In this manual :
1. WHAT IS FLECTORTISSUGELEP 1%, medicated plaster and WHEN IS IT USED?
2. WHAT YOU SHOULD KNOW BEFORE USING FLECTORTISSUGELEP 1%, medicated plaster
3. HOW DO I USE FLECTORTISSUGELEP 1% medicated plaster?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO USE FLECTORTISSUGELEP 1%, medicated plaster?
6. ADDITIONAL INFORMATION
1. WHAT IS FLECTORTISSUGELEP 1%, medicated plaster and WHEN IS IT USED?
Pharmacotherapeutic class
This medicine is a non-steroidal anti-inflammatory drug (NSAID).
This medicine is indicated in adults (over 15 years of age) for the symptomatic treatment of pain of tendino-ligamentary origin, and post-traumatic pain: sprains and contusions.
This medicine is indicated in adults for the treatment of painful flare-ups of osteoarthritis of the knee, after an initial medical opinion.
2. WHAT YOU SHOULD KNOW BEFORE USING FLECTORTISSUGELEP 1%, medicated plaster
List of information needed before taking the medicine
Not applicable.
Never use FLECTORTISSUGELEP 1%, medicated plaster
- if you are allergic to Diclofenac, aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs) or to any of the other ingredients of this product (see What does FLECTORTISSUGELEP 1% medicated plaster contain?).
- If you have broken skin, regardless of the lesion: oozing lesions, eczema, infected lesions, burns or wounds.
- In case of an evolving digestive ulcer.
- From the 6th month of pregnancy
In case of doubt, it is essential to ask your doctor or pharmacist for advice.
Precautions for use; special warnings
Be careful with FLECTORTISSUGELEP 1%, medicated plaster
This medicine is for adults only (over 15 years of age).
Do not apply to mucous membranes or the eyes. Do not use under occlusive bandages.
If a rash appears after application, treatment must be stopped immediately.
In order to avoid any risk of skin reaction during exposure to solar radiation (photosensitisation), it is preferable to avoid any direct exposure to the sun or in a UV cabin during the treatment.
Never apply more than the recommended dose (see Dosage).
Respect the frequency and duration of treatment indicated in this leaflet or recommended by your doctor.
To be used with caution under medical supervision:
- if you have heart, kidney or liver disease,
- in case of a history of ulcer or digestive bleeding and,
- in cases of inflammatory bowel disease.
- in subjects with a history of asthma, allergic disease or allergy to aspirin or other NSAIDs, administration of this drug may result in respiratory discomfort or an asthma attack.
By extrapolation with other routes of administration.
Interactions with other drugs
Taking or using other medications
Talk to your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
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FLECTORTISSUGELEP contains the anti-inflammatory drug Diclofenac.
You should not take other medicines, either systemic or for application to the skin, containing Diclofenac or other non-steroidal anti-inflammatory drugs with this medicine.
Read the package insert of other medicines you are taking carefully to make sure they do not contain Diclofenac and/or non-steroidal anti-inflammatory drugs.
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Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breastfeeding
Pregnancy
During the first and second trimesters of pregnancy, this medicine should only be used on the advice of your doctor and taken for short periods. Prolonged use of this medicine is strongly discouraged.
From the beginning of the 6th month of pregnancy, you should NOT take this medicine under any circumstances, as its effects on your child may have serious consequences, particularly in terms of cardio-pulmonary and renal health, even with a single dose.
If you have taken this medicine when you are more than five months pregnant, talk to your obstetrician-gynecologist so that appropriate monitoring can be offered to you.
Ask your doctor or pharmacist for advice before taking any medicine.
Breastfeeding
There are no experimental data on the excretion of Diclofenac epolamine into human or animal milk, therefore, the use of FLECTORTISSUGELEP should be avoided when breast-feeding.
Ask your doctor or pharmacist for advice before taking any medication.
Not applicable.
Effects on ability to drive and use machines
Driving and using machines
Although the occurrence of such effects is very unlikely when using skin preparations such as FLECTORTISSUGELEP, patients who have previously experienced dizziness or other central nervous system disorders while taking NSAIDs should not drive or operate machinery.
List of excipients with a known effect
List of excipients with a notable effect:propylene glycol, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216).
3. HOW TO USE FLECTORTISSUGELEP 1% medicated plaster
Instructions for proper use
Not applicable.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
Always follow the dosage instructions given by your doctor. In case of uncertainty, consult your doctor or pharmacist.
Dosage
FLECTORTISSUGELEP is used topically at the following dosage:
- Treatment of painful flare-ups of osteoarthritis of the knee: 7 days, to be continued, if necessary, but not exceeding a maximum of 14 days of treatment.
- Treatment of pain of tendino-ligamentary origin: 7 days. If pain persists after 7 days, consult your doctor, who will decide whether to continue the treatment.
- Treatment of sprains and bruises: 3 days, up to 7 days maximum if necessary. If there is no improvement after 3 days of treatment, consult your doctor.
If there is no improvement during the recommended treatment period, a doctor should be consulted.
Method of administration
1. Cut the envelope containing FLECTORTISSUGELEP (box of 2, 5, 10 or 14 medicated plasters) where indicated.
2. Remove one FLECTORTISSUGELEP and carefully close the envelope with the slide.
3. Remove the clear plastic sheet that protects the adhesive surface of FLECTORTISSUGELEP.
4. Apply the adhesive surface of FLECTORTISSUGELEP to the joint or painful area.
FLECTORTISSUGELEP can be held in place by an elastic net, if the area to be treated requires it.
In all cases, follow the recommendations of your doctor or pharmacist.
Symptoms and instructions in case of overdose
If you have used more FLECTORTISSUGELEP 1%, medicated plaster than you should have
You should tell your doctor or pharmacist.
Instructions in case of missed doses
If you forget to use FLECTORTISSUGELEP 1% medicated plaster
Do not take a double dose to make up for the dose you forgot to take.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, FLECTORTISSUGELEP 1%, medicated plaster is likely to have side effects, although not everyone is susceptible.
If you notice any side effects not listed in this leaflet, or if you experience any of the effects listed as serious, please tell your doctor or pharmacist.
- Skin reactions are sometimes reported: itching, redness of the skin, rash, eczema, skin inflammation.
- Allergic reactions or skin reactions after exposure to the sun and UV light have been observed in exceptional cases.
In all such cases, treatment should be stopped immediately and your doctor notified.
- Other general effects of non-steroidal anti-inflammatory drugs may also occur, depending on the condition of the treated area and the duration of treatment.
In these cases, you should inform your doctor.
5. HOW TO STORE FLECTORTISSUGELEP 1%, medicated plaster
Keep out of the reach and sight of children.
Do not use FLECTORTISSUGELEP 1% medicated plaster after the expiry date stated on the box. The expiry date refers to the last day of the month.
Store at a temperature not exceeding +25°C.
After first opening the sealed envelope: Store for a maximum of 3 months.
Do not dispose of the medicine in the sewage system or in the household waste. Ask your pharmacist what to do with unused medicines. This will help protect the environment.
If necessary, warnings about visible signs of deterioration
Medicines should not be disposed of down the drain or in the household waste. Ask your pharmacist what to do with unused medicines. This will help to protect the environment.
6. ADDITIONAL INFORMATION
Full list of active ingredients and excipients
What does FLECTORTISSUGELEP 1% medicated plaster contain?
The active substance is:
Diclofenac sodium (1% w/w) ...................................................................................................... 140 mg
As diclofenac epolamine
For a medicated plaster of 10 cm x 14 cm.
The other components are:
Carrier:
Polyester non-woven backing.
Adhesive layer (active gel):
Gelatin, povidone K90, liquid sorbitol (non-crystallizable), heavy kaolin, titanium dioxide (E 171), propylene glycol, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), disodium edetate (E 385), tartaric acid, aluminium aminoacetate, sodium carmellose, sodium polyacrylate, 1,3-butylene glycol, polysorbate 80, perfume DALIN PH (propylene glycol, benzyl salicylate, phenyl ethyl alcohol, alpha amylcinnamic aldehyde, hydroxycitronellal, phenyl ethyl acetate, cinnamyl acetate, benzyl acetate, terpineol, cinnamic alcohol, cyclamenaldehyde), purified water.
Pharmaceutical form and content
What is FLECTORTISSUGEP 1%, MEDICINAL SPRAY and what does it contain?
This medicine is in the form of a medicated plaster. The plasters are packaged in a sealed envelope containing 2 or 5 plasters.
Not all presentations may be marketed.
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
Laboratoires GENEVRIER SA
280, rue de Goa
Les Trois Moulins - Parc de Sophia Antipolis
06600 Antibes
Operator
LABORATOIRES GENEVRIER S.A.
280 RUE DE GOA
LES TROIS MOULINS
PARC DE SOPHIA ANTIPOLIS
06600 ANTIBES
Manufacturer
LABORATOIRES GENEVRIER S.A.
280 RUE DE GOA
LES TROIS MOULINS
PARC DE SOPHIA ANTIPOLIS
06600 ANTIBES
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the package leaflet
The last date on which this package insert was approved was {date}.
MA under exceptional circumstances
Not applicable.
Detailed information on this medicinal product is available on the website of Afssaps (France).
Information for healthcare professionals only
Not applicable.
HEALTH EDUCATION ADVICE
If you have just suffered a trauma or contusion, or if you have osteoarthritis of the knee, you can use FLECTORTISSUGELEP to relieve your pain, but:
If you have a sprained ankle
- if you absolutely cannot stand on your leg to take 4 steps,
- or if a haematoma (bruise) appears within 24 to 48 hours or if there is a deformation or a very important oedema (swelling), you must consult your doctor who alone will judge the necessity of an X-ray and an orthopaedic treatment.
In case of tendino-ligamentary pain
if the pain is such that you cannot use the upper or lower limb that is causing you pain, you must consult your doctor without delay.
In case of knee osteoarthritis, your doctor has made the diagnosis your doctor has diagnosed your knee osteoarthritis and has prescribed a treatment with FLECTORTISSUGELEP which should allow your pain to diminish or even disappear completely within 15 days. If a new attack of pain occurs, you will recognize your mechanical pain when going up and down stairs or when walking, especially on uneven ground. You can use FLECTORTISSUGELEP under these conditions. If the pain is different: predominantly nocturnal or accompanied by redness, rash, severe swelling, fever, malaise or diffuse pain, you should consult your doctor immediately.
In all cases
if there is a complete functional impotence, you must consult your doctor without delay.
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