What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet are: EU/1/15/991/003, EU/1/15/991/002.


Sivextro 200 mg powder for concentrate for solution for infusion

Package leaflet: Information for the patient

Sivextro® 200 mg powder for concentrate for solution for infusion

tedizolid phosphate

Read all of this leaflet carefully before you start receiving 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 nurse.
  • If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Sivextro is and what it is used for
2. What you need to know before you are given Sivextro
3. How you will be given 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.”

It is used to treat adults with infections of the skin and tissues below the skin.

It works by stopping the growth of certain bacteria which can cause serious infections.

2. What you need to know before you are given Sivextro

Do not use 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 have decided if Sivextro is suitable to treat your infection.

Talk to your doctor or nurse before being given Sivextro if any of the following apply to you:

  • are suffering from diarrhoea, or have suffered from diarrhoea whilst (or up to 2 months after) being treated with antibiotics in the past.
  • are allergic to other medicines belonging to the group “oxazolidinones” (e.g., linezolid, cycloserine).
  • are taking certain medicines to treat depression, known as tricyclics, SSRIs (selective serotonin reuptake inhibitors) or MAOIs (monoamine oxidase inhibitors). See Other medicines and Sivextro for examples.
  • are taking certain medicines to treat migraine known as “triptans”. See Other medicines and Sivextro for examples.

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

Diarrhoea

Contact your doctor straight away if you suffer from diarrhoea during or after your treatment. Do not take any medicine to treat your diarrhoea without first checking with your doctor.

Resistance to antibiotics

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

Possible side effects

Certain side effects have been observed with another member of the oxazolidinone class when administered over a duration exceeding that recommended for Sivextro. Tell your doctor straight away if you suffer from any of the following while taking Sivextro:

  • a low white blood cell count
  • anaemia (low red blood cells)
  • bleeding or bruising easily
  • loss of sensitivity in your hands or feet (such as numbness, prickling/tingling, or sharp pains)
  • any problems with your eyesight such as blurred vision, changes in colour vision, difficulty in seeing detail or if your field of vision becomes restricted.

Children and adolescents

This medicine should not be used in children and adolescents as it has not been studied enough in these populations.

Other medicines and Sivextro

Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines. It is especially important that you tell your doctor if you are also taking:

  • amitriptyline, citalopram, clomipramine, dosulepin, doxepin, fluoxetine, fluvoxamine, imipramine, isocarboxazid, lofepramine, moclobemide, paroxetine, phenelzine, selegiline and sertraline (used to treat depression)
  • sumatriptan, zolmitriptan (used to treat migraine)

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 nurse for advice before using this medicine.

It is not known if Sivextro passes into breast milk in humans. Ask your doctor for advice 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.

Sivextro contains sodium

This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e., essentially “sodium-free.”

3. How you will be given Sivextro

Sivextro will be given to you by a nurse or doctor.

It will be given to you through a drip directly into a vein (intravenously) over approximately 1 hour.

You will be given one 200 mg infusion of Sivextro once a day for 6 days.

Talk to a doctor if you do not feel better, or if you feel worse after 6 days.

If you are given more Sivextro than you should

Tell your doctor or nurse immediately if you are concerned that you may have been given too much Sivextro.

If you miss a dose of Sivextro

Tell your doctor or nurse immediately if you are concerned that you may have missed a dose.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Contact your doctor straight away if you suffer from diarrhoea 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
  • Tiredness
  • Dizziness
  • Infusion site pain or swelling.

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

  • Fungal infections of skin , mouth and vagina (oral / vaginal thrush)
  • Itching (including itching due to allergic reaction), hair loss, acne, red and/or itchy rash or hives, excessive sweating
  • Decrease or loss of skin sensitivity, tingling/prickling skin sensation
  • Hot flush or blushing/redness in the face, neck or upper chest
  • Abscess (swollen, pus-filled lump)
  • Vaginal infection, inflammation or itching
  • Anxiety, irritability, shaking or trembling
  • Respiratory tract (sinuses, throat and chest) infection
  • Dryness in the nose, congestion in the chest, cough
  • Sleepiness, abnormal sleep pattern, difficulty sleeping, nightmares (unpleasant/disturbing dreams)
  • Dry mouth, constipation, indigestion, pain/discomfort in the belly (abdomen), retching, dry heaving, bright red blood in the stool
  • Acid reflux disease (heartburn, pain or difficulty swallowing), flatulence/passing wind
  • Joint pain, muscle spasms, back pain, neck pain, pain/discomfort in limbs, decrease of grip strength
  • Blurred vision, ‘floaters’ (small shapes seen floating in the field of vision)
  • Swollen or enlarged lymph nodes
  • Allergic reaction
  • Dehydration
  • Poor control of diabetes
  • Abnormal sense of taste
  • Slow heartbeat
  • Fever
  • Swelling in ankles and/or feet
  • Abnormal smelling urine, abnormal blood tests
  • Infusion reactions (chills, shaking or shivering with fever, muscle pain, swelling of the face, weakness, fainting, shortness of breath, chest tightness and angina pectoris).

Reporting of side effects

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store 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 vial label after “EXP”. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not use this medicine if you notice any particles or the solution is cloudy.

Once opened this medicine must be used immediately. If not, the reconstituted and diluted solution should be stored at room temperature or in a refrigerator at 2°C to 8°C, and administered within 24 hours after reconstitution.

Any unused medicine or waste material, including materials used for reconstitution, dilution and administration, should be disposed of in accordance with local requirements.

6. Contents of the pack and other information

What Sivextro contains

  • The active substance is tedizolid phosphate. Each vial of powder contains disodium tedizolid phosphate which is equal to 200 mg of tedizolid phosphate.
  • The other ingredients are mannitol, sodium hydroxide (for pH adjustment) and hydrochloric acid (for pH adjustment).

What Sivextro looks like and contents of the pack

Sivextro is a white to off-white powder for concentrate for solution for infusion in a glass vial. The powder will be reconstituted in the vial with 4 mL of water for injections. The reconstituted solution will be withdrawn from the vial and added to an infusion bag of 0.9% sodium chloride in the hospital.

It is available in packs containing 1 or 6 vials.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The Netherlands

Manufacturer

Laboratoires Merck Sharp & Dohme-Chibret
Route de Marsat
Riom 63963
Clermont-Ferrand Cedex 9
France

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Merck Sharp & Dohme Limited
Tel: +44 (0) 1992 467272

This leaflet was last revised in January 2020.

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

© Merck Sharp & Dohme Limited, 2020. All rights reserved.

PIL.SVT-INF.20.UK.7092.R0031