B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Sivextro 200 mg 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 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.

What is in this leaflet

• 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

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 and adolescents 12 years of age and older 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 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 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) 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 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.

Children

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

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 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)
• 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.

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 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.

3. How to take Sivextro

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

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

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

If you take more Sivextro than you should

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 Sivextro

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

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.

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

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

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)

Reporting of side effects

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 national reporting system listed in 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 carton or blister label after “EXP”. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other 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 within the tablet core. The film coat of the tablet contains polyvinyl alcohol, titanium dioxide (E171), macrogol, talc and yellow iron oxide (E172).

What Sivextro looks like and contents of the pack

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

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN Haarlem

The Netherlands

Manufacturer

FAREVA Mirabel

Route de Marsat, Riom

63963, Clermont-Ferrand Cedex 9

France

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN Haarlem

The Netherlands

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

España Merck Sharp & Dohme de España, S.A. Tel: +34 91 321 06 00	Polska MSD Polska Sp.z o.o. Tel.: +48 22 549 51 00
France MSD France Tél: + 33 (0) 1 80 46 40 40	Portugal Merck Sharp & Dohme, Lda Tel: +351 21 4465700
Hrvatska Merck Sharp & Dohme d.o.o. Tel: + 385 1 6611 333	România Merck Sharp & Dohme Romania S.R.L. Tel: +40 21 529 29 00
Ireland Merck Sharp & Dohme Ireland (Human Health) Limited Tel: +353 (0)1 299 8700	Slovenija Merck Sharp & Dohme, inovativna zdravila d.o.o. Tel: + 386 1 5204 201
Ísland Vistor hf. Sími: +354 535 7000	Slovenská republika Merck Sharp & Dohme, s. r. o. Tel.: +421 2 58282010
Italia MSD Italia S.r.l. Tel: +39 06 361911	Suomi/Finland MSD Finland Oy Puh/Tel: +358 (0) 9 804650
Kùnpoç Merck Sharp & Dohme Cyprus Limited TqX: 800 00 673 (+357 22866700)	Sverige Merck Sharp & Dohme (Sweden) AB Tel: +46 77 5700488
Latvija SIA Merck Sharp & Dohme Latvija Tel: +371 67364224 .	United Kingdom (Northern Ireland) Merck Sharp & Dohme Ireland (Human Health) Limited Tel: +353 (0)1 2998700

This leaflet was last revised in {MM/YYYY }.

Detailed information on this medicine is available on the European Medicines Agency web site:

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 and adolescents 12 years of age and older 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).

• – 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) 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 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.

Children

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

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 medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say 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).

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)

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 national reporting system listed in 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 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

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN Haarlem

The Netherlands

Manufacturer

FAREVA Mirabel

Route de Marsat, Riom

63963, Clermont-Ferrand Cedex 9

France

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN Haarlem

The Netherlands

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

España Merck Sharp & Dohme de España, S.A. Tel: +34 91 321 06 00	Polska MSD Polska Sp.z o.o. Tel.: +48 22 549 51 00
France MSD France Tél: + 33 (0) 1 80 46 40 40	Portugal Merck Sharp & Dohme, Lda Tel: +351 21 4465700
Hrvatska Merck Sharp & Dohme d.o.o. Tel: + 385 1 6611 333	România Merck Sharp & Dohme Romania S.R.L. Tel: +40 21 529 29 00
Ireland Merck Sharp & Dohme Ireland (Human Health) Limited Tel: +353 (0)1 299 8700	Slovenija Merck Sharp & Dohme, inovativna zdravila d.o.o. Tel: + 386 1 5204 201
Ísland Vistor hf. Sími: +354 535 7000	Slovenská republika Merck Sharp & Dohme, s. r. o. Tel.: +421 2 58282010
Italia MSD Italia S.r.l. Tel: +39 06 361911	Suomi/Finland MSD Finland Oy Puh/Tel: +358 (0) 9 804650
Kùnpoç Merck Sharp & Dohme Cyprus Limited TqX: 800 00 673 (+357 22866700)	Sverige Merck Sharp & Dohme (Sweden) AB Tel: +46 77 5700488
Latvija SIA Merck Sharp & Dohme Latvija Tel: +371 67364224 .	United Kingdom (Northern Ireland) Merck Sharp & Dohme Ireland (Human Health) Limited Tel: +353 (0)1 2998700

This leaflet was last revised in {MM/YYYY }.

Detailed information on this medicine is available on the European Medicines Agency web site:

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 and adolescents 12 years of age and older 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).

• – 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) 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 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.

Children

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

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 medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say 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).

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)

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 national reporting system listed in 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).