Teicoplanin Sun: detailed information

Patient Information Leaflet

Teicoplanin SUN 200 mg powder and solvent for injectable/infusion solution or oral solution
Teicoplanin SUN 400 mg powder and solvent for injectable/infusion solution or oral solution
Teicoplanin
Generic medicine
Please read this leaflet carefully before taking this medicine, as 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. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What Teicoplanin SUN is and what it is used for
What you need to know before you are given Teicoplanin SUN
How to use Teicoplanin SUN
Possible side effects
How to store Teicoplanin SUN
Contents of the pack and other information

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

Teicoplanin SUN is an antibiotic that contains the active substance teicoplanin. It works by killing the bacteria responsible for infections in the body.
Teicoplanin SUN is used in adults and children (including newborns) to treat bacterial infections of:

Skin and underlying tissues – sometimes referred to as "soft tissues"
Bones and joints
Lungs
Urinary tract
Heart – sometimes referred to as "endocarditis"
Abdominal area – peritonitis
Blood, when caused by any of the above conditions.

Teicoplanin SUN may be used to treat certain intestinal infections caused by Clostridium difficile bacteria. In this case, the solution is taken by mouth.

2. What you should know before being given Teicoplanina SUN

Do not use Teicoplanina SUN:

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 before you are given Teicoplanina SUN if:

you are allergic to an antibiotic called "vancomycin"
you have experienced redness of the upper part of the body (red man syndrome)
you have a low platelet count (thrombocytopenia)
you have kidney problems
you are taking other medicines that could cause hearing and/or kidney problems. You may need regular tests to monitor whether your blood, kidneys and/or liver are functioning properly (see "Other medicines and Teicoplanina SUN"). If any of the above applies to you (or if you are unsure), talk to your doctor, pharmacist or nurse before being given Teicoplanina SUN.

Tests
During treatment, you may need to have tests to monitor your blood, kidneys and/or hearing.
This is more likely if:

your treatment will last a long time
you have kidney problems
you are taking or may take other medicines that can affect the nervous system, kidneys or hearing.

In people receiving long-term treatment with Teicoplanina SUN, bacteria not affected by the antibiotic may grow more than usual – your doctor will carry out checks to monitor for this possibility.
Other medicines and Teicoplanina SUN
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Teicoplanina SUN may affect how other medicines work. Likewise, some medicines may affect how Teicoplanina SUN works.
In particular, tell your doctor, pharmacist or nurse if you are taking any of the following medicines:

aminoglycosides, which must not be mixed with Teicoplanina SUN in the same injection. These 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
ciclosporin – a medicine that affects the immune system and may cause hearing and/or kidney problems
cisplatin – a medicine used to treat malignant tumours that may cause hearing and/or kidney problems
diuretic tablets (such as furosemide) – which may cause hearing and/or kidney problems. If any of the above applies to you (or if you are unsure), talk to your doctor, pharmacist or nurse before being given Teicoplanina SUN.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor, pharmacist or nurse for advice before being given this medicine. They will decide whether you should be given this medicine during pregnancy.
There may be a potential risk of inner ear and kidney problems.
Inform your doctor if you are breastfeeding before being given this medicine. They will decide whether you can continue breastfeeding while receiving Teicoplanina SUN.
Animal reproduction studies have not shown evidence of fertility problems.
Driving and using machines
While being treated with Teicoplanina SUN, you may experience headache or dizziness. If this occurs, do not drive or operate machinery.
Teicoplanina SUN contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. essentially "sodium-free".

3. How to use Teicoplanina SUN

Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Recommended dose

Adults and children (12 years of age and older) with normal kidney function

Skin, soft tissue, lung and urinary tract infections

Initial dose (for the first 3 doses): 6 mg per kg of body weight administered every 12 hours by intravenous or intramuscular injection
Maintenance dose: 6 mg per kg of body weight administered once daily by intravenous or intramuscular injection

Bone and joint infections, and heart infections

Initial dose (for the first three to five doses): 12 mg per kg of body weight administered every 12 hours by intravenous injection
Maintenance dose: 12 mg per kg of body weight administered once daily by intravenous or intramuscular injection

Infections caused by bacteria Clostridium difficile

The recommended dose is 100–200 mg orally twice daily for 7–14 days.

Adults and elderly patients with kidney problems

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

For patients with mild to moderate renal impairment: the maintenance dose will be given every two days, or half the maintenance dose will be given daily
For patients with severe renal impairment or undergoing hemodialysis: the maintenance dose will be given every three days, or one-third of the maintenance dose will be given daily

Peritonitis in patients undergoing peritoneal dialysis

Initial dose: 6 mg per kg of body weight, given 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 the nighttime dialysis bag

Neonates (from birth to 2 months)

Initial dose (first day): 16 mg per kg of body weight administered as an intravenous infusion
Maintenance dose: 8 mg per kg of body weight administered once daily as an intravenous infusion

Children (from 2 months to 12 years of age)

Initial dose (for the first three doses): 10 mg per kg of body weight administered every 12 hours by intravenous injection
Maintenance dose: 6 to 10 mg per kg of body weight administered once daily by intravenous injection

How Teicoplanina SUN is administered

This medicine is usually administered by a doctor or nurse.

It is given by intravenous (IV) or intramuscular (IM) injection
It may also be given as an intravenous infusion. In children from birth to 2 months of age, it must be administered only by infusion. For the treatment of certain infections, the solution may be taken orally.

If you receive more Teicoplanina SUN 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 Teicoplanina SUN or if you feel unwell, inform your doctor or nurse immediately.

If you miss a dose of Teicoplanina SUN

Your doctor or nurse will have specific instructions on when to administer Teicoplanina SUN. It is unlikely that you will miss a scheduled dose. However, if you are concerned, inform your doctor or nurse.

If you stop Teicoplanina SUN treatment

Do not stop taking this medicine without first talking to your doctor, pharmacist, or nurse.

If you have any questions about how to use this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Serious side effects
Stop treatment and immediately contact your doctor or nurse if you experience any of the
following serious side effects – you may need urgent medical treatment:
Uncommon (may affect up to 1 in 100 people)

sudden allergic reaction that may be life-threatening – signs may include: difficulty breathing or wheezing, swelling, rash, itching, fever, chills.

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

hot flushes in the upper part of the body

Not known (frequency cannot be estimated from the available data)

blistering rash of the skin, mouth, eyes, or genitals – these may be signs of a condition called “toxic epidermal necrolysis” or “Stevens-Johnson syndrome” or “drug reaction with eosinophilia and systemic symptoms (DRESS)”. DRESS initially presents with flu-like symptoms and a rash on the face, followed by widespread rash and high fever, increased liver enzyme levels observed in blood tests, an increase in a type of white blood cells (eosinophilia), and swollen lymph nodes.

Contact your doctor or nurse immediately if you notice any of the side effects listed above.
Contact your doctor or nurse immediately 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)

swelling and blood clot in a vein
difficulty breathing or wheezing (bronchospasm)
increased occurrence of infections – this could be a sign of reduced number of blood cells

Not known (frequency cannot be estimated from the available data)

lack of white blood cells – signs may include: fever, severe chills, sore throat, or mouth ulcers (agranulocytosis)
kidney problems or changes in kidney function – detected by blood tests
seizures

Contact your doctor or nurse immediately if you notice any of the side effects listed above.
Other side effects
Inform your doctor, pharmacist, or nurse if you notice 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)

decreased platelet count
increased liver enzyme levels in the blood
increased creatinine levels in the blood (to monitor kidney function)
hearing loss, ringing in the ears, or sensation that you or objects around you are moving
feeling unwell or nausea, diarrhoea
dizziness or headache

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

infection (abscess)

Not known (frequency cannot be estimated from the available data)

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

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Teicoplanina SUN

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 on the label of the
vial after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature.
Store in the original packaging.
Information on storage and duration of use of Teicoplanina SUN after reconstitution and once ready for use are described in the "Practical information for healthcare professionals on the preparation and handling of Teicoplanina SUN".
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Teicoplanina SUN contains

The active substance is teicoplanin. Each vial of powder contains 200 mg or 400 mg of teicoplanin.
The other components are sodium chloride (E551) and sodium hydroxide (E524) (for pH adjustment) in the powder, and water for injections in the solvent.

Description of the appearance of Teicoplanina SUN and contents of the pack
Teicoplanina SUN is a powder and solvent for injectable/infusion solution or oral solution. The
powder is a white to ivory-colored, spongy lyophilisate. The solvent is a clear, colourless and
odourless liquid.
The powder is packaged:

in a 10 ml colourless Type I glass vial containing 200 mg, closed with a bromobutyl rubber stopper and an aluminium flip-off seal
in a 20 ml colourless Type I glass vial containing 400 mg, closed with a bromobutyl rubber stopper and an aluminium flip-off seal. The solvent is packaged:
in a colourless Type I glass ampoule.

Pack sizes:
1 vial with 200 mg powder and 1 ampoule with 3 ml solvent
5 vials with 200 mg powder and 5 ampoules with 3 ml solvent
10 vials with 200 mg powder and 10 ampoules with 3 ml solvent
25 vials with 200 mg powder and 25 ampoules with 3 ml solvent
1 vial with 400 mg powder and 1 ampoule with 3 ml solvent
5 vials with 400 mg powder and 5 ampoules with 3 ml solvent
10 vials with 400 mg powder and 10 ampoules with 3 ml solvent
25 vials with 400 mg powder and 25 ampoules with 3 ml solvent
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands

Local Representative:
Sun Pharma Italia Srl - Viale Giulio Richard, 3 - 20143 Milano

Manufacturer:
Sirton Pharmaceuticals S.p.A., Piazza XX Settembre 2, 22079 Villa Guardia (CO), Italy

This medicinal product is authorised in the European Economic Area (EEA) Member States under the following names:
Italy Teicoplanina SUN
Netherlands Teicoplanine SUN 200mg 400mg powder and solvent for solution for injection/infusion or oral solution
United Kingdom Teicoplanin 200 mg 400mg powder and solvent for solution for injection/infusion or oral solution

The following information is intended exclusively for physicians or healthcare professionals:
Practical information for healthcare professionals on the preparation and handling of Teicoplanina SUN
This medicinal product is for single use only.

Method of administration
The reconstituted solution may be injected directly or alternatively further diluted.
The injection may be administered as a bolus over 3-5 minutes or as a 30-minute infusion.
In children from birth up to 2 months of age, administration should only be performed via infusion.
The reconstituted solution may also be administered orally.

Preparation of the reconstituted solution

slowly inject the entire contents of the solvent provided into the vial of powder
gently rotate the vial between hands until the powder is completely dissolved. If foaming occurs, allow the solution to stand for approximately 15 minutes. The reconstituted solutions contain 200 mg of teicoplanin in 3.0 mL and 400 mg in 3.0 mL. Only clear, yellowish solutions should be used. The final solution is isotonic with plasma and has a pH of 7.2–7.8.

Nominal content of vial 200 mg 400 mg
teicoplanin
Powder vial volume 10 ml 22 ml
Volume extractable from solvent ampoule for 3.14 ml 3.14 ml
reconstitution
Volume containing the nominal dose of 3.0 ml 3.0 ml
teicoplanin (to be extracted with a 5 mL
syringe and 23 G needle)

Preparation of the diluted solution prior to infusion
Teicoplanina SUN may be administered in the following infusion solutions:

sodium chloride 9 mg/mL (0.9%)
5%, 1.36%, 3.86% dextrose for injection
Ringer's lactate
0.18% NaCl 4% Dextrose

Stability of the reconstituted solution
Chemical and physical in-use stability of the reconstituted solution prepared according to the recommendations has been demonstrated for 24 hours at a temperature between 2 and 8°C.
From a microbiological standpoint, the product should be used immediately. If not used immediately, the user is responsible for the storage period and conditions prior to use, which should not normally exceed 24 hours at a temperature between 2 and 8°C, unless reconstitution is carried out under controlled and validated aseptic conditions.

Stability of the diluted medicinal product
Chemical and physical in-use stability of the diluted solution prepared according to the recommendations has been demonstrated for 24 hours at a temperature between 2 and 8°C.
From a microbiological standpoint, the product should be used immediately. If not used immediately, the user is responsible for the storage period and conditions prior to use, which should not normally exceed 24 hours at a temperature between 2 and 8°C, unless reconstitution/dilution is carried out under controlled and validated aseptic conditions.

Disposal
Unused medicine and waste materials derived from this medicinal product must be disposed of in accordance with current local regulations.

Patient Information Leaflet

Teicoplanin SUN 200 mg powder for injectable/infusion solution or oral solution, 400 mg powder for injectable/infusion solution or oral solution

Teicoplanin
Equivalent medicine
Please read this leaflet carefully before taking 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. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What Teicoplanin SUN is and what it is used for
What you need to know before you are given Teicoplanin SUN
How to use Teicoplanin SUN
Possible side effects
How to store Teicoplanin SUN
Contents of the pack and other information

4. What Teicoplanina SUN is and what it is used for

Teicoplanina SUN is an antibiotic that contains the active substance teicoplanin. It works by killing the bacteria responsible for infections in the body.
Teicoplanina SUN is used in adults and children (including newborns) to treat bacterial infections of:

skin and underlying tissues – sometimes called “soft tissues”
bones and joints
lungs
urinary tract
heart – sometimes called “endocarditis”
abdominal area – peritonitis
blood, when caused by one of the above-mentioned conditions.

Teicoplanina SUN may be used to treat certain infections caused by Clostridium difficile bacteria in the intestine. In this case, the solution is taken orally.

5. What you need to know before you are given Teicoplanina SUN

Do not use Teicoplanina SUN:

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 before you are given Teicoplanina SUN if:

You are allergic to an antibiotic called "vancomycin"
You have experienced redness of the upper part of the body (red man syndrome)
You have a low platelet count (thrombocytopenia)
You have kidney problems
You are taking other medicines that could cause hearing and/or kidney problems. You may need regular tests to monitor whether your blood, kidneys, and/or liver are functioning properly (see "Other medicines and Teicoplanina SUN"). If any of the above applies to you (or if you are not sure), talk to your doctor, pharmacist, or nurse before you are given Teicoplanina SUN.

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 skin rash or other skin symptoms described in section 4, stop taking Teicoplanina SUN and contact your doctor immediately or go to a medical center.

Tests
During treatment, you may need to undergo tests to monitor your blood, kidneys, and/or hearing. This is more likely if:

The treatment will last a long time
You have kidney problems
You are taking or may take other medicines that can affect the nervous system, kidneys, or hearing.

In people receiving Teicoplanina SUN for a prolonged period, bacteria not affected by the antibiotic may grow more than usual – your doctor will carry out checks to monitor this possibility.

Other medicines and Teicoplanina SUN
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Teicoplanina SUN may affect how other medicines work. Likewise, some medicines may affect how Teicoplanina SUN works.

In particular, inform your doctor, pharmacist, or nurse if you are taking any of the following medicines:

Aminoglycosides – these must not be mixed with Teicoplanina SUN 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 that affects the immune system and 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) – which may cause hearing and/or kidney problems. If any of the above applies to you (or if you are not sure), talk to your doctor, pharmacist, or nurse before you are given Teicoplanina SUN.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor, pharmacist, or nurse for advice before this medicine is administered. They will decide whether you should be given this medicine during pregnancy. There may be a potential risk of inner ear and kidney problems.

Inform your doctor if you are breastfeeding before this medicine is administered. Your doctor will decide whether you can continue or not to breastfeed while you are receiving Teicoplanina SUN.

Animal reproduction studies have not shown evidence of fertility problems.

Driving and using machines
While being treated with Teicoplanina SUN, you may experience headache or dizziness. If this happens, do not drive or operate machinery.

Teicoplanina SUN contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. essentially "sodium-free".

6. How to use Teicoplanin SUN

Use this medicine exactly as prescribed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Recommended dose

Adults and children (aged 12 years and older) with normal kidney function

Skin and soft tissue infections, lung infections, and urinary tract infections

Initial dose (for the first 3 doses): 6 mg per kg of body weight administered every 12 hours by intravenous or intramuscular injection.
Maintenance dose: 6 mg per kg of body weight administered once daily by intravenous or intramuscular injection.

