Sivextro 200 mg film-coated tablets

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Sivextro 200mg film-coated tablets

tedizolid phosphate

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

Leaflet contents

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

1. What Sivextro is and what it is 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, used to treat 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 taking Sivextro

Do not take Sivextro:

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

Warnings and precautions

Your doctor will decide whether Sivextro is appropriate for treating your infection.

Consult your doctor or nurse before starting to take Sivextro if any of the following apply to you:

• if you have diarrhoea or have previously had diarrhoea when taking antibiotics (or up to 2 months after taking them).
• if you are allergic to other medicines belonging to the group of “oxazolidinones” (for example, linezolid, cycloserine).
• if you have a history of bleeding or bruising easily (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 depression, known as tricyclics, SSRIs (selective serotonin reuptake inhibitors), opioids, or MAOIs (monoamine oxidase inhibitors). Using these medicines together with tedizolid phosphate may lead to serotonin syndrome, a potentially life-threatening condition (with symptoms such as confusion, difficulty concentrating, high body temperature, increased reflexes, and difficulty coordinating muscle movements). See Other medicines and Sivextro for examples.
• if you are taking certain migraine medicines called "triptans". See Other medicines and Sivextro for examples.

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

Diarrhoea

Contact your doctor immediately if you develop diarrhoea during or after your treatment. Do not take any medicine for diarrhoea without first consulting your doctor.

Antibiotic resistance

Bacteria can become resistant to antibiotic treatment over time. This occurs when antibiotics can no longer stop bacterial growth or treat the infection. Your doctor will decide whether you should be given Sivextro to treat your infection.

Possible side effects

Some adverse effects have been observed with Sivextro or another member of the oxazolidinone class when administered for longer than the recommended duration for Sivextro. Inform your doctor immediately if you experience any of the following while taking Sivextro:

• low white blood cell count
• anaemia (low red blood cell count)
• bleeding or easy bruising
• loss of sensation in hands or feet (e.g., numbness, tingling/pins and needles, or sharp pain)
• any vision problems, such as blurred vision, changes in colour perception, difficulty seeing fine details, or narrowing of the visual field.

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

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. It is especially important that you 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 medicines, including those listed, and cause adverse effects such as changes in blood pressure or body 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 blood cholesterol)

Sivextro may interfere with the effects of these medicines. Your doctor will provide further details.

Pregnancy and breastfeeding

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.

It is unknown whether Sivextro passes into breast milk. Consult your doctor before breastfeeding your baby.

Driving and using machines

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

3. How to take Sivextro

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

The recommended dose is one 200 mg tablet once daily for 6 days. The tablets should be swallowed whole and may be taken with or without food or drinks.

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 take the medicine with you.

If you forget to take Sivextro

If you forget to take your medicine, take the dose as soon as possible, provided that it is at least 8 hours before your next scheduled dose. If less than 8 hours remain before your next dose, wait and take your next dose at the scheduled time. Do not take a double dose to make up for a missed dose. If you have any doubts, consult your pharmacist.

You should 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 worsen. Consult your doctor or pharmacist before stopping the medicine.

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 may cause adverse effects, although not everyone will experience them.

Contact your doctor immediately if you experience diarrhea during or after your treatment.

Other adverse effects may include:

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

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

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

• Fungal infections (fungi) of the skin, mouth, and vagina (thrush / vaginal candidiasis)
• Itching (including itching due to allergic reaction), hair loss, acne, rash with redness and/or itching or hives, excessive sweating
• Decreased or loss of skin sensitivity, tingling or prickling sensation in the skin
• Hot flushes or redness/flushing of the face, neck, or upper chest
• Abscess (inflamed lump containing pus)
• Vaginal infection, inflammation, or itching
• Anxiety, irritability, agitation, or tremors
• Respiratory tract infection (sinuses, throat, and chest)
• Dry nose, chest congestion, cough
• Drowsiness, abnormal sleep pattern, difficulty sleeping, nightmares (unpleasant/disturbing dreams)
• Dry mouth, constipation, indigestion, stomach/abdominal pain/discomfort, retching, dry heaves, bright red blood in stools
• Acid reflux disorder (heartburn, pain or difficulty swallowing), flatulence/gas
• Joint pain, muscle spasms, back pain, neck pain, pain/discomfort in limbs, reduced hand grip strength
• Blurred vision, "floaters" (small floating shapes in the visual field)
• Swelling or enlargement of lymph nodes
• Allergic reaction
• Dehydration
• Poor control of diabetes
• Taste disturbances
• Slow heart rate
• Fever
• Swelling of ankles and/or feet
• Abnormal urine odor, abnormalities in blood tests

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

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

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse 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 stated on the carton or blister pack following "EXP". The expiry date refers to the last day of the month indicated.

This medicine requires no special storage conditions.

Medicines should not be disposed of via wastewater drains or household waste. 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 Sivextro

• The active substance 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 tablet film coating contains polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, and yellow iron oxide (E172).

Nature and contents of the container

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

It is available in blisters of 6 × 1 perforated tablets in unit dose packs.

Marketing Authorization Holder and Manufacturer Responsible

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN Haarlem

The Netherlands

Further information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet: {MM/YYYY}.

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