Sivextro 200 mg film-coated tablets

• 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 you get any side effects, talk to your doctor or pharmacist. 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 take Sivextro
3. How to take 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 taking 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) taking 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 pharmacist 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)
• 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 can interfere with the effects of these medicines. Your doctor will explain more.

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 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.

Contact your doctor, pharmacist or nearest hospital casualty department as soon as possible if you have taken more tablets than you should, and take your medicine with you.

If you forget to take your medicine, take the dose as soon as possible anytime up to 8 hours prior to the next scheduled dose. If less than 8 hours remains before the next dose, then wait until the next scheduled dose. Do not take a double dose to make up for a forgotten dose. If in any doubt, contact your pharmacist for advice.

You should take all 6 tablets to complete your course of treatment, even if you have missed a dose.

If you stop taking Sivextro without the advice of your doctor, your symptoms may get worse. Talk to your doctor or pharmacist before you stop taking your medicine.

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

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

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

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 pharmacist. 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 film-coated tablet contains 200 mg of tedizolid phosphate.
• The other ingredients are microcrystalline cellulose, mannitol, povidone, crospovidone and magnesium stearate within the tablet core. The film coat of the tablet contains polyvinyl alcohol, titanium dioxide (E171), macrogol, talc and yellow iron oxide (E172).

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

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

Marketing Authorisation Holder:

Manufacturer: