Ilmodol joint and muscle pain

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ilmodol joint and muscle pain 180 mg medicated patch

Diclofenac epolamine
Please read this leaflet carefully before using this medicine because it contains important information for you.

• 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 advice or information, consult your doctor or pharmacist.
• If you experience any side effect, 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 a short period of treatment.

Contents of this leaflet:

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

1. What Ilmodol joint and muscle pain is and what it is used for

Ilmodol joint and muscle pain belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs reduce pain and inflammation.
Ilmodol joint and muscle pain is used to relieve pain and inflammation of rheumatic or traumatic origin affecting joints, muscles, tendons, and ligaments.
Consult your doctor if you do not notice any improvement or if you notice a worsening of symptoms after a short period of treatment with Ilmodol joint and muscle pain.

2. What you need to know before using Ilmodol joint and muscle pain

Do not use Ilmodol joint and muscle pain:

• if you are allergic to diclofenac, acetylsalicylic acid (aspirin), or any other NSAID;
• if you are allergic to any of the other ingredients of Ilmodol joint and muscle pain (listed in section 6);
• if you have experienced asthma, breathing difficulties, skin rash, or rhinitis (runny nose) after taking acetylsalicylic acid (aspirin) or other NSAIDs;
• if you are in the last three months of pregnancy;
• if you currently have a stomach ulcer (peptic ulcer);
• if you have damaged skin, including oozing or infected areas, eczema, burns, or wounds;
• if the person to be treated is a child or adolescent under 16 years of age.

Inform your doctor or pharmacist if any of the above conditions apply to you.
Warnings and precautions
Talk to your doctor or pharmacist before using Ilmodol joint and muscle pain if:

• you suffer from heart disease;
• you suffer from kidney disease;
• you suffer from liver disease;
• you have had gastric ulcers in the past;
• you have an inflammatory bowel disease such as Crohn’s disease or ulcerative colitis, or are prone to episodes of intestinal bleeding;
• you have asthma;
• you have had breathing problems, skin rashes, or runny nose after taking acetylsalicylic acid (aspirin) or other NSAIDs;
• you are currently taking diclofenac or other NSAIDs, either orally or topically;
• you regularly use sunbeds or are exposed to direct sunlight;
• you are elderly, as you may be more susceptible to adverse effects.

Other important information
Always use the lowest effective dose of Ilmodol joint and muscle pain and for the shortest possible duration
needed to control your symptoms.
Ilmodol joint and muscle pain should be used with caution in elderly patients, who may be more likely
to experience adverse effects.
To minimize the occurrence of adverse effects, it is recommended to use the lowest effective dose for the
shortest possible time.
Children and adolescents
Do not apply the patch to children and adolescents under 16 years of age.
Other medicines and Ilmodol joint and muscle pain
If Ilmodol joint and muscle pain is used correctly, the risk of interactions with other
medicines is very low.
However, inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding,
consult your doctor or pharmacist before using this medicine.
Do not use Ilmodol joint and muscle pain during the last three months of pregnancy. Do not use Ilmodol joint
and muscle pain 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 should be used for the shortest possible time.
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 Ilmodol joint and muscle pain when applied to the skin.
Ilmodol joint and muscle pain should be used under medical advice during breastfeeding, as diclofenac passes into breast milk in small amounts. However, Ilmodol joint and muscle pain must not be applied to the breast of a breastfeeding mother, nor to other large areas of skin or for prolonged periods.
Consult your doctor or pharmacist for further information if you are pregnant or breastfeeding.
Driving and using machines
The diclofenac medicated patch does not impair the ability to drive or operate machinery.
Ilmodol joint and muscle pain contains methyl 4-hydroxybenzoate and propyl 4-hydroxybenzoate
May cause allergic reactions (including delayed reactions).
Ilmodol joint and muscle pain contains propylene glycol
This medicine contains 420 mg of propylene glycol per patch, which may cause skin irritation.
Ilmodol joint and muscle pain contains polysorbate 80
This medicine contains 28 mg of polysorbate 80 per patch. Polysorbates may cause allergic reactions.