Bone and joint infections, and heart infections

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

Infections caused by bacteria Clostridium difficile

The recommended dose is 100–200 mg orally twice daily for 7–14 days.

Adults and elderly patients with kidney problems

If you have kidney problems, your dose is generally reduced after the fourth day of treatment:

For patients with mild to moderate kidney impairment – the maintenance dose will be given every two days, or half the maintenance dose will be given daily.
For patients with severe kidney impairment or undergoing hemodialysis – the maintenance dose will be given every three days, or one-third of the maintenance dose will be given daily.

Peritonitis in patients undergoing peritoneal dialysis

Initial dose: 6 mg per kg of body weight, given 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 the nighttime dialysis bag.

Neonates (from birth to 2 months of age)

Initial dose (first day): 16 mg per kg of body weight, administered by intravenous infusion.
Maintenance dose: 8 mg per kg of body weight, administered once daily by intravenous infusion.

Children (from 2 months to 12 years of age)

Initial dose (for the first three doses): 10 mg per kg of body weight, administered every 12 hours by intravenous injection.
Maintenance dose: 6 to 10 mg per kg of body weight, administered once daily by intravenous injection.

How Teicoplanin SUN is administered

This medicine is usually administered by a doctor or nurse.

It is given by intravenous (IV) or intramuscular (IM) injection.
It may also be given by intravenous infusion. In children from birth to 2 months of age, it must be administered only by infusion. For the treatment of certain infections, the solution may be taken orally (oral use).

If you receive more Teicoplanin SUN 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 SUN, or if you feel unwell, inform your doctor or nurse immediately.

If you miss a dose of Teicoplanin SUN

Your doctor or nurse will have specific instructions on when to administer Teicoplanin SUN. It is unlikely that the medicine will be omitted as prescribed. However, if you are concerned, inform your doctor or nurse.

If you stop treatment with Teicoplanin SUN

Do not stop taking this medicine without first discussing it with your doctor, pharmacist, or nurse.

If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Serious side effects
Stop treatment and contact your doctor or nurse immediately 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 allergic reaction that may be life-threatening – signs may include: difficulty breathing or wheezing, swelling, rash, itching, fever, chills.

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

hot flushes in the upper part of the body

Not known (frequency cannot be estimated from the available data)

blistering rash of the skin, mouth, eyes, or genitals – these may be signs of a condition 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 disease called "acute generalised exanthematous pustulosis" (AGEP).
drug reaction with eosinophilia and systemic symptoms (DRESS). DRESS initially presents with flu-like symptoms and a rash on the face, followed by widespread rash, high temperature, elevated liver enzymes, elevated temperature, increased liver enzymes observed in blood tests, increase in a type of white blood cells (eosinophilia), and swollen lymph nodes.

Contact your doctor or nurse immediately if you notice any of the side effects listed above.
Contact your doctor or nurse immediately 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)

swelling and blood clot in a vein
difficulty breathing or wheezing (bronchospasm)
increased occurrence of infections – this could be a sign of a reduced number of blood cells

Not known (frequency cannot be estimated from the available data)

lack of white blood cells – signs may include: fever, severe chills, sore throat, or mouth ulcers (agranulocytosis)
kidney problems or changes in how the kidneys are working, as shown in tests. The frequency or severity of kidney problems may increase if you receive a higher dose.
seizures

rash, redness, itching
pain
fever

Uncommon (may affect up to 1 in 100 people)

decrease in the number of platelets
increased levels of liver enzymes in the blood
increased levels of creatinine in the blood (to monitor kidney function)
hearing loss, ringing in the ears, or sensation that you or objects around you are moving
feeling unwell or nausea, diarrhoea
dizziness or headache

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

infection (abscess)

Not known (frequency 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 (pancytopenia).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Teicoplanina SUN

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 on the label of the
vial after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature conditions.
Store in the original packaging.
Information on storage and duration of use of Teicoplanina SUN after reconstitution and once ready for use are described in the “Practical information for healthcare professionals on the preparation and handling of Teicoplanina SUN”.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

7. Contents of the pack and other information

What Teicoplanin SUN contains

The active substance is teicoplanin. Each vial of powder contains 200 mg or 400 mg of teicoplanin.
The other components are sodium chloride (E551) and sodium hydroxide (E524) (for pH adjustment) in the powder.

Description of the appearance of Teicoplanin SUN and contents of the pack
Teicoplanin SUN is a powder for injectable/infusion solution or oral solution. The powder is a white to ivory, sponge-like lyophilisate. The solvent is a clear, colourless and odourless liquid.
The powder is packed:

in a 10 ml colourless Type I glass vial for 200 mg, closed with a bromobutyl rubber stopper and an aluminium tear-off cap
in a 20 ml colourless Type I glass vial for 400 mg, closed with a bromobutyl rubber stopper and an aluminium tear-off cap.

Pack sizes:
1 vial containing 200 mg of powder
5 vials containing 200 mg of powder
10 vials containing 200 mg of powder
25 vials containing 200 mg of powder
1 vial containing 400 mg of powder
5 vials containing 400 mg of powder
10 vials containing 400 mg of powder
25 vials containing 400 mg of powder
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands

Local representative:
Sun Pharma Italia Srl - Viale Giulio Richard, 3 - 20143 Milano

Manufacturer:
Sirton Pharmaceuticals S.p.A., Piazza XX Settembre 2, 22079 Villa Guardia (CO), Italy

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Italy: Teicoplanina SUN
Netherlands: Teicoplanine SUN 200mg 400mg poeder en oplosmiddel voor oplossing voor injectie/infusie of orale oplossing
United Kingdom: Teicoplanin 200 mg 400mg powder and solvent for solution for injection/infusion or oral solution

The following information is intended exclusively for physicians or healthcare professionals:
Practical information for healthcare personnel on the preparation and handling of Teicoplanin SUN
This medicinal product is for single use only.

Route of administration
The reconstituted solution may be injected directly or alternatively further diluted.
The injection can be administered as a bolus over 3–5 minutes or by infusion over 30 minutes.
In neonates and 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 3.14 mL of water for injections into the vial of powder.
Gently rotate the vial between the hands until the powder is completely dissolved. If foaming occurs, allow the solution to stand for approximately 15 minutes. The reconstituted solutions contain 200 mg of teicoplanin in 3.0 mL and 400 mg in 3.0 mL. Only clear, yellowish solutions should be used. The final solution is isotonic with plasma and has a pH of 7.2–7.8.

Nominal content of 200 mg 400 mg
teicoplanin in the vial
Volume of powder vial 10 mL 22 mL
Volume of solvent to be added for 3.14 mL 3.14 mL
reconstitution
Volume containing the nominal dose of 3.0 mL 3.0 mL
teicoplanin (to be withdrawn using a 5 mL
syringe and 23 G needle)

Preparation of diluted solution prior to infusion
Teicoplanin SUN may be administered in the following infusion solutions:

Sodium chloride 9 mg/mL (0.9%) solution
Ringer-lactate solution
Dextrose 1.36%, 3.86%, 5% solutions
Solution containing 0.18% sodium chloride and 4% glucose

Stability of the reconstituted solution
Chemical and physical in-use stability of the reconstituted solution prepared according to the recommendations has been demonstrated for 24 hours at a temperature of 2–8°C.
From a microbiological point of view, the product should be used immediately. If not used immediately, the user is responsible for the storage period and conditions prior to use, which should not normally exceed 24 hours at 2–8°C, unless reconstitution has been carried out under controlled and validated aseptic conditions.

Stability of the diluted medicinal product
Chemical and physical in-use stability of the reconstituted solution prepared according to the recommendations has been demonstrated for 24 hours at a temperature of 2–8°C.
From a microbiological point of view, the product should be used immediately. If not used immediately, the user is responsible for the storage period and conditions prior to use, which should not normally exceed 24 hours at 2–8°C, unless reconstitution/dilution has been carried out under controlled and validated aseptic conditions.

Disposal
Unused medicine and waste materials derived from this medicinal product must be disposed of in accordance with local applicable regulations.