Linezolid Teva

Package leaflet: Information for the user

Linezolid Teva 600 mg film-coated tablets

Equivalent medicine
Please 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 or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Linezolid Teva is and what it is used for

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

2. What you need to know before taking Linezolid Teva

Do not take Linezolid Teva:

• 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 medicine belonging to the class of 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. This is because Linezolid Teva passes into breast milk and may harm the baby.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Linezolid Teva.
Linezolid Teva may not be suitable for you if your answer is "yes" to any of the following questions. In this case, discuss it with your doctor, who will evaluate your general health condition and your blood pressure before and during treatment, or decide to prescribe another treatment more appropriate for your case.
Contact your doctor if you are unsure whether any of the following conditions apply to you.

• Do you have high blood pressure, whether or not you are taking medicines for it?
• Have you ever been diagnosed with an overactive thyroid?
• Do you have a tumor of the adrenal glands (pheochromocytoma) or do you suffer from 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 problems?

Take special care with Linezolid Teva
Inform your doctor before taking Linezolid Teva if:

• you bruise easily or have bleeding problems
• you are anemic (you have a low number of red blood cells)
• you are prone to developing infections
• you have a history of seizures
• you have liver or kidney problems, especially if you are undergoing dialysis
• you suffer from diarrhea

Inform your doctor immediately if the following symptoms occur during treatment:

• vision problems, such as blurred vision, changes in color vision, difficulty distinguishing details, or narrowing of the visual field;
• loss of sensation in arms and legs or tingling or prickling sensations in arms and legs;
• diarrhea may occur during or after taking antibiotics, including Linezolid Teva. If this condition becomes severe or persistent, or if you notice blood or mucus in your stools, you must stop taking Linezolid Teva 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 Teva
There is a risk that Linezolid Teva may sometimes interact with certain medicines, causing unwanted effects such as changes in blood pressure, body 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 within the last 2 weeks the following medicines,
since Linezolid Teva must not be taken if you are already taking these medicines or have taken them recently (see also section 2 “Do not take Linezolid Teva”).

• medicines that may cause inhibition of monoamine oxidase (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 the following medicines. Your doctor may decide to still prescribe Linezolid Teva, but will monitor your general health condition and blood pressure before and during treatment. In other cases, your doctor may decide that another type of therapy would be preferable.

• Decongestants for colds or flu remedies containing pseudoephedrine and phenylpropanolamine.
• Some medicines used to treat asthma, such as salbutamol, terbutaline, fenoterol.
• Some antidepressants known as tricyclics or SSRIs (selective serotonin reuptake inhibitors). These include 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 sudden and severe 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 Teva with food, drinks, and alcohol

• You may take Linezolid Teva before, during, or after meals.
• Avoid eating large amounts of aged cheese, yeast extracts, or soy extracts (e.g. soy sauce), and avoid drinking alcohol, especially draught beer and wine. This is necessary because Linezolid Teva can react with a substance called tyramine, naturally present in certain foods, causing an increase in blood pressure.
• If you experience a pulsating headache after eating or drinking, inform your doctor or pharmacist immediately.

Pregnancy, breastfeeding, and fertility
The effect of Linezolid Teva in pregnant women is unknown. Therefore, this medicine should not be taken during pregnancy unless your doctor tells you otherwise.
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
You must not breastfeed while taking Linezolid Teva, as the medicine passes into breast milk and may harm the baby.

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

Linezolid Teva contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Linezolid Teva

Use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Adults
The recommended dose is one film-coated tablet (600 mg of linezolid) twice daily (every 12 hours).
Swallow the film-coated tablet with some water.
The tablet has a score line, which is only intended to help you break the tablet if you have difficulty swallowing it whole.
If you are on dialysis, take Linezolid Teva after your dialysis treatment.
A treatment course usually lasts 10–14 days, but may last up to 28 days. The safety and efficacy of this medicine have not been established for periods longer than 28 days. Your doctor will decide how long you should continue treatment.
During treatment with Linezolid Teva, your doctor will perform regular blood tests to monitor your blood cell counts.
Your doctor will monitor your vision if your treatment with Linezolid Teva lasts longer than 28 days.

Use in children and adolescents
Linezolid Teva is not normally used to treat children and adolescents (under 18 years of age).

If you take more Linezolid Teva than you should:
Contact your doctor or pharmacist immediately.

If you forget to take Linezolid Teva

• Take the missed tablet as soon as you remember. Then take the next tablet 12 hours after the missed one, and continue taking the film-coated tablets every 12 hours.
• Do not take a double dose to make up for the forgotten tablet.

