FASTUFLEX 180 MG MEDICATED PATCH 10 PATCHES IN PAP/PE/AL/EMAA SACHET

Name
FASTUFLEX 180 mg medicated plaster
Diclofenac epolamine


What it is and what it is used for
FASTUFLEX belongs to a class of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs reduce pain and inflammation.
FASTUFLEX is used to relieve pain and inflammation of rheumatic or traumatic nature of joints, muscles, tendons and ligaments.

Talk to your doctor if you do not feel better or if you feel worse after a short time of using FASTUFLEX.


What you need to know before taking the medicine
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 had asthma, breathing problems, rash or rhinitis (runny nose) after taking acetylsalicylic acid (aspirin) or other NSAIDs;
• if you are entering or have already passed the 6th month of pregnancy;
• if you currently have a stomach ulcer (peptic ulcer);
• if you have broken skin, including areas of oozing or infection, eczema, burns or wounds;
• if the subject to be treated is a child or an 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:
• suffers from heart disease;
• suffers from kidney disease;
• has liver disease;
• has suffered from stomach ulcers in the past;
• have an inflammatory bowel disease, such as Crohn's disease or ulcerative colitis, or are prone to intestinal bleeding;
• suffers from asthma;
• have breathing problems, a rash or runny nose after taking acetylsalicylic acid (aspirin) or other NSAIDs;
• is taking diclofenac or other NSAIDs, in the form of an oral or topical preparation;
• regularly uses tanning lamps or exposes himself to direct sunlight;
• is elderly, as he is more susceptible to the onset of side effects.

Other important information
Always use the lowest effective dose of FASTUFLEX for the shortest time necessary to control your symptoms.
FASTUFLEX should be used with caution in elderly patients who may be more susceptible to adverse effects.
In order to minimize the occurrence of side effects, it is recommended to use the lowest effective dose and for the shortest possible time.

Children and adolescents
Do not apply the patch to children and adolescents under 16 years of age.


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 asthma attack , signs of a serious allergic reaction (affects less than 1 in 10,000 users);
• rash, irritation or burning at the site of patch application (affects 1 to 10 users in 1,000).

Other possible side effects are usually mild, transient and harmless (if you are concerned, consult a doctor or pharmacist).

Common side effects (affect 1 to 10 users in 100)
• Itching

Uncommon side effects (affect 1 to 10 users in 1,000)
• Skin rash
• Redness of the skin
• Tiny red or purple spots under the skin

Rare side effects (affect 1 to 10 users in 10,000)
• Dry and flaky skin
• Swelling at the site of patch application

Very rare side effects (affect less than 1 user in 10,000)
• Skin rashes made worse by sunlight

Unknown side effects (frequency cannot be estimated from the available data)
• Burning sensation at the application site

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, indigestion or signs of bleeding in the stomach or intestines, which can occur after taking diclofenac by mouth. However, if FASTUFLEX is not used correctly, these side effects may occur.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.