ILMODOL 1% Cream

Зміст інструкції

1. ILMODOL DOLORE E INFIAMMAZIONE 1% cutaneous foam
   1. What is ILMODOL DOLORE E INFIAMMAZIONE and what is it used for
   2. What you need to know before using ILMODOL DOLORE E INFIAMMAZIONE
   3. How to use ILMODOL DOLORE E INFIAMMAZIONE
   4. Possible side effects
   5. How to store ILMODOL DOLORE E INFIAMMAZIONE
   6. Contents of the pack and other information
2. ILMODOL DOLORE E INFIAMMAZIONE 1% cream
   1. What is ILMODOL DOLORE E INFIAMMAZIONE and what is it used for
   2. What you need to know before using ILMODOL DOLORE E INFIAMMAZIONE
   3. How to use ILMODOL DOLORE E INFIAMMAZIONE
   4. Possible side effects
   5. How to store ILMODOL DOLORE E INFIAMMAZIONE
   6. Package contents and other information

ILMODOL DOLORE E INFIAMMAZIONE 1% cutaneous foam

Piroxicam
Equivalent medicine

Read this leaflet carefully before taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, 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 get worse.

Contents of this leaflet:

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

1. What is ILMODOL DOLORE E INFIAMMAZIONE and what is it used for

ILMODOL DOLORE E INFIAMMAZIONE contains the active ingredient piroxicam, which belongs to a
category of drugs called non-steroidal anti-inflammatory drugs (NSAIDs), used for the treatment of
inflammation and to relieve pain.
ILMODOL DOLORE E INFIAMMAZIONE is used for the local treatment of pain and inflammation of the
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 need to know before using ILMODOL DOLORE E INFIAMMAZIONE

Do not use ILMODOL DOLORE E INFIAMMAZIONE

• If you are allergic to piroxicam or 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
Consult your doctor or pharmacist before using ILMODOL DOLORE E INFIAMMAZIONE.
Inform your doctor and immediately stop treatment:

• if you develop severe allergic reactions such as skin rash, facial swelling, wheezing or difficulty breathing. These reactions may occur during treatment, especially with prolonged use of topical products. Your doctor will indicate a substitute therapy.
• if you experience severe skin reactions such as exfoliative dermatitis (intense redness of the skin, with scaling or layering), blistering reactions (Stevens-Johnson Syndrome, characterized by skin with red blisters, eroded, bleeding or covered with a crust and Toxic Epidermal Necrolysis, characterized by blisters and peeling of the superficial layer of the skin, especially in the first weeks of treatment). These reactions have not been reported with the use of piroxicam for topical use, however, the possibility of their occurrence cannot be excluded.

Page 1to 8
If you develop Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis (TEN) following the use of
ILMODOL DOLORE E INFIAMMAZIONE, never use this medicine again.

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

Other medicines and ILMODOL DOLORE E INFIAMMAZIONE
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicine.

Pregnancy, breastfeeding and fertility

Pregnancy
Oral forms (e.g., tablets) of piroxicam can cause adverse effects in the fetus.
It is not known whether the same risk applies to ILMODOL DOLORE E INFIAMMAZIONE.
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine. Do not use ILMODOL
DOLORE E INFIAMMAZIONE if you are in the last 3 months of pregnancy. You should not use ILMODOL DOLORE E
INFIAMMAZIONE during the first 6 months of pregnancy unless strictly necessary and under the advice of your
doctor. If you need to take it during this period, the lowest dose should be used for the
shortest possible time.

Breastfeeding
If you are breastfeeding: the use of ILMODOL DOLORE E INFIAMMAZIONE foam is not recommended.

Fertility
ILMODOL DOLORE E INFIAMMAZIONE can cause reversible infertility. It is advisable to stop the
treatment with this medicine if you have difficulty conceiving or are undergoing tests
to assess your fertility.

Driving and using machines
No effects of ILMODOL DOLORE E INFIAMMAZIONE foam on the ability to drive
vehicles and operate machinery have been reported.

