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METRONIDAZOLE 200 MG/ 5 ML ORAL SUSPENSION

Active substance(s): METRONIDAZOLE BENZOATE / METRONIDAZOLE BENZOATE

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Package leaflet: Information for the user

Metronidazole 200 mg/5 ml Oral Suspension
(metronidazole benzoate)
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 further questions, please ask your doctor or 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 pharmacist.
In this leaflet:
1. What Metronidazole is and what it is used for
2. Before you take Metronidazole
3. How to take Metronidazole
4. Possible side effects
5. How to store Metronidazole
6. Further information

1. What Metronidazole is and what it is used for
The name of this medicine is Metronidazole 200 mg/5 ml Oral Suspension (called Metronidazole in this leaflet).
Metronidazole contains a medicine called metronidazole benzoate.
This belongs to a group of medicines called antibiotics.
It works by killing bacteria and parasites that cause infections in your body.
It can be used to:
• Treat infections of the blood, brain, lung, bones, genital tract, pelvic area, stomach and intestines
• Treat gum ulcers and other dental infections
• Treat infected leg ulcers and pressure sores
• Prevent infections after surgery
If you need any further information on your illness, speak to your doctor.

2. Before you take Metronidazole
Do not take Metronidazole and tell your doctor if:


You are allergic (hypersensitive) to metronidazole, nitroimidazoles (e.g. tinidazole) or any of the other
ingredients in your medicine (listed in Section 6: Further information).
Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.

Do not take Metronidazole if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Metronidazole.
Take special care with Metronidazole and check with your doctor or pharmacist before using your medicine if:

You have or have ever had a liver problem.

You are having kidney dialysis (see section 3: ‘People having kidney dialysis’)

You have a disease of the nervous system
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking your
medicine. Do this even if they have applied in the past.
Cases of severe liver toxicity/acute liver failure, including cases with a fatal outcome, in patients with Cockayne syndrome have been reported with Flagyl.
If you are affected by Cockayne syndrome, your doctor should also monitor your liver function frequently while you are being treated with Flagyl and afterwards.
Tell your doctor immediately and stop taking Flagyl if you develop:

Stomach pain, anorexia, nausea, vomiting, fever, malaise, fatigue, jaundice, dark urine, putty or mastic coloured stools or itching.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription,
including herbal medicines. This is because Metronidazole can affect the way some other medicines work. Also, some other medicines can affect the way
Metronidazole works.
In particular tell your doctor if you are taking any of the following medicines:

Medicines used to thin the blood such as warfarin

Lithium for mental illness

Phenobarbital or phenytoin for epilepsy

5 fluorouracil for cancer

Busulfan for leukaemia (cancer of the blood cells)

Ciclosporin – to prevent the rejection of organs after transplant

Disulfiram for alcoholism
If you are not sure, talk to your doctor or pharmacist before taking Metronidazole.
Taking Metronidazole with food and drink
Do not drink any alcohol while you are taking Metronidazole and for 48 hours after finishing your course. Drinking alcohol while using Metronidazole might cause
unpleasant side effects, such as feeling sick (nausea), being sick (vomiting), stomach pain, hot flushes, very fast or uneven heartbeat (palpitations) and
headache.
Pregnancy and breast-feeding
Tell your doctor before using Metronidazole if:

You are pregnant, might become pregnant or think you may be pregnant. Metronidazole should not be taken during pregnancy unless considered absolutely
necessary.

You are breast-feeding. It is better not to use Metronidazole if you are breast-feeding. This is because small amounts may pass into the mother’s milk.
Driving and using machines
While taking Metronidazole you may feel sleepy, dizzy, confused, see or hear things that are not there (hallucinations), have fits (convulsions) or temporary
eyesight problems (such as blurred or double vision).
If this happens, do not drive or use any machinery or tools
Tests
Your doctor may wish to carry out some tests if you have been using this medicine for more than 10 days.
Important information about some of the ingredients of your medicine

Sucrose: This is a type of sugar. If you have been told by you doctor that you cannot tolerate some sugars, talk to your doctor before taking this medicine.

Methyl hydroxybenzoate (E218) and propyl hydroxybenzoate (E216): These are preservatives that are added to Metronidazole to make the medicine
last longer. These can cause an allergic reaction in some people.

Alcohol: Metrondiazole contains 0.8% alcohol (ethanol) by volume; this is equivalent to 32mg alcohol per 5ml dose. At high doses this could be harmful for
those suffering from alcoholism, liver disease or epilepsy.

3. How to take Metronidazole
Taking your medicine
Always take Metronidazole exactly as your doctor has told you. It is important to finish a full course of treatment. The length of a course will depend on your
needs and the illness being treated.
Check with your doctor or pharmacist if you are not sure.

