FASTUADVANCE

Package leaflet: Information for the user

FASTUADVANCE 4% Cutaneous Spray Solution

Sodium Diclofenac
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What FASTUADVANCE is and what it is used for
2. What you need to know before using FASTUADVANCE
3. How to use FASTUADVANCE
4. Possible side effects
5. How to store FASTUADVANCE
6. Contents of the pack and other information

1. What FASTUADVANCE is and what it is used for

FASTUADVANCE contains the active substance sodium diclofenac, 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 injuries affecting small and medium-sized joints and surrounding tissues.

2. What you need to know before using FASTUADVANCE

Do not use FASTUADVANCE

• If you are allergic to sodium diclofenac, peanuts, soy or any of the other ingredients of FASTUADVANCE (listed in section 6).
• If you have previously experienced an allergic reaction to aspirin (acetylsalicylic acid) or to any other NSAID (non-steroidal anti-inflammatory drug), such as ibuprofen, associated with breathing difficulties, skin rash or rhinorrhea (runny nose).
• During the last three months of pregnancy – see the section on pregnancy and breastfeeding.
• On open wounds, inflamed or infected areas of the skin, 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 have or have previously had gastric ulcers, liver or kidney problems, a tendency to bleeding, or inflammatory bowel disease.
• If you have previously suffered from bronchial asthma or allergies.
• Do not apply this medicine to the eyes, nose, mouth, open wounds or infected skin areas. In case of accidental contact with the eyes, rinse thoroughly with clean water and consult your doctor.
• Do not swallow FASTUADVANCE.
• Avoid exposure to sunlight or use of sunlamps during treatment with this medicine.
• If you develop skin rashes, stop treatment with FASTUADVANCE.
• Do not cover the treated area with occlusive dressings (waterproof or non-breathable) or plasters.
  When this medicine is used over large skin areas or for prolonged periods, the occurrence of systemic adverse effects cannot be ruled out.
  Adverse effects may be minimized by using the lowest effective dose for the shortest possible duration.

Other medicines and FASTUADVANCE
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Inform your doctor before using FASTUADVANCE:

• If you are taking tablets, capsules or suppositories for pain, including any product containing sodium diclofenac, acetylsalicylic acid (aspirin) or any other anti-inflammatory drug, such as ibuprofen.
  The use of another NSAID (e.g. acetylsalicylic acid or ibuprofen) concomitantly with FASTUADVANCE may increase the risk of adverse effects.

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
If you are pregnant, breastfeeding, suspect you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
FASTUADVANCE must not be used during the last three months of pregnancy, as it may harm the unborn baby or cause complications during delivery.
FASTUADVANCE should be used during the first six months of pregnancy only under medical advice, with the dose kept as low as possible and the treatment duration as short as possible.
FASTUADVANCE should be used during breastfeeding only under medical advice, since sodium diclofenac passes into breast milk in small amounts. However, FASTUADVANCE must not be applied to the breasts of nursing mothers or to other extensive skin areas or for prolonged periods.

Driving and using machines
The topical application of FASTUADVANCE does not affect the ability to drive or operate machinery.

FASTUADVANCE contains

• Propylene glycol (E1520), which may in some individuals cause mild local skin irritation,
• Peppermint essential oil, which may cause allergic reactions,
• Soy: if you are allergic to peanuts or soy, do not use this medicine.

3. How to use FASTUADVANCE

Use this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
‐ Remove the protective cap.
‐ Hold the bottle in an upright position, directing the spray nozzle onto the painful or swollen area.
‐ Apply the recommended number of sprays.
Adults and adolescents aged 14 years and older: the recommended dose is 4-5 sprays of
FASTUADVANCE applied 3 times a day at regular intervals. The number of sprays
depends on the size of the area to be treated. The maximum number of sprays is 15
per day. The maximum single dose should not exceed 5 sprays.
‐ To enhance absorption of FASTUADVANCE, gently massage the skin. Wash your hands
after application, unless they are the area being treated.
‐ Wait until FASTUADVANCE is completely absorbed before covering the skin area with clothing or bandages. Be careful, as the spray may stain clothing if wet.
‐ Discontinue treatment once symptoms (pain and swelling) have improved.
Do not use this medicine for more than 7 days without consulting your doctor.
‐ If there is no improvement after 3 days or if symptoms worsen, consult your doctor.
If you use more FASTUADVANCE than you should
‐ If you apply more medicine than indicated, wipe off the excess FASTUADVANCE with a cloth.
‐ In case of accidental ingestion of any part of the spray, immediately inform your doctor or go to the nearest emergency room. Take the bottle and this leaflet with you.
If you forget to use FASTUADVANCE
‐ Use the spray as soon as you remember, but do not apply more than the recommended amount at one time. Then continue treatment as before.
‐ Do not use a double dose to make up for a forgotten dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
‐ Discontinue treatment with FASTUADVANCE if any skin rash occurs. Following topical use (application to the skin) of formulations containing diclofenac, reactions at the application site have been frequently reported, including skin rashes, itching, redness, burning sensation or skin peeling.
‐ If you experience any of the following signs of allergy, STOP TREATMENT WITH FASTUADVANCE AND IMMEDIATELY CONTACT YOUR DOCTOR OR PHARMACIST:
‐ 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 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):
‐ Skin rash, eczema, redness of the skin, dermatitis (including contact dermatitis), itching*.
‐ Some side effects are very rare (may affect up to 1 in 10,000 people):
‐ The skin may become more sensitive to sunlight. Possible symptoms include sunburn accompanied by itching, swelling and blistering.
‐ Pustular rash.
‐ Some side effects have 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, 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 prolonged period and/or applied to large areas of skin, systemic side effects may occur, including stomach pain and discomfort, heartburn, liver or kidney problems, and hypersensitivity reactions.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report side effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store FASTUADVANCE

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label, carton, and vial after "Exp". The expiry date refers to the last day of that month.
Store in the original packaging.
Do not use FASTUADVANCE more than 6 months after first opening.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Pack contents and other information

What FASTUADVANCE contains
The active substance is sodium diclofenac 4% (w/w).
The other ingredients are: isopropyl alcohol, soybean lecithin, ethyl alcohol, disodium phosphate
dodecahydrate, sodium dihydrogen phosphate dihydrate, disodium edetate, propylene glycol (E1520),
peppermint flavour, ascorbyl palmitate, hydrochloric acid 10% (w/w) or sodium hydroxide 10% (w/w) (for
pH adjustment), and purified water.
Description of the appearance of FASTUADVANCE and pack contents
FASTUADVANCE is a clear, golden-yellow solution which becomes gel-like after application. Each bottle
contains 7.5 g, 12.5 g or 25 g of cutaneous spray, solution.
Not all pack sizes may be marketed.
Marketing Authorization Holder
A. MENARINI INDUSTRIE FARMACEUTICHE RIUNITE S.R.L.
VIA SETTE SANTI, 3
50131 FLORENCE
Manufacturer
Pharbil Waltrop GmbH, Im Wirrigen 25 - 45731 Waltrop - Germany.
This medicinal product is authorized in the EEA (European Economic Area) Member States under the
following names: