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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Teicoplanina Altan 400 mg powder for solution for injection and for infusion EFG

Read the entire 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 questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Teicoplanina Altan is an antibiotic. It contains a medicine called "teicoplanin". It works by killing the bacteria that cause infections in your body.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as influenza or the common cold. It is important to follow your doctor's instructions regarding dosage, dosing interval, and duration of treatment. Do not keep or reuse this medicine. If you have leftover antibiotics after completing the treatment, return them to the pharmacy for proper disposal. Do not dispose of medicines down the drain or in the trash.

Teicoplanin Altan 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 lungs
• 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 Altan can be used to treat certain infections caused by “Clostridioides difficile”, a bacterium in the intestine. In this case, the solution should be taken orally.

2. What you need to know before using Teicoplanina Altan

Do not use Teicoplanina Altan:

• 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 using Teicoplanina Altan if:

• you are allergic to an antibiotic called “vancomycin”
• you have experienced 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.

During treatment, you may need to have regular tests to monitor whether your blood, kidneys, and/or liver are functioning properly (see “Other medicines and Teicoplanina Altan”).

If any of the conditions listed above apply to you (or if you are unsure), inform your doctor, pharmacist, or nurse before receiving Teicoplanina Altan.

Serious 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 Teicoplanina Altan and contact your doctor or seek immediate medical attention.

Tests

During treatment, you may be required to undergo 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 long-term treatment with Teicoplanina Altan, bacteria not affected by the antibiotic may overgrow—your doctor will monitor for this.

Other medicines and Teicoplanina Altan

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines. Teicoplanina Altan may affect how other medicines work. Other medicines may also affect how Teicoplanina Altan works. In particular, inform your doctor, pharmacist, or nurse if you are taking the following medicines:

• aminoglycosides, as they must not be mixed with Teicoplanina Altan in the same injection. They may also cause hearing and/or kidney problems
• amphotericin B – a medicine used to treat fungal infections that may cause hearing and/or kidney problems
• cyclosporine – a medicine affecting the immune system that may cause hearing and/or kidney problems
• cisplatin – a medicine used to treat malignant tumors that may cause hearing and/or kidney problems
• diuretic tablets (such as furosemide), also known as “water pills,” which may cause hearing and/or kidney problems.

If any of the conditions listed above apply to you (or if you are unsure), inform your doctor, pharmacist, or nurse before receiving Teicoplanina Altan.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

They will decide whether or not you should receive this medicine during pregnancy. There may be a potential risk of problems affecting the inner ear and kidneys.

Inform your doctor if you are breastfeeding before receiving this medicine.

They will decide whether or not you can continue breastfeeding while receiving Teicoplanina Altan.

Animal reproduction studies have not shown evidence of fertility problems.

Driving and use of machines

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

Teicoplanina Altan contains sodium

This medicine contains less than 23 mg (1 mmol) of sodium per vial and is therefore considered essentially sodium-free.

3. How to use Teicoplanina Altan

Follow exactly the administration instructions for this medicine as indicated by your doctor. If in doubt, consult your doctor again.

The recommended dose is

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

Skin and soft tissue, lung, and urinary tract infections

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

Infection caused by the bacterium Clostridioides 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 problems – the maintenance dose should be administered every two days, or half the maintenance dose once daily.
• For patients with severe kidney problems and on hemodialysis – the maintenance dose should be administered every three days, or one-third of the maintenance dose once daily.

Treatment of peritonitis in patients undergoing peritoneal dialysis

The initial dose is 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 dialysis bags overnight.

Infants (from birth up to 2 months of age)

• Initial dose (on day one): 16 mg per kilogram of body weight, as an intravenous infusion by drip.
• Maintenance dose: 8 mg per kilogram of body weight, administered once daily as an intravenous infusion by 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 via intravenous injection.
• Maintenance dose: 6–10 mg per kilogram of body weight, administered once daily via intravenous injection.

The method for preparing the reconstituted solution (for dilution, oral administration, or injection) and the diluted solution is described in section 6 of this leaflet.

How Teicoplanina Altan is administered

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

• It will be given by intravenous (i.v.) or intramuscular (i.m.) injection.
• It may also be administered as an intravenous infusion by drip.

Intravenous infusion should only be used in infants from birth up to 2 months of age.

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

If you use more Teicoplanina Altan than you should

It is unlikely that your doctor or nurse will administer too much of the medicine. However, if you think you have received too much Teicoplanina Altan 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 telephone number: 915 620 420, indicating the medicine and the amount taken. 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 use Teicoplanina Altan

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

If you stop treatment with Teicoplanina Altan

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, ask 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 Teicoplanin Altan 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 part of the body.

Not known (frequency cannot be estimated from available data)

• appearance of blisters on the skin, mouth, eyes, or genitals – could be signs of so-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)"

• “drug reaction with eosinophilia and systemic symptoms (DRESS)”. DRESS initially appears as flu-like symptoms and a rash on the face; the rash spreads with fever, increased liver enzyme levels in blood tests, increased number of a type of white blood cells (eosinophilia), and enlarged lymph nodes.

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

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 – could be signs of a decrease in your blood cell count.

Not known (frequency 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.
  • low levels of all types of blood cells.

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

Other adverse effects

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

Frequent (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 function)
  • hearing loss, ringing in the ears (tinnitus), or sensation that you or things around you are moving
  • feeling unwell or sick (nausea), vomiting, diarrhea
  • dizziness or headache.

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

• infection (abscess)

Not known (frequency cannot be estimated from available data)

• problems at the injection site – such as redness of the skin, pain, or swelling.

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 via 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 Altan

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 vial label after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Information regarding storage and the time within which Teicoplanina Altan must be used after reconstitution and preparation for administration is detailed in "Practical information for healthcare professionals on the preparation and handling of Teicoplanina Altan".

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Teicoplanina Altan

Vial of powder:

• The active substance is teicoplanin. Each vial contains 400 mg of teicoplanin.
• The other ingredients are sodium chloride, hydrochloric acid, and sodium hydroxide.

Appearance of the product and contents of the container

Teicoplanin Altan is a powder for injectable solution and for infusion. The powder is white or almost white. The reconstituted solution is colourless or slightly yellowish.

The powder is contained in a 10 ml colourless type I glass vial with a useful volume, closed with a bromobutyl rubber stopper and a green flip-off plastic cap.

Pack sizes:

• 1 vial with powder
• 5 vials with powder

Marketing Authorization Holder and Manufacturer

Holder:

Altan Pharmaceuticals S.A.

C/ Cólquide 6, portal 2, 1st floor, office F, Edificio Prisma

28231 Las Rozas (Madrid)

Spain

Manufacturer:

Altan Pharmaceuticals S.A.

Polígono Industrial de Bernedo, s/n

01118 Bernedo (Álava)

Spain

or

Altan Pharmaceuticals S.A.

Avda. Constitución 198-199. Pol. Industrial Monte Boyal

45950 Casarrubios del Monte (Toledo)

Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Germany: Teicoplanin Altan 400 mg Pulver zur Herstellung einer Injektions-/Infusionslösung oder einer Lösung zum Einnehmen

Italy: Teicoplanina Altan 400 mg Polvere per soluzione iniettable o infusione

Portugal: Teicoplanina Altan 400 mg Pó para solução injectável ou para perfusão

United Kingdom: Teicoplanin Altan 400 mg Powder for solution for injection/infusion or oral solution

Date of the most recent review of this summary: 02/2026

Other sources of information

Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/, and on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/). Links to other websites on rare diseases and orphan medicinal products are also available.

This information is intended for healthcare professionals only:

Practical information for healthcare professionals on the preparation and handling of Teicoplanin Altan

This medicine is for single use only.

Method of administration

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

The injection may be given either as a bolus over 3-5 minutes or by 30-minute infusion.

In infants from birth up to 2 months of age, administration must be by infusion only.

The reconstituted solution may also be administered orally.

Preparation of the reconstituted solution

• Slowly inject 3.2 ml of water for injection into the vial of 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 400 mg in 3.0 ml.

Only clear, slightly yellowish solutions should be used.

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

Nominal content of teicoplanina per vial	400 mg
Vial volume with powder	10 ml
Volume containing the nominal dose of teicoplanina (extracted using a 5 ml syringe and 23G needle)	3.0 ml

Preparation of the diluted solution prior to infusion

Teicoplanin can be administered in the following infusion solutions:

• Sodium chloride solution 9 mg/ml (0.9%)
• Ringer's solution
• Ringer-lactate solution
• 5% glucose injection
• 10% glucose 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.

Shelf life of the reconstituted solution and diluted product

Chemical and physical in-use stability has been demonstrated for the reconstituted solution and diluted product prepared as recommended, for 24 hours between 2 and 8 °C.

From a microbiological standpoint, the medicinal product should be used immediately. If not used immediately, the storage times and conditions during use are the responsibility of the user and normally should not exceed 24 hours between 2 and 8 °C, unless reconstitution/dilution has been carried out under controlled and validated aseptic conditions.

Disposal

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