Metronidazole 500 mg / 100 ml Intravenous Infusion

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

1. What Metronidazole 500mg/100ml is and what it is used for
2. What you need to know before you use Metronidazole 500mg/100ml
3. How to use Metronidazole 500mg/100ml
4. Possible side effects
5. How to store Metronidazole 500mg/100ml
6. Contents of the pack and other information

The active ingredient in your medicine is metronidazole. It is an antimicrobial agent (an agent that kills micro-organisms or suppresses their multiplication and growth).

Your medicine contains metronidazole 500mg per 100ml (5 mg per ml). This is a sterile solution for intravenous infusion free from bacterial endotoxin (substances causing fever reactions).

This medicine is used when oral medication is not possible, for the prevention and treatment of infections caused by certain species of bacteria. It is used in adults and children for:

• the prevention of postoperative infections due to sensitive bacteria in surgical procedure with a high risk of occurrence of this type of infection
• the treatment of severe established abdominal and gynaecological infections where sensitive bacteria have been identified as the cause or are suspected to be the cause

Metronidazole 500mg/100ml must only be used under medical supervision.

If you need any further information on your condition, please ask your doctor.

• If you are allergic to metronidazole or any of the other ingredients of this medicine (listed in section 6)
• If you have a condition called Cockayne Syndrome, which is a rare genetic disease.

Tell your doctor immediately and stop taking metronidazole if you develop:

• Stomach pain, anorexia, nausea, vomiting, fever, malaise, fatigue, jaundice, dark urine, putty or mastic coloured stools or itching.

Talk to your doctor before using Metronidazole 500mg/100ml:

• if you are suffering from liver disease
• if you are actively suffering from disease of the nervous system. In this case you should inform your doctor, particularly if you experience poor coordination (ataxia), dizziness or confusion during the treatment.
• if you have blood cells disorders
• if you are undergoing kidney dialysis

Your doctor may want to carry out some tests if you receive this medicine for more than 10 days.

Your doctor may want to carry out some tests if you receive this medicine for more than 10 days.

Certain medicines are known to change the normal effect of this infusion. Certain medicines can have their effect changed by this infusion. These medicines should not be used at the same time as Metronidazole 500 mg/100ml Intravenous Infusion. Please tell your doctor if you are taking, have recently taken or might take any of the following medicines:

• warfarin (medicine to thin the blood) as your blood clotting time will need to be monitored more frequently
• vecuronium (medicine used to relax your muscles during surgery)
• disulfiram (to treat alcohol addiction)
• 5-Fluoro-uracile (used to treat some forms of cancer)
• Lithium (used to treat depression) as lithium treatment should be reduced or stopped before you are given Metronidazole
• medicines to treat epilepsy such as phenobarbital, phenytoin and carbamazepine
• cholestyramine (used to lower cholesterol)
• cimetidine (used to treat stomach ulcers)
• medicines used following organ transplants such as ciclosporin and tacrolimus
• medicines used to correct irregular heartbeats such as amiodarone and quinidine
• busulfan (used to treat leukemia which is a cancer of the blood cells)

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Do not drink any alcohol while receiving your medicine, and for 72 hours afterwards. This might cause unpleasant side effects, such as feeling sick and vomiting, abdominal pain, hot flushes, palpitations, and headache.

This medicine should be avoided during pregnancy or breast-feeding unless your doctor considers it essential.

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.

You should not drive or use machines while being treated with this medicine.

This medicinal product contains 310 mg sodium per dose. To be taken into consideration by patients on a controlled sodium diet.

Each bag is one dose and will be administered through a plastic tube into a vein using a drip. It will be given at a rate of approximately 5 ml/minute (equivalent to the infusion of one bag over 20 to 60 minutes). As soon as possible after the infusion has been completed, your treatment will be continued using oral medication. Your doctor will decide when you can start to take oral medication instead of the drip.

The amount you will be given depends upon

• your age,
• your weight,
• your clinical condition and
• the reason it is being prescribed for you.

• Prevention of infection after abdominal or gynaecological surgery:

The preventive treatment duration will be short and mostly limited to the post-operative period (24 hours but no more than 48 hours).

Adults will usually receive

• a single dose of 1000 to 1500 mg (2 to 3 bags) up to one hour before surgery or
• 500 mg (1 bag) immediately before, during or after the operation.

A 500 mg dose (1 bag) will then usually be repeated every 8 hours as necessary.

Children less than 12 years will receive a smaller dose which is calculated from their body weight as a single dose of 20-30mg/kg given one to two hours before surgery

Newborn infants born prematurely (gestational age less than 40 weeks) will receive one single dose of 10 mg/kg body weight prior to surgery.

