LINEZOLID 600 mg Film-Coated Tablets

Зміст інструкції

1. Linezolid Aurobindo Italia 600 mg film-coated tablets
   1. What is Linezolid Aurobindo Italia and what it is used for
   2. What you need to know before you take Linezolid Aurobindo Italia
   3. How to take Linezolid Aurobindo Italia
   4. Possible side effects
   5. How to store Linezolid Aurobindo Italia
   6. Package contents and other information

Linezolid Aurobindo Italia 600 mg film-coated tablets

Generic medicine

Read this leaflet carefully before you start taking this medicine as 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 their symptoms are the same as yours, as it could 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 Aurobindo Italia is and what it is used for
• 2. What you need to know before you take Linezolid Aurobindo Italia
• 3. How to take Linezolid Aurobindo Italia
• 4. Possible side effects
• 5. How to store Linezolid Aurobindo Italia
• 6. Contents of the pack and other information

1. What is Linezolid Aurobindo Italia and what it is used for

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

2. What you need to know before you take Linezolid Aurobindo Italia

Do not take Linezolid Aurobindo Italia:

• If you are allergic to linezolid or to 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 for the treatment of depression or Parkinson's disease.
• If you are breastfeeding, as the medicine passes into breast milk and could have effects on your baby.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Linezolid Aurobindo Italia.
Linezolid Aurobindo Italia 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 general 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 if these categories apply to you.

• Do you have high blood pressure, whether or not you are taking medicines for this condition?
• 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?

Be particularly careful with Linezolid Aurobindo Italia
Talk to your doctor before taking this medicine if:

• you develop bruises and bleed easily;
• you are anemic (have few red blood cells);
• you tend to develop infections;
• you have a history of seizures;
• you have problems with your liver or kidneys, especially if you are on dialysis;
• you have diarrhea.

Immediately inform your doctor if you experience any of the following during treatment:

• 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 feeling of tingling or pins and needles in your arms or legs;
• you may develop diarrhea during or after taking antibiotics, including Linezolid Aurobindo Italia. If this becomes severe or persistent or if you notice that your stools contain blood or mucus, you should immediately stop taking Linezolid Aurobindo Italia 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 rapid breathing.

Other medicines and Linezolid Aurobindo Italia
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
There is a risk that Linezolid Aurobindo Italia may interact with some other medicines causing unwanted effects
such as changes in blood pressure, temperature or heart rate.

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

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

Also tell your doctor if you are taking the following medicines. The doctor may still decide to
prescribe you Linezolid Aurobindo Italia, but will need to check your general 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 in the treatment of 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 raise blood pressure, such as noradrenaline (norepinephrine), dopamine, and dobutamine;
• medicines used to treat moderate to severe pain, such as pethidine;
• medicines used to treat anxiety disorders, such as buspirone;
• medicines that block blood clotting such as warfarin;
• an antibiotic called rifampicin.

Linezolid Aurobindo Italiawith food, drinks and alcohol

• You can take Linezolid Aurobindo Italia before, during or after a meal.
• Avoid eating large amounts of aged cheese, yeast extracts or soy products, e.g. soy sauce, and drinking alcohol, especially draft beer and wine. This is because this medicine can react with a substance called tyramine which is naturally present in some foods. This interaction can cause an increase in blood pressure.
• If you experience a severe headache after eating or drinking, inform your doctor, pharmacist or nurse immediately.

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

Driving and using machines
Linezolid Aurobindo Italia may 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 Aurobindo Italia contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking
this medicine.

Linezolid Aurobindo Italia contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which is
essentially ‘sodium-free’.

3. How to take Linezolid Aurobindo Italia

Adults
Take this medicine following exactly the instructions given in this leaflet or as directed 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 should take Linezolid Aurobindo Italia 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 has not been established for treatment periods longer than 28 days. Your
doctor will decide how long you should be treated.
During treatment with Linezolid Aurobindo Italia your doctor will perform regular blood tests to
monitor your blood count.
If you take Linezolid Aurobindo Italia for more than 28 days your doctor will monitor your vision.

Use in children and adolescents
Linezolid Aurobindo Italia is normally not used for the treatment of children and adolescents (under
18 years of age).

If you take more Linezolid Aurobindo Italiathan you should
Tell your doctor or pharmacist immediately.

If you forget to take Linezolid Aurobindo Italia
Take the forgotten film-coated 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 Aurobindo Italia
Unless your doctor tells you to stop treatment, it is important that you continue to
take Linezolid Aurobindo Italia.
If you stop and your original symptoms reappear, tell your doctor or pharmacist immediately.
If you have any questions about using this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Tell your doctor, pharmacist or nurse immediatelyif you notice any of these side effects during treatment with Linezolid Aurobindo Italia:
The serious side effects (with frequency indicated in parentheses) of Linezolid Aurobindo Italia are:

• Severe skin reactions (frequency not known), swelling, especially around the face and neck (frequency not known), shortness of breath and/or difficulty breathing (frequency not known). These may be signs of an allergic reaction and it may be necessary to stop treatment with Linezolid Aurobindo Italia. Skin reactions such as skin ulceration and peeling (dermatitis) (uncommon), rash (common), itching (common).
• Visual disturbances such as blurred vision (uncommon), changes in color vision (frequency not known), difficulty seeing details (frequency 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 (rare).
• Recurrent nausea or vomiting, abdominal pain or rapid breathing (frequency not known).
• Seizures or convulsions have been reported with linezolid (uncommon). You should inform your doctor if you experience agitation, confusion, delirium, rigidity, tremor, lack of coordination and seizures if you are also taking antidepressants known as SSRIs (see section 2) (frequency not known).
• 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 (common) some signs of infection include: fever (common), sore throat (uncommon), mouth ulcers (uncommon) and fatigue (uncommon).
• Pancreatitis (uncommon).
• Convulsions (uncommon).
• Transient ischemic attacks (temporary disruption of blood flow to the brain that causes short-term symptoms such as vision loss, weakness in the legs and arms, difficulty articulating speech, and loss of consciousness) (uncommon).
• Tinnitus (ringing in the ears) (uncommon).

Numbness, tingling or blurred vision have been reported in patients to whom Linezolid Aurobindo Italia has been administered for more than 28 days. If you have vision problems, consult your doctor as soon as possible.

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

• Fungal infections, especially oral thrush or vaginal candidiasis.
• Headache.
• Metallic taste in the mouth.
• Diarrhea, nausea and vomiting.
• Changes in blood tests measuring kidney or liver function or blood sugar levels.
• Difficulty sleeping.
• Increased blood pressure.
• Anemia (low number of red blood cells in the blood).
• Dizziness.
• Diffuse or localized abdominal pain.
• Constipation.
• Indigestion.
• Localized pain.

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

• Inflammation of the vagina or genital area in women.
• Sensation of tingling or numbness.
• Inflammation of the veins (IV only).
• Swollen, painful or discolored tongue.
• Need to urinate more often.
• Chills.
• Feeling of fatigue or thirst.
• Increased sweating.
• Changes in proteins, salts or enzymes in the blood that measure kidney or liver function.
• Hyponatremia (low sodium levels in the blood).
• Kidney failure.
• Decreased number of platelets.
• Bloated abdomen.
• Pain at the injection site.
• Increased creatinine.
• Stomach ache.
• Changes in heart rate (e.g. increased rate).

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

• Superficial discoloration of the teeth, removable with dental cleaning (manual removal).
• Decreased blood cell count (pancytopenia).

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

• Sideroblastic anemia (a type of anemia (low number of red blood cells in the blood)).
• Alopecia (hair loss).
• Decreased production of blood cells (myelosuppression).
• Weakness and/or sensory changes.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system at http://www.aifa.gov.it/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 Aurobindo Italia

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 pack, blister and bottle
after EXP. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
For vials: use within 100 days of first opening.
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. Package contents and other information

What Linezolid Aurobindo Italia contains

• The active ingredient is linezolid. Each film-coated tablet contains 600 mg of linezolid.
• The other ingredients are: The tablet core contains poloxamer 407, sodium starch glycolate (type A), povidone K30, anhydrous colloidal silica, microcrystalline cellulose, lactose monohydrate, talc and magnesium stearate. The coating contains hypromellose, polyethylene glycol (macrogol) MW 400 and titanium dioxide (E171). The blue ink contains purified shellac, propylene glycol, Blue No. 1 FD&C (E133 Brilliant Blue FCF) and ammonium hydroxide.

Description of the appearance of Linezolid Aurobindo Italia and package contents
Linezolid Aurobindo Italia 600 mg are white, oval, biconvex tablets, with “600” printed on one side in blue ink.
Linezolid Aurobindo Italia tablets are available in PA-Aluminum/PVC blisters or in PVC/PE/PVDC-Aluminum blisters containing 10, 20, 30, 50 or 60 tablets packaged in a carton. Linezolid Aurobindo Italia tablets are also available in HDPE bottles of 10, 14, 20, 24, 30, 50 or 60 tablets with a child-resistant screw cap.
Linezolid Aurobindo Italia tablets are also available in 100 tablet bottles (for hospital use only).

Marketing Authorisation Holder
Aurobindo Pharma (Italia) S.r.l
via San Giuseppe, 102

• 21047 - Saronno (VA) Italy

Manufacturer
Pharmathen International S.A. Sapes Industrial Park Block 5, Rodopi 69300 Greece
Pharmathen SA 6 Dervenakion str. Pallini, Attiki 15351 Greece

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
Austria Linezolid Pharmathen 600 mg Filmtabletten
Greece Lizedia
Germany Linezolid PUREN 600 mg Filmtabletten
Italy
Spain
Linezolid Aurobindo Italia
Linezolid Aurovitas 600 mg film-coated tablets EFG
Portugal Linezolid Aurovitas
France Linezolid Ohre Pharman 600 mg comprimé pelliculé
United Kingdom Linezolid 600 mg film-coated tablets
Netherlands Linezolid Aurobindo 600 mg, filmomhulde tabletten