The drug Flector EFFIGEL DICLOFENAC 1% GEL BOTTLE 50G is indicated as local acute treatment in adults (and children over 15 years, in case of Benin injuries: sprains (sprain), contusion.
For warnings, precautions for use and contraindications, please consult the instructions for use of Flector effigel.
The drug FLECTOR EFFIGEL DICLOFENAC 1% GEL BOTTLE 50G is indicated as a short-term local treatment in adults (and children over 15 years of age, in the event of mild trauma: sprains (strain), contusion .
Flector effigel contains an anti-inflammatory and an analgesic (relieves pain). This medication is indicated as a short-term local treatment, in adults and children over 15 years of age , in cases of mild trauma: sprain , strain , contusion.
Muscle pain is found in many cases: cramps, body aches, elongations, contractures, muscle tears, lumbago, torticollis.
These muscle pains are not serious and heal on their own in a week maximum: treating aches is relatively easy.
By dermal route. The dosage depends on the indication. It varies from 2 to 4 applications per day. The use of the product in children has not been evaluated and is therefore not recommended.
Flector Effigel Diclofenac 1% Gel 50g bottle contains: diclofenac epolamine 1,293 g, corresponding amount of diclofenac sodium 1 g. Excipients: macrogolglycerol hydroxystearate, macrogol stearate, soy lecithin, polymerized acrylic acid, sodium hydroxide, isopropanol, Floral PH * fragrance, purified water.
60g tube
We advise you in addition to treatment, the use of Piasclédine effective in osteoarthritis .
Please note, the Flector effigel medication is not like any other product. Read the package insert for Flector effigel carefully before ordering. Keep medicines out of the reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Beware of incompatibilities on your current products.
Pharmacovigilance Report an adverse drug reaction(s)
ANSM - Last updated: 10/07/2017
Diclofenac epolamine
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 FLECTOREFFIGEL 1%, gel and in which cases it is used?
2. What should I know before using FLECTOREFFIGEL 1%, gel?
3. How to use FLECTOREFFIGEL 1%, gel?
4. What are the possible side effects?
5. How to store FLECTOREFFIGEL 1%, gel?
6. Package contents and other information.
1. WHAT FLECTOREFFIGEL 1%, gel AND WHAT IT IS USED FOR?
Pharmacotherapeutic group - NON-STEROID ANTI-INFLAMMATORY FOR TOPICAL USE.
(M: locomotor system).
2. BEFORE YOU USE FLECTOREFFIGEL 1%, GEL?
Do not use FLECTOREFFIGEL 1%, gel:
· From the 25th week of amenorrhea (beginning of the 6th month of pregnancy).
· In case of allergy (hypersensitivity) to this drug or to a related drug, including other non-steroidal anti-inflammatory drugs, aspirin;
· If you are allergic to any of the excipients,
· On injured skin, whatever the lesion: oozing lesions, eczema, infected lesion, burn or wound.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST
Warnings and Precautions
Take special care with FLECTOREFFIGEL 1%, gel:
Warnings
· Do not apply on mucous membranes or eyes.
· The appearance of a rash after application requires immediate cessation of treatment.
· This medicine contains propylene glycol and may cause skin irritation.
· Due to the presence of methyl benzoate, this medicinal product may cause irritation to the skin, eyes and mucous membranes.
Precautions for use
This medication should not be used as an occlusive dressing.
IN THE ABSENCE OF IMPROVEMENT after 4 days of treatment, CONSULT YOUR DOCTOR.
If you are pregnant or breast-feeding: Do not use this medication on your own. Seek advice from your doctor or pharmacist.
Do not use this gel in children (under 15 years of age).
children
Not applicable.
Other drugs and FLECTOREFFIGEL 1%, gel
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even medicines obtained without a prescription.
This medicine contains Diclofenac . Other medications contain certain medicines taken orally ... Do not combine them, so as not to exceed the maximum recommended doses (see Dosage and Mode of Administration).
FLECTOREFFIGEL 1%, gel with food and beverages
Not applicable.
Pregnancy
· Until the 24th week of amenorrhea (5 months of pregnancy), your doctor may be required to prescribe this medication on a case-by-case basis.
· From the 25th week of amenorrhea (beginning of the 6th month of pregnancy), you should not under any circumstances take this medication yourself because its effects on your child can have serious consequences, especially on a cardio- pulmonary and renal, even with a single intake.
feeding
This drug passes into breast milk. As a precaution, it should be avoided during breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Although this is unlikely when using a topical NSAID, FLECTOREFFIGEL 1%, gel can cause dizziness. If this happens to you, do not drive or use machines.
FLECTOREFFIGEL 1%, gel contains methyl benzoate, propylene glycol.
3. HOW TO USE FLECTOREFFIGEL 1%, gel?
1 application 3 times a day.
Administration mode
Dermal.
EXTERNAL USE.
Allow the gel to penetrate through a gentle and prolonged massage on the painful or inflammatory area.
Wash hands thoroughly after each use.
Duration of treatment
The duration of treatment is limited to 4 days
If you used more than 1% FLECTOREFFIGEL, you should not have frozen
In case of overdose, rinse thoroughly with water and possibly apply symptomatic treatment
If you forget to use FLECTOREFFIGEL 1%, gel
If you stop using FLECTOREFFIGEL 1%, gel
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
Exceptionally severe reactions may occur:
· allergic skin reactions: rash, urticaria, bullae,
· respiratory problems such as asthma attack (noisy and short breath, decreased breathing ability);
· general manifestations of anaphylaxis (swelling of the face, lips, tongue, throat).
Immediately stop taking the medication and tell your doctor or pharmacist.
More commonly, adverse effects can occur, usually mild and transient:
· local skin effects such as redness, itching, skin irritation, local eruption or ulceration,
· very exceptionally, an increase in sensitivity to the sun,
· other general effects of non-steroidal anti-inflammatory agents, depending on the amount of gel applied, the surface area treated and its condition, duration of treatment and whether or not an occlusive (closed) dressing is used.
You should tell your doctor or pharmacist.
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 FLECTOREFFIGEL 1%, gel?
Keep this medicine out of the reach and sight of children.
Do not use FLECTOREFFIGEL 1%, gel after the expiry date stated on the carton.
Tube
FLECTOREFFIGEL 1% tube gel must be used within 18 months of first opening.
Pressurized bottle
After opening, FLECTOREFFIGEL 1% gel in pressurized bottle must be used before the date mentioned on the outer packaging.
No special storage conditions.
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 FLECTOREFFIGEL contains 1%, gel
· The active substance is:
Diclofenac epolamine ................................................ .................................................. ... 1,293 g
Corresponding amount of diclofenac sodium ............................................. .................. 1,000 g
For 100 g of gel.
· The other components are:
Excipients : Macrogolglycerol hydroxystearate, macrogol stearate, soya lecithin, polymerized acrylic acid, sodium hydroxide, isopropanol, Floral PH * fragrance, purified water.
* Main components of floral fragrance PH :
Benzyl acetate, phenylethyl alcohol, hydroxycitronellal, small grain oil paraguay, cinnamic alcohol, propylene glycol, methyl benzoate
What is FLECTOREFFIGEL 1%, gel and contents of the pack
This medication is in the form of a gel. Box of 1 tube of 50 g, 60 g or 100 g, or box of 1 pressurized bottle of 50 g, 60 g or 100 g. Not all pack sizes may be marketed.
Marketing Authorization Holder
LABORATOIRES GENEVRIER SA
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
VIA MARTIRI DI CEFALONIA 2
26900 LODI (LO)
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 just have a trauma or a bruise, you can use the gel to relieve your pain but:
In case of ankle sprain:
· if you absolutely can not put yourself in support on the leg to take a few steps,
· or if a hematoma (blue) appears within 24 to 48 hours or if there is a considerable distortion or edema (swelling)
You should consult your physician who alone will judge the need for x-rays and orthopedic treatment ;
In case of knee injury:
· In cases of severe swelling of the knee with or without hematoma and / or inability to support,
You should also consult your doctor;
In all cases :
· If there is a complete functional impairment, ie if you can not use the upper limb or the lower limb and in case of a large (blue) hematoma,
You should also consult your doctor without delay.
Anti-inflammatory local action
. Presentations . Composition . Indications . Contraindications . Warning . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon
FLECTOR EFFIGEL 1%: gel for local application; 50 g bottle.
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FLECTOR EFFIGEL 1%: gel for local application; 60 g tube.
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The
| p 100 g | |
| Diclofenac sodium (as diclofenac epolamine) | 1 g |
| Propylene glycol | + |
| Methyl benzoate | + |
Usual dosage:
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