Local relief of pain in case of traumatic or rheumatic inflammation caused by
knocks, sprains, twisting, muscular pains and inflammation of tendons and
ligaments

Posology
Apply one medicated plaster to the painful area once to twice a day, in the
morning and/or at night. The total maximum daily dose is 2 medicated plasters,
even if there is more than one injured area to be treated. Only one painful area
must be treated each time.
Method of administration
For use on skin.
The medicated plaster must not be divided up.
If necessary, the medicated plaster can be held in place using an elastic mesh
bandage.
The medicated plaster should not be used with an occlusive bandage.
Duration of use
FLECTOR TISSUGEL must be used for as short a period of time as possible.
It must not be used for longer than 14 days. The therapeutic benefit of using it for
a longer period has not been established

Elderly patients and patients with kidney or liver failure
No recommendations regarding special administration (see section 4.4).
Children and adolescents
FLECTOR TISSUGEL is not recommended for use with children and adolescents of
under 18 years of age due to the lack of data on safety and efficacy.

FLECTOR TISSUGEL must not be used in the following circumstances: - Hypersensitivity to the active principle, or any of the excipients of the medicinal product. - Hypersensitivity to any other analgesic and antirheumatic medication (non-steroid anti-inflammatories [NSAIDs], including acetylsalicylic acid) - Patients who have previously experienced an attack of asthma, urticaria or acute rhinitis due to acetylsalicylic acid or any other NSAID - Active gastroduodenal ulcer - On open wounds, burns, skin infection or eczema - From the beginning of the 6th month of pregnancy

If the symptoms persist or worsen, a doctor should be contacted.
The medicated plaster must not come into contact with the eyes or the mucous
membranes, nor must it be applied to these.
Adverse reactions can be reduced by using the lowest effective dose for as short a
period as possible.
Bronchospasm may occur in patients who suffer or have previously suffered with
bronchial asthma or allergies.
Treatment must be stopped immediately if a skin rash occurs after applying the
medicated plaster.
To reduce the risk of photosensitivity patients must be told to avoid directly exposing
the treated area to the sun and other sources of ultraviolet rays (for example solarium)
for at least one day after removing the medicated plaster.
Although systemic effects are minimal, the medicated plaster must be used with care in
patients with problems associated with kidney, heart or liver function, or who have a
history of gastroduodenal ulcer, intestinal inflammation or hemorrhagic diathesis.
NSAIDs must be used with care in elderly patients, since these patients are more likely
to experience adverse reactions.
FLECTOR TISSUGEL contains methylparahydroxybenzoate and
propylparahydroxybenzoate. It may cause allergic reactions (possibly delayed). It also
contains propylene glycol, which may cause skin irritation.

If the medicated plaster is used correctly, the rate of systemic transfer is low, so that it
is highly unlikely that the interactions listed for oral diclofenac will occur.

Pregnancy
There is not sufficient clinical data on the use of diclofenac on the skin during
pregnancy. Animal studies have revealed reproductive toxicity after systemic
administration (see section 5.3).
The potential risk for humans is unknown. Therefore FLECTOR TISSUGEL must be
used during the first 5 months of pregnancy after carefully evaluating the risk benefit
ratio and is contra-indicated from the beginning of the 6th month of pregnancy.
During the third trimester of pregnancy, all the prostaglandin synthesis inhibitors may
expose the foetus to:
- cardiopulmonary toxicity (with premature closure of the ductus arteriosus and
pulmonary hypertension);
- renal dysfunction, which may progress to kidney failure with oligohydroamniosis
in both the mother and the newborn, at the end of pregnancy;
- possible extension of bleeding time, an antiaggregant effect which may occur even at
very low doses;
- inhibition of uterine contractions resulting in a delayed or extended labour.
Lactation
Experimental data regarding excretion of diclofenac epolamine in human or animal
milk are not available therefore, FLECTOR TISSUGEL is not recommended in nursing
mothers.

No effects on ability to drive and use machines are expected from using the product.

The medicated plaster is generally very well tolerated with mild, localised and selfresolving
cutaneous reactions as the main adverse events.
Within each System Organ Class, the adverse reactions are classified according to
frequency of observation, using the following convention: very common (>1/10);
common (>1/100, <1/10), uncommon (>1/1.000, <1/100); rare (>1/10.000, <1/1.000);
very rare (<1/10.000); unknown (not assessable based on the available data). The most
appropriate MedDRA term (version 12.0) is listed to describe a certain reaction.
Synonyms or related conditions are not listed, but should be taken into consideration as
well.
Skin and subcutaneous tissue disorders:
- Common (from ≥ 1/100 to < 1/10): pruritus,
- Uncommon (from ≥ 1/1,000 to < 1/100): redness, burning sensation, oedema, erythema
(including in very rare cases erythema bullosum), skin rash, sometimes with papules or
vesicles, exfoliative skin
In patients who use topical NSAIDs, isolated cases of generalized skin rash, skin
atrophy, skin discolouration, reactions of hypersensitivity, such as angioedema,
reactions of an anaphylactic type and photosensitivity have been notified.
Since systemic plasma diclofenac levels measured during labelled use of FLECTOR
TISSUGEL medicated plasters are hundred-fold lower compared to those obtained after
oral intake of diclofenac, the risk to develop systemically induced side effects (e.g.
adverse gastric, or renal reactions) appears therefore to be unlikely. However, when the
medicated plaster is used over larger areas and over a prolonged period, the possibility
of systemic induced side effects cannot be excluded

No cases of overdose have been notified.
If serious adverse reactions occur after incorrect use or accidental overdose (e.g. in
children), the precautionary measures appropriate for cases of NSAID poisoning must
be taken.

Pharmacotherapeutic group: preparations with non steroid anti-inflammatories for
topical use
ATC code: M02AA15
Diclofenac is a non-steroid analgesic/antiinflammatory that, in standard animal models
of inflammation, has shown that it effectively inhibits prostaglandin synthesis. In
humans, diclofenac reduces the pain, inflammation and fever caused by inflammation.
In addition, diclofenac reversibly inhibits the platelet aggregation induced by ADP
and collagen

Diclofenac is absorbed slowly and incompletely from skin formulations. Plasma
concentrations of diclofenac in equilibrium are characterized by the continuous and
sustained absorption of diclofenac from the plaster during the plaster’s application
period, independently of whether or not the plaster is applied in the morning or at
night. After administration to the skin, it is possible that diclofenac i s absorbed int o
a d e rma l de po s i t , whence it is slowly released into the central compartment.
Consistently, in the therapeutic clinical trials the plaster was found to provide a
sustained pain relief lasting 12-to-24 hours.
The therapeutic efficacy observed is mainly explained by the tissue concentrations of
the active principle which are therapeutically significant below the site of application.
Penetration into the site of action may vary according to the degree and type of
problem and the areas of administration and action.
After 2 days of twice-daily FLECTOR TISSUGEL plaster applications, plasma levels
of diclofenac are in steady state and in the order of mean 1.3 – 3.5 ng/ml (4 – 12
nmol/L).
Diclofenac’s bond with plasma proteins is high, at 99%. Since diclofenac is slowly
released from the tissues under the application site to the systemic circulation, the
plasma elimination half-life of diclofenac after single as well as repeated 12-hour
applications and subsequent removal of the medicated plaster is approximately 12
hours. Once in the blood, the pattern of diclofenac metabolism is the same after topical
and oral administration. The metabolites are mainly excreted through the urine (>60%)
and in feces (30%).

Data from non-clinical studies based on conventional pharmacological safety studies,
genotoxicity, and carcinogenic potential, did not reveal any special risks for human
beings beyond those described in other sections of the data sheet. In studies performed
on animals, chronic toxicity of diclofenac after systemic administration mainly
concerned lesions and ulcers. In a 2-year study on toxicity, rats treated with diclofenac
showed a dose-dependent increase of thrombotic occlusion of cardiac vessels.
Studies on experimental animals relating to reproductive toxicity revealed that
diclofenac administered systemically inhibited ovulation in rabbits, and rendered
embryo implantation and early development impossible in rats. Diclofenac prolongs
the gestation period and the duration of labour. The embryotoxic potential of
diclofenac was studied in three animal species (rat, mouse and rabbit). Foetal death
and delayed growth occurred at maternotoxic dose levels. According to the data
available, diclofenac is classified as non teratogenic. Doses below the maternotoxic
threshold had no effect on the postnatal development of the young animals.
Also, diclofenac epolamine and epolamine monosubstance have caused
embryotoxicity and increased embryolethality after oral administration in rats and
rabbits.
Conventional studies on local tolerability did not indicate any special risk in humans

Gelatine,
Povidone (K90),
Liquid sorbitol (non crystallising),
Heavy kaolin,
Titanium dioxide (E171),
Propylene glycol,
Methyl parahydroxybenzoate,
Propyl parahydroxybenzoate,
Disodium edetate,
Tartaric acid,
Aluminium glycinate,
Carmellose sodium,
Sodium polyacrylate,
1,3-butylene glycol,
Polysorbate 80,
Dalin PH perfume (propylene glycol, benzyl salicylate, phenylethyl alcohol, alpha
amylcinnamic aldehyde, hydroxycitronellal, phenyethyl phenylacetate, cinnamyl
acetate, benzyl acetate, terpineol, cinnamic alcohol, cyclamenaldehyde),
Purified water.
Unwoven polyester support and protective layer of polypropylene

Not applicable

3 years Shelf life once the packet is open: 3 months

Store in original packaging and keep the packet perfectly sealed to protect the plasters
from drying out and from light, do not store above 25° C.

Sealed packets, which can be hermetically re-sealed, made of
paper/polyethylene/aluminium/ethylene and methacrylic acid copolymer containing 2
or 5 medicated plasters

Each container holds 2, 5 or 10 medicated plasters.

Used plasters must be folded in half, with the adhesive side facing inwards. Do not
flush used plasters down the toilet. Place them in common waste disposal systems
according to local requirements.
Store and dispose out of the reach of children and pets.