Linezolid Aurobindo Italia

Package leaflet: Information for the user

Linezolid Aurobindo Italia 600 mg film-coated tablets

Generic medicine
Read 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 questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to 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 taking 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 Linezolid Aurobindo Italia is and what it is used for

Linezolid Aurobindo Italia is an antibiotic belonging to the oxazolidinone group, which works by inhibiting the growth of certain bacteria causing infections. It is used to treat pneumonia and certain skin or soft tissue infections. Your doctor will decide whether Linezolid Aurobindo Italia is suitable for treating your infection.

2. What you need to know before taking 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 within the last 2 weeks any medicines known as monoamine oxidase inhibitors (MAOIs, for example phenelzine, isocarboxazid, selegiline, moclobemide). These medicines may be used to treat depression or Parkinson's disease.
• If you are breastfeeding, as the medicine passes into breast milk and may affect 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 you answer yes to any of the following questions. In this case, discuss with your doctor, who may need to monitor your general health condition and blood pressure before and during treatment, or may decide that another treatment is more appropriate for you.
Ask your doctor if you are unsure whether any of these categories apply to you.

• Do you have high blood pressure, whether or not you are taking medication for this condition?
• Have you been diagnosed with an overactive thyroid?
• Do you have a tumour of the adrenal glands (pheochromocytoma) or carcinoid syndrome (caused by tumours of the hormonal system with symptoms such as diarrhoea, skin flushing, shortness of breath)?
• Do you suffer from manic depression, schizoaffective disorder, confusion, or other mental health problems?

Take special care with Linezolid Aurobindo Italia
Talk to your doctor before taking this medicine if:

• you develop bruising or bleed easily;
• you are anaemic (have low 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 diarrhoea.

Inform your doctor immediately if, during treatment, you experience:

• vision problems such as blurred vision, changes in colour vision, difficulty seeing details, or narrowing of the visual field;
• loss of sensation in the arms or legs, or a tingling or prickling sensation in the arms or legs;
• you may develop diarrhoea during or after taking antibiotics, including Linezolid Aurobindo Italia. If this becomes severe or persistent, or if you notice blood or mucus in your stools, stop taking Linezolid Aurobindo Italia immediately and consult your doctor. In this situation, do not take medicines that block or slow intestinal movement;
• recurrent 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 certain other medicines, causing unwanted effects such as changes in blood pressure, body temperature, or heart rate.
Tell your doctor if you are taking or have taken any of the following medicines within the last 2 weeks, as Linezolid Aurobindo Italia must not be taken if you are already taking these medicines or have recently taken them (see also section 2 above, “Do not take Linezolid Aurobindo Italia”).

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

Also inform your doctor if you are taking any of the following medicines. Your doctor may still decide to prescribe Linezolid Aurobindo Italia, but will need to monitor your general health and blood pressure before and during treatment. In other cases, your doctor may decide that another treatment is more suitable for you.

• Decongestants for cold or flu containing pseudoephedrine or phenylpropanolamine;
• Certain 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, sudden allergic reactions, such as adrenaline (epinephrine);
• Medicines that increase blood pressure, such as noradrenaline (norepinephrine), dopamine, and dobutamine;
• Medicines used to treat moderate to severe pain, such as meperidine;
• Medicines used to treat anxiety disorders, such as buspirone;
• Medicines that prevent blood clotting, such as warfarin;
• An antibiotic called rifampicin.

Linezolid Aurobindo Italia with food, drinks, and alcohol

• You may take Linezolid Aurobindo Italia before, during, or after a meal.
• Avoid eating large amounts of aged cheese, yeast extracts, or soybean derivatives (e.g. soy sauce), and avoid drinking alcoholic beverages, especially draught beer and wine. This is because this medicine may react with a substance called tyramine, which is naturally present in some foods. This interaction may cause a rise in blood pressure.
• If you develop a sudden, 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 unknown. Therefore, the medicine should not be taken during pregnancy unless advised by your doctor. If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
You must not breastfeed while taking Linezolid Aurobindo Italia, as the medicine may pass into breast milk and could affect your baby.

Driving and using machines
Linezolid Aurobindo Italia may cause dizziness or vision problems. If this happens, do not drive or operate machinery. Remember that your ability to drive or use machines may be impaired if you do not feel well.

Linezolid Aurobindo Italia contains lactose
If your doctor has told you that you have an intolerance to certain sugars, consult 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, i.e. essentially 'sodium-free'.

3. How to take Linezolid Aurobindo Italia

Adults
Take this medicine exactly as described in this leaflet or as instructed by your doctor, pharmacist, or nurse. If you have any doubts, consult your doctor, pharmacist, or nurse.
The recommended dose is one film-coated tablet (600 mg of linezolid) twice daily (every 12 hours). Swallow the film-coated tablet whole with a little water.
If you are undergoing renal dialysis, you must take Linezolid Aurobindo Italia after your dialysis treatment.
A treatment course 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. Your doctor will decide how long your treatment should continue.
During treatment with Linezolid Aurobindo Italia, your doctor will perform regular blood tests to monitor your blood cell counts.
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 to treat children and adolescents (under 18 years of age).

If you take more Linezolid Aurobindo Italia than you should
Inform your doctor or pharmacist immediately.

If you forget to take Linezolid Aurobindo Italia
Take the missed film-coated tablet as soon as you remember. Then take the next tablet 12 hours after that. Continue taking the tablets every 12 hours. Do not take a double dose to make up for the forgotten tablet.

If you stop taking Linezolid Aurobindo Italia
Unless your doctor specifically instructs you to stop treatment, it is important that you continue taking Linezolid Aurobindo Italia.
If you stop and your original symptoms return, inform your doctor or pharmacist immediately.

If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Immediately inform your doctor, pharmacist or nurse if you notice any of the following side effects during treatment with Linezolid Aurobindo Italia:
The serious side effects (with frequency indicated in brackets) of Linezolid Aurobindo Italia are:

• Severe skin reactions (not known), swelling, especially around the face and neck (not known), breathlessness and/or difficulty breathing (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).
• Vision disturbances such as blurred vision (uncommon), changes in colour vision (not known), difficulty seeing details (not known), or narrowing of the visual field (rare).
• Severe diarrhoea containing blood and/or mucus (antibiotic-associated colitis, including pseudomembranous colitis), which in rare cases may lead to life-threatening complications (rare).
• Recurrent nausea or vomiting, abdominal pain or rapid breathing (not known).
• Seizures or convulsions have been reported with linezolid (uncommon). Inform your doctor if you experience agitation, confusion, delirium, stiffness, tremor, lack of coordination or seizures while also taking antidepressants known as SSRIs (see section 2) (not known).
• Unexplained bleeding or bruising, probably due to changes in the number of certain blood cells that may affect blood clotting or lead to anaemia (common).
• Changes in the number of certain blood cells that may affect the ability to fight infections (common); some signs of infection include: fever (common), sore throat (uncommon), mouth ulcers (uncommon), and fatigue (uncommon).
• Inflammation of the pancreas (uncommon).
• Convulsions (uncommon).
• Transient ischaemic attacks (temporary disruption of blood supply to the brain causing short-term symptoms such as loss of vision, weakness in arms and legs, difficulty speaking and loss of consciousness) (uncommon).
• Ringing in the ears (tinnitus) (uncommon).

Numbness, tingling sensations or blurred vision have been reported in patients treated with Linezolid Aurobindo Italia 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, particularly oral candidiasis ("thrush") or vaginal candidiasis.
• Headache.
• Metallic taste in the mouth.
• Diarrhoea, nausea and vomiting.
• Changes in blood test results measuring kidney or liver function or blood sugar levels.
• Difficulty sleeping.
• Increased blood pressure.
• Anaemia (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.
• Tingling or numbness sensations.
• Inflammation of the veins (IV only).
• Swollen, painful or discoloured tongue.
• Need to urinate more often.
• Chills.
• Feeling of fatigue or thirst.
• Increased sweating.
• Changes in proteins, salts or enzymes in the blood measuring kidney or liver function.
• Hyponatraemia (low levels of sodium in the blood).
• Renal failure.
• Reduction in platelet count.
• Abdominal distension.
• Pain at injection site.
• Increased creatinine.
• Stomach ache.
• Changes in heart rate (e.g. increased rhythm).

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

• Superficial tooth discolouration, removable by dental cleaning (manual removal).
• Decrease in blood cell counts (pancytopenia).

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

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You may also report side effects directly via 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 stated on the carton, blister pack, and bottle after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
For bottles: use within 100 days after first opening.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package Contents and Other Information

What Linezolid Aurobindo Italia Contains

• The active substance is linezolid. Each film-coated tablet contains 600 mg of linezolid.
• The other components are:
  Tablet core: poloxamer 407, sodium starch glycolate (type A), povidone K30, anhydrous colloidal silica, microcrystalline cellulose, lactose monohydrate, talc, and magnesium stearate.
  Coating: hypromellose, polyethylene glycol (macrogol) MW 400, and titanium dioxide (E171).
  Blue ink: purified shellac, propylene glycol, FD&C Blue No. 1 (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 in blue ink on one side.
Linezolid Aurobindo Italia tablets are available in blisters made of PA-Aluminium/PVC-Aluminium foil or in PVC/PE/PVDC-Aluminium blisters, containing 10, 20, 30, 50, or 60 tablets, packed in a box. Linezolid Aurobindo Italia tablets are also available in HDPE bottles with child-resistant screw caps containing 10, 14, 20, 24, 30, 50, or 60 tablets.
Linezolid Aurobindo Italia tablets are additionally available in bottles containing 100 tablets (for hospital use only).

Marketing Authorization 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 authorized in the European Economic Area Member States under the following names:
Austria: Linezolid Pharmathen 600 mg Filmtabletten
Greece: Lizedia
Germany: Linezolid PUREN 600 mg Filmtabletten
Italy: Linezolid Aurobindo Italia
Spain: Linezolid Aurovitas 600 mg comprimidos recubiertos con película 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