TEICOPLANIN HIKMA

Patient Information Leaflet: Information for the User

Teicoplanin Hikma 200 mg Powder for injectable/infusion solution or oral solution, 400 mg Powder for injectable/infusion solution or oral solution

Teicoplanin
Generic medicine
Please read this leaflet carefully before taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this Patient Information Leaflet

1. What Teicoplanin Hikma is and what it is used for
2. What you need to know before using Teicoplanin Hikma
3. How to use Teicoplanin Hikma
4. Possible side effects
5. How to store Teicoplanin 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 medicinal substance called 'teicoplanin'. It works
by killing bacteria responsible for infections in the body.
Teicoplanina Hikma is used in adults and children (including newborns) to treat bacterial infections of:

• skin and underlying tissues (sometimes referred to as 'soft tissues')
• bones and joints
• lungs
• urinary tract
• heart (sometimes referred to as 'endocarditis')
• abdominal area (peritonitis)
• blood, when caused by one of the above-mentioned conditions

Teicoplanina Hikma may be used to treat certain intestinal infections caused by the bacterium
' Clostridioides difficile '. For this use, the solution is taken orally.

2. What you need to know before using Teicoplanin Hikma

Do not use Teicoplanin 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 you are given Teicoplanin Hikma:

• if you are allergic to an antibiotic called 'vancomycin'
• if you have experienced redness of the upper part of the body (red man syndrome)
• if you have a low platelet count (thrombocytopenia)
• if you have kidney problems
• if you are taking other medicines that could cause hearing and/or kidney problems. You may need regular tests to check that your blood, kidneys, and liver are functioning properly (see 'Other medicines and Teicoplanin Hikma'). If any of the above applies to you (or if you are not sure), talk to your doctor, pharmacist, or nurse before being administered Teicoplanin 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 described in section 4, stop taking Teicoplanin Hikma and contact your doctor immediately or seek medical assistance.

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

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

In patients receiving prolonged treatment with Teicoplanin Hikma, bacteria not affected by the antibiotic may grow more than usual – your doctor will perform checks to monitor for this possibility.

Other medicines and Teicoplanin Hikma
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines. This is because Teicoplanin Hikma may affect how other medicines work. Likewise, some medicines may affect how Teicoplanin Hikma works.
In particular, inform your doctor, pharmacist, or nurse if you are taking any of the following medicines:

• aminoglycosides – these must not be mixed with Teicoplanin 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
• diuretic tablets (such as furosemide) – also known as 'water pills' that may cause hearing and/or kidney problems.

If any of the above applies to you (or if you are not sure), talk to your doctor, pharmacist, or nurse before being administered Teicoplanin Hikma.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you might be pregnant, suspect you could be pregnant, or are planning a pregnancy, consult your doctor, pharmacist, or nurse before being given this medicine. They will decide whether 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 being administered this medicine. They will decide whether you can continue breastfeeding while receiving Teicoplanin Hikma. Reproduction studies in animals have not shown evidence of fertility problems.

Driving and using machines
While being treated with Teicoplanin Hikma, you may experience headache or dizziness. If this occurs, do not drive or operate machinery.

Teicoplanin Hikma contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per vial and is essentially sodium-free.

3. How to use Teicoplanin Hikma

The recommended dose is:
Adults and children (12 years of age and older) with normal kidney function
Skin and soft tissue, lung, and urinary tract infections

• Initial dose (for the first 3 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 3–5 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.

Infections caused by bacteria ‘Clostridioides difficile’
The recommended dose is 100–200 mg orally, twice daily for 7–14 days.
Adults and elderly patients with kidney problems
If you have kidney problems, your dose will generally be reduced after the fourth day of treatment:

• For patients with mild to moderate kidney impairment – the maintenance dose will be given every 2 days, or half the maintenance dose will be given daily.
• For patients with severe kidney impairment or on hemodialysis – the maintenance dose will be given every 3 days, or one-third of the maintenance dose will be given daily.

