FLECTOR TISSUGELEP 1% 5 EMPLATERS: Symptomatic treatment of painful flares of osteoarthritis of the knee (a medical opinion will be associated). Symptomatic treatment of tendon-ligament pain. Symptomatic treatment in benign traumatology: sprains and bruises
The sprain is a joint trauma that occurs most often after a fall. It induces spontaneous recovery with rest and immobilization (plaster / splint), as well as with physiotherapy work in some cases. Sprain can lead to trauma-related sequelae. The repetitive sprain is linked to the fragility of the joint that arose during the initial sprain.
Flector tissugel is a drug indicated, in adults (over 15 years), as a symptomatic treatment of pain of tendino-ligament origin , and post-traumatic pain : sprains and bruises. This medication is indicated in adults for the treatment of painful flares of osteoarthritis of the knee, after a first medical opinion. EP.
Sprains are stretching or tearing of ligaments at the joints. The most common are ankle sprains. The sprains follow an abnormal movement undergone by the joint, causing it to perform a torsion which is not articulated in the usual axis. This is why sprains are more frequently encountered in children or sportsmen.
Symptoms to recognize sprains are variable: pain , edema , bruising , heat ... These signals show that this phenomenon is associated with an inflammatory condition of the joint. It is therefore interesting to treat them orally or locally with molecules with anti-inflammatory properties such as diclofenac or ibuprofen. Arnica topical gels are also very effective in treating small sprains.
Local treatments are sometimes combined with active ingredients that restore a feeling of cold , allowing rapid pain relief. The first attitude to have when facing a sprain is the application of ice and the strict rest of the joint, sometimes requiring the use of canes . It is also advisable to raise the affected limb to facilitate the elimination of edema. More severe sprains are also treated by orthopedic measures such as the wearing of wrist splints or ankle braces .
Always take the dose recommended by your doctor. If you are uncertain, consult your doctor or pharmacist.
FLECTORTISSUGELEP is used in local application at the following dose :
Without improvement during the recommended treatment period, a doctor should be consulted.
We advise you in addition to treatment, the use of Piasclédine effective in osteoarthritis .
Oligosol® fluorine Used as a field modifier, especially during minor ligament injuries in adults. Take one vial a day sublingually in the morning on an empty stomach; leave under the tongue for a minute before swallowing
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.
Cutaneous use only.
The ankles, orthoses allow a controlled mobilization of the joint and avoid reproducing the mechanism causing the trauma. According to their elasticity, their rigidity, the presence of reinforcements or straps, they give the joint a greater or lesser stabilization, analgesia (reduction of pain), drainage of edema, reduction of joint stiffening, effect proprioceptive and scarring.
The larger the lesion, the more essential it is to stabilize the joint.
It is possible to immobilize the sprained joint with a bandage that is not too compressive, the edema being liable to progress. Adhesive elastic compression bands (Elastoplast®, Tensoplast®.) Or cohesive (Coheban®) are used in this case. A strapping, a bandage allowing flexible immobilization, can be carried out by a physiotherapist or a doctor for whom the technique is mastered.
The ankle pads or knee pads can be used in simple strains, but are rather reserved in prevention of the resumption of a sporting or professional activity after a trauma. For benign sprains, the use of ankle braces or ligament knee braces is preferred. They have straps that should not be too tight or not enough, or lateral reinforcements that strengthen the injured ligaments and promote ligament healing. The kneepads exist with or without patellar opening, the patellar recess allowing the reduction of the pressure on the patella (Ligastrap®, Gibortho® ligament.).
Diclofenac sodium 140 mg for 1 medicated plaster 10 cm x 14 cm (in the form of diclofenac epolamine). Excipients with known effect: propylene glycol, methyl parahydroxybenzoate (E218), propyl parhydroxybenzoate
Box of 5 LOCATIONS.
Pharmacovigilance Report an adverse drug reaction(s)
ANSM - Last updated: 10/07/2017
FLECTORTISSUGELEP 1%, medicated plaster
Sodium diclofenac
You should always use this medication exactly as prescribed in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Ask your pharmacist for advice or information.
· If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
· You should talk to your doctor if you do not feel better or feel less well.
1. What is FLECTORTISSUGELEP 1%, medicated plaster and in which cases it is used?
2. What should I know before using FLECTORTISSUGELEP 1%, medicated plaster?
3. How to use FLECTORTISSUGELEP 1%, medicated plaster?
4. What are the possible side effects?
5. How to store FLECTORTISSUGELEP 1%, medicated plaster?
6. Package contents and other information.
1. WHAT FLECTORTISSUGELEP 1%, medicated plaster AND WHAT IT IS USED FOR?
Pharmacotherapeutic group - This drug is a nonsteroidal anti-inflammatory drug (NSAID).
This medication is indicated in adults (over 15 years of age) for symptomatic treatment of tendon-ligament pain and post-traumatic pain: sprains and bruises.
This medication is indicated in adults in the treatment of painful spurts of osteoarthritis of the knee, after an initial medical opinion.
2. BEFORE YOU USE FLECTORTISSUGELEP 1%, medicated plaster?
Never use FLECTORTISSUGELEP 1%, medicated plaster:
· if you are allergic to Diclofenac, aspirin or other NSAIDs or any of the other ingredients of this product (see What contains FLECTORTISSUGELEP 1%, medicated plaster)?
· If you have damaged skin, regardless of the lesion: oozing lesions, eczema, infected lesion, burn or wound.
· In case of an evolutionary digestive ulcer.
· From the 6th month of pregnancy
If in doubt, it is essential to seek the advice of your doctor or pharmacist.
Warnings and Precautions
Take special care with FLECTORTISSUGELEP 1%, medicated plaster
This medication is for adults only (over 15 years).
Do not apply on mucous membranes or eyes. Do not use under occlusive dressing.
The appearance of a rash after application requires immediate cessation of treatment.
To avoid the risk of skin reaction when exposed to sunlight (photosensitization), it is preferable to avoid direct exposure to the sun or UV cabin during treatment.
Never apply a dose higher than recommended (see Dosage).
Observe the frequency and duration of treatment indicated in this leaflet or recommended by your doctor.
Use with caution under medical supervision:
· in case of heart, kidney or liver disease,
· in case of a history of ulceration or digestive bleeding and,
· in the case of inflammatory bowel disease.
· in subjects with a history of asthma, allergic disease or allergy to aspirin or other NSAIDs, the use of this medication may cause respiratory distress or an asthma attack.
By extrapolation with other routes of administration.
children
Not applicable.
Other drugs and FLECTORTISSUGELEP 1%, medicated plaster
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
FLECTORTISSUGELEP contains an anti-inflammatory: Diclofenac. You should not take any other medicines, either by the general route or intended for application to the skin, containing Diclofenac or other non-steroidal anti-inflammatory drugs. Read the leaflet carefully before you start taking any of the other medicines you are taking to ensure that you are not taking Diclofenac and / or non-steroidal anti-inflammatory drugs. |
FLECTORTISSUGELEP 1%, medicated plaster with food and beverages.
Not applicable.
Pregnancy
During the first and second trimesters of pregnancy, this medication can only be used on the advice of your doctor and in brief dosage. Prolonged use of this medication is strongly discouraged.
From the beginning of the 6th month of pregnancy, you should NOT take this medication because its effects on your child can have serious consequences, especially on a cardiopulmonary and renal plan, even with a single dose.
If you have taken this medication while you are pregnant for more than five months, talk to your obstetrician gynecologist for appropriate monitoring.
Ask your doctor or pharmacist for advice before taking any medicine.
feeding
There are no experimental data concerning the excretion of Diclofenac epolamine in human or animal milk, therefore use of FLECTORTISSUGELEP should be avoided in case of breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Although the occurrence of such effects is highly unlikely when using skin preparations such as FLECTORTISSUGELEP, patients who have experienced dizziness or other central nervous system disorders while taking NSAIDs should refrain from drive vehicles or use machines.
FLECTORTISSUGELEP 1%, medicated plaster contains propylene glycol, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216).
3. HOW TO USE FLECTORTISSUGELEP 1%, medicated plaster?
Always take the dose recommended by your doctor. In case of uncertainty consult your doctor or pharmacist.
Dosage
FLECTORTISSUGELEP is used as a local application at the following dose:
· Treatment of painful relapses of osteoarthritis of the knee: 7 days, to continue, if necessary, but without exceeding 14 days of treatment to the maximum.
· Treatment of tendin-ligament pain: 7 days. If pain persists after 7 days, consult your doctor, who alone will decide the need for further 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.
Without improvement during the recommended treatment period, a physician should be consulted.
Administration mode
1. Cut the envelope containing FLECTORTISSUGELEP (box of 2, 5, 10 or 14 medicated plasters) to the indicated location.
2. Remove a FLECTORTISSUGELEP and carefully close the envelope by means of the slide.
3. Remove the transparent plastic sheet that protects the FLECTORTISSUGELEP adhesive surface.
4. Apply the adhesive surface of FLECTORTISSUGELEP to the joint or to the painful area.
FLECTORTISSUGELEP can be held in place by the tubular elastic net provided, if the area to be treated requires it.
In all cases, follow the recommendations of your doctor or pharmacist.
If you used more FLECTORTISSUGELEP 1%, medicated plaster than you should have
You should tell your doctor or pharmacist.
If you forget to use FLECTORTISSUGELEP 1%, medicated plaster
Do not take a double dose to make up for a missed dose.
If you stop using FLECTORTISSUGELEP 1%, medicated plaster
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
· Skin reactions are sometimes reported: itching, redness of the skin, rashes, eczema, skin inflammation.
· Exceptionally, allergic reactions or skin reactions have been observed after exposure to the sun and UV.
· In all these cases, you should stop treatment immediately and notify your doctor.
· Other general effects of non-steroidal anti-inflammatory drugs may also occur, depending on the condition of the surface treated and the duration of the treatment.
· In these cases, you should tell your doctor.
Declaration of side effects
If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr
By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE FLECTORTISSUGELEP 1%, medicated plaster?
Keep this medicine out of the reach and sight of children.
Do not use FLECTORTISSUGELEP 1%, medicated plaster after the expiry date stated on the carton. The expiry date refers to the last day of the month.
Store at a temperature not exceeding + 25 ° C.
After 1 st opening of the sealed envelope: Keep at the most 3 months.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What FLECTORTISSUGELEP 1% contains, medicated plaster
· The active substance is:
Sodium diclofenac (1% w / w) ........................................ 140 mg
In the form of diclofenac epolamine
For a medicated plaster of 10 cm x 14 cm.
· The other components are:
Support:
Polyester nonwoven support.
Adhesive layer (active gel):
Gelatin, povidone K90, liquid sorbitol (uncrystallizable), heavy kaolin, titanium dioxide (E 171), propylene glycol, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E 216), tartaric acid , aluminum amino-acetate, sodium carmellose, sodium polyacrylate, 1,3-butylene glycol, polysorbate 80, DALIN PH perfume (propylene glycol, benzyl salicylate, phenylethyl alcohol, alpha amylcinnamic aldehyde, hydroxycitronellal, phenylethyl phenylacetate, cinnamyl acetate, benzyl acetate, terpineol, cinnamic alcohol, cyclamenaldehyde), purified water.
What is FLECTORTISSUGELEP 1%, medicated plaster and contents of the pack
This medication is in the form of a medicated plaster. The plasters are packaged in a sealed envelope containing 2 or 5 plasters.
Each package contains a tubular elastic net.
Not all pack sizes may be marketed.
Marketing Authorization Holder
280, RUE DE GOA
THE THREE MILLS - SOPHIA ANTIPOLIS PARK
06600 ANTIBES
Marketing Authorization Operator
LABORATOIRES GENEVRIER SA
280, RUE DE GOA
THE THREE MILLS - SOPHIA ANTIPOLIS PARK
06600 ANTIBES
ZONA INDUSTRIALE
83040 MORRA DE SANCTIS AVELLINO
ITALY
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
The last date on which this leaflet was revised is:
[to be completed later by the holder]
Detailed information on this medicine is available on the ANSM website (France).
Health Education Council
You have just undergone trauma or bruising, or you have osteoarthritis of the knee, you can use FLECTORTISSUGELEP to relieve your pain but:
In case of ankle sprain
· if you absolutely can not put yourself in support on the leg to do 4 steps,
· or if a hematoma (blue) appears within 24 to 48 hours or if there is a significant distortion or edema (swelling) you should consult your doctor who alone will judge the need for x-rays and orthopedic treatment .
In case of tendon-ligament pain :
If the pain is such that you can not use the upper or lower limb that makes you suffer, you should consult your doctor without delay.
In case of osteoarthritis of the knee, your doctor has made the diagnosis and has prescribed you a treatment by FLECTORTISSUGELEP which must allow your pain to diminish or even completely disappear in 15 days. If a new painful surge appears, you will recognize your mechanical pain as you climb up and down stairs or walk, especially in rough terrain. Under these conditions, you can use FLECTORTISSUGELEP. If the pain is different: nocturnal preponderance or accompanied by redness, rash, swelling, fever, malaise or diffuse pain, you should re-consult your doctor immediately.
In all cases :
If there is a complete functional impairment, you should consult your doctor without delay.
Anti-inflammatory local action
diclofenac
. Presentations . Composition . Indications . Contraindications . Warning . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon
FLECTOR TISSUGEL EP 1%: medicated plaster; box of 5.
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FLECTOR TISSUGEL EP 1%: medicated plaster; box of 10.
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The
| p pllâtre | |
| Diclofenac epolamine expressed as sodium diclofenac | 140 mg |
| parahydroxybenzoates | + |
| Propylene glycol | + |
Usual dosage:
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