TEICOPLANIN HIKMA 200 mg POWDER FOR INJECTABLE SOLUTION AND FOR INFUSION

Introduction

Package Leaflet: Information for the User

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

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

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if you think they might be unrelated to this medicine. See section 4.

Contents of the package leaflet

1. What is Teicoplanin Hikma and what is it used for
2. What you need to know before you use Teicoplanin Hikma
3. How to use Teicoplanin Hikma
4. Possible side effects
5. Storage of Teicoplanin Hikma
6. Contents of the pack and further information

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

Teicoplanin 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 will not work for viral infections such as flu or the common cold.

It is important that you follow the instructions regarding dose, administration interval, and treatment duration as indicated by your doctor.

Do not store or reuse this medicine. If you have any leftover antibiotic after finishing treatment, return it to the pharmacy for proper disposal. Do not throw medicines down the drain or in the trash.

Teicoplanin Hikma is used in adults and children (including newborns) to treat infections in:

• the skin and under the skin - sometimes called “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 can be used to treat some infections caused by the bacteria Clostridioides difficilein the intestine. In this case, the solution should be taken by mouth.

2. What you need to know before you use Teicoplanin Hikma

Do not use Teicoplanin Hikma:

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

Warnings and precautions

Talk to your doctor, pharmacist or nurse before starting Teicoplanin Hikma if:

• you are allergic to an antibiotic called “vancomycin”
• you have had a reddening of the upper 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 if your blood, kidneys, and/or liver are working properly (see “Other medicines and Teicoplanin Hikma”).

If any of the above applies to you (or if you are not sure), tell your doctor, pharmacist or nurse before using Teicoplanin 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 acute generalized exanthematous pustulosis (AGEP). If you develop a severe rash or other skin symptoms as described in section 4, stop taking Teicoplanin Hikma and contact your doctor or seek medical attention immediately.

Tests

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

• your treatment is going to last a long 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 medicines that may affect your nervous system, kidneys, and hearing.

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

Other medicines and Teicoplanin Hikma

Tell your doctor, pharmacist or nurse if you are using, have recently used or might use any other medicines. This is because Teicoplanin Hikma may affect how other medicines work. Also, some medicines may affect how Teicoplanin Hikma works.

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

• Aminoglycosides, as they should not be mixed with Teicoplanin Hikma in the same injection. They may also cause hearing and/or kidney problems.
• amphotericin B – a medicine that treats fungal infections that may cause hearing and/or kidney problems
• cyclosporin – a medicine that affects the immune system that may cause hearing and/or kidney problems
• cisplatin – a medicine that treats malignant tumors that may cause hearing and/or kidney problems
• water pills (such as furosemide) also called “diuretics” that may cause hearing and/or kidney problems.

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

Pregnancy, breast-feeding and fertility

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before using this medicine. They will decide whether you should be given this medicine while pregnant. There may be a potential risk of problems in the inner ear and kidneys.

Tell your doctor if you are breast-feeding before they give you this medicine. They will decide whether you can continue breast-feeding while being given Teicoplanin Hikma.

Animal reproduction studies have not shown any evidence of fertility problems.

Driving and using machines

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

Teicoplanin Hikma contains sodium

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

3. How to use Teicoplanin Hikma

The recommended dose is:

Adults and children (12 years or older) without kidney problems

Infections of the skin and soft tissues, lung, and urinary tract

• Initial dose (for the first three doses): 400 mg (this is equivalent to 6 mg per kilogram of body weight), given every 12 hours, by injection into a vein or muscle
• Maintenance dose: 400 mg (this is equivalent to 6 mg per kilogram of body weight), given once a day, by injection into a vein or muscle

Infections of the bones and joints, and heart

• Initial dose (for the first three to five doses): 800 mg (this is equivalent to 12 mg per kilogram of body weight), given every 12 hours, by injection into a vein or muscle
• Maintenance dose: 800 mg (this is equivalent to 12 mg per kilogram of body weight), given once a day, by injection into a vein or muscle

Infection caused by the bacteria Clostridioides difficile

The recommended dose is 100 to 200 mg by mouth, twice a day for 7 to 14 days.

