Diclofenac 1% Anti-Inflammatory Patch – Targeted Relief for Sprains, Tendon Pain & Knee Osteoarthritis (10 x 14 cm)

Flector Tissugel EP 1% is a medicated anti-inflammatory patch formulated with diclofenac epolamine (NSAID) to relieve pain and inflammation associated with minor injuries and musculoskeletal conditions. Designed for short-term treatment, this patch delivers localized relief directly to the painful area.

Each box contains 5 medicated patches (10 x 14 cm).

Active Ingredient (per 10 x 14 cm patch)

• Diclofenac sodium 1% (140 mg)
(as diclofenac epolamine)

Indications

• Sprains
• Contusions (bruises)
• Tendon and ligament pain (tendinitis)
• Painful flare-ups of knee osteoarthritis (after medical advice)

Suitable for adults and adolescents 15 years and older.

How It Works

Flector Tissugel uses a hydrogel adhesive layer to deliver diclofenac directly through the skin to the inflamed area. This allows for targeted anti-inflammatory action while reducing overall systemic exposure compared to oral NSAIDs.

Dosage & Duration

Sprains and Contusions
• Apply 1 patch daily
• Use for 3 days (up to 7 days maximum)
• Consult a doctor if no improvement

Tendon & Ligament Pain / Knee Osteoarthritis
• Apply 1 patch morning and evening
• Treat for 7 days
• May extend up to 14 days for osteoarthritis under medical supervision

Without medical advice, treatment should not exceed 4 days.

How to Use

1. Open the sachet and remove the patch.

2. Peel off the transparent protective film.

3. Apply the adhesive side directly to clean, dry skin over the painful area.

4. Use a retention net if needed depending on location.

5. Do not double the dose if a patch is missed.

Contraindications

Do not use if:

• Allergic to diclofenac, aspirin, or other NSAIDs
• Skin is damaged (eczema, infected lesions, burns, wounds)
• Active peptic ulcer
• From the beginning of the 6th month of pregnancy onward
• During breastfeeding

Precautions

• External use only
• Avoid contact with eyes and mucous membranes
• Do not use under occlusive dressing
• Avoid sun or UV exposure during treatment (risk of photosensitivity)
• Discontinue if rash develops
• Consult a doctor if you have heart, liver, kidney disease, digestive ulcer history, asthma, or NSAID allergy

Diclofenac may pass into breast milk. Avoid use while breastfeeding.

Patients who experience dizziness or central nervous system effects with NSAIDs should avoid driving or operating machinery.

Composition (Adhesive Layer)

Gelatin, Povidone K90, Sorbitol solution, Kaolin, Titanium dioxide, Propylene glycol, Methyl & Propyl Parahydroxybenzoate, Disodium EDTA, Tartaric acid, Aluminum glycinate, Carmellose sodium, Sodium polyacrylate, 1,3-Butylene glycol, Polysorbate.

Backing: Non-woven polyester support.

Flector Tissugel EP 1% Diclofenac Patch 10 x 14 cm – 5 Patches provides targeted, short-term anti-inflammatory relief for muscle, tendon, and joint pain when used as directed.

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

NOTICE

ANSM – Updated: 12/11/2024

Name of the Medicine

FLECTORTISSUGELEP 1% Medicated Patch
Diclofenac sodium

Important Information

Please read this leaflet carefully before using this medicine because it contains important information for you.

Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet. You may need to read it again.
• Ask your pharmacist for advice or more information.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• You must consult your doctor if you do not feel better or if you feel worse.

What this leaflet contains

1. What FLECTORTISSUGELEP 1% is and what it is used for

2. What you need to know before using FLECTORTISSUGELEP 1%

3. How to use FLECTORTISSUGELEP 1%

4. Possible side effects

5. How to store FLECTORTISSUGELEP 1%

6. Contents of the pack and other information

1. WHAT IS FLECTORTISSUGELEP 1% AND WHAT IS IT USED FOR?

Pharmacotherapeutic class: Non-steroidal anti-inflammatory drug (NSAID) – ATC code: M02AA15.

This medicine is indicated in adults (over 15 years old) for:

• Symptomatic treatment of tendon and ligament pain
• Post-traumatic pain: sprains and bruises

It is also indicated in adults for painful flare-ups of knee osteoarthritis, after prior medical advice.

2. WHAT YOU NEED TO KNOW BEFORE USING FLECTORTISSUGELEP 1%

Do NOT use FLECTORTISSUGELEP 1% if:

• You are allergic to diclofenac or any of the other ingredients listed in section 6.
• You are pregnant from the beginning of the 6th month of pregnancy (after 24 weeks).
• You have damaged skin: oozing lesions, eczema, infected lesions, burns, wounds.
• You have an active stomach ulcer.

If in doubt, consult your doctor or pharmacist.

Warnings and Precautions

This medicine is for adults and adolescents over 15 years only.

• Do not apply to mucous membranes or eyes.
• Do not use under occlusive dressing.
• Stop treatment immediately if a skin rash appears.
• Avoid sun or UV exposure during treatment (risk of photosensitivity).
• Never exceed the recommended dose.
• Follow dosage and duration instructions carefully.

Contains:

• 420 mg propylene glycol (may cause skin irritation).
• Methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) – may cause allergic reactions.
• Fragrance containing benzyl salicylate, alpha amylcinnamic aldehyde, hydroxycitronellal, cinnamyl alcohol (possible allergens).

Use with medical supervision if you have:

• Heart, kidney, or liver disease
• History of ulcer or digestive bleeding
• Inflammatory bowel disease
• Asthma or NSAID allergy (may trigger breathing difficulty or asthma attack)

Other Medicines

FLECTORTISSUGELEP contains diclofenac.

Do NOT use at the same time as other medicines (oral or topical) containing diclofenac or other NSAIDs.

Check other medicines carefully to avoid duplication.

Pregnancy, Breastfeeding and Fertility

Pregnancy

Before the 6th month (before 24 weeks):
Only use if absolutely necessary and prescribed by your doctor, at the lowest dose and shortest duration.

From the 6th month onward:
CONTRAINDICATED. Do NOT use. It may cause serious or fatal harm to the baby (heart, lungs, kidneys), even after one dose.

If taken during pregnancy, contact your doctor immediately.

Breastfeeding

Diclofenac passes into breast milk. Not recommended during breastfeeding.
Never apply to the breasts.

Fertility

May temporarily reduce female fertility. Inform your doctor if trying to conceive.

Driving and Using Machines

Very unlikely to cause effects when used topically.
However, if you have experienced dizziness or nervous system effects with NSAIDs, avoid driving or operating machinery.

3. HOW TO USE FLECTORTISSUGELEP 1%

Always follow your doctor’s instructions.

Dosage

• Knee osteoarthritis flare: 7 days, may extend up to 14 days max.
• Tendon/ligament pain: 7 days. If pain persists, consult doctor.
• Sprains/bruises: 3 days, up to 7 days if needed. If no improvement after 3 days, consult doctor.

If no improvement within recommended duration, consult a physician.

Method of Application

1. Cut the sealed sachet.

2. Remove one patch and reseal the sachet carefully.

3. Remove protective plastic film.

4. Apply adhesive side to painful area or joint.

A tubular elastic net may be used if necessary.

Overdose

Inform your doctor or pharmacist.

Missed Dose

Do not use a double dose to make up for a forgotten dose.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this may cause side effects.

Reported:

• Itching
• Redness
• Rash
• Eczema
• Skin inflammation

Rare:

• Allergic reactions
• Skin reaction after sun/UV exposure

Stop treatment immediately and consult a doctor if these occur.

Unknown frequency:

• Burning sensation at application site
• Dry skin

Report side effects via the French national reporting system (ANSM website).

5. HOW TO STORE

Keep out of sight and reach of children.

Do not use after expiration date.

No special storage conditions required.

After first opening of sachet: use within 3 months.

Do not dispose via wastewater or household waste. Ask your pharmacist how to dispose properly.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

Active Ingredient (per 10 x 14 cm patch)

Diclofenac sodium 1% (140 mg)
As diclofenac epolamine

Other Ingredients

Backing: Non-woven polyester.

Adhesive layer:

Gelatin, Povidone K90, Sorbitol solution, Kaolin, Titanium dioxide, Propylene glycol, Methyl parahydroxybenzoate, Propyl parahydroxybenzoate, Disodium EDTA, Tartaric acid, Aluminum glycinate, Carmellose sodium, Sodium polyacrylate, 1,3-Butylene glycol, Polysorbate 80, DALIN PH fragrance, Purified water.

Pack Presentation

Medicated patch.
Available in sealed sachets containing 2 or 5 patches.

Each pack includes a tubular elastic net.

Marketing Authorization Holder

IBSA Pharma SAS
Parc de Sophia Antipolis
06600 Antibes
France

Manufacturer

Altergon Italia SRL
Zona Industriale
83040 Morra de Sanctis (Avellino)
Italy

Health Advice

After ankle sprain:

• If unable to bear weight for 4 steps
• If significant swelling, deformity, or large bruise

Consult a doctor (may require X-ray).

For severe tendon pain or complete functional loss, consult immediately.

For knee osteoarthritis:

If pain differs from usual mechanical pain or includes redness, swelling, fever, or diffuse pain, consult a doctor urgently.

In all cases:

If there is complete functional impairment, consult your doctor immediately.