PATIENT INFORMATION LEAFLET

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METROTOP

0.8% W/V GEL METRONIDAZOLE

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

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask a 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 becomes serious, or if you notice any side effects not listed in this leaflet, please tell a doctor or pharmacist.

In this leaflet:

1.    What Metrotop is and what it is used for

2.    Before you use Metrotop

3.    How to use Metrotop

4.    Possible side effects

5.    How to store Metrotop

6.    Further information

1. WHAT METROTOP IS AND WHAT IT IS USED FOR

Metrotop is a clear water-based gel containing the active ingredient metronidazole. Metronidazole is an anti-microbial agent that kills bacteria present in wounds (especially bacteria found in wounds with poor oxygen supply).

Metrotop is used when tumours have produced open wounds on the skin surface and the bacteria in these wounds are causing an unpleasant smell. The anti-microbial agent in Metrotop kills the bacteria and so helps to reduce or remove the smell. Studies have shown that applying Metrotop usually controls the odour in one to two weeks.

Metrotop can also be used to treat bad odours in leg ulcers and pressure sores.

2. BEFORE YOU USE METROTOP Do not use Metrotop:

If you are allergic (hypersensitive) to metronidazole or any of the other ingredients of Metrotop listed in section 6 of this leaflet.

Do not use Metrotop if the above applies to you. If you are not sure, talk to your doctor or pharmacist.

Taking other medicines

Please tell a doctor or healthcare professional if:

•    You are taking a blood-thinning medication such as coumarin or warfarin

•    You are taking Phenobarbital (a barbiturate used to treat seizures and fits)

•    You are taking, or have recently taken, any other medicines, including medicines obtained without a prescription.

If you are not sure if the above applies to you, talk to your doctor or pharmacist before using Metrotop.

Using Metrotop with food and drink

Avoid using alcohol while using Metrotop

Pregnancy and breast-feeding

Ask a doctor or pharmacist for advice before using Metrotop

Important information about some of the ingredients of Metrotop

Benzalkonium chloride is an irritant and may cause skin reactions.

3. HOW TO USE M ETROTOP

Always use Metrotop exactly as your doctor has told you. You should check with a doctor or pharmacist if you are not sure.

Metrotop is for use on the skin only. Do not use Metrotop inside your body.

IF YOU ACCIDENTALLY SWALLOW ANY METROTOP, GO TO YOUR NEAREST ACCIDENT AND EMERGENCY DEPARTMENT OR CONTACT YOUR DOCTOR IMMEDIATELY. TAKE THIS LEAFLET AND ANY PACKAGING WITH YOU SO THEY KNOW WHAT YOU HAVE TAKEN.

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3. HOW TO USE METROTOP (continued)

For topical administration/application

The usual method of use is:

•    Clean the wounds thoroughly before application

Flat wounds: apply the gel generously over the entire wound area Sunken wounds: loosely pack with paraffin gauze smeared with the gel

•    Cover the wound with a non-adherent dressing and a pad of lint or gauze

•    Apply the gel once or twice daily as necessary, or as directed by your doctor.

If you forget to use Metrotop

Apply the gel when you remember and continue as normal.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

No side effects have been reported when using Metrotop on the skin.

However, the following side effects have been reported when the active ingredient,

metronidazole, is taken by mouth:
•	Allergic reactions such as red raised	•	headache
	patches on the skin - these may	•	furred tongue
	involve the lips, eyes or tongue	•	itching skin
•	Skin rash	•	dizziness
•	Nausea or vomiting	•	shaky movements or
•	Gastrointestinal disturbances		unsteadiness
•	drowsiness	•	unpleasant taste in the mouth
		•	darkening of the urine
You should talk to your doctor if any of these symptoms			occur, or if notice any side effects

not listed in this leaflet.

5. HOW TO STORE METROTOP

Keep out of the reach and sight of children.

Do not store above 25°C.

Do not use Metrotop after the expiry date which is stated on the carton and on the crimp area of the tube. The expiry date relates to the last day of that month.

Once opened, the contents of the tube should be used within 28 days.

Metrotop should not be disposed of via wastewater of household waste. Ask a pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION What Metrotop contains

•    The active substance is metronidazole

•    The other ingredients are hypromelose 4500, benzalkonium chloride solution and purified water.

What Metrotop looks like; and contents of the pack

Metrotop is a clear, water-based gel packed in a plastic tube and a cardboard outer carton. Metrotop is available in 60g, 30g and 15g pack sizes.

MARKETING AUTHORISATION HOLDER AND MANUFACTURER

Marketing Authorisation Holder:

Ayrton Saunders Ltd 9 Arkwright Road Astmoor Industrial Estate Runcorn

Cheshire WA7 1NU UK

This leaflet was last approved in November 2012

Ayrton Saunders Ltd, 9 Arkwright Road, Astmoor Industrial Estate, Runcorn, Cheshire WA7 1NU

Metrotop is a trademark