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FLECTOR TISSUGEL 140MG MEDICATED PLASTER

Active substance(s): DICLOFENAC EPOLAMINE

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PATIENT LEAFLET: Information for the user
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.

Flector® Tissugel
140 mg
Medicated plaster

FI/149 (UK) xxxx Ed. I/02.14

Diclofenac sodium
(as diclofenac epolamine)

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 6th
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 to your doctor or pharmacist before using
Flector Tissugel if:
· You have heart disease
· You have kidney disease

· You have liver disease
· You have had stomach ulcers in the past
· You have inflammatory bowel disease such as Crohn’s
disease or ulcerative colitis or you are susceptible to
bleeding from your bowel
· You have asthma
· You have breathing problems, skin rash or a runny
nose after taking acetylsalicylic acid (aspirin) or other
NSAIDs
· You are taking diclofenac or other NSAIDs, as an oral
or topical preparation
· You regularly use a sun-bed or sunbathe
· You are elderly as you may be more prone to side
effects.
Children and adolescents
Do not use in case of children or adolescent aged less
than 16 years
Other medicines and Flector Tissugel
If Flector Tissugel is correctly used the risk of
interaction with other medicinal products is very low.
However inform your doctor or pharmacist if recently
you used or took or you are currently using or taking
any other medicines.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor
or pharmacist for advice before taking this medicine.
Flector Tissugel must not be used if you are entering
or are already beyond your 6th month of pregnancy, as
it could harm your unborn child or cause problems at
delivery. Flector Tissugel should only be used under
medical advice before the 6th month of pregnancy and
the dose should be kept as low and duration of treatment
as short as possible.
Flector Tissugel should only be used under medical
advice during breast-feeding as diclofenac passes into
breast milk in small amounts. However, Flector Tissugel
should not be applied on the breasts of nursing mothers
nor elsewhere on large areas of skin or for a prolonged
period of time.
Consult your doctor or pharmacist for further information
if you are pregnant or breastfeeding.
Driving and using machines
Diclofenac medicated plaster application has no
influence on the ability to drive and use machines.
Flector Tissugel contains
· preservatives known as parahydroxybenzoates
which may cause allergic reactions (possibly
delayed)
· and propylene glycol, which may cause skin
irritation.
3. HOW TO USE FLECTOR TISSUGEL
Always use Flector Tissugel exactly as your doctor has
told you.

Important:
Your doctor will choose the dose that is right for
you. Your dose will be shown clearly on the label
that your pharmacist puts on your medicine. If it
does not, or you are not sure, ask your doctor or
pharmacist.
Adults or adolescents 16 years of age and over
How many plasters to use
•• Tennis elbow or golfer’s elbow
· Apply one plaster in the morning
· Remove the plaster in the evening and apply a new
one
· Remove the plaster in the morning
· Repeat these steps for a maximum of 14 days.
•• Ankle sprains
· Apply one plaster per day
· Remove the plaster the next day and apply a new
one
· Repeat these steps for a maximum of 3 days.
Remember: Ankle sprains will normally improve
within 3 days and elbow pain within 14 days. If they
do not, or if your symptoms get worse, tell your
doctor.
Use in children and adolescents (under 16 years
of age)
There are insufficient data on efficacy and safety
available for children and adolescents below 16 years
(see Do not use Flector Tissugel).
In children aged 16 years and over, if the symptoms
worsen, the patient/parents of the adolescent is/are
advised to consult a doctor.
How to apply Flector Tissugel
· Cut the top off the resealable sachet, take out a
plaster and carefully close the seal.
· Record the date on which the sachet was opened in
the space provided
· Remove the plastic backing protecting the sticky side
of the plaster.
· Apply the plaster to the skin around the painful or
swollen area. If necessary, it may be held in place
with an open weave gauze bandage or thin strips of
tape. These can be obtained from your pharmacist.
· Do not cover the plaster with any other kind of
dressing.
· The medicated plaster should be applied only to
intact, non-diseased skin, and not to skin wounds or
open injuries, and should not be worn when bathing
or showering.
· Take care to keep the gel away from your eyes, nose,
mouth, genital and anal areas. If gel does come into
contact with these, rinse away with water.
· The plaster should not be cut.
If you forget to use Flector Tissugel
Do not apply an additional plaster to make up for
a missed dose. Simply apply your next plaster as
planned.
If you have any further questions about the use of this
medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines Flector Tissugel can cause side
effects, although not everybody gets them.
Some uncommon and very rare side effects might
be serious
If you experience any of the following signs of allergy,
STOP using Flector Tissugel and tell a doctor or a
pharmacist immediately:
- Swelling of the lips, eyes or tongue, wheezing or
asthma attack which are signs of severe allergic
reaction (affect less than 1 user in 10,000),
- Rash, stinging or burning at the site where the
plaster was applied (affect 1 to 10 users in 1,000).
Other side effects which may occur are usually
mild, passing and harmless (if you are concerned,
tell a doctor or pharmacist).
Common side effects (affect 1 to 10 users in 100)
· Itchy skin.
Uncommon side effects (affect 1 to 10 users in 1,000)
· Skin rash
· Redness of the skin
· Tiny red or purple coloured spots under the skin
Rare side effects (affect 1 to 10 users in 10,000)
· Dry scaly skin
· Swelling at the site where the plaster was applied.
Very rare side effects (affect less than 1 user in 10,000)
· Skin rashes made worse by sunlight
Because Flector Tissugel is applied to the skin over the
affected area, there is less risk of unwanted effects,
such as stomach problems including pain, indigestion,
or any signs of bleeding in the stomach or intestine, that
can occur when diclofenac is taken by mouth. However,
if Flector Tissugel is not used correctly, these unwanted
effects could occur.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects
directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more
information on the safety of this medicine.

Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will
help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Flector Tissugel contains
The active substance is diclofenac epolamine. Each
medicated plaster contains a total of 180 mg of
diclofenac epolamine, corresponding to 140 mg
diclofenac sodium (1% w/w).
The other ingredients are gelatine, povidine (K90),
sorbitol, kaolin, titanium dioxide (E171), propylene
glycol,
methylparahydroxybenzoate
(E218),
propylparahydroxybenzoate (E216), disodium edetate
(E385), tartaric acid, aluminium glycinate, carmellose
sodium, sodium polyacrylate, 1,3-butylene glycol,
polysorbate 80, fragrance (propylene glycol, benzyle
salicylate, phenyl ethyl alcohol, alpha amyl cinnamic
aldehyde, hydroxycitronellal, phenylethyl phenylacetate,
cinnamyl acetate, benzyl acetate, terpineol, cinnamic
alcohol, cyclamenaldehyde.), purified water and
unwoven polyester support.
What Flector Tissugel looks like and contents of
the pack
Each medicated plaster consists of a white to pale
yellow paste impregnated into a dressing with a
removable clear plastic backing protecting an adhesive
layer. Resealable sachets contain either 2 or 5 plasters.
Flector Tissugel comes in packs of 2, 5, 10 and 14
plasters per box. Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing authorization holder
IBSA Farmaceutici Italia srl,
Via Martiri di Cefalonia 2
26900 Lodi, Italy
Manufacturers
Laboratoires Genévrier,
280 rue de Goa
Z.I. Les Trois Moulins, Parc de Sophia Antipolis
06600 Antibes, France

5. HOW TO STORE FLECTOR TISSUGEL

and
Altergon Italia srl
Zona Industriale
83040 Morra De Sanctis (AV)
Italy

Keep this medicine out of the sight and reach of children.

This leaflet was last revised in January 2014.

Do not use this medicine after the expiry date which is
stated on the sachet and carton. The expiry date refers
to the last day of that month.

If this leaflet is difficult to see or read or you would
like it in a different format, please contact IBSA
Farmaceutici Italia srl, via Martiri di Celfalonia, 2 –
26900 Lodi, Italy.

Do not store above 25°C
Do not use after 3 months after first opening the sachet.
After removing each plaster, ensure the sachet is
resealed.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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