Linezolid polpharma

Patient Information Leaflet

Linezolid Polpharma, 600 mg, film-coated tablets
Linezolidum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Leaflet Contents

1. What Linezolid Polpharma is and what it is used for
2. What you need to know before you take 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 Linezolid Polpharma is and what it is used for

Linezolid Polpharma is an antibiotic belonging to the oxazolidinone group. It works by 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.
Your doctor will decide whether linezolid is appropriate for treating your specific infection.

2. Important information before using Linezolid Polpharma

When not to use 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 within the last 2 weeks any medicines known as monoamine oxidase inhibitors (MAOIs, 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. Linezolid passes into breast milk and may harm the baby.

Warnings and precautions
Before starting treatment with Linezolid Polpharma, discuss this with the doctor or
pharmacist.
If the patient answers "yes" to any of the questions below, it means that Linezolid
Polpharma may not be suitable for them.
In such a case, inform the doctor, who may decide to perform, before and during treatment,
a general examination and blood pressure monitoring, or decide to use another, more appropriate treatment.
If there is any uncertainty whether the situations described below apply to the patient, consult the doctor.

• Does the patient have high blood pressure?
• Has the patient been diagnosed with hyperthyroidism?
• Does the patient have a tumour of the adrenal gland (pheochromocytoma) or carcinoid syndrome (caused by a tumour of the endocrine system, with symptoms such as diarrhoea, hot flushes, wheezing)?
• Does the patient have: manic depression, schizoaffective disorders, disorientation or other psychiatric disorders?
• Is the patient taking any opioid medicines?
• Is the patient taking any of the following medicines:
  • Decongestants used in colds or flu containing pseudoephedrine or phenylpropanolamine,
  • Medicines used to treat asthma, e.g. salbutamol, terbutaline, fenoterol,
  • Antidepressants known as tricyclic antidepressants or SSRIs (selective serotonin reuptake inhibitors), e.g. amitriptyline, cypramine, clomipramine, dosulepin, doxepin, fluoxetine, fluvoxamine, imipramine, lofepramine, paroxetine, sertraline,
  • Medicines used to treat migraine, e.g. sumatriptan and zolmitriptan,
  • Medicines used to treat sudden, severe allergic reactions, e.g. adrenaline (epinephrine),
  • Medicines that raise blood pressure, e.g. noradrenaline (norepinephrine), dopamine and dobutamine,
  • Opioids, e.g. pethidine – used for moderate or severe pain,
  • Medicines used to treat anxiety disorders, e.g. buspirone,
  • An antibiotic called rifampicin.

If the patient has any of the following conditions, inform the doctor before starting treatment with this medicine:

• Tendency to bruising and bleeding,
• Anaemia (low number of red blood cells),
• Susceptibility to infections,
• History of seizures,
• Impaired liver or kidney function, especially if the patient is on dialysis,
• Diarrhoea.

Inform the doctor immediately if the patient experiences any of the following during treatment:

• Vision disturbances, such as blurred vision, changes in colour vision, difficulty seeing details or narrowing of the visual field;
• Loss of sensation or tingling or prickling in the hands or feet;
• Diarrhoea, which may occur during or after treatment with antibiotics, including Linezolid Polpharma; if diarrhoea is severe or persistent, or if blood or mucus is visible in the stool, stop taking Linezolid Polpharma immediately and contact the doctor; in such a case, do not take medicines that stop or slow down intestinal movements;
• Recurrent nausea or vomiting, abdominal pain or increased breathing rate.

Concomitant use of certain medicines, including antidepressants and opioids, with Linezolid Polpharma may lead to serotonin syndrome – a potentially life-threatening condition (see section 2 "Linezolid Polpharma and other medicines" and section 4).

Linezolid Polpharma and other medicines
Tell the doctor about all medicines currently or recently taken by the patient, as well as any medicines the patient plans to take.
Linezolid Polpharma may sometimes interact with certain medicines, which in turn may cause adverse effects such as changes in blood pressure, temperature or heart rate.
If the patient has taken any of the following medicines within the last 2 weeks,
tell the doctor, as concomitant use is contraindicated in such cases (see also section 2 "When not to use Linezolid Polpharma").

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

Also inform the doctor if the patient is taking any of the following medicines. The doctor may decide to continue treatment with Linezolid Polpharma, but monitoring of the patient's general health and blood pressure will be required before and during treatment.
Otherwise, the doctor may decide that another treatment is best for the patient.

• Decongestants used in colds and flu containing pseudoephedrine or phenylpropanolamine.
• Certain medicines used to treat asthma, e.g. salbutamol, terbutaline, fenoterol.
• Certain antidepressants, known as tricyclic antidepressants or selective serotonin reuptake inhibitors (SSRIs). There are many such medicines, including amitriptyline, cypramine, clomipramine, dosulepin, doxepin, fluoxetine, fluvoxamine, imipramine, lofepramine, paroxetine, sertraline.
• Medicines used to treat migraine, e.g. sumatriptan and zolmitriptan.
• Medicines used to treat sudden, severe allergic reactions, e.g. adrenaline (epinephrine).
• Medicines that raise 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.
• Anticoagulants, e.g. warfarin.

Linezolid Polpharma with food, drink and alcohol

• Avoid consuming large amounts of mature cheeses, yeast extracts or soybean seed extracts (e.g. soy sauce) and drinking alcohol, especially draught beer and wine. This medicine may react with a substance called tyramine, naturally present in certain foods, causing an increase in blood pressure.
• If the patient experiences a throbbing headache after eating or drinking, inform the doctor or pharmacist immediately.

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

Driving and operating machinery
Linezolid Polpharma may cause dizziness or visual disturbances. If such symptoms occur, the patient should not drive or operate any machinery. Remember that poor well-being may affect the ability to drive and operate machinery.

Sodium content
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

3. How to use Linezolid Polpharma

Adults
This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
The usual dose of Linezolid Polpharma is 1 tablet (600 mg of linezolid) taken twice daily (every 12 hours).
The tablet should be swallowed whole with a small amount of water.
The tablet may be taken before, during, or after a meal.
For patients undergoing dialysis, Linezolid Polpharma should be administered after completion of 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 longer than 28 days have not been established. The doctor will decide how long treatment should continue.
While taking Linezolid Polpharma, the doctor will recommend regular blood tests to monitor blood counts.
If a patient uses Linezolid Polpharma for longer than 28 days, the doctor should recommend 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 Linezolid Polpharma than prescribed
Inform a doctor or pharmacist immediately.

If you miss a dose of Linezolid Polpharma
Take the missed tablet as soon as possible. Then take the next tablet after 12 hours, and continue taking the medicine every 12 hours. Do not take a double dose to make up for a missed tablet.

Stopping Linezolid Polpharma
It is important to continue taking Linezolid Polpharma unless the doctor advises stopping treatment.
If the patient stops taking the medicine and the initial symptoms of the disease return, inform a doctor or pharmacist immediately.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any of the adverse effects listed below occur during treatment, you must immediately inform your doctor or pharmacist:

• skin reactions such as redness, pain or peeling of the skin (skin inflammation), rash, itching or swelling, particularly around the face and neck; these may be symptoms of an allergic reaction and may require discontinuation of Linezolid Polpharma;
• vision problems such as changes in visual acuity, changes in colour vision, difficulty perceiving details or narrowing of the visual field;
• severe diarrhoea with blood and (or) mucus (intestinal inflammation, including antibiotic-associated pseudomembranous colitis), which very rarely may lead to life-threatening complications;
• recurrent nausea or vomiting, abdominal pain or increased breathing rate;
• seizures or epileptic fits have been reported during treatment with this medicine;
• serotonin syndrome (frequency unknown) – if the patient develops excessive agitation, confusion, disorientation, rigidity, tremor, lack of coordination, seizures, rapid heartbeat, severe breathing difficulties or diarrhoea (suggesting serotonin syndrome), especially when taking antidepressant medicines known as SSRIs or opioids concurrently, inform the doctor immediately (see section 2).

In patients treated with this medicine for longer than 28 days, numbness, tingling sensations or blurred vision have been reported. If visual disturbances occur, the patient should contact a doctor as soon as possible.

Other adverse effects

Common (occur in no more than 1 in 10 people):

• fungal infections, particularly of the vagina or oral cavity ("thrush")
• headache
• metallic taste in the mouth
• diarrhoea, nausea or vomiting
• changes in results of certain blood tests, including kidney or liver function tests or increased blood glucose levels
• unexplained bleeding or bruising, which may be due to changes in the number of certain blood cells, affecting blood clotting and potentially leading to anaemia
• difficulty sleeping
• increased blood pressure
• anaemia (low concentration of red blood cells)
• changes in the number of certain blood cells, which may affect the ability to fight infections
• rash
• skin itching
• dizziness
• localized or general abdominal pain
• constipation
• indigestion
• localized pain
• fever

Uncommon (occur in no more than 1 in 100 people):

• inflammation of the vagina or genital area in women
• sensation of tingling and numbness
• blurred vision
• ringing in the ears (tinnitus)
• phlebitis (vein inflammation)
• dryness or pain in the mouth, swelling, irritation or discoloration of the tongue
• increased need to urinate
• chills
• feeling of fatigue or thirst
• pancreatitis
• increased sweating
• changes in blood levels of proteins and salts, or enzyme activity indicating kidney or liver function
• seizures
• low sodium levels in the blood
• kidney failure
• decreased number of certain platelets
• abdominal bloating
• transient ischaemic attacks (temporary disturbances in blood flow to the brain causing short-term symptoms such as loss of vision, weakness in upper and lower limbs, speech difficulties and loss of consciousness)
• skin inflammation
• increased creatinine levels
• abdominal pain
• changes in heart rate (e.g. increased rate)

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

• reduced visual field
• superficial tooth discoloration, removable by professional dental cleaning (manual removal of tartar)

The following adverse effects have also been reported (frequency unknown):

• serotonin syndrome (symptoms include rapid heartbeat, disorientation, profuse sweating, hallucinations, involuntary movements, chills and tremors)
• lactic acidosis (symptoms include recurrent nausea and vomiting, abdominal pain, increased breathing rate)
• severe skin reactions
• sideroblastic anaemia (a type of anaemia – low number of red blood cells)
• hair loss (alopecia)
• colour vision disturbances or difficulty perceiving details
• decreased number of blood cells
• weakness and (or) sensory disturbances

Reporting of adverse effects

If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse effects may also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Linezolid Polpharma

Keep this medicine 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 stated month.
The marking on the packaging following the abbreviation EXP indicates the expiry date, and following the abbreviation Lot/LOT indicates the batch number.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures will help protect the environment.

6. Contents of the pack and other information

What Linezolid Polpharma contains

• The active substance is linezolid. Each tablet contains 600 mg of linezolid.
• The other ingredients are: sodium carboxymethyl starch (Type A), microcrystalline cellulose PH 101, microcrystalline cellulose PH 102, povidone K30, sodium dihydrogen citrate powder (Type F0100), magnesium stearate.
  Coating composition: hypromellose, microcrystalline cellulose, stearic acid polyglycol 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 each, packed in cardboard boxes.
Each package contains 10 film-coated tablets.

Marketing Authorisation Holder and Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01