Aknemycin Plus solution

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Erythromycin; Tretinoin

Available from:

Almirall 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; GTIN: 5000167025101

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
AKNEMYCIN
® PLUS
Erythromycin Ph Eur 4.0% w/w and Tretinoin Ph Eur 0.025% w/w
Solution
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
1.
WHAT AKNEMYCIN PLUS IS AND WHAT IT IS USED FOR
Aknemycin Plus is a treatment for acne which is applied to the skin.
Aknemycin Plus is a solution and contains Erythromycin and Tretinoin
as active
ingredients. Erythromycin is an antibiotic which kills the germs found
in acne and
reduces the inflammation of your skin.
Tretinoin encourages the layer of dead and hardened skin cells that
form on the skin
surface to peel off. At the same time, it clears the blackheads which
block your skin pores
and cause spots to form. Once the pore is unblocked, sebum can escape
so that germ
activity is limited. Aknemycin Plus also helps dissolve away the
excess oil in your skin.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE AKNEMYCIN PLUS
DO NOT USE AKNEMYCIN PLUS

if you are allergic (hypersensitive) to Erythromycin, Tretinoin or any
of the other
ingredients of Aknemycin Plus (listed in section 6).

if you are suffering from acute eczema, rosacea (a skin disease which
affects the
face and is characterised by redness, pimples and peeling) or acute
inflammatory
conditions of the skin, especially around the mouth.
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 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 of the side effects, talk to your doctor or pharmacist.
This
includes any possible side effects not listed in this leaflet.

if your skin is sunburnt.

if you are using

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