NOTICE
ANSM - Last updated: 10/07/2017
Name of the medicinal product
FLECTOR 1 PER CENT, gel
framed
Please read this leaflet carefully before you start using this medicine because it contains important information for you.
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.
What is in this leaflet?
1. What is FLECTOR 1 PER CENT, gel and in which cases is it used?
2. What should I know before using FLECTOR 1 PER CENT, gel?
3. How to use FLECTOR 1 PER CENT, gel?
4. What are the possible side effects?
5. How to keep FLECTOR 1 PER CENT, gel?
6. Package contents and other information.
1. WHAT FLECTOR 1 PER CENT, gel and WHAT IT IS USED FOR?
NON-STEROIDAL ANTI-INFLAMMATORY THERAPY
(M: locomotor system)
This medication is an anti-inflammatory and an analgesic (it calms the pain), in the form of gel for application on the skin, only in the region of pain.
This drug is recommended in adults for upper and lower limb tendonitis (inflammation of muscle tendons) and in edema after an operation or after trauma.
2. BEFORE YOU USE FLECTOR 1 PER CENT, gel?
Never use FLECTOR 1 PER CENT, gel:
· from the 6th month of pregnancy;
· allergy to this or any related drug, including other non-steroidal anti-inflammatory drugs, aspirin;
· allergy to any of the excipients;
· 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
Special warnings
· FLECTOR 1 PER CENT, gel should only be used on healthy skin.
· Do not apply on mucous membranes or eyes.
· The appearance of a rash after application requires immediate cessation of treatment.
· If you have or have a history of bronchial asthma or allergic disease.
· If you suffer from kidney, heart or liver disease.
· If you have an inflammatory bowel disease or you are prone to intestinal bleeding.
· Do not use under occlusive dressing.
· Do not expose yourself to sunlight or tanning lamps during treatment.
Precautions for use
· FLECTOR 1 PER CENT, gel is not recommended in children.
· The use of gloves by the masseur physiotherapist, in case of intensive use, is recommended.
· This medicinal product contains castor oil and may cause skin reactions (eg eczema).
· Due to the presence of methyl benzoate, this medicinal product may cause irritation to the skin, eyes and mucous membranes.
· This medicine contains propylene glycol and may cause skin irritation.
IN CASE OF DOUBT DO NOT HESITATE TO REQUEST THE NOTICE OF YOUR DOCTOR OR PHARMACIST.
children
Not applicable.
Other drugs and FLECTOR 1 PER CENT, gel
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
FLECTOR 1 PER CENT, gel with food and beverages
Not applicable.
Pregnancy and breast feeding
Pregnancy
Your doctor may prescribe this medication if necessary during the first 5 months of pregnancy.
However, IN NO EVENT WILL THIS MEDICATION BE MADE FROM THE SIXTH MONTH, as its effects on your child can have serious consequences, especially at the vascular and renal level, even with a single dose, child is term.
Ask your doctor or pharmacist for advice before taking any medicine.
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
Not applicable.
FLECTOR 1 PER CENT, gel contains methyl benzoate, propylene glycol, polyoxyethylenated hydrogenated castor oil.
3. HOW TO USE FLECTOR 1 PER CENT, gel?
Reserved for adults only.
Dosage
The dosage depends on the indication. It varies from 2 to 4 applications per day.
children
The use of the product in children has not been evaluated and is therefore not recommended.
Elderly
This medication should be used with caution in elderly people who are more prone to adverse effects.
Renal or hepatic impairment
For the use of FLECTOR 1 PER CENT, gel in patients with renal or hepatic impairment, see section "2. WHAT TO DO ABOUT BEFORE USING FLECTOR 1 PER CENT, gel? ".
Administration mode
Local track.
Allow the gel to penetrate through a gentle and prolonged massage on the painful or inflammatory area.
Wash hands thoroughly after each use.
Frequency of Administration
2 to 4 applications per day.
Duration of the treatment
Treatment is limited to 5 days, in the absence of a medical prescription.
Without improvement during the recommended treatment period, a physician should be consulted.
If you take more FLECTOR 1 PER CENT, gel than you should have
· If you use more FLOREST 1 PER CENT, gel than you should, rinse thoroughly with water.
· If you accidentally swallow product FLECTOR 1 PER CENT, gel, contact your doctor or go to the nearest hospital. Take the bottle and this leaflet with you.
In case of overdose or accidental poisoning, immediately notify a doctor.
If you forget to take FLECTOR 1 PER CENT, gel
Not applicable.
If you stop taking FLIGHT 1 PER CENT, gel
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
· Exceptionally, allergic skin reactions may occur; respiratory asthma or general anaphylaxis type.
Immediately stop treatment and tell your doctor.
· Can occur:
o local skin effects such as redness, itching, rash;
o other general effects of non-steroidal anti-inflammatory drugs, depending on the amount of gel applied, the surface area treated and its condition, duration of treatment and whether or not a dressing is used;
o irritation of the skin, eyes and mucous membranes (depending on the place of application) due to the presence of methyl benzoate;
o due to the presence of propylene glycol, there is a risk of contact dermatitis.
You should tell your doctor.
If you notice any side effects not listed in this leaflet, or if any of the side effects gets serious, contact 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 FLECTOR 1 PER CENT, gel?
Do not use FLIGHT 1 PERCENT, gel after the expiry date stated on the outer packaging.
Tube
FLECTOR 1 PER CENT, tube gel must be used within 18 months of opening.
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 FLECTOR contains 1 PER CENT, 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 ingredients are: Polyoxyethylenated hydrogenated castor oil, macrogol stearate, soy lecithin, polymerized acrylic acid, sodium hydroxide, isopropanol, Floral PH perfume, purified water.
What is FLECTOR 1 PER CENT, gel and contents of the pack
This medication is in the form of a gel. Tube of 50 g, 60 g or 100 g. Bottle of 100 g.
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
Maker
IBSA FARMACEUTICI ITALIA SRL
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]
Other
Detailed information on this medicine is available on the ANSM website (France).