Dicloreumact

Patient information leaflet

DICLOREUMACT 20 mg/g gel

For adults and adolescents aged 14 years and older
Diclofenac, equivalent to sodium diclofenac (as diethylamine salt)
Please read this leaflet carefully before 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 instructed.

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

Contents of this leaflet

1. What DICLOREUMACT is and what it is used for
2. What you need to know before using DICLOREUMACT
3. How to use DICLOREUMACT
4. Possible side effects
5. How to store DICLOREUMACT
6. Package contents and other information

1. What DICLOREUMACT is and what it is used for

DICLOREUMACT contains the active substance diclofenac, which belongs to a class of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).
DICLOREUMACT 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 DICLOREUMACT

Do not use DICLOREUMACT

• 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 areas, eczema, or 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 DICLOREUMACT.
If you suffer from asthma, allergic rhinitis, swelling of the nasal mucosa (nasal polyps), chronic obstructive bronchopulmonary disease, or chronic respiratory tract infections (particularly associated with symptoms similar to 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 (so-called Quincke's edema), or hives.
In such patients, DICLOREUMACT 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 DICLOREUMACT is applied over a large skin area and for prolonged periods, the possibility of systemic adverse effects related to application cannot be ruled out.
Apply DICLOREUMACT only to intact, healthy, and undamaged skin. Avoid contact with eyes and oral mucous membranes. The gel must not be swallowed.
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 DICLOREUMACT if you develop a skin rash.
Avoid exposure to sunlight, including sunlamps, while using this medicine.
Take appropriate precautions to prevent children from touching the area where the gel has been applied.

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

Other medicines and DICLOREUMACT
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 topical use intended for DICLOREUMACT.

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 DICLOREUMACT during the last three months of pregnancy. Do not use DICLOREUMACT during the first six months of pregnancy unless strictly necessary and as directed by your doctor. If treatment is required during this period, the lowest effective dose for the shortest possible duration should be used.
Oral forms (e.g., tablets) of diclofenac may cause adverse effects in the unborn child. It is not known whether the same risk applies with DICLOREUMACT when used on the skin.

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

Driving and using machines
DICLOREUMACT does not affect or affects negligibly the ability to drive or operate machinery.

DICLOREUMACT 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 DICLOREUMACT

Use this medicine exactly as described in this leaflet or as directed 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 cherry-sized to walnut-sized, corresponding to 1–4 g of gel.
Apply DICLOREUMACT 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 impaired liver or kidney function
Dose reductions are not required.

Use in children and adolescents under 14 years of age
DICLOREUMACT is contraindicated in children and adolescents under 14 years of age (see section 2 “Do not use DICLOREUMACT”).

Adolescents aged 14 years and older
If this medicine is needed for more than 7 days for pain treatment, or if symptoms worsen, patients/parents of adolescents are advised to consult a doctor.

Method of administration
DICLOREUMACT 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.
After application, clean your hands with a paper towel and then wash them, unless the hands are the area being treated.
If an excessive amount of gel is accidentally applied, wipe off the excess with a paper towel.
Dispose of the used paper towel in household waste to prevent unused product from entering the aquatic environment.
Wait a few minutes after application to allow the gel to dry before applying a bandage. 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 tube cap.
• To remove the safety seal of the tube, use the back of the cap.

Duration of treatment
The duration of treatment depends on the indication and the patient's response. DICLOREUMACT 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 DICLOREUMACT than you should
Overdose is unlikely when applying more DICLOREUMACT than recommended, since absorption into the bloodstream is low when the medicine is used topically. However, if a significantly higher than recommended dose is applied to the skin, remove the gel (e.g. with a paper towel) and rinse the area with water.
In case of accidental ingestion of DICLOREUMACT, contact your doctor immediately or go to the nearest hospital emergency department. Accidental ingestion of the contents of a tube of DICLOREUMACT may cause adverse effects similar to those observed after ingestion of an excessive dose of systemic diclofenac.

If you forget to use DICLOREUMACT
Do not use a double dose to make up for a forgotten dose.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
The following adverse reactions can be serious. Stop using DICLOREUMACT and contact your doctor immediately:

Rare adverse reactions (may affect up to 1 in 1,000 people)

• Skin inflammation with blisters (bullous dermatitis)

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

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

Other adverse reactions:
Common (may affect up to 1 in 10 people)

• Skin 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 DICLOREUMACT is applied over a large area of skin and for prolonged periods, systemic adverse reactions (e.g., renal, hepatic or gastrointestinal adverse reactions, systemic hypersensitivity reactions) similar to those occurring after systemic administration of medicines containing diclofenac cannot be ruled out.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . Reporting adverse reactions can help provide more information on the safety of this medicine.

5. How to store DICLOREUMACT

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date 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 conditions.
Store the medicine in the original packaging to protect it from light.
Do not refrigerate or freeze.
After first opening, the gel may 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 medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What DICLOREUMACT 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 flavour (containing limonene), butylated hydroxytoluene (E 321), oleyl alcohol, purified water.

Description of the appearance of DICLOREUMACT and contents of the pack
DICLOREUMACT is a homogeneous gel, white to almost white.
Each pack contains one 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 Authorisation Holder
Epifarma S.r.l. - Via San Rocco, 6 - 85033 Episcopia (PZ) – 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