3. How to use Ilmodol joint and muscle pain patches

Use Ilmodol joint and muscle pain patches exactly as instructed by your doctor.
Adults and adolescents aged 16 years and older
Number of patches to use
The recommended dose of Ilmodol joint and muscle pain patches is one (1) patch applied to the most painful area, once or twice daily (one application every 12 or 24 hours), for a maximum of 14 consecutive days. If you do not notice any improvement during the recommended treatment period, or if symptoms worsen, consult your doctor.
Use in children and adolescents (under 16 years of age)
There are no data available on efficacy and safety in children and adolescents under 16 years of age (see section "Do not use Ilmodol joint and muscle pain patches").
In adolescents aged 16 years and older, if symptoms worsen, patients/parents of the adolescent should consult a doctor.
How to apply Ilmodol joint and muscle pain patches
Cut open the top of the resealable pouch and remove one patch.

Carefully reseal the pouch.

Remove the plastic protective layer covering the adhesive side of the patch.

Apply the patch to the swollen area or where pain is felt.

• If necessary, the patch may be secured in place with a gauze bandage with wide mesh or with thin strips of adhesive tape. These may be provided by your pharmacist.
• Do not cover the patch with other types of dressings.
• The medicated patch must be applied only to intact, undamaged skin. Avoid applying it to lesions or open wounds. The patch must not be used during bathing or showering.
• Take care to keep the patch away from eyes, nose, mouth, genital and anal areas. If the patch comes into contact with these areas, rinse thoroughly with water.
• The patch must not be cut.

Patch replacement

• Remove the patch every 12 or 24 hours and apply a new one.

If you forget to use Ilmodol joint and muscle pain patches
Do not apply an additional patch to make up for the missed dose. Simply apply the next patch as scheduled.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Ilmodol joint and muscle pain patches may cause side effects, although not
all people experience them.
Some uncommon and very rare side effects can be serious.
If you experience any of the following signs of allergy, STOP using Ilmodol joint and muscle pain patches and contact your doctor or pharmacist immediately:

• Swelling of lips, eyes or tongue, wheezing or asthma attack, which are signs of a severe allergic reaction (affects fewer than 1 in 10,000 users);
• Skin rash, stinging or burning at the site where the patch was applied (affects 1 to 10 in 1,000 users).

Other side effects that may occur are usually mild, temporary and harmless (if concerned, inform your doctor or pharmacist).
Common side effects (affects 1 to 10 in 100 users)

• Itching.

Uncommon side effects (affects 1 to 10 in 1,000 users)

• Skin rash;
• Skin redness;
• Small red or purple spots under the skin.

Rare side effects (affects 1 to 10 in 10,000 users)

• Dry, scaly skin;
• Swelling at the application site.

Very rare side effects (affects fewer than 1 in 10,000 users)

• Skin rashes worsened by sunlight.

Side effects with unknown frequency (frequency cannot be determined from available data)

• Burning sensation at the application site.

Since Ilmodol joint and muscle pain patches are applied directly to the skin over the affected area, there is a lower risk of experiencing side effects such as stomach problems including pain, indigestion, or any sign of bleeding in the stomach or intestine, which may occur when diclofenac is taken orally. However, if Ilmodol joint and muscle pain patches are not used correctly, these side effects may occur.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact 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 Ilmodol joint and muscle pain patches

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the sachet and packaging. The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature.
Do not use more than 4 months after first opening the sachet. After removing each patch, make sure the sachet is properly resealed.
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 Ilmodol joint and muscle pain contains
The active substance is diclofenac epolamine. Each medicated patch contains a total of 180 mg of diclofenac
epolamine, equivalent to 140 mg of diclofenac sodium.
The other ingredients are gelatin, povidone (K90), liquid sorbitol (non-crystallizable), heavy kaolin,
titanium dioxide (E171), propylene glycol, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate
(E216), disodium edetate (E385), tartaric acid, aluminum glycinate, sodium carmellose, sodium polyacrylate,
1,3-butylene glycol, polysorbate 80 (E433), purified water.
The non-woven fabric backing layer is made of polyester.
The removable protective layer is made of polypropylene.

Description of the appearance of Ilmodol joint and muscle pain and package contents
Each medicated patch consists of a bandage impregnated with a paste ranging in color from white to pale yellow,
with the adhesive layer protected by a removable transparent plastic backing. Resealable pouches contain 5 patches.
Ilmodol joint and muscle pain is available in packages of 5 or 10 patches per box.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Farmitalia S.r.l.
Via Pinciana 25
00198 Rome (Italy)

Manufacturer
Miat S.p.A.
Piazza Pasolini, 2
20159 Milan (Italy)