Prospect: information for the user

Linezolid Teva Pharma 600mg film-coated tablets EFG

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

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

It is used to treat pneumonia and some skin or subcutaneous infections. Your doctor will decide if linezolid is suitable for treating your infection.

Do not take Linezolid Teva Pharma:

• 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 belonging to the class of monoamine oxidase inhibitors (MAOIs, for example, phenelzine, isocarboxazid, selegiline, moclobemide). You may have been prescribed these medicines to treat depression or Parkinson's disease.
• if you are breastfeeding. The reason is that linezolid passes into breast milk and may affect the baby.

Warnings and precautions

Consult 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 this case, inform your doctor that you will need a general health check and blood pressure check before and during treatment and they will decide if there is a better treatment for you.
Ask your doctor if you are unsure if these categories apply to you.

• Do you have high blood pressure, whether or not you are taking medicines to treat it?
• Have you been diagnosed with hyperthyroidism?
• Do you have a tumor of the adrenal glands (pheochromocytoma) or carcinoid syndrome (caused by hormone-producing tumors with symptoms of diarrhea, flushing of the skin, wheezing)?
• Do you suffer from manic depression, schizoaffective disorders, confusion or other mental problems?
• Have you had low sodium levels in your blood (hyponatremia) or are you taking medicines that reduce sodium levels in the blood, such as certain diuretics like hydrochlorothiazide?
• Are you taking opioids?

The use of 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).

Be particularly careful with Linezolid Teva Pharma

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

• you are an elderly patient.
• you have bruises and bleed easily,
• you have anemia (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 diarrhea.

Inform your doctorimmediatelyif during treatment you experience:

• visual problems such as blurred vision, changes in color vision, difficulty seeing in detail or narrowing of your field of vision,
• loss of sensation in your arms or legs or a feeling of tingling or itching in your arms or legs,
• diarrhea if you are taking or have taken antibiotics, including Linezolid Teva Pharma. If this becomes severe or persistent or you notice that your stools contain blood or mucus,stop taking Linezolid Teva Pharma immediately and consult your doctor. In this situation, do not take medicines that slow down or inhibit intestinal movements,
• repeated nausea or vomiting, abdominal pain or rapid breathing.
• feeling unwell and dizzy with muscle weakness, headache, confusion and memory deterioration that may indicate hyponatremia (low sodium levels in the blood).

Other medicines and Linezolid Teva Pharma

Inform your doctor or pharmacist if you are taking/using, have taken/used recently or may need to take/use any other medicine.

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

Inform your doctor if you are taking or have taken in the last 2 weeksthe following medicines, as Linezolid Teva Pharmashould notbe taken if you are already taking these medicines or have taken them recently (see also in section 2 above, “Do not take Linezolid Teva Pharma 600 mg ”):

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

Inform your doctor also if you are taking the following medicines. Your doctor will still be able to decide if they prescribe Linezolid Teva Pharma for you, but they will need to examine your general health and blood pressure before and during treatment. In other cases, your doctor may decide to prescribe a different treatment that is better for you.

• over-the-counter cold and flu remedies containing pseudoephedrine or phenylpropanolamine
• some medicines for asthma, such as salbutamol, terbutaline, fenoterol
• specific antidepressants such as tricyclics or SSRIs (selective serotonin reuptake inhibitors). There are many of these, such as amitriptyline, citalopram, clomipramine, dosulepin, doxepin, fluoxetine, fluvoxamine, imipramine, lofepramine, paroxetine, sertraline
• medicines used to treat migraines, such as sumatriptan and zolmitriptan
• medicines used to treat severe allergic reactions, such as adrenaline (epinephrine)
• medicines that increase blood pressure, such as noradrenaline (norepinephrine), dopamine and dobutamine
• opioids (for example, pethidine) used to treat severe pain
• medicines used to treat anxiety disorders, such as buspirone
• medicines that prevent blood clotting, such as warfarin.
• a type of antibiotic called rifampicin.

Taking Linezolid Teva Pharma with food, drink and alcohol

• You can take Linezolid Teva Pharma 600 mg before, during or after meals.
• Avoid taking large amounts of strong cheese, yeast extracts or soy extracts such as soy sauce and alcoholic beverages, especially draught beer and wine. The reason is that this medicine may react with a substance called tyramine that is present in some foods. This interaction may cause an increase 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, or think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Linezolid Teva Pharma has not been shown to have any effects on pregnant women. Therefore, it should not be taken during pregnancy, unless your doctor advises you to.

Do not breastfeed while taking Linezolid Teva Pharma as it passes into breast milk and may affect the baby.

Driving and operating machines

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

Linezolid Teva Pharma contains lactose

Each film-coated tablet contains 195.50 mg of lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medicine.

Linezolid Teva Pharma contains sodium

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

Follow exactly the administration instructions for this medication or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Adults

The recommended dose is one film-coated tablet (600 mg of Linezolid) twice a day (every 12 hours). Swallow the tablet whole with a little water.

The tablet has a groove. The groove is only for breaking the tablet in half if you have difficulty swallowing it whole.

If you are on dialysis, take Linezolid Teva Pharma after your treatment.

A typical treatment period usually lasts 10 to 14 days, but may reach 28 days. The safety and efficacy of this medication have not been established for periods longer than 28 days. Your doctor will decide the duration of treatment.

Your doctor should perform blood tests periodically during treatment with Linezolid Teva Pharma to monitor your blood count.
Your doctor should check your vision if you take Linezolid Teva Pharma for more than 28 days.

Use in children and adolescents

Linezolid Teva Pharma is not usually used for the treatment of children and adolescents (under 18 years old).

