FLECTOR TISSUGEL EP 1 % Medicated plaster box of 10

Diclofenac sodium (1% w/w) ..............................................................................................................140 mg

As diclofenac epolamine

For a medicated plaster of 10 cm x 14 cm.

Excipients with known effect: propylene glycol (420 mg), methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), polysorbate 80 and Dalin PH fragrance containing benzyl salicylate, alpha-amylcinnamaldehyde, hydroxycitronellal and cinnamic alcohol.

Symptomatic treatment of painful flare-ups of knee osteoarthritis (medical advice will be associated).

Symptomatic treatment of pain of tendon and ligament origin.

Symptomatic treatment in minor trauma: sprains, bruises.

Cutaneous use only.

Dosage

Adults:

• Treatment of painful flare-ups of knee osteoarthritis: 1 application morning and evening.

• Treatment of pain of tendon and ligament origin: 1 application morning and evening.

• Treatment of sprains and bruises: 1 application per day

Duration of administration

The use of FLECTORTISSUGELEP should be as short as possible and depend on the indication:

• Treatment of painful flare-ups of knee osteoarthritis: 7 days, to be continued if necessary, but without exceeding a maximum of 14 days of treatment.

• Treatment of pain of tendon and ligament origin: 7 days. If pain persists after 7 days, a doctor should be consulted to judge whether treatment should be continued.

• Treatment of sprains and bruises: 3 days, extendable up to a maximum of 7 days if needed. In the absence of improvement after 3 days of treatment, a medical consultation is recommended.

If there is no improvement during the recommended treatment duration, a doctor must be consulted.

Elderly subject:

This medicine should be used with caution in elderly people who are more prone to adverse effects (see section Warnings and precautions).

Child:

Due to the absence of specific studies, the use of FLECTORTISSUGELEP is not recommended in children under 15 years of age.

Hepatic or renal impairment:

For the use of FLECTORTISSUGELEP in patients with hepatic or renal impairment, refer to the section Warnings and precautions.

Method of administration

Cut the envelope containing FLECTORTISSUGELEP at the indicated place.

Remove FLECTORTISSUGELEP, peel off the plastic sheet protecting the adhesive surface and apply FLECTORTISSUGELEP to the painful area or joint. If necessary, FLECTORTISSUGELEP can be held in place with a tubular elastic net supplied in the pack.

Carefully reseal the envelope using the zip.

FLECTORTISSUGELEP must be used intact.

This medicine is contraindicated in the following cases:

• Hypersensitivity to the active substances or to any of the excipients listed in section Composition.

• pregnancy, from the beginning of the 6th month (24 weeks of amenorrhoea) (see section Fertility, pregnancy and breastfeeding),

• Damaged skin, whatever the lesion: weeping dermatoses, eczema, infected lesion, burn or wound.

• Patients suffering from an active peptic ulcer.

Do not bring into contact with or apply to mucous membranes or to the eyes.

Do not use under an occlusive dressing.

The appearance of a skin rash after application of FLECTORTISSUGELEP requires immediate discontinuation of treatment.

Concomitant administration of medicinal products containing diclofenac or other NSAIDs, whether by topical or systemic route, is to be avoided.

Although the occurrence of systemic undesirable effects is rare, FLECTORTISSUGELEP must be used with caution in patients with impaired cardiac, renal or hepatic function, in patients with a history of peptic ulcer, inflammatory bowel disease or gastrointestinal bleeding. Non-steroidal anti-inflammatory drugs should be used with particular caution in elderly people, who are more prone to undesirable effects.

This medicine contains methyl parahydroxybenzoate and propyl parahydroxybenzoate. It may cause allergic reactions (possibly delayed). This medicine contains 420 mg of propylene glycol which may cause skin irritation.

This medicine contains polysorbate 80 which may cause skin reactions.

This medicine contains a fragrance containing the following allergens which may cause allergic reactions: benzyl salicylate, alpha-amylcinnamaldehyde, hydroxycitronellal and cinnamyl alcohol.

In order to reduce any risk of photosensitization, patients must be informed to avoid any exposure to solar radiation (sun or UV booths).

Bronchospasm may be provoked in patients with bronchial asthma, allergic disease or an allergy to acetylsalicylic acid or to another NSAID, or with a history of these conditions. FLECTORTISSUGELEP must be used with caution in patients with or without chronic asthma, in whom asthma attacks, urticaria or acute rhinitis are provoked by aspirin or other non-steroidal anti-inflammatory drugs (see section Contraindications).

