180 0 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT If you forget to take Linezolid The following side effects have also been reported Take the forgotten tablet as soon as you remember. Take the next tablet (Not known: frequency cannot be estimated from the Linezolid 12 hours after this and continue taking your tablets every 12 hours. Do available data): not take a double dose to make up for a forgotten tablet. • alopecia (hair loss) If you stop using Linezolid • decrease of the blood cell count 600mg film-coated tablets Unless your doctor instructs you to stop treatment, it is important to • weakness and/or sensory changes continue taking Linezolid. Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you. If you stop and your original symptoms come back tell your doctor or Reporting of side effects • Keep this leaflet. You may need to read it again. pharmacist immediately. If you get any side effects, talk to your doctor or pharmacist. This • If you have any further questions, ask your doctor or pharmacist. If you have any further questions on the use of this medicine, ask your includes any possible side effects not listed in this leaflet. You can also • 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 doctor or pharmacist. report side effects directly via the Yellow Card Scheme at the same as yours. www.mhra.gov.uk/yellowcard or search for ‘MHRA Yellow Card’ in the • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 4. Possible side effects Google Play or Apple App Store. See section 4. By reporting side effects you can help provide more information on the Like all medicines, this medicine can cause side-effects, although not safety of this medicine. everybody gets them. What is in this leaflet Also tell your doctor if you are taking the following medicines. Your Tell your doctor, nurse or pharmacist immediately if you notice any of 5. How to store Linezolid these side effects during your treatment with linezolid: 1. What Linezolid is and what it is used for doctor may still decide to give you linezolid, but will need to check your Keep this medicine out of the sight and reach of children. 2. What you need to know before you take Linezolid general health and your blood pressure before and during your The serious side effects (with frequency in brackets) of linezolid are: Do not use this medicine after the expiry date which is stated on the 3. How to take Linezolid treatment. In other cases, your doctor may decide that another treatment • Severe skin disorder (not known), swelling particularly around the blister and the carton after EXP.The expiry date refers to the last day of 4. Possible side effects is better for you. face and neck (not known), wheezing and/or difficulty breathing that month. 5. How to store Linezolid • Decongestant cold or flu remedies containing pseudoephedrine or (not known). This may be the sign of an allergic reaction and it may This medicinal product does not require any special storage conditions. 6. Contents of the pack and other information phenylpropanolamine. be necessary for you to stop taking linezolid. Skin reactions such as Do not throw away any medicines via wastewater <or household red sore skin and flaking (dermatitis) (uncommon), rash (common), • Some medicines used to treat asthma such as salbutamol, waste>. Ask your pharmacist how to throw away medicines you no itching (common). terbutaline, fenoterol. longer use. These measures will help to protect the environment. 1. What Linezolid is and what it is used for • problems with your vision such as blurred vision (uncommon), • Certain antidepressants known as tricyclics or SSRIs (selective changes in colour vision (not known), difficulty in seeing detail Linezolid is an antibiotic of the oxazolidinones group that works by serotonin reuptake inhibitors). There are many of these, including (not known) or if your field of vision becomes restricted (rare) 6. Contents of the pack and other information stopping the growth of certain bacteria (germs) that cause infections. amitriptyline, citalopram, clomipramine, dosulepin, doxepin, It is used to treat pneumonia and some infections in the skin or under fluoxetine, fluvoxamine, imipramine, lofepramine, paroxetine, • severe diarrhoea containing blood and/or mucus (antibiotic What Linezolid contains the skin. Your doctor will have decided if linezolid is suitable to treat your sertraline. associated colitis including pseudomembranous colitis), which in rare circumstances may develop into complications that are • The active substance in this medicine is linezolid. Each tablet infection. • Medicines used to treat migraine such as sumatriptan and life-threatening (rare) contains 