Peritonitis in patients undergoing peritoneal dialysis
The initial dose is 6 mg per kilogram of body weight, given 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 nighttime dialysis bag.

Neonates (from birth to 2 months of age)

• Initial dose (on the first day): 16 mg per kilogram of body weight, administered by intravenous infusion.
• Maintenance dose: 8 mg per kilogram of body weight, administered once daily by intravenous infusion.

Children (from 2 months to 12 years of age)

• Initial dose (for the first 3 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 daily by intravenous injection.

How Teicoplanin Hikma is given
This medicine is usually administered by a doctor or nurse.

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

In children from birth up to 2 months of age, this medicine must be administered only by infusion.
To treat certain infections, the solution may be taken orally (oral use).
If you receive more Teicoplanin Hikma 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 Hikma, or if you feel restless, inform your doctor or nurse immediately.
If you miss a dose of Teicoplanin Hikma
Your doctor or nurse will have specific instructions on when to administer Teicoplanin Hikma. It is unlikely that the medicine will be omitted as prescribed. However, if you are concerned, inform your doctor or nurse.
If you stop Teicoplanin Hikma treatment
Do not stop taking this medicine without first discussing it with your doctor, pharmacist, or nurse.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Serious side effects
Stop treatment and immediately contact your 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 patients)

• Sudden allergic reaction that may be life-threatening – signs may include: difficulty breathing or shortness of breath, swelling, rash, itching, fever, chills

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

• Hot flushes in the upper part of the body

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

• Blisters on the skin, mouth, eyes or genitals – these may be signs of a condition called ‘toxic epidermal necrolysis’ or ‘Stevens-Johnson syndrome’
• Widespread, red, scaly rash with subcutaneous bumps (including skin folds, chest, abdomen (including stomach), back and arms) and blisters accompanied by fever – these may be symptoms of so-called ‘acute generalized exanthematous pustulosis’ (AGEP)
• ‘Drug reaction with eosinophilia and systemic symptoms (DRESS)’. DRESS syndrome initially presents with flu-like symptoms and a rash on the face, followed by widespread rash, high temperature, increased liver enzyme levels observed in blood tests, an increase in white blood cells (eosinophilia), and swollen lymph nodes. Immediately contact your doctor or nurse if you notice any of the side effects listed above.

Immediately contact your 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 patients)

• Swelling and blood clot in a vein
• Difficulty breathing or shortness of breath (bronchospasm)
• Increased occurrence of infections – these could be signs of a reduced number of blood cells

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

• Lack of white blood cells – signs may include: fever, severe chills, sore throat or mouth ulcers (agranulocytosis)
• Kidney problems or changes in how the kidneys function – shown by blood tests. The frequency or severity of kidney problems may increase if higher doses are administered.
• Seizures
• Low levels of all types of blood cells

Immediately contact your doctor or nurse if you notice any of the side effects listed above.
Other side effects
Inform your doctor, pharmacist, or nurse if you notice any of the following side effects:
Common (may affect up to 1 in 10 patients)

• Rash, redness, itching
• Pain
• Fever

Uncommon (may affect up to 1 in 100 patients)

• Decrease in the number of platelets
• Increased liver enzyme levels in the blood
• Increased creatinine levels in the blood (to monitor kidney function)
• Hearing loss, ringing in the ears or sensation that you or things around you are moving
• Feeling unwell or nausea, vomiting, diarrhoea
• Dizziness or headache

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

• Infection (abscess)

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

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Teicoplanin Hikma

Keep this medicine out of the sight and reach of children.
Do not use Teicoplanin Hikma after the expiry date stated on the label and the carton, after
EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Information on storage and duration of use of Teicoplanin Hikma after reconstitution and once ready for use are described in the 'Practical information for healthcare personnel on the preparation and handling of Teicoplanin Hikma'.

