Prospect: Information for the User

Teicoplanina Hikma 200 mg Powder for Injection and Infusion EFG

Teicoplanina Hikma 400 mg Powder for Injection and Infusion EFG

Read this prospect carefully before starting to use this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospect. See section 4.

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

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

3. How to use Teicoplanina Hikma

4. Possible adverse effects

5. Storage of Teicoplanina Hikma

6. Contents of the package and additional information

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

Teicoplanina Hikma 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

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

No use Teicoplanina Hikma:

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

Advertencias y precauciones

Consult your doctor, pharmacist, or nurse before starting to use Teicoplanina Hikma 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 problems and/or kidney problems.

You may undergo regular tests to check if your blood, kidneys, and/or liver are functioning correctly (see “Other medications and Teicoplanina Hikma”).

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

Severe 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 generalized acute pustular psoriasis (PEGA). 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.

Pruebas

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

• your treatment will 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 can affect your nervous system, kidneys, and/or hearing.

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

Otros medicamentos y Teicoplanina Hikma

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 Hikma may affect the functioning of other medications. Additionally, some medications may affect the functioning of Teicoplanina Hikma.

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 Hikma in the same injection. They may also cause hearing problems and/or kidney problems.
• Anidulafungin – an antifungal medication that may cause hearing problems and/or kidney problems
• Ciclosporin – an immunosuppressive medication that may cause hearing problems and/or kidney problems
• Cisplatin – a medication used to treat malignant tumors that may cause hearing problems and/or kidney problems
• Diuretics (such as furosemide) that may cause hearing problems 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 Hikma.

Embarazo, lactancia y fertilidad

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 or not to administer this medication while you are 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 or not you can continue breastfeeding while taking Teicoplanina Hikma.

Animal reproduction studies have not shown evidence of fertility problems.

Conducción y uso de máquinas

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

Teicoplanina Hikma contains sodium

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

The recommended dose is:

Adults and children (12 years 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 a day, by intravenous or intramuscular injection

Bone and joint, and heart infections

• Initial dose (for three to five first 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 a day, by intravenous or intramuscular injection

Infection caused by the bacteriaClostridioides 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 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 dialysis bags alternately
• Week three: 20 mg/l in dialysis bags used 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)

• 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 Hikma

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

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

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

For certain infections, the solution can be administered orally.

If you take more Teicoplanina Hikma than you should

It is unlikely that the doctor or nurse will administer too much medicine. However, if you think you have received too much Teicoplanina Hikma 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 5620420, indicating the medicine and the amount ingested.

If you forget to take Teicoplanina Hikma

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

If you interrupt the treatment with Teicoplanina Hikma

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 medicine, 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 urgent medical treatment:

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

Frequency not known(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"
• Generalized red and scaly rash with bumps under the skin (including skin folds, chest, abdomen, back, and arms) and blisters accompanied by fever – may be symptoms of "acute generalized pustular psoriasis (AGPP)".
• "Drug 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 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

Frequency not known(cannot be estimated from available data)

• Lack of white blood cells in the blood – symptoms may include: fever, intense chills, sore throat, or mouth ulcers (agranulocytosis)
• Problems with the kidneys 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 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 control 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)

Frequency not known(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 the vial label after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conservation conditions.

Information about the conservation and the time to use Teicoplanina Hikma once it is reconstituted and ready to use is detailed in “Practical information for healthcare professionals about the preparation and handling of Teicoplanina Hikma”.

Medications should not be thrown down the drain or in the trash. If in doubt, ask your pharmacist how to dispose of the packaging and medications that you do not need. In this way, you will help protect the environment.

Composition of Teicoplanin Hikma

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

Appearance of the product and contents of the package

Teicoplanin Hikma is a lyophilized powder of white to yellowish color. The powder is packaged in vials of 10 ml for Teicoplanin Hikma 200 mg and 20 ml for Teicoplanin Hikma 400 mg.

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

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Hikma Farmacêutica (Portugal), S.A.

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

2705-906 Terrugem SNT, Portugal

Tel.: +351 219608410

e-mail:[email protected]

Responsible for Manufacturing:

Hikma Italia S.P.A.

Viale Certosa, 10

27100 Pavia

Italy

Tel.: +39 0382 1751801

Fax: +39 0382 422745

e-mail:[email protected]

You can request more information about this medication by contacting 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 medication is authorized in the member states of the European Economic Area with the following names:

AustriaTeicoplanin Hikma 200 mg Powder for the preparation of an injection/infusion solution or an oral solution

Teicoplanin Hikma 400 mg Powder for the preparation of an injection/infusion solution or an oral solution

SpainTeicoplanin Hikma 200 mg powder for injectable and perfusion solution EFG

Teicoplanin Hikma 400 mg powder for injectable and perfusion solution EFG

FranceTeicoplanine Hikma 200 mg powder for injectable/perfusion solution or oral solution

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

IrelandTeicoplanin Hikma 200mg powder for solution for injection/infusion or oral solution

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

ItalyTeicoplanin Hikma 200mg powder for injectable/infusion solution or oral solution

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

NetherlandsTeicoplanine Hikma 200 mg powder for solution for injection/infusion or oral solution

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

PortugalTeicoplanin Hikma 200 mg Powder for injectable or perfusion solution or oral solution

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

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

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

Last review date of this leaflet: November 2022

This information is intended solely for healthcare professionals: