorders, disorientation or other psychiatric disorders?
• Is the patient taking any opioid medicines? Using certain medicines, including antidepressants and opioids, together with Dilizolen may lead to serotonin syndrome, a potentially life-threatening condition (see section 2 “Dilizolen with other medicines” and section 4).
• Has the patient previously experienced hyponatraemia (low sodium levels in the blood), or is the patient taking medicines that reduce sodium levels in the blood, such as certain diuretics (also called “water tablets”), e.g. hydrochlorothiazide?

Precautions during use of Dilizolen
Before starting treatment with this medicine, consult your doctor if the patient:

• is elderly
• has a tendency to bruise easily or to bleed
• has anaemia (low red blood cell count)
• has a tendency to develop infections
• has had seizures in the past
• has impaired liver or kidney function, especially if undergoing dialysis
• has diarrhoea

Immediately inform the doctor if, during treatment:

• visual disturbances occur, such as blurred vision, changes in colour perception, difficulty seeing details or narrowing of the visual field;
• loss of sensation in hands and feet occurs, or tingling or prickling sensations in hands and feet;
• diarrhoea develops during or after antibiotic treatment, including with Dilizolen. If diarrhoea is severe or worsening, or if the patient notices blood or mucus in the stool, treatment with Dilizolen must be stopped immediately and the doctor contacted. In such cases, do not take medicines that inhibit or slow intestinal motility.
• recurrent nausea or vomiting, abdominal pain or increased breathing rate occur;
• unexplained muscle pain, tenderness or weakness and/or darkly coloured urine occur. These may be symptoms of a serious condition called rhabdomyolysis (muscle breakdown), which may lead to kidney damage;
• nausea and malaise occur, including muscle weakness, headache, confusion and memory disturbances, which may indicate hyponatraemia (low sodium levels in the blood).

Dilizolen with other medicines
Taking Dilizolen together with certain other medicines may cause adverse effects such as changes in blood pressure, body temperature or heart rate.
Tell your doctor or pharmacist about all medicines currently or recently taken by the patient.
Inform your doctor if the patient is taking or has taken within the last 2 weeks the following medicines, because Dilizolen must not be taken if the patient is already taking these medicines or has recently taken them (see also section 2 above “When not to use Dilizolen”).

• monoamine oxidase inhibitors (e.g. phenelzine, isocarboxazid, selegiline, moclobemide). These medicines may be used in the treatment of depression or Parkinson's disease.

Also inform your doctor if the patient is taking any of the medicines listed below. The doctor may decide to prescribe Dilizolen, but before starting treatment the doctor should perform a general examination and measure blood pressure, which should be monitored throughout the treatment period. In other cases, the doctor may decide to use another, more suitable treatment.

• medicines used to reduce nasal congestion in colds or flu, containing pseudoephedrine or phenylpropanolamine;
• certain medicines used to treat asthma, such as salbutamol, terbutaline, fenoterol;
• certain antidepressants, including tricyclic antidepressants or selective serotonin reuptake inhibitors (SSRIs). There are many such medicines, including amitriptyline,
  citalopram, clomipramine, dosulepin, doxepin, fluoxetine, fluvoxamine, imipramine, lofepramine,
  paroxetine, sertraline;
• medicines used to treat migraine, such as sumatriptan, zolmitriptan;
• medicines used to treat sudden, severe allergic reactions, such as adrenaline;
• medicines that raise 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;
• anticoagulants, such as warfarin;
• the antibiotic known as rifampicin.

Dilizolen with food, drink and alcohol

• Dilizolen may be taken before, during or after meals.
• Avoid consuming large amounts of mature cheeses, yeast extracts or soybean products (e.g. soy sauce), and alcoholic beverages, especially draught 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, inform the doctor, pharmacist or nurse immediately.

Pregnancy, breastfeeding and fertility
The effect of Dilizolen in pregnant women is unknown. Therefore, this medicine should not be used during pregnancy unless prescribed by a doctor.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Breastfeeding must not be continued during treatment with Dilizolen, because it passes into breast milk and may affect the baby.

Driving and using machines
Dilizolen may cause dizziness and visual disturbances. If these symptoms occur, the patient should not drive or operate machinery.
Remember that feeling unwell may impair the ability to drive or operate machinery.

Dilizolen contains glucose and sodium.

Glucose
1 ml of Dilizolen solution contains 45.7 mg glucose (13.7 g glucose in one infusion bag).
Inform your doctor or nurse if the patient has diabetes.

Sodium
1 ml of Dilizolen solution contains 0.38 mg sodium (114 mg sodium in one infusion bag).
Inform your doctor or nurse if the patient is on a low-sodium diet.

3. How to use Dilizolen

Adults
This medicine should always be used exactly as advised by your doctor, pharmacist, or nurse. If in
doubt, consult your doctor, pharmacist, or nurse.
The medicine will be administered as an intravenous infusion (drip) by a doctor or medical staff. The recommended
dose for adults (aged 18 years and older) is 300 ml of solution (600 mg linezolid) given twice daily,
administered directly into the bloodstream as an intravenous infusion lasting between 30 and
120 minutes.
If the patient is undergoing dialysis, Dilizolen should be administered after completion of dialysis.
The treatment course usually lasts from 10 to 14 days, but may extend up to 28 days. The safety and
efficacy of this medicine have not been established for use longer than 28 days. The decision on the duration of treatment
will be made by the doctor.
During treatment with Dilizolen, the doctor will order regular blood tests to monitor blood counts.
If Dilizolen is used for longer than 28 days, the doctor will order an eye examination for the patient.
Use in children and adolescents
Dilizolen is not usually indicated for use in children and adolescents (under 18 years of age).
Use of a higher than recommended dose of Dilizolen
If the patient is concerned that they have received too high a dose of Dilizolen, they should immediately inform
their doctor or nurse.
Missed dose of Dilizolen
Since the medicine will be administered under strict medical supervision, missing a dose is unlikely. However, if a missed dose is suspected, the patient should immediately inform their doctor or nurse. Do not use a double dose to make up for a missed dose.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
You should immediately inform your doctor, nurse or pharmacist if any of the following adverse effects occur while taking
Dilizolen:
Severe adverse effects that may occur with Dilizolen (frequency in brackets) include:

