Teicoplanin Aptapharma

Package Leaflet: Information for the User

Teicoplanin AptaPharma, 200 mg,

powder and solvent for solution for injection/infusion

Teicoplanin AptaPharma, 400 mg, powder and solvent for solution for injection/infusion

Teicoplanin
Read carefully the entire leaflet before using the medicine, as 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 experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet:

• 1. What is Teicoplanin AptaPharma and what is it used for
• 2. Before you use Teicoplanin AptaPharma
• 3. How to use Teicoplanin AptaPharma
• 4. Possible side effects
• 5. How to store Teicoplanin AptaPharma
• 6. Contents of the pack and other information

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

Teicoplanin AptaPharma is an antibiotic. It contains the active substance teicoplanin. It works by killing bacteria that cause infections in the body.

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

• of the skin and soft tissues - sometimes called "soft tissue infections"
• of bones and joints
• of the lungs
• of the urinary tract
• of the heart - sometimes called "endocarditis"
• of the abdominal cavity - peritonitis
• of the blood, if caused by any of the above conditions.

Teicoplanin AptaPharma can be used to treat some infections caused by bacteria called Clostridium difficile in the gut. For this purpose, the solution of the medicine is taken orally.

2. Before you use Teicoplanin AptaPharma

When not to use Teicoplanin AptaPharma

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

Warnings and precautions

Before starting treatment with Teicoplanin AptaPharma, tell your doctor, pharmacist, or nurse if:

• you are allergic to an antibiotic called vancomycin
• you have had a redness of the upper body (called "red man syndrome")
• you have a low platelet count (thrombocytopenia)
• you have kidney problems
• you are taking other medicines that may affect your hearing and/or kidney function. You may need to have regular tests to check that your kidneys and/or liver are working properly (see "Teicoplanin AptaPharma and other medicines").

If any of the above applies to you (or you are not sure), tell your doctor, pharmacist, or nurse before using Teicoplanin AptaPharma.

During treatment with teicoplanin, severe skin reactions have been reported, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP).

If you experience a severe rash or other skin symptoms described in section 4, stop using Teicoplanin AptaPharma and contact your doctor or seek medical attention immediately.

Tests

During treatment, you may have blood tests, kidney function tests, liver function tests, and/or hearing tests. This is more likely if:

• treatment is long-term
• you are being 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, or hearing.

In people taking Teicoplanin AptaPharma for a long time, there may be a greater than usual increase in bacteria that are not affected by the antibiotic. Your doctor will check for this.

Teicoplanin AptaPharma and other medicines

Tell your doctor, pharmacist, or nurse about all the medicines you are taking, have recently taken, or might take.

This is because Teicoplanin AptaPharma may affect the way other medicines work. Also, some medicines may affect the way Teicoplanin AptaPharma works.

In particular, tell your doctor, pharmacist, or nurse if you are taking:

• aminoglycosides - because they must not be mixed with Teicoplanin AptaPharma in the same injection. These medicines 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.
• cyclosporin - a medicine that affects the immune system, which may cause hearing and/or kidney problems.
• cisplatin - a medicine used to treat cancer, which may cause hearing and/or kidney problems.
• diuretics (such as furosemide) - also known as "water tablets", which may cause hearing and/or kidney problems.

If any of the above applies to you (or you are not sure), tell your doctor, pharmacist, or nurse before using Teicoplanin AptaPharma.

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 using this medicine.

They will decide whether you can use Teicoplanin AptaPharma during pregnancy. There is a risk of damage to the inner ear and kidney problems.

If you are breastfeeding, tell your doctor before using this medicine. They will decide whether you can breastfeed while using Teicoplanin AptaPharma.

Studies in animals have shown no evidence of fertility problems.

Driving and using machines

During treatment with Teicoplanin AptaPharma, you may experience pain or dizziness.

If you experience these symptoms, do not drive or operate any tools or machines.

Teicoplanin AptaPharma contains sodium:

The medicine contains 10 mg of sodium (the main ingredient of common salt) per vial. This is equivalent to 0.5% of the maximum recommended daily intake of sodium for adults.

3. How to use Teicoplanin AptaPharma

Recommended dose:

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

Skin and soft tissue infections, lung and urinary tract infections

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

Bone and joint infections and heart infections

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

Infections caused by bacteria called Clostridium difficile
Recommended dose is 100 to 200 mg orally, twice a day for 7 to 14 days.

Adults and elderly patients with kidney problems

If you have kidney problems, the dose will usually be reduced after the fourth day of treatment:

• For patients with mild to moderate kidney problems - the maintenance dose will be given every other day or half the maintenance dose will be given once a day.
• For patients with severe kidney problems or those undergoing hemodialysis - the maintenance dose will be given every three days or one-third of the maintenance dose will be given once a day.

Peritonitis in patients undergoing peritoneal dialysis

Initial dose is 6 mg per kilogram of body weight in a single injection into a vein, 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 overnight dialysis bag.

Newborns and infants (from birth to 2 months)

• Initial dose (on the first day): 16 mg per kilogram of body weight in an intravenous infusion by drip.
• Maintenance dose: 8 mg per kilogram of body weight given once a day in an intravenous infusion by drip.

Children (from 2 months to 12 years)

• 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 AptaPharma is given

This medicine is usually given by a doctor or nurse.

• The medicine will be given by injection into a vein (intravenous) or into a muscle (intramuscular).
• The medicine can also be given by intravenous infusion by drip. In newborns from birth to 2 months, only intravenous infusion should be used. For the treatment of some infections, the solution can be taken orally (by mouth).

Using more Teicoplanin AptaPharma 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 AptaPharma or if you feel unwell, tell your doctor or nurse immediately.

Missing a dose of Teicoplanin AptaPharma

Your doctor or nurse will have instructions on how to give you Teicoplanin AptaPharma. It is unlikely that they will give you the wrong dose. However, if you have concerns, talk to your doctor or nurse.

Stopping Teicoplanin AptaPharma

Do not stop using Teicoplanin AptaPharma without talking to your doctor, pharmacist, or nurse first.

4. Possible side effects

Like all medicines, Teicoplanin AptaPharma can cause side effects, although not everybody gets them.

Severe side effects

If you experience any of the following severe side effects, stop treatment and contact your doctor or nurse immediately, as you may need urgent medical attention.

Uncommon(may affect up to 1 in 100 people):

• severe allergic reaction - symptoms may include 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):

• blisters on the skin, mouth, eyes, or genitals - these may be symptoms of a condition called toxic epidermal necrolysis or Stevens-Johnson syndrome
• red, scaly, widespread rash with bumps under the skin (including skin folds, chest, abdomen, back, and arms) and blisters with fever - these may be symptoms of a condition called acute generalized exanthematous pustulosis (AGEP)
• drug reaction with eosinophilia and systemic symptoms (DRESS). Initially, DRESS appears as flu-like symptoms and a rash on the face, then as a widespread rash with high fever, increased liver enzyme activity in blood tests, and an increase in a type of white blood cell (eosinophilia) and swollen lymph nodes.

If you experience any of the above side effects, tell your doctor or nurse immediately.

Other side effects

Tell your doctor, pharmacist, or nurse if you experience any of the following side effects:

Common(may affect up to 1 in 10 people):

• rash, redness, itching
• pain
• fever

Uncommon(may affect up to 1 in 100 people):

• low platelet count
• increased liver enzyme activity in blood tests
• increased creatinine levels in blood tests (kidney function tests)
• hearing loss, ringing in the ears, or feeling that you or things around you are spinning
• nausea or vomiting, diarrhea
• dizziness or headache

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

• infection (abscess)

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

• problems at the injection site - such as redness of the skin, pain, or swelling
• low levels of all types of blood cells

Reporting side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.

Side effects can be reported to the Medicines and Healthcare products Regulatory Agency (MHRA) using the Yellow Card Scheme.

5. How to store Teicoplanin AptaPharma

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 refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Store in the original package to protect from light.

