PATIENT LEAFLET: INFORMATION FOR THE USER

FASTUFLEX 180 mg medicated patch

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

Contents of this leaflet:

What FASTUFLEX is and what it is used for
What you need to know before using FASTUFLEX
How to use FASTUFLEX
Possible side effects
How to store FASTUFLEX
Contents of the pack and other information

1. What FASTUFLEX is and what it is used for

FASTUFLEX belongs to a class of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs reduce pain and inflammation.
FASTUFLEX is used to relieve painful and inflammatory conditions of rheumatic or traumatic origin affecting joints, muscles, tendons, and ligaments.
Consult your doctor if you do not feel better or if you feel worse after a short period of using FASTUFLEX.

2. What you need to know before using FASTUFLEX

Do not use FASTUFLEX:

if you are allergic to diclofenac, acetylsalicylic acid (aspirin), or any other NSAID;
if you are allergic to any of the other ingredients of FASTUFLEX (listed in section 6);
if you have experienced asthma, breathing problems, skin rash, or rhinitis (runny nose) after taking acetylsalicylic acid (aspirin) or other NSAIDs;
if you are entering or have passed the 6th month of pregnancy;
if you currently have a stomach ulcer (peptic ulcer);
if you have damaged skin, including areas with exudation or infection, eczema, burns, or wounds;
if the person to be treated is a child or adolescent under 16 years of age. If any of the above conditions apply to you, consult your doctor or pharmacist.

Warnings and precautions
Talk to your doctor or pharmacist before using FASTUFLEX if:

you have heart disease;
you have kidney disease;
you have liver disease;
you have previously had stomach ulcers;
you have an inflammatory bowel disease, such as Crohn's disease or ulcerative colitis, or are prone to intestinal bleeding;
you suffer from asthma;
you experience breathing problems, skin rash, or runny nose after taking acetylsalicylic acid (aspirin) or other NSAIDs;
you are currently taking diclofenac or other NSAIDs, either orally or topically;
you regularly use tanning lamps or expose yourself to direct sunlight;
you are elderly, as you may be more susceptible to adverse effects.

Other important information
Always use the lowest effective dose of FASTUFLEX for the shortest duration necessary to control symptoms.
FASTUFLEX should be used with caution in elderly patients, who may be more susceptible to adverse effects.
To minimize the occurrence of adverse effects, it is recommended to use the lowest effective dose for the shortest possible time.
Children and adolescents
Do not apply the patch to children and adolescents under 16 years of age.
Other medicines and FASTUFLEX
If FASTUFLEX is used correctly, the risk of interaction with other medicines is very low.
However, inform your doctor or pharmacist if you have recently used or are currently using any other medicine.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
You must not use FASTUFLEX if you are entering or have passed the 6th month of pregnancy, as it may harm the fetus or cause problems during delivery. FASTUFLEX should be used only on medical advice before the 6th month of pregnancy, the dose should be kept as low as possible, and the treatment duration as short as possible.
FASTUFLEX should be used only on medical advice during breastfeeding, as diclofenac passes into breast milk in small amounts. However, FASTUFLEX must not be applied to the breasts of nursing mothers, nor to other extensive areas of skin or for prolonged periods of time.
If you are pregnant or breastfeeding, consult your doctor or pharmacist for further information.
Driving and using machines
Application of the diclofenac medicated patch does not affect the ability to drive vehicles or operate machinery.
FASTUFLEX contains

preservatives such as parahydroxybenzoates which may cause allergic reactions (including delayed reactions);
propylene glycol, which may cause skin irritation.

3. How to use FASTUFLEX

Use FASTUFLEX exactly as directed by your doctor.
Adults and adolescents aged 16 years and older
How many patches to use
The recommended dose of FASTUFLEX is one (1) patch applied to the most painful area once or twice daily (every 12 or 24 hours), for up to 14 consecutive days. If you do not experience any improvement within the recommended treatment period, or if your symptoms worsen, consult your doctor.
Use in children and adolescents (under 16 years of age)
There is no data available on the efficacy and safety of FASTUFLEX in children and adolescents under 16 years of age (see Do not use FASTUFLEX).
In adolescents aged 16 years and older, if symptoms worsen, patients/parents of adolescents are advised to consult a doctor.
How to apply FASTUFLEX
Cut open the top of the resealable pouch and remove one patch.

Illustration of a rectangular container with lid lifted and a red dashed line with scissors indicating packaging cut

Diagram showing a red arrow pointing downward

Reseal the pouch carefully.

A finger pressing on the skin of the arm while a red arrow indicates the direction of downward movement on a clear skin surface

Remove the plastic backing film that protects the adhesive side of the patch.

A hand pressing a white patch onto the skin while a red arrow indicates the application movement of the blue device

Apply the patch to the skin around the painful or swollen area.

A hand pressing a blue patch onto an arm with a red arrow indicating the direction of application onto the skin

If necessary, the patch may be secured in place with a wide-mesh gauze or thin strips of adhesive tape.
Do not cover the patch with any other type of dressing.
The medicated patch must be applied only to intact skin and not on damaged skin or open wounds, and must not be worn while bathing or showering.
Keep the patch away from eyes, nose, mouth, genital and anal areas. If the patch comes into contact with these areas, rinse thoroughly with water.
The patch must not be cut.

Replacing the patch.

Medical diagram showing the removal of a patch from the skin of an arm with red arrows and a clock indicating a 12-hour interval

Remove the patch every 12 or 24 hours and apply a new one.
If you forget to use FASTUFLEX Do not apply an extra patch to make up for the missed dose. Simply apply the next patch as scheduled. If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, FASTUFLEX can cause side effects, although not everybody gets them.
Some uncommon and very rare side effects can be serious.
If you experience any of the following signs of allergy, STOP using FASTUFLEX and consult a doctor or pharmacist immediately:

Swelling of the lips, eyes or tongue, wheezing or an asthma attack, signs of a severe allergic reaction (affect fewer than 1 in 10,000 users);
Skin rash, irritation or burning at the site of patch application (affect 1 to 10 out of 1,000 users).
Other possible side effects are usually mild, temporary and harmless (if you are concerned, consult a doctor or pharmacist).
Common side effects (affect 1 to 10 out of 100 users)
Itching
Uncommon side effects (affect 1 to 10 out of 1,000 users)
Skin rash
Redness of the skin
Very small red or purple spots under the skin
Rare side effects (affect 1 to 10 out of 10,000 users)
Dry, scaly skin
Swelling at the site of patch application
Very rare side effects (affect fewer than 1 in 10,000 users)
Skin rashes worsened by sunlight exposure

Since FASTUFLEX is applied to the skin over the affected area, there is a lower risk of side effects such as stomach problems, including pain, digestive disturbances or signs of bleeding in the stomach or intestine, which may occur with oral intake of diclofenac. However, if FASTUFLEX is not used correctly, these side effects may occur.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at: www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store FASTUFLEX

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pouch and carton. The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature.
Do not use this medicine 4 months after first opening the pouch.
After removing each patch, make sure the pouch has been properly resealed.
Do not dispose of medicines 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 FASTUFLEX contains
The active substance is diclofenac epolamine. Each medicated patch contains a total of 180 mg of diclofenac epolamine, equivalent to 140 mg of sodium diclofenac.
The other components are gelatin, povidone (K90), liquid sorbitol (non-crystallizable), heavy kaolin, titanium dioxide (E171), propylene glycol, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), disodium edetate (E385), tartaric acid, aluminium glycinate, sodium carmellose, sodium polyacrylate, 1,3-butylene glycol, polysorbate 80, purified water.
The non-woven backing layer is made of polyester.
The removable protective layer is made of polypropylene.

Description of the appearance of FASTUFLEX and contents of the pack
Each medicated patch consists of a dressing impregnated with a paste ranging in colour from white to light yellow, with a removable transparent plastic backing film protecting an adhesive layer. The resealable pouches contain 5 patches.
FASTUFLEX is available in packs of 5 or 10 patches. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
A. Menarini Industrie Farmaceutiche Riunite s.r.l. - Via Sette Santi, 3 – 50131 Florence, Italy
Manufacturer
Miat S.p.A.
Via Menabrea 20
20159 Milan (Italy)

This medicinal product is authorized in the EEA Member States under the following names:
Greece FASTAIN
Italy FASTUFLEX
Portugal FASTINE