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ACEA 0.75% W/W GEL - Patient leaflet, side effects, dosage

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Sources: Original (products.mhra.gov.uk)

Patient leaflet - ACEA 0.75% W/W GEL

5. how to store acea gel

Keep out of the reach and sight of children.

Do not store above 25oC.

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.

  • 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 parahydroxybenzoate (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:

Manufacturer:

Laleham Health and Beauty Ltd, Sycamore Park, Mill Lane, Alton, Hampshire, GU34 2PR, UK.

This leaflet was last approved in June 2018

Leaflet Ref: LF LF000166/JUN2018


Acea 0.75% w/w Gel

Metronidazole

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.

Information in this leaflet:

  • 1. What Acea Gel is & what it is used for

  • 2. Before you use Acea Gel

  • 3. How to use Acea Gel

  • 4. Possible side effects

  • 5. How to store Acea Gel

  • 6. Further information

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.

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 before you see any noticeable improvement in your condition.

Not recommend 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 1 cm (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.

Sources: Original (products.mhra.gov.uk)

Frequently Asked Questions

What is ACEA 0.75% W/W Gel used for?

ACEA 0.75% W/W Gel is typically used to treat skin conditions such as acne, rosacea, and certain types of dermatitis by helping to reduce inflammation and promote healing.

How do I apply ACEA 0.75% W/W Gel?

To apply ACEA 0.75% W/W Gel, gently clean the affected area and apply a thin layer of the gel. Massage it into the skin until fully absorbed.

Is ACEA 0.75% W/W Gel safe for all skin types?

ACEA 0.75% W/W Gel is generally safe for various skin types, but it's important to consult your healthcare provider if you have sensitive skin or specific allergies.

Can I use ACEA 0.75% W/W Gel on my face?

Yes, ACEA 0.75% W/W Gel can be used on the face, particularly for conditions like acne or rosacea, but avoid contact with eyes and mouth.

How often should I use ACEA 0.75% W/W Gel?

Typically, ACEA 0.75% W/W Gel is applied once or twice daily, but follow your healthcare provider's instructions for the best results.

What should I do if I miss a dose of ACEA 0.75% W/W Gel?

If you miss a dose of ACEA 0.75% W/W Gel, apply it as soon as you remember unless it’s close to the time of your next dose; then skip the missed dose and continue with your schedule.

Can I use ACEA 0.75% W/W Gel with other skincare products?

Yes, but it’s advised to wait at least 30 minutes after applying ACEA 0.75% W/W Gel before using other products to avoid irritation.

Are there any side effects associated with ACEA 0.75% W/W Gel?

Some users may experience mild side effects such as redness, burning sensation, or dryness at the application site; if these persist or worsen, consult your doctor.

How long does it take to see results from ACEA 0.75% W/W Gel?

Results can vary by individual; however, many users start noticing improvements within a few weeks of consistent use.

Is there anyone who should avoid using ACEA 0.75% W/W Gel?

Individuals with hypersensitivity to any ingredient in ACEA 0.75% W/W Gel or those with certain skin conditions should avoid its use; consult a healthcare professional if unsure.

Can pregnant or breastfeeding women use ACEA 0.75% W/W Gel?

Pregnant or breastfeeding women should consult their healthcare provider before using ACEA 0.75% W/W Gel to ensure it's safe for them.

Can I use makeup over ACEA 0.75% W/W Gel?

Yes, applying makeup over dry areas after using ACEA 0.75% W/W Gel is usually fine; just allow the gel to fully absorb first.

What happens if I accidentally swallow ACEA 0.75% W/W Gel?

If ingested accidentally, seek medical attention or contact poison control immediately for advice on the next steps you should take.

Does ACEA 0.75% W/W Gel expire, and how should I store it?

Yes, like many medications, ACEA 0.75% W/W Gel has an expiration date; store it in a cool, dry place away from direct sunlight to ensure its effectiveness.

Can children use ACEA 0.75% W/W Gel?

ACEA 0.75% W/W Gel is not typically recommended for children under specific age thresholds without consulting a healthcare professional first.

What should I do if my condition does not improve after using ACEA 0.75% W/W Gel?

If your condition does not show signs of improvement after several weeks of treatment with ACEA 0.75% W/W Gel, consult your healthcare provider for further evaluation and alternative options.

Does ACEA 0.75% W/W Gel cause photosensitivity?

While not common, some individuals may experience increased sensitivity to sunlight; wearing sunscreen is recommended when using this gel during the day.

Is it safe to share my tube of ACEA 0.75% W/W Gel with someone else?

No, sharing personal medication like ACEA 0.75% W/W Gel is not advisable due to individual variations in skin sensitivities and potential contaminants.

Will using ACEA 0.75% W/W Gel lead to skin thinning over time?

ACEA 0.75% W/W Gel generally does not cause skin thinning but always follow guidance from your healthcare provider regarding proper usage duration.