Patient leaflet - TEICOPLANIN 400 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION OR ORAL SOLUTION
Teicoplanin 200 mg
Powder for solution for Injection/infusion or oral solution teicoplanin
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, pharmacist or nurse.
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
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1. What Teicoplanin is and what it is used for
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2. What you need to know before you take Teicoplanin
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3. How to take Teicoplanin
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4. Possible side effects
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5. How to store Teicoplanin
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6. Contents of the pack and other information
1. what teicoplanin is and whatit is used forteicoplanin is an antibiotic. it contains a medicine called ‘teicoplanin’. it works by killing the bacteria that cause infections in your body.
Teicoplanin is used in adults and children (including newborn babies) to treat bacterial infections of:
- the skin and underneath the skin – sometimes called ‘soft tissue’
- the bones and joints
- the lung
- the urinary tract
- the heart – sometimes called ‘endocarditis’
- the abdominal wall – peritonitis
- the blood, when caused by any of the conditions listed above
Teicoplanin can be used to treat some infections caused by ‘Clostridium difficile’ bacteria in the gut. For this, the solution is taken by mouth.
2. what you need to know before you take teicoplanin
Do not take Teicoplanin:
- if you are allergic to teicoplanin or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Teicoplanin:
- if you are allergic to an antibiotic called ‘vancomycin’
- if you have a flushing of your upper part of your body (red man syndrome)
- if you have a decrease in platelet count (thrombocytopenia)
- if you have kidney problems
- if you are taking other medicines which may cause hearing problems and/or kidney problems. You may have regular tests to check if your blood, kidneys and/or liver are working properly (see ‘Other medicines and Teicoplanin).
If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before you take Teicoplanin.
Tests
During treatment you may have tests to check your kidneys and/or your hearing. This 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.
In people who take Teicoplanin for a long time, bacteria that are not affected by the antibiotic may grow more than normal – your doctor will check for this.
Other medicines and Teicoplanin
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. This is because Teicoplanin can affect the way some other medicines work. Also, some medicines can affect the way Teicoplanin works.
In particular, tell your doctor, pharmacist or nurse if you are taking the following medicines:
- Aminoglycosides as they must not be mixed together with Teicoplanin in the same injection. They may also cause hearing problems and/or kidney problems.
- amphotericin B – a medicine that treats fungal infections which may cause hearing problems and/or kidney problems
- ciclosporin – a medicine that affects the immune system which may cause hearing problems and/or kidney problems
- cisplatin – a medicine that treats malignant tumours which may cause hearing problems and/or kidney problems
- water tablets (such as furosemide) – also called ‘diuretics’ which may cause hearing problems and/or kidney problems.
If any of the above apply to you, (or you are not sure), talk to your doctor, pharmacist or nurse before taking Teicoplanin.
Pregnancy, breast-feeding and fertility
If you are pregnant, think that you might be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before taking this medicine. They will decide whether or not you are given this medicine while you are pregnant. There may be a potential risk of inner ear and kidney problems.
Tell your doctor if you are breast-feeding, before using this medicine. They will decide whether or not you can keep breast-feeding, while you are given Teicoplanin. Studies in animals reproduction have not shown evidence of fertility problems.
Driving and using machines
You may have headaches or feel dizzy while being treated with Teicoplanin. If this happens, do not drive or use any tools or machines.
Teicoplanin contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per vial and is essentially ‘sodium-free’.
3. how to take teicoplanin
Teicoplanin 200 mg
Powder for solution for Injection/infusion or oral solution teicoplanin
The following information is intended for medical or healthcare professionals only:
Practical information for healthcare professionals on preparation and handling of Teicoplanin.
This medicine is for single use only.
Method of administration
The reconstituted solution may be injected directly or alternatively further diluted.
The injection will be given either as a bolus over 3 to 5 minutes or as a 30-minute infusion. Only the infusion should be given in babies from birth to the age of 2 months.
The reconstituted solution may also be given by mouth.
Preparation of reconstituted solution
- Slowly inject 3.14 ml of water for injections into the powder vial.
- Gently roll the vial between the hands until the powder is completely dissolved. If the solution does become foamy, then it should be left to stand for about 15 minutes.
The reconstituted solutions will contain 200 mg of teicoplanin in 3.0 ml and 400 mg in
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3.0 ml.
Only clear and yellowish solutions should be used.
The final solution is isotonic with plasma and has a pH of 6.0–8.0.
| Nominal teicoplanin content of vial | 200 mg | 400 mg |
| Volume of powder vial | 10 ml | 20 ml |
| Volume containing nominal teicoplanin dose (extracted by 5 mL syringe and 23 G needle) | 3.0 ml | 3.0 ml |
4. possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Stop your treatment and tell your doctor or nurse straight away, if you notice any of the following serious side effects – you may need urgent medical treatment:
- Uncommon (may affect up to 1 in 100 people) sudden life-threatening allergic reaction – the signs may include: difficulty in breathing or wheezing, swelling, rash, itching, fever, chills
- Rare (may affect up to 1 in 1000 people) flushing of the upper body
Not known (frequency cannot be estimated from the available data)
- blistering of the skin, mouth, eyes or genitals – these may be signs of something called ‘toxic epidermal necrolysis’ or ‘Stevens-Johnson syndrome’ or ‘drug reaction with eosinophilia and systemic symptoms (DRESS)’. DRESS appears initially as flu-like symptoms and a rash on the face then an extended rash with a high temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes.
Tell your doctor or nurse straight away, if you notice any of the side effects above.
Tell your doctor or nurse straight away, if you notice any of the following serious side effects – you may need urgent medical treatment:
Uncommon (may affect up to 1 in 100 people)
- swelling and clotting in a vein
- difficulty in breathing or wheezing (bronchospasm)
- getting more infections than usual – these could be signs of a decrease in your blood cell count
Not known (frequency cannot be estimated from the available data)
- lack of white blood cells – the signs may include: fever, severe chills, sore throat or mouth ulcers (agranulocytosis)
- kidney problems or changes in the way your kidneys work – shown in tests
- epileptic fits
Tell your doctor or nurse straight away, if you notice any of the side effects above.
Other side effects
Talk to your doctor, pharmacist or nurse if you get any of these:
Common (may affect up to 1 in 10 people)
- Rash, erythema, pruritus
- Pain
- Fever
Uncommon (may affect up to 1 in 100 people)
- decrease in platelet count.
- raised blood levels of liver enzymes
- raised in blood levels of creatinine (to monitor your kidney)
- hearing loss, ringing in the ears or a feeling that you, or things around you are moving
- feeling or being sick (vomiting), diarrhoea
- feeling dizzy or headache
Rare (may affect up to 1 in 1,000 people)
- infection (abscess).
Not known (frequency cannot be estimated from the available data)
- problems where the injection was given – such as reddening of the skin, pain or swelling
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. how to store teicoplanin
Keep this medicine out of the sight and reach of children.
Do not use Teicoplanin after the expiry date which is stated on the label and carton, after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Information about storage and the time to use Teicoplanin, after it has been reconstituted and is ready to use, are described in the ‘Practical information for healthcare professionals on preparation and handling of Teicoplanin’
6. contents of the pack and other information
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Preparation of the diluted solution before infusion
Teicoplanin can be administered in the following infusion solutions:
- Sodium chloride 9 mg/ml (0.9%) solution
- Ringer solution
- Ringer-lactate solution
- 5% dextrose injection
- 10% dextrose injection
- 0.18% sodium chloride and 4% glucose solution
- 0.45% sodium chloride and 5% glucose solution
- Peritoneal dialysis solution containing 1.36% or 3.86% glucose solution.