Lidonit 600 mg Film-Coated Tablets

LIDONIT contains linezolid, an antibiotic belonging to a group of medicines called oxazolidinones.

LIDONIT is used to treat:

• infections resistant to the antibiotic vancomycin (e.g. infections of the urinary tract, blood or wound)
• pneumonia (a severe lung disease) contracted either inside or outside a hospital or healthcare facility

Do not take LIDONIT:

• if you are hypersensitive (allergic) to linezolid, or to any of the ingredients of LIDONIT (see section 5 6)
• if you are pregnant or breastfeeding your baby
• if you are taking, or have taken within the last 2 weeks, any medicines known as monoamine oxidase inhibitors (MAOIs e.g. phenelzine, isocarboxazid, moclobemide or selegiline). These medicines may be used to treat depression or Parkinson’s disease
• if you have high blood pressure
• if you have a tumour of the adrenal glands (pheochromocytoma) or carcinoid syndrome (caused by tumours of the hormone system with symptoms of diarrhoea, flushing of the skin or wheezing)
• if you suffer from a disorder associated with episodes of mood swings ranging from depressive lows to manic highs (bipolar disorder) or suffer from mental health condition including schizoaffective disorder and mood disorder symptoms or feeling abnormally confused for a short while
• if you are taking any of the following medicines: antidepressants known as tricyclics or SSRIs (selective serotonin reuptake inhibitors), medicines to treat migraines, those to treat moderate to severe pain, such as pethidine, decongestant and cold or flu remedies containing pseudoephedrine or phenylpropanolamine, medicines used to treat asthma such as salbutamol, terbutaline, fenoterol, medicines used to treat anxiety disorders, medicines to raise your blood pressure (vasopressors such as epinephrine (adrenaline), norepinephrine (noradrenaline)), medicines to treat low blood pressure, low heart rate, and cardiac arrest

Warnings and precautions

Take special care with LIDONIT:

• if you have diarrhoea, pain and abdominal cramping
• if you are anaemic (reduction in red blood cells which can make the skin pale and cause weakness or breathlessness)
• if you bruise or bleed easily
• if you have liver or kidney problems, especially if you are on dialysis
• if you have a history of seizures (fits)
• if you are prone to infections
• if you have any foot related sores/lesions due to diabetes, bed sores, severe burns or gangrene.

Tell your doctor immediately if during treatment with LIDONIT you suffer from:

• problems with your vision, such as blurred or loss of vision, changes to the colours you normally see, difficulty seeing detail or your field of vision becomes restricted. Your doctor may want to monitor your progress by conducting regular blood and eye tests during therapy with LIDONIT, especially if you are taking this medicine for extended periods.
• recurrent nausea or vomiting, abdominal pain or breathing too quickly
• severe diarrhoea containing blood and/or mucus which in very rare circumstances may develop into complications that are life-threatening
• fast heart rate, confusion, abnormal sweating, hallucinations, involuntary movements, chills and shivering

Do not share medicines prescribed for you with any other person. Always use LIDONIT exactly as your doctor has told you. You should check with your doctor or pharmacist if you are unsure.

Adults and adolescents (12 years and older): The usual dose is one LIDONIT tablet every 12 hours. LIDONIT may be taken with or without food.

Children: LIDONIT is not normally used to treat children below the age of 12 years. Your doctor will tell you how long your treatment with LIDONIT will last. Do not stop treatment early because your infection may return.

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

If you take more LIDONIT 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. Take the medicine pack with you. Symptoms of overdose may include:

• decreased activity, loss of muscle control, vomiting and tremors.

If you forget to take LIDONIT

If you forget to take LIDONIT, take as soon as you remember then take the next tablet 12 hours after this and continue taking your tablets every 12 hours. Do not take a double dose to make up for forgotten individual doses.

If you stop taking LIDONIT

Unless your doctor instructs you to stop treatment, it is important to continue taking LIDONIT. If you stop and your original symptoms come back tell your doctor or pharmacist immediately.

LIDONIT can have side effects. Not all side effects reported for LIDONIT are included in this leaflet. Should your general health worsen, or if you experience any untoward effects while using LIDONIT, please consult your healthcare provider for advice.

If any of the following happens, stop using LIDONIT and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing
• rash or itching
• fainting

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to LIDONIT. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• severe diarrhoea containing blood and/or mucus which in very rare circumstances may develop into complications that are life-threatening
• problems with your vision, such as blurred or loss of vision, changes to the colours you normally see, difficulty seeing detail or your field of vision becomes restricted
• recurrent nausea or vomiting, abdominal pain or breathing too quickly
• fits or seizures
• changes in heart rate (e.g. increased heart rate), blood clots or inflammation of a vein
• inflammation of the pancreas, kidney failure
• Stevens-Johnson syndrome or other serious skin disorder (begins with flu-like symptoms, followed by a painful red or purplish rash that spreads and blisters).

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• fungal infections especially vaginal or oral ‘thrush’
• anaemia
• headache, metallic taste in mouth, dizziness
• insomnia
• high blood pressure
• abdominal pains or cramps, bloated stomach, diarrhoea, feeling or being sick, indigestion, constipation
• abnormal blood test results
• severe itching of the skin, rash
• fever, pain in a specific area of your body
• abnormal urine test results

Less frequent side effects:

• inflammation of the vagina or genital area in women
• swelling or inflammation of the large intestine (colon) due to an overgrowth of Clostridium difficile (C difficile) bacteria. This infection is a common cause of diarrhoea after antibiotic use
• unexplained bleeding or bruising, which may be due to changes in the number of certain cells in the blood which may affect blood clotting or lead to anaemia, low red or white blood cells with symptoms including easy bruising, nose bleeds, bleeding of the gums, or mouth, tiny red spots on the skin
• changes in some blood test results including those measuring your kidney or liver function, or blood sugar levels, reduced sodium levels in the blood (symptoms may include nausea, headache, confusion and fatigue)
• convulsions, sensations such as tingling or feeling numb
• blurred vision and damage to the optic nerve
• ringing in the ears (tinnitus)
• low blood pressure, 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)
• dry or sore mouth, stomach and stomach lining inflammation, swollen sore or discoloured tongue (due to inflammation of the tongue), increased thirst, superficial tooth discolouration, removable with professional dental cleaning (descaling)
• a need to urinate more often
• mild skin reactions or skin rash, excessive sweating, hives
• chills, feeling extremely tired, increased thirst.

The following side effects have been reported but the frequency for them to occur is not known:

• myelosuppression (a bone marrow disorder with symptoms may include pale skin and lips, pale nails, fatigue, feeling dizzy or weak, headaches, shortness of breath, rapid breathing)
• sideroblastic anaemia (when the bone marrow fails to produce a sufficient number of healthy red blood cells)
• serotonin syndrome (symptoms include fast heart rate, confusion, abnormal sweating, hallucinations, involuntary movements, chills and shivering)
• inflammation of the optic nerve
• hair loss.

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

Reporting of side effects

If you get side effects, talk to your doctor or pharmacist. You can also report side effects to SAHPRA via the online service for adverse drug reaction reporting by following the link: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of LIDONIT. An email can be sent directly to the company, [email protected] to ensure safety of the product.

Store all medicines out of reach of children.

Store at or below 30 °C. Protect from moisture.

Keep tablets in blister until time for use. Keep blisters in the carton until required for use. Do not use after the expiry date stated on the carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).