LINEZOLID TEVA PHARMA 600 mg FILM-COATED TABLETS

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

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, e.g., 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, who will need to examine your overall health and blood pressure before and during treatment and decide if there is a better treatment 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 to treat it?
• Have you been diagnosed with hyperthyroidism?
• Do you have a tumor of the adrenal glands (pheochromocytoma) or carcinoid syndrome (caused by tumors of the hormonal system with symptoms of diarrhea, skin flushing, wheezing)?
• Do you suffer from manic depression, schizoaffective disorders, mental confusion, or other mental problems?
• Do you have a history of hyponatremia (low sodium levels in the blood) or take medicines that reduce sodium levels in the blood, such as certain diuretics, e.g., hydrochlorothiazide?
• Do you take opioids?

The use of certain medicines, including antidepressants and opioids, along with linezolid, may cause adverse reactions, 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, as Linezolid Teva Pharma must notbe 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, e.g., phenelzine, isocarboxazid, 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 needs to examine your overall 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.

• Decongestant remedies for colds or flu that contain pseudoephedrine or phenylpropanolamine
• certain medicines for treating asthma, such as salbutamol, terbutaline, fenoterol
• certain 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 for treating 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 (e.g., pethidine) used to treat severe pain
• medicines for treating 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 can take Linezolid Teva Pharma 600 mg before, during, or after meals.
• Avoid taking large amounts of mature cheese, yeast extracts, or soy extracts such as soy sauce and alcoholic beverages, especially draft beer and wine. The reason is that this medicine may react with a substance called tyramine that is present in some foods. This interaction can 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, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

The effects of Linezolid Teva Pharma in pregnant women are not known. Therefore, it must not be taken during pregnancy, unless your doctor advises you to do so.

You must not breastfeed if you are taking Linezolid Teva Pharma, as it passes into breast milk and may affect the baby.

Driving and using machines

Linezolid Teva Pharma may cause dizziness or vision problems. If this happens, do not drive or use machines. Remember that if you feel unwell, your ability to drive or use 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 an intolerance to some sugars, consult 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; this is essentially "sodium-free".

3. How to take Linezolid Teva Pharma 600 mg

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

Adults

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.

The tablet has a score line. The score line is only to help you break the tablet if you have difficulty swallowing it whole.

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

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

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

Use in children and adolescents

Linezolid Teva Pharma 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

Tell your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicological Information Service, phone: 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. Take the next tablet 12 hours after this one and continue taking your tablets every 12 hours.

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

If you stop taking Linezolid Teva Pharma

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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: frequency cannot be estimated from the available data.

Tell 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 (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). This may be a sign of an allergic reaction and treatment with Linezolid Teva Pharma may need to be stopped. Skin reactions such as a purple raised rash due to inflammation of the blood vessels (rare), red and painful skin and peeling (dermatitis) (uncommon), rash (common), itching (common).
• vision problems such as blurred vision (uncommon), changes in color vision (not known), difficulty seeing details (not known), or narrowing of the field of vision (rare);
• severe diarrhea, with bloody or mucous stools (antibiotic-associated colitis, including pseudomembranous colitis), which in rare circumstances can lead to potentially life-threatening 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): You should tell your doctor if you experience restlessness, confusion, delirium, rigidity, tremors, uncoordinated movements, seizures, rapid heartbeat, serious breathing problems, and diarrhea (suggestive of serotonin syndrome) while taking antidepressants such as SSRIs or opioids at the same time (see section 2).
• unexplained bleeding or bruising, which may be due to changes in certain blood cells that can affect blood clotting or cause anemia (common)
• changes in blood cell counts that can 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).
• seizures (uncommon).
• transient ischemic attacks (temporary alteration of blood flow to the brain causing short-term symptoms such as loss of vision, weakness in legs and arms, slurred speech, and loss of consciousness) (uncommon).
• Tinnitus (ringing in the ears) (uncommon)

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

Other side effects include:

Common

• Fungal infections, especially vaginal or oral candidiasis
• Headache
• Metallic taste in the mouth
• Diarrhea, nausea, or vomiting
• Changes in some blood test results, including protein, salt, or enzyme tests that measure liver, kidney, or blood sugar function
• Difficulty sleeping
• Increased blood pressure
• Anemia (low red blood cell count)
• Dizziness
• Abdominal pain, localized or generalized
• Constipation
• Indigestion
• Localized pain
• Decreased platelet count

Uncommon

• Vaginal or genital inflammation in women
• Tingling or numbness sensations
• Swollen, painful, or discolored tongue
• Dry mouth
• Frequent need to urinate.
• Chills
• Feeling of thirst
• Increased sweating
• Hypokalemia (low potassium levels in the blood)
• Kidney failure
• Abdominal distension
• Increased creatinine
• Stomach pain
• Changes in heart rate (e.g., increased heart rate)
• Decreased blood cell count
• Weakness and/or sensory changes

Rare

• Change in tooth surface color, which can be removed with a professional dental cleaning (manual removal of dental tartar)

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

• Alopecia (hair loss)

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side 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 which is stated on the blister and carton after EXP. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Container Content and Additional Information

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, spray-dried lactose monohydrate, cornstarch, 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 Container Content

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

It is presented in blister packs of 10, 10x1, 20, 20x1, 28, 30, 60, 90, and 100 film-coated tablets, and a hospital pack of 50x1 film-coated tablets. Not all 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, 1ª planta

28108 Alcobendas – Madrid

Spain

Manufacturer:

TEVA Pharmaceutical Works Private Limited CompanyPallagi ùt 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 GmbHLudwig-Merckle-Straße 3, 89143Blaubeuren

Germany

or

Merckle GmbHGraf-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 medicinal product is authorized in the Member Statesof the European Economic Areaunder the following names:

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

Bulgaria: Linezolid Teva 600mg filmomhulde tabletten/comprimés pelliculés/Filmtabletten

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 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 revision of this leaflet: October 2023

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