Prescribing Information for the Patient

Sivextro 200Film-Coated Tablets

Tedizolid Phosphate

Read this entire prescribing information carefully before starting to take this medication, as it contains important information for you.

• Keep this prescribing information, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, and you should not give it to others who may 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 prescribing information. See section4.

Sivextro is an antibiotic that contains the active ingredient tedizolid phosphate. It belongs to a group of medications called "oxazolidinones".

It is used for the treatment of skin and soft tissue infections in adults and adolescents 12 years of age and older.

It works by inhibiting the proliferation of certain bacteria that can cause severe infections.

Do not take Sivextro:

• if you are allergic to tedizolid phosphate or any of the other components of this medication (listed in section6).

Warnings and precautions

Your doctor will decide if Sivextro is suitable for treating your infection.

Consult your doctor or nurse before starting Sivextro if you have any of the following conditions:

• if you have diarrhea or have had diarrhea after taking antibiotics (or up to 2months after taking them) in the past.
• if you are allergic to other medications belonging to the "oxazolidinones" group (such as linezolid, cycloserine).
• if you have a history of bleeding or easy bruising (which may be a sign of low platelet count, the small cells involved in blood clotting).
• if you have kidney problems.
• if you are taking certain medications for depression, known as tricyclics, SSRIs (selective serotonin reuptake inhibitors), opioidsor MAOIs (monoamine oxidase inhibitors).The use of these medications with tedizolid phosphate may lead to a potentially fatal serotonin syndrome (with symptoms such as disorientation, difficulty concentrating, high temperature, increased reflexes, difficulty coordinating muscle movements).See Other Medications and Sivextro for examples.
• if you are taking certain medications for migraine, known as "triptans". See Other Medications and Sivextro for examples.

Consult your doctor or pharmacist if you are unsure if you are taking any of these medications.

Dysentery

Consult your doctor immediately if you experience diarrhea during or after treatment. Do not take any medication to treat diarrhea without consulting your doctor first.

Antibiotic resistance

Bacteria can become resistant to antibiotic treatment over time. This is when antibiotics cannot stop the proliferation of bacteria or treat the infection. Your doctor will decide if you should be given Sivextro to treat your infection.

Possible side effects

Some side effects have been observed with Sivextro or other members of the oxazolidinones class when administered for a period exceeding the recommended duration for Sivextro. Inform your doctor immediately if you experience any of the following side effects while taking Sivextro:

• low white blood cell count
• anemia (low red blood cell count)
• bleeding or easy bruising
• numbness or tingling in hands or feet (e.g. numbness, pins and needles, or stabbing pain)
• any vision problems, such as blurred vision, changes in color perception, difficulty seeing details, or restricted visual field.

Children

This medication should not be used in children under 12years, as it has not been sufficiently studied in this population.

Other medications and Sivextro

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. It is especially important to inform your doctor if you are also taking:

• amitriptyline, citalopram, clomipramine, dosulepin, doxepin, fluoxetine, fluvoxamine, imipramine, isocarboxazid, lofepramine, moclobemide, paroxetine, phenelzine, selegiline, sertraline, duloxetine, and venlafaxine(used to treat depression).There is a risk that tedizolid phosphate may interact with certain medications, including those listed, and cause side effects such as changes in blood pressure or temperature.
• sumatriptan, zolmitriptan (used to treat migraine)
• opioids (such as fentanyl)
• imatinib, lapatinib (used to treat cancer)
• methotrexate (used to treat cancer, rheumatoid arthritis, or psoriasis)
• sulfasalazine (used to treat inflammatory bowel diseases)
• topotecan (used to treat cancer)
• statins such as pitavastatin, rosuvastatin (used to lower cholesterol in the blood)

Sivextro may interfere with the effects of these medications. Your doctor will explain more details.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

The safety of Sivextro during pregnancy and breastfeeding has not been established. Consult your doctor before breastfeeding your baby.

Driving and operating machinery

Do not drive or operate machinery if you feel dizzy or tired after taking this medication.

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

The recommended dose is one 200 mg tablet once a day for 6 days. The tablets are taken whole, and they can be taken with or without food or beverages.

Consult a doctor if you do not improve, or if you worsen after 6 days.

If you take more Sivextro than you should

Contact your doctor, pharmacist, or the nearest hospital emergency department as soon as possible if you have taken more tablets than you should, and bring the medication with you.

If you forgot to take Sivextro

If you forgot to take the medication, take the dose as soon as possible at any time up to 8 hours before the next scheduled dose. If less than 8 hours remain until the next dose, wait until the next scheduled dose. Do not take a double dose to make up for the missed dose. If you have any doubts, consult your pharmacist.

You must take the 6 tablets to complete the treatment, even if you have missed a dose.

If you interrupt treatment with Sivextro

If you stop taking Sivextro without your doctor's indication, your symptoms may worsen. Consult your doctor or pharmacist before stopping the medication.

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

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

Consult your doctor immediatelyif you experience diarrhea during or after treatment.

Other side effects may include:

Frequent side effects (may affect up to 1 in 10people):

• Nausea
• Vomiting
• Headache
• Itching all over the body
• Fatigue
• Dizziness

Rare side effects (may affect up to 1 in 100people):

• Fungal infections (fungus) on the skin, mouth, and vagina (muguet / vaginal candidiasis)
• Itching (including itching caused by allergic reaction), hair loss, acne, rash with redness and/or itching or hives, excessive sweating
• Decreased or loss of skin sensitivity, sensation of tingling/pinching in the skin
• Heat waves or redness/rubor on the face, neck, or upper chest
• Abscess (inflamed lump, with pus)
• Infection, inflammation, or vaginal pruritus
• Anxiety, irritability, agitation, or tremors
• Respiratory tract infection (frontal sinuses, throat, and chest)
• Nasal dryness, chest congestion, cough
• Drowsiness, abnormal sleep pattern, difficulty sleeping, nightmares (unpleasant/disturbing dreams)
• Dry mouth, constipation, indigestion, stomach pain (abdomen), hiccups, dry gasps, bright red blood in stool
• Acid reflux disorder (heartburn, pain, or difficulty swallowing), flatulence/gases
• Joint pain, muscle spasms, back pain, neck pain, pain/malaise in limbs, decreased hand grip strength
• Blurred vision, "floaters" (small floating shapes in the visual field)
• Lymph node inflammation or enlargement
• Allergic reaction
• Dehydration
• Impaired glucose control
• Abnormal taste
• Slow heart rate
• Fever
• Swelling of ankles and/or feet
• Urine with abnormal odor, abnormalities in blood tests

Unknown frequency (cannot be estimated from available data):

• Bleeding or appearance of petechiae with ease (due to low platelet count, small cells involved in blood clotting)

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 prospectus.You can also report them directly through the national notification system included in theAppendix V.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 box or blister after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need.By doing so, you will help protect the environment.

Composition of Sivextro

• The active ingredient is tedizolid phosphate. Each film-coated tablet contains 200 mg of tedizolid phosphate.
• The other components are microcrystalline cellulose, mannitol, povidone, crospovidone, and magnesium stearate in the tablet core. The film coating of the tablet contains polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, and iron oxide yellow (E172).

Appearance of the product and contents of the pack

Sivextro is an oval-shaped, yellow, film-coated tablet with the imprint 'TZD' on one side and '200' on the other.

It is available in blisters of 6 x 1 perforated tablets with unit doses.

Marketing authorization holder and responsible manufacturer

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN Haarlem

Netherlands

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Last date of revision of this leaflet: {MM/AAAA}.

The detailed information about this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu.