Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or your pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or your pharmacist.

In this leaflet:

• 1. What INVANZ is and what it is used for
• 2. Before you take INVANZ
• 3. How to take INVANZ
• 4. Possible side effects
• 5. How to store INVANZ
• 6. Further information

Do not take INVANZ

• if you are allergic to the active substance (ertapenem) or any of the other ingredients of INVANZ
• if you are allergic to antibiotics such as penicillines, cephalosporins or carbapenems.

Take special care with INVANZ

Tell your doctor about any medical condition you have or have had including:

• Kidney disease (see Patients with kidney disease)
• Allergies to any medicines, including antibiotics
• Colitis or any other gastro-intestinal disease.
• Central nervous system disorders, such as localised tremors, or seizures.

Patients with kidney disease

It is particularly important that your doctor knows if you have kidney disease and whether you undergo dialysis treatment.

Children and adolescents (3 months to 17 years of age)

INVANZ can be given to children 3 months of age and older. Experience with INVANZ is limited in children less than two years of age. In this age group your doctor will decide on the potential benefit of its use. There is no experience in children under 3 months of age.

Elderly

INVANZ works well and is well tolerated by most older and younger adult patients. The recommended dosage of INVANZ can be administered without regard to age.

Taking other medicines

Always tell your doctor about all medicines that you are taking or plan to take, including those obtained without a prescription.

Pregnancy and breast-feeding

It is important that you tell your doctor if you are pregnant or are planning to become pregnant before receiving INVANZ.

INVANZ has not been studied in pregnant women. INVANZ should not be used during pregnancy unless your doctor decides the potential benefit justifies the potential risk to the foetus.

It is important that you tell your doctor if you are breast-feeding or if you intend to breast-feed before receiving INVANZ.

Women who are receiving INVANZ should not breast-feed, because it has been found in human milk and the breast-fed baby may therefore be affected.

Driving and using machines

Do not drive or use any tools or machines until you know how you react to the medicine.

Certain side effects, such as dizziness and sleepiness, have been reported with INVANZ, which may affect some patients' ability to drive or operate machinery.

Important information about some of the ingredients of INVANZ :

This medicinal product contains approximately 6.0 mEq (approximately 137 mg) of sodium per 1.0 g dose which should be taken into consideration by patients on a controlled sodium diet.

If you take more INVANZ than you should

If you are concerned that you may have been given too much INVANZ, contact your doctor or another healthcare professional immediately.

If you forget to take INVANZ

If you are concerned that you may have missed a dose, contact your doctor or another healthcare professional immediately.

Adults 18 years of age and older:

The most common (more than 1 in 100 patients and less than 1 in 10 patients) side effects are:

• Headache
• Diarrhoea, nausea, vomiting
• Rash, itching
• Problems with the vein into which the medicine is given (including inflammation, formation of a lump, swelling at the injection site, or leaking of fluid into the tissue and skin around the injection site).

Less common (more than 1 in 1,000 patients and less than 1 in 100 patients) side effects are:

• Dizziness, sleepiness, sleeplessness, confusion, seizure
• Low blood pressure, slow heart rate
• Shortness of breath, sore throat
• Constipation, yeast infection of the mouth, antibiotic-associated diarrhoea, acid regurgitation, dry mouth, indigestion, loss of appetite
• Skin redness
• Vaginal discharge and irritation
• Abdominal pain, fatigue, fungal infection, fever, oedema/swelling, chest pain, abnormal taste

Side effects reported rarely (more than 1 in 10,000 patients and less than 1 in 1,000 patients) are:

• Decrease in white blood cells, decrease in blood platelet count
• Low blood sugar
• Agitation, anxiety, depression, tremor
• Irregular heart rate, increased blood pressure, bleeding, fast heart rate
• Nasal congestion, cough, bleeding from the nose, pneumonia, abnormal breathing sounds, wheezing
• Inflammation of the gall bladder, difficulty in swallowing, faecal incontinence, jaundice, liver disorder
• Inflammation of the skin, fungal infection of the skin, skin peeling, infection of the wound after an operation
• Muscle cramp, shoulder pain
• Urinary tract infection, kidney impairment
• Miscarriage, genital bleeding
• Allergy, feeling unwell, pelvic peritonitis, changes to the white part of the eye, fainting.

There have also been reports of changes in some laboratory blood tests.

Children and adolescents (3 months to 17 years of age):

The most common (more than 1 in 100 patients and less than 1 in 10 patients) side effects are:

 

• Diarrhoea
• Diaper rash
• Pain at the infusion site

Less common (more than 1 in 1,000 patients and less than 1 in 100 patients) side effects are:

• Headache
• Hot flush, high blood pressure, red or purple, flat, pinhead spots under the skin
• Discoloured faeces, black tar-like faeces
• Skin redness, skin rash
• Burning, itching, redness and warmth at infusion site, redness at injection site
• Increase in platelet count,

What INVANZ contains

The active ingredient of INVANZ is ertapenem 1g.

The other ingredients are: sodium bicarbonate (E500) and sodium hydroxide (E524).

What INVANZ looks like and contents of the pack

INVANZ is a sterile, white to off-white, freeze-dried powder.

Solutions of INVANZ range from colourless to pale yellow. Variations of colour within this range do not affect potency.

What INVANZ looks like and contents of the pack

INVANZ 1 g powder for concentrate for solution for infusion is supplied in packs of 1 vial or 10 vials.

Not all pack sizes may be marketed.