Sivextro 200 mg powder for concentrate for solution for infusion

• 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.

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

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

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).
• have a history of bleeding or easy bruising (which may be a sign of low numbers of platelets, the small cells involved in clotting in your blood).
• have kidney problems.
• are taking certain medicines to treat depression, known as tricyclics, SSRIs (selective serotonin reuptake inhibitors), opioids or MAOIs (monoamine oxidase inhibitors). The use of these medicines together with tedizolid phosphate can lead to serotonin syndrome, a potentially life-threatening condition (with symptoms such as feeling disorientated, difficulty concentrating, high temperature, increased reflexes, difficulty to coordinate muscle movements). 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 Sivextro or 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.

This medicine should not be used in children under 12 years of age as it has not been studied enough in this population.

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, sertraline, duloxetine and venlafaxine (used to treat depression). There is a risk that tedizolid phosphate could interact with certain medicines, including those mentioned, to cause side effects such as changes in blood pressure or temperature.
• sumatriptan, zolmitriptan (used to treat migraine)
• opioids (such as fentanyl)

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.

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

This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free’.

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

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

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).

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

• Bleeding or bruising easily (due to low numbers of platelets, the small cells involved in clotting in your blood).

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.

• 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).

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.

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