MUSCORIL 20 mg /G Gel

Зміст інструкції

1. MUSCORIL DOLORE 20 mg/g gel
   1. What is MUSCORIL DOLORE and what is it 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

MUSCORIL DOLORE 20 mg/g gel

For adults and adolescents aged 14 years and over
Diclofenac, corresponding to diclofenac sodium (as diclofenac diethylamine)

Read this leaflet carefully before using this medicine as 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.

• Keep this leaflet. You may need to read it again.
• If you would like more information or advice, ask your pharmacist.
• If any side effect occurs, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better 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 is MUSCORIL DOLORE and what is it used for

MUSCORIL DOLORE contains the active ingredient diclofenac which belongs to a class of medicines called
non-steroidal anti-inflammatory drugs (NSAIDs).
MUSCORIL DOLORE is indicated
For adults and adolescents aged 14 years and older
For the symptomatic local treatment of pain associated with acute muscle strains, sprains or
contusions following impact trauma, for example injuries and sports 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 developed asthma attacks, urticaria, runny nose (acute rhinitis) after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs);
• on open wounds, skin inflammation or infections, on 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
Consult your doctor or pharmacist before using MUSCORIL DOLORE.
If you suffer from asthma, allergic rhinitis, swelling of the nasal mucosa (so-called nasal polyps) or chronic obstructive bronchopneumopathy, chronic respiratory infections (particularly associated with symptoms similar to allergic rhinitis), you are more exposed than other patients to asthma attacks (so-called analgesic/asthma intolerance), local swelling of the skin or mucous membranes (so-called Quincke's edema) and urticaria.
In these patients, MUSCORIL DOLORE can only be used with certain precautions (emergency preparedness) and under direct medical supervision. The same applies to patients who are also allergic to other substances and experience, for example, skin reactions, itching or urticaria.
When MUSCORIL DOLORE is applied to a large area of skin and for a prolonged period, the possibility of systemic adverse effects associated with the application of MUSCORIL DOLORE cannot be excluded.
Apply MUSCORIL DOLORE only to intact, healthy skin without wounds. Avoid contact with eyes and oral mucous membranes. The gel should not be ingested.
After applying the gel to the skin, you can use a breathable (non-occlusive) bandage, but you must first allow the gel to dry on the skin for a few minutes. Do not use it with occlusive bandages that do not allow air to pass through.
Consult your doctor if symptoms worsen or do not improve within 3-5 days.
The use of MUSCORIL DOLORE should be discontinued if you develop a skin rash.
Avoid exposure to sunlight, including solariums, during the use of this medicine.
Necessary precautions must be taken to prevent children from touching the area to which 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
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those available without 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 are pregnant, are planning a pregnancy or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not use MUSCORIL DOLORE if you are in 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 necessary during this period, the lowest dose should be used for the shortest possible time.
Oral forms (e.g. tablets) of diclofenac can 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 to the breast or elsewhere on large areas of skin or for a prolonged period (see section 2 “Warnings and precautions”).

Driving and operating machinery
MUSCORIL DOLORE does not alter or alters negligibly the ability to drive vehicles or operate machinery.

MUSCORIL DOLORE contains propylene glycol (E1520), butylhydroxytoluene (E 321) and a fragrance with limonene
This medicine contains 60 mg of propylene glycolper gram of gel.
This medicine contains butylhydroxytoluene (E 321)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 MUSCORIL DOLORE

Use this medicine following exactly as described in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.

Use in adults and adolescents aged 14 years and over
Depending on the size of the area to be treated, a quantity of gel varying between a cherry and a walnut, corresponding to 1-4 g of gel, should be applied.
MUSCORIL DOLORE should be applied twice a day (preferably in the morning and evening).
The maximum daily dose is 8 g of gel.

Use in elderly patients
No special dose adjustments are necessary. If you are elderly, you should pay particular attention to undesirable effects and, if necessary, consult your doctor or pharmacist.

Use in hepatic or renal impairment
No dose reductions are necessary.

Use in children and adolescents under 14 years
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 over
If this medicine is needed for more than 7 days for pain treatment or if symptoms worsen, it is recommended that the patient/parents of the adolescent consult a doctor.

Route of administration
MUSCORIL DOLORE is for external use.
Apply a thin layer of MUSCORIL DOLORE to the affected parts of the body and massage gently into the skin. Afterwards, wipe your hands with a paper towel and then wash them, unless they are the area to be treated.
If an excessive amount of gel is applied accidentally, the excess gel should be wiped off with a paper towel.
The paper towel should be disposed of in household waste to prevent unused product from reaching the aquatic environment.
Before applying a bandage, the gel should be allowed to dry for a few minutes on the skin. Also, before showering or bathing, wait for the gel to dry on the skin.
How to remove the seal on first use:

• Unscrew and remove the cap
• Use the back of the cap to remove the safety seal from 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 more than 1 – 2 weeks without consulting a doctor. If symptoms worsen or do not improve after 3 – 5 days, consult a doctor.

If you use more MUSCORIL DOLORE than you should
An overdose is unlikely, as absorption into the bloodstream is poor when the medicine is used only on the skin. If a significantly higher dose than recommended 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 MUSCORIL DOLORE, contact your doctor immediately or go to the nearest hospital emergency room.
If you accidentally ingest the contents of a tube of MUSCORIL DOLORE, side effects similar to those observed after ingesting an overdose of diclofenac for systemic use may occur.

If you forget to use MUSCORIL DOLORE
Do not use a double dose to make up for a missed dose.
If you have any questions about using 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.
The following side effects may 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)

It is possible that other side effects may 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)

• Scaling, dehydration of the skin, edema.

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

• Skin rash with pustules
• Gastrointestinal disorders
• Hypersensitivity reactions, including urticaria
• Spots or redness of the skin following exposure to sunlight or sunlamps (photosensitivity reaction).

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

• Burning sensation at the application site.

When MUSCORIL DOLORE is applied to a large area of skin and for a prolonged period, it is not
possible to exclude the possibility of systemic side effects (e.g., renal, hepatic or
gastrointestinal effects, systemic hypersensitivity reactions) similar to those that may occur after
systemic administration of medicines containing diclofenac.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this
leaflet. You can also report side effects directly through 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 MUSCORIL DOLORE

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 pack after “Exp.”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage temperature.
Store the medicine in the original packaging to protect it from light.
Do not refrigerate or freeze.
After first opening, the gel must be used within 2 years, but not beyond the expiry date; after this period, any remaining gel must be discarded.
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 MUSCORIL DOLORE contains

• The active ingredient is diclofenac. 1 g of gel contains 23.2 mg of diclofenac diethylamine corresponding to 20 mg of diclofenac sodium.
• The other ingredients are: diethylamine, carbomer 974P, caprylic/capric triglyceride, macrogol cetostearyl ether, isopropyl alcohol, liquid paraffin, propylene glycol (E 1520), eucalyptus essence (contains limonene), butylhydroxytoluene (E 321), oleyl alcohol, purified water.

Description of the appearance of MUSCORIL DOLORE and contents of the pack
MUSCORIL DOLORE is a homogeneous gel, from 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 Authorisation 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