Teicopix

Package leaflet: Information for the patient

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Teicopix (Teicoplanin Sandoz)
400 mg, powder and solvent for solution for injection/infusion or for oral solution
Teicoplaninum
Teicopix and Teicoplanin Sandoz are different trade names for the same medicine.
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

1. What Teicopix is and what it is 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 Teicopix is and what it is used for

Teicopix is an antibiotic. It contains the active substance teicoplanin, which kills bacteria (bactericidal action) causing infection in the patient's body.
Teicopix is used in adults and children (including newborns) to treat bacterial infections of:

• skin and subcutaneous tissue (sometimes referred to as soft tissue infections);
• joints and bones;
• lungs;
• urinary tract;
• heart (sometimes referred to as endocarditis);
• abdominal cavity (peritonitis);
• blood, if caused by any of the above conditions.

Teicopix may be used in the treatment of certain infections caused by Clostridium difficile,

• bacteria located in the intestines. In treating such infections, the medicinal solution is taken orally.

2. Important information before using Teicopix

When not to use Teicopix:

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

Warnings and precautions
Before using Teicopix, discuss with your doctor, pharmacist, or nurse if the patient:

• is allergic to an antibiotic called vancomycin,
• has redness of the upper part of the body (so-called "red man syndrome"),
• has a low platelet count (thrombocytopenia), Page 1 of 8
• has impaired kidney function,
• is taking other medicines that may cause hearing problems and (or) kidney problems. Your doctor may order regular tests to monitor blood counts and (or) kidney and (or) liver function (see "Teicopix and other medicines").

If any of the conditions listed above apply to the patient (or if the patient is unsure), please consult a doctor, pharmacist, or nurse before administering Teicopix.
Tests
During treatment, the patient may undergo tests to monitor blood, liver function, kidney function, and (or) hearing. This is more likely if:

• treatment will be long-term,
• high loading doses are required (12 mg/kg twice daily),
• the patient has impaired kidney function,
• the patient is taking or may take other medicines that may affect the nervous system, kidneys, or hearing. In patients receiving Teicopix for a prolonged period, there may be an increased risk of overgrowth of bacteria not susceptible to the antibiotic. Your doctor will monitor for this.

Teicopix and other medicines
Tell your doctor, pharmacist, or nurse about all medicines the patient is currently 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 also affect the action of Teicopix.
In particular, inform your doctor, pharmacist, or nurse if the patient is taking any of the following medicines:

• aminoglycoside antibiotics, as they must not be mixed with Teicopix in the same injection; they may also cause hearing and (or) kidney problems;
• amphotericin B (a medicine used to treat fungal infections), which may cause hearing and (or) kidney problems;
• cyclosporine (a medicine that affects the immune system), which may cause hearing and (or) kidney problems;
• cisplatin (a medicine used to treat malignant tumours), which may cause hearing and (or) kidney problems;
• diuretics (water pills), such as furosemide, which may cause hearing and (or) kidney problems.

If the patient is taking any of these medicines (or if the patient is unsure), consult a doctor, pharmacist, or nurse before administering Teicopix.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor, pharmacist, or nurse before using this medicine.
The doctor will decide whether Teicopix can be administered during pregnancy. There is a risk of damage to the inner ear and kidney function impairment.
If the patient is breastfeeding, she should inform the doctor before receiving this medicine.
The doctor will decide whether the patient can breastfeed while taking Teicopix.
Animal studies on reproductive toxicity did not show any effect on fertility.
Driving and operating machinery
Teicopix may cause headache or dizziness. If the patient experiences these symptoms, driving or operating tools or machinery should be avoided.
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Teicopix contains sodium
This medicine contains 9.45 mg of sodium (the main component of table salt) per vial. This corresponds to 0.47% of the maximum recommended daily dietary intake of sodium for adults.

3. How to use Teicopix

Teicopix is available in strengths of 200 mg and 400 mg.
Recommended dosage
Adults and adolescents (aged 12 years and older) with normal kidney function
Skin and soft tissue infections, lung infections, and urinary tract infections

• Initial dose (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 (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 or intramuscular injection.

Infection caused by Clostridium difficile
The recommended dose is 100 to 200 mg taken orally twice daily for 7 to 14 days.
Adults and elderly patients with impaired kidney function
In patients with impaired kidney function, dose adjustment is usually required after
day four of treatment:

• Patients with mild to moderate kidney impairment will receive the maintenance dose every two days or half the maintenance dose once daily;
• Patients with severe kidney impairment or undergoing hemodialysis will receive the 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 given as a single intravenous injection, followed by:

• Week 1: 20 mg/L in each dialysis bag
• Week 2: 20 mg/L in every other dialysis bag
• Week 3: 20 mg/L in the dialysis bag left overnight.

Neonates (from birth to 2 months of age)

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

Children (aged 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 administered
Teicopix is usually administered by a doctor or nurse.

• The medicine will be given by intravenous (IV) or intramuscular (IM) injection.
• It may also be administered as an intravenous infusion (by drip).

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In neonates aged from birth to 2 months, the medicine should only be administered by infusion.
In the treatment of certain infections, the solution may be taken orally (oral administration).
Administration of a higher than recommended dose of Teicopix
It is unlikely that a doctor or nurse would administer too high a dose of the medicine. However,
if the patient feels they have received too much Teicopix, or if the patient becomes agitated, seek
immediate advice from a doctor or nurse.
Missed dose of Teicopix
The doctor or nurse will know when to administer Teicopix to the patient. It is unlikely they
would administer the medicine incorrectly. However, if the patient has any doubts, they should
consult their doctor or nurse.
Stopping Teicopix treatment
Do not stop taking Teicopix without first consulting 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 reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Serious adverse reactions
If the patient experiences any of the serious adverse reactions described below, treatment must be
discontinued and immediate medical advice sought from a doctor or nurse – urgent medical help
may be required.
Uncommon (may occur in fewer than 1 in 100 patients):

• sudden, life-threatening allergic reaction with symptoms such as: difficulty breathing or wheezing, swelling, rash, itching, fever, chills.

