FASTUFLEX*10CER MEDIC 180MG

FASTUFLEX 180 mg medicated plaster
Diclofenac epolamine

What it is and what it is used for
FASTUFLEX belongs to a class of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs reduce pain and inflammation.
FASTUFLEX is used to relieve pain and inflammation of a rheumatic or traumatic nature in 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.

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 weeping or infected areas, 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 a history of stomach ulcers;
• you have inflammatory bowel disease, such as Crohn's disease or ulcerative colitis, or are prone to intestinal bleeding;
• you suffer from asthma;
• you have breathing problems, rash or runny nose after taking acetylsalicylic acid (aspirin) or other NSAIDs;
• you are taking diclofenac or other NSAIDs, in oral or topical form;
• you regularly use sunbeds or expose yourself to direct sunlight;
• you are elderly, as you are more susceptible to side effects.

Other important information
Always use the lowest effective dose of FASTUFLEX for the shortest period necessary to control symptoms.
FASTUFLEX should be used with caution in elderly patients who may be more prone to side effects.
To minimise 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 plaster 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 an asthma attack, signs of a severe allergic reaction (affecting fewer than 1 in 10,000 users);
• rash, irritation or burning at the site of plaster application (affecting 1 to 10 in 1,000 users).

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

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

Uncommon side effects (affecting 1 to 10 in 1,000 users)
• Rash
• Skin redness
• Very small red or purple spots under the skin

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

Very rare side effects (affecting fewer than 1 in 10,000 users)
• Skin rashes worsened 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 at the affected area, there is a lower risk of side effects, such as stomach problems including pain, digestive disorders or signs of bleeding in the stomach or intestines, which can occur after taking diclofenac orally. However, if FASTUFLEX is not used correctly, these side effects can occur.

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. 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.