Teicoplanin Altan

Package Leaflet: Information for the User

Teicoplanin Altan 200 mg Powder for solution for injection or infusion, 400 mg Powder for solution for injection or infusion

Equivalent medicine
Please read this leaflet carefully before using 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. Do not give it to others, even if their symptoms are the same as yours, as it may 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:

1. What Teicoplanin Altan is and what it is used for
2. What you need to know before Teicoplanin Altan is administered to you
3. How to use Teicoplanin Altan
4. Possible side effects
5. How to store Teicoplanin Altan
6. Contents of the pack and other information

1. What Teicoplanina Altan is and what it is used for

Teicoplanina Altan is an antibiotic that contains the active substance "teicoplanin". It works
by killing the bacteria responsible for infections in the body.
Teicoplanina Altan 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 one of the above-mentioned conditions.

Teicoplanina Altan may be used to treat certain intestinal infections caused by Clostridium
difficile bacteria. For this purpose, the solution is taken orally.

2. What you should know before being given Teicoplanina Altan

Do not use Teicoplanina Altan 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, pharmacist, or nurse before being given
Teicoplanina Altan if:

• you are allergic to an antibiotic called “vancomycin”
• you experience 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 may 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 Altan”).

If any of the above apply to you (or if you are unsure), talk to your doctor, pharmacist, or
nurse before being given Teicoplanina Altan.
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 require high loading doses (12 mg/kg twice daily)
• you have kidney problems
• you are taking or may need to take other medicines that can affect the nervous system, kidneys, or hearing.

In patients receiving Teicoplanina Altan for a prolonged period, bacteria not affected by the
antibiotic may grow more than usual – your doctor will carry out checks to monitor for this.
Other medicines and Teicoplanina Altan
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines. This is because Teicoplanina Altan may affect how other medicines work. Some medicines may also affect how Teicoplanina Altan works. In particular, inform your doctor, pharmacist, or nurse if you are taking any of the following medicines:

• aminoglycosides, which must not be mixed with Teicoplanina Altan 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
• 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) that may cause hearing and/or kidney problems

If any of the above apply to you (or if you are unsure), talk to your doctor, pharmacist, or
nurse before being given Teicoplanina Altan.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, or if you suspect you may be pregnant or are planning to become pregnant, 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 should continue or stop breastfeeding while receiving Teicoplanina Altan.
Reproduction studies in animals have not shown evidence of fertility problems.
Driving and using machines
While being treated with Teicoplanina Altan, you may experience headache or dizziness. If this occurs, do not drive or operate machinery.
Teicoplanina Altan contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per vial, i.e. it is essentially “sodium-free”.

3. How to use Teicoplanin Altan

Use this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The recommended dose is
Adults and children (12 years of age 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 3 doses): 12 mg per kg of body weight, administered every 12 hours by intravenous or intramuscular injection.
• Maintenance dose: 12 mg per kg of body weight, administered once daily by intravenous or intramuscular injection.

To treat infections caused by the bacterium 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 kidney impairment: the maintenance dose will be given every 2 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 3 days, or one-third of the maintenance dose will be given daily.

Peritonitis in patients undergoing peritoneal dialysis
The initial dose is 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 bags
• Week three: 20 mg/L in the nighttime bag.

Neonates (from birth to 2 months of age)

• Initial dose (on the 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: 6–10 mg per kg of body weight, administered once daily by intravenous injection.

Instructions on how to prepare the reconstituted solution (to be diluted or administered orally,
or by injection) and diluted solutions are provided in section 6.
How Teicoplanin Altan 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 up to 2 months of age, this medicine 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 Altan 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 Altan or if you feel unwell, inform your doctor or
nurse immediately.
If you miss a dose of Teicoplanin Altan
Your doctor or nurse will have specific instructions on when to administer Teicoplanin Altan. 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 Altan
Do not stop taking this medicine without first discussing it with your doctor, pharmacist, or
nurse.
If you have any doubts about how to use this medicine, consult 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 tell 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 could 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)

• skin, mouth, eye or genital lesions – these may be signs of a condition called “toxic epidermal necrolysis” or “Stevens-Johnson syndrome” or “drug reaction with eosinophilia and systemic symptoms (DRESS)”.

