• 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 Tigecycline is and what it is used for
2. What you need to know before you receive Tigecycline
3. How Tigecycline is given
4. Possible side effects
5. How to store Tigecycline
6. Contents of the pack and other information

• If you are allergic to tigecycline, or any of the other ingredients of this medicine (listed in section 6). If you are allergic to tetracycline class antibiotics (e.g., minocycline, doxycycline, etc.), you may be allergic to tigecycline.

Talk to your doctor or nurse before receiving Tigecycline :

• If you have poor or slow wound healing.
• If you are suffering from diarrhoea before you are given Tigecycline. If you develop diarrhoea during or after your treatment, tell your doctor at once. Do not take any diarrhoea medicine without first checking with your doctor.
• If you have or previously had any side effects due to antibiotics belonging to the tetracycline class (e.g., skin sensitization to sun light, staining on developing teeth, pancreas inflammation, and alteration of certain laboratory values aimed at measuring how well your blood clots).
• If you have, or previously had liver problems. Depending on the condition of your liver, your doctor may reduce the dose to avoid potential side effects.
• If you have blockage of the bile ducts (cholestasis).
• If you suffer from a bleeding disorder or are in treatment with anticoagulant drugs, as this medicine can interfere with blood coagulation.

• Tell your doctor immediately if you develop symptoms of an allergic reaction.
• Tell your doctor immediately if you develop severe abdominal pain, nausea, and vomiting. These may be symptoms of acute pancreatitis (inflamed pancreas which may result in severe abdominal pain, nausea, and vomiting).
• In certain serious infections, your doctor may consider to use Tigecycline in combination with other antibiotics.
• Your doctor will monitor you closely for the development of any other bacterial infections. If you develop another bacterial infection, your doctor may prescribe a different antibiotic specific for the type of infection present.
• Although antibiotics, including Tigecycline, fight certain bacteria, other bacteria and fungi may continue to grow. This is called overgrowth. Your doctor will monitor you closely for any potential infections and treat you if necessary.

Tigecycline is not to be used in children less than 8 years of age due to the lack of data on safety and efficacy in this age group and because it may induce permanent dental defects such as staining on the developing teeth.

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

Tigecycline may prolong certain tests that measure how well your blood is clotting. It is important that you tell your doctor if you are taking medicines to avoid an excess of blood clotting (named anticoagulants). If this were the case, your doctor will monitor you closely.

Tigecycline may interfere with the contraceptive pill (birth control pill). Talk to your doctor about the need for an additional method of contraception while receiving Tigecycline.

Tigecycline may increase the effect of medicines used to suppress the immune system (such as tacrolimus or cyclosporine). It is important that you tell your doctor if you are taking these medicines so you can be closely monitored.

Tigecycline may cause foetal harm. 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 Tigecycline.

It is not known if Tigecycline passes into breast milk in humans. Ask your doctor for advice before breast-feeding your baby.

Tigecycline may cause side effects such as dizziness. This may impair your ability to drive or operate machinery.

Tigecycline contains less than 1 mmol sodium (23 mg) per 5 ml of solution, that is to say essentially ‘sodium-free’.

The recommended dose in children aged 8 to < 12 years is 1.2 mg/kg given every 12 hours intravenously to a maximum dose of 50 mg every 12 hours.

The recommended dose in adolescents aged 12 to < 18 years is 50 mg given every 12 hours.

A course of treatment usually lasts for 5 to 14 days. Your doctor will decide how long you should be treated.

If you are concerned that you may have been given too much Tigecycline, talk to your doctor or nurse immediately.

If you are concerned that you may have missed a dose, talk to your doctor or nurse immediately.

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

Once the powder has been made into a solution and diluted ready for use, it should be given to you immediately.

The Tigecycline solution should be orange to orange-red in colour after dissolving; if it is not, the solution should be discarded.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

The active substance is tigecycline. Each vial contains 50 mg of tigecycline. After reconstitution, each 1 ml contains 10 mg of tigecycline.

The other ingredients are trehalose dihydrate, hydrochloric acid (pH adjustment), sodium hydroxide (pH adjustment).

Tigecycline is supplied as a powder for solution for infusion in 5 ml Type I clear colourless glass vials fitted with grey bromobutyl rubber stoppers and aluminium cap with orange PP flip-off cap, packaged into a box, and looks like an orange to orange red powder before it is diluted.

These vials are distributed to the hospital in packs of 10 vials. The powder should be mixed in the vial with a small amount of solution. The vial should be gently swirled until the medicine is dissolved. Thereafter, the solution should be immediately withdrawn from the vial and added to a 100 ml intravenous bag or other suitable infusion container in the hospital.

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