Full description:
Linezolid Denk 2 mg/ml is an antibiotic of the oxazolidinones group 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 has decided that this medicine is suitable to treat your infection.
What Linezolid Denk 2 mg/ml contains:
- The active substance is linezolid. Each millilitre (ml) of solution contains 2 mg of linezolid. Each 300 ml infusion bag contains 600 mg linezolid.
- The other ingredients are glucose monohydrate, sodium citrate dihydrate, citric acid anhydrous, hydrochloric acid, sodium hydroxide solution and water for injections.
Possible side effects:
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 Denk 2 mg/ml:
The serious side effects (with frequency in brackets) of linezolid are:
- Severe skin disorder (not known), swelling, particularly around the face and neck (Steven-Johnson-Syndrome, toxic epidermal necrolysis) (not known), wheezing and/ or difficulty breathing (not known). This may be the sign of an allergic reaction and it may be necessary for you to stop taking Linezolid Denk 2 mg/ml. Skin reactions such as red sore skin and flaking (dermatitis) (uncommon), rash (common), itching (common).
- Problems with your eyes, such as blurred vision (uncommon), changes in colour vision (not known), difficulty in seeing detail (not known) or if your field of vision becomes restricted (rare).
- 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 (rare).
- Recurrent nausea or vomiting, abdominal pain or rapid breathing (not known).
- Fits or seizures (uncommon) have been reported with linezolid. You should let your doctor know if you experience increased agitation, confusion, delirium, rigidity, tremor, poor coordination and seizures while taking antidepressants known as SSRIs at the same time (see section 2) (not known).
- 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 (common).
- Changes in numbers of certain cells in the blood which may affect your ability to fight infection (common), some signs of infection include: any fever (common), sore throat (uncommon), mouth ulcers (uncommon) and tiredness (uncommon).
- Inflammation of the pancreas (uncommon).
- Convulsions (uncommon).
- 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) (uncommon).
- “Ringing” in the ears (tinnitus) (uncommon). Numbness, tingling or blurred vision have been reported by patients who have been given this medicine for more than 28 days. If you experience difficulties with your vision you should consult your doctor as soon as possible.
Other side effects include:
Common (may affect up to 1 in 10 people)
- Fungal infections (especially of the vaginal or oral mucosa)
- 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
- Sleep disturbances
- Increased blood pressure
- Anaemia (low number of red blood cells)
- Dizziness
- Abdominal pain over the entire abdomen or certain parts of it
- Constipation
- Indigestion
- Pain in certain areas
Uncommon (may affect up to 1 in 100 people)
- Inflammation of the vagina or genital area in women
- Sensations such as tingling or feeling numb
- Swollen, sore or discoloured tongue
- Pain at and around the place where the infusion (drip) was given
- Inflammation of the veins (including where the infusion (drip) was given)
- A need to urinate more often
- Chills
- Feeling thirsty
- Increased sweating
- Changes in proteins, salts or enzymes in the blood which affect kidney or liver function
- Hyponatraemia (low levels of sodium in the blood)
- Kidney failure
- Reduced number of platelets in the blood
- Distended stomach
- Pain at the injection site
- Increased creatinine values
- Stomach ache
- Change in heart rhythm (e.g. more rapid heart beat)
Rare (may affect up to 1 in 1000 people)
- Superficial tooth discolouration, which can usually be removed by professional teeth cleaning
The following side effects have also been reported (not known: frequency cannot be estimated from the available data)
- Alopecia (hair loss)
- Reduction in number of blood cells
- Weakness and/or altered sensations
How to take:
Always use this medicine exactely as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
This medicine will be given to you through a drip (by infusion into a vein) by a doctor or healthcare professional. The recommended dose for adults (18 years and older) is 300 ml (600 mg linezolid) twice daily which is given directly into the blood stream (intravenously) by a drip over a period of 30 to 120 minutes.
If you are on kidney dialysis, you should be given this medicine 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 being given Linezolid Denk 2 mg/ml, your doctor should perform regular blood tests to monitor your blood count. Your doctor should monitor your eyesight if you are given this medicine for more than 28 days.