Adults and elderly patients with kidney problems

If you have kidney problems, it will normally be necessary to reduce your dose after the fourth day of treatment:

• For people with mild to moderate kidney problems - the maintenance dose will be given every two days, or half of the maintenance dose will be given once a day.
• For people with severe kidney problems and on hemodialysis - the maintenance dose will be given every three days, or one-third of the maintenance dose will be given 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 injection into a vein, 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 at night.

Babies (from birth to 2 months of age)

• Initial dose (on day one): 16 mg per kilogram of body weight, as an infusion into a vein through a drip.
• Maintenance dose: 8 mg per kilogram of body weight, given once a day, as an infusion into a vein through a drip.

Children (from 2 months to 12 years of age)

• Initial dose (for the first three doses): 10 mg per kilogram of body weight, given every 12 hours, by injection into a vein.
• Maintenance dose: 6 to 10 mg per kilogram of body weight, given once a day, by injection into a vein.

How Teicoplanin Hikma is given

This medicine will normally be given to you by a doctor or nurse.

• It will be given by injection into a vein (intravenously) or into a muscle (intramuscularly).
• It can also be given by infusion into a vein through a drip.

In babies from birth to two months, it will only be given by infusion.

For the treatment of certain infections, the solution may be given by mouth (orally).

If you are given too much Teicoplanin Hikma

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 are concerned, talk 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, telephone 91 5620420, indicating the medicine and the amount taken.

If you miss a dose of Teicoplanin Hikma

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

If you stop treatment with Teicoplanin Hikma

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

Stop treatment immediately and contact a 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 people)

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

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

• reddening of the upper body

Frequency not known(cannot be estimated from the available data)

• appearance of blisters on the skin, mouth, eyes, or genitals – these could be signs of a condition called “toxic epidermal necrolysis” or “Stevens-Johnson syndrome”
• red, scaly rash all over your body with bumps under the skin (including skin folds, chest, abdomen, back, and arms) and blisters, accompanied by fever - these may be symptoms of something called "acute generalized exanthematous pustulosis (AGEP)".
• "drug reaction with eosinophilia and systemic symptoms (DRESS)". DRESS appears initially as flu-like symptoms and a rash on the face, then a prolonged rash with a high temperature, increased liver enzymes seen in blood tests, and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes.

Tell your doctor or nurse immediately if you experience any of the above side effects.

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

Uncommon(may affect up to 1 in 100 people)

• inflammation and 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 the available data)

• lack of white blood cells in the blood – the signs may include: fever, severe chills, sore throat or mouth ulcers (agranulocytosis)
• 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
• low levels of all types of blood cells

Tell your doctor or nurse immediately if you experience any of the above side effects.

Other side effects

Talk to your doctor, pharmacist or nurse if you get any of the following side effects:

Common(may affect up to 1 in 10 people)

• skin rash, redness, itching
• pain
• fever

Uncommon(may affect up to 1 in 100 people)

• decrease in platelet count
• increase in blood levels of liver enzymes
• increase in blood levels of creatinine (to check your kidney)

• hearing loss, ringing in the ears or the feeling that you or your surroundings are spinning
• 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 the available data)

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

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist or nurse, even if you think they might be unrelated to this medicine. You can also report side effects directly to the Spanish Medicines Agency's Pharmacovigilance System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Teicoplanin Hikma

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

Do not use this medicine after the expiry date which is stated on the carton and vial label after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Information about the storage and use of Teicoplanin Hikma once it has been reconstituted and is ready to use is detailed in “Practical information for healthcare professionals on the preparation and handling of Teicoplanin Hikma”.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Content and Additional Information

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 Container Content

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

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

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

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]

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 further 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 Member States of the European Economic Area under the following names:

AustriaTeicoplanin 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

SpainTeicoplanina Hikma 200 mg powder for injectable solution and perfusion EFG

Teicoplanina Hikma 400 mg powder for injectable solution and perfusion EFG

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

Teicoplanine Hikma 400 mg powder for injectable solution/perfusion 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

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

Teicoplanina Hikma 400mg powder for injectable solution/infusion 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

PortugalTeicoplanina 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 KingdomTeicoplanin 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 last revision of this leaflet: November 2022

This information is intended only for healthcare professionals: