Flector patch

Package leaflet: Information for the patient

Flector Patch, 1% medicated patch
(Diclofenacum epolaminum)
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a
doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse effects, including any possible adverse effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement or if you feel worse, contact your doctor.

Leaflet contents:

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

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

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

2. Before using Flector Patch medicated patch

When not to use Flector Patch medicated patch:

• If you are allergic (hypersensitive) to diclofenac, acetylsalicylic acid, or any other NSAID
• If you are allergic to any of the ingredients of Flector Patch medicated patch (see section 6)
• If you have asthma, breathing problems, skin rash, or runny nose after taking acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory drugs
• In pregnant women from the sixth month of pregnancy
• If you have active peptic ulcer disease (stomach ulcer)
• In case of skin damage, including exudative dermatitis, infected skin lesions, eczema, burns, or wounds
• In children and adolescents under 16 years of age

If any of the above 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 peptic ulcer disease
• If you have inflammatory bowel disease (Crohn’s disease), ulcerative colitis, or intestinal bleeding
• If you have asthma
• If you have breathing problems, skin rash, or mucosal irritation after taking acetylsalicylic acid or other NSAIDs
• If you are using diclofenac or other NSAIDs orally or topically
• If you are regularly exposed to sunlight or use solariums
• In elderly patients, who may be more susceptible to severe adverse 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 recommended in this leaflet, the risk of interaction with other medicines is very low.
However, inform your doctor or pharmacist about all medicines you are currently using, have recently used, or plan to use.

Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.
Flector Patch medicated patch must not be used from the beginning of the sixth month of pregnancy, as it may harm the unborn child or cause complications during delivery. Before the sixth month of pregnancy, Flector Patch medicated patch may be used only on medical advice, at the lowest possible dose and for the shortest possible duration.
During breastfeeding, Flector Patch medicated patch may be used only on medical advice, as diclofenac passes into breast milk in small amounts. Do not apply Flector Patch medicated patch on the breast area of breastfeeding women, over large areas of the body, or for prolonged periods.
If you are pregnant or breastfeeding, consult your doctor before using Flector Patch medicated patch to obtain further information.

Driving and using machines
Diclofenac contained in medicated patches does not affect the ability to drive or operate machinery.

This medicine contains:

• Propylene glycol, which may cause skin irritation.
• Methyl parahydroxybenzoate (E281), propyl parahydroxybenzoate (E216), and Dalin PH fragrance containing amyl cinnamic aldehyde, pentyl cinnamic alcohol, benzyl alcohol, benzyl benzoate, benzyl salicylate, cinnamic aldehyde, cinnamic alcohol, citronellol, d-limonene, eugenol, farnesol, geraniol, hexyl cinnamic aldehyde, hydroxycitronellal, isoeugenol, linalool, and methyl heptin carbonate, which may cause allergic reactions (including delayed-type reactions).

3. How to use Flector Patch medicated patch

Flector Patch medicated patch should always be used as directed by your doctor.
Important:
The dosage will be clearly indicated on the packaging. If in doubt, contact your
doctor or pharmacist.
Adults and adolescents aged 16 years and older
Dosage

• Epicondylitis (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 the next morning

Use patches for a maximum of 14 days.

• Ankle sprain
• Apply one patch per day
• Remove the patch the next day and apply a new one

Use patches for a maximum of 3 days.
Note: Symptoms associated with ankle sprain usually improve within 3 days, and symptoms related to epicondylitis within 14 days. If symptoms do not improve or worsen, consult your doctor.
Use in children and adolescents (under 16 years of age)
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 adolescents aged 16 years and older, if treatment longer than 7 days is required or if symptoms worsen, medical advice should be sought.
How to apply the patch

• Open the envelope containing the patches, remove one patch, and close the envelope tightly.
• Record the date of first opening in the designated space.
• Remove the plastic protective film covering the adhesive layer.
• Apply the patch to the painful or swollen area. If necessary, secure the patch with an elastic support bandage.
• Do not cover the patch with another dressing.
• The medicated patch should only be applied to healthy, intact skin; it must not be used if there are wounds or open skin injuries. The patch should not be used during bathing or showering.
• Avoid contact of the gel substance with eyes, nose, mouth, genitals, and anus. If the gel substance comes into contact with these areas, rinse thoroughly with water.
• Do not cut the patch.

Missed dose of Flector Patch:
Do not apply an additional patch to make up for a missed dose. Apply the next scheduled dose at the usual time.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Flector Patch medicated plaster may cause side effects, although not
everyone will experience them.
Some uncommon and very rare side effects may be serious.
If any of the following symptoms of allergy occur, stop using Flector Patch medicated plaster immediately and contact your doctor or pharmacist without delay:

• Swelling of the lips, eyes or tongue, wheezing or asthma attack, i.e. symptoms of a severe allergic reaction (affects fewer than 1 in 10,000 patients)
• Rash, burning or stinging sensation at the site of patch application (affects 1 to 10 in 1,000 patients).

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

• Itching of the skin

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

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

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

• Dry and peeling skin
• Swelling at the site of patch application

Very rare side effects (occur in fewer than 1 in 10,000 patients)

• Skin rash worsened by exposure to sunlight.

Because Flector Patch medicated plaster is applied to the skin at the site of the affected area, the risk of side effects such as gastrointestinal disorders with pain, indigestion or bleeding from the stomach or intestines, which may occur during oral use of diclofenac, is reduced. Nevertheless, if Flector Patch medicated plaster is not used as directed, the above side effects may occur.
Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +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.
Reporting side effects helps provide more information on the safety of the medicine.

5. How to store Flector Patch medicated patch

• Keep the medicine out of the sight and reach of children.
• Do not use the Flector Patch medicated patch after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
• Do not store above 25°C.
• Use within 3 months of opening the envelope. After removing the patch from the envelope, close the envelope carefully.
• Medicines must 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 Package and Other Information

What Flector Patch medicated patch contains
The active substance is diclofenac epolamine. Each medicated patch of 140 cm (10 cm x 14 cm) contains
180 mg of diclofenac epolamine, equivalent to 140 mg of sodium diclofenac (1% w/w).
The other ingredients are gelatin, povidone K90, liquid non-crystallizing sorbitol, heavy kaolin, titanium
dioxide (E171), propylene glycol, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216),
disodium edetate, tartaric acid, glycine aluminum, sodium carboxymethylcellulose, sodium polyacrylate,
1,3-butanediol, polysorbate 80, flavour (containing cinnamaldehyde, pentyl cinnamyl alcohol, benzyl alcohol,
benzyl benzoate, benzyl salicylate, cinnamic aldehyde, cinnamic alcohol, citronellol, d-limonene, eugenol,
farnesol, geraniol, hexyl cinnamaldehyde, hydroxycitronellal, isoeugenol, linalool and methyl heptine carbonate),
purified water, a polyester support layer, and a polypropylene protective film.
Excipients with known effects, see section 2.

What Flector Patch medicated patch looks like and contents of the pack
The medicated patch consists of a white or yellowish paste evenly spread in a uniform layer on a non-woven fabric backing, with a protective film covering the adhesive side.
A sealed envelope made of paper/PE/Aluminum/copolymer of methacrylic acid and ethyl acrylate contains
2 or 5 medicated patches.
Pack sizes:
2, 5, 10 patches per cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 medical product is authorised for sale in the European Economic Area countries 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