Targocid ® Oral Solution

TARGOCID is an antibiotic and is used to treat potentially serious infections caused by certain types of bacteria known as Gram positive organisms. These include infections of:

• the heart - sometimes called ‘endocarditis’
• the blood, when caused by any of the conditions listed here
• the bones and joints
• the respiratory track, e.g. the lungs
• the skin and underneath the skin - sometimes called ‘soft tissue’
• the urinary tract (kidneys and bladder)
• the abdominal wall (peritonitis) associated with chronic ambulatory peritoneal dialysis (CAPD). CAPD is done to remove wastes, chemicals, and extra fluid from your body.

TARGOCID may be used to prevent infection caused by Gram-positive bacteria in patients undergoing orthopaedic surgery (involving bones or joints) and vascular (involving veins) surgery who are at risk of Gram-positive infection. TARGOCID can be used to treat antibiotic associated diarrhoea caused by Clostridium difficile bacteria in the gut. For this, the solution is taken by mouth.

BEFORE YOU ARE GIVEN TARGOCID: You should not be given TARGOCID if:

• you are hypersensitive (allergic) to teicoplanin
• you are pregnant or
• you are breastfeeding
• you have severe renal failure, unless your blood levels can be monitored closely.

TARGOCID should not be given to children under 3 years of age. TARGOCID must not be injected into the subarachnoid space between the two membranes surrounding the brain.

Take special care with TARGOCID: Tell your doctor or healthcare professional before you are given this injection if:

• you are allergic to an antibiotic called vancomycin. You may also experience an allergic reaction to TARGOCID which can be very serious
• you have kidney problems
• you have a decrease in platelet count (thrombocytopenia)
• you are taking other medicines which may cause hearing problems and/or kidney problems (see Using other medicines with TARGOCID).

You may require regular tests during treatment to check your blood, hearing, kidneys and/or liver. Testing is more likely if:

• your treatment will last for a long time
• you have a kidney problem
• you are taking or may take other medicines that may affect your nervous system, kidneys or hearing.

HOW TO RECEIVE TARGOCID: Do not share medicines prescribed for you with any other person. You will not be expected to give yourself TARGOCID. It will be given to you by a person qualified to do so, as it needs to be given as an injection into a muscle or a vein, or as an infusion through a drip into a vein. Your doctor will have prescribed the dose of TARGOCID which is correct for you, as well as the length of your treatment, depending on the type and severity of the infection you may have and your response to the treatment. Your progress will be monitored during the treatment.

If you have the impression that the effect of TARGOCID is too strong or too weak, tell your doctor or health care provider.

Moderate infection: The usual adult dose of TARGOCID is 400 mg on the first day of treatment, followed by 200 mg once daily.

Severe infection: The usual adult dose of TARGOCID is 400 mg every 12 hours for the first 3 doses, followed by 400 mg once daily. For some severe infections, you will receive higher doses for at least 3 weeks of treatment. However, if you suffer from kidney problems, you may be given a lower dose of TARGOCID from the fourth day of treatment. The dose of TARGOCID given to children (aged 3 years and above) will be calculated according to the weight of the child. A single dose of 400 mg TARGOCID may also be used for the prevention of infections prior to surgery. A dose of 200 mg TARGOCID twice a day for 10 days can also be given by mouth to treat inflammation of the large intestine (gut), caused by infection of bacteria called Clostridium difficile. You should not receive TARGOCID for more than 4 months.

If you receive more TARGOCID than you should: Since a health care professional will administer TARGOCID, he/she will control the dosage. However, if you think you have been given too much TARGOCID or if you are agitated, talk to your doctor or health care provider straight away. In the event of over-dosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre. If you missed a dose of TARGOCID: Since your healthcare professional will have instructions on when to give TARGOCID, it is most unlikely that you will not be given the dose as it has been prescribed. However, if you do think you have missed a dose, talk to your doctor or health care professional.

POSSIBLE SIDE EFFECTS: TARGOCID can have side effects. If any of the following happens, stop receiving TARGOCID and tell your doctor or health care professional immediately or go to the casualty department at your nearest hospital:

Frequency unknown:

• sudden life-threatening allergic reaction, the signs may include: difficulty in breathing or wheezing (bronchospasm), swelling (e.g. of the face and lips or tongue), rash, itching, fever, chills
• DRESS syndrome (medicine reaction with eosinophilia and systemic symptoms). DRESS appears initially with flu-like symptoms and rash on the face, followed by extended rash with a high temperature. Abnormal blood test results include an increase in liver enzymes and a type of white blood cells (eosinophilia) as well as enlarged lymph nodes.

Less frequent:

• blistering of the skin, mouth, eyes or genitals - these may be signs of a side effect called Toxic Epidermal Necrolysis or Stevens-Johnson syndrome
• flushing of the upper body (Red-man syndrome). These are all very serious side effects (see Take Special Care with TARGOCID). If you have them, you may have had a serious reaction to TARGOCID. You may need urgent medical attention or hospitalisation.

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

• Less frequent: fits (seizures)
• lack of white blood cells - the signs may include: fever, severe chills, sore throat or mouth ulcers (agranulocytosis)

Frequency unknown:

• swelling and clotting in a vein near the injection site
• kidney problems or changes in the way your kidneys work (shown in tests) such as raised blood levels of creatinine or symptoms like a reduced amount of urine, swelling and fatigue. These are all serious side effects. You may need urgent medical attention.

Tell your doctor or health care professional if you notice any of the following:

• Less frequent: decrease in platelet count
• getting more infections than usual. This could be due to a decrease in your blood cell count
• feeling or being sick (vomiting), diarrhoea or other stomach and intestine problems
• feeling dizzy or headache.

Frequency unknown:

• raised blood levels of liver enzymes (shown in test to monitor your liver)
• problems where the injection was given - such as reddening of the skin, pain or swelling
• infection (abscess) at the injection site.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist. Not all side-effects reported for TARGOCID are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking TARGOCID, please consult your doctor, pharmacist or other health care professional for advice.

STORING AND DISPOSING OF TARGOCID: Vials of TARGOCID must be stored at or below 25 °C. Reconstituted vials of TARGOCID should be used immediately; may be retained for 24 hours if stored at 2 to 8 °C. This product is for single use only. The unused portion should be discarded. Store all medicine out of reach of children. Do not use this medicine after the expiry date shown on the label. Return all unused medicine to your pharmacist.