Tell your doctor or nurse immediately if you notice any of the side effects listed above.
Tell 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 clots in a vein
• breathing difficulties or wheezing (bronchospasm)
• increased risk of infections – these could be signs 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 kidney function – shown by blood tests. The frequency or severity of kidney problems may increase if you receive higher doses.
• seizures
• low levels of all types of blood cells

Other side effects
Tell your doctor, pharmacist or nurse if you notice 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)

• decreased number of platelets
• increased liver enzyme levels 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

Reporting of side effects
If you get any side effects, 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 Altan

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 Scad/EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Information on storage and duration of use of Teicoplanina Altan after reconstitution and once ready for administration are described in the "Practical information for healthcare professionals on the preparation and handling of Teicoplanina Altan".
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures help protect the environment.

6. Package contents and other information

What Teicoplanin Altan contains
Vial of powder:

• The active substance is teicoplanin. Each vial contains 200 mg or 400 mg of teicoplanin.
• The other components are sodium chloride, hydrochloric acid, and sodium hydroxide.

Description of the appearance of Teicoplanin Altan and contents of the package
Vial of powder:
Teicoplanin is a powder for solution for injection/infusion. The powder is a white or whitish mass. The reconstituted solution is a clear, colourless or slightly yellowish liquid.
The powder is packaged:

• in colourless type I glass vials with a useful volume of 10 mL for 200 mg, closed with a bromobutyl rubber stopper and an aluminium yellow seal with a plastic pull-tab.
• in colourless type I glass vials with a useful volume of 10 mL for 400 mg, closed with a bromobutyl rubber stopper and an aluminium green seal with a plastic pull-tab.

Pack sizes:

• 1 vial of powder
• 5 vials of powder

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Altan Pharmaceuticals S.A.
C/ Cólquide Nº 6, Portal 2, 1st Floor, Office F. Prisma Building
Las Rozas, 28230 Madrid, Spain
Manufacturer
Altan Pharmaceuticals S.A.
Pol. Industrial de Bernedo s/n
01118 Bernedo (Álava)
Spain
or
Altan Pharmaceuticals S.A.
Avda. Constitución 198-199. Pol. Industrial Monte Boyal
45950 Casarrubios del Monte (Toledo)
Spain
This medicinal product is authorized in the Member States of the European Economic Area with
the following names:
Spain:
Teicoplanina Altan 200 mg Powder for injection and infusion solution EFG
Teicoplanina Altan 400 mg Powder for injection and infusion solution EFG
United Kingdom:
Teicoplanin Altan 200 mg Powder for solution for injection and infusion
Teicoplanin Altan 400 mg Powder for solution for injection and infusion
Germany:
Teicoplanin Ethypharm 200 mg Powder for the preparation of an injection/infusion solution or an oral solution
Teicoplanin Ethypharm 400 mg Powder for the preparation of an injection/infusion solution or an oral solution
Portugal:
Teicoplanina Altan 200 mg Powder for injectable solution or perfusion solution
Teicoplanina Altan 400 mg Powder for injectable solution or perfusion solution
Belgium:
Teicoplanine Altan Pharma 200 mg powder for injectable solution/perfusion solution or oral solution
Teicoplanine Altan Pharma 400 mg powder for injectable solution/perfusion solution or oral solution

Further sources of information
More detailed information on this medicinal product is available on the website of the Italian Medicines Agency:
http://www.agenziafarmaco.gov.it/

The following information is intended exclusively for physicians or healthcare professionals:
Practical information for healthcare personnel on the preparation and handling of
Teicoplanin Altan.
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 an infusion over 30 minutes.
In children from birth up to 2 months of age, administration must be given only by infusion.
The reconstituted solution may also be administered orally (oral use).
Preparation of the reconstituted solution

• Slowly inject 3.2 mL of water for injection into the vial of powder. Gently rotate the vial between the hands until the powder is completely dissolved. If the solution becomes foamy, allow it 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, slightly yellowish solutions should be used. The final solution is isotonic with plasma and has a pH of 7.2–7.8.

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

• sodium chloride solution 9 mg/mL (0.9%)
• Ringer's solution
• Ringer's lactate solution
• 5% dextrose solution
• 10% dextrose solution
• solution containing 0.18% sodium chloride and 4% glucose
• solution containing 0.45% sodium chloride and 5% glucose
• peritoneal dialysis solution containing 1.36% or 3.86% glucose solution.

Stability of the reconstituted and diluted 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 this is not
possible, the user is responsible for the duration and conditions of storage, which should not
normally exceed 24 hours at a temperature between 2 and 8°C.

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