• Treatment of severe established abdominal or gynaecological infection:

This medicine will be used for the treatment of established infections when you are unable to take the medicine by mouth.

Adults will usually receive a single daily dose of 1000 to 1500 mg (2 to 3 bags) or 500 mg (1 bag)every 8 hours.

Children more than 8 weeks to 12 years of age will receive a smaller dose which is calculated from their body weight as

• either a single daily dose of 20-30mg/kg
• or alternatively 3 doses of 7.5mg/kg given every 8 hours.
• The daily dose may be increased to 40 mg/kg, depending on the severity of the infection. Duration of treatment is usually 7 days.

Newborn infants (less than 8 weeks old) will receive one single daily dose of 15mg/kg of body weight or 7.5mg/kg every 12 hours.

Newborn infants born prematurely (gestational age less than 40 weeks) will have their level of metronidazole in blood controlled after a few days of therapy as accumulation of the drug substance in the blood might occur during the first week of life.

• Elderly:

Metronidazole will be administered to the Elderly with caution, especially where high doses are required. Your doctor will modify your dose as required.

• Patients with renal failure:

There is no need to adjust the dosage if you have problems with your kidneys. Your doctor will most probably not adjust the dosage of your medicine if you are undergoing peritoneal dialysis. Your doctor can however take the decision to reduce the dosage of metronidazole if excessive levels of metabolites are found in your blood.

If you are undergoing haemodialysis your doctor will re-administer your medicine just after haemodialysis.

• Patients with advanced liver deficiency:

Your doctor will reduce the dosage. Your doctor will at the same time monitor the level of metronidazole in your blood.

Duration of treatment for ongoing infections is usually 7 to 10 days.

Depending upon your clinical condition and results of bacteriological assessment, your doctor may decide to prolong the treatment. This is intended to eradicate infections from parts of your body where the anti-infective metronidazole has difficulties to access or where self-recontamination is possible.

• Symptoms:

If you have received more infusion than you should, the following symptoms could appear:

• Feeling sick (nausea)
• Vomiting
• poor coordination (ataxia) and
• slight disorientation.

No symptoms developed where too much of this medicine is given to newborn infant born prematurely.

• Treatment:

Please inform your doctor immediately if any of these symptoms occur.

In the event of accidental over-infusion, your doctor will stop the infusion. Your doctor will take the appropriate measures according to the symptoms you have developed.

The following severe side effects can occur rarely (may affect up to 1 in 1,000 people):

• severe allergic reaction (which may cause sudden faintness, severe breathlessness, abdominal pain, or swelling of the face and/or of the tongue and throat.)
• severe neurological effects: convulsion or fits, brain disease, disorder of the nerves which can causes loss of vision, brain fever not caused by bacterials (aseptic meningitis) or speech disorder
• inflammation of your pancreas which may cause pain in your belly with radiation through the back (pancreatitis)
• severe skin effects (erythema, serious illness with blistering of the skin, mouth and genitals and skin peeling)
• Unexpected infections, mouth ulcers, bruising, bleeding gums, or severe tiredness. This could be caused by a blood problem.

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

• Acute liver failure in patients with Cockayne Syndrome (see section 2 “Warnings and precautions”)

If you experience any of these severe side effects, please tell your doctor immediately. The doctor will stop the infusion.

Tell your doctor if any of the following side effects occur:

• feeling sick (nausea, malaise), vomiting, sweating, chills, chest pain, diarrhea, constipation, decreased or loss of appetite
• fever
• headache, drowsiness, dizziness, confusion or hallucinations
• depressed mood, poor sleep
• itching, inflammation, swelling, eruption/rash of your skin all of which may sometimes be severe
• unpleasant metallic taste, inflammation of mouth and/or tongue, tongue discoloration, dry mouth
• numbness, tingling, pain, or a feeling of weakness in arms or legs
• clumsiness, or poor coordination
• alteration of your blood that can modify results of your blood tests, abnormal liver test results
• yellowing of the skin and eyes (jaundice)
• darkening of your urine, painful urination
• fast or irregular heartbeat
• pain in in muscles and/or joints
• double vision or near sightedness

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

It is an isotonic solution.

The active substance is Metronidazole. Each 100 ml consists of: Metronidazole 500 mg

The other inactive ingredients (excipients) are Disodium phosphate dodecahydrate, Citric acid monohydrate, Sodium chloride and Water for injections.

It is a clear solution for infusion intended for intravenous administration.

The solution is in 100ml polyolefin/polyamide transparent plastic containers protected by a transparent plastic overwrap.

The pack size is: 20 x 100 ml, 50 x 100 ml and 60 x 100 ml.

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