Flector Tissugel 140 mg medicated plaster

Pajjiż: Irlanda

Lingwa: Ingliż

Sors: HPRA (Health Products Regulatory Authority)

Ingredjent attiv:

Diclofenac epolamine

Disponibbli minn:

IBSA Farmaceutici Italia S.r.l

Kodiċi ATC:

M02AA; M02AA15

INN (Isem Internazzjonali):

Diclofenac epolamine

Dożaġġ:

140 milligram(s)

Għamla farmaċewtika:

Medicated plaster

Tip ta 'preskrizzjoni:

Product subject to prescription which may be renewed (B)

Żona terapewtika:

Antiinflammatory preparations, non-steroids for topical use; diclofenac

L-istatus ta 'awtorizzazzjoni:

Marketed

Data ta 'l-awtorizzazzjoni:

2003-11-04

Fuljett ta 'informazzjoni

PATIENT LEAFLET: INFORMATION FOR THE USER
FLECTOR TISSUGEL® 140 MG MEDICATED PLASTER
DICLOFENAC SODIUM (AS DICLOFENAC EPOLAMINE)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE START USING THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have 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 Flector Tissugel
is and what it is used for
2.
What you need to know before you use Flector Tissugel
3.
How to use Flector Tissugel
4.
Possible side effects
5.
How to store Flector Tissugel
6.
Contents of the pack and other information.
1.
WHAT FLECTOR TISSUGEL IS AND WHAT IT IS USED FOR
Flector Tissugel
belongs to a group of medicines called non-steroidal anti-inflammatory
drugs
(NSAIDs). NSAIDs reduce pain and inflammation.
Flector Tissugel
is used to relieve the pain and inflammation of tennis elbow,
golfer’s elbow and a
sprained ankle.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE FLECTOR TISSUGEL
DO NOT USE FLECTOR TISSUGEL:

if you are allergic to diclofenac, acetylsalicylic acid (aspirin) or
any other NSAID

if you are allergic to any of the other ingredients of Flector
Tissugel
(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, burns or wounds

if you are a children or adolescent aged less than 16 years.
If any of the above applies to you talk to your doctor or pharmacist.
WARNINGS AND PRECAUTIONS
TALK

Karatteristiċi tal-prodott

Health Products Regulatory Authority
23 April 2021
CRN00C2N7
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Flector Tissugel 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:
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.
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
Flector Tissugel 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_
Health Products Regulatory Authority
23 April 2021
CRN00C2N7
Page 2 of 6
There are insufficient data on efficacy and safety available for
children and adolescents below