Teicopix

Package Leaflet: Information for the Patient

Teicopix, 200 mg

powder and solvent for solution for injection/infusion or for preparation of oral solution

Teicopix, 400 mg powder and solvent for solution for injection/infusion or for preparation of oral solution

Teicoplanin

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Teicopix and what is it used for
• 2. Important information before using Teicopix
• 3. How to use Teicopix
• 4. Possible side effects
• 5. How to store Teicopix
• 6. Contents of the pack and other information

1. What is Teicopix and what is it used for

Teicopix is an antibiotic. It contains the active substance teicoplanin, which kills bacteria (bactericidal action) that cause infection in the patient's body. Teicoplanin is used in adults and children (including newborns) to treat bacterial infections: skin and subcutaneous tissue (sometimes called soft tissue infections); joints and bones; lungs; urinary tract; heart (sometimes called endocarditis); abdominal cavity (peritonitis); blood, if caused by any of the above conditions. Teicopix can be used to treat some infections caused by Clostridium difficile- bacteria found in the intestines. In the treatment of such infections, the solution is taken orally.

2. Important information before using Teicopix

When not to use Teicopix:

if the patient is allergicto teicoplanin or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before using Teicopix, discuss this with your doctor, pharmacist, or nurse if the patient: has an allergy to an antibiotic called vancomycin, has a red upper body („red man syndrome”), has a decreased number of platelets (thrombocytopenia), has kidney problems, is taking other medicines that may cause hearing or kidney problems. The doctor may order regular tests to check the blood count and kidney and/or liver function (see „Teicopix and other medicines”). If any of the above conditions apply to the patient (or the patient is unsure), consult a doctor, pharmacist, or nurse before Teicopix is given.

Tests

During treatment, the patient may have tests to check the blood, liver, kidney, and/or hearing function. This is more likely if: treatment will be long-term, high loading doses are required (12 mg/kg twice daily) the patient has kidney problems, the patient is taking or may take other medicines that may affect the nervous system, kidneys, or hearing. In patients receiving Teicopix for a long time, it is possible that there will be a greater than usual increase in bacteria that the antibiotic does not work against. The doctor will check this.

Teicopix and other medicines

Tell your doctor, pharmacist, or nurse about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans to take. Teicopix may affect the action of other medicines, and other medicines may affect the action of Teicopix. In particular, tell your doctor, pharmacist, or nurse if the patient is taking: aminoglycoside antibiotics, as they must not be mixed with Teicopix in the same injection; they may also cause hearing or kidney problems; amphotericin B (a medicine used to treat fungal infections) may cause hearing or kidney problems; cyclosporin (a medicine that affects the immune system) may cause hearing or kidney problems; cisplatin (a medicine used to treat cancer) may cause hearing or kidney problems; diuretics, such as furosemide (also called „water tablets”), may cause hearing or kidney problems. If the patient is taking any of these medicines (or the patient is unsure), consult a doctor, pharmacist, or nurse before Teicopix is given.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a baby, she should consult a doctor, pharmacist, or nurse before using this medicine. The doctor will decide whether the medicine can be given to the pregnant patient. There is a risk of damage to the inner ear and kidney problems. If the patient is breastfeeding, she should tell her doctor before receiving this medicine. The doctor will decide whether the patient can breastfeed while taking Teicopix. Studies in animals have shown no effect on fertility.

Driving and using machines

Teicopix may cause headache or dizziness. If the patient experiences these symptoms, she should not drive or use any tools or machines.

Teicopix contains sodium

Teicopix, 200 mg, 400 mg This medicine contains 9.45 mg of sodium (the main ingredient of common salt) in each vial. This corresponds to 0.47% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use Teicopix

Recommended dosage

Adults and adolescents (12 years and older) with normal kidney function

Skin and subcutaneous tissue, lung, and urinary tract infections Initial dose (first three doses): 6 mg per kilogram of body weight administered every 12 hours by intravenous injection or intramuscularly. Maintenance dose: 6 mg per kilogram of body weight administered once daily by intravenous injection or intramuscularly. Bone and joint infections, and heart infections Initial dose (first three to five doses): 12 mg per kilogram of body weight administered every 12 hours by intravenous injection. Maintenance dose: 12 mg per kilogram of body weight administered once daily by intravenous injection or intramuscularly. Infection caused by Clostridium difficileThe recommended dose is 100 to 200 mg administered orally twice daily for 7 to 14 days.

