Linezolid 600 Mg Film-Coated Tablets
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LEAFLET SIZE: 160 mm x 400 mm
Package leaflet: Information for the user Linezolid 600 mg Film-coated Tablets
Linezolid
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 Linezolid 600 mg Film-coated Tablets are and what they are used for
2. What you need to know before you take Linezolid 600 mg Film-coated Tablets
3. How to take Linezolid 600 mg Film-coated Tablets
4. Possible side effects
5. How to store Linezolid 600 mg Film-coated Tablets
6. Contents of the pack and other information
1.What Linezolid 600 mg Film-coated Tablets are and what they are used for
Linezolid is an antibiotic that works by stopping the growth of certain bacteria (germs) that cause infections. It is used to treat pneumonia and some infections in the skin or under the skin. Your doctor will have decided if Linezolid 600 mg Film-coated Tablets is suitable to treat your infection.
2.What you need to know before you take Linezolid 600 mg Film-coated Tablets
Do not take Linezolid 600 mg Film-coated Tablets:
• if you are allergic to linezolid or any of the other ingredients of this medicine (listed in section 6).
• if you are taking or have taken within the last 2 weeks any medicines known as monoamine oxidase inhibitors (MAOIs, for example phenelzine, isocarboxazid, selegiline, moclobemide). These may be used to treat depression or Parkinson's disease.
• if you are breast-feeding. This is because it passes into breast milk and could affect the baby.
This medicine may not be suitable for you if you answer yes to any of the following questions. In this case tell your doctor as he/she will need to check your general health and your blood pressure before and during your treatment, or may decide that another treatment is better for you. Ask your doctor if you are not sure whether these categories apply to you.
• Do you have high blood pressure?
• Have you been diagnosed with an overactive thyroid?
• Do you have a tumour of the adrenal glands (phaeochromocytoma) or carcinoid syndrome (caused by tumours of the hormone system with symptoms of diarrhoea, flushing of the skin, wheezing)?
• Do you suffer from manic depression, schizoaffective disorder, mental confusion or other mental problems?
• Are you taking any of the medicines listed under “Other medicines and Linezolid Film-coated Tablets?
Warnings and precautions
Talk to your doctor or pharmacist before taking Linezolid 600 mg Film-coated Tablets if you:
• bruise and bleed easily
• are anaemic
• are prone to getting infections
• have a history of seizures
• have liver problems or kidney problems particularly ifyou have dialysis
• have diarrhoea.
Tell your doctor or pharmacist immediately if you suffer from any of the following during treatment (see also section 4 “Possible side effects”):
• problems with your vision such as blurred vision, changes in colour vision, difficulty in seeing detail or if your field of vision becomes restricted.
• you develop diarrhoea. If this becomes severe or persistent or you notice that your stools contains blood or mucus, you should stop taking these tablets immediately and consult your doctor. In this situation, you should not take medicines that stop or slow bowel movement.
• recurrent nausea or vomiting, abdominal pain or over breathing.
Children and adolescents
These tablets are not recommended for children and adolescents.
Other medicines and Linezolid 600 mg Film-coated Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
There is a risk that these tablets may sometimes interact with certain other medicines to cause side effects such as changes in blood pressure, temperature or heart rate.
Do not take Linezolid 600 mg Film-coated Tablets:
• if you are taking or have taken within the last 2 weeks any medicines known as monoamine oxidase inhibitors (MAOIs, for example phenelzine, isocarboxazid, selegiline, moclobemide). These may be used to treat depression or Parkinson's disease.
Also tell your doctor if you are taking the following medicines. Your doctor may still decide to give you Linezolid 600 mg Film-coated Tablets, but will need to check your general health and your blood pressure before and during your treatment. In other cases, your doctor may decide that another treatment is better for you.
• Decongestant cold or flu remedies containing pseudoephedrine or phenylpropanolamine.
• Some medicines used to treat asthma such as salbutamol, terbutaline, fenoterol.
• Certain antidepressants known as tricyclics or SSRIs (selective serotonin reuptake inhibitors). There are many of these, including amitriptyline, cipramil, clomipramine, dosulepin, doxepin, fluoxetine, fluvoxamine, imipramine, lofepramine, paroxetine, sertraline.
• Medicines used to treat migraine such as sumatriptan and zolmitriptan.
• Medicines used to treat sudden, severe allergic reactions such as adrenaline (epinephrine).
• Medicines which increase your blood pressure, such as noradrenaline (norepinephrine) dopamine and dobutamine.
• Medicines used to treat moderate to severe pain, such as pethidine.
• Medicines used to treat anxiety disorders, such as buspirone.
• Medicines that stop blood clotting, such as warfarin.
Linezolid 600 mg Film-coated Tablets with food, drink and alcohol
You can take these tablets either before, during or after a meal.
Avoid eating large amounts of mature cheese, yeast extracts, or soya bean extracts e.g. soy sauce and drinking alcohol, especially draught beers and wine. This is because this medicine may react with a substance called tyramine which is naturally present in some foods to cause an increase in your blood pressure.
If you develop a throbbing headache after eating or drinking, tell your doctor or pharmacist immediately.
Pregnancy and breast-feeding and fertility
The effect of Linezolid 600 mg Film-coated Tablets in pregnant women is not known. Therefore these tablets should not be taken in pregnancy unless advised by your doctor. Tell your doctor if you are pregnant, think you may be pregnant or are trying to become pregnant.
You should not breast-feed when taking these tablets because linezolid passes into breast milk and could affect the baby.
Driving and using machines
These tablets may make you feel dizzy or experience problems with your vision. If this happens, do not drive or operate any machinery. Remember that if you are unwell your ability to drive or operate machinery may be affected.
Linezolid 600 mg Film-coated Tablets contains lactose
This product contains lactose monohydrate. If you have been told that you have an intolerance to some sugars contact your doctor or pharmacist before taking this medicine.
3.How to take Linezolid 600 mg Film-coated Tablets
Adults
Always take these tablets as your doctor has told you. If you are unsure ask your doctor or pharmacist.
The usual dose is one tablet (600 mg linezolid) twice daily (every twelve hours). Swallow the tablet whole with some water.
If you are on kidney dialysis, you should take the tablets after dialysis.
A course of treatment usually lasts 10 to 14 days but can last up to 28 days. The safety and effectiveness of this medicine have not been established for treatment periods longer than 28 days. Your doctor will decide how long you should be treated.
While you are taking these tablets, your doctor should perform regular blood tests to monitor your blood count. Your doctor should monitor your eyesight if you take the tablets for more than 28 days.
Children and adolescents
These tablets are not recommended for children and adolescents (under 18 years old).
If you take more Linezolid 600 mg Film-coated Tablets than you should
Tell your doctor or pharmacist immediately.
If you forget to take Linezolid 600 mg Film-coated Tablets
Take the forgotten tablet as soon as you remember. Take the next tablet 12 hours after this and continue taking your tablets every 12 hours. Do not take twice as many tablets to make up for missing a dose.
If you stop taking Linezolid 600 mg Film-coated Tablets
Unless your doctor instructs you to stop treatment, it is important to continue taking these tablets. If you stop and your original symptoms come back tell your doctor or pharmacist immediately. If you have any further questions on the use of this product, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor, nurse or pharmacist immediately if you notice any of these side effects during your treatment with Linezolid 600 mg Film-coated Tablets:
• skin reactions such as red sore skin and flaking (dermatitis), rash, itching, or swelling, particularly around the face and neck. This may be the sign of an allergic reaction and it may be necessary for you to stop taking these tablets.
• problems with your vision such as blurred vision, changes in colour vision, difficulty in seeing detail or if your field of vision becomes restricted.
• severe diarrhoea containing blood and/or mucus (antibiotic associated colitis including pseudomembranous colitis), which in very rare circumstances may develop into complications that are life-threatening.
• recurrent nausea or vomiting, abdominal pain or over breathing.
• fits or seizures have been reported with Linezolid 600 mg Film-coated Tablets. You should let your doctor know if you experience agitation, confusion, delirium, rigidity, tremor, incoordination and seizure while also taking antidepressants known as SSRI's (see section 2).
• numbness, tingling or blurred vision if you have been taking these tablets for more than 28 days.
Other side effects include:
Common side-effects (likely to occur in less than 1 in 10 people):
• Fungal infections especially vaginal or oral “thrush”
• Headache
• Metallic taste in the mouth
• Diarrhoea, nausea or vomiting
• Changes in some blood test results including those measuring your kidney or liver function or blood sugar levels
• Unexplained bleeding or bruising, which may be due to changes in the numbers of certain cells in the blood which may affect blood clotting or lead to anaemia
• Difficulty in sleeping
• Increased blood pressure
• Anaemia (low red blood cell)
• Changes in numbers of certain cells in the blood which may affect your ability to fight infection
• Skin rash
• Dizziness
• Localised or general abdominal pain
• Constipation
• Indigestion
• Localised pain
• Fever
Uncommon side-effects (likely to occur in less than 1 in 100 people
• Inflammation of the vagina or genital area in women
• Sensations such as tingling or feeling numb
• Blurred vision
• “Ringing” in the ears (tinnitus)
• Inflammation of the veins
• Dry or sore mouth , swollen, sore, or discoloured tongue
• A need to urinate more often
• Chills
• Feeling tired or thirsty
• Inflammation of the pancreas
• Increased sweating
• Changes in proteins, salts or enzymes in the blood which measure kidney or liver function.
• Convulsions
• Hyponatraemia (low blood sodium levels)
• Kidney failure
• Reduction in platelets
• Abdominal bloating
• Transient ischaemic attacks (temporary disturbance of blood flow to the brain causing short term symptoms such as loss of vision, leg and arm weakness, slurring of speech and loss of consciousness)
• Inflammation of the skin
• Increase in creatine
• Stomach pain
• Changes in heart rate (e.g. increase rate)
Rare side-effects (likely to occur in less than 1 in 1000 people):
• Restricted field of vision
• Superficial tooth discolouration, removable with professional dental cleaning (manual descaling)
The following side effects have also been reported (frequency not known):
• Serotonin syndrome (symptoms include fast heart rate, confusion, abnormal sweating, hallucinations, involuntary movements chills and shivering)
• Lactic acidosis (symptoms include recurrent nausea and vomiting, abdominal pain, over breathing)
• Severe skin disorders
• Sideroblastic anaemia (a type of anaemia (low red blood cells))
• Alopecia (hair loss)
• Changes in colour vision or difficulty in seeing detail Decrease of the blood cell count
• Weakness and/or sensory changes 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 Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard. 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 and blister 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 use this medicine if you notice the tablets are discolured.
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.
What Linezolid 600 mg Film-coated Tablets contains
- The active substance is linezolid
- The other ingredients are Lactose monohydrate, Povidone, Croscarmellose sodium, Magnesium stearate, Hypromellose, Titanium dioxide and Macrogol.
What Linezolid 600 mg Film-coated Tablets looks like and contents of the pack
Linezolid 600 mg Film-coated Tablets 600 mg Film-coated Tablets are white to off-white, oval, biconvex, film-coated tablets with “G” debossed on one side and “469” on the other.
The tablets are available in blister packs containing 10, 20 and 30 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Glenmark Pharmaceuticals Europe Limited,
Laxmi House, 2 B Draycott Avenue, Kenton, Middlesex, HA3 0BU United Kingdom
Manufacturers
Glenmark Pharmaceuticals Europe Limited. Building 2, Croxley Green Business Park Croxley Green
Hertfordshire, WD 18 8YA United Kingdom
Glenmark Pharmaceuticals s.r.o.,
Fibichova 143, 566 17 Vysoke Myto,
Czech Republic
This leaflet was last revised in 08/2015.
DATE: 26-08-2015
VERSION: 03 (UK)