Acnecide 5% gel

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Benzoyl peroxide

Available from:

CST Pharma Ltd

ATC code:

D10AE01

INN (International Name):

Benzoyl peroxide

Dosage:

50mg/1gram

Pharmaceutical form:

Cutaneous gel

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13060100; GTIN: 5055946800127 5055946808765

Patient Information leaflet

BENZOYL PEROXIDE
5% W/W GEL
PACKAGE LEAFLET: INFORMATION FOR THE USER
ACNECIDE 5% W/W GEL
Benzoyl Peroxide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
Always use this medicine exactly as described in this leaflet or as
your doctor or pharmacist has told you.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. See
section 4.
- You must talk to a doctor if you do not feel better or if you feel
worse.
WHAT IS IN THIS LEAFLET
1. What Acnecide is and what it is used for
2. What you need to know before you use Acnecide
3. How to use Acnecide
4. Possible side effects
5. How to store Acnecide
6. Contents of the pack and other information
1. WHAT ACNECIDE IS AND WHAT IT IS USED FOR
•
Acnecide contains the active ingredient benzoyl peroxide which attacks
the bacteria (germs) known as Propionibacterium
acnes, one of the main causes of acne.
•
Your doctor or pharmacist has recommended this medicine to treat your
acne. Acne appears as blackheads and white-
heads which people often refer to as pimples or spots.
•
Acne of the face, chest or back may be treated with this medicine.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE ACNECIDE
DO NOT USE ACNECIDE IF YOU ARE:
•
Allergic (hypersensitive) to benzoyl peroxide or any of the other
ingredients of this medicine (listed in section 6). An allergic
reaction may include a rash or itching.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Acnecide.
•
Avoid contact with the eyes, mouth, angles of the nose and other
mucous surfaces such as the lining of your nose. If accidental
contact should occur, rinse thoroughly with warm water.
•
Acnecide should not be applied to damaged skin.
•
Acnecide may cause swelling and blistering of the skin, if any of
these symptoms occur, use of the produ

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Acnecide 5%w/w Gel
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Hydrous benzoyl peroxide equivalent to Benzoyl Peroxide 5% w/w
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Topical Gel
White to off-white, smooth gel
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Topical therapy for the treatment of acne vulgaris
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For external use only.
Adults and children:
Before each application, the skin should be cleaned and dried. Apply
in a thin layer once or twice
daily or as directed to the affected areas. Persons with sensitive
skin should be directed to apply
the gel once daily before going to bed. The extent of any drying or
peeling may be adjusted by
modifying the dosage schedule.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
For external use only.
Acnecide may cause swelling and blistering of the skin, if any of
these symptoms occur,
medication has to be discontinued.
A mild burning sensation will probably be felt on first application
and some reddening and
peeling of the skin will occur within a few days. During the first
weeks of treatment a sudden
increase in peeling will occur in most patients. This is not harmful
and will normally subside
within a day or two if treatment is temporarily discontinued. If
severe irritation occurs, patients
should be directed to use the medication less frequently, to
temporarily discontinue use or to
discontinue use altogether.
Patients should be advised that excessive application will not improve
efficacy, but may increase
the risk of skin irritation.
Concomitant topical acne therapy should be used with caution because a
possible cumulative
irritancy may occur, which sometimes may be severe, especially with
the use of peeling,
desquamating, or abrasive agents.
Benzoyl peroxide gel should not come into contact with the eyes,
mouth, angl