ILMODOL DOLORE E INFIAMMAZIONE contains propylene glycol
This medicine contains propylene glycol, which can cause skin irritation.

3. How to use ILMODOL DOLORE E INFIAMMAZIONE

Use this medicine following exactly the instructions 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 3-5 cm of foam or more, depending on the extent of the affected area, massaging gently to promote absorption.

ILMODOL DOLORE E INFIAMMAZIONE 1% cutaneous foam
Remove the protective cap, dispense the foam onto the affected area and close it again.

If you use more ILMODOL DOLORE E INFIAMMAZIONE than you should
No cases of overdose are known.

If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Page 2to 8
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
DOLORE E INFIAMMAZIONE and immediately inform your doctor 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 skin with red blisters, eroded, bleeding or covered with a crust, and Toxic Epidermal Necrolysis, characterized by blisters and shedding of the superficial skin layer);
• severe inflammatory skin reactions of an immune nature (contact dermatitis, eczema) and skin reactions following exposure to sunlight;
• difficulty breathing caused by a narrowing of the bronchi.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly
through the national reporting system available at
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 DOLORE E INFIAMMAZIONE

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the label after {Scad}.
The expiry date refers to the last day of that month.
The pressurized container must not be punctured, and must not be brought near, even if empty, to sources
of heat, do not freeze and protect the medicine from direct sunlight.
Do not expose to temperatures above 50°C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help to protect the environment.

6. Contents of the pack and other information

What ILMODOL DOLORE E INFIAMMAZIONE contains
The active ingredient is piroxicam.
100 g of solution of ILMODOL DOLORE E INFIAMMAZIONE 1% cutaneous foamcontains 1 g of piroxicam.
The other ingredients are:
propylene glycol, hydrochloric acid, sodium hydroxide, sodium phosphate monobasic monohydrate, nicotinamide,
polysorbate 80, povidone, ethyl alcohol, benzyl alcohol, lavender essence, nerolene essence, purified water.
Propellant: propane-butane-isobutane

Description of the appearance of ILMODOL DOLORE E INFIAMMAZIONE and contents of the pack

ILMODOL DOLORE E INFIAMMAZIONE 1% cutaneous foam
Aluminum container coated with a valve and applicator, 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
Page 3to 8
Farmol Health Care S.r.l.
Via Del Maglio, 6
23868 Valmadrera (LC)
Italy
Page 4to 8

ILMODOL DOLORE E INFIAMMAZIONE 1% cream

Piroxicam
Equivalent medicine

Read this leaflet carefully before taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See your doctor if you do not feel better or if your symptoms worsen.

Contents of this leaflet:

• 7.What ILMODOL DOLORE E INFIAMMAZIONE is and what it is used for
• 8.What you need to know before using ILMODOL DOLORE E INFIAMMAZIONE
• 9.How to use ILMODOL DOLORE E INFIAMMAZIONE
• 10.Possible side effects
• 11.How to store ILMODOL DOLORE E INFIAMMAZIONE
• 12.Contents of the pack and other information

7. What is ILMODOL DOLORE E INFIAMMAZIONE and what is it used for

ILMODOL DOLORE E INFIAMMAZIONE contains the active ingredient piroxicam which belongs to a
category of drugs called non-steroidal anti-inflammatory drugs (NSAIDs), used for the treatment of
inflammation and to relieve pain.
ILMODOL DOLORE E INFIAMMAZIONE is used for the local treatment of pain and inflammation of the
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.

8. What you need to know before using ILMODOL DOLORE E INFIAMMAZIONE

Do not use ILMODOL DOLORE E INFIAMMAZIONE

• If you are allergic to piroxicam or 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
Consult your doctor or pharmacist before using ILMODOL DOLORE E INFIAMMAZIONE.
Inform your doctor and immediately stop treatment:

• if you develop severe allergic reactions such as skin rash, facial swelling, wheezing or difficulty breathing. These reactions may occur during treatment, especially with prolonged use of topical products. Your doctor will indicate a substitute therapy.
• if you experience severe skin reactions such as exfoliative dermatitis (intense redness of the skin, with scaling or layering), vesiculo-bullous reactions (Stevens-Johnson Syndrome, characterized by skin with red blisters, eroded, bleeding or covered with a crust and Necrolysis

Pag. 5to 8
Toxic Epidermal Necrolysis, characterized by blisters and peeling of the superficial layer of the skin,
especially in the first weeks of treatment).
These reactions have not been reported with the use of piroxicam for topical use, however, the possibility
of their occurrence cannot be excluded.
If you develop Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis (TEN) following the use of
ILMODOL DOLORE E INFIAMMAZIONE, never use this medicine again.

