Muscoril pain

Patient Information Leaflet

MUSCORIL DOLORE 20 mg/g gel

For adults and adolescents aged 14 years and over
Diclofenac, equivalent to diclofenac sodium (as diclofenac diethylamine)
Please read all of 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 told you to.

• 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 improvement or if your symptoms worsen after 3–5 days.

Contents of this leaflet

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

1. What MUSCORIL PAIN is and what it is used for

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

Do not use MUSCORIL DOLORE

• 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, eczema, or mucous membranes;
• if you are in the last 3 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 MUSCORIL DOLORE.
If you suffer from asthma, allergic rhinitis, nasal mucosa swelling (nasal polyps), or 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 these patients, MUSCORIL DOLORE 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 experience, for example, skin reactions, itching, or hives.
When MUSCORIL DOLORE is applied over a large skin area and for prolonged periods, the possibility of systemic adverse effects associated with the application of MUSCORIL DOLORE cannot be ruled out.
Apply MUSCORIL DOLORE only to intact, healthy, and non-wounded skin. Avoid contact with the 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 you must first allow the gel to dry on the skin for a few minutes. Do not use occlusive dressings that do not allow air passage.
Consult your doctor if symptoms worsen or do not improve within 3–5 days.
Stop using MUSCORIL DOLORE 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
MUSCORIL DOLORE is contraindicated in children and adolescents under 14 years of age.

Other medicines and MUSCORIL DOLORE
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
To date, no interactions have been reported with the intended cutaneous use of MUSCORIL DOLORE.

Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Do not use MUSCORIL DOLORE during the last 3 months of pregnancy. Do not use MUSCORIL DOLORE during the first 6 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 MUSCORIL DOLORE when used on the skin.

Breastfeeding
Small amounts of diclofenac are excreted in breast milk.
Consult your doctor before using MUSCORIL DOLORE during breastfeeding. In any case, if you are breastfeeding, do not apply MUSCORIL DOLORE directly on the breast or over large skin areas or for prolonged periods (see section 2 "Warnings and precautions").

Driving and using machines
MUSCORIL DOLORE does not affect or affects negligibly the ability to drive or use machinery.

MUSCORIL DOLORE contains propylene glycol (E1520), butylated hydroxytoluene (E 321), and a fragrance containing limonene
This medicine contains 60 mg of propylene glycol in each g of gel.
This medicine contains butylated hydroxytoluene (E 321), 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 MUSCORIL DOLORE

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.
MUSCORIL DOLORE 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
MUSCORIL DOLORE is contraindicated in children and adolescents under 14 years of age (see section 2, "Do not use MUSCORIL DOLORE").

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

Method of administration
MUSCORIL DOLORE is for topical use only.
Apply a thin layer of MUSCORIL DOLORE to the affected areas of the body and gently massage into the skin. Afterwards, wipe 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, remove the excess gel with a paper towel.
The paper towel must be disposed of in household waste to prevent unused product from entering the aquatic environment.
Before applying a dressing, allow the gel to dry on the skin for a few minutes. 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.
• Use the bottom of the cap to remove the safety seal of the tube.

Duration of treatment
The duration of treatment depends on the indication and the patient's response. MUSCORIL DOLORE should not be used for longer than 1–2 weeks without consulting a doctor. If symptoms worsen or do not improve after 3–5 days, consult your doctor.

If you use more MUSCORIL DOLORE than you should
Overdose is unlikely because absorption into the bloodstream is low when the medicine is applied only to the skin. 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 MUSCORIL DOLORE, contact your doctor immediately or go to the nearest hospital emergency department.
If the contents of a tube of MUSCORIL DOLORE 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 MUSCORIL DOLORE
Do not use a double dose to make up for the missed dose.
If you have any questions 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 gets them.
The following side effects can be serious. Stop using MUSCORIL DOLORE 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 may also occur:
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, oedema.

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

• Rash with pustules
• Gastrointestinal disturbances
• Hypersensitivity reactions, including urticaria
• Skin rash or redness 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 MUSCORIL DOLORE is applied over a large skin area and for a prolonged period, the possibility of systemic side effects (e.g., renal, hepatic or gastrointestinal side effects, systemic hypersensitivity reactions) similar to those occurring 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 MUSCORIL DOLORE

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 conditions.
Store the medicine in its original packaging to protect it from light.
Do not refrigerate or freeze.
After first opening, the gel should be used within 2 years, but not beyond the expiry date; after this period, any remaining gel should be discarded.
Do not dispose of any medicine 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 MUSCORIL DOLORE contains

• The active substance is diclofenac. 1 g of gel contains 23.2 mg of diclofenac diethylamine, corresponding to 20 mg of sodium diclofenac.
• The other components are: diethylamine, carbomer 974P, coco-caproyl caprate, macrogol cetostearyl ether, isopropyl alcohol, liquid paraffin, propylene glycol (E 1520), eucalyptus fragrance (contains limonene), butylated hydroxytoluene (E 321), oleyl alcohol, purified water.

Description of the appearance of MUSCORIL DOLORE and contents of the pack
MUSCORIL DOLORE 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 Authorization Holder
DOC Generici S.r.l. – Via Turati, 40 – 20121 Milan, Italy

Manufacturer
Doppel Farmaceutici S.r.l. – Via Martiri delle Foibe, 1 – 29016 Cortemaggiore (PC), Italy