AKNEMYCIN

Riik: Iisrael

keel: inglise

Allikas: Ministry of Health

Toimeaine:

ERYTHROMYCIN

Saadav alates:

NEOPHARM LTD

ATC kood:

D10AF02

Ravimvorm:

SOLUTION - EXTERNAL

Koostis:

ERYTHROMYCIN 2 %

Manustamisviis:

DERMAL

Retsepti tüüp:

Required

Valmistatud:

ALMIRALL HERMAL GMBH, GERMANY

Terapeutiline rühm:

ERYTHROMYCIN

Terapeutiline ala:

ERYTHROMYCIN

Näidustused:

All forms of acne, particularly inflammatory forms with papules and pustules.

Loa andmise kuupäev:

2014-06-30

Infovoldik

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) 1986
This medicine is to be supplied by physician’s prescription only
AKNEMYCIN
Solution for topical use – for external use
10g solution/0.2g Erythromycin
COMPOSITION:
ACTIVE INGREDIENT AND ITS CONCENTRATION –10g of solution for
application to the skin contain
Erythromycin 0.2g.
Inactive ingredients and allergens in the product: See section
“Additional information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet contains essential
information about this medicine. If you have any further questions,
refer to the physician or the
pharmacist.
This medicine has been prescribed for your treatment. Do not pass it
on to others. It may harm them,
even if it seems to you that their medical condition is similar.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
For external antibiotic treatment of all forms of acne (
skin lesions)
particularly inflammatory forms with
papules and pustules.
THERAPEUTIC GROUP: Erythromycin – Macrolide antibiotics.
2.
BEFORE USING THIS MEDICINE
.X. DO NOT USE THIS MEDICINE IF:

You are sensitive (allergic) to the active ingredient or to any of the
other ingredients that this
medicine contains
The inactive ingredients are listed in the section "Additional
Information".
.!. SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE
BEFORE THE TREATMENT WITH AKNEMYCIN, TELL YOUR PHYSICIAN:

If you are sensitive to any food or medicine
Oxidants (oxidizing agents) and water impair the efficacy of the
product.
Do not light a cigarette or expose yourself to flames until product
has completely dried.
IF YOU ARE TAKING OR HAVE RECENTLY TAKEN OTHER MEDICINES, INCLUDING
NONPRESCRIPTION MEDICATIONS
AND FOOD SUPPLEMENTS, INFORM YOUR PHYSICIAN OR PHARMACIST.
PREGNANCY AND BREASTFEEDING
If you are pregnant or breast-feeding, you should consult a physician
or pharmacist before using this
medicine.
3.
HOW SHOULD YOU USE THE MEDICINE?
Always use according to the physician's instructions. You shoul

Toote omadused

Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Aknemycin
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
10 g of solution contains 0.2 g of erythromycin.
Structural formula of erythromycin
Excipient with known effect:
This medicinal product contains 752 mg alcohol (ethanol) per ml.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Cutaneous solution
Aknemycin is a clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
All forms of acne, in particular inflammatory forms with papules and
pustules.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Generally the solution should be applied twice a day.
Method of Administration
The bottle has a special applicator; with this Aknemycin can be
applied directly on to the skin.
Page 2 of 6
The applicator bottle is prepared for use each time by pressing
vigorously on the applicator
beforehand with the reversed cap. This releases the safety mechanism
and Aknemycin can be
applied.
Treatment with Aknemycin should not be longer than 4 – 6 weeks.
4.3
CONTRAINDICATIONS
Aknemycin must not be used in cases of
-
hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
As
with
other
macrolides,
rare
serious
allergic
reactions,
including
acute
generalised
exanthematous pustulosis (AGEP) have been reported. If an allergic
reaction occurs, the drug
should be discontinued and appropriate therapy should be instituted.
Physicians should be aware
that reappearance of the allergic symptoms may occur when symptomatic
therapy is discontinued.
Aknemycin should not be allowed to get into the eyes.
This medicinal product contains 752 mg alcohol (ethanol) per ml. It
may cause burning sensation
on damaged skin.
Do not light a cigarette or expose yourself to open flames until the
medicine has dried completely
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None known to date.
4.6
FERTILITY, PREGNANCY AND LACTATI