TEICOPLANIN ACCORD 400 mg POWDER FOR INJECTION AND INFUSION SOLUTION

Introduction

Package Leaflet: Information for the User

TeicoplaninAccord400 mg powder for solution for injection and infusion EFG

This medicinal product is subject to additional monitoring, which will allow quick identification of new safety information. You can help by reporting any side effects you may get. The last section of section 4 will tell you 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, 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, even if you think they are not serious. See section 4.

Contents of the pack

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

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

Teicoplanin Accord is an antibiotic. It contains the active substance 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 under the skin - sometimes called "soft tissues"
• Bones and joints
• The lung
• The urinary tract
• The heart - sometimes called "endocarditis"
• The abdominal wall - peritonitis
• The blood, when caused by one of the conditions listed above

Teicoplanin can be used to treat some infections caused by "Clostridium difficile" bacteria in the intestine. In this case, the solution should be taken by mouth.

2. What you need to know before you take Teicoplanin Accord

Do not use this medicine:

• If you are allergic to teicoplanin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Tell your doctor, pharmacist or nurse before you are given Teicoplanin Accord if:

• You are allergic to an antibiotic called "vancomycin"

• You have had a reddening of the upper 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 if your kidneys and/or liver are working properly (see "Using Teicoplanin Accord with other medicines").

If any of the above applies to you (or if you are not sure), tell 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 medical attention immediately.

Tests

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

• Your treatment is going to last a long time
• You need to be treated with high loading doses (12 mg/kg twice a day)
• You have kidney problems
• You are taking or may take other medicines that may affect your nervous system, kidneys and hearing.

In people who are being treated with Teicoplanin Accord for a long time, bacteria that are not affected by the antibiotic may grow more than usual - your doctor will check this.

Using Teicoplanin Accord with other medicines

Tell your doctor, pharmacist or nurse if you are using, have recently used or might use any other medicines. This is because Teicoplanin Accord may affect how other medicines work. Also, some medicines may affect how Teicoplanin Accord works.

In particular, tell 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 - a medicine that treats fungal infections that may cause hearing and/or kidney problems
• Cyclosporin - a medicine that affects the immune system that may cause hearing and/or kidney problems
• Cisplatin - a medicine that treats malignant tumors that may cause hearing and/or kidney problems
• Water pills (such as furosemide) also called "diuretics" that may cause hearing and/or kidney problems.

If any of the above applies to you (or if you are not sure), tell 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 have a baby, ask your doctor, pharmacist or nurse for advice before you are given this medicine. They will decide whether you should be given this medicine while you are pregnant. There may be a potential risk of problems in the inner ear and kidneys.

Tell your doctor if you are breastfeeding before you are given this medicine. They will decide whether you can continue to breastfeed while you are being given Teicoplanin Accord.

Animal reproduction studies have not shown any evidence of fertility problems.

Driving and using machines

You may have headaches or feel dizzy while you are being treated with Teicoplanin Accord. If this happens, do not drive or use tools or machines.

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

The recommended dose is

Adults and children (12 years or older) without kidney problems

Infections of the skin and soft tissues, lung and urinary tract

• Initial dose (for the first three doses): 400 mg (this is equivalent to 6 mg per kilogram of body weight), given every 12 hours, by injection into a vein or muscle.
• Maintenance dose: 400 mg (this is equivalent to 6 mg per kilogram of body weight), given once a day, by injection into a vein or muscle.

Infections of the bones and joints, and heart

• Initial dose (for the first three to five doses): 800 mg (this is equivalent to 12 mg per kilogram of body weight), given every 12 hours, by injection into a vein or muscle.
• Maintenance dose: 800 mg (this is equivalent to 12 mg per kilogram of body weight), given once a day, by injection into a vein or muscle.

Infection caused by the bacterium "Clostridium difficile"

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, it will normally be necessary to reduce your dose after the fourth day of treatment:

• For people with mild to 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 and on hemodialysis - the maintenance dose will be given every three days, or one-third of the maintenance dose will be given once a day.

Treatment of peritonitis in patients on peritoneal dialysis

The initial dose is 6 mg per 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 alternate dialysis bags.
• Week three: 20 mg/l in the dialysis bags used at night.

Babies (from birth to 2 months of age)

• Initial dose (on day one): 16 mg per kilogram of body weight, as an infusion into a vein through a drip.
• Maintenance dose: 8 mg per kilogram of body weight, given once a day, as an infusion into a vein through a drip.

Children (from 2 months to 12 years of age)

• Initial dose (for the first three doses): 10 mg per kilogram of body weight, given every 12 hours, by injection into a vein.
• Maintenance dose: 6 to 10 mg per kilogram of body weight, given once a day, by injection into a vein.

