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ACEA 0.75% W/W GEL

Active substance(s): METRONIDAZOLE

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Product title:

Acea Gel PIL

Product Size/weight:

40g

Date:

13/03/15

Reason for change/
required changes:

Add ADR reporting requirements

Product Codes:

3036620P/MARCH2015

FERNDALE PHARMACEUTICALS LTD APPROVAL
APPROVED BY:

Signature:

PRODUCTION:
MARKETING:
TECHNICAL:

ARTWORK SPECIFICATION:
Pack dimensions:

125mm x 160mm

Fonts:

Avenir LT std (rom&hea), Century Schoolbook, Arial (Bold & Regular)

Colours:

Pantone 488c Pantone 180c

Text sizes:

Min 6 point - Max 50 point

Artwork contact:

Black

...continued

Acea 0.75% w/w Gel
Metronidazole

5. HOW TO STORE ACEA GEL

6. FURTHER INFORMATION
What Acea Gel contains:
The active ingredient is 0.75% w/w metronidazole.
The other ingredients are: glycerol, hydroxyethylcellulose,
disodium edetate, methyl parahydroxybenzoate (E218), propyl
parahydroxybenzoate (E216), ethyl parahydroxy- benzoate
(E214), sodium hydroxide, potassium dihydrogen phosphate and
purified water.
What Acea Gel looks like and the contents of the pack:
Acea Gel is a clear, pale yellow gel contained in a metal tube
with a plastic screw cap, containing either 5g, 25g or 40g.
Marketing Authorisation Holder and Manufacturer:
PL20685/0020
Marketing Authorisation Holder: Ferndale Pharmaceuticals Ltd,
Unit 740 Thorp Arch Estate, Wetherby, West Yorkshire LS23 7FX, UK.
Tel: (01937) 541122 e-mail: info@ferndalepharma.co.uk
Manufacturer:
Ecolab Ltd., Lotherton Way, Garforth, Leeds, LS25 2JY, UK.
This leaflet was last approved in March 2015.
Leaflet Ref: 3036620P/MARCH2015 HW130315

Acea Gel belongs to a group of medicines called ‘Antiprotozoal
and Antibacterial Agents’, which are used to control infection and
inflammation in skin problems.

2. BEFORE YOU USE ACEA GEL
Do not use Acea Gel, and talk to your doctor, if:
You are allergic (hypersensitive) to metronidazole, parahydroxybenzoates or any of the other listed ingredients (see Section 6).
Using with other medicines:
Some medicines can interfere with your treatment, so please tell
your doctor if you are taking or have recently taken any other
medicines, including any obtained without a prescription.
You must talk to your doctor before using Acea Gel if:
• You are undergoing haemodialysis.
• You take warfarin type oral anti-coagulants (used to
prevent blood clots).
• You are taking phenobarbitone (a sedative).
Using Acea Gel with alcohol:
You are advised not to drink alcohol during treatment with
this medicine, because of the possibility of an unpleasant
reaction, such as a headache, nausea, blurred vision,
weakness, confusion or breathing difficulties.
Pregnancy and breast-feeding:
The safety of applying metronidazole to the skin during
pregnancy and breast-feeding has not been adequately
established, so you must talk to your doctor before use.
Important information about some of the ingredients:
The parahydroxybenzoates present in the gel may cause allergic
reactions (possibly delayed).

3. HOW TO USE ACEA GEL
Always use Acea Gel exactly as instructed below. You should
check with your doctor if you are not sure.
Dosage:
Adults and the elderly - Apply the gel twice daily, once in the
morning and again in the evening, for 8 weeks. It is important to
complete the course of treatment as it may take a few weeks

Simon 0113 2440064

acea gel

Reporting of side effects.
If you get any side effects, talk to your doctor 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
at www.mhra.gov.uk/yellowcard. By reporting side effects you
can help provide more information on the safety of this medicine.

Keep out of the reach and sight of children.
Do not store above 25ºC. Do not refrigerate or freeze.
Do not use Acea Gel after the expiry date which is stated on the
tube and the carton. The expiry date refers to the last day of that
month. Use within 8 weeks of opening.
Ask your pharmacist how to dispose of your medicine.

DGTG:

Read all of this leaflet carefully because it contains
important information for you.
• 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 your doctor.
• 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 side effect becomes more serious, or if you
notice any side effect not listed in this leaflet, please
tell your doctor.

1.
2.
3.
4.
5.
6.

Information in this leaflet:
What Acea Gel is & what it is used for
Before you use Acea Gel
How to use Acea Gel
Possible side effects
How to store Acea Gel
Further information

1. WHAT ACEA GEL IS & WHAT IT IS USED FOR
Your medicine is called Acea 0.75% w/w Gel (referred to in
this leaflet as Acea Gel). It is a water based gel containing
0.75% w/w of the active ingredient metronidazole.
Acea Gel is used for the treatment of rosacea, a skin condition
usually affecting the facial cheeks and forehead in which the skin
appears redder than normal.

before you see any noticeable improvement in your condition.
Not recommended for use on children.
Application:
1. Wash the face and forehead with a mild soap and dry.
2. Remove the tube from the carton and unscrew the cap.
3. Use the spike in the top of the cap to pierce the thin metal
seal covering the tube nozzle.
4. Gently squeeze 1cm (1/2 inch) of the gel onto clean fingers.
5. Apply the gel to the affected area of the skin, and rub gently
to form a thin film.
6. Wash your hands and replace the cap.
This medicine is for external use only and if it is accidentally
swallowed you should seek medical assistance.
If you forget to use Acea Gel, continue your treatment as before
at the next planned morning or evening application.
If you accidentally apply too much Acea Gel, remove the excess
with a tissue or soft cloth.
Avoid contact with the eyes. If accidental contact occurs,
immediately wash out the gel carefully with water.

4. POSSIBLE SIDE EFFECTS
Like all medicines, as well as benefits, Acea Gel can cause side
effects, although not everybody will experience them.
If any side effect becomes more serious, or if you notice any side
effect not listed below, please tell your doctor. If necessary,
remove the gel by washing the affected area with warm water.
• Use on unbroken skin may cause dryness and irritation.
• On rare occasions drowsiness, dizziness, headache,
unsteadiness, skin rash, itching and darkening of the urine
have been reported.
• If taken orally, metronidazole may lead to an unpleasant
taste in the mouth, furred tongue, nausea, vomiting, stomach
upset, hives (red, itchy raised areas of skin), swelling of the
eyelids, face, lips, tongue and airways (causing difficulty in
breathing) or a serious allergic reaction.
continued...

Date:

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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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