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, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Linezolid Teva Pharma

Take the missed tablet as soon as you remember. Take the next tablet 12 hours after this one and continue taking your film-coated tablets every 12 hours.

Do not take a double dose to make up for the missed dose

If you interrupt treatment with Linezolid Teva Pharma

Unless your doctor tells you to stop treatment, it is essential to continue taking Linezolid Teva Pharma. If you stop treatment and your original symptoms return, inform your doctor or pharmacist immediately.

If you have any other questions about using this medication, ask your doctor or pharmacist.

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

Very common: may affect more than 1 in 10 people

Common: may affect up to 1 in 10 people

Uncommon: may affect up to 1 in 100 people

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

Very rare: may affect up to 1 in 10,000 people

Frequency not known: the frequency cannot be estimated from the available data.

Inform your doctor, pharmacist or nurse immediatelyif you experience any of these side effects during treatment with Linezolid Teva Pharma 600 mg.

The serious side effects (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). This may be a sign of an allergic reaction and treatment with Linezolid Teva Pharma may need to be discontinued. Skin reactions such as purple elevated rash due to inflammation of blood vessels (rare), red and painful skin and peeling (dermatitis) (uncommon), rash (common), itching (common).
• Visual problems such as blurred vision (uncommon), changes in color vision (not known), difficulty seeing details (not known) or narrowing of the visual field (rare);
• Intense diarrhea, with stools containing blood or mucus (antibiotic-associated colitis including pseudomembranous colitis), which in rare cases may lead to potentially fatal complications (uncommon);
• Repeated nausea or vomiting, abdominal pain or rapid breathing (rare);
• Seizures (uncommon) or convulsions have been reported with Linezolid Teva Pharma.
• Serotonin syndrome (not known): Inform your doctor if you experience restlessness, confusion, delirium, rigidity, tremors, discoordination, seizures, rapid heart rate, severe respiratory problems and diarrhea (suggestive of serotonin syndrome) while taking Linezolid Teva Pharma simultaneously with antidepressants such as SSRIs or opioids (see section 2).
• Unexplained bleeding or bruising, which may be due to changes in certain blood cells that can affect blood clotting or produce anemia (common)
• Changes in certain blood cell counts 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).
• Pancreatitis (uncommon).
• Convulsions (uncommon).
• Transient ischemic attacks (temporary disruption of blood flow to the brain causing symptoms such as loss of vision, weakness in legs and arms, slurred speech and loss of consciousness) (uncommon).
• Tinnitus (ringing in the ears) (uncommon)

Linezolid Teva Pharma has been reported to cause numbness, tingling or blurred vision in patients treated for more than 28 days. If you experience vision difficulties, consult your doctor as soon as possible.

Other side effects include:

Common

• Infections caused by fungi, especially vaginal or oral candidiasis
• Headache
• Metalllic taste in the mouth
• Diarrhea, nausea or vomiting
• Changes in some blood test results, including those measuring liver, kidney or blood sugar function
• Difficulty falling asleep
• Increased blood pressure
• Anemia (low red blood cell count)
• Dizziness
• Abdominal pain localized or general
• Constipation
• Indigestion
• Pain localized
• Decreased platelet count

Uncommon

• Vaginal or genital inflammation in women
• Numbness or tingling sensations
• Swollen, painful or discolored tongue
• Dry mouth
• Very frequent urination.
• Chills
• Thirst
• Increased sweating
• Hyponatremia (low sodium levels in the blood)
• Renal failure
• Abdominal distension
• Increased creatinine
• Abdominal pain
• Changes in heart rate (e.g. increased frequency)
• Decreased blood cell count
• Weakness and/or sensory changes

Rare

• Change in the surface color of the teeth, which may be removed with a professional dental cleaning (manual removal of dental plaque)

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

• Alopecia (hair loss)

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the blister pack and on the carton box after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Linezolid Teva Pharma

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

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

Appearance of the product and contents of the package

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

It is presented in blister packs of 10, 10x1, 20, 20x1, 28, 30, 60, 90, and 100 film-coated tablets, and the hospital pack of 50x1 film-coated tablets. Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Teva Pharma S.L.U.
C/ Anabel Segura, nº 11 Edificio Albatros B, 1ª planta

28108 Alcobendas – Madrid

Spain

Responsible for manufacturing:

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

Teva Pharma B.V.

Swensweg 5, 2031 GA Haarlem

Netherlands

or

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

Croatia

This medicine is authorized in the member states of the European Economic Area with the following names: European Economic Area with the following names:

Germany: Linezolid-ratiopharm 600 mg Filmtabletten
Austria: Linezolid ratiopharm 600 mg Filmtabletten

Bulgaria: Linezolid Teva 600mg filmomhulde tabletten/comprimés pelliculés/Fil mtabletten

Denmark: Linezolid “Teva”

Spain: Linezolid Teva Pharma 600 mg comprimidos recubiertos con película EFG

France: Linézolide Teva 600 mg, comprimé pelliculé

Hungary: Linezolid Pliva 600 mg filmom obložene tablete

Ireland: Linezolid Teva 600 0 mg Film-coated Tablets

Italy: LINEZOLID TEVA

Luxembourg: Linezolid Teva 600 mg comprimés pelliculés

Malta: Linezolid Teva 600 mg Filmcoated Tablets

Netherlands: Linezolid Teva 600mg, filmomhulde tabletten

Portugal: Linezolida Teva

Sweden: Linezolid Teva

United Kingdom: Linezolid 600 mg Film-coated Tablets

Date of the last review of this leaflet: October 2023

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