Aknemycin Plus solution

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Erythromycin; Tretinoin

Available from:

Lexon (UK) Ltd

ATC code:

D10AF52

INN (International Name):

Erythromycin; Tretinoin

Dosage:

40mg/1gram ; 250microgram/1gram

Pharmaceutical form:

Cutaneous solution

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13060100

Patient Information leaflet

Date and Signature
PROOF:
DESCRIPTION:
REGULATORY TEXT:
ITEM NUMBER:
MATERIAL SIZE:
DESIGNER:
FONTS:
DATE:
MINIMUM FONT SIZE:
PREFIXES (EG.LOT/EXP) FONT SIZE:
ARTWORK INFORMATION PANEL
LEADING:
PRINTING COLOURS
NON PRINTING COLOURS
INLINE CONTROL CODE
COLOUR REFERENCE IN PMS BRIDGE
EQUATE WITH CMYK
MANUFACTURER’S TECHNICAL CHECK
Manufacturer confirms the printability and technical compliance of
this packaging material for correct use during packaging process.
_“8pt in Graphic Font equal to 9pt on Times New Roman”_
PHES CODE
PIL Aknemycin Plus Solution GB Mock up
PIL Aknemycin Plus Solution GB 80015571annotated /
uk-pl-aknemycinplus-QRD-Sep2018_annotated
(1-2)
Graphik Regular / _Regular Italic _/ SEMIBOLD
00000000
148 x 297 mm
30.03.2020
8 pt
3 mm
1
P Black
Die Cut
PACKAGE LEAFLET: INFORMATION FOR THE USER
AKNEMYCIN PLUS
4.0% W/W AND 0.025% W/W CUTANEOUS SOLUTION
Erythromycin and Tretinoin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
• 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 only. Do not pass it on
to others. It may harm them,
even if their signs of illness are the same as yours.
• 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.
WHAT IS IN THIS LEAFLET
1. What Aknemycin Plus is and what it is used for
2. What you need to know before you use Aknemycin Plus
3. How to use Aknemycin Plus
4. Possible side effects
5. How to store Aknemycin Plus
6. Contents of the pack and other information
2. WHAT YOU NEED TO KNOW BEFORE YOU USE AKNEMYCIN PLUS
DO NOT USE AKNEMYCIN PLUS
• if you are allergic to Erythromycin, Tretinoin or any of the other
ingredients of this medicine
(listed in section 6).
characterised by redness, pimples and peeling) or acute inflammatory
conditions of the
skin, especially around the mouth.
•

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Aknemycin Plus 4.0% w/w and 0.025% w/w cutaneous solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of cutaneous solution contains 40 mg of erythromycin and
0.25 mg of tretinoin.
Excipients with known effect:
1 ml of solution contains 752 mg of alcohol (ethanol).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Cutaneous solution.
Aknemycin Plus is a clear solution for topical administration.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Aknemycin Plus is indicated for the treatment of all forms of acne,
both non-inflammatory
forms with comedones and inflammatory forms with papules and pustules
particularly those
associated with a very oily skin.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
To be applied to the affected areas once or twice daily. Treatment
should continue for 9-12
weeks according to the condition of the skin. It should be noted that
therapeutic improvement
may not be observed for several weeks after starting treatment.
Consistent application makes a significant contribution to the success
of the therapy.
Excess application of Aknemycin Plus should be avoided since it may
result in marked
erythema, drying and discomfort of the treated areas.
The dosage is the same for all ages.
Method of administration
For application to the skin.
The applicator allows direct administration to the skin. The patient
should press the top of the
screw cap on the foam pad before each use and should feel a 'click'
which indicates that the
applicator will close again automatically.
4.3
CONTRAINDICATIONS
•
Hypersensitivity to the active substances or to any of the excipients
listed in section
6.1.
•
A family history of cutaneous epithelioma.
•
In acute eczemas, rosacea and acute inflammatory conditions of the
skin, especially
around the mouth.
•
When underlying sunburn is present
•
Concomitant use with other skin medications particularly those
containing keratolytic
agents (see section 4.5).
•
P