• severe skin reactions (uncommon), swelling particularly in the face and neck area (uncommon), wheezing and (or) shortness of breath (rare). These may be symptoms of an allergic reaction, and treatment with Dilizolen may need to be discontinued. Skin reactions such as raised, purple rash caused by inflammation of blood vessels (vasculitis) (rare), redness, peeling of the skin (dermatitis) (uncommon), rash (common), itching (common).
• visual disturbances (uncommon), such as blurred vision (uncommon), changes in colour perception (frequency not known), difficulty seeing details (frequency not known), or narrowing of the visual field (rare).
• severe diarrhoea with blood and (or) mucus in the stool (antibiotic-associated colitis, including pseudomembranous colitis); life-threatening complications may rarely occur (uncommon).
• recurrent nausea or vomiting, abdominal pain or increased respiratory rate (rare).
• seizures or convulsions (uncommon) have been reported during treatment with Dilizolen.
• serotonin syndrome (frequency not known): inform your doctor if symptoms such as agitation, disorientation, hallucinations, rigidity, tremor, coordination disturbances, and convulsions, rapid heartbeat, severe breathing difficulties, and diarrhoea occur while taking antidepressants of the SSRI class (selective serotonin reuptake inhibitors) or opioids concomitantly (see section 2).
• bleeding or bruising of unknown cause, which may be due to changes in the number of certain blood cells, affecting blood clotting or leading to anaemia (frequency common).
• changes in the number of certain blood cells, which may affect the ability to fight infections (uncommon); some signs of infection include fever (common), sore throat (uncommon), mouth ulcers (uncommon), and fatigue (uncommon).
• rhabdomyolysis (rare): objective and subjective symptoms include unexplained muscle pain, tenderness or weakness, and (or) dark discolouration of urine. These may be signs of a serious condition called rhabdomyolysis (muscle breakdown), which may lead to kidney damage.
• pancreatitis (uncommon).
• convulsions (uncommon).
• transient ischaemic attacks (transient disturbances in blood supply to the brain causing temporary symptoms such as loss of vision, limb weakness, slurred speech and loss of consciousness) (uncommon).
• "ringing" in the ears (tinnitus) (uncommon).

Numbness, tingling or blurred vision have been reported in patients treated with Dilizolen for longer than 28 days. If visual disturbances occur, the patient should contact a doctor as soon as possible.
Other adverse effects include:
Common (may occur in less than 1 in 10 people):

• fungal infections, particularly vaginal candidiasis or oral thrush
• headache
• metallic taste in the mouth
• diarrhoea, nausea or vomiting
• sleep disturbances
• increased blood pressure
• anaemia (low number of red blood cells)
• dizziness
• localised or general abdominal pain
• constipation
• digestive disorders (dyspepsia)
• local pain
• decreased platelet count

Uncommon (may occur in less than 1 in 100 people):

• inflammation of the vagina or external genital area in women
• sensation of numbness or tingling
• swelling, pain or discolouration of the tongue
• dryness of the oral mucosa
• pain at or around the infusion site
• phlebitis (including at the infusion site)
• frequent urination
• chills
• sensation of thirst
• increased sweating
• hyponatraemia (low sodium levels in blood)
• kidney dysfunction
• flatulence
• pain at the injection site
• increased creatinine levels
• abdominal pain
• changes in heart rate (e.g. increased rate)
• decreased number of blood cells
• weakness and (or) sensory disturbances

Rare (may occur in less than 1 in 1000 people):

• superficial tooth discolouration, reversible after dental cleaning (manual removal of tartar)

The following adverse effects have also been reported (frequency not known: frequency cannot be determined
from available data):

• alopecia (hair loss)

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Adverse effects can also be reported to the representative of the responsible entity.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Dilizolen

Hospital staff will ensure that Dilizolen solution is not used after the expiry date printed on the infusion bag and that it is administered to the patient immediately after removing the closure. Hospital staff will also visually inspect the solution before use and use only clear solution without solid particles. They will also ensure that the solution is properly stored in the cardboard box and outer foil to protect it from light and kept out of sight and reach of children until the time when the medicine is needed.

After opening:
From a microbiological point of view, the medicine should be used immediately, unless the method of opening excludes the risk of microbiological contamination. If the medicine is not used immediately, the user is responsible for the duration and storage conditions.

Medicines must not be disposed of via wastewater or household waste. Please ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Dilizolen contains

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

What Dilizolen looks like and contents of the pack
Dilizolen is available as a clear solution packed in single polyethylene infusion bags,
containing 300 ml (600 mg linezolid) of solution.
The bags are packed in cardboard boxes containing 1 or 10 bags.
Not all pack sizes may be marketed.
Marketing Authorisation 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 further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Glenmark Pharmaceuticals Sp. z o.o.
ul. Dziekońskiego 3
00-728 Warsaw
Email: [email protected]