Diclofenac 140 mg medicated plaster

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Diclofenac epolamine

Available from:

IBSA Farmaceutici Italia S.r.l

ATC code:

M02AA15

INN (International Name):

Diclofenac epolamine

Pharmaceutical form:

Medicated plaster

Therapeutic area:

diclofenac

Authorization status:

Not marketed

Authorization date:

2022-10-28

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
DICLOFENAC 140 MG MEDICATED PLASTER
diclofenac sodium (as diclofenac epolamine)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again
-
If you have any further questions, ask your doctor or pharmacist
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may
harm them, even if their signs of illness are the same as yours
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Diclofenac 140 mg Medicated Plaster is and what it is used for
2.
What you need to know before you use Diclofenac 140 mg Medicated
Plaster
3.
How to use Diclofenac 140 mg Medicated Plaster
4.
Possible side effects
5.
How to store Diclofenac 140 mg Medicated Plaster
6.
Contents of the pack and other information
1.
WHAT DICLOFENAC 140 MG MEDICATED PLASTER IS AND WHAT IT IS USED FOR
Diclofenac belongs to a group of medicines called non-steroidal
anti-inflammatory drugs
(NSAIDs). NSAIDs reduce pain and inflammation.
Diclofenac 140 mg medicated plaster is used to relieve the pain and
inflammation of tennis
elbow, golfer’s elbow and a sprained ankle in adolescents from 16
years of age and adults.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE DICLOFENAC 140 MG MEDICATED
PLASTER
DO NOT USE DICLOFENAC 140 MG MEDICATED PLASTER:
•
if you are allergic to diclofenac, acetylsalicylic acid (aspirin) or
any other NSAID
•
if you are allergic to any of the other ingredients of this medicine
(listed in section 6)
•
if you have asthma, breathing problems, skin rash or a runny nose
after taking
acetylsalicylic acid (aspirin) or other NSAIDs
•
if you are entering or are already beyond your 6
th
month of pregnancy
•
if you currently have a stomach ulcer (peptic ulcer)
•
if you have any damaged skin including weeping or infected areas,
eczema, bur

Summary of Product characteristics

Health Products Regulatory Authority
13 January 2023
CRN00DCQQ
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Diclofenac 140 mg medicated plaster
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 140 cm
2
(10 cm x 14 cm) of medicated plaster contains a total of 180 mg of
diclofenac epolamine corresponding to 140
mg of diclofenac sodium (1% w/w).
Excipients with known effect:
methyl parahydroxybenzoate (E218): 14 mg
propyl parahydroxybenzoate (E216): 7 mg
propylene glycol: 420 mg
Dalin PH perfume containing amyl cinnamal, amylcinnamyl alcohol,
benzyl alcohol, benzyl benzoate, benzyl salicylate, cinnamal,
cinnamyl alcohol, citronellol, d‐Limonene, eugenol, farnesol,
geraniol, hexyl cinnamaldehyde, hydroxycitronellal, isoeugenol,
linalool, methyl heptine carbonate
Referred to amount per plaster.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Medicated plaster.
White to pale yellow paste spread as a uniform layer onto unwoven
support.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Local symptomatic treatment of pain in epicondylitis and ankle sprain
in adolescents from 16 years of age and adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Cutaneous use only
_Posology_
Adults and adolescents 16 years and older

Symptomatic treatment of ankle sprains: 1 application a day

Symptomatic treatment of epicondylitis: 1 application morning and
evening.
_Duration of administration_
Diclofenac is to be used for as short as possible depending on the
indication:

Symptomatic treatment of ankle sprains: 3 days

Symptomatic treatment of epicondylitis: max. 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 16 years_
There are insufficient data on efficacy and safety available for
children and adolescents below 16 years