Teicoplanin altan

Package leaflet: Information for the user

Teicoplanin Altan, 200 mg, powder for solution for injection/infusion
or oral solution
Teicoplaninum
Please read all of this leaflet carefully before using this medicine because 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 get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Teicoplanin Altan is and what it is used for
2. What you need to know before you use Teicoplanin Altan
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 Teicoplanin Altan is and what it is used for

Teicoplanin Altan is an antibiotic. It contains the active substance
teicoplanin. It works by killing bacteria causing infection in the patient's body.
Teicoplanin Altan is used in adults and children (including newborns) to treat the
following bacterial infections:

• Skin and subcutaneous tissue – sometimes referred to as soft tissue
• Bones and joints
• Lungs
• Urinary tract
• Heart – sometimes referred to as endocarditis
• Abdomen – peritonitis
• Blood, if caused by any of the above conditions

Teicoplanin Altan may be used to treat certain infections caused by
"Clostridium difficile" – bacteria in the intestines. For this purpose, the solution is taken orally.

2. Important information before using Teicoplanin Altan

When not to use Teicoplanin Altan

• 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 starting treatment with Teicoplanin Altan, consult your doctor, pharmacist, or nurse if:

• the patient is allergic to an antibiotic called vancomycin
• the patient has experienced redness of the upper part of the body (red man syndrome)
• the patient has a low platelet count (thrombocytopenia)
• the patient has impaired kidney function
• the patient is taking other medicines that may cause hearing problems and/or kidney problems. The patient may have regular tests to check whether the kidneys and/or liver are functioning properly (see "Teicoplanin Altan and other medicines")

If any of the above conditions apply to the patient (or if the patient is unsure),
contact a doctor, pharmacist, or nurse before taking Teicoplanin Altan.
Diagnostic tests
During treatment, the patient may undergo blood tests, kidney function tests, liver function tests, and/or hearing tests. This is more likely if:

• treatment will be long-term
• the patient is to be treated with high loading doses (12 mg/kg twice daily)
• the patient has impaired kidney function
• the patient is taking or may take other medicines that may damage the nervous system, kidneys, or hearing

In patients taking Teicoplanin Altan for a prolonged period, there may be an increased growth of bacteria not affected by this antibiotic – the treating doctor will monitor this.
Teicoplanin Altan and other medicines
Inform 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. This is because Teicoplanin Altan may affect the action of other medicines. Likewise, some medicines may affect the action of Teicoplanin Altan. In particular, inform the doctor, pharmacist, or nurse if the patient is taking any of the following medicines:

• aminoglycosides – because they must not be mixed with Teicoplanin Altan in the same injection. They may also cause hearing problems and/or kidney problems
• amphotericin B – a medicine used to treat fungal infections, which may cause hearing problems and/or kidney problems
• cyclosporine – an immunosuppressive medicine which may cause hearing problems and/or kidney problems
• cisplatin – a medicine used to treat malignant tumours, which may cause hearing problems and/or kidney problems
• colistin – a medicine used to treat bacterial infections, which may cause hearing problems
• diuretics (such as furosemide and ethacrynic acid) – also called “water pills”, which may cause hearing problems and/or kidney problems

If any of the above points apply to the patient (or if the patient is unsure),
contact a doctor, pharmacist, or nurse before taking Teicoplanin Altan.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant, suspects she may be pregnant, or is planning to have a child, she should
consult a doctor, pharmacist, or nurse before using this medicine. They will decide whether this
medicine can be given during pregnancy. There is a risk of damage to the inner ear and kidney
dysfunction.
If the patient is breastfeeding, she should inform the doctor before taking this medicine.
The doctor will decide whether the patient can breastfeed while taking Teicoplanin Altan.
Animal studies on the effect on fertility did not show any adverse effect of the medicine on fertility.
Driving and operating machinery
During treatment with Teicoplanin Altan, the patient may experience pain or dizziness.
If such adverse effects occur, the patient should not drive or operate any tools or machinery.
Teicoplanin Altan contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per vial, meaning this medicine is considered "sodium-free".

3. How to use Teicoplanin Altan

This medicine should always be used exactly as directed 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 three to five doses): 400 mg (equivalent to 6 mg per kilogram of body weight) administered every 12 hours by intravenous or intramuscular injection.
• Maintenance dose: 400 mg (equivalent to 6 mg per kilogram of body weight) administered once daily by intravenous or intramuscular injection.

Bone and joint infections, and heart infections

• Initial dose (for the first three doses): 800 mg (equivalent to 12 mg per kilogram of body weight) administered every 12 hours by intravenous injection.
• Maintenance dose: 800 mg (equivalent to 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 orally, twice daily for 7 to 14 days.
Adults and elderly patients with impaired kidney function
If the patient has impaired kidney function, the dose is usually reduced after the fourth day of treatment:

• In patients with mild to moderate kidney impairment – the maintenance dose should be given every two days, or half the maintenance dose should be given once daily.
• In patients with severe kidney impairment or undergoing hemodialysis – the maintenance dose should be given every three days, or one-third of the maintenance dose should be given 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 second dialysis bag
• Week 3: 20 mg/L in the dialysis bag left overnight.

Newborns and infants (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 (for the 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 Teicoplanin Altan is administered
This medicine is usually administered by a doctor or nurse.

• This medicine will be given by intravenous (IV) or intramuscular (IM) injection.
• It may also be administered by intravenous infusion. In newborns and infants from birth to 2 months of age, only infusion should be used. In the treatment of certain infections, the solution may be taken orally (oral administration).

Use of a higher than recommended dose of Teicoplanin Altan
It is unlikely that a doctor or nurse will administer too high a dose of this medicine. However, if you believe you have received too high a dose of Teicoplanin Altan, or if you feel unwell, contact your doctor or nurse immediately.
Missed dose of Teicoplanin Altan
Your doctor or nurse will have received instructions on how to administer Teicoplanin Altan to you. It is unlikely they will administer the medicine incorrectly. However, if you have any concerns, speak to your doctor or nurse.
Stopping treatment with Teicoplanin Altan
Do not stop taking this medicine 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 any of the following serious adverse reactions occur, treatment must be stopped and
medical advice must be sought immediately from a doctor or nurse – urgent medical
assistance may be required.

Not common (may occur in up to 1 in 100 patients):

• sudden, life-threatening allergic reaction – symptoms may include: difficulty breathing or wheezing, swelling, rash, itching, fever, chills
• abnormal increase in the number of a certain type of white blood cells (eosinophilia)

Rare (may occur in up to 1 in 1,000 patients):

• redness of the upper part of the body

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

• blisters on the skin, mouth, eyes or genital organs – these may be symptoms of a disease called toxic epidermal necrolysis [Lyell’s syndrome] or Stevens-Johnson syndrome,
  or drug reaction with eosinophilia and systemic symptoms (DRESS). DRESS initially presents as flu-like symptoms and facial rash, followed by widespread rash, high fever, increased liver enzyme activity observed in blood tests, increased number of a certain type of white blood cells (eosinophilia), and enlarged lymph nodes.
  Decrease in a certain type of white blood cells (neutrop enia).
  Inflammation of a vein with blood clot formation in the vein (thrombophlebitis)
  If any of the above adverse reactions occur, inform your doctor or nurse immediately.
  If the patient experiences any of the following serious adverse reactions, inform the doctor or nurse immediately, as urgent medical assistance may be required.

Not common (may occur in up to 1 in 100 patients):

• swelling and blood clots in a vein
• difficulty breathing or wheezing (bronchospasm)
• increased number of infections – may be symptoms of reduced number of blood cells

Frequency unknown (frequency cannot be estimated from the 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 – visible in laboratory tests. When higher doses are administered, the frequency or severity of kidney function disorders may increase.
• seizures
• low number of all types of blood cells

If any of the above adverse reactions occur, inform your doctor or nurse immediately.

Other adverse reactions
Consult your doctor, pharmacist or nurse if any of the following symptoms occur:

Common (may occur in up to 1 in 10 patients):

• rash, redness, itching
• pain
• fever

Not common (may occur in up to 1 in 100 patients):

• decreased number of platelets
• increased levels of liver enzymes in blood
• increased creatinine levels in blood (monitoring kidney function)
• hearing loss, ringing in the ears, or sensation that the patient or surrounding objects are moving
• 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 the available data):

• injection site reactions – such as skin redness, pain or swelling

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions 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 at 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
Adverse reactions can also be reported to the marketing authorisation holder or its representative in Poland.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Teicoplanin 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 vial label after:
"Expiry date (EXP)". The expiry date refers to the last day of the stated month.
No special storage instructions apply for this medicine.
Information on storage conditions and duration of use of teicoplanin after reconstitution of the powder and preparation for administration is described in the section "Practical information for healthcare professionals on preparation and handling of teicoplanin".
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Teicoplanin Altan contains

• The active substance is teicoplanin. Each vial contains 200 mg of teicoplanin.
• The other components are: sodium chloride, sodium hydroxide (for pH adjustment), and hydrochloric acid (for pH adjustment).

What Teicoplanin Altan looks like and contents of the pack
Teicoplanin Altan is a powder for solution for injection/infusion or for oral solution.
The powder is white to slightly yellow.
The reconstituted solution is yellowish to slightly brownish.
The powder is packed in 10 ml colourless type I glass vials containing 200 mg, closed with a bromobutyl rubber stopper type I, aluminium yellow seal, and a plastic "flip-off" cap.
Pack sizes:

• 1 vial of powder

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Altan Pharmaceuticals, S.A.
C/ Cólquide Nº 6, Portal 2, 1ª Planta, Oficina F. Edificio Prisma
Las Rozas, 28230 Madrid
Spain
Manufacturer
Altan Pharmaceuticals S.A.
Pol. Industrial de Bernedo S/N
01118 Bernedo, Álava
Spain
Altan Pharmaceuticals S.A.
Avda. de la Constitución 198-199
Polígono Industrial Monte Boyal
45950 Casarrubios del Monte, Toledo
Spain
This medicinal product is authorised in the European Economic Area countries under the following names:
Poland: Teicoplanin Altan, 200 mg, powder for solution for injection/infusion or for oral solution
Austria: Teicoplanin Altan 200 mg Pulver zur Herstellung einer Injektions-/Infusionslösung oder einer Lösung zum Einnehmen
France: Teicoplanine Altan 200 mg poudre pour solution injectable/pour perfusion ou solution buvable
Other sources of information

Information intended exclusively for healthcare professionals:

Practical information for healthcare professionals on the preparation and handling of
teicoplanin
This medicinal product is for single use only.
Administration method
The reconstituted solution may be administered directly by injection or further diluted if necessary.
The solution may be given as an injection lasting from 3 to 5 minutes or as a 30-minute infusion.
In infants from birth to 2 months of age, administration must be by infusion only.
The reconstituted solution may also be administered orally.
Preparation of the solution

• Slowly inject 3 ml of water for injections 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 resulting solution will contain 200 mg in 3.0 ml.
Only clear, slightly yellow solutions should be used.
The final solution is isotonic with serum and has a pH of 6.3–7.7.

Dilution of the solution prior to infusion
Teicoplanin Altan can be administered in the following infusion solutions:

• 9 mg/ml (0.9%) sodium chloride solution
• Ringer's solution
• Ringer's lactate solution
• 5% glucose solution for injection
• 10% glucose solution for injection
• 0.18% sodium chloride and 4% glucose solution
• 0.45% sodium chloride and 5% glucose solution
• Peritoneal dialysis solution containing 1.36%

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 not used immediately, the user is responsible for the storage time and conditions prior to use, which generally should not exceed 24 hours at a temperature of 2 to 8°C, unless the reconstitution and dilution process was carried out under controlled and validated aseptic conditions.

Disposal
Any unused residues of the medicinal product or waste materials should be disposed of in accordance with local regulations.