Rare (may occur in fewer than 1 in 1,000 patients):

• redness of the upper part of the body.

Frequency unknown (cannot be estimated from available data):

• formation of blisters on the skin, inside the mouth, eyes or genital organs – these may be symptoms of diseases called “toxic epidermal necrolysis”, “Stevens-Johnson syndrome” or “drug reaction with eosinophilia and systemic symptoms (DRESS)”. Initially, DRESS presents with flu-like symptoms and rash on the face, followed by widespread rash, high fever, increased liver enzyme activity detected in blood tests, increased number of eosinophils (a type of white blood cell), and swollen lymph nodes.

If any of these adverse reactions occur, immediate medical advice must be sought from a
doctor or nurse.
If the patient experiences any of the following serious adverse reactions, treatment must be
discontinued and immediate medical advice sought from a doctor or nurse – urgent medical help
may be required.
Uncommon (may occur in fewer than 1 in 100 patients):

• swelling of a vein and blood clot in the vein (venous thrombosis)
• difficulty breathing or wheezing (bronchospasm)
• increased susceptibility to infections – these may be symptoms of reduced white blood cell count.

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Frequency unknown (cannot be estimated from available data):

• absence of white blood cells – symptoms may include: fever, severe chills, sore throat or mouth ulcers (agranulocytosis)
• kidney function disorders or changes in kidney function – detectable in tests. The frequency or severity of kidney problems may increase when higher doses of the medicine are used.
• seizures
• low levels of all types of blood cells

If any of these adverse reactions occur, immediate medical advice must be sought from a
doctor or nurse.
Other adverse reactions
Consult a doctor, pharmacist or nurse if any of the following occur.
Common (may occur in fewer than 1 in 10 patients):

• rash, redness, itching
• pain
• fever

Uncommon (may occur in fewer than 1 in 100 patients):

• reduced platelet count
• increased liver enzyme activity
• increased blood creatinine levels (a marker of kidney function)
• hearing loss, ringing in the ears or sensation of spinning
• nausea or vomiting, diarrhoea
• dizziness or headache

Rare (may occur in fewer than 1 in 1,000 patients):

• infection (abscess)

Frequency unknown (frequency cannot be estimated from available data):

• reaction at the injection site, e.g. redness, pain or swelling

Reporting of adverse reactions
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store the medicine Teicopix

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Information on storage conditions for Teicopix after reconstitution and on the period of usability are provided in the section "Practical information for healthcare professionals on the preparation and handling of Teicopix".
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Do not store in a syringe.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the package and other information

What Teicopix contains
The active substance is teicoplanin.

• Each vial contains 400 mg of teicoplanin (400,000 IU). After reconstitution, the solution contains 400 mg of teicoplanin in 3.0 mL.
• Other components are:
• powder: sodium chloride and, if necessary, sodium hydroxide to adjust pH (see sodium-related information provided at the end of section 2);
• solvent: water for injections.

What Teicopix looks like and contents of the pack
Teicopix is a powder for the preparation of a solution for injection/infusion or for the preparation of an oral solution, supplied with a solvent. The powder is white to slightly yellowish in colour.
The solvent is a clear, particle-free liquid.
The powder is packed in 22 mL clear type I glass vials containing 400 mg, closed with a bromobutyl rubber stopper, aluminium seal and a plastic flip-off cap.
The solvent is packed in a 3 mL ampoule made of clear type I glass.
Pack sizes:

• 1 vial of powder + 1 ampoule of solvent (3 mL)
• 5 vials of powder + 5 ampoules of solvent (3 mL each)

For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Italy, the country of export:
Sandoz S.p.A., L.go U. Boccioni 1 - 21040 Origgio (VA), Italy
Manufacturer:
Lek Pharmaceuticals d.d., Verovskova 57, 1526 Ljubljana, Slovenia
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany
Parallel importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Italian marketing authorisation number, country of export: 041769050
Parallel import authorisation number: 191/23
This medicinal product is authorised for marketing in 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)

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Information intended exclusively for medical professionals

Practical information for medical professionals on handling and preparation of the medicinal product
Teicopix and its preparation for use
This medicinal product is intended for single use only.
Administration method
The solution obtained after reconstitution of the powder may be administered directly or further diluted.
The solution may be given as an intravenous injection ( bolus ) lasting from 3 to 5 minutes or as a 30-minute infusion.
In infants from birth to 2 months of age, the medicinal product must be administered only as an infusion.
The solution obtained after dissolving the powder may also be administered orally.
Preparation of the solution

• Slowly inject the entire contents of the solvent provided into the vial containing the powder.
• Gently rotate the vial in the hands until the powder is completely dissolved. If foaming occurs, allow the solution to stand for approximately 15 minutes. Only clear, slightly yellow solutions should be used.

The prepared solution contains 400 mg of teicoplanin in 3.0 mL.
The final solution is isotonic with serum and has a pH of 7.2–7.8.

Dilution of the solution prior to infusion
Teicopix medicinal product may 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 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 according to recommendations has been demonstrated for 24 hours at a temperature of 2 to 8°C.
From a microbiological point of view, the medicinal product should be used immediately. If it is not used immediately, the responsibility for storage conditions and duration prior to use lies with the user and usually should not exceed 24 hours at a temperature of 2 to 8°C.
Disposal
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Any unused portions of the medicinal product or waste materials should be disposed of in accordance with local regulations.
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