Sivextro
tedizolid phosphate
tedizolid phosphate
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 Sivextro is and what it is used for
What you need to know before you take Sivextro
How to take Sivextro
Possible side effects
How to store Sivextro
Contents of the pack and other information
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.
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) 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.
Resistanceto 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.
Possibleside 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 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.
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.
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.
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.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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 nationalreportingsystem listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
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.
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.
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:
MSD Belgium
Tél/Tel: +32(0)27766211
UAB Merck Sharp & Dohme Tel.: +370 5 278 02 47
Мерк Шарп и Доум България ЕООД
Тел.: +359 2 819 3737
MSD Belgium
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Merck Sharp & Dohme s.r.o. Tel.: +420 233 010 111
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