LINEZOLID 600 mg Film-Coated Tablets

Зміст інструкції

1. Linezolid Krka d.d. 600 mg film-coated tablets
   1. What is Linezolid Krka d.d. and what it is used for
   2. What you need to know before you take Linezolid Krka d.d.
   3. How to take Linezolid Krka d.d.
   4. Possible side effects
   5. How to store Linezolid Krka d.d.
   6. Contents of the pack and other information

Linezolid Krka d.d. 600 mg film-coated tablets

linezolid

Generic medicine

Read this leaflet carefully before you start taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What Linezolid Krka d.d. is and what it is used for
• 2. What you need to know before you take Linezolid Krka d.d.
• 3. How to take Linezolid Krka d.d.
• 4. Possible side effects
• 5. How to store Linezolid Krka d.d.
• 6. Contents of the pack and other information

1. What is Linezolid Krka d.d. and what it is used for

Linezolid Krka d.d. is an antibiotic from the oxazolidinone group that works by blocking the
growth of certain bacteria (germs) that cause infections. It is used for the treatment of
pneumonia and some skin or subcutaneous infections. The doctor will decide whether Linezolid Krka
d.d. is suitable for treating your infection.

2. What you need to know before you take Linezolid Krka d.d.

Do not take Linezolid Krka d.d.

• 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 known as monoamine oxidase inhibitors (MAOIs, for example phenelzine, isocarboxazide, selegiline, moclobemide). These medicines can be used to treat depression or Parkinson's disease.
• if you are breastfeeding, as Linezolid Krka d.d. passes into breast milk and may have effects on your baby.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Linezolid Krka d.d..
Linezolid Krka d.d. may not be suitable for you if the answer to any of the following
questions is yes. In this case, talk to your doctor who may need to check your
overall health and your blood pressure before and during treatment, or
may decide that another treatment is better for you.
Ask your doctor if you are not sure whether these categories apply to you.

• Do you have high blood pressure, regardless of whether you are taking medicine for it?
• Have you been diagnosed with an overactive thyroid?
• Do you have a tumor of the adrenal glands (pheochromocytoma) or a carcinoid syndrome (caused by tumors of the hormonal system with symptoms such as diarrhea, skin flushing, shortness of breath)?
• Do you suffer from manic depression, schizoaffective disorder, mental confusion or other mental health problems?
• Do you have a history of hyponatremia (low sodium levels in the blood) or are you taking medicines that lower sodium levels in the blood, e.g. some diuretics (also called “medicines that increase the amount of urine produced”) such as hydrochlorothiazide?
• Are you taking opioids? The use of some medicines, including antidepressants and opioids, together with Linezolid Krka d.d. can lead to the development of serotonin syndrome, a potentially life-threatening condition (see section 2 “Other medicines and Linezolid Krka d.d.” and section 4).

Be particularly careful with Linezolid Krka d.d.
Talk to your doctor or pharmacist before taking this medicine if:

• you are elderly
• you bleed and bruise easily
• you are anemic (have a low number of red blood cells)
• you tend to develop infections
• you have a history of seizures
• you have liver or kidney problems, especially if you are on dialysis
• you have diarrhea

Tell your doctor immediately if you experience:

• eye problems such as blurred vision, altered color vision, difficulty seeing details, or if your field of vision becomes restricted.
• loss of sensation in your arms or legs or a tingling or prickling sensation in your arms or legs
• you may develop diarrhea during or after taking antibiotics, including Linezolid Krka d.d.. If this becomes severe or persistent or if you notice blood or mucus in your stools, you should immediately stop taking Linezolid Krka d.d. and consult your doctor. In this situation, you should not take medicines that block or slow down bowel movements.
• recurring nausea or vomiting, abdominal pain, or excessive breathing
• a feeling of unwellness with muscle weakness, headache, confusion, and memory impairment that may indicate hyponatremia (low sodium levels in the blood).

Children and adolescents
Linezolid Krka d.d. is normally not used for the treatment of children and
adolescents (under 18 years of age).

Other medicines and Linezolid Krka d.d.
There is a risk that Linezolid Krka d.d. may sometimes interact with certain medicines causing
undesirable effects such as changes in blood pressure, temperature or
heart rate.
Tell your doctor or pharmacist if you are taking or have recently taken any other
medicine.

Tell your doctor if you are taking or have taken in the last 2 weeksthe following
medicines because Linezolid Krka d.d. must notbe taken if you are already taking these
medicines or have taken them recently. (See also section 2 above “Do not take
Linezolid Krka d.d.”).

• Monoamine oxidase inhibitors (MAOIs, for example phenelzine, isocarboxazide, selegiline, moclobemide). These medicines can be used to treat depression or Parkinson's disease.

Also tell your doctor if you are taking the following medicines. The doctor may still decide to prescribe Linezolid Krka d.d., but will need to check your overall health and your blood pressure before and during treatment. In other cases, the
doctor may decide that another treatment is better for you.

• Decongestant remedies for colds or flu containing pseudoephedrine or phenylpropanolamine.
• Some medicines used to treat asthma such as salbutamol, terbutaline, fenoterol.
• Certain antidepressants known as tricyclics or SSRIs (selective serotonin reuptake inhibitors). There are many of these, including amitriptyline, citalopram, clomipramine, dosulepin, doxepin, fluoxetine, fluvoxamine, imipramine, lofepramine, paroxetine, sertraline.
• Medicines used to treat migraine such as sumatriptan and zolmitriptan.
• Medicines used to treat severe and sudden allergic reactions such as adrenaline (epinephrine).
• Medicines that increase blood pressure, such as noradrenaline (norepinephrine), dopamine, and dobutamine.
• Opioids, e.g. pethidine used to treat moderate to severe pain, Medicines used to treat anxiety disorders, such as buspirone.
• Medicines that block blood clotting such as warfarin
• An antibiotic called rifampicin.

Linezolid Krka d.d. with food, beverages and alcohol

• You can take Linezolid Krka d.d. before, during or after a meal.
• Avoid eating large amounts of aged cheese, yeast extracts or soybean extracts, such as soy sauce, and drinking alcohol, especially draft beer and wine. This is because Linezolid Krka d.d. can react with a substance called tyramine which is naturally present in some foods causing an increase in blood pressure.
• If you develop a severe headache after eating or drinking, tell your doctor, pharmacist or nurse immediately.

Pregnancy, breastfeeding and fertility
The effect of Linezolid Krka d.d. in pregnant women is not known. Therefore, it should not
be taken during pregnancy unless recommended by your doctor. If you are pregnant or
breastfeeding, if you suspect or are planning a pregnancy, ask your
doctor or pharmacist for advice before taking this medicine.
You should not breastfeed during the intake of Linezolid Krka d.d. as the medicine
can pass into breast milk and may have effects on the baby.

Driving and using machines
Linezolid Krka d.d. can cause dizziness or vision problems. If this happens, do not
drive vehicles and do not use machines. Remember that if you do not feel well, your ability to
drive or use machines may be affected.

Linezolid Krka d.d. contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is
essentially “sodium-free”.

3. How to take Linezolid Krka d.d.

Take this medicine following exactly what is stated in this leaflet or as instructed by your doctor, pharmacist or nurse. If you have any doubts, ask your doctor, pharmacist or nurse. The recommended dose is one film-coated tablet (600 mg of linezolid) twice a day (every 12 hours). Swallow the film-coated tablet whole with a little water.
If you are on renal dialysis, you must take Linezolid Krka d.d. after your dialysis treatment.
A 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 treatment periods longer than 28 days. The doctor will decide how long you should be treated.
During treatment with Linezolid Krka d.d., the doctor will perform regular blood tests to monitor your blood count.
If you take Linezolid Krka d.d. for more than 28 days, the doctor will monitor your vision.

Use in children and adolescents
Normally Linezolid Krka d.d. is not used for the treatment of children and adolescents (under 18 years of age).

If you take more Linezolid Krka d.d. than you should
Inform your doctor or pharmacist immediately.

If you forget to take Linezolid Krka d.d.
Take the forgotten tablet as soon as you remember. Take the next film-coated tablet 12 hours after this one and continue to take the tablets every 12 hours. Do not
take a double dose to make up for a forgotten film-coated tablet.
If you stop taking Linezolid Krka d.d.
Unless your doctor tells you to stop treatment, it is important that you continue to take Linezolid Krka d.d..
If you stop and your original symptoms reappear, inform your doctor or pharmacist immediately.
If you have any questions about the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The serious side effects (with the frequency in parentheses) of Linezolid Krka d.d. are:

Tell your doctor, nurse or pharmacist immediatelyif you notice any of
these side effects during treatment with Linezolid Krka d.d.:

• Severe skin reactions (uncommon) swelling, especially on the face and neck (uncommon), shortness of breath and/or difficulty breathing (rare). These may be signs of an allergic reaction

and it may be necessary to stop treatment with Linezolid Krka d.d..
Skin reactions such as raised purplish rash due to inflammation of the
blood vessels (rare), skin redness and scaling (dermatitis) (uncommon), rash (common), itching (common).

• Vision disorders (uncommon) such as blurred vision (uncommon), changes in color vision (not known), difficulty seeing details (not known), or if the field of vision narrows (rare).
• Severe diarrhea containing blood and/or mucus (antibiotic-associated colitis, including pseudomembranous colitis), which in rare cases can cause complications that can be life-threatening (uncommon).
• Recurrent nausea or vomiting, abdominal pain or rapid breathing (rare).
• Seizures or convulsions have been reported (uncommon) with Linezolid Krka d. d..
• Serotonin syndrome (not known): if agitation, confusion, delirium, rigidity, tremor, lack of coordination, convulsions, fast heartbeat, severe breathing problems and diarrhea (suggestive of serotonin syndrome) appear while you are also taking antidepressant medicines called SSRIs or opioids (see section 2), you should tell your doctor.
• Inflammation of the pancreas (uncommon).
• Unexplained bleeding or bruising, probably due to changes in the number of certain blood cells that can affect coagulation or lead to anemia (common).
• Changes in the number of certain blood cells that can affect the ability to fight infections (uncommon) some signs of infection include: fever (common), sore throat (uncommon), mouth ulcers (uncommon) and fatigue (uncommon).
• Convulsions (uncommon).
• Transient ischemic attacks (temporary disturbance of blood flow to the brain causing short-term symptoms such as vision loss, weakness of legs and arms, confused speech and loss of consciousness) (uncommon).
• "Ringing" in the ears (tinnitus) (uncommon).

In patients treated with Linezolid Krka d.d. for more than 28 days, numbness, tingling and blurred vision have been reported. If you experience difficulty with your vision, you should
consult your doctor as soon as possible.

Other side effects include:
Common side effects(may affect up to 1 in 10 people):

• Fungal infections, especially oral or vaginal thrush
• Headache
• Metallic taste in the mouth
• Diarrhea, nausea and vomiting
• Changes in some blood test results, including values to check proteins, salts or enzymes that measure kidney or liver function or blood sugar levels
• Difficulty sleeping
• Increased blood pressure
• Anemia (low number of red blood cells)
• Dizziness
• General or localized abdominal pain
• Constipation
• Indigestion
• Localized pain
• Reduced platelets

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

• Inflammation of the vagina or genital area in women
• Sensation of tingling or numbness
• Swelling, pain or discoloration of the tongue
• Dry mouth
• Need to urinate more often
• Chills
• Feeling of thirst
• Increased sweating
• Hyponatremia (low levels of sodium in the blood)
• Kidney failure
• Abdominal bloating
• Increased creatinine
• Stomach ache
• Changes in heart rate (e.g. increased rhythm)
• Reduced number of blood cells
• Weakness and/or sensory changes

Rare side effects(may affect up to 1 in 1,000 people):

• Superficial tooth discoloration, removable with a dental cleaning by the dentist (manual scaling)

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

• Alopecia (hair loss)

If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly
through the national reporting system at
https://www.aifa.gov.it/en/content/segnalazioni-reazioni-avverse. By reporting side
effects you can help provide more information on the safety of this
medicine.

5. How to store Linezolid Krka d.d.

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging and on the
blister after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Linezolid Krka d.d. contains

• The active substance is linezolid. Each film-coated tablet contains 600 mg of linezolid.
• The other ingredients are microcrystalline cellulose, corn starch, sodium starch glycolate (type A), hydroxypropylcellulose (type EF), magnesium stearate in the tablet core and hypromellose 3 mPas, titanium dioxide (E171), macrogol 6000 and talc in the film coating. See section 2 “Linezolid Krka d.d. contains sodium”.

Description of the appearance of Linezolid Krka d.d. and contents of the pack
Tablets from white to off-white, oval, slightly biconvex. Tablet size:
18 x 9 mm
Linezolid Krka d.d. is available in blister packs of 10, 20 and 30 film-coated
tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer
TAD Pharma GmbH, Heinz-Lohmann-Str. 5, 27472 Cuxhaven, Germany
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

This medicinal product is authorised in the Member States of the European Economic Area
under the following denominations: