FASTUADVANCE 4% Cutaneous spray, solution

Зміст інструкції

1. FASTUADVANCE 4%, Cutaneous Spray solution
   1. What is FASTUADVANCE and what is it used for?
   2. What you need to know before using FASTUADVANCE
   3. How to use FASTUADVANCE
2. FASTUADVANCE applied 3 times a day at regular intervals. The number of sprays
   1. Possible side effects
   2. How to store FASTUADVANCE
   3. Contents of the pack and other information

FASTUADVANCE 4%, Cutaneous Spray solution

Diclofenac Sodium

Read this leaflet carefully before using this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 is FASTUADVANCE and what is it 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 symptomatic treatment
of local pain from mild to moderate and inflammation following acute contusion trauma to
small and medium-sized joints and surrounding structures.

2. What you need to know before using FASTUADVANCE

Do not use FASTUADVANCE

• If you are allergic to diclofenac sodium, peanuts, soy 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 in the past, such as ibuprofen, associated with difficulty breathing, rash and runny nose (rhinorrhea). - During the last three months of pregnancy - see the section regarding pregnancy and breastfeeding. - On open wounds, inflammation and skin infections as well as eczema or mucous membranes. - In children and adolescents under 14 years of age.

Warnings and precautions
Consult your doctor or pharmacist before using FASTUADVANCE:
- If you suffer from or have suffered in the past from 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 use this medicine in the eyes, 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 solariums during treatment with this medicine.
- If you develop a rash, stop treatment with FASTUADVANCE.
- Do not cover the treated area with occlusive (waterproof or non-breathable) bandages or
plasters.
If the medicine is used on large areas of skin and for a long period of time, the possible occurrence of systemic adverse effects after use of FASTUADVANCE cannot be excluded.
Adverse effects can be reduced by using the lowest effective dose for the shortest possible time.

Other medicines and FASTUADVANCE
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Tell your doctor before using FASTUADVANCE:
- If you are taking tablets, capsules or suppositories for pain, including any agent
containing diclofenac sodium, acetylsalicylic acid (aspirin) or any other anti-inflammatory drug, such as ibuprofen.
The use of another NSAID (e.g. acetylsalicylic acid or ibuprofen) in conjunction 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 or are planning a pregnancy, ask
your doctor or pharmacist before using this medicine.
FASTUADVANCE should not be used during the last 3 months of pregnancy, as it may
harm the fetus or cause problems at the time of delivery.
FASTUADVANCE should only be used on the advice of a doctor during the first 6 months of
pregnancy, the dose should be kept as low as possible and the duration of treatment should be
as short as possible.
FASTUADVANCE should only be used on the advice of a doctor during breastfeeding, given that
diclofenac sodium passes into breast milk in small amounts. However, FASTUADVANCE should not
be applied to the breasts of breastfeeding mothers or to other large areas of skin or for a long
period of time.

Driving and using machines
The cutaneous application of FASTUADVANCE does not impair the ability to drive vehicles and operate
machinery.

FASTUADVANCE contains
- propylene glycol (E1520), which can cause mild local skin irritation in some subjects,
- 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 following the instructions of your doctor or pharmacist exactly. If you have
any doubts, consult your doctor or pharmacist.
‐ Remove the protective cap.
‐ Hold the bottle in an upright position, with the applicator directed at the painful or swollen area.
‐ Apply the recommended number of sprays.
Adults and adolescents aged 14 years and over: 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
times a day. The maximum single dose should not exceed 5 sprays.
‐ To promote the absorption of FASTUADVANCE, gently massage the skin. Wash your
hands after application, unless they are the area to be treated.
‐ Wait until FASTUADVANCE is completely absorbed before covering the skin area with clothing or bandages. Be careful because the spray may stain clothing
if wet.
‐ Stop treatment once the 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 a larger amount of medicine than indicated, remove the excess
FASTUADVANCE with a cloth.
‐ In case of accidental ingestion of part of the spray, immediately inform your doctor or

If you forget to use FASTUADVANCE
‐ Use the spray as soon as you remember, but do not apply at once a quantity greater
than that recommended. Then continue treatment as before.
‐ Do not use a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. 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 the topical (skin)
application of preparations containing diclofenac, the appearance of reactions at the site of
application has 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 inform your doctor or pharmacist:
‐ 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 person

in 10,000).
‐ 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 based on
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 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 large areas of skin,
systemic side effects may occur, including pain and stomach discomfort, heartburn, liver or
kidney problems and hypersensitivity reactions.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist.
You can also report side effects directly through 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 which is stated on the label, on the carton and on the
vial after “Exp”. The expiry date refers to the last day of that month.
Store in the original package.
Do not use FASTUADVANCE after 6 months from first opening.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What FASTUADVANCE contains
The active ingredient is diclofenac sodium 4% (w/w).
The other ingredients are: isopropyl alcohol, soybean lecithin, ethyl alcohol, disodium phosphate
dodecahydrate, disodium phosphate dihydrate, disodium edetate, propylene glycol (E1520), peppermint
oil, ascorbyl palmitate, 10% hydrochloric acid (w/w) or 10% sodium hydroxide (w/w) (for pH
adjustment) and purified water.

Description of the appearance of FASTUADVANCE and contents of the pack
FASTUADVANCE is a transparent, golden-yellow solution, which becomes gelatinous in
consistency 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 Authorisation Holder

• A. MENARINI INDUSTRIE FARMACEUTICHE RIUNITE S.R.L.

VIA SETTE SANTI, 3
50131 FIR ENZE

Manufacturer
Pharbil Waltrop GmbH, Im Wirrigen 25 - 45731 Waltrop - Germany.

This medicinal product is authorised in the Member States of the EEA (European Economic Area) with the
following names: