Flector Path

Package Leaflet: Information for the Patient

Flector Patch,1% medicinal patch
(Diclofenacum epolaminum)

Read the package leaflet carefully before using the medicine, as it contains

important information for the patient.
This medicine should always be used exactly as described in the package leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult your pharmacist.
• If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If you do not improve or feel worse, contact your doctor.

Table of Contents of the Leaflet:

• 1. What is Flector Patch medicinal patch and what is it used for
• 2. Important information before using Flector Patch medicinal patch
• 3. How to use Flector Patch medicinal patch
• 4. Possible side effects
• 5. How to store Flector Patch medicinal patch
• 6. Contents of the pack and other information

1. What is Flector Patch medicinal patch and what is it used for

Flector Patch medicinal patch belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs), used to relieve pain and inflammation.
Flector Patch medicinal patch is used for the symptomatic treatment of pain associated with tennis elbow (epicondylitis) and ankle sprains.

2. Before using Flector Patch medicinal patch

When not to use Flector Patch medicinal patch:

• If you are allergic (hypersensitive) to diclofenac, acetylsalicylic acid, or any other NSAID
• If you are allergic to any of the ingredients in Flector Patch medicinal patch (see section 6)
• If you have asthma, breathing problems, skin rash, or runny nose after using acetylsalicylic acid (aspirin) or other NSAIDs
• In women from the 6th month of pregnancy
• If you have active stomach ulcers (peptic ulcers)
• In case of skin damage, including weeping eczema, infected skin lesions, rash, burns, or injuries
• In children and adolescents under 16 years of age

If any of the above points apply to you, consult your doctor or pharmacist.

Warnings and precautions

Consult your doctor in the following cases:

• If you have heart disease
• If you have kidney disease
• If you have liver disease
• If you have a history of stomach ulcers
• If you have inflammatory bowel disease (Crohn's disease), ulcerative colitis, or gastrointestinal bleeding
• If you have asthma
• If you have breathing problems, skin rash, or runny nose after using acetylsalicylic acid or other NSAIDs
• If you are using diclofenac or other NSAIDs orally or topically
• If you are regularly exposed to the sun or use a sunbed
• In elderly patients who may be at risk of increased side effects

Children and adolescents

Do not use this medicine in children and adolescents under 16 years of age.

Flector Patch and other medicines

If Flector Patch is used as directed in this leaflet, the risk of interactions with other medicines is very low.
However, tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, or think you may be pregnant, consult your doctor before using this medicine.
Flector Patch medicinal patch should not be used from the start of the sixth month of pregnancy, as it may harm the baby or cause complications during delivery. Before the start of the sixth month of pregnancy, Flector Patch medicinal patch should only be used on prescription, in the lowest possible dose, and for the shortest possible duration.
During breastfeeding, Flector Patch medicinal patch may be used only on prescription, as diclofenac passes into breast milk in small amounts. Do not use Flector Patch medicinal patch on the breast area of breastfeeding women, on large areas of the body, or for an extended period.
If you are pregnant or breastfeeding, consult your doctor before using Flector Patch medicinal patch for further information.

Driving and using machines

Diclofenac in the patches does not affect the ability to drive or use machines.

This medicine contains:

• propylene glycol, which may cause skin irritation.
• methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), and Dalin PH flavor containing amylcinnamaldehyde, pentyl alpha hydroxy cinnamaldehyde, benzyl alcohol, benzyl benzoate, benzyl salicylate, cinnamaldehyde, cinnamyl alcohol, citronellol, d-limonene, eugenol, farnesol, geraniol, hexyl cinnamaldehyde, hydroxycitronellal, iso-eugenol, linalool, and methylheptin carbonate, which may cause allergic reactions (possible late reactions).

3. How to use Flector Patch medicinal patch

Flector Patch medicinal patch should always be used as directed by your doctor.

Important:

The dose will be clearly described on the packaging. If in doubt, consult your doctor or pharmacist.

Adults and adolescents from 16 years

Dosage

Tennis elbow (tennis elbow or golfer's elbow)

• Apply one patch in the morning
• Remove the patch in the evening and apply a new patch
• Remove the patch in the morning

Use the patches for a maximum of 14 days.

Ankle sprain

• Use one patch per day
• Remove the patch the next day and apply a new one

Use the patches for a maximum of 3 days.

Note: Symptoms associated with ankle sprains usually improve within 3 days, and symptoms associated with tennis elbow usually improve within 14 days. If symptoms do not improve or worsen, consult your doctor.

Use in children and adolescents (under 16 years)

There is insufficient data on the efficacy and safety of using Flector Patch in children under 16 years of age (see also section "When not to use Flector Patch").
In the case of use in children aged 16 and over, if the medicinal product requires use for more than 7 days or if symptoms worsen, consult your doctor.

How to apply the patch

• Open the envelope containing the patches, remove one patch, and close the envelope carefully.
• Write the date of first opening the envelope in the designated place.
• Remove the plastic foil covering the adhesive layer.
• Apply the patch to the painful or swollen area. If necessary, you can hold the patch in place with an elastic bandage.
• Do not cover the patch with another dressing.
• The medicinal patch can only be used on healthy, undamaged skin; it must not be used if there are wounds or open skin injuries. Do not use the patch while bathing or showering.
• Avoid contact between the gel-like substance and the eyes, nose, mouth, genitals, and anus. If the gel-like substance gets into these areas, rinse them thoroughly with water.
• Do not cut the patches.

Missing a dose of Flector Patch:

Do not use an additional patch to make up for a missed application. Use the next scheduled dose at the usual time.
If you have any further doubts about using the medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Flector Patch medicinal patch can cause side effects, although not everybody gets them.
Some uncommon and very rare side effects may be serious.
If you experience any of the following symptoms of an allergic reaction, stop using Flector Patch medicinal patch immediately and contact your doctor or pharmacist:

• Swelling of the mouth, eyes, or tongue, wheezing, or asthma attack, i.e., symptoms of an acute allergic reaction (affects less than 1 in 10,000 patients)
• Rash, burning sensation, or itching at the patch application site (affects 1 to 10 in 1,000 patients).

Other side effects are usually mild, harmless, and temporary (if they occur, consult your doctor or pharmacist).
Common side effects(affect 1 to 10 in 100 patients)

• Itching of the skin

Uncommon side effects(affect 1 to 10 in 1,000 patients)

• Skin rash
• Redness of the skin
• Small red or purple spots under the skin

Rare side effects(affect 1 to 10 in 10,000 patients)

• Dry and flaking skin
• Swelling at the patch application site

Very rare side effects(affect less than 1 in 10,000 patients)

• Skin rash worsening in sunlight.

Since Flector Patch medicinal patch is used on the skin at the site of the disease, the risk of side effects such as gastrointestinal disorders with pain, nausea, or stomach or intestinal bleeding, which may occur with oral diclofenac, is reduced. Nevertheless, if Flector Patch medicinal patch is not used as directed, the above side effects may occur.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Pharmacovigilance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Flector Patch medicinal patch

• Keep the medicine out of the sight and reach of children.
• Do not use Flector Patch medicinal patch after the expiry date stated on the packaging. The expiry date refers to the last day of the given month
• Do not store above 25°C.
• Use within 3 months of opening the envelope. After removing a patch from the envelope, close the envelope carefully.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Flector Patch medicinal patch contains

The active substance is diclofenac epolamine. Each 140 cm (10 cm x 14 cm) patch contains 180 mg of diclofenac epolamine, equivalent to 140 mg of sodium diclofenac (1% w/w).
The medicine also contains gelatin, povidone K90, liquid sorbitol, non-crystallizing, heavy kaolin, titanium dioxide (E171), propylene glycol, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), disodium edetate, tartaric acid, aluminum glycinate, sodium carmellose, sodium polyacrylate, 1,3-butylene glycol, polysorbate 80, flavor (containing amylcinnamaldehyde, pentyl alpha hydroxy cinnamaldehyde, benzyl alcohol, benzyl benzoate, benzyl salicylate, cinnamaldehyde, cinnamyl alcohol, citronellol, d-limonene, eugenol, farnesol, geraniol, hexyl cinnamaldehyde, hydroxycitronellal, iso-eugenol, linalool, and methylheptin carbonate), purified water, polyester backing layer, and protective polypropylene film.

What Flector Patch medicinal patch looks like and contents of the pack

The medicinal patch is a white or yellowish paste spread evenly on a backing made of fabric with a protective foil covering the adhesive layer.
A sealed envelope made of paper/PE/aluminum/copolymer of methacrylic acid and ethyl acrylate contains 2 or 5 medicinal patches.
Pack sizes:
2, 5, 10 patches in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

IBSA Farmaceutici Italia S.r.l.
via Martiri di Cefalonia 2
26900 Lodi
Italy

Manufacturer:

ALTERGON ITALIA SRL
Zona Industriale
83040 Morra de Sanctis (AV)
Italy

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

FR/H/0225/001
Cyprus, France, Ireland
Flector Tissugel
Poland
Flector Patch
Denmark, Sweden
Flector
FR/H/0267/001
France
Diclofenac Genevrier
Germany
Flector Schmerzpflaster
United Kingdom
Flector Tissugel
Date of revision of the leaflet:April 2021