SIVEXTRO 200 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Sivextro 200mg film-coated tablets

tedizolid phosphate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

if they have the same symptoms as you.

• If you experience any side effects, talk to your doctor or pharmacist, even if it is not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Sivextro and what is it used for
2. What you need to know before you take Sivextro
3. How to take Sivextro
4. Possible side effects
5. Storage of Sivextro
6. Contents of the pack and further information

1. What is Sivextro and what is it used for

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

Sivextro is a tablet for adults, adolescents, and children weighing at least 35 kg for the treatment of skin and soft tissue infections.

Sivextro works by stopping the growth of certain bacteria that can cause serious infections.

2. What you need to know before you take Sivextro

Do not take Sivextro:

• if you are allergic to tedizolid phosphate or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

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

Tell your doctor or nurse before you start taking Sivextro if any of the following apply to you:

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

Tell your doctor or pharmacist if you are not sure if you are taking any of these medicines.

Diarrhea

Tell your doctor immediately if you get diarrhea during or after your treatment. Do not take any medicine to treat diarrhea without first checking with your doctor.

Resistance to antibiotics

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

Possible side effects

Some side effects have been seen with Sivextro or another member of the class of oxazolidinones when given for a period longer than recommended for Sivextro. Tell your doctor immediately if you get any of the following side effects while taking Sivextro:

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

Children

Sivextro 200 mg tablets are indicated for adolescents and children weighing at least 35 kg. For adolescents and children weighing less than 35 kg, tedizolid phosphate powder for concentrate for solution for infusion is available.

Other medicines and Sivextro

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. It is especially important to tell 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 medicines, 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 disease)
• topotecan (used to treat cancer)
• statins such as pitavastatin, rosuvastatin (used to lower blood cholesterol)

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

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

It is not known if Sivextro passes into breast milk. Ask your doctor before breast-feeding your baby.

Driving and using machines

Do not drive or use machines if you feel dizzy or tired after taking this medicine.

3. How to take Sivextro

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

The recommended dose is one 200 mg tablet once a day for 6 days. The tablets should be swallowed whole and can be taken with or without food or drink.

Consult a doctor if you do not get better, or if you get worse after 6 days.

If you take more Sivextro than you should

Contact your doctor, pharmacist, or the nearest hospital emergency department immediately if you have taken more tablets than you should, and take the medicine with you.

If you forget to take Sivextro

If you forget to take the medicine, take the dose as soon as you remember, at any time up to 8 hours before the next scheduled dose. If it is less than 8 hours before the next dose, wait until the next scheduled dose. Do not take a double dose to make up for a forgotten dose. If you are not sure, ask your pharmacist.

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

If you stop taking Sivextro

If you stop taking Sivextro without your doctor's advice, your symptoms may get worse. Consult your doctor or pharmacist before stopping the medicine.

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.

Tell your doctor immediatelyif you get diarrhea during or after your treatment.

Other side effects may include:

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

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

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

• Fungal infections (thrush) of the skin, mouth, and vagina (vaginal thrush/candidiasis)
• Itching (including itching caused by allergic reaction), hair loss, acne, redness and/or itching or hives, excessive sweating
• Decreased or lost sensation in the skin, tingling/numbness in the skin
• Hot flushes or redness/flushing of the face, neck, or upper chest
• Abscess (a painful swelling filled with pus)
• Vaginal infection or inflammation or itching
• Anxiety, irritability, restlessness, or tremors
• Respiratory tract infection (sinusitis, pharyngitis, and bronchitis)
• Dry nose, chest congestion, cough
• Drowsiness, abnormal sleep pattern, difficulty sleeping, nightmares (unpleasant or disturbing dreams)
• Dry mouth, constipation, indigestion, stomach pain (abdominal pain), retching, dry heaves, bright red blood in the stool
• Acid reflux disorder (heartburn, pain or difficulty swallowing), flatulence/gas
• Joint pain, muscle spasms, back pain, neck pain, pain/discomfort in the limbs, decreased hand grip strength
• Blurred vision, "floaters" (small floating spots in the field of vision)
• Inflammation or swelling of lymph nodes
• Allergic reaction
• Dehydration
• Poor control of diabetes
• Abnormal taste
• Slow heart rate
• Fever
• Swelling of ankles and/or feet
• Abnormal urine odor, abnormal blood test results

Frequency not known (cannot be estimated from the available data):

• Bleeding or easy bruising (due to a low platelet count, the small cells involved in blood clotting)

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Sivextro

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 carton or blister after "EXP". The expiry date refers to the last day of the month shown.

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. Contents of the pack and further information

What Sivextro contains

• The active substance is tedizolid phosphate. Each film-coated tablet contains 200 mg of tedizolid phosphate.
• The other ingredients 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 yellow iron oxide (E172).

Appearance and packaging

Sivextro is a yellow, oval, film-coated tablet with "TZD" printed on one side and "200" on the other.

It is available in blister packs of 6 x 1 tablet unit doses.

Marketing Authorisation Holder and Manufacturer

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN Haarlem

Netherlands

For further information on this medicine, contact the local representative of the Marketing Authorisation Holder:

Date of last revision of this leaflet: {MM/YYYY}.

Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu.