Fastuactiv

Patient Information Leaflet

FastuActiv 20 mg/g gel

For adults and adolescents aged 14 years and over
Diclofenac, equivalent to sodium diclofenac (as diclofenac diethylamine)
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to do.

• Keep this leaflet. You may need to read it again.
• If you need more advice or information, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if your symptoms worsen after 3–5 days.

Contents of this leaflet

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

1. What FastuActiv is and what it is used for

FastuActiv contains the active substance diclofenac, which belongs to a class of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).
FastuActiv is indicated:
For adults and adolescents aged 14 years and older.
For the local symptomatic treatment of pain associated with acute muscle strains, sprains or bruises following impact injuries, such as sports injuries and accidents.
For adolescents aged 14 years and older, the medicine is indicated for short-term treatment.

2. What you need to know before using FastuActiv

Do not use FastuActiv

• if you are allergic to diclofenac or to any of the other ingredients of this medicine (listed in section 6);
• if you have experienced asthma attacks, hives, or runny nose (acute rhinitis) after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs);
• on open wounds, inflamed or infected skin, on eczema, or on mucous membranes;
• during the last three months of pregnancy (see "Pregnancy and breastfeeding");
• in children and adolescents under 14 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before using FastuActiv.
If you suffer from asthma, allergic rhinitis, swelling of the nasal mucosa (nasal polyps), chronic obstructive pulmonary disease, or chronic respiratory tract infections (particularly associated with symptoms resembling allergic rhinitis), you are at higher risk than other patients of experiencing asthma attacks (so-called analgesic intolerance/analgesic-induced asthma), local skin or mucosal swelling (angioedema, also known as Quincke's edema), or hives.
In such patients, FastuActiv should only be used with specific precautions (emergency preparedness) and under direct medical supervision. The same applies to patients who are allergic to other substances and experience, for example, skin reactions, itching, or hives.
When FastuActiv is applied over a large skin area or for prolonged periods, the possibility of systemic adverse effects related to application cannot be ruled out.
Apply FastuActiv only to intact, healthy, and non-wounded skin. Avoid contact with eyes and oral mucous membranes. The gel must not be ingested.
After applying the gel to the skin, a breathable (non-occlusive) dressing may be used, but only after allowing the gel to dry on the skin for a few minutes. Occlusive dressings that do not allow air passage must not be used.
Consult your doctor if symptoms worsen or do not improve within 3–5 days.
Discontinue use of FastuActiv if you develop a skin rash.
Avoid exposure to sunlight, including sunbeds, while using this medicine.
Appropriate precautions must be taken to prevent children from touching the area where the gel has been applied.

Children and adolescents
FastuActiv is contraindicated in children and adolescents under 14 years of age.

Other medicines and FastuActiv
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
To date, no interactions have been reported with the intended cutaneous use of FastuActiv.

Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.

Pregnancy
Do not use FastuActiv during the last three months of pregnancy. Do not use FastuActiv during the first six months of pregnancy unless strictly necessary and under medical advice. If treatment is required during this period, the lowest effective dose should be used for the shortest possible duration.
Oral formulations (e.g., tablets) of diclofenac may cause adverse effects in the unborn child. It is not known whether the same risk applies with FastuActiv when used topically.

Breastfeeding
Diclofenac passes into breast milk in small amounts.
Consult your doctor before using FastuActiv while breastfeeding. In any case, if you are breastfeeding, do not apply FastuActiv directly on the breast or over large skin areas or for prolonged periods (see section 2 "Warnings and precautions").

Driving and using machines
FastuActiv does not affect or has negligible influence on the ability to drive or operate machinery.

FastuActiv contains propylene glycol (E1520), butylated hydroxytoluene (E321), and a fragrance containing limonene
This medicine contains 60 mg of propylene glycol per gram of gel.
This medicine contains butylated hydroxytoluene, which may cause local skin reactions (e.g., contact dermatitis) or irritation of the eyes and mucous membranes.
This medicine contains a fragrance with limonene, which may cause allergic reactions.

3. How to use FastuActiv

Use this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Use in adults and adolescents aged 14 years and older
Depending on the size of the area to be treated, apply a quantity of gel ranging from the size of a cherry to a walnut, corresponding to 1–4 g of gel.
FastuActiv should be applied twice daily (preferably in the morning and evening).
The maximum daily dose is 8 g of gel.
Use in elderly patients
No special dose adjustments are required. If you are elderly, you should pay particular attention to possible adverse effects and, if necessary, consult your doctor or pharmacist.
Use in patients with hepatic or renal impairment
Dose reductions are not required.
Use in children and adolescents under 14 years of age
FastuActiv is contraindicated in children and adolescents under 14 years of age (see section 2 “Do not use FastuActiv”).
Adolescents aged 14 years and older
If this medicine is needed for more than 7 days for pain treatment, or if symptoms worsen, patients or parents of adolescents are advised to consult a doctor.
Method of administration
FastuActiv is for topical use only.
Apply a thin layer of gel to the affected areas of the body and gently massage it into the skin. Afterwards, clean your hands with a paper towel and then wash them, unless your hands are the area being treated.
If an excessive amount of gel is accidentally applied, wipe off the excess with a paper towel.
The paper towel must be disposed of in household waste to prevent unused product from entering the aquatic environment.
Allow the gel to dry for a few minutes on the skin before applying a dressing. Also, wait until the gel has dried on the skin before taking a shower or bath.
How to remove the seal upon first use:

• Unscrew and remove the cap of the tube.
• To remove the tube’s safety seal, use the back of the cap.

Duration of treatment
The duration of treatment depends on the indication and the patient’s response. FastuActiv must not be used for longer than one to two weeks without consulting a doctor. If symptoms worsen or do not improve within 3–5 days, consult your doctor.
If you use more FastuActiv than you should
Overdose is unlikely if you apply more FastuActiv than recommended, since absorption into the bloodstream is low when the medicine is used topically. If a significantly higher than recommended dose is applied to the skin, the gel should be removed (e.g. with a paper towel) and the area rinsed with water.
In case of accidental ingestion of FastuActiv, contact your doctor immediately or go to the nearest hospital emergency department. If the contents of a tube of FastuActiv are accidentally ingested, adverse effects may occur similar to those observed after ingestion of an excessive dose of systemic diclofenac.
If you forget to use FastuActiv
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 everybody gets them.
The following side effects can be serious. Stop using FastuActiv and contact your doctor immediately:

Rare side effects (may affect up to 1 in 1,000 people)

• Skin inflammation with blisters (bullous dermatitis)

Very rare side effects (may affect up to 1 in 10,000 people)

• Asthma
• Swelling of the face, lips, tongue or throat (angioedema)

Other side effects:
Common (may affect up to 1 in 10 people)

• Rash, redness of the skin (erythema), dermatitis (including contact dermatitis), itching.

Uncommon (may affect up to 1 in 100 people)

• Skin peeling, skin dryness, oedema.

Very rare (may affect up to 1 in 10,000 people)

• Skin rash with pustules
• Gastrointestinal disorders
• Hypersensitivity reactions, including urticaria
• Skin tightness or erythema following exposure to sunlight or sunlamps (photosensitivity reaction).

Frequency not known (frequency cannot be estimated from the available data)

• Burning sensation at the application site.

When FastuActiv is applied over a large area of skin and for a prolonged period, the possibility of systemic side effects (e.g., renal, hepatic or gastrointestinal adverse effects, systemic hypersensitivity reactions) similar to those that may occur after systemic administration of medicines containing diclofenac cannot be ruled out.

Reporting of side effects
If you experience any side effect, including those 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/segnalazioni-reazioni-avverse. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store FastuActiv

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 packaging after "Exp.". The
expiry date refers to the last day of that month.
This medicine does not require any special storage temperature.
Store the medicine in its original packaging to protect it from light.
Do not refrigerate or freeze.
After first opening, the gel can be used for a period not exceeding 24 months,
but not beyond the expiry date; after this period, any remaining gel must be discarded.
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. Package contents and other information

• What FastuActiv contains
• The active substance is diclofenac. 1 g of gel contains 23.2 mg of diclofenac diethylamine, equivalent to 20 mg of sodium diclofenac.
• The other components are: diethylamine, carbomer 974P, cocoile caprilocaprate, macrogol cetostearyl ether, isopropyl alcohol, liquid paraffin, propylene glycol (E1520), eucalyptus fragrance (contains limonene), butylated hydroxytoluene (E 321), oleic alcohol, purified water.

Description of the appearance of FastuActiv and contents of the pack
FastuActiv is a homogeneous gel, white to almost white.
Each pack contains a tube, sealed with a tamper-evident seal and a screw cap, containing 60 g, 100 g, 120 g or 150 g of gel.
Not all pack sizes may be marketed.

Marketing Authorization Holder
A. MENARINI FARMACEUTICA INTERNAZIONALE S.R.L.
Via dei Sette Santi 1,
50131 Florence - Italy

Manufacturer
Doppel Farmaceutici S.r.l.
Via Martiri delle Foibe, 1
29016 Cortemaggiore (PC) – Italy
Or
Mipharm S.p.A.
Via Bernardo Quaranta, 12
20141 Milan, Italy