TEICOPLANIN ALTAN 400 mg POWDER FOR INJECTABLE SOLUTION AND FOR INFUSION

2. What you need to know before you use Teicoplanin Altan

Do not 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

Talk to your doctor, pharmacist, or nurse before starting Teicoplanin Altan if:

• you are allergic to an antibiotic called “vancomycin”
• you have had a reddening of the upper 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.

During treatment, you may need to have regular tests to check if your blood, kidneys, and/or liver are working properly (see “Other medicines and Teicoplanin Altan”).

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

Tests

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

• your treatment is going to last a long time
• you need to be 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, and hearing.

In people who are being treated with Teicoplanin Altan for a long time, bacteria that are not affected by the antibiotic may grow more than normal – your doctor will check this.

Other medicines and Teicoplanin Altan

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. Teicoplanin Altan may affect how other medicines work. Other medicines may also affect how Teicoplanin Altan works. In particular, tell your doctor, pharmacist, or nurse if you are taking:

• aminoglycosides, as they must not be mixed with Teicoplanin Altan in the same injection. They may also cause hearing and/or kidney problems
• amphotericin B - a medicine that treats fungal infections that may cause hearing and/or kidney problems
• ciclosporin - a medicine that affects the immune system that may cause hearing and/or kidney problems
• cisplatin - a medicine that treats malignant tumors that may cause hearing and/or kidney problems
• water pills (such as furosemide) also called “diuretics” that may cause hearing and/or kidney problems.

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

They will decide whether you should be given this medicine while you are pregnant. There may be a potential risk of problems with the inner ear and kidneys.

Tell your doctor if you are breastfeeding before you are given this medicine.

They will decide whether you can continue breastfeeding while you are being given Teicoplanin Altan.

Animal reproduction studies have not shown evidence of fertility problems.

Driving and using machines

You may have headaches or feel dizzy while being treated with Teicoplanin Altan. If this happens, do not drive or use tools or machines.

Teicoplanin Altan contains sodium

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

3. How to use Teicoplanin Altan

Follow exactly the administration instructions for this medicine as indicated by your doctor. If you are unsure, ask your doctor again.

The recommended dose is

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

Infections of the skin and soft tissues, lung, and urinary tract

• Initial dose (for the first three doses): 6 mg per kilogram of body weight, administered every 12 hours, by intravenous or intramuscular injection.
• Maintenance dose: 6 mg per kilogram of body weight, administered once a day, by intravenous or intramuscular injection.

Infections of the bones and joints, and heart

• Initial dose (for the first three doses): 12 mg per kilogram of body weight, administered every 12 hours, by intravenous or intramuscular injection.
• Maintenance dose: 12 mg per kilogram of body weight, administered once a day, by intravenous or intramuscular injection.

Infection caused by the bacteria“Clostridium difficile”

The recommended dose is 100 to 200 mg by mouth, twice a day for 7 to 14 days.

Adults and elderly patients with kidney problems

If you have kidney problems, it will normally be necessary to reduce your dose after the fourth day of treatment:

• For people with mild to moderate kidney problems - the maintenance dose will be administered every two days, or half of the maintenance dose will be administered once a day.

• For people with severe kidney problems and on hemodialysis - the maintenance dose will be administered every three days, or one-third of the maintenance dose will be administered once a day.

Treatment of peritonitis in patients on peritoneal dialysis

The initial dose is 6 mg per kilogram of body weight, 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 dialysis bags at night.

Babies (from birth to 2 months of age)

• Initial dose (on day one): 16 mg per kilogram of body weight, as an intravenous infusion through a drip.

• Maintenance dose: 8 mg per kilogram of body weight, administered once a day, as an intravenous infusion through a drip.

Children (from 2 months to 12 years of age)

• Initial dose (for the first three doses): 10 mg per kilogram of body weight, administered every 12 hours, by intravenous injection.

• Maintenance dose: 6-10 mg per kilogram of body weight, administered once a day, by intravenous injection.

The method of preparation of the reconstituted solution (for dilution or administration by mouth or injection) and diluted is indicated in section 6 of this leaflet.

How Teicoplanin Altan is administered

This medicine will normally be administered to you by a doctor or nurse.

• It will be administered by intravenous injection (into a vein) or intramuscular injection (into a muscle).
• It can also be administered by intravenous infusion through a drip.

Intravenous infusion is only to be administered in babies, from birth to 2 months of age.

For the treatment of certain infections, the solution may be administered by mouth (orally).

If you use 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 are concerned, talk to your doctor or nurse immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 915 620 420, indicating the medicine and the amount taken. You may need to go to the hospital. It is recommended to take the package and leaflet of the medicine to the healthcare professional.

If you forget to use Teicoplanin Altan

Your doctor or nurse will have instructions on when to administer Teicoplanin Altan. It is unlikely that you will not be given the medicine as prescribed. However, if you are concerned, talk to your doctor or nurse.

If you stop using Teicoplanin Altan

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

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

Stop taking Teicoplanin Altan immediately and contact a doctor or nurse 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 life-threatening allergic reaction - the signs may include: difficulty breathing or wheezing, swelling, skin rash, itching, fever, chills.

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

• reddening of the upper body.

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

• appearance of blisters on the skin, mouth, eyes, or genitals - could be signs of “toxic epidermal necrolysis” or “Stevens-Johnson syndrome” or “drug reaction with eosinophilia and systemic symptoms (DRESS)”.

Tell your doctor or nurse immediately if you experience any of the above side effects.

Tell your doctor or nurse immediately 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)

• inflammation and clot in a vein
• difficulty breathing and wheezing (bronchospasm)
• if you get more infections than usual - could be signs of a decrease in your blood cell count.

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

• lack of white blood cells in the blood - the signs may include: fever, severe chills, sore throat, or mouth ulcers (agranulocytosis)
  • kidney problems or changes in kidney function - shown in tests. The frequency or severity of kidney problems may increase if you receive higher doses.
  • seizures.
  • low levels of all types of blood cells.

Tell your doctor or nurse immediately if you experience any of the above side effects.

Other side effects

Talk to your doctor, pharmacist, or nurse immediately if you experience 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)

• decrease in platelet count
• increase in blood levels of liver enzymes
  • increase in blood levels of creatinine (to check your kidney)
  • hearing loss, ringing in the ears, or the feeling that you or your surroundings are spinning
  • feeling sick or being sick (vomiting), diarrhea
  • feeling dizzy or having a 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 skin redness, pain, or swelling.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 is the last day of the month stated.

This medicine does not require any special storage conditions.

Information on the storage and use of Teicoplanin Altan once reconstituted and ready to use is detailed in “Practical information for healthcare professionals for the preparation and handling of Teicoplanin Altan”.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Contents and Additional Information

Composition of Teicoplanina Altan

Vial of powder:

• The active ingredient is teicoplanin. Each vial contains 400 mg of teicoplanin.
• The other ingredients are sodium chloride, hydrochloric acid, and sodium hydroxide.

Appearance of the Product and Container Contents

Teicoplanina Altan is a powder for solution for injection and infusion. The powder is white or almost white. The reconstituted solution is colorless or slightly yellowish.

The powder is packaged in a 10 ml clear glass type I vial, closed with a bromobutyl rubber stopper and a green plastic flip-off cap.

Presentation:

• 1 vial with powder

Marketing Authorization Holder and Manufacturer

Holder:

Altan Pharmaceuticals S.A.

C/ Cólquide 6, portal 2, 1ª planta, oficina F, Edificio Prisma

28230 Las Rozas (Madrid)

Spain

Manufacturer

Altan Pharmaceuticals S.A.

Polígono 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 under the following names:

Germany: Teicoplanin Altan 400 mg Pulver zur Herstellung einer Injektions-/Infusionslösung oder einer Lösung zum Einnehmen

Belgium: Teicoplanine Altan Pharma 400 mg poudre pour solution injectable/pour perfusion ou solution buvable

Italy: Teicoplanina Altan 400 mg Polvere per soluzione iniettable o infusione

Netherlands: Teicoplanine Altan Pharma 400 mg poeder voor oplossing voor injectie/infusie

Portugal: Teicoplanina Altan 400 mg Pó para solução injectável ou para perfusão

United Kingdom: Teicoplanin Altan 400 mg Powder for solution for injection/infusion or oral solution

Date of the last revision of this leaflet:

Other sources of information

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu/ , and on the Spanish Agency for Medicines and Health Products (AEMPS) website (http://www.aemps.gob.es/). There are also links to other websites on rare diseases and orphan medicines.

This information is intended exclusively for healthcare professionals:

Practical information for healthcare professionals on the preparation and handling of Teicoplanina Altan

This medicinal product is for single use.

Method of administration.

The reconstituted solution can be injected directly or alternatively in a diluted form.

The injection will be administered either as a bolus over 3-5 minutes or by infusion over 30 minutes.

In infants from birth to 2 months, it will only be administered by infusion.

The reconstituted solution can also be administered orally.

Preparation of the reconstituted solution

• Slowly inject 3.2 ml of water for injections into the powder vial.
• Gently rotate the vial between the hands until the powder is completely dissolved. If the solution becomes foamy, it should be left to stand for 15 minutes.

The reconstituted solutions will contain 400 mg in 3.0 ml.

Only clear and yellowish solutions should be used.

The final solution is isotonic and has a pH of 7.2-7.8

Preparation of the diluted solution before infusion

Teicoplanin can be administered in the following infusion solutions:

• Sodium chloride 9 mg/ml (0.9%) solution
• Ringer's solution
• Ringer-lactate solution
• 5% glucose injection
• 10% glucose injection
• Solution with 0.18% sodium chloride and 4% glucose
• Solution with 0.45% sodium chloride and 5% glucose
• Peritoneal dialysis solution containing 1.36% or 3.86% glucose solution.

Validity period of the reconstituted solution and the diluted product:

Chemical and physical stability has been demonstrated for the reconstituted solution and the diluted product prepared as recommended for 24 hours between 2 and 8°C.

From a microbiological point of view, the medicinal product should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user and normally should not exceed 24 hours between 2 and 8°C.

Elimination

Disposal of unused medicinal products and waste materials should be done in accordance with local regulations.