600 mg linezolid. zolmitriptan. • recurrent nausea or vomiting, abdominal pain or rapid breathing • The other ingredients are silicified microcrystalline cellulose 2. What you need to know before you take Linezolid • Medicines used to treat sudden, severe allergic reactions such as (cellulose microcrystalline, silica, colloidal anhydrous), sodium starch (not known) adrenaline (epinephrine). glycolate (type A), cellulose, microcrystalline, povidone K90, DO NOT take Linezolid if you are • Medicines which increase your blood pressure, such as noradrenaline • fits or seizures (uncommon) have been reported with linezolid. You magnesium stearate. should let your doctor know if you experience agitation, confusion, • allergic to linezolid or any of the other ingredients of this medicine (norepinephrine), dopamine and dobutamine. • The film-coating contains hypromellose, propylene glycol, titanium delirium, rigidity, tremor, incoordination and seizure while also taking (listed in section 6). • Medicines used to treat moderate to severe pain, such as pethidine. dioxide (E171), talc. antidepressants known as SSRI’s (see section 2) (not known) • taking or have taken within the last 2 weeks any medicines known as • Medicines used to treat anxiety disorders, such as buspirone. monoamine oxidase inhibitors (MAOIs for example phenelzine, • unexplained bleeding or bruising, which may be due to changes in • Medicines that stop blood clotting, such as warfarin. the numbers of certain cells in the blood which may affect blood What Linezolid looks like and contents of the pack isocarboxazid, selegiline, moclobemide). These medications may be • An antibiotic called rifampicin. used to treat depression or Parkinson’s disease. clotting or lead to anaemia (common) Linezolid 600 mg film-coated tablets are oval, biconvex, white to off - white film-coated tablets. • breast-feeding. This is because linezolid passes into breast milk and • changes in numbers of certain cells in the blood which may affect could affect the baby. Linezolid with food, drink and alcohol your ability to fight infection (common) some signs of infection Linezolid tablets are packed in cartons containing PVC/PVdC-Aluminium You can take linezolid either before, during or after a meal. include: any fever (common), sore throat (uncommon), mouth ulcers foil blisters containing 10 film-coated tablets. (uncommon) and tiredness (uncommon) Warnings and precautions Avoid eating large amounts of mature cheese, yeast extracts, or soya Not all pack sizes may be marketed. bean extracts e.g. soy sauce and drinking alcohol, especially draught • inflammation of the pancreas (uncommon) Talk to your doctor or pharmacist before taking Linezolid. Marketing Authorisation Holder beers and wine. This is because linezolid may react with a substance • convulsions (uncommon) Linezolid may not be suitable for you if you answer yes to any of the called tyramine which is naturally present in some foods. This interaction • transient ischaemic attacks (temporary disturbance of blood flow to STADA, following questions. In this case tell your doctor as he/she will need to may cause an increase in your blood pressure. the brain causing short term symptoms such as loss of vision, leg Linthwaite, Huddersfield, HD7 5QH, UK check your general health and your blood pressure before and during If you develop a throbbing headache after eating or drinking, tell your and arm weakness, slurring of speech and loss of consciousness) your treatment, or may decide that another treatment is better for you. Manufacturer doctor or pharmacist immediately. (uncommon) Ask your doctor if you are not sure whether these categories apply to • "ringing" in the ears (tinnitus) (uncommon) STADA Arzneimittel GmbH, Stadastrasse 2-18, 61118 Bad Vilbel, you. Germany Pregnancy and breast-feeding Numbness, tingling or blurred vision have been reported by patients who • Do you have high blood pressure, whether or not you are taking have been given linezolid for more than 28 days. If you experience This leaflet was last revised in May 2018. medicines for this? The effect of linezolid in pregnant women is not known. Therefore it should not be taken in pregnancy unless advised by your doctor. difficulties with your vision you should consult your doctor as soon as • Have you been diagnosed with an overactive thyroid? possible. • Do you have a tumour of the adrenal glands (phaeochromocytoma) or You should not breast-feed when taking linezolid because it passes into carcinoid syndrome (caused by tumours of the hormone system with breast milk and could affect the baby. Other side effects include: symptoms of diarrhoea, flushing of the skin, wheezing)?