Teicoplanin Noridem 200 mg powder and solvent for solution for injection and for infusion EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Teicoplanina Noridem 200 mg Powder and solvent for injectable solution and for infusion EFG

Teicoplanin

Read the entire 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, ask your doctor, pharmacist or nurse.
• If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What Teicoplanina Noridem is and what it is used for
2. What you need to know before using Teicoplanina Noridem
3. How to use Teicoplanina Noridem
4. Possible adverse effects
5. How to store Teicoplanina Noridem
6. Contents of the pack and other information

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

Teicoplanina Noridem is an antibiotic. It contains a medicine called "teicoplanin".

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

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as flu or the common cold.

It is important that you follow your doctor's instructions regarding dose, dosing interval, and duration of treatment.

Do not store or reuse this medicine. If you have any antibiotic left after completing the treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines via wastewater or household waste.

Teicoplanina Noridem 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 lung
• the urinary tract
• the heart – sometimes called "endocarditis"
• the abdominal wall – peritonitis
• the blood, when caused by one of the conditions listed above

Teicoplanin may be used to treat certain intestinal infections caused by the bacterium Clostridioides difficile. In this case, the solution must be taken orally.

2. What you need to know before using Teicoplanin Noridem

Do not use Teicoplanin Noridem:

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before using Teicoplanin Noridem if:

• you are allergic to an antibiotic called “vancomycin”
• you have experienced redness of the upper part of your 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. You may be given regular tests to check whether your kidneys and/or liver are functioning properly (see “Use of Teicoplanin Noridem with other medicines”).

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

Tests

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

• your treatment will last for a long period
• you require high loading doses (12 mg/kg twice daily)
• you have kidney problems
• you are taking or may need to take other medicines that could affect your nervous system, kidneys, or hearing.

In patients receiving long-term treatment with Teicoplanin Noridem, bacteria not affected by the antibiotic may grow excessively—your doctor will monitor for this.

Use of Teicoplanin Noridem with other medicines

Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might need to take any other medicines. This is because Teicoplanin Noridem may affect how other medicines work. Likewise, some medicines may affect how Teicoplanin Noridem works.

In particular, inform your doctor, pharmacist, or nurse if you are taking any of the following medicines:

• Aminoglycosides, as they must not be mixed with Teicoplanin Noridem in the same injection. They may also cause hearing and/or kidney problems.
• amphotericin B – a medicine used to treat fungal infections that may cause hearing and/or kidney problems
• cyclosporine – a medicine that affects the immune system and may cause hearing and/or kidney problems
• cisplatin – a medicine used to treat malignant tumors that may cause hearing and/or kidney problems
• diuretic tablets (such as furosemide), also known as “diuretics,” which may cause hearing and/or kidney problems.

If any of the above situations apply to you (or if you are unsure), inform your doctor, pharmacist, or nurse before using Teicoplanin 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 medicine. They will decide whether or not you should be given this medicine during pregnancy. There may be a potential risk of problems affecting the inner ear and kidneys.

Inform your doctor if you are breastfeeding before receiving this medicine. They will decide whether or not you can continue breastfeeding while being treated with Teicoplanin Noridem.

Animal reproduction studies have not shown evidence of fertility impairment.

Driving and using machines

You may experience headaches or dizziness during treatment with Teicoplanin Noridem. If this occurs, do not drive or operate tools or machinery.

Teicoplanin Noridem contains sodium

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

3. How to use Teicoplanin Noridem

Recommended dose:

Adults and children (12 years of age or older) with normal kidney function

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 daily by intravenous or intramuscular injection

Bone and joint infections, and heart infections

• Initial dose (for the first three to five 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 daily by intravenous or intramuscular injection

Infection caused by the bacterium Clostridioides difficile

The recommended dose is 100 to 200 mg orally, twice daily 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 patients with mild to moderate kidney problems – the maintenance dose should be administered every two days, or half the maintenance dose should be given once daily.
• For patients with severe kidney problems and those on hemodialysis – the maintenance dose should be administered every three days, or one-third of the maintenance dose should be given once daily.