Take Metronidazole Suspension by mouth

The dose of Metronidazole will depend on your needs and the illness being treated

The length of your treatment will depend on the type of illness you have and how bad it is

Your doctor or pharmacist may dilute your Metronidazole Suspension. In this case the pharmacist’s label on the
packaging will tell you how exactly much to take and how often.
The usual dose for adults and children is given below:
To treat certain bacterial infection
Adults and children over 10 years

Take 10ml (400mg) of Metronidazole Suspension once every 8 hours

Children and infants

Your doctor will work out how much your child should take depending on their weight

Repeat the dose every 8 hours

If your child is a baby under 8 weeks of age, your doctor will give them one daily dose or two separate doses 12 hourly
To prevent infections from happening after surgery
Children

Give your child Metronidazole suspension 2-3 hours before their operation

Your doctor will work out how much your child should take depending on their weight
Other types of infections
For treatment of other infections caused by parasites and some bacteria your doctor will decide how much Metronidazole you need to take. This will depend on
your illness and how bad it is. The pharmacist’s label on the packaging will tell you exactly how much Metronidazole Suspension to take and how often.
People having kidney dialysis
Kidney dialysis removes Metronidazole from your blood. If you are having kidney dialysis you must take this medicine after your dialysis treatment.
People with liver problems
Your doctor may tell you to use a lower dose or to use the medicine less often.
If you take more Metronidazole than you should
If you take more Metronidazole than you should, tell your doctor or go to your nearest hospital casualty department straight away. Take the carton and bottle with
you. This is so the doctor knows what you have taken.
If you forget to take Metronidazole
If you forget to take Metronidazole take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose. Do not use a double
dose to make up for a forgotten dose.

4. Possible side effects
Like all medicines, Metronidazole can cause side effects, although not everybody gets them.
Stop taking Metronidazole and see a doctor or go to a hospital straight away if:








You get swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing or breathing. You could also notice an itchy, lumpy
rash (hives) or nettle rash (urticaria)
This may mean you are having an allergic reaction to Metronidazole.
A serious but very rare side effect is a brain disease (encephalopathy). Symptoms vary but you might get a fever, stiff neck, headache, see or hear things
that aren’t there. You might also have problems using your arms and legs, problems with speaking or feel confused.
You develop skin rashes with blistering, peeling or bleeding of the skin around the lips, eyes, mouth, nose and genitals. You may also have flu-like symptoms
and a high temperature. These could be signs of something called ‘Stevens Johnson Syndrome or toxic epidermal necrolysis’.
Talk to your doctor straight away if you notice the following side effects.
Yellowing of the skin and eyes. This could be due to a liver problem (jaundice).
Unexpected infections, mouth ulcers, bruising, bleeding gums, or severe tiredness. This could be caused by a blood problem.
Severe stomach pain which may reach through to your back (pancreatitis)

Tell your doctor or pharmacist if you notice any of the following side effects:
Very rare (affects less than 1 in 10 000 people)

Fits (convulsions)

Mental problems such as feeling confused and seeing or hearing things that are not there (hallucinations)

Problems with your eyesight such as blurred or double vision

Skin rash or flushing

Headache

Darkening of the urine

Feeling sleepy or dizzy

Pains in the muscles or joints

Liver problems including life-threatening liver failure (hepatocellular liver injury)
Not known (frequency cannot be estimated from the available data)

Numbness, tingling, pain, or a feeling of weakness, in the arms or legs

Unpleasant taste in the mouth

Furred tongue

Feeling sick (nausea), being sick (vomiting), upset stomach, stomach pain or diarrhoea

Loss of appetite

Fever

Feeling depressed

Pain in your eyes (optic neuritis)

A group of symptoms together including: fever, nausea, vomiting, headache, stiff neck and extreme
sensitivity to bright light. This may be caused by an inflammation of the membranes that cover the brain
and spinal cord (meningitis)

Hearing impairment/hearing loss

Ringing in the ears (tinnitus)

You get a rash or skin discolouration with or without raised areas which often reoccurs at the same location each time the drug is taken
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. You can also report side
effects directly via the Yellow Card Scheme: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store Metronidizole









Keep out of the sight and reach of children.
Do not store above 25°C.
Store in the original package in order to protect from light.
After opening discard any unused suspension after 28 days.
Metronidazole 200 mg/5 ml Oral Suspension may be diluted, if necessary, with Syrup BP. Discard any unused diluted suspension after 14 days.
Do not use this medicine after the expiry date which is stated on the bottle label and carton after ‘EXP’. The expiry date refers to the last day of that month.
If your medicine becomes discoloured or shows any other signs of deterioration, consult your pharmacist who will advise you what to do.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment.

6. Further information
What Metronidazole contains
The active subtance is metronidazole benzoate. Each 5 ml of suspension contains 200 mg metronidazole (as benzoate).
The other ingredients are sucrose, sodium dihydrogen phosphate dihydrate (E339), aluminium magnesium silicate, methyl parahydroxybenzoate (E218), propyl
parahydroxybenzoate (E216), ethanol (96% v/v), 0.8%, lemon flavour (contains propylene glycol), orange oil terpeneless and purified water.
What Metronidazole looks like and the contents of the pack
White to cream suspension with a slight yellow tinge and an odour of orange and lemon.
It is available in bottles of 100ml.
Manufactured by Unither Liquid Manufacturing, 1-3 Allee de la Neste, Z.I. en Sigal, 31770 Colomiers, France.
Procured from within the EU and Repackaged by PL Holder PilsCo Ltd, 10-16 Colvilles Place, East Kilbride, G75 0SN.

Blind or partially sighted?
Is this leaflet hard to see or read?
Call 0800 198 5000 to obtain the leaflet in a format suitable for you.
PL 39467/0234 Metronidazole 200 mg/5 ml Oral Suspension

POM

This leaflet was last revised on 01.02.2017.

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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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