Due to the low systemic exposure during normal use of FLECTORTISSUGELEP, drug interactions reported for oral diclofenac are unlikely.

Pregnancy

There are no clinical data on the use of FLECTORTISSUGELEP during pregnancy. Even though the systemic exposure to FLECTORTISSUGELEP achieved after topical administration is lower compared with that observed following oral administration, the risk of possible harmful effects on the embryo or foetus is not known.

During the first 5 months of pregnancy, FLECTORTISSUGELEP must not be used except in case of absolute necessity. If used, the dose should be the lowest and the duration of treatment as short as possible.

From the beginning of the 6th month of pregnancy (24 weeks of amenorrhea), systemic use of prostaglandin synthesis inhibitors such as diclofenac may induce cardiopulmonary and renal toxicity in the fetus. At the end of pregnancy, prolonged bleeding time in the mother and child may occur, and labor may be delayed.

Consequently, any use of FLECTORTISSUGELEP is contraindicated from the beginning of the sixth month of pregnancy (24 weeks of amenorrhea) (see section Contraindications.).

Breast-feeding

As NSAIDs pass into breast milk, this medicine is not recommended for women who are breastfeeding.

In case of breastfeeding, this medicine must under no circumstances be applied to the breast.

Fertility

As with all NSAIDs, the use of this medicine may temporarily impair female fertility by affecting ovulation; it is therefore not recommended for women wishing to conceive a child. In women having difficulty conceiving or undergoing fertility testing, discontinuation of treatment should be considered.

Although the occurrence of such effects is very unlikely with the use of skin preparations such as FLECTORTISSUGELEP, patients who have already suffered from dizziness or other central nervous system disorders while taking NSAIDs must refrain from driving vehicles or operating machinery.

Skin reactions are commonly reported.

Skin: pruritus, redness, erythema (including bullous erythema in very rare cases), rashes, application site reactions, allergic dermatitis.

Burning sensations at the application site and skin dryness have been reported at unknown frequencies.

1252 patients were treated with FLECTORTISSUGELEP and 734 with a Placebo in clinical studies. The following adverse effects were reported:

Adverse effects may be reduced by using the minimum effective dose for the shortest possible duration.

In patients using topical NSAID preparations, isolated cases of generalized skin erythema, hypersensitivity reactions such as Quincke's edema, anaphylactic-type reactions and photosensitivity reactions have been reported.

The systemic absorption of Diclofenac is very low compared with plasma levels observed after use of oral forms of Diclofenac, and the probability of systemic adverse effects (such as gastric and renal disorders) is very low compared with the frequency of such effects associated with oral Diclofenac. However, when FLECTORTISSUGELEP is applied over a relatively large skin surface and for a prolonged period, the possibility of systemic adverse effects cannot be excluded.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Centres of Pharmacovigilance - Website: https://signalement.social-sante.gouv.fr/.

Pharmacotherapeutic class: Non-steroidal anti-inflammatory drugs for topical use.

ATC code: M02AA15.

Diclofenac hydroxyethylpyrrolidine, or diclofenac epolamine, is a water-soluble salt of diclofenac.

Diclofenac is a non-steroidal anti-inflammatory drug derived from phenylacetic acid, belonging to the aryl carboxylic acid group.

In the form of a medicated plaster, it has local anti-inflammatory and analgesic activity.

Upon application of the medicated plaster, diclofenac epolamine is absorbed through the skin.

The absorption kinetics at steady state show a prolonged release of the active ingredient, with a maximum plasma concentration of diclofenac (Cmax) of 17,4 ± 13,5 ng/mL, which is reached after approximately 5 hours (Tmax 5,4 ± 3,7 hours).

Diclofenac is highly bound to plasma proteins (approximately 99 %).

The systemic exposure from the medicated plaster compared with that of oral forms of diclofenac in healthy volunteers is of the order of 2 %, estimated from its urinary excretion and that of its metabolites, and from a comparison between studies.

In rats and rabbits, diclofenac epolamine, mono-substance epolamine and epolamine N-oxide (the main metabolite of epolamine in humans) caused embryotoxicity and increased embryolethality after oral administration.

The other preclinical data revealed no particular risk for humans, except for the information reported in the other sections of the Summary of Product Characteristics.

3 years.

After first opening of the sealed envelope: To be stored for a maximum of 3 months.

This medicine does not require any particular storage precautions.

The active substance remaining in the plaster may pose a risk to the aquatic environment. Do not dispose of used plasters in the toilet. Plasters must be disposed of in accordance with national requirements.