Silkaderm cream

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

tretinoin

Available from:

Arpimed LLC

ATC code:

D10AD01

INN (International Name):

tretinoin

Dosage:

0,5mg/g

Pharmaceutical form:

cream

Units in package:

aluminum tube 15g

Prescription type:

OTC

Authorization status:

Registered

Authorization date:

2019-05-24

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS (SPC)
SILKADERM 0.05% CREAM
1.1 BRAND NAME – Silkaderm
1.2 INTERNATIONAL NON-PROPERTY NAME - Tretinoin
2. QUANTITATIVE AND QUALITATIVE COMPOSITION
Each gram of SILKADERM 0.05% cream contains:
_ACTIVE INGREDIENT:_ tretinoin - 0.5 mg.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
A yellowish cream.
Cream for topical use.
4. CLINICAL PARTICULARS
4.1 INDICATIONS AND USAGE
Silkaderm is indicated for topical application in the treatment of
acne vulgaris. The safety
and efficacy of the long-term use of this product in the treatment of
other disorders have not been
established.
4.2 DOSAGE AND ADMINISTRATION
Silkaderm should be applied once a day, before retiring, to the skin
where acne lesions appear,
using enough to cover the entire affected area lightly.
Application may cause a transitory feeling of warmth or slight
stinging. In cases where it has
been necessary to temporarily discontinue therapy or to reduce the
frequency of application,
therapy may be resumed or frequency of application increased when the
patients become able to
tolerate the treatment.
Alteration of vehicle, drug concentration, or dose frequency should be
closely monitored by
careful observation of the clinical therapeutic response and skin
tolerance.
During the early weeks of therapy, an _apparent _exacerbation of
inflammatory lesions may occur.
This is due to the action of the medication on deep, previously unseen
lesions and should not be
considered a reason to discontinue therapy.
Therapeutic results should be noticed after two to three weeks but
more than six weeks of
therapy may be required before definite beneficial effects are seen.
Once
the
acne
lesions
have
responded
satisfactorily,
it
may
be
possible
to
maintain
the
improvement with less frequent applications, or other dosage forms.
Patients treated with Silkaderm (tretinoin) acne treatment may use
cosmetics, but the area to be
treated should be cleansed thoroughly before the medication is
applied. (SEE PRECAUTIONS)
4.3 CONTRA