Teicoplanin Hikma 400 mg powder for injection and for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Teicoplanina Hikma 200 mg powder for solution for injection and infusion EFG

Teicoplanina Hikma 400 mg powder for solution for injection and infusion EFG

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

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

Teicoplanina Hikma is an antibiotic. It contains a medicine called "teicoplanin". It works by killing 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 the instructions regarding dose, dosing interval, and duration of treatment as directed by your doctor.

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

Teicoplanina Hikma 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 called "endocarditis"
• the abdominal wall – peritonitis
• the bloodstream, when caused by any of the conditions listed above

Teicoplanin can 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 Teicoplanina Hikma

Do not use Teicoplanina Hikma:

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

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Teicoplanina Hikma if:

• you are allergic to an antibiotic called “vancomycin”
• you have had redness on 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 have regular tests to check whether your blood, kidneys and/or liver are working properly (see “Other medicines and Teicoplanina Hikma”).

If any of the conditions listed above apply to you (or if you are not sure), inform your doctor, pharmacist or nurse before using Teicoplanina Hikma.

Serious skin reactions have been reported with the use of teicoplanin, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). If you develop a severe rash or other skin symptoms as described in section 4, stop taking Teicoplanina Hikma and contact your doctor or seek immediate medical attention.

Tests

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

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

In people receiving Teicoplanina Hikma for a long time, bacteria not affected by the antibiotic may grow excessively – your doctor will monitor this.

Other medicines and Teicoplanina Hikma

Tell your doctor, pharmacist or nurse if you are using, have recently used, or might need to use any other medicines. This is because Teicoplanina Hikma may affect how other medicines work. In addition, some medicines may affect how Teicoplanina Hikma 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 Teicoplanina Hikma 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
• tablets for urination (such as furosemide), also known as “diuretics”, which may cause hearing and/or kidney problems.

If any of the conditions listed above apply to you (or if you are not sure), inform your doctor, pharmacist or nurse before using Teicoplanina Hikma.

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 inner ear and kidney problems.

Inform your doctor if you are breastfeeding before this medicine is administered. They will decide whether or not you can continue breastfeeding while receiving Teicoplanina Hikma.

Animal reproduction studies have not shown evidence of fertility problems.

Driving and using machines

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

Teicoplanina Hikma contains sodium

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

3. How to use Teicoplanin Hikma

The recommended dose is:

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): 400 mg (equivalent to 6 mg per kilogram of body weight), administered every 12 hours by intravenous or intramuscular injection
• Maintenance dose: 400 mg (equivalent to 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): 800 mg (equivalent to 12 mg per kilogram of body weight), administered every 12 hours by intravenous or intramuscular injection
• Maintenance dose: 800 mg (equivalent to 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 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 once daily.

Treatment of peritonitis in peritoneal dialysis patients

The initial dose is 6 mg per kilogram of body weight, as a single intravenous infusion, followed by:

• Week one: 20 mg/l in each dialysis bag
• Week two: 20 mg/l in dialysis bags on alternate days
• Week three: 20 mg/l in dialysis bags used overnight

Infants (from birth up to 2 months of age)

• Initial dose (on day one): 16 mg per kilogram of body weight, as a single intravenous infusion by slow drip.
• Maintenance dose: 8 mg per kilogram of body weight, administered once daily as an intravenous infusion by slow 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 Hikma is administered

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

• It will be given by intravenous or intramuscular injection.
• It may also be given by intravenous infusion (slow drip).

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

To treat certain infections, the solution may be given orally.

If you take more Teicoplanin Hikma 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 Hikma or if you feel concerned, speak to your doctor or nurse immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at 91 5620420, stating the name of the medicine and the amount ingested.

If you forget to take Teicoplanin Hikma

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

If you stop treatment with Teicoplanin Hikma

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 part of the 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" or "Stevens-Johnson syndrome"
• widespread red, scaly rash with bumps under the skin (including skin folds, chest, abdomen (including stomach), back, and arms), and blisters accompanied by fever – these may be symptoms of a condition called "acute generalized exanthematous pustulosis (AGEP)"
• "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, high fever, increased liver enzyme levels observed in blood tests, an increase in a type of white blood cell (eosinophilia), and swollen 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)

• swelling 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)
• kidney problems or changes in kidney function – shown in laboratory 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 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, ringing in the ears, or sensation that you or surrounding objects 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 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 can 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 Hikma

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

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

This medicine does not require any special storage conditions.

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

Medicines must not be disposed of via wastewater or household waste. If you are unsure how to dispose of unused medicines or their packaging, ask your pharmacist. This will help protect the environment.

6. Contents of the container and other information

Composition of Teicoplanina Hikma

• The active substance is teicoplanin. Each vial contains 200 mg or 400 mg of teicoplanin.
• The other components are sodium chloride and sodium hydroxide.

Appearance of the medicinal product and contents of the container

Teicoplanina Hikma is a lyophilized powder, white to yellowish in colour. The powder is contained in 10 ml vials for Teicoplanina Hikma 200 mg and 20 ml vials for Teicoplanina Hikma 400 mg.

Teicoplanina Hikma is marketed in packs of 1 vial or 10 vials.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Hikma Farmacêutica (Portugal), S.A.

Estrada do Rio da Mó 8, 8A and 8B – Fervença

2705-906 Terrugem SNT, Portugal

Tel.: +351 219608410

e-mail: [email protected]

Manufacturer:

Hikma Italia S.P.A.

Viale Certosa, 10

27100 Pavia

Italy

Tel.: +39 0382 1751801

Fax: +39 0382 422745

e-mail: [email protected]

For more information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Hikma España, S.L.U.

Calle Anabel Segura nº11, Edificio A, planta 1ª, oficina 2

28108 - Alcobendas, Madrid

Spain

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

Austria Teicoplanin Hikma 200 mg Powder for solution for injection/infusion or for oral solution

Teicoplanin Hikma 400 mg Powder for solution for injection/infusion or for oral solution

Spain Teicoplanin Hikma 200 mg powder for injectable solution and for perfusion EFG

Teicoplanin Hikma 400 mg powder for injectable solution and for perfusion EFG

France Teicoplanin Hikma 200 mg powder for injectable solution/perfusion or oral solution

Teicoplanin Hikma 400 mg powder for injectable solution/perfusion or oral solution

Ireland Teicoplanin Hikma 200mg powder for solution for injection/infusion or oral solution

Teicoplanin Hikma 400mg powder for solution for injection/infusion or oral solution

Italy Teicoplanin Hikma 200mg powder for injectable solution/infusion or oral solution

Teicoplanin Hikma 400mg powder for injectable solution/infusion or oral solution

Netherlands Teicoplanin Hikma 200 mg powder for solution for injection/infusion or oral solution

Teicoplanin Hikma 400 mg powder for solution for injection/infusion or oral solution

Portugal Teicoplanin Hikma 200 mg Powder for injectable solution or for perfusion or for oral solution

Teicoplanin Hikma 400 mg Powder for injectable solution or for perfusion or for oral solution

United Kingdom Teicoplanin Hikma 200mg powder for solution for injection/infusion or oral solution

Teicoplanin Hikma 400mg powder for solution for injection/infusion or oral solution

Date of latest review of this summary: November 2022

This information is intended for healthcare professionals only:

Practical information for healthcare professionals on the preparation and handling of Teicoplanina Hikma. This medicinal product is for single use only. Route of administration The reconstituted solution can be injected directly or alternatively administered in diluted form. Intravenous injection may be given either as a bolus over 3–5 minutes or as a 30-minute infusion. In infants from birth to two months of age, administration must be by infusion only. The reconstituted solution may also be administered orally. Preparation of the reconstituted solution: Slowly inject 3.14 ml of water for injections into the vial containing the powder. Gently roll the vial between the hands until the powder is completely dissolved. If foam appears, allow the solution to stand for approximately 15 minutes. The reconstituted solutions will contain 200 mg of teicoplanin in 3.0 ml and 400 mg of teicoplanin in 3.0 ml. Only clear, slightly yellow solutions should be used. The final solution is isotonic with plasma and has a pH of 6.0–8.0. Nominal content of teicoplanin per vial 200 mg 400 mg Vial volume with powder 10 ml 20 ml Volume containing the nominal dose of teicoplanin (to be withdrawn using a 5 ml syringe and 23 G needle) 3.0 ml 3.0 ml Preparation of the diluted solution prior to infusion Teicoplanin Hikma can be administered in the following infusion solutions: Sodium chloride solution 9 mg/ml (0.9%) Ringer's solution Ringer-lactate solution 5% glucose injection 10% glucose injection Solution containing 0.18% sodium chloride and 4% glucose Solution containing 0.45% sodium chloride and 5% glucose Peritoneal dialysis solution containing 1.36% or 3.86% glucose solution. Stability period of the reconstituted solution: Chemical and physical in-use stability of the reconstituted solution with water for injections has been demonstrated for 24 hours between 2°C and 8°C. From a microbiological standpoint, the product should be used immediately. If not used immediately, the user is responsible for in-use storage times and conditions, and these should normally not exceed 24 hours between 2°C and 8°C, unless reconstitution has been carried out under controlled and validated aseptic conditions. Stability period of the diluted medicinal product Chemical and physical in-use stability of the reconstituted solution prepared as recommended has been demonstrated for 24 hours between 2°C and 8°C. From a microbiological standpoint, the medicinal product should be used immediately. If not used immediately, the user is responsible for in-use storage times and conditions, and these should normally not exceed 24 hours between 2°C and 8°C, unless reconstitution/dilution has been carried out under controlled and validated aseptic conditions. Disposal Disposal of unused medicinal product and all materials that have come into contact with it should be carried out in accordance with local regulations.