6. Package contents and other information

What Teicoplanin Hikma contains

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

Description of the appearance of Teicoplanin Hikma and package contents
Teicoplanin Hikma is a lyophilized powder, white to yellowish. The powder is contained in
10 ml vials for Teicoplanin 200 mg or 20 ml vials for Teicoplanin 400 mg.
Teicoplanin is supplied in packages containing 1 vial.

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]

This medicinal product is authorized in the European Economic Area countries under the following names:
Austria Teicoplanin Hikma 200 mg Powder for the preparation of an injection/infusion solution or oral solution
Teicoplanin Hikma 400 mg Powder for the preparation of an injection/infusion solution or oral solution
Spain Teicoplanina Hikma 200 mg powder for injectable and perfusion solution or oral solution EFG
Teicoplanina Hikma 400 mg powder for injectable and perfusion solution or oral solution EFG
France Teicoplanine Hikma 200 mg powder for injectable solution/perfusion or oral solution
Teicoplanine Hikma 400 mg powder for injectable solution/perfusion or oral solution
Ireland 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
Italy Teicoplanina Hikma 200 mg powder for injectable solution/infusion or oral solution
Teicoplanina Hikma 400 mg powder for injectable solution/infusion or oral solution
Netherlands Teicoplanine Hikma 200 mg powder for injection/infusion solution or oral solution
Teicoplanine Hikma 400 mg powder for injection/infusion solution or oral solution
Portugal Teicoplanina Hikma 200 mg Powder for injectable solution or perfusion or oral solution
Teicoplanina Hikma 400 mg Powder for injectable solution or perfusion or oral solution
United Kingdom
Teicoplanin 200 mg Powder for solution for Injection/Infusion or Oral Solution
Teicoplanin 400 mg Powder for solution for Injection/Infusion or Oral Solution

The following information is intended exclusively for physicians or healthcare professionals:
Practical information for healthcare personnel on the preparation and handling of Teicoplanin Hikma.
This medicinal product is for single use only.

Method of administration
The reconstituted solution may be injected directly or alternatively further diluted.
The injection may be administered as a 3-5 minute bolus or as a 30-minute infusion.
In children from birth up to 2 months of age, administration must be performed only via infusion.
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 rotate the vial between the hands until the powder is completely dissolved. If the solution becomes frothy, allow it to stand for approximately 15 minutes. The reconstituted solutions will contain 200 mg of teicoplanin in 3.0 ml and 400 mg in 3.0 ml. Only clear, yellowish solutions should be used. The final solution is isotonic with plasma and has a pH of 6.0–8.0.

Nominal vial content 200 mg 400 mg
of
t i l i
Powder vial volume 10 ml 20 ml
Volume containing the nominal dose
of teicoplanin 3.0 ml 3.0 ml
(to be extracted with a 5 ml syringe and 23G needle)

Preparation of diluted solution prior to infusion
Teicoplanin Hikma may be administered in the following infusion solutions:

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

Stability of the reconstituted solution
The chemical and physical stability in-use of the reconstituted solution prepared according to the recommendations has been demonstrated for 24 hours at a temperature between 2 and 8°C.
From a microbiological standpoint, the medicinal product should be used immediately. If not used immediately, the storage times in-use and conditions prior to use are the responsibility of the user and normally should not exceed 24 hours at 2–8°C, unless reconstitution is carried out under controlled and validated aseptic conditions.

Stability of the diluted medicinal product:
The chemical and physical stability in-use of the reconstituted solution prepared according to the recommendations has been demonstrated for 24 hours at temperatures of 2–8°C.
From a microbiological standpoint, the medicinal product should be used immediately. If not used immediately, the storage times in-use and conditions prior to use are the responsibility of the user and should normally not exceed 24 hours at 2–8°C, unless reconstitution/dilution was performed under controlled and validated aseptic conditions.

Disposal
Unused medicine and waste materials derived from this medicine must be disposed of in accordance with local regulatory requirements.