Linezolid Teva Pharma 600 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Linezolid Teva Pharma 600mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as 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 pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What Linezolid Teva Pharma 600 mg is and what it is used for
2. What you need to know before taking Linezolid Teva Pharma 600 mg
3. How to take Linezolid Teva Pharma 600 mg
4. Possible side effects
5. How to store Linezolid Teva Pharma 600 mg
6. Contents of the pack and other information

1. What Linezolid Teva Pharma 600 mg is and what it is used for

Linezolid is an antibiotic belonging to the oxazolidinone group. It works by inhibiting the growth of certain types of bacteria (germs) that cause infections.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as flu or the common cold.

It is important that you follow your doctor's instructions regarding dose, dosing interval, and duration of treatment.

Do not store or reuse this medicine. If you have any antibiotic left over after completing your treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines via wastewater or household waste.

It is used to treat pneumonia and certain skin or soft tissue infections. Your doctor will decide whether linezolid is appropriate for treating your infection.

2. What you need to know before taking Linezolid Teva Pharma 600 mg

Do not take Linezolid Teva Pharma:

• 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, isocarboxazide, selegiline, moclobemide). You may have been prescribed these medicines to treat depression or Parkinson's disease.
• if you are breastfeeding. This is because linezolid passes into breast milk and may affect the infant.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to use linezolid.

Linezolid Teva Pharma may not be suitable for you if you answer yes to any of the following questions. In such cases, inform your doctor, who will need to assess your general health and blood pressure before and during treatment, and will decide whether there is a better treatment option 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 it?
• Have you been diagnosed with overactive thyroid (hyperthyroidism)?
• 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, wheezing)?
• Do you suffer from manic depression, schizoaffective disorders, confusion, or other mental health problems?
• Do you have a history of hyponatraemia (low sodium levels in the blood), or are you taking medicines that reduce sodium levels in the blood, such as certain diuretics like hydrochlorothiazide?
• Are you taking opioids?

Using certain medicines, including antidepressants and opioids, together with linezolid may cause serotonin syndrome, a potentially life-threatening condition (see section 2 “Other medicines and linezolid” and section 4).

Take special care with Linezolid Teva Pharma

Inform your doctor or pharmacist before starting to take this medicine if:

• you are elderly.
• you bruise easily or bleed excessively,
• you have anaemia (low red blood cell count),
• you are prone to infections,
• you have a history of epileptic 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:

• visual problems such as blurred vision, changes in colour vision, difficulty seeing fine details, or narrowing of your field of vision,
• loss of sensation in your arms or legs, or tingling or itching sensations in your arms or legs,
• diarrhoea. Diarrhoea may occur if you are taking or have taken antibiotics, including Linezolid Teva Pharma. If it becomes severe or persistent, or if you notice blood or mucus in your stools, you must stop taking Linezolid Teva Pharma immediately and consult your doctor. In such a situation, you should not take medicines that inhibit or slow down intestinal motility,
• nausea or repeated vomiting, abdominal pain, or rapid breathing.
• unexplained muscle pain, tenderness or weakness, and/or dark urine. These may be signs of a serious condition called rhabdomyolysis (muscle breakdown), which can lead to kidney damage.
• malaise and dizziness with muscle weakness, headache, confusion, and memory impairment, which may indicate hyponatraemia (low sodium levels in blood).

Other medicines and Linezolid Teva Pharma

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

There is a risk that Linezolid Teva Pharma may sometimes interact with other medicines, causing adverse reactions such as changes in blood pressure, body temperature, or heart rate.

Tell your doctor if you are taking or have taken within the last 2 weeks the following medicines, as Linezolid Teva Pharma must not be taken if you are already taking these medicines or have taken them recently (see also section 2 above, "Do not take Linezolid Teva Pharma 600 mg"):

• monoamine oxidase inhibitors (MAOIs, for example, phenelzine, isocarboxazide, selegiline, moclobemide). You may have been prescribed these medicines to treat depression or Parkinson's disease.

Also inform your doctor if you are taking the following medicines. Your doctor may still decide to prescribe Linezolid Teva Pharma, but will need to assess your general health and blood pressure before and during treatment. In other cases, your doctor may decide to prescribe a different treatment that is more suitable for you.

