SUNACTIC

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

DICLOFENAC SODIUM

Available from:

PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL

ATC code:

D11AX18

Pharmaceutical form:

GEL

Composition:

DICLOFENAC SODIUM 3 %

Administration route:

TOPICAL

Prescription type:

Required

Manufactured by:

PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL

Therapeutic group:

DICLOFENAC

Therapeutic area:

DICLOFENAC

Therapeutic indications:

For the treatment of Actinic Keratoses

Authorization date:

2018-07-31

Patient Information leaflet

PATIENT PACKAGE INSERT
IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS
)PREPARATIONS) – 1986
The medicine is dispensed with a doctor’s
prescription only
SUNACTIC 3% GEL
The gel contains Diclofenac Sodium at a
concentration of 3%.
1 gram of Sunactic Gel contains 30 mg
Diclofenac Sodium.
Inactive
ingredients
and
allergens
in
the
product:
see
in
section
2
"
IMPORTANT
INFORMATION ABOUT SOME OF THE INGREDIENTS
OF THIS MEDICINE
"
and section 6 in the leaflet.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY
BEFORE USING THE MEDICINE. This leaflet
contains
concise
information
about
the
medicine. If you have further questions, refer
to the doctor or pharmacist.
This medicine has been prescribed for you.
Do not pass it on to others. It may harm them
even if it seems to you that their medical
condition is similar.
1. WHAT IS THE MEDICINE INTENDED
FOR?
Sunactic Gel in intended for topical treatment
of actinic keratosis.
THERAPEUTIC
GROUP:
non-steroidal
anti-
inflammatories.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
• You
are
hypersensitive
)allergic(
to
the
active ingredient diclofenac sodium or to
any of the other ingredients contained in the
medicine.
• You have previously had an allergic reaction,
such as skin rash )hives/nettle-rash(, breathing
difficulties )wheezing( or allergic rhinitis as
a result of taking aspirin or any other non-
steroidal anti-inflammatory medicine.
• You are in the last three months of pregnancy.
SPECIAL WARNINGS REGARDING USE OF THE
MEDICINE:
The
possibility
of
systemic
side
effects
cannot be excluded if you use Sunactic on
large areas of skin and over a prolonged
period of time.
BEFORE TREATMENT WITH SUNACTIC, INFORM
THE DOCTOR IF:
• you have, or have had in the past, a gastric
ulcer or gastric bleeding.
• you have heart, liver or kidney problems.
• you have any type of bleeding disorder or you
bruise very easily.
• Avoid sun exposure, including tanning salons,
during the course of treatment with Sunactic.
If skin reactions occur, discontinue use of the
medicine.

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sunactic
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram contains 30 mg diclofenac sodium (3% w/w)
Excipient(s) with known effect 1 g of gel contains 10 mg of benzyl
alcohol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gel.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the topical treatment of actinic keratosis
4.2 Posology and method of administration
Use in Adults_: _Sunactic is applied locally to the affected area
twice daily and
smoothed into the skin gently. The amount needed depends on the size
of the
affected area. Normally 0.5 grams (the size of a pea) of the gel is
used on a 5 cm x 5
cm lesion site. The usual duration of therapy is from 60 to 90 days.
Maximum efficacy has been observed with treatment duration towards the
upper end
of this range. Complete healing of the lesion(s) or optimal
therapeutic effect may not
be evident for up to 30 days following cessation of therapy.
A maximum of 8 grams daily should not be exceeded. Long term efficacy
has not
been established.
Use in the Elderly_: _The usual adult dose may be used.
Use in Children: Dosage recommendations and indications for the use of
Sunactic
have not been established for use in children.
4.3 Contraindications
Hypersensitivity to the active substance diclofenac or any of the
excipients listed in
section 6.1.
Because of cross-reactions, the gel should not be used by patients who
have
experienced hypersensitivity reactions such as symptoms of asthma,
allergic rhinitis
or urticaria, to acetylsalicylic acid or other non-steroidal
anti-inflammatory agents.
The use of Sunactic is contraindicated during the third trimester of
pregnancy (see
Section 4.6).
4.4 Special warnings and precautions for use
The likelihood of systemic side effects occurring following the
topical application of
Sunactic is very small compared to the frequency of side effects with
oral diclofenac,
owing to low systemic absorption with Sunactic. However, the
possibility of