Zineryt 40 mg + 12 mg powder and solvent for cutaneous solution

国: アイルランド

言語: 英語

ソース: HPRA (Health Products Regulatory Authority)

有効成分:

Erythromycin; Zinc Acetate Dihydrate

から入手可能:

Leo Laboratories Limited

ATCコード:

D10AF; D10AF52

INN（国際名）:

Erythromycin; Zinc Acetate Dihydrate

投薬量:

40 + 12 milligram(s)

医薬品形態:

Powder and solvent for cutaneous solution

処方タイプ:

Product subject to prescription which may not be renewed (A)

治療領域:

Antiinfectives for treatment of acne; erythromycin, combinations

認証ステータス:

Marketed

承認日:

1992-12-17

情報リーフレット

Page 1 of 5
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZINERYT
® 40 MG + 12 MG POWDER AND SOLVENT FOR CUTANEOUS SOLUTION
erythromycin and zinc acetate dihydrate
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 symptoms 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.
IN THIS LEAFLET:
1.
What Zineryt
®
is and what is it used for
2.
What you need to know before you use Zineryt
®
3.
How to use Zineryt
®
4.
Possible side effects
5.
How to store Zineryt
®
6.
Contents of the pack and other information
7.
Information for healthcare professionals
1.
WHAT ZINERYT
® IS AND WHAT IT IS USED FOR
The active substance of Zineryt belongs to the group of antibiotics
for treatment of acne, often referred
to as pimples or spots. These medicines are used to reduce the growth
of bacteria which cause acne.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ZINERYT
®
DO NOT USE ZINERYT

if you are allergic (hypersensitive) to erythromycin, or zinc or to
any of the other ingredients
of Zineryt (see list in section 6 ‘Contents of the pack and other
information’). Your doctor
may decide to give you another medicine instead

if you are allergic to antibiotics of the macrolide group. Ask your
doctor or pharmacist if you
are unsure.
_ _
_ _
WARNINGS AND PRECAUTIONS

Avoid contact with the eyes and mucous membranes of the nose and
mouth. However, if this
occurs, then rinse the affected area immediately with cold or lukewarm
water for several
minutes. Contact your doctor for further advice.
OTHER MEDICINES AND ZINERYT
Please tell your doctor or pharmacist if you are taking or have
recently taken, used or migh

製品の特徴

Health Products Regulatory Authority
20 December 2018
CRN008K2G
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zineryt 40 mg + 12 mg powder and solvent for cutaneous solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Erythromycin 40 mg per ml and zinc acetate dihydrate 12 mg per ml on
constitution.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder and solvent for cutaneous solution.
Powder: White crystalline powder
Solvent: Clear colourless liquid
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Topical treatment of acne vulgaris.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For adolescents, adults and the elderly. Apply twice daily over the
whole of the
affected area and immediately surrounding skin.
4.3 CONTRAINDICATIONS
Zineryt is contraindicated in patients who are hypersensitive to
erythromycin or other
macrolide antibiotics, or to zinc, di-isopropyl sebacate or ethanol.
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.
Cross resistance may occur with other antibiotics of the macrolide
group and also
with lincomycin and clindamycin. Contact with the eyes or the mucous
membranes
of the nose and mouth should be avoided. Prolonged use of an
anti‑infective may
Health Products Regulatory Authority
20 December 2018
CRN008K2G
Page 2 of 5
result in superinfection due to micro‑organisms resistant to the
anti‑infective.
If there is no response within 10 to 12 weeks alternative measures
should be
considered. Prolonged use is not recommended. A course should not
usually
exceed six months.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTIONS
Although use with other therapie