Zyomet 0.75% W/W Gel
MercuryPharma
PATIENT INFORMATION LEAFLET
Metronidazole 0.75% w/w Gel
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 any further questions, 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 becomes serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
The name of your medicine is Metronidazole 0.75% w/w Gel. It will be referred to as Metronidazole Gel for ease hereafter.
In this leaflet:
1. What is Metronidazole Gel and what is it used for
2. Before you use Metronidazole Gel
3. How to use Metronidazole Gel
4. Possible side effects
5. How to store Metronidazole Gel
6. Further information
1. What is Metronidazole Gel and what is it used for
This Gel contains metronidazole. Metronidazole belongs to a group of medicines called antiprotozoal and antibacterial agents and has been shown to help control infection and inflammation in certain skin problems, such as rosacea.
Rosacea is a skin condition which causes redness and spots on the face.
2. Before you use Metronidazole Gel
DO NOT use Metronidazole Gel if:
• you know you are allergic to Metronidazole or any of the other ingredients of this Gel (listed in Section 6 of this leaflet).
Metronidazole Gel is not suitable for children.
Take special care with Metronidazole Gel:
• Keep Metronidazole Gel away from your eyes. If you accidentally get some in your eye, wash it carefully and thoroughly with water.
• If you suffer from any blood disorders do not use Metronidazole Gel unless your doctor says you can.
• This product should not be used in children.
• Do not go out into strong sunlight or use UV lamps while you are using this product.
• Avoid drinking alcohol while using this product.
• Avoid prolonged and unnecessary use of this medicine.
Using Metronidazole Gel with other medicines:
Using Metronidazole Gel could interfere with drugs used to thin the blood (anticoagulants) such as warfarin and coumarin. Contact your doctor for advice if you are taking medicines to thin your blood, or if you suffer from any other blood disorder.
Please tell your doctor or pharmacist if you are taking or having recently taken any other medicines, including medicines obtained without a prescription.
Using Metronidazole Gel with food and drink:
Metronidazole taken by mouth can react with alcohol. This reaction is unlikely with Metronidazole Gel because it is only applied on the skin. However, you are advised not to drink alcohol while you are using Metronidazole Gel.
Pregnancy and breast feeding:
If you are or think that you may be pregnant, or are planning to become pregnant, or are breast feeding, please tell your doctor before using Metronidazole Gel. Normally, its use is not recommended in pregnancy or breast feeding.
Ask your doctor or pharmacist for advice before taking or using any medicine.
Important information about some of the ingredients of Metronidazole Gel
Metronidazole Gel contains propylene glycol which may cause skin irritation. This will cause the original rash to get worse instead of better. If this happens, please contact your doctor.
3. How to use Metronidazole Gel
Always use Metronidazole Gel exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Metronidazole Gel is for EXTERNAL uSe only.
• Metronidazole Gel should be applied twice a day, in the morning and evening, usually three to four months. Your doctor may recommend a longer treatment depending on the severity of your condition.
• Wash your hands before and after using the gel.
• First, wash and dry the affected area of the skin.
• Using you fingertips, apply a thin layer of gel to the affected area of the skin. If it does not rub into your skin easily, you are using too much.
• If you accidentally get some gel in your eye, wash it carefully and thoroughly with warm water.
Your doctor or pharmacist will tell you how long to use Metronidazole
Gel for to keep your condition under control.
If you accidentally swallow Metronidazole Gel:
You should contact your doctor or pharmacist immediately for advice.
If you forget to use Metronidazole Gel:
Apply it when you remember then carry on as normal.
If you stop using Metronidazole Gel:
Ensure that you use Metronidazole Gel for the full length of time
recommended by your doctor.
4. Possible side effects
Like all medicines, Metronidazole Gel can cause side effects, although not everybody gets them.
Common side effects (occur in less than 1 in 10 patients):
• dry skin
• redness of the skin (erythema)
• itching of the skin (pruritus)
• skin discomfort (burning, pain of skin / stinging)
• skin irritation
• worsening of rosacea
Uncommon side effects (occur in less than 1 in 100 patients):
• numbness (hypothesia) and tingling (paraesthesia) in the fingers or toes
• metallic taste (dysgeusia)
• feeling sick (nausea)
Unknown frequency of occurrence (cannot be estimated from the available data):
• contact dermatitis
• watering of the eyes(if used too closely to the eyes )
If skin irritation should occur either use the gel a little less often or even stop using it until the irritation settles down.
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.
5. How to store Metronidazole Gel
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after “Exp”. The expiry date refers to the last day of that month. Do not store above 25°C. Do not refrigerate.
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.
Remember:
This medicine is for you. Only a doctor can prescribe it for you.
Never give this medicine to someone else, it could harm them, even if their symptoms seem the same as yours.
6. Further information
What Metronidazole Gel Contains:
The active substance is 0.75% w/w metronidazole.
The other ingredients are propylene glycol, disodiumedetate, hydroxyethyl cellulose, benzyl alcohol and purified water.
What Metronidazole Gel looks like and contents of the pack: Metronidazole Gel is supplied in tubes each containing 5g, 15g, 30g, 50g or 60g of gel. Not all pack sizes are marketed.
Marketing Authorisation Holder:
Mercury Pharmaceuticals Ltd., Capital House, 85 King William Street,
London EC4N 7BL, UK
Manufacturer:
Dales Pharmaceuticals Ltd., Snaygill Industrial Estate, Keighley Road, Skipton, North Yorkshire, BD23 2RW, UK This leaflet was last revised in April 2014.
102046/LF/2
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MercuryPharma |
Date of Approval: N/A To be implemented by: N/A |
PROOF 1 02/04/2014 | |
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Product Description: |
Originated by Date: |
Tech Approved |
Date: |
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Metronidazole Gel 30g |
ST 31/10/2013 |
Yes |
13/11/2013 |
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Component: |
Revised by |
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Leaflet |
ADD |
102046/LF/2 | |
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Manufacturer: |
File Name: |
CRF No.: | |
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Dales |
102046LF Metro Gel 30g v2_1 |
AMCo.CRF.133.2013 | |
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Market: |
Software Package: |
Barcode: | |
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UK |
Quark Xpress 9 |
N/A | |
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Minimum Font Size & Typeface: |
Dimensions: |
Pharma Code: | |
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8pt Swiss 721BT |
100 x 250 mm |
NA | |
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Colours: H Black |
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