Xydalba 500 mg powder for concentrate for solution for infusion

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Xydalba is and what it is used for
2. What you need to know before you are given Xydalba
3. How you will be given Xydalba
4. Possible side effects
5. How to store Xydalba
6. Contents of the pack and other information

Talk to your doctor, pharmacist or nurse before being given Xydalba:

• If you have or have had kidney problems. Depending on your age and the condition of your kidney, your doctor may have to reduce your dose.
• If you are suffering from diarrhoea, or you have previously suffered from diarrhoea when being treated with antibiotics.
• If you are allergic to other antibiotics such as vancomycin or teicoplanin.

Diarrhoea during or after treatment

If you develop diarrhoea during or after your treatment, tell your doctor at once. Do not take any medicine to treat your diarrhoea without first checking with your doctor.

Infusion-related reactions

Intravenous infusions with these types of antibiotics can cause flushing of the upper body, hives, itching and/or rashes. If you experience these types of reactions your doctor may decide to stop or slow the infusion.

Other infections

Using antibiotics may sometimes allow a new and different infection to develop. If this happens tell your doctor and they will decide what to do.

Do not give this medicine to children under 3 months. The use of Xydalba in children under 3 months has not been studied enough.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Xydalba is not recommended during pregnancy unless clearly necessary. This is because it is not known what effect it might have on an unborn baby. Before you are given this medicine, tell your doctor if you are pregnant, think you may be pregnant or are planning to have a baby. You and your doctor will decide if you will be given Xydalba.

It is not known if Xydalba passes into breast milk in humans. Ask your doctor for advice before breast-feeding your baby. You and your doctor will decide if you will be given Xydalba. You should not breastfeed when given Xydalba.

Xydalba may cause dizziness. Take care with driving and using machines after you have been given this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

If you suffer from chronic kidney problems, your doctor may decide to reduce your dose. There is not enough information to recommend the use of Xydalba for children with chronic kidney problems.

Tell your doctor or nurse immediately if you are concerned that you may have been given too much Xydalba.

Tell your doctor or nurse immediately if you are concerned that you are missing the 2^nd dose.

Tell your doctor straight away if you get any of these symptoms - you may need urgent medical attention:

• Sudden swelling of your lips, face, throat or tongue; severe rash; itchiness; throat tightening; drop in blood pressure; difficulty in swallowing and /or difficulty in breathing. These may all be signs of a hypersensitivity reaction and may be life-threatening. This severe reaction has been reported as a rare side effect. It may affect up to 1 in 1,000 people.
• Abdominal pain (stomach ache) and/or watery diarrhoea. The symptoms may become severe or may not go away and the stools may contain blood or mucus. These may be signs of an infection of the bowel. In this situation, you should not take medicines that stop or slow bowel movement. Infection of the bowel has been reported as an uncommon side effect. It may affect up to 1 in 100 people.
• Changes in hearing. This has been reported as a side effect with a similar medicine. The frequency is not known. The frequency cannot be estimated from the available data.

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:

• Headache
• Feeling sick (nausea)
• Diarrhoea

Uncommon - may affect up to 1 in 100 people:

• Vaginal infections, fungal infections, oral thrush
• Urinary tract infections
• Anaemia (low levels of red blood cells), high blood platelet counts (thrombocytosis), increased blood counts of a type of white blood cell called eosinophils (eosinophilia), low levels of other types of white blood cell (leucopenia, neutropenia)
• Changes in other blood tests
• Decreased appetite
• Difficulty sleeping
• Dizziness
• Change in sense of taste
• Inflammation and swelling of surface veins, flushing
• Cough
• Abdominal pain and discomfort, indigestion, constipation
• Abnormal liver function test
• An increase in alkaline phosphatase (an enzyme found in the body)
• Itching, hives
• Genital itching (females)
• Pain, redness or swelling at the place where the infusion was given
• Feeling hot
• Increase in blood levels of gamma-glutamyl transferase (an enzyme produced by the liver and other body tissues)
• Rash
• Being sick (vomiting)

Rare - may affect up to 1 in 1,000 people:

• Difficulty breathing (bronchospasm)

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via:

United Kingdom

or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is dalbavancin. Each vial of powder contains dalbavancin hydrochloride equivalent to 500 mg of dalbavancin.
• The other ingredients are mannitol (E421), lactose monohydrate, hydrochloric acid and/or sodium hydroxide (for pH adjustment only).

Xydalba powder for concentrate for solution for infusion is provided in a 48 ml glass vial with a green flip off seal. The vial contains white to off-white to pale yellow powder.

It is available in packs containing 1 vial.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: