Ilmodol for pain and inflammation

Patient Information Leaflet

ILMODOL PAIN AND INFLAMMATION 1% Topical Foam

Piroxicam
Generic medicine
Please read this leaflet carefully before using this medicine as it contains important information for 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, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement or if your symptoms worsen.

Contents of this leaflet:

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

1. What ILMODOL PAIN AND INFLAMMATION is and what it is used for

ILMODOL PAIN AND INFLAMMATION contains as the active ingredient piroxicam, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), used to treat inflammation and relieve pain.
ILMODOL PAIN AND INFLAMMATION is used for the local treatment of pain and inflammation affecting joints, muscles, tendons and ligaments caused by trauma or inflammatory rheumatic diseases.
Consult your doctor if you do not feel better or if you feel worse after a short period of time.

2. What you should know before using ILMODOL PAIN AND INFLAMMATION

Do not use ILMODOL PAIN AND INFLAMMATION

• If you are allergic to piroxicam or to any of the other ingredients of this medicine listed in section 6.
• If you are in the last 3 months of pregnancy.

Warnings and precautions
Talk to your doctor or pharmacist before using ILMODOL PAIN AND INFLAMMATION.
Inform your doctor and stop treatment immediately:

• If you develop severe allergic reactions such as skin rash, facial swelling, wheezing or difficulty breathing. These reactions may occur during treatment, especially if prolonged, with topical products. Your doctor will advise you on alternative therapy.
• If you experience severe skin reactions such as exfoliative dermatitis (intense redness of the skin with flaking or peeling), or vesiculobullous reactions (Stevens-Johnson Syndrome, characterized by red blisters on the skin, erosive, bloody or covered with a crust; and Toxic Epidermal Necrolysis, characterized by blisters and shedding of the superficial layer of the skin), especially during the first weeks of treatment. These reactions have not been reported with the use of topical piroxicam; however, the possibility that they may occur cannot be ruled out.

If you develop Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis (TEN) following the use of
ILMODOL PAIN AND INFLAMMATION, you must never use this medicine again.

• If you develop serious kidney problems, you may have developed certain disorders due to impaired kidney function.
• See also the information provided in section 4.

Other medicines and ILMODOL PAIN AND INFLAMMATION
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
Pregnancy, breastfeeding and fertility
Pregnancy
Oral forms (e.g., tablets) of piroxicam may cause adverse effects on the fetus.
It is not known whether the same risk applies to ILMODOL PAIN AND INFLAMMATION.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine. Do not use ILMODOL PAIN AND INFLAMMATION if you are in the last 3 months of pregnancy. You should not use ILMODOL PAIN AND INFLAMMATION during the first 6 months of pregnancy unless strictly necessary and under medical advice. If use during this period is required, the lowest dose for the shortest possible duration should be used.
Breastfeeding
If you are breastfeeding: use of ILMODOL PAIN AND INFLAMMATION foam is not recommended.
Fertility
ILMODOL PAIN AND INFLAMMATION may cause reversible infertility. It is advisable to discontinue treatment with this medicine if you have difficulty conceiving or are undergoing fertility testing.
Driving and using machines
No effects of ILMODOL PAIN AND INFLAMMATION foam on the ability to drive vehicles or operate machinery have been reported.
ILMODOL PAIN AND INFLAMMATION contains propylene glycol
This medicine contains propylene glycol, which may cause skin irritation.

3. How to use ILMODOL PAIN AND INFLAMMATION

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.
Adults
Apply to the skin 2–3 times a day a 3–5 cm strip of foam, or more depending on the size of the affected area, gently massaging to promote absorption.
ILMODOL PAIN AND INFLAMMATION 1% cutaneous foam
Remove the protective cap, dispense the foam onto the affected area, and close the container.
If you use more ILMODOL PAIN AND INFLAMMATION than you should
Cases of overdose are not known.
If you have any doubts 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 everyone will experience them.
If you experience any of the following side effects, stop treatment with ILMODOL
PAIN AND INFLAMMATION and contact your doctor immediately or go to the nearest
hospital.

• severe allergic reactions and local irritation (especially with prolonged use);
• urticaria;
• severe skin reactions (Stevens-Johnson Syndrome, characterized by red blistered skin, eroded, bloody, or covered with scabs, and Toxic Epidermal Necrolysis, characterized by blisters and peeling of the outer layer of skin);
• severe immune-mediated inflammatory skin reactions (contact dermatitis, eczema) and skin reactions following exposure of the skin to sunlight;
• breathing difficulties caused by bronchial constriction.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist. You may also report side effects directly via the national reporting system at the following website:
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 PAIN AND INFLAMMATION

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label after {Exp.}.
The expiry date refers to the last day of that month.
The pressurised container must not be pierced, and must not be exposed, even when empty, to heat sources; do not freeze and protect the medicine from direct sunlight.
Do not expose to temperatures above 50°C.
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 PAIN AND INFLAMMATION contains
The active substance is piroxicam.
100 g of ILMODOL PAIN AND INFLAMMATION 1% cutaneous foam solution contain 1 g of piroxicam.
The other components are:
propylene glycol, hydrochloric acid, sodium hydroxide, monosodium phosphate monohydrate, nicotinamide,
polysorbate 80, povidone, ethanol, benzyl alcohol, lavender essence, nerolene essence, purified water.
Propellant: propane-butane-isobutane

Description of the appearance of ILMODOL PAIN AND INFLAMMATION and contents of the pack
ILMODOL PAIN AND INFLAMMATION 1% cutaneous foam
Painted aluminium container fitted with valve and dispenser, closed with a protective cap,
filled with 45 g of solution and pressurized with 5 g of gas mixture.

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

Manufacturer
Farmol Health Care S.r.l.
Via Del Maglio, 6
23868 Valmadrera (LC)
Italy

Patient Information Leaflet

ILMODOL PAIN AND INFLAMMATION 1% cream

Piroxicam
Equivalent medicine
Please read this leaflet carefully before using this medicine as it contains important information for 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, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement, or if your symptoms worsen.

Contents of this leaflet:

7. What ILMODOL PAIN AND INFLAMMATION is and what it is used for
8. What you need to know before using ILMODOL PAIN AND INFLAMMATION
9. How to use ILMODOL PAIN AND INFLAMMATION
10. Possible side effects
11. How to store ILMODOL PAIN AND INFLAMMATION
12. Package contents and other information

7. What ILMODOL PAIN AND INFLAMMATION is and what it is used for

ILMODOL PAIN AND INFLAMMATION contains the active substance piroxicam, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), used for the treatment of inflammation and relief of pain.
ILMODOL PAIN AND INFLAMMATION is used for the local treatment of pain and inflammation affecting joints, muscles, tendons and ligaments caused by trauma or inflammatory rheumatic diseases.
Consult your doctor if you do not feel better or feel worse after a short period of time.

8. What you need to know before using ILMODOL PAIN AND INFLAMMATION

Do not use ILMODOL PAIN AND INFLAMMATION

• If you are allergic to piroxicam or to any of the other ingredients of this medicine (listed in section 6).
• If you are in the last 3 months of pregnancy.

Warnings and precautions
Talk to your doctor or pharmacist before using ILMODOL PAIN AND INFLAMMATION.
Inform your doctor and stop treatment immediately:

• If you develop severe allergic reactions such as skin rash, facial swelling, wheezing or breathing difficulties. These reactions may occur during treatment, especially if prolonged, with topical products. Your doctor will advise you on an alternative therapy.
• If you experience severe skin reactions such as exfoliative dermatitis (intense skin redness with flaking in scales or layers), vesiculobullous reactions (Stevens-Johnson Syndrome, characterized by blistering red skin, erosion, bleeding, or crusting, and Toxic Epidermal Necrolysis,

characterized by blisters and peeling of the superficial layer of the skin),
especially during the first weeks of treatment.
Such reactions have not been reported with the use of topical piroxicam; however, the possibility that they may occur cannot be ruled out.
If you develop Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis (TEN) following the use of ILMODOL PAIN AND INFLAMMATION, you must never use this medicine again.

• If you experience serious kidney problems, as you may have developed certain conditions due to impaired renal function.
• See also the information provided in section 4.

The cream formulation contains a substance called cetostearyl alcohol. This substance may cause local skin reactions (e.g., contact dermatitis).
Other medicines and ILMODOL PAIN AND INFLAMMATION
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breast-feeding and fertility
Pregnancy
Oral forms (e.g., tablets) of piroxicam may cause adverse effects on the fetus.
It is not known whether the same risk applies to ILMODOL PAIN AND INFLAMMATION.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breast-feeding, consult your doctor or pharmacist before taking this medicine. Do not use ILMODOL PAIN AND INFLAMMATION if you are in the last 3 months of pregnancy. You should not use ILMODOL PAIN AND INFLAMMATION during the first 6 months of pregnancy unless strictly necessary and under medical advice. If use during this period is required, the lowest effective dose for the shortest possible duration should be used.
Breast-feeding
If you are breast-feeding: use of ILMODOL PAIN AND INFLAMMATION cream is not recommended.
Fertility
ILMODOL PAIN AND INFLAMMATION may cause reversible infertility. It is advisable to discontinue treatment with this medicine if you are experiencing difficulty conceiving or undergoing fertility investigations.
Driving and using machines
No effects of ILMODOL PAIN AND INFLAMMATION cream on the ability to drive or operate machinery have been reported.
ILMODOL PAIN AND INFLAMMATION contains cetostearyl alcohol and propylene glycol
This medicine contains cetostearyl alcohol and propylene glycol, which may cause skin irritation and allergic reactions.

9. How to use ILMODOL PAIN AND INFLAMMATION

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Adults
Apply to the skin 2–3 times a day a 3–5 cm strip of cream, or more depending on the size of the affected area, gently massaging to promote absorption.
If you use more ILMODOL PAIN AND INFLAMMATION than you should
Overdose cases are unknown.
If you have any doubts about how to use this medicine, speak to your doctor or pharmacist.

10. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following side effects, stop treatment with ILMODOL PAIN AND INFLAMMATION and inform your doctor immediately or go to the nearest hospital.

• severe allergic reactions and local irritation (especially with prolonged use);
• urticaria;
• severe skin reactions (Stevens-Johnson Syndrome, characterized by red, blistered, eroded, bloody skin or covered with a crust, and Toxic Epidermal Necrolysis, characterized by blisters and shedding of the superficial layer of the skin);
• severe immune-mediated inflammatory skin reactions (contact dermatitis, eczema) and skin reactions following exposure of the skin to sunlight;
• breathing difficulties caused by narrowing of the bronchi.

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website: www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

11. How to store ILMODOL PAIN AND INFLAMMATION

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label after {Exp.}. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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.

12. Package contents and other information

What ILMODOL PAIN AND INFLAMMATION contains
The active substance is piroxicam.
100 g of ILMODOL PAIN AND INFLAMMATION 1% cream contain 1 g of piroxicam.
The other components are:
cetomacrogol ether, polyglycol esters with fatty acids, cetyl stearyl alcohol, propylene glycol,
sodium citrate, citric acid, benzyl alcohol, purified water.

Description of the appearance of ILMODOL PAIN AND INFLAMMATION and contents of the pack
ILMODOL PAIN AND INFLAMMATION 1% cream
Aluminium tube with a flexible inner coating made of a material called epoxy resin.

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

Manufacturer
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo, 1
03012 Anagni (FR)
Italy