VERSATIS 5 % PLASTER

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Adcock Ingram Limited

Dosage:

See ingredients

Pharmaceutical form:

PLASTER

Composition:

EACH PLASTER CONTAINS LIDOCAINE 700,0 mg

Authorization status:

Registered

Authorization date:

2019-05-09

Patient Information leaflet

ADCOCK INGRAM LTD VERSATIS 5 %
02/12/2020
Lidocaine HCl 0,700 grams medicated plaster
1.5.5.4 Proposed Clean Patient Information Leaflet
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PROPOSED CLEAN PATIENT INFORMATION LEAFLET FOR VERSATIS 5 %
SCHEDULING STATUS
VERSATIS 5 %
Medicated Plaster
LIDOCAINE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING VERSATIS 5 %
MEDICATED PLASTERS
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor or your
pharmacist, nurse or other healthcare provider.
•
VERSATIS 5 %
Medicated Plasters has been prescribed for you personally and you
should not share your medicine
with other people. It may harm them, even if their symptoms are the
same as yours.
WHAT IS IN THIS LEAFLET
1. What VERSATIS 5 % is and what it is used for
2. What you need to know before you use VERSATIS 5 %
3. How to use VERSATIS 5 %
4. Possible side effects
5. How to store VERSATIS 5 %
6. Contents of the pack and other information
1.
WHAT VERSATIS 5 % IS AND WHAT IT IS USED FOR
VERSATIS 5 %
contains lidocaine which works by reducing the pain in your skin.
It is used to treat the pain caused by post-herpetic neuralgia. After
you have had shingles, post herpetic neuralgia may
develop due to damage to the nerves in your skin. This can be very
painful and the pain can last for a long time.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE VERSATIS 5 %
S4
ADCOCK INGRAM LTD VERSATIS 5 %
02/12/2020
Lidocaine HCl 0,700 grams medicated plaster
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Do not use
VERSATIS 5 % IF
•
you are hypersensitive (allergic) to lidocaine or any of the other
ingredients of
VERSATIS 5 %.
•
you have had an allergic reaction to other products which are similar
to lidocaine, such as bupivacaine,
etidocaine, mepivacaine or prilocaine.
WARNINGS AND PRECAUTIONS
TAKE SPECIAL CARE WITH VERSATIS 5 %:
If you have severe liver disease, or severe heart problems, or severe
kidney problems, you should talk to your doctor
before using
VERSATIS 5 %.
VERSATIS 5 %
SHOULD NOT

Summary of Product characteristics

ADCOCK INGRAM LTD VERSATIS 5 %
02/12/2020
Lidocaine HCl 0,700 grams medicated plaster
_ _
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PROPOSED PROFESSIONAL INFORMATION FOR VERSATIS 5 %
SCHEDULING STATUS
1. NAME OF THE MEDICINE
VERSATIS 5 %
medicated plaster
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE INGREDIENT
Each plaster contains 700 mg (5 %
_m/m_
) lidocaine in an aqueous adhesive base (50 mg lidocaine per gram
adhesive base).
Area containing the active substance: 10 cm x 14 cm.
For the full list of excipients, see section 6.1.
_Preservatives: _
Methyl parahydroxybenzoate 0,1 %
_m/m_
Propyl parahydroxybenzoate 0,05 %
_m/m_
3. PHARMACEUTICAL FORM
Medicated plaster.
The medicated plaster is 14 cm long and 10 cm wide. It is a white to
pale yellow polymeric adhesive material
with a faint characteristic odour, spread on one side of non-woven
fabric, and covered with a plastic film. The non-
woven fabric is embossed “Lidocaine 5 %”.
4. CLINICAL PARTICULARS
S4
ADCOCK INGRAM LTD VERSATIS 5 %
02/12/2020
Lidocaine HCl 0,700 grams medicated plaster
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VERSATIS 5 %
medicated plaster is indicated for the treatment of neuropathic pain
associated with previous
herpes zoster infection (post- herpetic neuralgia, PHN).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS AND ELDERLY PATIENTS
After first opening the sachet, the plasters must be used within 14
days.
Apply not more than three plasters to cover the painful area
_once daily_
for up to 12 hours within a 24 hours period.
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 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).
When needed, plasters