Flector Effigel 1% gel 50 g for Strains, Sprains, Bruises - From 15 years old

Flector Effigel 1% Gel - 50g
For Relief from Strains, Sprains, and Bruises
Not suitable for pregnant or breastfeeding women
For use in adults and adolescents aged 15 and older

Product Overview
Flector Effigel 1% is a topical anti-inflammatory gel containing diclofenac, specifically formulated for short-term relief of minor trauma such as strains, sprains, and bruises. This fast-acting gel is ideal for reducing pain and inflammation directly at the site of injury.

Active Ingredients
Each 100g of gel contains:

• Diclofenac Epolamine (1.293g)
  Equivalent to 1.0g of diclofenac sodium

Other Ingredients: Macrogolglycerol hydroxystearate, macrogol stearate, soya lecithin, polymerized acrylic acid, sodium hydroxide, isopropanol, floral fragrance PH, purified water.
Floral Fragrance PH includes: Benzyl acetate, phenylethyl alcohol, hydroxycitronellal, petit grain oil Paraguay, cinnamic alcohol, propylene glycol, methyl benzoate.

Usage Instructions

• Application: Apply a thin layer of Flector Effigel to the affected area 3 times a day.
• Method: Gently massage the gel into the skin until fully absorbed.
• Duration: Limit use to a maximum of 4 days.
• Important: Wash hands thoroughly after each use.

In cases of accidental overuse, rinse with water and apply symptomatic relief as needed.

Precautions

• Not for use:
  • During pregnancy from the 25th week of amenorrhea (6th month) onward
  • If allergic to diclofenac, aspirin, other NSAIDs, or any excipient in the gel
  • On damaged skin, including oozing lesions, eczema, infected areas, burns, or wounds
  • On mucous membranes or near the eyes
• Avoid use with occlusive dressings
• Discontinue: Stop use if rash or irritation develops, particularly if sensitive to propylene glycol or methyl benzoate. If no improvement after 4 days, consult a healthcare professional.

Pregnancy and Breastfeeding

• This gel should be avoided during pregnancy beyond the 24th week and during breastfeeding as it may pass into breast milk. Consult your doctor before use if pregnant or breastfeeding.

Packaging Options
Available in a 50g pump bottle or a 60g tube for convenient and hygienic dispensing.

Please read the following full disclosure before purchasing or using this product.

4. CLINICAL DATA

4.1 Therapeutic Indications

Short-term local treatment for minor trauma in adults and children over 15 years of age: strains (sprains), bruises.

4.2 Dosage and Method of Administration

Dosage
1 application, 3 times daily.

Duration of Treatment
Treatment duration is limited to 4 days.

Administration Method
For local application only.
Reserved for adults and children over 15 years of age.
External Use Only
Apply the gel with gentle, prolonged massage over the painful or inflamed area. Wash hands thoroughly after each application.

4.3 Contraindications

This medication is contraindicated in the following cases:

• Hypersensitivity to the active substance or any of the excipients listed in Section 6.1.
• Pregnancy, starting from the 6th month (beyond 24 weeks of amenorrhea) (see Section 4.6).
• Damaged skin, regardless of the lesion: oozing dermatitis, eczema, infected lesion, burn, or wound.
• Contraindicated in patients allergic to peanuts or soy.

4.4 Special Warnings and Precautions for Use

• Do not apply to mucous membranes or eyes; apply only to the painful area.
• If a skin rash appears, stop treatment immediately.
• Contains castor oil, which may cause skin reactions.
• Contains methyl benzoate, which may cause local irritation.
• Contains a fragrance with allergens (hydroxycitronellal, cinnamic alcohol, amyl cinnamal, methyl benzoate, benzyl salicylate) that may cause allergic reactions.
• Should not be used under an occlusive dressing.

4.5 Interaction with Other Medicinal Products and Other Forms of Interaction

Due to low systemic absorption in normal use, interactions with orally administered diclofenac are unlikely.

4.6 Fertility, Pregnancy, and Lactation

Pregnancy
NSAIDs inhibit prostaglandin synthesis, which can affect pregnancy and/or fetal development.

Risks associated with use during the first trimester
Epidemiological studies suggest an increased risk of miscarriage, heart malformations, and gastroschisis with prostaglandin synthesis inhibitors early in pregnancy. Cardiovascular malformation risk increased from less than 1% to approximately 1.5% with NSAID exposure, depending on dose and treatment duration. Animal studies show increased embryo-fetal death rates and malformations with prostaglandin inhibitors during organogenesis.

Risks associated from the 12th week of amenorrhea until birth
From the 12th week, NSAIDs may expose the fetus to renal impairment:

• In utero: Oligohydramnios (usually reversible when treatment stops) or even anhydramnios with prolonged exposure.
• At birth: Possible renal failure, particularly with late and prolonged exposure.

Risks beyond 24 weeks of amenorrhea
NSAIDs from the 24th week may cause cardio-pulmonary toxicity in the fetus (premature closure of the ductus arteriosus and pulmonary hypertension). This constriction risk is irreversible and becomes more critical closer to term.

In late pregnancy, risks to the mother and newborn include:

• Prolonged bleeding due to platelet inhibition.
• Uterine contraction inhibition, leading to delayed or prolonged delivery.

Therefore:

• This medication should not be prescribed during the first 5 months of pregnancy unless absolutely necessary.
• From the 6th month of pregnancy, this medication is contraindicated. Accidental intake after this period requires cardiac and renal monitoring of the fetus.

Lactation
NSAIDs pass into breast milk, so this product should not be used during breastfeeding. Do not apply the medication to the chest if breastfeeding.

Fertility
NSAIDs may temporarily impair female fertility by affecting ovulation. This medication is not recommended for women attempting to conceive.

4.7 Effects on Driving and Machine Operation

While unlikely with topical applications like FLECTOREFFIGEL, those experiencing dizziness or other CNS effects while using NSAIDs should avoid driving or operating machinery.

4.8 Adverse Effects

• Common: Skin reactions like rash, eczema, erythema, dermatitis (including contact dermatitis).
• Rare: Blistering dermatitis.
• Very Rare: Pustular eruptions, urticaria, purpura, local ulcerations.
• Hypersensitivity Reactions: Angioedema (Quincke's edema).
• Respiratory Issues: Asthma attacks related to aspirin or NSAID allergies, contraindicating this medication.

Other rare reactions include photosensitivity and a burning sensation or dryness at the application site. Systemic NSAID effects are contingent on gel absorption and may include digestive or renal issues.

Reporting Adverse Effects
Healthcare professionals are encouraged to report any suspected adverse reactions via the national reporting system: www.signalement-sante.gouv.fr.

4.9 Overdose

In case of overdose, rinse thoroughly with water. Accidental ingestion may lead to systemic NSAID side effects, in which case gastric lavage and activated charcoal may be considered.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic Properties

Pharmacotherapeutic Class: Non-steroidal anti-inflammatory topical agent, ATC Code: M02AA15.
Diclofenac is an NSAID derived from phenylacetic acid, effective in local anti-inflammatory and analgesic action when used as a gel.

5.2 Pharmacokinetic Properties

Topically applied diclofenac is absorbed through the skin, with systemic passage estimated at 6% in single doses and 13.9% in repeated doses. Synovial fluid and tissue concentrations are significantly higher than plasma concentrations.

5.3 Preclinical Safety Data

No specific hazards for humans were noted at therapeutic doses in toxicity, genotoxicity, and carcinogenicity studies. Animal studies showed an increase in embryo-fetal mortality and malformation rates.

6. PHARMACEUTICAL DATA

6.1 List of Excipients

Polyoxyethylene hydrogenated castor oil, macrogol stearate, soya lecithin, polymerized acrylic acid, sodium hydroxide, isopropanol, Floral PH fragrance, purified water.

6.3 Shelf Life

• Bottle: 3 years.
• Tube: 3 years unopened; 18 months after opening.
• Roller applicator tube: 3 years unopened; 12 months after opening.

6.5 Packaging

Available in:

• Aluminum Tubes: 50g, 60g, 100g.
• Aluminum Bottles: 50g, 60g, 100g.
• Polyethylene Roller Applicator: 100g.

7. MARKETING AUTHORIZATION HOLDER

IBSA PHARMA SAS
Sophia-Antipolis Park, 280 rue de Goa
06600 Antibes, France

8. MARKETING AUTHORIZATION NUMBER(S)

• 277 212-6 or 34009 277 212 6 7: 1 aluminum tube (50 g)
• 277 213-2 or 34009 277 213 2 8: 1 aluminum tube (60 g)
• 277 214-9 or 34009 277 214 9 6: 1 aluminum tube (100 g)
• 277 215-5 or 34009 277 215 5 7: 1 aluminum bottle (50 g)
• 277 216-1 or 34009 277 216 1 8: 1 aluminum bottle (60 g)
• 277 217-8 or 34009 277 217 8 6: 1 aluminum bottle (100 g)
• 34009 302 477 0 9: 1 polyethylene tube with roller applicator (100 g)

9. DATE OF FIRST AUTHORIZATION/RENEWAL

First Authorization Date: April 17, 2014

0. DATE OF TEXT UPDATE

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11. DOSIMETRY

Not applicable.

12. INSTRUCTIONS FOR THE PREPARATION OF RADIOPHARMACEUTICALS

Not applicable.

PRESCRIPTION AND DISPENSING CONDITIONS

This medication is available over the counter and does not require a prescription.