Teicoplanin Altan

Package Leaflet: Information for the User

Teicoplanin Altan, 200 mg, powder for solution for injection/infusion or oral solution

or oral solution
Teicoplanin

Read all of this leaflet carefully before taking this medicine because it contains important information for you.

• You should 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.

Contents of the pack and other information:

• 1. What Teicoplanin Altan is and what it is used for
• 2. Before you take Teicoplanin Altan
• 3. How to take 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 that cause infections in the body.
Teicoplanin Altan is used in adults and children (including newborns) to treat the following bacterial infections:

• skin and soft tissue infections - sometimes called soft tissue infections
• bone and joint infections
• lung infections
• urinary tract infections
• heart infections - sometimes called endocarditis
• abdominal infections - peritonitis
• blood infections - if caused by any of the above conditions

Teicoplanin Altan can be used to treat some infections caused by Clostridium difficilebacteria in the gut. For this purpose, the solution is taken orally.

2. Before you take Teicoplanin Altan

When not to use Teicoplanin Altan

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

Warnings and precautions

Before taking Teicoplanin Altan, tell your doctor, pharmacist, or nurse if:

• you are allergic to the antibiotic vancomycin
• you have had a red man syndrome (a condition that causes flushing and rash)
• you have a low platelet count (thrombocytopenia)
• you have kidney problems
• you are taking other medicines that may cause hearing or kidney problems. You may need to have regular tests to check that your kidneys and/or liver are working properly (see "Teicoplanin Altan with other medicines")

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

Diagnostic 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 doses (12 mg/kg twice a day)
• you have kidney problems
• you are taking or may take other medicines that can damage your nervous system, kidneys, or hearing

In people taking Teicoplanin Altan for a long time, there may be a greater than usual increase in bacteria that the antibiotic does not work against - your doctor will check for this.

Teicoplanin Altan with 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 Altan can affect the way other medicines work. Some medicines can also affect the way Teicoplanin Altan works. In particular, tell your doctor, pharmacist, or nurse if you are taking:

• aminoglycosides - because they must not be mixed with Teicoplanin Altan in the same injection. They can also cause hearing or kidney problems
• amphotericin B - a medicine used to treat fungal infections, which can cause hearing or kidney problems
• cyclosporin - a medicine that affects the immune system, which can cause hearing or kidney problems
• cisplatin - a medicine used to treat cancer, which can cause hearing or kidney problems
• colistin - a medicine used to treat bacterial infections, which can cause hearing problems
• diuretics (such as furosemide and ethacrynic acid) - also known as "water tablets", which can cause hearing or kidney problems

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

Pregnancy, breastfeeding, and fertility

If you are pregnant, think you may be pregnant, or plan to have a baby, ask your doctor, pharmacist, or nurse for advice before taking this medicine. They will decide whether you can take Teicoplanin Altan during pregnancy. There is a risk of damage to the inner ear and kidney problems.
If you are breastfeeding, tell your doctor before taking this medicine. They will decide whether you can breastfeed while taking Teicoplanin Altan.
Studies in animals have shown no harmful effects on fertility.

Driving and using machines

During treatment with Teicoplanin Altan, you may experience pain or dizziness. If you experience these side effects, do not drive or operate machinery.

Teicoplanin Altan contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per vial, which is essentially "sodium-free".

3. How to take Teicoplanin Altan

Always take this medicine exactly as your doctor, pharmacist, or nurse has told you. If you are not sure, ask your doctor, pharmacist, or nurse.

Recommended dose

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

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

• Initial dose (for the first three to five doses): 400 mg (which is 6 mg per kilogram of body weight) given every 12 hours by injection into a vein or muscle.
• Maintenance dose: 400 mg (which is 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 doses): 800 mg (which is 12 mg per kilogram of body weight) given every 12 hours by injection into a vein.
• Maintenance dose: 800 mg (which is 12 mg per kilogram of body weight) given once a day by injection into a vein or muscle.

Infection caused by Clostridium difficile
The 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 is usually reduced after the fourth day of treatment:

• In patients with mild to moderate kidney problems, the maintenance dose will be given every two days or half the maintenance dose will be given once a day.
• In 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

The initial dose is 6 mg per kilogram of body weight, given as 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 dialysis bag left overnight.

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.

in a drip.

• Maintenance dose: 8 mg per kilogram of body weight given once a day in an intravenous infusion in a 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 Altan is given

This medicine is usually given by a doctor or nurse.

• The medicine will be given by injection into a vein (intravenously) or into a muscle (intramuscularly).
• It can also be given in an intravenous infusion in a drip. In newborns and infants 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).

Overdose of Teicoplanin Altan

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 agitated, tell your doctor or nurse immediately.

Missed dose of Teicoplanin Altan

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

Stopping Teicoplanin Altan treatment

Do not stop taking Teicoplanin Altan without first talking to your doctor, pharmacist, or nurse.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine 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 – you may need urgent medical attention.

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

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

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

• red man syndrome.

Frequency not known(frequency 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 (Lyell's syndrome)" or "Stevens-Johnson syndrome"

or drug reaction with eosinophilia and systemic symptoms (DRESS). Initially, DRESS appears as flu-like symptoms and a rash on the face, and then as a widespread rash with high fever, increased liver enzyme activity observed in blood tests, and an increased number of a type of white blood cell (eosinophilia) and swollen lymph nodes.
Decreased number of a type of white blood cell (neutropenia).
Inflammation of a vein with blood clot formation (thrombophlebitis)

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

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

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

• swelling and blood clots in a vein
• difficulty breathing or wheezing (bronchospasm)
• more infections than usual - these may be symptoms of a low white blood cell count

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

• lack of white blood cells - symptoms may include: fever, severe chills, sore throat, or mouth ulcers (agranulocytosis)
• kidney problems or changes in kidney function - seen in tests. If you are given higher doses, you may be more likely to get kidney problems.
• seizures
• low levels of all types of blood cells

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):

• decreased platelet count
• increased liver enzymes in the blood
• increased creatinine levels in the blood (monitoring kidney function)
• hearing loss, ringing in the ears, or feeling that you or things around you are moving
• nausea or vomiting, diarrhea
• dizziness or headache

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

• infection (abscess).

Frequency 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 side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder or its representative in Poland.
By reporting side effects, you can help provide more information on the safety of this 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 which is stated on the carton and vial label after "EXP". The expiry date refers to the last day of that month.
There are no special storage instructions for this medicine.
Information on storage conditions and shelf-life after reconstitution of the powder and preparation for use is described in the section "Practical information for healthcare professionals to prepare and handle teicoplanin".
Medicines should 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 pack and other information

What Teicoplanin Altan contains

• The active substance is teicoplanin. Each vial contains 200 mg of teicoplanin.
• The other ingredients 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 oral solution.
The powder is white to slightly yellow.
The reconstituted solution is a yellowish to light brown solution.
The powder is packed in type I glass vials with a nominal volume of 10 ml for 200 mg, closed with a type I bromobutyl rubber stopper and a yellow aluminum seal and a plastic "flip-off" cap.
Pack sizes:

• 1 vial of powder

Marketing authorization holder and manufacturer

Marketing authorization holder

Altan Pharma Limited
The Lennox Building, 50 South Richmond street
Dublin 2, D02FK02
Ireland

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 authorized in the Member States of the European Economic Area under the following names:

Poland: Teicoplanin Altan, 200 mg, powder for solution for injection/infusion or 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

Date of revision of the leaflet: 11/2023

Other sources of information:

Information intended only for healthcare professionals:

Practical information for healthcare professionals to prepare and handle teicoplanin

This medicinal product is for single use only.
Administration
The reconstituted solution can be injected directly or further diluted if necessary.
The solution can be administered by injection over 3 to 5 minutes or by 30-minute infusion.
In newborns and infants from birth to 2 months, only infusion should be used. The reconstituted solution can also be administered orally.
Preparation of the solution

• Slowly inject 3 ml of water for injections into the vial with the powder.
• Gently rotate the vial in your hands until the powder is completely dissolved. If the solution becomes frothy, let it stand for about 15 minutes. Only clear and yellowish solutions should be used.

The resulting solutions will contain 200 mg in 3.0 ml.
Only clear and yellowish solutions should be used.
The final solution is isotonic with blood and has a pH of 6.3-7.7.

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

• 9 mg/ml (0.9%) sodium chloride solution
• Ringer's solution
• Ringer's solution with lactate
• 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 of the powder and dilution
The chemical and physical stability of the solution prepared as directed has been demonstrated for 24 hours at a temperature of 2 to 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 conditions and time prior to use, which normally should not exceed 24 hours at 2 to 8°C, unless the reconstitution and dilution process is carried out under controlled and validated aseptic conditions.
Disposal

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