Adults and elderly patients with kidney problems

In patients with kidney problems, it is usually necessary to reduce the dose after the fourth day of treatment: patients with mild and moderate kidney problems will receive a maintenance dose every two days or half the maintenance dose once daily; patients with severe kidney problems or undergoing hemodialysis will receive a maintenance dose every three days or one-third of the maintenance dose once daily. Peritonitis in patients undergoing peritoneal dialysis The initial dose is 6 mg per kilogram of body weight in a single intravenous injection, and then: first week: 20 mg/L in each dialysis bag second week: 20 mg/L in every other dialysis bag third week: 20 mg/L in the dialysis bag left overnight.

Infants (from birth to 2 months)

Initial dose (on the first day): 16 mg per kilogram of body weight in an intravenous infusion. Maintenance dose: 8 mg per kilogram of body weight administered once daily in an intravenous infusion.

Children (from 2 months to 12 years)

Initial dose (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 Teicopix is given

The medicine is usually given by a doctor or nurse. The medicine will be given by intravenous injection (intravenously) or intramuscularly (into a muscle). It can also be given by intravenous infusion (drip). Infants from birth to 2 months should only receive the medicine by intravenous infusion. In the treatment of some infections, the solution may be taken orally (by mouth).

Overdose of Teicopix

It is unlikely that the doctor or nurse will give too much medicine. However, if the patient thinks they have received too much Teicopix or if the patient is agitated, they should contact their doctor or nurse immediately.

Missing a dose of Teicopix

The doctor or nurse will know when to give the patient Teicopix. It is unlikely that they will give the patient the medicine incorrectly. However, if the patient has any doubts, they should contact their doctor or nurse.

Stopping Teicopix

Do not stop taking the medicine without consulting a doctor, pharmacist, or nurse. If the patient has any further questions about using this medicine, they should contact their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Severe side effects

If the patient experiences any of the following severe side effects, they should stop the treatment and contact their doctor or nurse immediately – they may need urgent medical attention.

Uncommon(may affect up to 1 in 100 people):
life-threatening allergic reactionwith symptoms such as: difficulty breathing or wheezing, swelling, 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 the available data)
blistering of the skin, mouth, eyes, or genitals – these may be symptoms of conditions called „toxic epidermal necrolysis” or „Stevens-Johnson syndrome” or „drug reaction with eosinophilia and systemic symptoms (DRESS)”. Initially, DRESS appears as flu-like symptoms and a rash on the face, followed by a widespread rash with high fever, elevated liver enzymes in blood tests, and an increased number of eosinophils (a type of white blood cell) and swollen lymph nodes.
If the patient experiences any of these side effects, they should contact their doctor or nurse immediately.

If the patient experiences any of the following severe side effects, they should stop the treatment and contact their doctor or nurse immediately – they may need urgent medical attention.

Uncommon(may affect up to 1 in 100 people):
swelling of the vein and blood clot in the vein
difficulty breathing or wheezing (bronchospasm)
increased susceptibility to infections – these may be symptoms of a decrease in the number of white blood cells.
Frequency not known(cannot be estimated from the available data)
lack of white blood cells – symptoms may include: fever, severe chills, sore throat or mouth ulcers (agranulocytosis)
kidney problems or changes in their function – visible in tests. The frequency or severity of kidney problems may increase when using higher doses of the medicine.
seizures.
low levels of all types of blood cells.
If the patient experiences any of these side effects, they should contact their doctor or nurse immediately.

Other side effects

The patient should tell their doctor, pharmacist, or nurse if they experience any of the following symptoms:
Common(may affect up to 1 in 10 people)
rash, redness, itching
pain
fever
Uncommon(may affect up to 1 in 100 people)
decrease in the number of platelets
increase in liver enzymes
increase in creatinine levels in the blood (a measure of kidney function)
hearing loss, ringing in the ears, or feeling dizzy
nausea or vomiting, diarrhea
dizziness or headache
Rare(may affect up to 1 in 1,000 people)
infection (abscess)
Frequency not known(frequency cannot be estimated from the available data)
reaction at the injection site, e.g., redness of the skin, pain, or swelling

Reporting side effects

If the patient experiences any side effects, including those not listed in this package leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Teicopix

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 after EXP. The expiry date refers to the last day of that month. Do not store above 25°C. Information on the storage conditions for Teicopix after reconstitution and its shelf-life are described in the section „Practical information for healthcare professionals on handling and preparation of Teicopix”. Do not store in a syringe. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Teicopix contains

The active substance is teicoplanin. Each vial contains 200 mg of teicoplanin (200,000 IU). After reconstitution, the solution contains: 200 mg of teicoplanin in 3.0 mL or 400 mg of teicoplanin in 3.0 mL. The other ingredients are: powder: sodium chloride and, if necessary, sodium hydroxide to adjust the pH (see information about sodium at the end of section 2); solvent: water for injections.

What Teicopix looks like and contents of the pack

Teicopix is a powder for solution for injection/infusion or for preparation of oral solution, with a solvent provided. The powder is white to slightly yellowish. The solvent is a clear, particle-free liquid. The powder is packed in: vials of colorless glass type I with a usable capacity of 10 mL for 200 mg, closed with a bromobutyl rubber stopper, aluminum seal, and green plastic flip-off cap in a cardboard box; vials of colorless glass type I with a usable capacity of 22 mL for 400 mg, closed with a bromobutyl rubber stopper, aluminum seal, and blue plastic flip-off cap in a cardboard box. The solvent is packed in an ampoule of colorless glass type I and contains 3 mL (for 200 mg and 400 mg). Pack sizes: 1 vial of powder + 1 ampoule of solvent, 5 vials of powder + 5 ampoules of solvent. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder Sandoz GmbH Biochemiestrasse 10 6250 Kundl Austria Manufacturer Lek Pharmaceuticals d.d. Verovškova 57 1526 Ljubljana Slovenia Salutas Pharma GmbH Otto-von-Guericke-Allee 1 39179 Barleben Germany

For further information about this medicine, please contact:

Sandoz Polska Sp. z o.o. ul. Domaniewska 50 C 02-672 Warsaw tel. 22 209 70 00

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Teicoplanin Sandoz - Austria Planitec - Bulgaria Teicoplanina Sandoz - Italy Teicoplanine Sandoz - Netherlands Teicoplanin Sandoz - Sweden Teicoplanin - United Kingdom (Northern Ireland)
Date of last revision of the package leaflet: 11/2022
(logo of the marketing authorization holder) -------------------------------------------------------------------------------------------------------------------------

Information intended for healthcare professionals only

Practical information for healthcare professionals on handling and preparation of Teicopix

This medicinal product is for single use only. Method of administration The solution obtained after reconstitution of the powder can be injected directly or further diluted. The solution can be administered by intravenous injection (bolus) lasting from 3 to 5 minutes or in a 30-minute infusion. In infants from birth to 2 months, the medicine should only be administered by infusion. The solution obtained after reconstitution of the powder can also be administered orally. Preparation of the solution To the vial of powder, slowly inject the entire contents of the provided solvent. Rotate the vial gently until the powder is completely dissolved. If the solution becomes foamy, let it stand for about 15 minutes. Only clear and yellowish solutions should be used.

• Slowly inject the entire contents of the provided solvent into the vial of powder.
• Gently rotate the vial until the powder is completely dissolved. If the solution becomes foamy, let it stand for about 15 minutes. Only clear and yellowish solutions should be used.

The resulting solution contains 200 mg of teicoplanin in 3.0 mL or 400 mg of teicoplanin in 3.0 mL. The final solution is isotonic with blood serum and has a pH of 7.2-7.8.

Dilution of the solution before infusion Teicopix can be administered in the following infusion solutions: 9 mg/mL (0.9%) sodium chloride solution, Ringer's solution, Hartmann's solution, 5% glucose solution for injection, 0.18% sodium chloride solution with 4% glucose solution, peritoneal dialysis solution containing 1.36% or 3.86% glucose solution.

Shelf-life of the solution after reconstitution and dilution Chemical and physical stability of the solution prepared as directed has been demonstrated for 24 hours at a temperature of 2 to 8°C. From a microbiological point of view, the product should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user and are normally not longer than 24 hours at 2 to 8°C. Disposal Any unused medicinal product or waste material should be disposed of in accordance with local requirements.