• Decongestants for cold or flu containing pseudoephedrine or phenylpropanolamine
• certain asthma medications such as salbutamol, terbutaline, fenoterol
• certain antidepressants such 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
• migraine treatments such as sumatriptan and zolmitriptan
• medicines used to treat sudden, severe allergic reactions, such as adrenaline (epinephrine)
• medicines that increase blood pressure such as noradrenaline (norepinephrine), dopamine, and dobutamine
• opioids (e.g., meperidine) used to treat severe pain
• medicines for anxiety disorders, such as buspirone
• medicines that prevent blood clotting, such as warfarin
• an antibiotic called rifampicin

Taking Linezolid Teva Pharma with food, drinks, and alcohol

• You may take Linezolid Teva Pharma 600 mg before, during, or after meals.
• Avoid eating large amounts of aged cheese, yeast extracts, or soya extracts such as soya sauce, and avoid alcoholic beverages, especially draught beer and wine. This is because this medicine may react with a substance called tyramine present in some foods. This interaction may cause a rise in your blood pressure.
• If you develop a throbbing headache after eating or drinking, inform your doctor or pharmacist immediately.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

The effects of Linezolid Teva Pharma in pregnant women are not known. Therefore, it should not be taken during pregnancy unless advised by your doctor.

You should not breastfeed while taking Linezolid Teva Pharma, as it passes into breast milk and may affect the infant.

Driving and using machines

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

Linezolid Teva Pharma contains lactose

Each film-coated tablet contains 195.50 mg of lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult him or her before taking this medicine.

Linezolid Teva Pharma contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per film-coated tablet; this is essentially “sodium-free”.

3. How to take Linezolid Teva Pharma 600 mg

Adults

Follow exactly the instructions for use of this medicine or those indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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.

The tablet has a score mark. The score mark is only intended to facilitate breaking the tablet if you have difficulty swallowing it whole.

If you are undergoing dialysis, you must take linezolid after your dialysis treatment.

The usual duration of treatment is 10–14 days, but it may be extended up to 28 days. The safety and efficacy of this medicine have not been established for treatment periods exceeding 28 days. Your doctor will decide the duration of treatment.

During treatment with linezolid, your doctor should perform periodic blood tests to monitor your blood count. Your doctor should monitor your vision if you are taking linezolid for more than 28 days.

Use in children and adolescents

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

If you take more Linezolid Teva Pharma than you should

Inform your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Linezolid Teva Pharma

Take the missed tablet as soon as you remember. Then take the next tablet 12 hours after that, and continue taking your film-coated tablets every 12 hours.

Do not take a double dose to make up for the forgotten dose.

If you stop taking Linezolid Teva Pharma

Unless your doctor tells you otherwise, it is important to continue taking linezolid. If you stop treatment and the original symptoms return, inform your doctor or pharmacist immediately.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Tell your doctor, pharmacist, or nurse immediately if you experience any of these adverse effects during treatment with Linezolid Teva Pharma 600 mg.

The serious adverse effects (with frequency in parentheses) of Linezolid Teva Pharma 600 mg are:

• Severe skin disorder (uncommon), swelling, particularly around the face and neck (uncommon), wheezing and/or difficulty breathing (rare). These may be signs of an allergic reaction and treatment with Linezolid Teva Pharma may need to be stopped. Skin reactions such as raised purplish rash due to inflammation of blood vessels (rare), red, painful and peeling skin (dermatitis) (uncommon), rash (common), itching (common).
• visual problems such as blurred vision (uncommon), changes in colour vision (frequency not known), difficulty seeing details (frequency not known), or narrowing of the visual field (rare);
• severe diarrhoea, with blood or mucus in the stool (antibiotic-associated colitis including pseudomembranous colitis), which in rare cases may lead to potentially life-threatening complications (uncommon);
• repeated nausea or vomiting, abdominal pain or rapid breathing (rare);
• epileptic seizures (uncommon) or convulsions have been reported with Linezolid Teva Pharma.
• serotonin syndrome (frequency not known): Inform your doctor if you experience restlessness, confusion, delirium, rigidity, tremors, lack of coordination, epileptic seizures, rapid heartbeat, severe breathing problems, and diarrhoea (suggestive of serotonin syndrome) while taking SSRIs or opioids concomitantly (see section 2).
• unexplained bleeding or bruising, which may be due to changes in certain blood cells that can affect blood clotting or cause anaemia (common)
• changes in counts of certain blood cells that may affect your ability to fight infections (uncommon); some signs of infection include: any fever (common), sore throat (uncommon), mouth ulcers (uncommon), and fatigue (uncommon).
• rhabdomyolysis (rare): symptoms include unexplained muscle pain, tenderness or weakness and/or dark urine (rare). These may be signs of a serious condition called rhabdomyolysis (muscle breakdown), which can lead to kidney damage.
• inflammation of the pancreas (uncommon).
• convulsions (uncommon).
• transient ischaemic attacks (temporary disruption of blood flow to the brain causing short-term symptoms such as loss of vision, weakness in arms and legs, slurred speech, and loss of consciousness) (uncommon).
• Ringing in the ears (tinnitus) (uncommon)

Numbness, tingling, or blurred vision have been reported in patients treated with Linezolid Teva Pharma for more than 28 days. If you experience vision problems, consult your doctor as soon as possible.

