FENLIPS COLOR

Country: Израел

Језик: Енглески

Извор: Ministry of Health

Активни састојак:

PENCICLOVIR

Доступно од:

PADAGIS ISRAEL AGENCIES LTD, ISRAEL

АТЦ код:

D06BB06

Фармацеутски облик:

CREAM

Састав:

PENCICLOVIR 10 MG/G

Пут администрације:

TOPICAL

Тип рецептора:

Not required

Произведен од:

OMEGA PHARMA LTD. UNITED KINGDOM

Терапеутска област:

PENCICLOVIR

Терапеутске индикације:

For the topical treatment for cold sores (oral herpes)

Датум одобрења:

2020-03-31

Информативни летак

·
ضارعلأا تناك نإو ىتح ,نيرخلآ ءاودلا
ءاطعإ زوجي لا
.كضارعلأ ةهباشم مهيدل ةعرجلاو قصلملا نم ققحت !ملاظلا يف
ةيودأ لوانت زوجي لا اذإ ةيبطلا تاراظنلا عضو بجي .ءاود اهب
لوانتت ةرم لك يف
.اهيلإ ةجاحب تنك ,ءاودلا لامعتساب قلعتي اميف ةيفاضإ
ةلئسأ يأ كيدل تناك اذإ
.يلديصلا وأ بيبطلا رشتسإ ةيبناجلا ضارعلأا .4
ةيبناج ا
ً
ضارعأ رولوك سپيلنف لامعتسا ببسي دق
,ءاود يأ لكك
ضارعلأا ةمئاق ةءارق نم عزفت لا
.نيمدختسملا ضعب ىدل
يتلا ةيبناجلا ضارعلأا .اهنم ةدحاو يأ
نم يناعت لا دق .ةيبناجلا
.ةفيفط
ً
ةداع نوكت رولوك سپيلنف لامعتسا ةجيتن
رهظت
ترهظ اذإ بيبطلا ىلإ ا
ً
روف هجوتلاو لامعتسلاا نع فقوتلا بجي
يسسحت دلج باهتلا لثم )ةيجرأ( سسحتلا طرف
نم لعف دودر
وأ ةكحلل ببسمو زراب خافتنا ,حفط ,)allergic
dermatitis(
.ميركلا نهد عضوم خافتنا
ةيفاضإ ةيبناج ضارعأ
نم 1 ىتح يف رهظت يتلا ,)common( ةعئاش ةيبناج
ضارعأ
.نهدلا عضوم يف ةيلوأ ردخ وأ ةكح ,ةقرح
,زخو :نيمدختسم 10 اذإ وأ ,ةيبناجلا ضارعلأا دحأ مقافت اذإ
,يبناج ضرع رهظ اذإ
.بيبطلا ةراشتسا كيلع ,ةرشنلا يف ركذ
ُ
ي مل يبناج ضرع نم تيناع ةيبناج ضارعأ نع غيلبتلا
طغضلا للاخ نم ةحصلا ةرازول ة
ّ
يبناج ضارعأ نع غيلبتلا نكمي
"يئاود جلاع بقع ة
ّ
يبناج ضارعأ نع غيلبتلا" طبارلا ىلع
ةحصلا ةرازو عقوم يف ةيسيئرلا
ةحفصلا يف دوجوملا
يتنرتنلإا جذ

Карактеристике производа

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCTS
Fenlips / Fenlips Color
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of the cream contains:
10 mg penciclovir
Excipients with known effect: cetostearyl alcohol, propylene glycol
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Cream
Smooth white cream of homogeneous appearance.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Fenlips / Fenlips Color is indicated for the topical treatment of cold
sores
(oral herpes).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults (including older people) and children over 12 years of age:
Fenlips / Fenlips Color should be applied at approximately two hourly
intervals during waking hours (approximately 8 times a day). Treatment
should be continued for 4 days. If the condition gets worse or does
not
improve after 4 days treatment, seek medical advice.
Treatment should be started as early as possible after the first sign
of an
infection; moreover the product has been shown to be beneficial in
accelerating lesion healing, reducing lesion pain and shortening the
duration of viral shedding even in patients who begin treatment later
in the
disease (e.g. when the papule or vesicle has developed).
Children (under 12 years):
No work has been carried out in children below 12 years of age.
4.3 CONTRAINDICATIONS
Hypersensitivity to penciclovir, famciclovir or to any of the
excipients listed
in section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The cream should only be used on cold sores on the lips and around the
mouth. It is not recommended for application to mucous membranes (e.g.
in the eyes, mouth, or nose or on the genitals). Particular care
should be
taken to avoid application in or near the eyes.
Patient with particularly severe cold sores should be encouraged to
seek
medical advice.
Patients should be advised to avoid transmitting the virus,
particularly
when active lesions are present.
Immunocompromised patients (e.g. AIDs patients or bone marrow
transplant recipients) shoul