DICLOPLAST

Country: Израел

Језик: Енглески

Извор: Ministry of Health

Активни састојак:

DICLOFENAC SODIUM

Доступно од:

CTS LTD

АТЦ код:

M02AA15

Фармацеутски облик:

PATCHES

Састав:

DICLOFENAC SODIUM 140 MG

Пут администрације:

TOPICAL

Тип рецептора:

Not required

Произведен од:

IBSA INSTITUTE BIOCHIMIQUE SA, SWITZERLAND

Терапеутска група:

DICLOFENAC

Терапеутска област:

DICLOFENAC

Терапеутске индикације:

Dicloplast is indicated for topical treatment of rheumatic diseases, pain and non-infectious inflammation.

Датум одобрења:

2013-12-31

Информативни летак

PATIENT PACKAGE INSERT IN ACCORDANCE
WITH THE PHARMACISTS’ REGULATIONS
)PREPARATIONS( – 1986
The medicine is dispensed
without a doctor’s prescription
DICLOPLAST
® PATCH
Each patch contains: 180 mg Diclofenac Epolamine
)equivalent to 140 mg Diclofenac Sodium(
For a list of the inactive and allergenic ingredients in the
preparation - see Section 6 “Further information” and
Section 2 “Important information about some of the
ingredients of the medicine”.
READ THE 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.
Use the preparation according to the instructions in the
section on dosage in this leaflet.
If you need further information, consult with the
pharmacist. Refer to the doctor if signs of the disease
)symptoms( worsen or do not improve after 7 days.
1. WHAT IS THE MEDICINE INTENDED FOR?
The medicine is indicated for topical treatment of rheumatic
diseases, pain and non-infectious inflammation.
THERAPEUTIC GROUP: Non-steroidal anti-inflammatory
drugs )NSAIDs(.
2. BEFORE USING THE MEDICINE:
DO NOT USE THE MEDICINE IF:
• You are hypersensitive )allergic( to the active
ingredient Diclofenac or to any of the other ingredients
contained in the medicine, to aspirin and salicylates,
or to other NSAID preparations.
• You have breathing problems, asthma, skin rash or a
runny nose after taking acetylsalicylic acid )aspirin( or
other NSAIDs.
• You have entered or are beyond your sixth month of
pregnancy.
• You have an active stomach ulcer )peptic ulcer(.
• You have damaged skin, including discharge,
infections, eczema, burns or wounds.
•
You are a child or adolescent below the age of 16 years. SPECIAL WARNINGS REGARDING USE OF THE MEDICINE
BEFORE TREATMENT WITH DICLOPLAST, TELL THE DOCTOR IF:
• You have heart disease.
• You have kidney disease.
• You have liver disease.
• You have had stomach ulcers in the past.
•
You have an inflammatory bowel dise

Карактеристике производа

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
DICLOPLAST 140mg medicated topical patch
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 140 cm
2
(10 cm x 14 cm) of medicated patch contains a total of 180 mg of
diclofenac epolamine corresponding to 140 mg of diclofenac sodium (1%
w/w).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Medicated patch
White to pale yellow paste spread as a uniform layer onto unwoven
support.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
DICLOPLAST IS INDICATED FOR TOPICAL TREATMENT OF RHEUMATIC DISEASES,
PAIN
AND ON-INFECTIOUS INFLAMMATION.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Cutaneous use only
_Posology _
Adults and adolescents 16 years and older
1 application morning and evening (for up to 12 hours)
_Duration of administration _
Dicloplast is to be used for as short as possible. The duration of the
treatment
should not exceed 14 days.
If there is no improvement, during the recommended duration of
treatment or
symptoms worsen, a doctor should be consulted.
_Elderly _
This medication should be used with caution in elderly patients who
are more
prone to adverse events. See also Section 4.4.
_Children and adolescents below the age of 16 years _
There are insufficient data on efficacy and safety available for
children and
adolescents below 16 years of age (see also contraindication section
4.3).
In children aged 16 years and over, if this product is required for
more than 7
days for pain relief or if the symptoms worsen, the patient/parents of
the
adolescents is/are advised to consult a doctor.
_Patients with hepatic or renal insufficiency _
For the use of Dicloplast in patients with hepatic or renal
insufficiency see
section 4.4.
_Method of administration _
Cut the envelope containing the medicated patch as indicated. Remove
one
medicated patch, remove the plastic film used to protect the adhesive
surface
and apply it to painful joint or region. If necessary, it can be held
in place with
an elastic net. Carefully reseal the envelop