Other adverse effects include:

Common

• Fungal infections, especially vaginal candidiasis or oral thrush
• Headache
• Metallic taste in the mouth
• Diarrhoea, nausea, or vomiting
• Changes in certain blood test results, including tests for proteins, salts, or enzymes measuring liver, kidney function, or blood sugar levels
• Difficulty sleeping
• Increased blood pressure
• Anaemia (low red blood cell count)
• Dizziness
• Localised or general abdominal pain
• Constipation
• Indigestion
• Localised pain
• Decrease in platelet count

Uncommon

• Inflammation of the vagina or genital area in women
• Tingling or numbness sensations
• Swollen, painful, or discoloured tongue
• Dry mouth
• Frequent need to urinate
• Chills
• Feeling thirsty
• Increased sweating
• Hypokalaemia (low potassium levels in blood)
• Hypoglycaemia (low blood sugar levels)
• Kidney failure
• Abdominal distension
• Increased creatinine
• Stomach pain
• Changes in heart rate (e.g., increased rate)
• Decrease in blood cell counts
• Weakness and/or sensory changes

Rare

• Change in surface colouration of teeth, which may be removed by professional dental cleaning (manual removal of dental calculus)
• Change in tongue surface colour to black, with a hairy appearance

The following adverse effects have also been reported (frequency not known)

• Alopecia (hair loss)

Reporting of adverse effects:

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Linezolid Teva Pharma 600 mg

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the blister and carton after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE point located at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Linezolid Teva Pharma

The active substance is linezolid. Each film-coated tablet contains 600 mg of linezolid.

The other components (excipients) are monohydrate lactose, spray-dried lactose, corn starch, crospovidone (E1202), hydroxypropylcellulose (E463), sodium croscarmellose (E468), magnesium stearate (E470b), hypromellose 2910 5cP (E464), macrogol 400, and titanium dioxide (E171).

Appearance of the product and contents of the pack

Film-coated tablet, capsule-shaped, white, with the inscription "600" on one side of the tablet. The other side is scored.

Available in blister packs of 10, 10x1, 20, 20x1, 28, 30, 60, 90 and 100 film-coated tablets, and hospital pack of 50x1 film-coated tablets. Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Teva Pharma S.L.U.
C/ Anabel Segura, nº 11 Edificio Albatros B, 1st floor
28108 Alcobendas – Madrid
Spain

Manufacturer:

TEVA Pharmaceutical Works Private Limited Company
Pallagi út 13, 4042 Debrecen
Hungary

or

TEVA UK Ltd.
Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG
England

or

Teva Operations Poland Sp. z.o.o
ul. Mogilska 80, 31-546 Krakow
Poland

or

Merckle GmbH
Ludwig-Merckle-Straße 3, 89143 Blaubeuren
Germany

or

Merckle GmbH
Graf-Arco-Str. 3, 89079 Ulm
Germany

or

PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)
Prilaz baruna Filipovica 25, 10000 Zagreb
Croatia

This medicinal product is authorized in the European Economic Area (EEA) member states under the following names:

Germany: Linezolid-ratiopharm 600 mg Filmtabletten
Austria: Linezolid ratiopharm 600 mg Filmtabletten
Bulgaria: Linezolid Teva 600mg filmomhulde tabletten/comprimés pelliculés/Filmtabletten
Denmark: Linezolid “Teva”
Spain: Linezolid Teva Pharma 600 mg film-coated tablets EFG
France: Linézolide Teva 600 mg, comprimé pelliculé
Hungary: Linezolid Pliva 600 mg filmom obložene tablete
Ireland: Linezolid Teva 600 mg Film-coated Tablets
Italy: LINEZOLID TEVA
Luxembourg: Linezolid Teva 600 mg comprimés pelliculés
Malta: Linezolid Teva 600 mg Film-coated Tablets
Netherlands: Linezolid Teva 600mg, filmomhulde tabletten
Portugal: Linezolida Teva
Sweden: Linezolid Teva
United Kingdom: Linezolid 600 mg Film-coated Tablets

Date of the most recent review of this leaflet: April 2026

“Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.es/”