How Teicoplanin Accord is given

This medicine will normally be given to you by a doctor or nurse.

• It will be given by injection into a vein (intravenously) or into a muscle (intramuscularly).
• It can also be given by infusion into a vein through a drip.

Infusion into a vein through a drip should only be given to babies, from birth to two months of age.

For the treatment of certain infections, the solution may be given by mouth (orally).

If you use more Teicoplanin Accord 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 Accord or if you are worried, talk to your doctor or nurse immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxic Information Service, telephone: 91 562 04 20, indicating the medicine and the amount ingested. It may be necessary to go to a hospital. It is recommended to take the package and the package leaflet of the medicine to the healthcare professional.

If you forget to use Teicoplanin Accord

Your doctor or nurse will have instructions on when to give you Teicoplanin Accord. 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 treatment with Teicoplanin Accord

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

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 taking Teicoplanin Accord immediately and contact a doctor or nurse, 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 breathing or wheezing, swelling, skin rash, itching, fever, chills

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

• Reddening of the upper body

Frequency not known(cannot be estimated from the available data)

• Appearance of blisters on the skin, mouth, eyes or genitals - these could be signs of "Toxic Epidermal Necrolysis" or "Stevens-Johnson Syndrome"
• Red and scaly rash on the skin, including 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, the rash spreads with fever, increased liver enzymes in the blood, increased eosinophils (a type of white blood cell) and swollen lymph nodes.
• Tell your doctor or nurse immediately if you experience any of the above side effects.

Tell your doctor or nurse immediately if you experience any of the following serious side effects - you may need urgent medical treatment:

Uncommon(may affect up to 1 in 100 people)

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

Frequency not known(cannot be estimated from the available data)

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

Tell your doctor or nurse immediately if you experience any of the above side effects.

Other side effects

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

Common(may affect up to 1 in 10 people)

• Skin rash, redness, itching
• Pain
• Fever

Uncommon(may affect up to 1 in 100 people)

• Low platelet count
• Increased liver enzymes in the blood
• Increased creatinine levels in the blood (to check your kidneys)
• Hearing loss, ringing in the ears or the feeling that you or your surroundings are spinning
• Feeling sick 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 the available data)

• Problems at the injection site - such as skin reddening, pain or swelling
• Low levels of all types of blood cells

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist or nurse, even if you think they are not serious. You can also report side effects directly to the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Teicoplanin Accord

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 vial label after EXP. The expiry date is the last day of the month shown.

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

Information about the storage and use of Teicoplanin Accord once it has been reconstituted and is ready to use is given in "Practical information for healthcare professionals for the preparation and handling of Teicoplanin Accord".

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy. Ask your pharmacist how to dispose of medicines no longer required. This will help to protect the environment.

6. Container Contents and Additional Information

Composition of Teicoplanina Accord

• The active ingredient is teicoplanin. Each vial contains 400 mg of teicoplanin.
• The other components are sodium chloride

Appearance of the Product and Container Contents

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

The powder is packaged in a 10 ml type II colorless glass vial, closed with a chlorobutyl rubber stopper and a 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 Last Revision of this Prospectus:July 2025

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

This information is intended only for healthcare professionals:

Practical Information for Healthcare Professionals on the Preparation and Handling of Teicoplanina Accord.

This medication is for single use.

Method of Administration

The reconstituted solution can be injected directly or alternatively in a diluted form.

The injection will be administered either as a bolus over 3-5 minutes or by perfusion over 30 minutes. In newborns from birth to two months, it will only be administered by perfusion.

The reconstituted solution can also be administered orally.

Preparation of the Reconstituted Solution:

• Slowly inject 3 ml of water for injection into the powder vial.

• Gently rotate the vial between the hands until the powder is completely dissolved. If the solution becomes foamy, it should be left to rest for about 15 minutes.

The reconstituted solutions will contain 400 mg in 3.0 ml.

Only transparent and yellowish 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 before Perfusion:

This medication can be administered in the following perfusion solutions:

• Sodium chloride solution 9 mg/ml (0.9%).
• Ringer's solution.
• Ringer-lactate solution.
• 5% dextrose injection.
• 10% dextrose injection.
• Solution with 0.18% sodium chloride and 4% glucose.
• Solution with 0.45% sodium chloride and 5% glucose.
• Peritoneal dialysis solution containing 1.36% or 3.86% glucose solution.

Proposed Validity Period

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

Elimination

The elimination of unused medication and waste materials will be carried out in accordance with local regulations.