Patient leaflet - Teicoplanin 200 mg powder and solvent for solution for injection/infusion or oral solution
1. What Teicoplanin is and what it is used for
Teicoplanin 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 are given Teicoplanin
Do not use 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 you are given teicoplanin if:
you are allergic to an antibiotic called 'vancomycin' · you have had a flushing of your upper part of your body (red man
syndrome)
- you have a decrease in platelet count (thrombocytopenia) · you have kidney problems
you are taking other medicines which may cause hearing problems
and/or kidney problems. You may have regular tests to check if your 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 are given teicoplanin.
Serious skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP) have been reported with the use of teicoplanin. If you develop a serious rash or other skin symptoms as described in section 4, stop taking teicoplanin and contact your doctor or seek medical attention immediately.
Tests
During treatment you may have tests to check your blood, your kidneys, your liver and/or your hearing. This is more likely if: · your treatment will last for a long time
you need to be treated with high loading doses (12mg/kg twice a
day)
- 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 are given 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 using, have recently used or might use 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 tumors 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 being given 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 being given 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 being given this medicine. He/she will decide whether or not you can keep breast-feeding, while you are given teicoplanin.
Studies in animal 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 use Teicoplanin The recommended dose is Adults and children (12 years and over) with no kidney problems Skin and soft tissue, lung and urinary tract infections
- Starting dose (for the first three doses): 6 mg for every kilogram of body weight, given every 12 hours, by injection into a vein or muscle
- Maintenance dose: 6 mg for every kilogram of body weight, given once a day, by injection into a vein or muscle
Bone and joint infections, and heart infections
- Starting dose (for the first three to five doses): 12 mg for every kilogram of body weight, given every 12 hours, by injection into a vein
- Maintenance dose: 12 mg for every kilogram of body weight, given once a day, by injection into a vein or muscle
Infection caused by 'Clostridium difficile' bacteria
The recommended dose is 100 to 200 mg by mouth, twice a day for 7 to 14 days.
Adults and elderly patients with kidney problems
If you have kidney problems, your dose will usually need to be lowered after the fourth day of treatment:
- For people with mild and moderate kidney problems - the maintenance dose will be given every two days, or half of the maintenance dose will be given once a day.
- For people with severe kidney problems or on haemodialysis - the maintenance dose will be given every three days, or one-third of the maintenance dose will be given once a day.
Peritonitis for patients on peritoneal dialysis
The starting dose is 6 mg for every kilogram of body weight, as a single injection into a vein, followed by:
- Week one: 20 mg/L in each dialysis bag
- Week two: 20 mg/L in every other dialysis bag
- Week three: 20 mg/L in the overnight dialysis bag.
Babies (from birth to the age of 2 months)
- Starting dose (on the first day): 16 mg for every kilogram of body weight, as an i nfusion through a drip into a vein.
- Maintenance dose: 8 mg for every kilogram of body weight, given once a day, as an infusion through a drip into a vein.
- Ringer solution
- Ringer-lactate solution
- 5% dextrose injection
- 10% dextrose injection
- 0.45% sodium chloride and 5% glucose solution
- 0.18% sodium chloride and 4% glucose solution
- Peritoneal dialysis solution containing 3.86% glucose Solution.
Shelf life of reconstituted solution:
Chemical and physical in-use stability of the reconstituted solution prepared as recommended has been demonstrated for 24 hours at 2° to 8°C.
From a microbiological point of view, the medicinal product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.
Shelf life of diluted medicinal product:
Chemical and physical in-use stability of the diluted solution prepared as recommended has been demonstrated for 2°-8°C for 24 hours followed by 15°-30°C for 1 hour.
From a microbiological point of view, the medicinal product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C followed by 1 hour at 20-25°C, unless dilution has taken place in controlled and validated aseptic conditions.
Disposal
Any unused medicine or waste material should be disposed of in accordance with local requirements.
Children (from 2 months to 12 years)
Starting dose (for the first three doses): 10 mg for every kilogram
of body weight, given every 12 hours, by injection into a vein. · Maintenance dose: 6 to 10 mg for every kilogram of body weight,
given once a day, by injection into a vein.
How Teicoplanin is given
The medicine will normally be given to you by a doctor or nurse. · It will be given by injection into a vein (intravenous use) or
muscle (intramuscular use).
- It can also be given as a infusion through a drip into a vein. Only the infusion should be given in babies from birth to the age of 2 months.
To treat certain infections, the solution may be taken by mouth (oral use).
If you have more Teicoplanin than you should
It is unlikely that your doctor or nurse will give you too much medicine. However, if you think you have been given too much teicoplanin or if you are agitated, talk to your doctor or nurse straight away.
If you forget to have Teicoplanin
Your doctor or nurse will have instructions about when to give you teicoplanin. It is unlikely that they will not give you the medicine as prescribed. However, if you are worried, talk to your doctor or nurse.
If you stop having Teicoplanin
Do not stop having this medicine without first talking to your doctor, pharmacist or nurse.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
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'
red scaly widespread rash with bumps under the skin (including
your skin folds, chest, abdomen, (including stomach), back and arms) and blisters accompanied by fever - these may be symptoms of something called 'Acute generalized exanthematous pustulosis (AGEP)'
'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)
- low levels of all types of blood cells
kidney problems or changes in the way your kidneys work -
shown in tests. Frequency or severity of kidney problems may be increased if you receive higher doses
- 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 Yellow Card Scheme website www.mhra.gov.uk/yellowcard 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 this medicine after the expiry date which is stated on the carton and label of the vial 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
What Teicoplanin contains
The active substance is teicoplanin.
Each vial contains 200 mg teicoplanin equivalent to not less than 200,000 IU.
Each vial contains 400 mg teicoplanin equivalent to not less than 400,000 IU.
The other ingredients are:
Powder for solution for injection/infusion or oral solution: Sodium chloride and sodium hydroxide (for pH adjustment). Solvent: Water for injection.
What Teicoplanin looks like and contents of the pack
Teicoplanin 200 mg & 400mg Powder for solution for injection/infusion or oral solution. The powder is a white to yellowish lyophilized cake or powder. The solvent is a clear, colourless liquid.
Primary packaging:
The freeze-dried medicinal product is packaged in:
200 mg/vial
Clear tubular Lyo glass vial EP type-I with Stopper Igloo GBB Lyo with Flip off seal glossy top (Lemon Yellow).
400 mg/vial
Clear tubular Lyo glass vial EP type-I with Stopper Igloo GBB Lyo with Flip off seal glossy top (New parrot green).
Water for injections is packaged in 3 mL Fiolax clear white OPC DOT ampoule.
Pack sizes:
1 powder vial with 1 solvent ampoule.
5x1 powder vials with 5x1 solvent ampoules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Amarox Limited
Congress House, 14 Lyon Road
Harrow, HA1 2EN
United Kingdom
This leaflet was last revised in 08/2026.
2097520