TEICOPLANIN SALA 400 mg POWDER FOR INJECTABLE SOLUTION AND FOR INFUSION

Introduction

Package Leaflet: Information for the User

Teicoplanin SALA 400 mg

Powder for solution for injection and infusion EFG

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 or nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Teicoplanin Sala and what is it used for
2. What you need to know before you use Teicoplanin Sala
3. How to use Teicoplanin Sala
4. Possible side effects
5. Storage of Teicoplanin Sala

1. Contents of the pack and further information

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

Teicoplanin is an antibiotic. It works by killing the bacteria that cause infections in your body.

Antibiotics are used to treat bacterial infections and will not work for viral infections such as the flu or the common cold.

It is important that you follow the instructions regarding dose, administration interval, and treatment duration as indicated by your doctor.

Do not store or reuse this medication. If you have any leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not throw medicines down the drain or in the trash.

Teicoplanin is used in adults and children (including newborns) to treat infections in:

• the skin and under 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 above conditions.

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

2. What you need to know before you use Teicoplanin Sala

Do not use Teicoplanin Sala

• 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 or nurse before you are given teicoplanin if:

• you are allergic to an antibiotic called “vancomycin”
• you have a reddening of 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 if your blood, kidneys, and/or liver are working properly (see “Other medicines and Teicoplanin Sala”).

If any of the above applies to you (or if you are not sure), tell your doctor or nurse before you are given teicoplanin.

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 teicoplanin and contact your doctor or seek medical attention immediately.

Tests

You may have tests to check your blood, kidneys, liver, and/or hearing during treatment. 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 for a long time, bacteria that are not affected by the antibiotic may grow more than usual – your doctor will check this.

Other medicines and Teicoplanin Sala

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

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

• aminoglycosides, as they must not be mixed with teicoplanin 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
• diuretics such as furosemide (medicines that help you urinate) 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 or nurse before you are given teicoplanin.

Pregnancy, breastfeeding, and fertility

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor, pharmacist, or nurse 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 of the fetus.

Tell your doctor if you are breastfeeding before you are given this medicine.

Your doctor will decide whether you can continue breastfeeding while you are being given teicoplanin.

Animal reproduction studies have not shown evidence of fertility problems.

Driving and using machines

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

Teicoplanin Sala 400 mg contains sodium

This medicine contains less than 23 mg (1 mmol) of sodium per vial, so it is essentially “sodium-free”.

3. How to use Teicoplanin Sala

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 bacteriaClostridium 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 Sala 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 should only be given to babies, from birth to two months of age.

To treat certain infections, the solution may be given by mouth (orally).

If you use more Teicoplanin Sala 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 worried, talk to your doctor or nurse immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 5620420, indicating the medicine and the amount taken.

If you forget to use Teicoplanin Sala

Your doctor or nurse will have instructions on when to give you teicoplanin. It is unlikely that you will not be given the medicine as prescribed. However, if you are worried, talk to your doctor or nurse.

If you stop using Teicoplanin Sala

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

If you have any further questions on the use of this medicine, ask your doctor 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 immediately and contact your 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 part of the 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”
• “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 levels of liver enzymes in the blood, increased levels of a type of white blood cell (eosinophilia), and swollen lymph nodes.
• red, scaly rash all over your body with bumps under the skin (including skin folds, chest, abdomen (including stomach), back, and arms) and blisters accompanied by fever - these could be symptoms of something called "acute generalized exanthematous pustulosis (AGEP)".

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

Tell your 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)

• inflammation and 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 the available data)

• lack of white blood cells in the blood – the signs may include: fever, severe chills, sore throat, or ulcers in the mouth (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 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)

• decrease in platelet count
• increase in blood levels of liver enzymes
• increase in blood levels of creatinine (to check your kidney function)
• hearing loss, ringing in the ears, or the feeling that you or your surroundings are spinning
• 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 the available data)

• problems at the injection site – such as skin redness, 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 or nurse, even if they are not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency's Pharmacovigilance 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. Storage of Teicoplanin Sala

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.

Information about the storage and use of Teicoplanin Sala 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 Sala 400 mg”.

6. Container Contents and Additional Information

Composition of Teicoplanin Sala 400 mg

The active ingredient is Teicoplanin. Each vial contains 400 mg of teicoplanin. The other component is sodium chloride.

Appearance of the Product and Container Contents

Teicoplanin Sala 400 mg is a powder for injectable and infusion solution. The powder is white or slightly beige.

The powder is packaged in a type II colorless glass vial closed with a rubber stopper and a plastic flip-off cap and aluminum seal.

Presentation:

• Unit package: 1 vial
• Clinical package: 5 vials.

Marketing Authorization Holder and Manufacturer:

Laboratory REIG JOFRÉ, S.A.

Gran Capitán, 10

08970 Sant Joan Despí – Barcelona

Spain

Date of the Last Revision of this Prospectus: January 2024

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 Teicoplanin Sala.

This medication is for single use.

Administration Method

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 infants 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 injectable preparations 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 solution is isotonic with plasma and has a pH of 7.2 – 7.8.

Preparation of the Diluted Solution before Perfusion:

Teicoplanin Sala 400 mg 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.

Validity Period of the Reconstituted Solution:

Chemical and physical stability has been demonstrated for the reconstituted solution prepared as recommended for 24 hours between 2 and 8°C.

From a microbiological point of view, the medication should be used immediately. If it is not used immediately, the storage times and conditions are the responsibility of the user and should not normally exceed 24 hours between 2 and 8°C, unless the reconstitution has been carried out under controlled and validated aseptic conditions.

Validity Period of the Diluted Medication

Chemical and physical stability has been demonstrated for the reconstituted solution prepared as recommended for 24 hours between 2 and 8°C.

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

Elimination

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