Libedol

Package leaflet: Information for the patient

LIBEDOL 20 mg/g gel

For adults and adolescents aged 14 years and older
Diclofenac, equivalent to sodium diclofenac (as diclofenac diethylamine)
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 you.

• 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, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if your symptoms worsen after 3–5 days.

Contents of this leaflet

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

1. What LIBEDOL is and what it is used for

LIBEDOL contains the active substance diclofenac, which belongs to a class of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
LIBEDOL 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, for example sports injuries and accidents.
In adolescents aged 14 years and older, the medicine is indicated for short-term treatment.

2. What you need to know before using LIBEDOL

Do not use LIBEDOL

• if you are allergic to diclofenac or to any of the other ingredients of this medicine (listed in section 6);
• if you have had 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;
• if you are in 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 LIBEDOL.
If you suffer from asthma, allergic rhinitis, swelling of the nasal mucosa (so-called nasal polyps), or chronic obstructive pulmonary 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, LIBEDOL 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 who, for example, experience skin reactions, itching, or hives.
When LIBEDOL 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 LIBEDOL only to intact, healthy, and non-wounded skin. Avoid contact with the 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 LIBEDOL 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
LIBEDOL is contraindicated in children and adolescents under 14 years of age.

Other medicines and LIBEDOL
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 topical use of LIBEDOL.

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 LIBEDOL during the last three months of pregnancy. Do not use LIBEDOL during the first six months of pregnancy unless strictly necessary and under medical advice. If treatment is required during this period, the lowest possible 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 LIBEDOL when used on the skin.

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

Driving and using machines
LIBEDOL does not affect or has negligible effect on the ability to drive vehicles or operate machinery.

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

3. How to use LIBEDOL

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 cherry-sized to walnut-sized, corresponding to 1–4 g of gel.
Apply LIBEDOL 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
LIBEDOL is contraindicated in children and adolescents under 14 years of age (see section 2 “Do not use LIBEDOL”).

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 adolescent patients are advised to consult a doctor.

Method of administration
LIBEDOL 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 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 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 cap from the tube.
• To remove the safety seal of the tube, use the back of the cap. 3/6

Duration of treatment
The duration of treatment depends on the indication and the patient's response. LIBEDOL 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 LIBEDOL than you should
Overdose is unlikely if you apply more LIBEDOL 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 excess gel should be removed (e.g. with a paper towel) and the area rinsed with water.
In case of accidental ingestion of LIBEDOL, contact your doctor immediately or go to the nearest hospital emergency department. If the contents of a tube of LIBEDOL 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 LIBEDOL
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 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 LIBEDOL and contact your doctor immediately:
Rare side effects (may affect up to 1 in 1,000 people)

• Inflammation of the skin 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)

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

Uncommon (may affect up to 1 in 100 people)

• Skin peeling, skin dehydration, edema.

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

• Skin rash with appearance of 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 LIBEDOL is applied over a large area of skin and for prolonged periods, systemic side effects (e.g., renal, hepatic or gastrointestinal adverse effects, systemic hypersensitivity reactions) similar to those observed after systemic administration of medicinal products containing diclofenac cannot be excluded.
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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store LIBEDOL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack 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 should be discarded.
Do not dispose of medicines 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 LIBEDOL 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 capril/caprate, macrogol cetostearyl ether, isopropyl alcohol, liquid paraffin, propylene glycol (E1520), eucalyptus fragrance (containing limonene), butylated hydroxytoluene (E321), oleyl alcohol, purified water.

Description of the appearance of LIBEDOL and package contents
LIBEDOL is a homogeneous gel, white to almost white.
Each package contains one tube, closed with a 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
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.
5/6
Via Bernardo Quaranta, 12
20141 Milan, Italy

This medicinal product is authorized in the European Economic Area countries under the following names:
Italy: Libedol
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