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

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

Xerava is an antibiotic medicine that contains the active substance eravacycline. It belongs to a group of antibiotics called ‘tetracyclines’ which work by stopping the growth of certain infectious bacteria.

Xerava is used to treat adults with a complicated infection in the abdomen.

• if you are allergic to eravacycline or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to any tetracycline antibiotics (e.g., minocycline and doxycycline) because you may also be allergic to eravacycline.

Talk to your doctor or nurse before you receive Xerava if you are concerned about any of the following:

Anaphylactic reactions

Anaphylactic (allergic) reactions have been reported with other tetracycline antibiotics. These can develop suddenly and can potentially be life-threatening. Seek urgent medical attention if you suspect you have an anaphylactic reaction whilst receiving Xerava. Symptoms to look out for include rash, swelling of the face, feeling lightheaded or faint, tightness of the chest, breathing difficulties, fast heartbeat, or losing consciousness (see also section 4).

Diarrhoea

Talk to your doctor or nurse if you are suffering from diarrhoea before being given Xerava. If you develop diarrhoea during or after your treatment, tell your doctor straight away. Do not take any medicine to treat your diarrhoea without first checking with your doctor (see also section 4).

Infusion site reactions

Xerava is given by an infusion (drip) directly into your vein. Tell your doctor or nurse if you notice any of the following at the site of infusion during or after your treatment: redness of the skin, rash, inflammation, or pain or tenderness.

New infection

Although Xerava fights certain bacteria, other bacteria and fungi may continue to grow. This is called ‘overgrowth’ or ‘superinfection’. Your doctor will monitor you closely for any new infections or stop treatment with Xerava and give you another treatment if necessary.

Pancreatitis

Severe pain in the abdomen and back with fever may be signs of inflammation of the pancreas. Tell your doctor or nurse if you notice any of these side effects during your treatment with Xerava.

Liver problems

Talk to your doctor if you have liver problems or if you are overweight, particularly if you are also taking itraconazole (a medicine to treat fungal infections), ritonavir (a medicine used to treat viral infections) or clarithromycin (an antibiotic) as your doctor will monitor you for side effects.

This medicine should not be used in children and adolescents under the age of 18 years as it has not been studied enough in these populations. Xerava must not be used in children below 8 years of age because it can cause permanent effects on their teeth such as discolouration.

Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines including rifampicin and clarithromycin (antibiotics), phenobarbital, carbamazepine and phenytoin (used to treat epilepsy), St. John’s Wort (a herbal remedy used for treatment of depression and anxiety) itraconazole (a medicine to treat fungal infections), ritonavir, atazanavir, lopinavir and saquinavir (medicines used to treat viral infections), and cyclosporine (a medicine used to suppress the immune system).

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before receiving this medicine. Xerava is not recommended for use during pregnancy as it can:

• permanently stain your unborn child’s teeth
• delay the natural formation of the bones of your unborn child.

It is not known if Xerava passes into breast milk. Long-term use of other similar antibiotic medicines by breast-feeding mothers can stain the child’s teeth permanently. Ask your doctor for advice before breast-feeding your baby.

Xerava may affect your ability to drive or use machines safely. Do not drive or use machines if you feel dizzy, light-headed or unsteady after receiving this medicine.

Xerava will be given to you in hospital by a doctor or nurse. It is, therefore, unlikely that you will be given too much. Tell your doctor or nurse immediately if you are concerned that you may have been given too much Xerava.

Xerava will be given to you in hospital by a doctor or nurse. It is, therefore, unlikely that you will miss a dose. Tell your doctor or nurse immediately if you are concerned that you may have missed a dose.

Common (may affect up to 1 in 10 people):

• Nausea
• Vomiting
• Inflammation and pain caused by blood clots at the injection site (thrombophlebitis)
• Inflammation of a vein causing pain and swelling (phlebitis)
• Redness or swelling at the site of the injection

Uncommon (may affect up to 1 in 100 people):

• Diarrhoea
• Allergic reaction
• Inflammation of the pancreas which causes severe pain in the abdomen or back (pancreatitis)
• Rash
• Dizziness
• Headache
• Increased sweating
• Abnormal blood test results for liver

Tell your doctor or nurse if you have any of these side effects.

Other tetracycline antibiotics

Other side effects have been reported with other tetracycline antibiotics including minocycline and doxycycline. These include sensitivity to light, headaches, vision problems, or abnormal blood tests.

Tell your doctor or nurse if you notice any of these during your treatment with Xerava.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, website: http://www.mhra.gov.uk/yellowcard 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 eravacycline. Each vial contains 100 mg of eravacycline.
• The other ingredients are mannitol (E421), hydrochloric acid (for pH adjustment) and sodium hydroxide (for pH adjustment).

Xerava is a pale yellow to dark yellow cake in a 10 mL glass vial. The powder for concentrate for solution for infusion (powder for concentrate) will be reconstituted in the vial with 5 mL of water for injections or with 5 mL sodium chloride 9 mg/mL (0.9%) solution for injection. The reconstituted solution will be withdrawn from the vial and added to an infusion bag of sodium chloride 9 mg/mL (0.9%) solution for injection in the hospital.

Xerava is available in packs containing 1 vial, 10 vials or multipacks comprising 12 cartons, each containing 1 vial.

Not all pack sizes may be marketed.

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