FASTUADVANCE*SPRAY 25G 4%

Fastuadvance 4%, Cutaneous spray solution
Diclofenac Sodium

What it is and what it is used for
Fastuadvance contains the active ingredient diclofenac sodium, which belongs to the class of non-steroidal 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 to 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, soy or any of the other ingredients of Fastuadvance (listed in paragraph 6);
- if you have previously had an allergic reaction to aspirin (acetylsalicylic acid) or any other NSAID, e.g., ibuprofen, associated with difficulty breathing, skin rash and rhinorrhea (runny nose);
- if you are in the last three months of pregnancy - see the paragraph regarding pregnancy and breastfeeding;
- on open wounds, skin inflammation and infections, 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 the eyes, in the nose or mouth, and on open wounds or infected skin areas. In case of accidental application to the eyes, rinse thoroughly with clean water and inform your doctor;
- do not ingest Fastuadvance;
- do not sunbathe or use sunlamps during treatment with this medicine;
- if you experience skin rashes, stop treatment with Fastuadvance. - do not cover the treated area with occlusive (waterproof or non-breathable) bandages or plasters.

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

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

Side 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. Following topical (skin application) use of diclofenac-containing preparations, reactions at the application site, including skin rashes, itching, redness, burning sensation or skin peeling, have been frequently reported. - 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 blister formation (rare: may affect up to 1 in 1,000 people); hypersensitivity (including urticaria) (very rare: may affect up to 1 in 10,000 people).
- Wheezing, shortness of breath or chest tightness (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):
- The skin may be more sensitive to the sun. Possible signs are sunburn associated with itching, swelling and blister formation.
- Pustular rash.

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

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

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