Flector

Package leaflet: Information for the patient

FLECTOR 180 mg medicated patch

Diclofenac hydroxyethylpyrrolidine
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any of the side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement or if you notice worsening of symptoms after a short period of treatment.

Contents of this leaflet:

1. What FLECTOR is and what it is used for
2. What you need to know before using FLECTOR
3. How to use FLECTOR
4. Possible side effects
5. How to store FLECTOR
6. Contents of the pack and other information

1. What FLECTOR is and what it is used for

FLECTOR contains the active substance diclofenac hydroxyethylpyrrolidine and belongs to a group of
medicines that reduce pain and inflammation called non-steroidal anti-inflammatory drugs (NSAIDs).
FLECTOR patch is applied to the skin and acts against pain and inflammation of joints,
muscles, tendons and ligaments due to trauma or rheumatic diseases.
Consult your doctor if, while using FLECTOR, you do not feel better or if you feel worse after a short
period of treatment.

2. What you should know before using FLECTOR

Do not use FLECTOR:

• if you are allergic to diclofenac hydroxyethylpyrrolidone, acetylsalicylic acid, or other NSAIDs;
• if you are allergic to any of the other ingredients of this medicine (listed in section 6);
• during the last three months of pregnancy (see “Pregnancy, breastfeeding and fertility”);
• if you have a stomach or duodenal (peptic) ulcer;
• if the skin where you intend to apply the patch is damaged or has lesions (exudative dermatitis, eczema, infections, burns, or wounds);
• if you have previously experienced asthma, urticaria, or nasal inflammation (acute rhinitis) after taking medications containing acetylsalicylic acid or other NSAIDs.

Do not use FLECTOR in children and adolescents under 16 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before using FLECTOR if:

• you have respiratory problems such as asthma, nasal inflammation due to allergy (allergic rhinitis), nasal polyps, or bronchial diseases;
• you have heart, liver, or kidney problems;
• you have previously had a stomach or duodenal (peptic) ulcer;
• you have suffered from inflammatory bowel diseases;
• you are prone to bleeding (haemorrhagic diathesis);
• you are elderly, as you may have a higher risk of experiencing adverse effects.

Avoid exposure to direct sunlight or sunbeds (tanning lamps) for at least one day after removing the patch; this will reduce the risk of developing a light-related adverse reaction (photosensitivity).
Like other topical medicines, especially with prolonged treatment, FLECTOR may cause redness and itching (sensitization phenomena). Stop treatment and consult your doctor or pharmacist if skin reactions occur at the application site while using this patch.
Adverse effects can be minimized by using the lowest effective dose for the shortest necessary duration. Do not exceed the recommended dose of FLECTOR, do not apply it to large areas of skin, and do not use it for extended periods.
Other medicines and FLECTOR
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking other medicines containing diclofenac or other NSAIDs.
Pregnancy, breastfeeding and fertility
Pregnancy

• If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, consult your doctor, who will decide whether FLECTOR should be used.
• Do not use FLECTOR during the last three months of pregnancy, as it may harm the fetal circulation or kidneys and may delay or prolong labour.

Breastfeeding
There are insufficient data available on use in breastfeeding women. If you are breastfeeding, consult your doctor, who will decide whether FLECTOR should be used.
During breastfeeding, do not apply the patch on the breast, on large skin areas, or for prolonged periods.
Fertility
If you have difficulty conceiving and are using FLECTOR, inform your doctor, as it may be advisable to discontinue treatment.
Driving and using machines
FLECTOR does not affect the ability to drive or operate machinery.
FLECTOR contains:

• 420 mg of propylene glycol in each patch: may cause skin irritation;
• methyl parahydroxybenzoate and propyl parahydroxybenzoate: may cause allergic reactions (including delayed reactions);
• a fragrance (perfume) containing amyl cinnamal, cinnamyl alcohol, benzyl alcohol, benzyl benzoate, benzyl salicylate, cinnamaldehyde, cinnamyl alcohol, citronellol, d-Limonene, eugenol, farnesol, geraniol, cinnamaldehyde, hydroxycitronellal, isoeugenol, linalool, methyl heptin carbonate: may cause allergic reactions;
• polysorbate 80: polysorbates may cause allergic reactions.

3. How to use FLECTOR

Use this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Adults over 18 years of age
The usual dose is 1 or 2 patches per day, every 12 or 24 hours, for a maximum period of 14 days.
The patch must be used in its entirety.
Consult your doctor if you do not feel better or if you feel worse after 14 days of treatment.

Adolescents over 16 years of age
Consult your doctor if you do not feel better or if you feel worse after 7 days of treatment.

Children and adolescents under 16 years of age
Do not use FLECTOR in children or adolescents under 16 years of age.

Elderly
Use this medicine with caution, as elderly patients are more likely to experience adverse effects.

Patients with hepatic or renal impairment
For use of diclofenac medicated patches in patients with hepatic or renal impairment, refer to the section "Warnings and precautions".

Application instructions for the patch
FLECTOR patch is applied to the skin (cutaneous use).

• Cut open the sachet containing the medicated patches and take out one patch.
• Remove the protective film covering the adhesive side of the patch.
• Apply the entire patch to the affected area. If necessary, the patch may be secured with the elastic mesh bandage provided in the package. Do not cover the medicated area with plastic or non-breathable (occlusive) dressings.
• Reseal the sachet carefully.

Apply FLECTOR only to healthy, intact skin without lesions or open wounds.
Avoid contact with eyes or mucous membranes.
The medicated patch should not get wet: it is advisable to bathe or shower between successive applications.
Do not exceed the recommended dose of FLECTOR and do not apply it to large areas of skin. Use FLECTOR for the shortest possible duration. Consult your doctor if you do not notice improvement or if symptoms worsen after a short period of treatment.

If you use more FLECTOR than you should
Systemic adverse effects may occur, such as stomach or intestinal problems. In this case, contact your doctor immediately or go to the nearest hospital, as appropriate measures may be required.

If you forget to use FLECTOR
Do not apply an additional patch to make up for the missed dose.

If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, FLECTOR may cause side effects, although not everyone experiences them.

Common side effects (may affect up to 1 in 10 people)

• Skin rashes and redness (rash, eczema, erythema), skin inflammation (dermatitis, including allergic and contact dermatitis), itching at the site of patch application.

Uncommon side effects (may affect up to 1 in 1,000 people)

• Skin inflammation with blister formation (bullous dermatitis).
• Dry skin.

Very rare side effects (may affect up to 1 in 10,000 people)

• Symptoms due to allergic reactions: urticaria, swelling (angioedema) of the face, eyes, lips and throat, with breathing difficulties.
• Skin lesions following exposure to sunlight (photosensitivity reaction).
• Asthma.
• Skin inflammation with pus formation (rash with pustules).

Since the FLECTOR patch is applied directly to the affected area, the risk of systemic side effects affecting the whole body, such as stomach or intestinal problems, is lower compared to oral intake of diclofenac.
However, if medicated patches are not used correctly, if they are applied over large skin areas or for prolonged periods, such systemic effects may still occur.
If medicated patches are used concomitantly with other medicines containing diclofenac, the likelihood of skin reactions increases, even after exposure to sunlight, such as blistering, erythema and eczema. In rare cases, severe reactions may occur, including skin eruptions with redness, blistering and skin peeling (e.g. Stevens-Johnson syndrome, Lyell's syndrome).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report side effects directly via the national reporting system at the website: “http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse”.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store FLECTOR

Keep this medicine out of the sight and reach of children.
After first opening the sachet, use the patches contained within within 3 months.
Do not use this medicine after the expiry date stated on the packaging. This date refers to the medicine kept in its original, undamaged packaging and stored correctly.
If the expiry date is indicated as month/year, the expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What FLECTOR contains
The active substance is diclofenac hydroxyethylpyrrolidine.
One medicated patch contains: 180 mg of diclofenac hydroxyethylpyrrolidine (equivalent to 140 mg of sodium diclofenac).
The other components are: gelatin, polyvinylpyrrolidone, 70% sorbitol solution, kaolin, titanium dioxide, propylene glycol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, disodium edetate, tartaric acid, dihydroxyaluminium aminoacetate, sodium carboxymethylcellulose, sodium polyacrylate, 1-3-butylene glycol, polysorbate 80, fragrance, purified water, synthetic felt, plastic film.

Description of the appearance of FLECTOR and contents of the pack
This medicine is a self-adhesive medicated patch with a protective liner, available in packs of:

• 5 patches contained in one sachet;
• 8 patches contained in two sachets, each containing 4 patches;
• 10 patches contained in two sachets, each containing 5 patches;
• 15 patches contained in three sachets, each containing 5 patches.

Each pack includes an elastic mesh bandage.
Not all pack sizes may be marketed.

Marketing Authorization Holder
IBSA Farmaceutici Italia S.r.l., Via Martiri di Cefalonia, 2, 26900 Lodi.

Manufacturer
Altergon Italia S.r.l., Zona Industriale, 83040 Morra de Sanctis, Avellino (Italy).