Linobact Film-Coated Tablets

The active ingredient, linezolid, is an antibiotic of the so-called oxazolidinones group. It either stops the growth of certain types of bacteria (germs) or limits the growth of other types of bacteria that cause infections. LINOBACT FC tablets may be used for various infections.

Do not take LINOBACT FC:

• if you are hypersensitive (allergic) to linezolid or any of the other ingredients of LINOBACT FC (see WHAT LINOBACT FC CONTAINS);
• if you are treated with monoamine oxidase inhibitors (MAOIs), or within two weeks of taking such a medicine. MAOIs (such as phenelzine, selegiline, moclobemide) may be used to treat depression or Parkinson’s disease.

Take special care with LINOBACT FC:

While you are taking LINOBACT FC, your doctor may perform regular blood tests to monitor changes in your blood count (see POSSIBLE SIDE EFFECTS). Your doctor will monitor your eyesight if you take LINOBACT FC for more than 28 days (see POSSIBLE SIDE EFFECTS).

Tell your doctor:

• if you have diarrhoea. LINOBACT FC may cause serious, life-threatening diarrhoea and inflammation of your bowels (see POSSIBLE SIDE EFFECTS);
• if you develop recurrent nausea or vomiting, abdominal pain or rapid breathing. You may have a serious metabolic condition and need immediate medical treatment (see POSSIBLE SIDE EFFECTS);
• if you develop problems with your vision, such as blurred vision, changes in colour vision, difficulty in seeing detail or if your field of vision becomes restricted (see POSSIBLE SIDE EFFECTS);
• if you have been told that you have a low blood cell count (bone marrow suppression). Your doctor may want to check you more frequently and may tell you to avoid sick people to prevent infection;
• if you experienced agitation, confusion, coma, stiff muscles, trembling, poor coordination and fits while also taking certain antidepressants (see Taking other medicines with LINOBACT FC);
• if you have a history of seizures (“fits”);
• if you have high blood pressure and also tell your doctor what medicines you are taking for this (see Taking other medicines with LINOBACT FC);
• if you have been diagnosed with an overactive thyroid gland (symptoms may be increased appetite, weight loss or sweating);
• if 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);
• if you suffer from manic depression, schizoaffective disorder (a mental condition that causes both a loss of contact with reality and mood problems), mental confusion or other mental problems;
• if you have porphyria (a rare inherited blood disease); or
• if you have liver or kidney problems (especially if you have dialysis).

Do not share medicines prescribed for you with any other person. LINOBACT FC is a type of antibiotic that will normally be given to you in hospital, by a health care professional. The usual dose is:

Adults: Always take LINOBACT FC exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. Your doctor will decide what dose you should receive.

• The usual dose for adults and adolescents (12 years and older) is one tablet (600 mg linezolid) twice daily, which is taken per mouth, with water. It does not matter if you have eaten or not. If you are on kidney dialysis, you should be given LINOBACT FC after dialysis. A course of treatment usually lasts 10 to 14 days, but can last up to 28 days. Your doctor will tell you how long your treatment with LINOBACT FC will last. Do not stop treatment early, since a full course of antibiotic treatment is necessary to kill the germs that made you ill (see below under Effects when treatment with LINOBACT FC is stopped).

If you have the impression that the effect of LINOBACT FC is too strong or too weak, tell your doctor of pharmacist.

If you take more LINOBACT FC than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

Usually you will be in hospital while receiving LINOBACT FC. Tell your health care professional at once if you think you may have been given too much LINOBACT FC.

If you forget to take/missed a dose of LINOBACT FC

Do not take/receive a double dose to make up for forgotten individual doses. If you think you have missed a dose, please ask your doctor or healthcare professional.

Effects when treatment with LINOBACT FC is stopped

To completely clear your infection, you should take the full course of LINOBACT FC, as prescribed by your doctor. Your symptoms may improve before the infection is completely treated. Stopping early may have the effect that the germs causing the infection become resistant to LINOBACT FC.

LINOBACT FC can have side effects. Not all side effects reported for LINOBACT FC are included in this leaflet. Should your general health worsen, or if you experience any untoward effects while taking LINOBACT FC, please consult your doctor, pharmacist or other healthcare professional for advice.

If any of the following happens, stop taking LINOBACT FC and tell your doctor immediately:

• Serious allergic reactions, including a shock reaction. You may have swelling of the tongue and/or throat, difficulty in swallowing, difficulties in breathing, facial swelling, severe dizziness with very fast heartbeat and heavy sweating.
• Skin reactions such as hives (nettle rash), red sore skin and flaking (dermatitis), rash, itching, or swelling, particularly around the face and neck. These signs may be due to a severe allergic reaction and it may be necessary for you to stop taking LINOBACT FC.
• Recurrent nausea or vomiting, abdominal pain or over breathing. You may have developed lactic acidosis. This condition occurs when lactic acid builds up in the bloodstream faster than it can be removed and can be life-threatening.
• Severe diarrhoea containing blood and/or mucus (antibiotic associated colitis including pseudomembranous colitis), which can develop into complications that are life-threatening. In this situation, you should not take medicines that stop or slow bowel movement (such as loperamide).
• Unusual tiredness or weakness, which may be due to decrease in red blood cells, or their haemoglobin (iron-containing pigment) content may be too low.
• Decrease in certain white blood cells, which may affect your ability to fight infection.
• Unexplained bleeding or bruising that may be due to decrease in blood platelets.
• Fits or seizures (see Special care should be taken with LINOBACT FC).
• Fast heart rate, confusion, abnormal sweating, hallucinations, involuntary movements, chills and shivering. You may have developed serotonin syndrome. This happens when you have an excessive accumulation of serotonin in your body, which may occur when two medicines that affect the body's level of serotonin are taken together at the same time. See Taking other medicines with LINOBACT FC.
• Blurred vision, changes in colour vision, difficulty in seeing detail or if your field of vision becomes restricted.
• Loss of vision with leg and arm weakness, slurring of speech and loss of consciousness. You may have a “mini-stroke” due to temporary disturbance of blood flow to the brain. These are all very serious side effects. You may require urgent medical attention or further hospitalisation.

Tell your doctor if you notice any of the following:

Side effects occurring frequently:

• Fungal infections, especially vaginal or oral “thrush”
• Difficulty in sleeping
• Headache
• Metallic taste in the mouth
• Diarrhoea, nausea (feeling sick), vomiting (being sick), abdominal pain or cramps.

Side effects occurring less frequently:

• Inflammation of the vagina or genital area in women
• Dizziness, sensations such as tingling or numbness of fingers and toes
• Convulsions (“fits”)
• Blurred vision, changes in colour vision, difficulty in seeing detail or if your field of vision becomes restricted
• “Ringing” in the ears (tinnitus)
• Changes in heart rate (e.g., increased rate)
• Increased or decreased blood pressure (your doctor will test your blood pressure)
• Indigestion, stomach pain, constipation, thirst, loose stools
• Dry or sore mouth, swollen, sore, or discoloured tongue
• Hair loss, sweating, itching
• Superficial tooth discolouration, removable with professional dental cleaning (manual descaling)
• Excessive production of urine or small volumes of urine with swelling of the limbs and back pain (kidney problems)

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Store all medicines out of reach of children. Store at or below 30 °C in the original packaging. Keep bottle or blister strips in cartons until required for use. Keep bottles well-closed. Do not store in a bathroom. Do not take after the expiry date stated on the label and carton. Return all unused or expired medicine to your pharmacist for safe disposal. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).