Treatment of peritonitis in patients undergoing peritoneal dialysis

Initial dose: 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 the dialysis bags used overnight

Neonates (from birth up to 2 months of age)

• Initial dose (on day one): 16 mg per kilogram of body weight, as an intravenous infusion by drip.
• Maintenance dose: 8 mg per kilogram of body weight, administered once daily as an intravenous infusion by 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 to 10 mg per kilogram of body weight, administered once daily by intravenous injection.

How Teicoplanin Noridem is administered

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

• It will be given by intravenous (into a vein) or intramuscular (into a muscle) injection.
• It may also be given as an intravenous infusion by drip.

In infants from birth up to two months of age, it will only be administered by infusion.

For the treatment of certain infections, the solution may be administered orally.

If you take more Teicoplanin Noridem than you should

It is unlikely that a doctor or nurse would administer too much medicine. However, if you think you have received too much Teicoplanin Noridem or if you feel unwell, speak immediately with your doctor or nurse.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Teicoplanin Noridem

Your doctor or nurse will have specific instructions on when to administer Teicoplanin Noridem. It is unlikely that the medicine will not be administered as prescribed. However, if you are concerned, speak with your doctor or nurse.

If you stop using Teicoplanin Noridem

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Serious adverse effects

Stop treatment immediately and contact a doctor or nurse if you notice any of the following serious adverse effects – you may need urgent medical treatment:

Uncommon (may affect up to 1 in 100 people)

• sudden, life-threatening allergic reaction – signs may include: difficulty breathing or wheezing, swelling, rash, itching, fever, chills

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

• redness of the upper body

Frequency not known (cannot be estimated from available data)

appearance of blisters on the skin, mouth, eyes, or genitals – these could be signs of toxic epidermal necrolysis, Stevens-Johnson syndrome, or drug reaction with eosinophilia and systemic symptoms (DRESS). DRESS initially presents with flu-like symptoms and a rash on the face, followed by a prolonged rash with high fever, increased liver enzymes in blood tests, elevated levels of a type of white blood cell (eosinophilia), and enlarged lymph nodes.

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

Inform your doctor or nurse immediately if you experience any of the following serious adverse effects – you may need urgent medical treatment:

Uncommon (may affect up to 1 in 100 people)

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

Frequency not known (cannot be estimated from available data)

• lack of white blood cells in the blood – signs may include: fever, severe chills, sore throat, or mouth ulcers (agranulocytosis)
• low levels of all types of blood cells
• kidney problems or changes in kidney function – shown in blood 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 above-mentioned adverse effects.

Other adverse effects

Talk to your doctor, pharmacist, or nurse if you experience any of the following adverse 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 blood levels of liver enzymes
• increased blood levels of creatinine (to monitor kidney function)
• hearing loss, tinnitus, or sensation that you or your surroundings are moving
• nausea or vomiting, diarrhea
• dizziness or headache

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

• infection (abscesses)

Frequency not known (cannot be estimated from available data)

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

Reporting of adverse effects

If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Teicoplanina Noridem

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

Do not use this medicine after the expiry date stated on the container and label of the vial after EXP. The expiry date refers to the last day of the month indicated.

For powder and solvent:

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

For single use only.

Discard any unused solution.

Information regarding storage and the time for using Teicoplanina Noridem once it has been reconstituted and is ready for use is detailed in "Practical information for healthcare professionals on the preparation and handling of Teicoplanina Noridem".

6. Contents of the pack and other information

Composition of Teicoplanina Noridem

• The active substance is teicoplanin. Each vial contains 200 mg of teicoplanin.

Each mL of reconstituted solution contains 66.7 mg of teicoplanin.

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

Appearance of the product and contents of the container

Teicoplanina Noridem is a powder and solvent for injectable solution and for perfusion or for oral solution.

The powder is a white to off-white powder. The solvent is a clear, colourless solution.

The powder is contained:

• in a colourless type I glass vial with a nominal capacity of 10 mL for 200 mg, closed with a rubber stopper (Ph.Eur., type I) and sealed with aluminium flip-off caps.

Presentations: 1 vial of 200 mg + 1 ampoule of 3 mL solvent

10 vials of 200 mg + 10 ampoules of 3 mL solvent

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

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

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

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

Date of the last review of this summary: 10/2022.

This information is intended for healthcare professionals only: