Cymex Cream

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

Cetrimide; Chlorocresol; Dimeticone; Urea

متاح من:

Teva B.V.

ATC رمز:

D08AJ; D08AJ04

INN (الاسم الدولي):

Cetrimide; Chlorocresol; Dimeticone; Urea

الشكل الصيدلاني:

Cream

المجال العلاجي:

Quaternary ammonium compounds; cetrimide

الوضع إذن:

Marketed

تاريخ الترخيص:

1997-04-23

خصائص المنتج

Health Products Regulatory Authority
16 September 2022
CRN00CSV2
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cymex Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Urea
1.0 % w/w
Cetrimide
0.5 % w/w
Dimeticone 350
9.0 % w/w
Chlorocresol
0.1 % w/w
For the full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Cream
Smooth white cream with characteristic odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the application to cold sores and cracked lips.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
There are no special hazards associated with the use of cetrimide in
specific patient groups. No special precautions or modified
dosage requirements are, therefore, indicated for its use in infants,
the elderly or during pregnancy or lactation. No hazardous
drug interactions are considered likely.
Adults, elderly and children: apply sparingly every hour for the
relief of cold sores and cracked lips.
Method of administration
Topical application.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substances or to any of the excipients
listed in section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Keep out of the reach and sight of children.
For external use only.
If symptoms persist consult your doctor.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None known.
4.6 FERTILITY, PREGNANCY AND LACTATION
Topical urea is considered suitable for use by all the age groups and
during pregnancy and lactation although few animal and
reproduction studies have been conducted.
Health Products Regulatory Authority
16 September 2022
CRN00CSV2
Page 2 of 4
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
Not applicable.
4.8 UNDESIRABLE EFFECTS
No serious toxicity has been reported with the use of topically
administered urea and it is considered to be a very safe
substance. No long-term side effects have been found and no epidermal
and dermal atrophy has been reported. It has,
however, been reported to causing burning and irritation if applied to
i