FASTUADVANCE 4% SKIN SPRAY SOLUTION 1 GLASS BOTTLE OF 25 G WITH DOSING PUMP

Name
Fastuadvance 4%, Cutaneous spray solution
Diclofenac Sodium


What is it and what is it for?
Fastuadvance contains the active ingredient diclofenac sodium, which belongs to the class of nonsteroidal anti-inflammatory drugs (NSAIDs). Fastuadvance is used for the local symptomatic treatment of mild to moderate pain and inflammation following acute blunt trauma to small and medium-sized joints and surrounding structures.


What you need to know before taking the medicine
Do not use Fastuadvance:
- if you are allergic to diclofenac sodium, peanuts, soya or any of the other ingredients of Fastuadvance (listed in section 6);
- if you have had an allergic reaction to aspirin (acetylsalicylic acid) or any other NSAID, e.g. ibuprofen, in the past, associated with difficulty breathing, rash and rhinorrhea (runny nose);
- if you are in the last three months of pregnancy - see the section on pregnancy and breastfeeding;
- on open wounds, inflammations and infections of the skin as well as eczema or mucous membranes;
- in children and adolescents under 14 years of age.


Warnings and precautions
Talk to your doctor or pharmacist before using Fastuadvance:
- if you suffer or have suffered in the past from stomach ulcers, liver or kidney problems, bleeding tendency or inflammatory bowel disease;
- if you have previously suffered from bronchial asthma or allergies;
- Do not use this medicine on your eyes, nose, or mouth, or on open wounds or infected skin. If you accidentally get it on your eyes, rinse thoroughly with clean water and tell your doctor.
- do not swallow Fastuadvance;
- do not sunbathe or use sunlamps during treatment with this medicine;
- if you experience a skin rash, stop treatment with Fastuadvance. - do not cover the treated area with occlusive (waterproof or non-breathable) dressings or plasters.

Do not use this medicine near open flames, lit cigarettes, or certain appliances (e.g. hair dryers).

If the medicine is used on large areas of skin and for a long period of time, the possible onset of systemic side effects after the use of Fastuadvance cannot be excluded.

Undesirable effects can be reduced by using the lowest effective dose for the shortest possible time.


Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
- Stop treatment with Fastuadvance if any skin rash appears. Application site reactions, including rash, itching, redness, burning, or peeling of the skin, have been frequently reported following topical use (skin application) of diclofenac-containing preparations. - If you experience any of the following signs of allergy, STOP treatment with Fastuadvance and inform your doctor or pharmacist immediately :
- Skin rash associated with the formation of blisters ( rare: may affect up to 1 in 1,000 people ); hypersensitivity (including hives) ( very rare: may affect up to 1 in 10,000 people ).
- Wheezing, shortness of breath or tightness in the chest (asthma) ( very rare: may affect up to 1 in 10,000 people ).
- Swelling of the face, lips, tongue or throat ( very rare: may affect up to 1 in 10,000 people ).

- Some side effects are common (may affect up to 1 in 10 people):
- Rash, eczema, skin redness, dermatitis (including contact dermatitis), itching*.

- Some side effects are very rare (may affect up to 1 in 10,000 people):
- Your skin may be more sensitive to the sun. Possible signs include sunburn associated with itching, swelling, and blistering.
- Pustular skin rash.

- Some side effects have an unknown frequency (the frequency cannot be estimated from the available data):
- Reaction at the application site, dry skin, burning sensation.

*Itching was reported at a frequency of 0.9% in a clinical study, in which 236 patients with ankle sprains were treated with 4-5 sprays of Fastuadvance three times daily (120 subjects) or placebo (116 subjects) for 14 days.

If this medicine is used for a long time and/or if it is applied to large areas of skin, systemic side effects may occur, including stomach pain and discomfort, heartburn, liver or kidney problems and hypersensitivity reactions.