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METRONIDAZOLE MACO PHARMA 0.5% W/V SOLUTION FOR INFUSION

Active substance(s): METRONIDAZOLE

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NTS033I 150X210 05/03/13 09:12 Page1

PACKAGE LEAFLET: INFORMATION FOR THE USER
METRONIDAZOLE MACOPHARMA
0.5%w/v SOLUTION FOR INFUSION
(metronidazole)

GB

Read all of this leaflet carefully before being given this medicine because it contains important
information for you.
- 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.
What is in this leaflet
1. What Metronidazole MacoPharma 0.5%w/v Solution for Infusion is and what it is used for
2. What you need to know before you are given Metronidazole MacoPharma 0.5%w/v Solution for Infusion
3. How Metronidazole MacoPharma 0.5%w/v Solution for Infusion is given
4. Possible side effects
5. How to store Metronidazole MacoPharma 0.5%w/v Solution for Infusion
6. Contents of the pack and other information
1. WHAT METRONIDAZOLE MACOPHARMA 0.5%w/v
SOLUTION FOR INFUSION IS AND WHAT IT IS USED FOR
Metronidazole is an antibiotic used in adults and children to
treat severe infection caused by certain anaerobic bacteria, ie
bacteria which do not live or grow in the presence of oxygen.
It may also be used to prevent infection in patients who cannot
be treated by mouth.
The solution is mainly used in abdominal and gynaecological
surgery and will be given to you by slow injection into a vein by
a doctor or nurse.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN
METRONIDAZOLE MACOPHARMA 0.5%w/v SOLUTION
FOR INFUSION
You must NOT be given this solution if you have ever had:
• an allergy (hypersensitivity) to metronidazole or any of the
other ingredients in the solution (see Section 6)
• acute pancreatitis, or pancreatitis as a serious side effect to
metronidazole.
Warnings and precautions
Talk to your doctor or nurse if you:
• have liver disease (the amount of medicine you are given may
be reduced or given less often)
• have any disease or condition affecting the brain or nervous
system
• are receiving the solution intensively, or for more than 10
days – you will be closely monitored
• are pregnant, think you may be pregnant, or are
breastfeeding

• vecuronium (used in anaesthesia)
• cimetidine (to treat stomach ulcers)
• disulfiram and metronidazole together may cause psychotic effects.
Some laboratory tests may also be affected during treatment
with metronidazole.
The solution may also be given at the same time (but
separately) as other appropriate antimicrobial medicines in
injection form.
Metronidazole MacoPharma 0.5%w/v Solution for Infusion
with food, drink and alcohol
You must NOT drink alcohol during treatment or for 48 hours
after treatment with metronidazole.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, or think you may be
pregnant, ask your doctor for advice before being given this
medicine.
Driving and using machines
If you feel dizzy or drowsy after receiving this medicine then
you must not drive or operate machinery.
Metronidazole MacoPharma 0.5%w/v Solution for Infusion
contains sodium.
This product contains 15 mmol or 340 mg sodium per bag
which needs to be taken into consideration by patients on a
sodium-controlled diet.
3. HOW METRONIDAZOLE MACOPHARMA 0.5%w/v
SOLUTION FOR INFUSION IS GIVEN

Treatment will be stopped if signs of nervous system problems
develop.

This solution will be given to you by slow injection into a vein
(usually in your arm) by a doctor or nurse. It should take 10 20 minutes to receive the contents of a 100ml bag.

Other medicines and Metronidazole MacoPharma 0.5%w/v
Solution for Infusion
Tell your doctor if you are taking or have recently taken any
other medicines.

Adults and children over 12 years: one 100ml bag is usually
given every 8 hours. This dose may differ if you are having
surgery.

In particular, the following medicines may affect, or be affected
by, metronidazole:
• anti-coagulants (blood thinning agents), such as warfarin or
coumarins. The dose of warfarin may need to be reduced if you
are taking this drug.
• lithium (used to treat depression). If taken at the same time
as metronidazole, your kidneys may be affected. Lithium
treatment should be withdrawn or gradually reduced before
receiving metronidazole. Additional blood tests will be done
during treatment.
• phenobarbitone or phenytoin (to treat epilepsy)
• 5-fluorouracil (to treat tumours)

Children over 8 weeks up to 12 years: The usual daily dose is 46ml/kg/day as a single dose or 1.5ml/kg every 8 hours. In severe
infections the dose may be increased to 8ml/kg/day.
Babies under 8 weeks: 3ml/kg as a single dose daily or 1.5ml/kg
every 12 hours.
Children doses given before surgery:
Children over 40 weeks up to 12 years: 4-6ml/kg as a single dose
Babies under 40 weeks: A single dose of 2ml/kg is given before
surgery.
Elderly: your doctor will decide the amount you will receive.

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NTS033I 150X210 05/03/13 09:12 Page2

Treatment usually lasts for 7 days, but may be longer
depending on your condition and response to treatment. Your
doctor will decide how long treatment is needed for.
As soon as possible, your doctor will change your treatment
from an injection to tablets (taken by mouth).
If you are receiving treatment for more than 10 days, your
doctor will do blood tests and monitor you regularly.
If you are given more Metronidazole MacoPharma 0.5%w/v
Solution for Infusion than you should
It is unlikely you will be given too much solution as your
doctor or nurse will monitor the amount you receive. If you
are concerned about the volume of solution given, or are
worried about any effects you notice, talk to the doctor or
nurse. If the side effects are severe the treatment may have to
be stopped.
If you have any further questions on the use of this medicine,
ask your doctor or nurse.
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Important side effects or symptoms to look out for. If you
think you may have any of the following side effects or
symptoms, tell the doctor or nurse immediately.

s

• If you have an allergic reaction to the medicine, tell the
doctor or nurse immediately as treatment must be stopped.
Symptoms of an allergic reaction are rash, itching, difficulty in
breathing or swelling of the face, lips, throat or tongue. This is
rare (affecting fewer than 1 in 1000 patients) and unlikely to
happen.
The following are very rare side affects (affecting fewer than
1 in 10,000 patients):
• confusion, fever, headache, hallucinations, paralysis, light
sensitivity, disturbances in sight and movement, or a stiff neck.
• severe pain in the abdomen and back.
• yellowing of the skin or whites of the eyes caused by liver or
blood problems.
Other possible side effects
You may feel some irritation and discomfort at the site of
injection. This will disappear.
Very rare side effects (affecting fewer than 1 in 10,000
patients). Some of these symptoms disappear on reducing or
stopping treatment
• tingling, numbness in fingers and toes, or epilepsy seen in
patients having high dose treatment for a long time
• skin rash redness or sores, itchy skin
• visual problems
• severe bleeding or bruising (due to blood disorders)
• severe infections (due to low blood cell count)
• fits (convulsions)
• drowsiness, dizziness
• darkening of the urine
• muscle or joint pain.
• weakness and lack of coordination of movement.

e

Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Store in the original outer container
in order to protect from light.
Do not freeze. Do not use this medicine after the expiry date
which is stated on the label after EXP. The expiry date refers
to the last day of that month.
The solution should only be used if it is clear without visible
particles and the container is not damaged. It should be used
immediately on removal from the overwrap. For single use
only. Any unused solution in the bag must be discarded.
Do not throw away any medicines via wastewater or
household waste. The doctor or nurse will dispose of this
medicine. These measures will help to protect the
environment.
6. CONTENTS OF THE PACK AND OTHER
INFORMATION

4. POSSIBLE SIDE EFFECTS
s.

5. HOW TO STORE METRONIDAZOLE MACOPHARMA
0.5%w/v SOLUTION FOR INFUSION

Side effects where the frequency is not known:
• nausea, upset stomach, diarrhoea, anorexia, unpleasant taste
in the mouth, furred tongue, sore mouth
• change in mood, depression, sleeplessness.

g

Results of some liver function laboratory tests may be
abnormal.
Side effects are the same in adults and children.

se

If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects not listed in this leaflet.

What Metronidazole MacoPharma 0.5%w/v Solution for
Infusion contains
The active substance is metronidazole (500mg of
metronidazole per 100ml)
The other ingredients are sodium chloride, anhydrous
disodium phosphate, citric acid monohydrate and water for
injections.
What Metronidazole MacoPharma 0.5%w/v Solution for
Infusion looks like and contents of the pack
Metronidazole MacoPharma 0.5%w/v Solution for Infusion is
a clear yellow solution without visible particles.
The solution for infusion is packaged in a plastic bag or
flexible container with an integral infusion set for direct
connection to a catheter. It is available in a pack size of 100ml.
Marketing Authorisation Holder
Maco Pharma (UK) Ltd - 8th Floor - Regal House
70 London Road - Twickenham
Middlesex TW1 3QS - United Kingdom
Manufacturer
Maco Productions SAS
Rue Lorthiois - 59420 Mouvaux - France
Distributor in Ireland
Technopharm Limited - Pharmapark - Chapelizod
Dublin 20
This leaflet was last revised in MM/YYYY.
PL 12580/0010

PA 931/3/1

For information on CD,
please contact
the Royal National
Institute of Blind People.
Central phone
number:
(+44) 0800 198 5000.

NTS033I-03/2012

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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