• if you experience severe kidney problems, you may have developed some conditions due to impaired renal function.
• See also the information reported in section 4.

The cream formulation contains a substance called cetostearyl alcohol. This substance can cause
local skin reactions (e.g., contact dermatitis).

Other medicines and ILMODOL DOLORE E INFIAMMAZIONE
Tell 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 can cause adverse effects in the fetus.
It is not known whether the same risk applies to ILMODOL DOLORE E INFIAMMAZIONE.
If you are pregnant, suspect you are pregnant, or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine. Do not use ILMODOL
DOLORE E INFIAMMAZIONE if you are in the last 3 months of pregnancy. You should not use ILMODOL DOLORE E
INFIAMMAZIONE during the first 6 months of pregnancy unless strictly necessary and under the advice of
your doctor. If you need to take it during this period, the lowest dose should be used for the
shortest possible time.

Breastfeeding
If you are breastfeeding: the use of ILMODOL DOLORE E INFIAMMAZIONE cream is not recommended.

Fertility
ILMODOL DOLORE E INFIAMMAZIONE can cause reversible infertility. It is advisable that you stop the
treatment with this medicine if you have difficulty conceiving or are undergoing tests
to assess your fertility.

Driving and using machines
No effects of ILMODOL DOLORE E INFIAMMAZIONE cream on the ability to drive
vehicles and operate machinery have been reported.

ILMODOL DOLORE E INFIAMMAZIONE contains cetostearyl alcohol and propylene glycol
This medicine contains cetostearyl alcohol and propylene glycol, which can cause skin irritation and
allergic reactions.

9. How to use ILMODOL DOLORE E INFIAMMAZIONE

Use this medicine following 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 3-5 cm of cream or more depending on the extent of the affected area,
massaging gently to promote absorption.
Page 6to 8
If you use more ILMODOL DOLORE E INFIAMMAZIONE than you should
No cases of overdose are known.

If you have any doubts about the use of this medicine, ask 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
DOLORE E INFIAMMAZIONE and immediately inform your doctor 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 skin with red blisters, eroded, bleeding or covered with a crust and Toxic Epidermal Necrolysis, characterized by blisters and peeling of the superficial layer of the skin);
• severe inflammatory skin reactions of an immune nature (contact dermatitis, eczema) and skin reactions following exposure to sunlight;
• difficulty breathing caused by a narrowing of the bronchi.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system available at 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 DOLORE E INFIAMMAZIONE

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the label after {Scad}. The expiry
date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate the
medicines that you no longer use. This will help protect the environment.

12. Package contents and other information

What ILMODOL DOLORE E INFIAMMAZIONE contains
The active ingredient is piroxicam.
100 g of ILMODOL DOLORE E INFIAMMAZIONE 1% creamcontain 1 g of piroxicam.
The other ingredients are:
polyethylene glycol cetyl ether, polyglycol esters with fatty acids, cetostearyl alcohol, propylene glycol,
sodium citrate, citric acid, benzyl alcohol, purified water.

Description of the appearance of ILMODOL DOLORE E INFIAMMAZIONE and package contents

ILMODOL DOLORE E INFIAMMAZIONE 1% cream
Aluminum tube, flexible, internally coated with a material called epoxy resin.

Marketing authorisation holder and manufacturer
Marketing authorisation holder
Farmitalia S.r.l.
Via Pinciana, 25
00198 Rome
Italy
Page 7to 8
Manufacturer
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo, 1
03012 Anagni (FR)
Italy
Page 8to 8