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Flector EFFIGEL DICLOFENAC 1% GEL BOTTLE 50G
Over-the-counter medication

Flector EFFIGEL DICLOFENAC 1% GEL BOTTLE 50G

Brand : Flector Flector
€5.68 EXCL. VAT €6.25 INCL. VAT
In stock
Reference : 3400927721557
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  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.

FLECTOR EFFIGEL DICLOFENAC 1% GEL BOTTLE 50G

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 .

Description of Flector Effigel Diclofenac 1% Gel Bottle 50g

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.

The main types of muscle pain

Muscle pain is found in many cases: cramps, body aches, elongations, contractures, muscle tears, lumbago, torticollis.

  • A cramp is a violent, unexpected and temporary muscle pain. The cramp leads to functional impotence: the muscle or muscle group concerned can no longer function normally and play its role.
  • Aches are frequent after significant and unusual effort. Aches appear within 2 days of exercise.

These muscle pains are not serious and heal on their own in a week maximum: treating aches is relatively easy.

  • The elongations are sudden lengths of the muscle which cause significant and instantaneous pain. They can appear in the event of violent effort, after the fact or when cold. The pain is localized hot, but can become diffuse later, the pain being imperceptible at rest. To treat an elongation, rest is imperative: the time is variable depending on the importance of the elongation.
  • Contractures can cause a tear when, despite the pain, the muscle continues to exert itself. To treat contracture, stopping and resting are essential.

Using advice from Flector Effigel Diclofenac 1% Gel 50g bottle

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.

Composition of Flector Effigel Diclofenac 1% Gel Bottle 50g

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.

Presentation of Flector Effigel Diclofenac 1% Gel Bottle 50g

60g tube

We advise you in addition to treatment, the use of Piasclédine effective in osteoarthritis .

Warnings on pain relievers

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.

  • Please inform your online pharmacist of the treatments in progress in order to identify any incompatibilities. The order validation form contains a personalized message field provided for this purpose.
  • Click here to find the leaflet for this medication on the website of the National Agency for the Safety of Medicines and Health Products.

Pharmacovigilance Report an adverse drug reaction(s)

Download PDF leaflet

NOTICE

ANSM - Last updated: 10/07/2017

Name of the medicinal product

FLECTOREFFIGEL 1%, gel

Diclofenac epolamine

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 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).

This medication is indicated as a short-term local treatment in adults and children over 15 years of age in the case of mild trauma: sprains (bruising), bruising.

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 and breast feeding

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?

Dosage

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

Not applicable.

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

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).

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.

VIDAL OF THE FAMILY

FLECTOR EFFIGEL

Anti-inflammatory local action

. Presentations . Composition . Indications . Contraindications . Warning . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon

PRESENTATIONS (summary)

FLECTOR EFFIGEL 1%: gel for local application; 50 g bottle.
-

FLECTOR EFFIGEL 1%: gel for local application; 60 g tube.
-

The

COMPOSITION (summary)
p 100 g
Diclofenac sodium (as diclofenac epolamine) 1 g
Propylene glycol +
Methyl benzoate +

INDICATIONS (summary)
This gel contains a non- steroidal anti-inflammatory drug ( NSAID ). It locally fights against inflammation and pain.
It is used in the treatment of short sprains and bruises.
CONTRAINDICATIONS (summary)
This medication should not be used in the following cases:
  • allergy to aspirin or NSAIDs ;
  • in application to the damaged skin ( eczema , burn, wound, following or infected lesion ...);
  • pregnancy (from the 6th month).
WARNING (Contents)
This medication can be used on the advice of your pharmacist. Nevertheless, medical advice is preferable in cases of severe pain, severe edema or limb or joint mobility.
Do not apply this gel to the mucous membranes or under a waterproof (occlusive) dressing.
If a rash occurs, do not repeat the applications until you have taken the advice of your doctor.
Avoid exposing the treated area to sunlight or ultraviolet rays during treatment.
PREGNANCY AND BREAST-FEEDING (summary)
Pregnancy :
NSAIDs taken orally may be toxic to the fetus; their use is contraindicated during the last 4 months of pregnancy. NSAIDs for local application may pass through the skin, pass through the blood, and expose the fetus to the same risk, when applied over a large area of ​​skin or under an occlusive dressing. Do not use this medication during pregnancy without medical advice.

Breastfeeding:
NSAIDs are low in breast milk: do not use this gel during breastfeeding without medical advice. It should not be applied to the breasts of a nursing woman.
DIRECTIONS FOR USE AND DOSAGE (summary)
The gel should be applied in gentle and prolonged massage on the painful area.

Usual dosage:

  • Adult and child over 15 years: 1 application, 3 times a day, for a maximum of 4 days. If symptoms persist after this time, consult your doctor to re-evaluate the treatment.
TIPS (summary)
This medicinal product may be freely available in certain pharmacies; nevertheless, do not hesitate to ask your pharmacist for advice.
This gel can be irritating to eyes or mucous membranes : wash your hands after application. In case of accidental contact with eyes, rinse thoroughly.
POSSIBLE ADVERSE EFFECTS (summary)
Most common: redness or irritation of the skin, itching.
Very rarely: allergic skin reaction ( urticaria , purpura ...) or general ( angioedema , asthma ) requiring discontinuation of treatment; photosensitization .


GLOSSARY (summary)


NSAIDs
Abbreviation for non-steroidal anti-inflammatory drug. Family of anti-inflammatory drugs that are not derived from cortisone (steroids), and the best known of which is aspirin.


allergy
Skin reaction (itching, pimples, swelling) or general discomfort occurring after contact with a particular substance, use of a medication, or ingestion of food. The main forms of allergy are eczema, urticaria, asthma, angioedema and allergic shock (anaphylactic shock). Food allergy can also result in digestive disorders.


anti-inflammatory
Medicine that fights against inflammation. It can be either derived from cortisone (steroidal anti-inflammatory), or not derived from cortisone (nonsteroidal anti-inflammatory or NSAID).


asthma
Disease characterized by difficulty breathing, often resulting in wheezing. Asthma, permanent or occurring by crisis, is due to a narrowing and inflammation of the bronchi.


eczema
Skin disease manifested by pimples and itching. Eczema may be due to contact with an allergic substance (contact eczema) or be linked to a genetic predisposition (atopic eczema).


skin rash
Appearance of pimples or plaques on the skin. These lesions can be due to a food, a drug, and translate an allergy or a toxic effect. Many viruses can also cause pimple eruptions: rubella, roseola and measles are the most common.


inflammation
Natural reaction of the organism against an element recognized as foreign. It manifests itself locally by redness, heat, pain or swelling.


mucous
Tissue (membrane) that lines the cavities and ducts of the body communicating with the outside (digestive tract, respiratory tract, urinary tract, etc.).


photosensitivity
Abnormal sensitivity of the skin to light or ultraviolet rays due to a drug or a natural or chemical substance.


purpura
Red or purplish skin patches due to small subcutaneous hemorrhages. Thrombocytopenic purpura is caused by a significant decrease in the number of platelets in the blood.


angioedema
Allergy edema usually affects the face. Quincke edema results in a sometimes spectacular swelling. Eyelids are often the first to be affected. In rare cases where edema affects the throat, respiratory problems may occur and urgent treatment is required.


allergic reaction
Reaction due to hypersensitivity of the organism to a drug. Allergic reactions can take a wide variety of aspects: urticaria, angioedema, eczema, eruption of pimples resembling measles, etc. Anaphylactic shock is a generalized allergic reaction that causes discomfort due to a sudden drop in blood pressure.


urticaria
Eruption of pimples on the skin, whose origin is mostly allergic. The buds look like nettles and their color varies from pale pink to red.

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