Ertapenem 1g 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, nurse or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

• if you are allergic to the active substance (ertapenem) or any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to antibiotics such as penicillins, cephalosporins or carbapenems (which are used to treat various infections).

Talk to your doctor, nurse or pharmacist before taking ERTAPENEM.

During treatment, if you experience an allergic reaction (such as swelling of the face, tongue or throat, difficulty in breathing or swallowing, skin rash), tell your doctor straight away as you may need urgent medical treatment.

While antibiotics including ERTAPENEM kill certain bacteria, other bacteria and fungi may continue to grow more than normal. This is called overgrowth. Your doctor will monitor you for overgrowth and treat you if necessary.

It is important that you tell your doctor if you have diarrhoea before, during or after your treatment with ERTAPENEM. This is because you may have a condition known as colitis (an inflammation of the bowel). Do not take any medicine to treat diarrhoea without first checking with your doctor.

Tell your doctor if you are taking medicines called valproic acid or sodium valproate (see Other medicines and ERTAPENEM below).

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

• Kidney disease. It is particularly important that your doctor knows if you have kidney disease and whether you undergo dialysis treatment.
• Allergies to any medicines, including antibiotics.
• Central nervous system disorders, such as localized tremors, or seizures.

Experience with ERTAPENEM 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.

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

Tell your doctor, nurse or pharmacist if you are taking medicines called valproic acid or sodium valproate (used to treat epilepsy, bipolar disorder, migraines, or schizophrenia). This is because ERTAPENEM can affect the way some other medicines work. Your doctor will decide whether you should use ERTAPENEM in combination with these other medicines.

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 taking this medicine.

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

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

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 ERTAPENEM, which may affect some patients' ability to drive or operate machinery.

This medicine contains approximately 137 mg sodium (main component of cooking/ table salt) in each 1.0 g dose. This is equivalent to 6.85% of the recommended maximum daily dietary intake of sodium for an adult.

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

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

Since the drug has been marketed, severe allergic reactions (anaphylaxis), hypersensitivity syndromes (allergic reactions including rash, fever, abnormal blood tests) have been reported. The first signs of a severe allergic reaction may include swelling of the face and/or throat. If these symptoms occur tell your doctor straight away as you may need urgent medical treatment.

Common (may affect up to 1 in 10 people) 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)
• Increase in platelet count
• Changes in liver function tests

Uncommon (may affect up to 1 in 100 people) 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
• Changes in some laboratory blood and urine tests

Rare (may affect up to 1 in 1,000 people) side effects 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.
• The skin may become hard at the site of injection
• Swelling of the skins blood vessels

Side effects reported with frequency not known (frequency cannot be estimated from the available data) are:

• hallucinations
• decreased consciousness
• altered mental status (including aggression, delirium, disorientation, mental status changes)
• abnormal movements
• muscle weakness
• unsteady walking
• teeth staining

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

If you experience raised or fluid-filled skin spots over a large area of your body, tell your doctor or nurse straight away.

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

• Diarrhoea
• Diaper rash
• Pain at the infusion site
• Changes in white blood cell count
• Changes in liver function tests

Uncommon (may affect up to 1 in 100 people) 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
• Changes in some laboratory blood tests

Side effects reported with frequency not known (frequency cannot be estimated from the available data) are:

• Hallucinations
• Altered mental status (including aggression)

If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

The active ingredient of ERTAPENEM is ertapenem 1g

The other ingredients are: sodium hydrogen carbonate and sodium hydroxide for pH adjustment.

ERTAPENEM is a white to off-white, freeze-dried powder for concentrate for solution for infusion. Solutions of ERTAPENEM range from colourless to pale yellow. Variations of colour within this range do not affect potency.

ERTAPENEM is supplied in packs of 1 vial or 10 vials. Not all pack sizes may be marketed.