Tegecen^®  is an antibiotic of the glycylcycline group that works by stopping the growth of bacteria that cause infections.

Your doctor has prescribed Tegecen^®  because you or your child at least 18 years old has one of the following types of serious infections:

• Complicated infection of the skin and soft tissues (the tissue below the skin), excluding diabetic foot infections.

• Complicated infection in the abdomen

Tegecen^®  is only used when your doctor thinks other antibiotics are not suitable.

Tegecen^®  should be used only to treat infections that are proven or strongly suspected to be caused by susceptibly bacteria.

Do not use Tegecen^® : 

• 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.

Warnings and precautions

Talk to your doctor or nurse before receiving Tegecen^® :

• If you have poor or slow wound healing.

• If you are suffering from diarrhoea before

you are given Tegecen^® . 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 are pregnant and in your second or third trimester.

• If you suffer from a bleeding disorder or are in treatment with anticoagulant drugs, as this medicine can interfere with blood coagulation.

During treatment with Tigecycline:

• 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 using Tegecen^®  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 Tegecen^®  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.

Children and Adolescents

Tegecen^®  is not to be used in children less than 18 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.

Other medicines and Tigecycline

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

Tegecen^® 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. If this were the case, your doctor will monitor you closely.

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

Pregnancy and breast-feeding

Tegecen^®  may cause foetal harm. If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, talk to your doctor for advice before receiving Tegecen^® , As Tegecen^®  may cause permanent discoloration of baby teeth and reversible inhibition of bone growth when taken during the second and third trimesters of pregnancy.

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

Driving and using machines

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

Tegecen^® contains sodium 

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

Tigecycline will be given to you by a doctor or a nurse.

The recommended dose is 100 mg given initially, followed by 50 mg every 12 hours. This dose is given intravenously (directly into your blood stream) over a period of 30 to 60 minutes.

The recommended dose in children aged 8 to 11 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 17 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.

Tigecycline should be preferably administered over a 60-minute length of infusion in pediatric patients.

Dosage in Elderly

No dosage adjustment is necessary in elderly patients.

Dosage in Renal impairment

No dosage adjustment is necessary in patients with renal impairment or in patients undergoing hemodialysis.

If you receive more Tegecen^®  than you should

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

If you miss a dose of Tegecen^® 

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

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

Pseudomembranous colitis may occur with most antibiotics including Tegecen^® 

• This consists of severe, persistent or bloody diarrhoea associated with abdominal pain or fever, which can be a sign of serious bowel inflammation, which may occur during or after your treatment.

Very common side effects are (may affect more than 1 in 10 people):

• Nausea, vomiting, diarrhoea.

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

• Abscess (collection of pus), infections

• Laboratory measurements of decreased ability to form blood clots

• Dizziness

• Vein irritations from the injection, including pain, inflammation, swelling and clotting

• Abdominal pain, dyspepsia (stomach ache and indigestion), anorexia (loss of appetite)

• Increases in liver enzymes, hyperbilirubinaemia (excess of bile pigment in the blood)

• Pruritus (itching), rash

• Poor or slow wound healing

• Headache

• Increase in amylase, which is an enzyme found in the salivary glands and pancreas, increased blood urea nitrogen (BUN).

• Pneumonia

• Low blood sugar

• Sepsis (severe infection in the body and blood stream)/septic shock (serious medical condition which can lead to multiple organ failure and death as a result of sepsis)

• Injection site reaction (pain, redness, inflammation)

• Low protein levels in the blood

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

• Acute pancreatitis (inflamed pancreas which may result in severe abdominal pain, nausea, and vomiting)

• Jaundice (yellow coloration of the skin), inflammation of the liver

• Low platelet levels in the blood (which may lead to an increased bleeding tendency and bruising/haematoma) 

Not known side effects are (frequency cannot be estimated from the available data):

• Anaphylaxis/anaphylactoid reactions

• (that may range from mild to severe, including a sudden, generalised allergic reaction that may lead to a life-threatening shock [e.g. difficulty in breathing, drop of blood pressure, fast pulse]).

• Liver failure

• Skin rash, which may lead to severe blistering and peeling of the skin (Stevens-Johnson Syndrome)

• Low fibrinogen levels in the blood (aprotein involved in blood clotting)

Reporting of side effects 

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine. 

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

Store below 30°C.
Once reconstituted, Tegecen^® . must be used immediately.

Do not use this medicine after the expiry date which is stated on the vial. The expiry date refers to the last day of that month. 

The Tegecen^®  solution should be yellow to orange 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.