VERSATIS 700 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

LIDOCAINE

Available from:

MEDISON PHARMA LTD

ATC code:

N01BB02

Pharmaceutical form:

MEDICATED PLASTER

Composition:

LIDOCAINE 700 MG

Administration route:

CUTANEOUS

Prescription type:

Required

Manufactured by:

GRUNENTHAL GMBH, GERMANY

Therapeutic area:

LIDOCAINE

Therapeutic indications:

Versatis 700 mg is indicated for the symptomatic relief of neuropathic pain associated with previous herpes zoster infection (post-herpetic neuralgia, PHN) in adults

Authorization date:

2019-03-18

Summary of Product characteristics

The format of this leaflet was determined by the Ministry of Health
and its content was checked and
approved in March 2019
1.
NAME OF THE MEDICINAL PRODUCT
Versatis® 700 mg medicated plaster
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 cm x 14 cm plaster contains 700 mg (5% w/w) lidocaine
(50 mg lidocaine per gram adhesive base)
Excipients with known effect: Methyl
parahydroxybenzoate 14 mg Propyl
parahydroxybenzoate 7 mg Propylene
glycol 700 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Medicated plaster
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Versatis® 700 mg is indicated for the symptomatic relief of
neuropathic pain associated with previous herpes
zoster infection (post-herpetic neuralgia, PHN) in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_ADULTS AND ELDERLY PATIENTS _
The painful area should be covered with the plaster once daily for up
to 12 hours within a 24 hours period.
Only the number of plasters that are needed for an effective treatment
should be used. When needed, the
plasters may be cut into smaller sizes with scissors prior to removal
of the release liner. In total, not more than
three plasters should be used at the same time.
The plaster must be applied to intact, dry, non-irritated skin (after
healing of the shingles).
Each plaster must be worn no longer than 12 hours. The subsequent
plaster-free interval must be at least 12 hours.
The plaster can be applied during the day or during the night.
The plaster must be applied to the skin immediately after removal from
the sachet and following removal of the
release liner from the gel surface. Hairs in the affected area must be
cut off with a pair of scissors (not shaved).
Treatment outcome should be re-evaluated after 2-4 weeks. If there has
been no response to Versatis® 700 mg after
this period (during the wearing time and/or during the plaster-free
interval), treatment must be discontinued as
potential risks may outweigh benefits in this context (see sections
4.4 and 5.1). Long-term use of