Patient Information Leaflet: Teicoplanina Altan 400 mg Powder for Injection and Infusion EFG

Read this leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before starting to use Teicoplanina Altan

3. How to use Teicoplanina Altan

4. Possible side effects

5. Storage of Teicoplanina Altan

6. Contents of the pack and additional information

Teicoplanina Altan is an antibiotic. It contains a medication called “teicoplanin”. It works by killing the bacteria that cause infections in your body.

Teicoplanina Altan is used in adults and children (including newborns) to treat infections in:

• the skin and beneath the skin - sometimes referred to as “soft tissues”
• bones and joints
• the lungs
• the urinary tract
• the heart - sometimes referred to as “endocarditis”
• the abdominal wall - peritonitis
• the blood, when caused by one of the conditions listed above.

Teicoplanina Altan can be used to treat some infections caused by “Clostridium difficile”, bacteria in the intestine.In this case, the solution should be taken orally.

No use Teicoplanina Altan:

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Teicoplanina Altan if:

• you are allergic to an antibiotic called “vancomycin”
• you have had a redness on the upper part of your body (red man syndrome)
• you have a decreased platelet count (thrombocytopenia)
• you have kidney problems
• you are taking other medications 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 functioning correctly (see “Other medications and Teicoplanina Altan”).

If any of the above cases apply to you (or if you are unsure), inform your doctor, pharmacist, or nurse before they administer Teicoplanina Altan.

Tests

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

• your treatment will last a long period of time
• you need to be treated with high dose loading (12 mg/kg twice a day)
• you have kidney problems
• you are taking or may take other medications that can affect your nervous system, kidneys, and/or ear.

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

Other medications and Teicoplanina Altan

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. Teicoplanina Altan may affect the functioning of other medications. Other medications can also affect the functioning of Teicoplanina Altan. Particularly, inform your doctor, pharmacist, or nurse if you are taking the following medications:

• aminoglycosides, as they should not be mixed with Teicoplanina Altan in the same injection. They can also cause hearing and/or kidney problems
• amphotericin B – a medication that treats fungal infections that can cause hearing and/or kidney problems
• ciclosporin – a medication that affects the immune system that can cause hearing and/or kidney problems
• cisplatin – a medication that treats malignant tumors that can cause hearing and/or kidney problems
• diuretics (such as furosemide) that can cause hearing and/or kidney problems.

If any of the above cases apply to you (or if you are unsure), inform your doctor, pharmacist, or nurse before they administer Teicoplanina Altan.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

They will decide if you should or should not be given this medication while pregnant. There may be a potential risk of inner ear and kidney problems.

Inform your doctor if you are breastfeeding before they administer this medication.

They will decide if you can or cannot continue breastfeeding while being treated with Teicoplanina Altan.

Animal reproduction studies have not shown evidence of fertility problems.

Driving and operating machinery

You may experience headaches or feel dizzy while being treated with Teicoplanina Altan. If this happens, do not drive or use tools or machinery.

Teicoplanina Altan contains sodium

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

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor again.

The recommended dose is

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

Skin and soft tissue, lung, and urinary tract infections

• 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.

Bone and joint, and heart infections

• 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 orally, twice a day for 7 to 14 days.

Adults and elderly patients with kidney problems

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

• For people with mild to moderate kidney problems - the maintenance dose will be administered every other day, or the 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 dialysis bags alternately.
• Week three: 20 mg/l in dialysis bags at night.

Infants (from birth to 2 months of age)

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

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

Children (from 2 months to 12 years)

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

The preparation of the reconstituted solution (to dilute or administer orally or by injection) and diluted solution is indicated in section 6 of this leaflet.

How to administer Teicoplanina Altan

This medication will usually be administered by a doctor or nurse.

• It will be administered by intravenous injection or intramuscular injection.
• It can also be administered by continuous intravenous infusion.

Continuous intravenous infusion administration should only be administered in infants, from birth to 2 months of age.

The solution can be administered orally for certain infections.

If you use more Teicoplanina Altan than you should

It is unlikely that the doctor or nurse will administer too much medication. However, if you think you have received too much Teicoplanina Altan or if you are worried, speak immediately with your doctor or nurse.

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

If you forget to use Teicoplanina Altan

Your doctor or nurse will have instructions on when to administer Teicoplanina Altan. It is unlikely that they will not administer the medication as prescribed. However, if you are concerned, speak with your doctor or nurse.

If you interrupt the treatment with Teicoplanina Altan

Do not stop this treatment without having spoken first with your doctor, pharmacist, or nurse.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Severe side effects

Stop treatment with Teicoplanina Altan immediately and contact a doctor or nurse if you notice any of the following severe side effects – you may need urgent medical treatment:

Uncommon(may affect up to 1 in 100 people)

•anaphylactic reaction threatening life – symptoms may include: difficulty breathing or wheezing, swelling, skin rash, itching, fever, chills.

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

•flushing of the upper body.

Unknown(frequency cannot be estimated from available data)

• appearance of blisters on the skin, mouth, eyes, or genitals – may be signs of the so-called

“toxic epidermal necrolysis” or “Stevens-Johnson syndrome” or “drug reaction with eosinophilia and systemic symptoms (DRESS)”.

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

Inform your doctor or nurse immediately if you experience any of the following severe 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 experience more infections than normal – may be signs of a decrease in your white blood cell count.

Unknown(frequency cannot be estimated from available data)

•low white blood cell count – symptoms may include: fever, intense chills, sore throat, or ulcers in the mouth (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.

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

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, erythema, itching

•pain

•fever

Uncommon(may affect up to 1 in 100 people)

•decreased platelet count

•increased levels in blood of liver enzymes

• increased levels in blood of creatinine (to control your kidney)
• loss of hearing, ringing in the ears, or the sensation that you or things around you are moving
• sensation of nausea or vomiting, diarrhea
• sensation of dizziness or headache.

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

•Infection (abscess)

Unknown (frequency cannot be estimated from available data)

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

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and the vial label after EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Information about the conservation and time to use Teicoplanina Altan once it is reconstituted and ready for use is detailed in “Practical Information for Healthcare Professionals for the Preparation and Handling of Teicoplanina Altan”.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need.This will help protect the environment.

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.

Aspect of the product and contents of the package

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

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

Presentation:

- 1 vial with powder

Holder of the marketing authorization and responsible for manufacturing

Holder:

Altan Pharmaceuticals S.A.

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

28230 Las Rozas (Madrid)

Spain

Responsible for manufacturing

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 medicine is authorized in the member states of the European Economic Area with the following names :

Germany: Teicoplanin Altan 400 mg Powder for the preparation of an injectable/infusion solution or an oral solution

Belgium: Teicoplanine Altan Pharma 400 mg powder for injectable solution/for perfusion or oral solution

Italy: Teicoplanina Altan 400 mg Powder for injectable solution or infusion

Netherlands: Teicoplanine Altan Pharma 400 mg powder for solution for injection/infusion

Portugal: Teicoplanina Altan 400 mg Pó for injectable solution or for perfusion

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

Date of the last review of this leaflet:

Other sources of information

This information is intended solely for healthcare professionals:

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

This medicine 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 perfusion over 30 minutes.

In babies from birth to 2 months, only perfusion will be administered.

The reconstituted solution can also be administered orally.

Preparation of the reconstituted solution

• Slowly inject 3.2 ml of water for injection into the powder vial.
• Gently shake the vial until the powder is completely dissolved. If the solution becomes foamy, it should be left to rest for 15 minutes.

The reconstituted solutions will contain 400 mg in 3.0 ml.

Only transparent and slightly 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 perfusion

Teicoplanin can be administered in the following perfusion solutions:

- Sodium chloride solution 9 mg/ml (0.9%)

- Ringer's solution

- Ringer-lactate solution

- Glucose injection 5%

- Glucose injection 10%

- 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 in use of 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 medicine should be used immediately. If not used immediately, the times and conditions of storage in use are the responsibility of the user and should not normally exceed 24 hours between 2 and 8°C.

Elimination

The elimination of unused medicine and waste materials will be carried out in accordance with local regulations.