Teicoplanin Accord 200 mg powder for solution for injection and for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Teicoplanin Accord 400 mg powder for solution for injection and infusion EFG

This medicinal product is subject to additional monitoring, which will allow quicker detection of new safety information. You can help by reporting any side effects you may experience. See the end of section 4 for information on how to report side effects.

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

Leaflet contents

1. What Teicoplanin Accord is and what it is used for
2. What you need to know before using Teicoplanin Accord
3. How to use Teicoplanin Accord
4. Possible side effects
5. How to store Teicoplanin Accord
6. Contents of the pack and other information

1. What Teicoplanina Accord is and what it is used for

Teicoplanina Accord 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 newborns) to treat infections in:

• The skin and beneath the skin – sometimes referred to as "soft tissues"
• Bones and joints
• The lung
• The urinary tract
• The heart – sometimes referred to as "endocarditis"
• The abdominal wall – peritonitis
• The blood, when caused by any of the conditions listed above

Teicoplanin may be used to treat certain infections caused by the bacterium "Clostridium difficile" in the intestine. In this case, the solution should be taken orally.

2. What you need to know before starting Teicoplanin Accord

Do not use this medicine:

• If you are allergic to teicoplanin or to 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 Accord if:

• You are allergic to an antibiotic called "vancomycin"

• You have had redness on the upper part of your body (red man syndrome)

• You have a low platelet count (thrombocytopenia)

• You have kidney problems

• You are taking other medicines that may cause hearing and/or kidney problems.

You may have regular tests to check whether your kidneys and/or liver are functioning properly (see "Use of Teicoplanin Accord with other medicines").

If any of the above conditions apply to you (or if you are unsure), inform your doctor, pharmacist, or nurse before you are given this medicine.

Severe skin reactions have been reported with the use of teicoplanin, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). If you develop a severe rash or other skin symptoms as described in section 4, stop taking Targocid and contact your doctor or seek immediate medical attention.

Tests

During treatment, you may have tests to monitor your blood, kidneys, liver, and/or hearing. This is more likely if:

• Your treatment will last for a long period
• You require high loading doses (12 mg/kg twice daily)
• You have kidney problems
• You are taking or may take other medicines that could affect your nervous system, kidneys, or hearing.

In people receiving Teicoplanin Accord for a prolonged period, bacteria not affected by the antibiotic may grow excessively—your doctor will monitor this.

Use of Teicoplanin Accord with other medicines

Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might need to take any other medicines. This is because Teicoplanin Accord may affect how other medicines work. In addition, some medicines may affect how Teicoplanin Accord works.

In particular, inform your doctor if you are taking any of the following medicines:

• Aminoglycosides, as they must not be mixed with Teicoplanin Accord in the same injection. They may also cause hearing and/or kidney problems
• Amphotericin B – an antifungal medicine that may cause hearing and/or kidney problems
• Cyclosporine – an immunosuppressant medicine that may cause hearing and/or kidney problems
• Cisplatin – an anticancer medicine that may cause hearing and/or kidney problems
• Diuretics (such as furosemide), also known as "water tablets," which may cause hearing and/or kidney problems.

If any of the above conditions apply to you (or if you are unsure), inform your doctor, pharmacist, or nurse before you are given this medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor, pharmacist, or nurse before you are given this medicine. They will decide whether or not you should be given this medicine during pregnancy. There may be a potential risk of inner ear and kidney problems.

Inform your doctor if you are breastfeeding before you are given this medicine. They will decide whether or not you can continue breastfeeding while receiving Teicoplanin Accord.

Animal reproduction studies have not shown evidence of impaired fertility.

Driving and using machines

You may experience headaches or feel dizzy while being treated with Teicoplanin Accord. If this happens, do not drive or operate tools or machinery.

Teicoplanin Accord contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per vial, which is essentially "sodium-free."

3. How to take Teicoplanin Accord

Recommended dose

Adults and children (12 years or older) with normal kidney function

Skin and soft tissue, lung, and urinary tract infections

• Initial dose (for the first three doses): 400 mg (equivalent to 6 mg per kilogram of body weight), administered every 12 hours by intravenous or intramuscular injection.
• Maintenance dose: 400 mg (equivalent to 6 mg per kilogram of body weight), administered once daily by intravenous or intramuscular injection.

Bone and joint infections, and heart infections

• Initial dose (for the first three to five doses): 800 mg (equivalent to 12 mg per kilogram of body weight), administered every 12 hours by intravenous or intramuscular injection.
• Maintenance dose: 800 mg (equivalent to 12 mg per kilogram of body weight), administered once daily by intravenous or intramuscular injection.

Infection caused by the bacterium “Clostridium difficile”

The recommended dose is 100 to 200 mg orally, twice daily for 7 to 14 days.

Adults and elderly patients with kidney problems

If you have kidney problems, your dose will usually need to be reduced after the fourth day of treatment:

• For patients with mild to moderate kidney impairment – the maintenance dose should be administered every two days, or half the maintenance dose should be given once daily.
• For patients with severe kidney impairment or undergoing hemodialysis – the maintenance dose should be administered every three days, or one-third of the maintenance dose should be given once daily.

Treatment of peritonitis in patients undergoing peritoneal dialysis

Initial dose: 6 mg per kilogram of body weight, as a single intravenous injection, followed by:

• Week one: 20 mg/l in each dialysis bag.
• Week two: 20 mg/l in alternate dialysis bags.
• Week three: 20 mg/l in the dialysis bags used overnight.

Infants (from birth up to 2 months of age)

• Initial dose (on day one): 16 mg per kilogram of body weight, administered as an intravenous infusion by slow drip.
• Maintenance dose: 8 mg per kilogram of body weight, administered once daily as an intravenous infusion by slow drip.

Children (from 2 months to 12 years of age)

• Initial dose (for the first three doses): 10 mg per kilogram of body weight, administered every 12 hours by intravenous injection.
• Maintenance dose: 6 to 10 mg per kilogram of body weight, administered once daily by intravenous injection.

How Teicoplanin Accord is administered

This medicine will normally be administered by a doctor or nurse.

• It is given by intravenous or intramuscular injection.
• It may also be given by intravenous infusion (slow drip).

Intravenous infusion should only be used in infants from birth up to the age of two months.

For the treatment of certain infections, the solution may be administered orally.

If you use more Teicoplanin Accord than you should

It is unlikely that your doctor or nurse will administer too much medicine. However, if you think you have received too much Teicoplanin Accord, or if you feel unwell, speak to your doctor or nurse immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, stating the medication and the amount ingested. It may be necessary to go to a hospital. It is recommended to bring the medicine’s packaging and leaflet to the healthcare professional.

If you forget to take Teicoplanin Accord

Your doctor or nurse will have specific instructions on when to administer Teicoplanin Accord. It is unlikely that the medicine will not be administered as prescribed. However, if you are concerned, speak to your doctor or nurse.

If you stop using Teicoplanin Accord

Do not stop this treatment without first talking to your doctor, pharmacist, or nurse.

If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Serious adverse effects

Stop treatment with TeicoplaninaAccord immediately and contact a doctor or nurse if you notice any of the following serious adverse effects – you may need urgent medical treatment:

Uncommon (may affect up to 1 in 100 people)

• Sudden, life-threatening allergic reaction – signs may include: difficulty breathing or wheezing, swelling, skin rash, itching, fever, chills

Rare (may affect up to 1 in 1,000 people)

• Redness of the upper body

Frequency not known (cannot be estimated from available data)

• Appearance of blisters on the skin, mouth, eyes or genitals – these could be signs of a condition called
• "Toxic epidermal necrolysis" or "Stevens-Johnson syndrome"
• widespread red, scaly rash with bumps under the skin (including skin folds, chest, abdomen (including stomach), back and arms) and blisters accompanied by fever – these may be symptoms of a condition called "Acute generalized exanthematous pustulosis (AGEP)".
• or "Drug reaction with eosinophilia and systemic symptoms (DRESS)". DRESS initially appears as flu-like symptoms and a rash on the face, which spreads along with fever, increased liver enzyme levels in blood tests, increased number of a type of white blood cells (eosinophilia), and swollen lymph nodes.

Inform your doctor or nurse immediately if you experience any of the above-mentioned adverse effects.

Inform your doctor or nurse immediately if you experience any of the following serious adverse effects – you may need urgent medical treatment:

Uncommon (may affect up to 1 in 100 people)

• Inflammation and blood clot in a vein
• Difficulty breathing and wheezing (bronchospasm)
• If you get more infections than usual – these could be signs of a decrease in your blood cell count.

Frequency not known (cannot be estimated from available data)

• Lack of white blood cells in the blood – signs may include: fever, severe chills, sore throat or mouth ulcers (agranulocytosis)
• Kidney problems or changes in kidney function – shown in blood tests
• The frequency or severity of kidney problems may increase if you receive higher doses.
• Seizures

Inform your doctor or nurse immediately if you experience any of the above-mentioned adverse effects.

Other adverse effects

Talk to your doctor, pharmacist, or nurse if you experience any of the following adverse effects:

Common (may affect up to 1 in 10 people)

• Skin rash, erythema, itching
• Pain
• Fever

Uncommon (may affect up to 1 in 100 people)

• Decrease in platelet count
• Increased blood levels of liver enzymes
• Increased blood levels of creatinine (to monitor your kidney)
• Hearing loss, ringing in the ears, or sensation that you or things around you are moving
• Nausea or vomiting, diarrhea
• Dizziness or headache

Rare (may affect up to 1 in 1,000 people)

• Infection (abscesses)

Frequency not known (cannot be estimated from available data)

• Problems at the injection site – such as redness, pain or swelling
• Low levels of all types of blood cells

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Teicoplanina Accord

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and label of the vial after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C. Store in the original packaging.

Information on storage and the time for use of Teicoplanina Accord once reconstituted and ready for administration is detailed in "Practical information for healthcare professionals on the preparation and handling of Teicoplanina Accord".

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Teicoplanina Accord

• The active substance is teicoplanin. Each vial contains 200 mg of teicoplanin.
• The other component is sodium chloride.

Appearance of the product and contents of the pack

Teicoplanina Accord is a powder for injectable solution and for infusion. The powder is a sterile, lyophilized, endotoxin-free powder of white or slightly beige color.

The powder is contained in a colorless type II glass vial with a useful volume of 10 ml, closed with a chlorobutyl rubber stopper and flip-off cap.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n
Edifici Est, 6th floor
08039 Barcelona

Manufacturer

Laboratorio Reig Jofré, S.A.

Gran Capitán, 10 - Sant Joan Despí
08970 Barcelona
Spain

Date of the most recent revision of this leaflet: July 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/

This information is intended for healthcare professionals only:

Practical information for healthcare professionals on the preparation and handling of Teicoplanina Accord.

This medicinal product is for single use only.

Method of administration

The reconstituted solution may be administered either directly by injection or alternatively in diluted form.

The injection may be given either as a bolus over 3–5 minutes or by infusion over 30 minutes. In infants from birth up to two months of age, administration must be by infusion only.

The reconstituted solution may also be administered orally.

Preparation of the reconstituted solution:

• Slowly inject 3 ml of water for injections into the vial containing the powder.
• Gently rotate the vial between the hands until the powder is completely dissolved. If foam appears, allow the solution to stand for approximately 15 minutes.

The reconstituted solutions will contain 200 mg in 3.0 ml.

Only clear, slightly yellow solutions should be used.

The final solution is isotonic with plasma and has a pH of 7.2–7.8.

Preparation of the diluted solution prior to infusion:

• This medicinal product may be administered in the following infusion solutions:
  • Sodium chloride 9 mg/ml (0.9%) solution
  • Ringer's solution
  • Ringer-lactate solution
  • 5% dextrose injection
  • 10% dextrose injection
  • Solution containing 0.18% sodium chloride and 4% glucose
  • Solution containing 0.45% sodium chloride and 5% glucose
  • Peritoneal dialysis solution containing 1.36% or 3.86% glucose solution.

Proposed shelf life

Proposed shelf life (after first opening of the container, reconstitution and dilution): 24 hours at 5±3°C

Disposal

Disposal of unused medicinal product and waste materials must be carried out in accordance with local regulations.