TRAULEN 4% GEL BOTTLE WITH 25 G DISPENSER

Name
Traulen 4% Gel
Diclofenac sodium


What is it and what is it used for?
Traulen contains the active substance diclofenac and belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs), used to relieve pain and inflammation.

Traulen is used to locally treat rheumatic or traumatic pain and inflammation of the joints, muscles, tendons, and ligaments.

Contact your doctor if you do not feel better or if you feel worse after 7 days.


What you need to know before taking the medicine
Do not use Traulen:
- if you are allergic to diclofenac or any of the other ingredients of this medicine (listed in section 6);
- if you are allergic to peanuts or soy, because it contains soy lecithin;
- if you have experienced asthma attacks, urticaria or acute rhinitis after taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs);
- if you are in the last 3 months of pregnancy (see section "Pregnancy, breastfeeding and fertility");
- in children and adolescents under 14 years of age.


Warnings and precautions
Talk to your doctor or pharmacist before using Traulen.

If the medicine is used on large areas of skin and for a prolonged period, the possibility of systemic side effects (i.e. which may affect different parts of the body) cannot be excluded (see section 4 "Possible side effects").

Stop treatment immediately and consult your doctor if a rash occurs after applying the gel .

Children and adolescents
There are insufficient data on efficacy and safety in children and adolescents under 14 years of age. Therefore, do not use Traulen in children under 14 years of age.


Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

If the medicine is used on large areas of skin and for a prolonged period, the possibility of systemic side effects (which can affect different parts of the body) such as nausea, indigestion, heartburn, excitement, altered sense of taste, and conjunctivitis cannot be ruled out. If you notice any of these symptoms, discontinue treatment and consult your doctor.

Common side effects (may occur in up to 1 in 10 patients) :
- Skin rash;
- Itching.

Uncommon side effects (may occur in up to 1 in 100 patients) :
- Redness and burning of the skin;
- Skin rash with blisters and vesicles;
- Peeling of the skin;
- Tingling;
- Involuntary muscle contractions.

Very rare side effects (may affect up to 1 in 10,000 people) :
- Allergic reactions (hypersensitivity, including urticaria);
- Rapid swelling of the skin and mucous membranes;
- Increased sensitivity of the skin to sunlight;
- Asthma.

Unknown side effects (frequency cannot be estimated from the available data) :
- Burning sensation at the application site;
- Dry skin.

Reporting of side effects
If you experience 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.