FLECTOR 180 mg Plaster Leczniczy

Treść ulotki

1. FLECTOR 180 mg medicated patch
   1. What is FLECTOR 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

FLECTOR 180 mg medicated patch

Diclofenac hydroxyethylpyrrolidine

Read this leaflet carefully before using this medicine as it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen 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 is FLECTOR and what it is used for

FLECTOR contains the active ingredient 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, when using FLECTOR, you do not feel better or if you feel worse after a short
period of treatment.

2. What you need to know before using FLECTOR

Do not use FLECTOR:

• if you are allergic to diclofenac hydroxyethylpyrrolidine, 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 ulcer (peptic);
• if the skin where you want to apply the patch is damaged or has lesions (exudative dermatitis, eczema, infections, burns or wounds);
• if you have had asthma, urticaria or nasal inflammation (acute rhinitis) after using medicines 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, bronchial diseases;
• you have problems with your heart, liver or kidneys;
• you have had a stomach or duodenal ulcer (peptic);
• you have suffered from inflammatory bowel diseases;
• you are prone to bleeding (bleeding diathesis);
• you are elderly, as you are more likely to experience undesirable effects.

Do not expose yourself to direct sunlight or to the light of sunbeds (tanning lamps) for at least one
day after removing the patch; this will reduce the risk of experiencing an adverse reaction to light
(photosensitivity).
Like other medicines for topical use, especially in case of prolonged therapy, FLECTOR can
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 duration
necessary. Do not exceed the dose of FLECTOR, do not apply it to large areas of the skin and do not take
it for long periods.

Other medicines and FLECTOR
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
In particular, tell your doctor if you are taking other medicines containing diclofenac or other NSAIDs.

Pregnancy, breastfeeding and fertility

Pregnancy

• If you are pregnant, suspect you are pregnant or are planning a pregnancy, ask your doctor for advice, who will assess whether to use FLECTOR.
• Do not useFLECTOR during the last three months of pregnancy as it may damage the circulation or kidneys of the fetus and delay or prolong labour.

Breastfeeding
There is not enough data available on women who are breastfeeding. If you are breastfeeding, ask your doctor for advice, who will assess whether to use FLECTOR;
During breastfeeding, do not apply the patch to the breast, to large areas of the skin or for prolonged periods.

Fertility
If you have problems conceiving and are using FLECTOR, tell your doctor, as
suspension of treatment may be appropriate.

Driving and operating machinery
FLECTOR does not impair the ability to drive vehicles 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 (even delayed);
• a fragrance (perfume) in turn containing amyl cinnamal, amyl cinnamyl alcohol, benzyl alcohol, benzyl benzoate, benzyl salicylate, cinnamal, cinnamyl alcohol, citronellol, d-Limonene, eugenol, farnesol, geraniol, hexyl cinnamal aldehyde, hydroxycitronellal, isoeugenol, linalool, methyl heptin carbonate: may cause allergic reactions
• polysorbate 80: polysorbates can cause allergic reactions

3. How to use FLECTOR

Use this medicine following 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 on children or adolescents under 16 years of age.
Elderly
Use this medicine with caution as if you are elderly you are more prone to experiencing
undesirable effects.
Patients with hepatic or renal insufficiency
For the use of diclofenac medicated patches in patients with hepatic or renal insufficiency, consult the
“Warnings and precautions” section.

How to apply the patch
FLECTOR patch is applied to the skin (cutaneous use).

• Cut open the bag containing the medicated patches and take one patch.
• Remove the protective film that protects the adhesive part of the patch.
• Apply the entire patch to the affected area. If necessary, the patch can be secured with the elastic net bandage found in the package. Do not cover the medicated area with plastic or non-breathable (occlusive) bandages.
• Close the bag carefully.

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

If you use more FLECTOR than you should, adverse effects affecting the whole
body (systemic) may occur, such as problems with the stomach or intestines. In this case, immediately inform your doctor
or go to the nearest hospital as appropriate measures may be necessary.

If you forget to use FLECTOR
Do not apply an extra patch to make up for the missed one.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, FLECTOR can cause side effects, although not everybody gets them.
manifest.

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

• Eruptions and redness of the skin (rash, eczema, erythema), skin inflammation (dermatitis, including allergic and contact dermatitis), itching at the site where you applied the patch.

Rare 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 difficulty breathing.
• Skin lesions after exposure to the sun (photosensitivity reaction).
• Asthma.
• Inflammation of the skin with pus (rash with pustules).

Since FLECTOR patch is applied directly to the affected area, the risk of having side effects
that affect the whole body (systemic), such as problems with the stomach or intestines, is lower than
taking diclofenac by mouth.
If the medicated patches are not used correctly, are used on large areas of skin and for a
very long period of time, these effects can still occur.
If the medicated patches are used in association with other medicines containing diclofenac, the
probability of skin reactions occurring increases, even after exposure to the sun, such as blister formation,
erythema and eczema. In rare cases, even serious reactions may occur, such as skin rashes with
redness, blister formation and exfoliation (e.g. Stevens-Johnson syndrome, Lyell's syndrome).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at the address “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 the first opening of the sachet, use the patches contained within it within 3 months.
Do not use this medicine after the expiry date which is stated on the packaging. This date is valid for the
medicine in intact packaging and correctly stored.
If the expiry date is stated as month/year, the expiry date refers to the last day of that
month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What FLECTOR contains
The active ingredient is diclofenac hydroxyethylpyrrolidine.
One medicated patch contains: 180 mg of diclofenac hydroxyethylpyrrolidine (equivalent to 140 mg of diclofenac
sodium).
The other ingredients are: gelatin, polyvinylpyrrolidone, sorbitol solution 70%, kaolin, titanium dioxide,
propylene glycol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, disodium edetate, tartaric
acid, dihydroxyaluminum 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 medicated patch with self-adhesive properties and equipped with a protective
film, available in packs of:

• 5 patches contained in a 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 contains an elastic net bandage.
Not all pack sizes may be marketed.

Marketing Authorisation 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).