PATIENT INFORMATION LEAFLET

Teicoplanina Noridem 400 mg Powder and solvent for injection and for infusion EFG

Teicoplanina

Read this leaflet carefully before you start using this medicine, because 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.
• 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 Noridem is and what it is used for

2. What you need to know before you start using Teicoplanina Noridem

3. How to use Teicoplanina Noridem

4. Possible side effects

5. Storage of Teicoplanina Noridem

6. Contents of the pack and additional information

Teicoplanina Noridem is an antibiotic. It contains a medication called “teicoplanin”.

It works by eliminating the bacteria that cause infections in your body.

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

• the skin and under 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

Teicoplanin may be used to treat some infections caused by the bacteriaClostridioidesdifficilein the intestine. In this case, the solution should be taken orally.

Do not use Teicoplanina Noridem:

• 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 Noridem if:

• you are allergic to an antibiotic called “vancomycin”
• you have hada 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. Regular tests may be performed to check if your kidneys and/or liver are functioning correctly (see “Using Teicoplanina Noridem with other medications”).

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

Tests

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

• your treatment is going to last a long period of 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 medications that may affect your nervous system, kidneys, and/or ear.

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

Using Teicoplanina Noridem with other medications

Inform your doctor, pharmacist, or nurse if you are using, have used recently, or may need to use any other medication. This is because Teicoplanina Noridem may affect the functioning of other medications. Additionally, some medications may affect the functioning of Teicoplanina Noridem.

Particularly, inform your doctor, pharmacist, or nurse if you are taking any of the following medications:

• Aminoglycosides, as they should not be mixed with Teicoplanina Noridem in the same injection. They may also cause hearing and/or kidney problems.
• Anidulafungin – an antifungal medication that may cause hearing and/or kidney problems
• Ciclosporin – an immunosuppressive medication that may cause hearing and/or kidney problems
• Cisplatin – a medication used to treat malignant tumors that may cause hearing and/or kidney problems
• Diuretics (such as furosemide) that may 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 using Teicoplanina Noridem.

Pregnancy, breastfeeding, and fertility

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor, pharmacist, or nurse before using this medication. They will decide whether 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 to you. They will decide whether you can or cannot continue breastfeeding while being treated with Teicoplanina Noridem.

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 Noridem. If this happens, do not drive or use tools or machinery.

Teicoplanina Noridem contains sodium

This medication contains less than 1 mmol (0.41 mmol/9.43 mg) of sodium (23 mg) per vial; this is essentially “sodium-free”.

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 three to five first doses): 12 mg per kilogram of body weight, administered every 12 hours, by intravenous injection
• Maintenance dose: 12 mg per kilogram of body weight, administered once a day, by intravenous or intramuscular injection

Infection caused by the bacteriaClostridioidesdifficile

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 be reduced after the fourth day of treatment:

• For people with mild to moderate kidney problems - the maintenance dose will be administered every two days, 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 alternating dialysis bags
• Week three: 20 mg/L in dialysis bags used at night.

Newborns (from birth to 2 months old)

• 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 old)

• 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 a day, by intravenous injection.

How to administer Teicoplanina Noridem

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.

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

For certain infections, the solution may be administered orally.

If you take more Teicoplanina Noridem 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 Noridem 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: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Teicoplanina Noridem

Your doctor or nurse will have instructions on when to administer Teicoplanina Noridem. 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 Noridem

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 immediately and contact a doctor or nurse if you notice any of the following severe side effects – you may need medical treatment
Urgent:

Rare(may affect up to 1 in 100 people)

• Life-threatening allergic reaction – symptoms may include: difficulty breathing or wheezing, inflammation, skin rash, itching, fever, chills

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

• Redness 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 "toxic epidermal necrolysis" or "Stevens-Johnson syndrome" ordrug reaction with eosinophilia and systemic symptoms (DRESS).DRESS initially appears as flu-like symptoms and a rash on the face, followed by a prolonged rash with high temperature, elevated liver enzymes observed in blood tests, and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes.

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:

Rare(may affect up to 1 in 100 people)

• Swelling and clotting in a vein
• Difficulty breathing and wheezing (bronchoconstriction)
• If you experience more infections than usual – may be signs of a decrease in your white blood cell count

Unknown frequency(cannot be estimated from available data)

• Lack of white blood cells in the blood – symptoms may include: fever, intense chills, sore throat, or ulcers in the mouth (agranulocytosis)
• Low levels of all types of blood cells
• 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

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 if you experience any of the following side effects:

Common(may affect up to 1 in 10 people)

• Skin rash, erythema, itching
• Pain
• Fever

Rare(may affect up to 1 in 100 people)

• Decrease in platelet count
• Increased levels of liver enzymes in the blood
• Increased levels of creatinine in the blood (to monitor kidney function)

• Loss of hearing, ringing in the ears, or the sensation 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 (abscesses)

Unknown frequency(cannot be estimated from available data)

• Problems at the injection site – such as skin redness, pain, or inflammation

Reporting 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 throughthe Spanish System for Pharmacovigilance of Medicines for human use: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 vial label after CAD. The expiration date is the last day of the month indicated.

For powder and solvent:

Store below 25°C. Store the container in the outer packaging to protect it from light.

For single use only.

Discard any unused solution.

The information about conservation and the time to use Teicoplanin Noridem once it is reconstituted and ready for use is detailed in “Practical information for healthcare professionals on the preparation and handling of Teicoplanin Noridem”.

Composition of Teicoplanin Noridem

• The active ingredient is teicoplanin. Each vial contains 400 mg of teicoplanin.

Each mL of reconstituted solution contains 133.4 mg of teicoplanin.

• The other components are sodium chloride and sodium hydroxide in the powder, and water for injection in the solvent.

Appearance of the product and contents of the package

Teicoplanin Noridem is a powder and solvent for injectable and infusible solution or oral solution.

The powder is a white to off-white powder. The solvent is a transparent and colorless solution.

The powder is packaged:

• in a colorless type I glass vial, with a useful volume of 22 mL for 400 mg, closed with a rubber stopper (Ph.Eur., type I) and sealed with aluminum flip-off capsules.

Presentations:

1 vial of 400 mg + 1 ampoule of 3 mL of solvent

10 vials of 400 mg + 10 ampoules of 3 mL of solvent

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:Noridem Enterprises Ltd., Evagorou & Makariou, Mitsi Building 3, Office 115, 1065 Nicosia, Cyprus.

Responsible manufacturer:DEMO S.A., 21st km National Road Athens-Lamia, 14568 Krioneri, Attica, Greece.

This medicinal product is authorized in the member states of the European Economic Area with the following names::

Last review date of this leaflet: 10/2022.

This information is intended solely for healthcare professionals: