Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Metronidazole may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
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.
Acea Gel 6. 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 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.
Acea 0.75% w/w Gel comes as gel. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Acea 0.75% w/w Gel is metronidazole.
Medicines with the same active substance, strength and form include: Metrogel 0.75% w/w Gel, Rozex 0.75% w/w Gel. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Acea 0.75% w/w Gel, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
The treatment of acute inflammatory exacerbations of rosacea.
For cutaneous use only.
(i) For adults and the elderly. Apply the gel to the affected area of the skin in a thin film twice daily for 8 weeks. Thereafter further applications may be necessary depending on the severity of the condition.
(ii) For Children. Not recommended.
Known hypersensitivity to metronidazole, parabens or any of the constituents.
Warnings: Avoid contact with the eyes. If contact with the eyes occurs the gel should be washed out carefully with water.
Precautions: The following statements take into account the possibility that metronidazole may be absorbed after topical application. However there is no evidence of any significant systemic concentrations of metronidazole following topical applications. Peripheral neuropathy has been reported in association with prolonged use of oral metronidazole. The elimination half-life of metronidazole remains unchanged in the presence of renal failure. Such patients, however, retain the metabolite of metronidazole. The clinical significance of this is not known at present. However in patients undergoing haemodialysis, metronidazole and its metabolites are efficiently removed.
Contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) and ethyl parahydroxybenzoate (E214), may cause allergic reactions (possibly delayed).
Patients are advised not to take alcohol during systemic metronidazole therapy because of the possibility of a disulfiram-like reaction.
Some potentiation of anti-coagulant therapy has been reported when metronidazole has been used with the warfarin type oral anticoagulants.
Patients receiving phenobarbitone metabolise metronidazole at a much faster rate than normal, reducing the half-life to 3 hours.
The safety of topically applied metronidazole in pregnancy and lactation has not been adequately established and should not be used in these circumstances unless the physician considers it essential.
No adverse effects on the ability to drive or use machines has been reported following the topical application of metronidazole.
Dryness or irritation of the skin may be experienced after application to unbroken skin. Systemic metronidazole therapy may occasionally cause an unpleasant taste in the mouth, furred tongue, nausea, vomiting, gastro-intestinal disturbance, urticaria, angioedema and anyphylaxis. Drowsiness, dizziness, headache, ataxia, skin rash, pruritis and darkening of urine has been reported, but rarely.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme: Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Overdose is unlikely. If necessary remove the medication by washing with warm water. If accidental ingestion occurs, an appropriate method of gastric emptying may be used if considered appropriate.
Ask anything about Acea 0.75% w/w Gel. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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