Information on storage and shelf life after reconstitution and preparation for use is given in section "Practical information on the preparation of Teicoplanin AptaPharma and handling of the medicinal product intended for healthcare professionals".

6. Contents of the pack and other information

What Teicoplanin AptaPharma contains

• The active substance is teicoplanin. Each vial contains 200 mg or 400 mg of teicoplanin.
• The other ingredients are sodium chloride and sodium hydroxide (for pH adjustment) in the powder; water for injections in the solvent.

What Teicoplanin AptaPharma looks like and contents of the pack

Teicoplanin AptaPharma is a powder and solvent for solution for injection/infusion.

The powder is a white or off-white freeze-dried powder. The solvent is a clear, colorless solution.

After reconstitution, Teicoplanin AptaPharma 200 mg is a slightly brownish, opalescent solution.

After reconstitution, Teicoplanin AptaPharma 400 mg is a brownish, opalescent solution.

The powder is packed in:

• a 10 mL glass vial type I closed with a grey rubber stopper type I and a blue flip-off seal type consisting of an aluminum cap and a polypropylene disc (PP disc).
• a 20 mL glass vial type I closed with a grey rubber stopper type I and a red flip-off seal type consisting of an aluminum cap and a polypropylene disc (PP disc).

The solvent is in an ampoule of colorless glass type I.

Pack size:

• 1 vial with powder + 1 ampoule with solvent in a carton.
• 10 x (1 vial with powder + 1 ampoule with solvent) in a carton.

Not all pack sizes may be marketed.

Marketing Authorization Holder

Apta Medica Internacional d.o.o.

Likozarjeva Ulica 6

1000 Ljubljana

Slovenia

Tel: 00386 51 615 015

e-mail: info@apta-medica.com

Manufacturer

Sirton Pharmaceuticals S.p.A.

Piazza XX Settembre, 2

22079 Villa Guardia (CO)

Italy

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

Date of last revision of the package leaflet:

Information intended for healthcare professionals only:

Practical information on the preparation of Teicoplanin AptaPharma and handling of the medicinal product intended for healthcare professionals.

This medicine is for single use only.

Method of administration

After reconstitution, the solution can be administered by injection directly or after further dilution.

The medicine will be given by injection in a bolus over 3-5 minutes or in a 30-minute intravenous infusion.

In newborns from birth to 2 months, the medicine should only be given by intravenous infusion.

After reconstitution, the solution can also be given orally.

Preparation of the solution:

• Slowly inject the entire contents of the solvent into the vial with the powder.
• Gently rotate the vial between your hands until the powder is completely dissolved. If the solution foams, let it stand for about 15 minutes. After reconstitution, the solutions will contain 200 mg of teicoplanin in 3.0 mL or 400 mg in 3.0 mL.

Only clear and brownish solutions should be used.

The resulting solution is isotonic with blood and has a pH of 7.2-7.8.

Dilution of the solution before infusion:

Teicoplanin AptaPharma can be administered in the following infusion solutions:

• 9 mg/mL (0.9%) sodium chloride solution
• Ringer's solution
• Ringer's solution with lactate
• 50 mg/mL (5%) glucose solution for injection
• 100 mg/mL (10%) glucose solution for injection
• 1.8 mg/mL (0.18%) sodium chloride solution and 40 mg/mL (4%) glucose solution
• 4.5 mg/mL (0.45%) sodium chloride solution and 50 mg/mL (5%) glucose solution
• peritoneal dialysis solution containing 13.6 mg/mL (1.36%) or 38.6 mg/mL (3.86%) glucose solution.

Shelf life of the solution after reconstitution

Chemical and physical stability of the solution prepared as directed has been demonstrated for 24 hours at a temperature of 2°C 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 would normally not be longer than 24 hours at 2°C to 8°C.

Shelf life of the solution after dilution

Chemical and physical stability of the solution prepared as directed has been demonstrated for 24 hours at a temperature of 2°C 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 would normally not be longer than 24 hours at 2°C to 8°C.

Disposal

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.