If you stop taking Linezolid Teva
Unless your doctor tells you otherwise, it is important that you continue taking Linezolid Teva. If you stop treatment and your original symptoms return, contact your doctor or pharmacist immediately.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

• Severe skin reactions (not known), swelling, particularly around the face and neck (not known), wheezing and/or difficulty breathing (not known). These may be signs of an allergic reaction and you may need to stop taking Linezolid Teva. Skin reactions such as red, peeling sores (dermatitis) (uncommon), rash (common), itching (common).
• Vision problems, such as blurred vision (uncommon), changes in colour vision (not known), difficulty distinguishing details (not known), or narrowing of the visual field (rare).
• Severe diarrhoea with blood and/or mucus (antibiotic-associated colitis, including pseudomembranous colitis), which in very rare cases may lead to life-threatening complications (rare).
• Recurrent nausea or vomiting, abdominal pain, or abnormally rapid breathing (not known).
• Seizures or convulsions have been reported with the use of Linezolid Teva (uncommon). You must inform your doctor if you are also taking antidepressants of the SSRI class and experience agitation, confusion, delirium, rigidity, tremor, lack of coordination, and convulsions (see section 2) (not known).
• Unexplained bleeding or easy bruising, which may be due to changes in the number of certain blood cells, possibly affecting blood clotting or leading to anaemia (common).
• Reduction in the number of certain blood cells, which may impair your 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 disturbance in blood supply to the brain causing short-term symptoms such as loss of vision, weakness in arms and legs, difficulty speaking properly, and loss of consciousness) (uncommon).
• Ringing in the ears (tinnitus) (uncommon).

Numbness, tingling, or blurred vision have been reported in patients who have taken Linezolid Teva for more than 28 days. If you notice any 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 vaginal or oral "thrush" (candidiasis)
• Headache
• Metallic taste in the mouth
• Diarrhoea, nausea or vomiting
• Changes in blood test results, including those related to kidney or liver function or sugar levels
• Difficulty sleeping
• Increased blood pressure
• Anaemia (low number of red blood cells)
• Dizziness
• Localised or general abdominal pain
• Constipation
• Indigestion
• Localised 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 (only if administered intravenously)
• Swollen, painful or discoloured tongue
• Need to urinate more frequently
• Chills
• Feeling thirsty
• Increased sweating
• Changes in levels of proteins, salts or enzymes in the blood that measure kidney or liver function
• Hyponatraemia (low levels of sodium in the blood)
• Kidney failure
• Reduced platelet count
• Abdominal swelling
• Pain at injection site
• Increased creatinine
• Stomach pain
• Changes in heart rate (e.g. increased rate)

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

• Superficial tooth discoloration, removable with professional dental cleaning (manual descaling)

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

• Alopecia (hair loss)
• Reduction in blood cell count
• 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 or
pharmacist. You can also report side effects directly via the national reporting system at
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Linezolid Teva

Keep this medicine out of the sight and reach of children.
Do not use after the expiry date stated on the blister and outer packaging 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 medicines via wastewater 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 Teva contains

• The active substance is linezolid. Each film-coated tablet contains 600 mg of linezolid.
• The other components are monohydrate lactose, spray-dried monohydrate lactose, maize starch, crospovidone (E1202), hydroxypropylcellulose (E463), sodium croscarmellose (E468), magnesium stearate (E470b), hypromellose 2910 5 cP (E464), macrogol 400 and titanium dioxide (E171).

Description of the appearance of Linezolid Teva and contents of the pack

• Modified capsule-shaped, film-coated tablet, white, with the number “600” engraved on one side. The other side has a score line.
• Available in blister packs containing 10, 10x1, 20, 20x1, 28, 30, 60, 90 and 100 film-coated tablets, and hospital pack of 50x1 film-coated tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder
Teva Italia S.r.l.
Piazzale Luigi Cadorna, 4
20123 Milan, Italy

Manufacturer
TEVA Pharmaceutical Works Private Limited Company, Pallagi út 13, 4042 Debrecen, Hungary
Teva Operations Poland Sp. z o.o., ul. Mogilska 80, 31-546 Krakow, Poland
Merckle GmbH, Graf-Arco-Str. 3, 89079 Ulm, Germany
PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.), Prilaz baruna Filipovica 25, 10000 Zagreb, Croatia
TEVA UK Ltd, Brampton Road, Hampden Park, Eastbourne, East Sussex BN22 9AG, United Kingdom
Teva Pharma B.V., Swensweg 5, 2031 GA Haarlem, The Netherlands
Merckle GmbH, Ludwig-Merckle-Straße 3, 89143 Blaubeuren, Germany