ACTALIDE

Package leaflet: Information for the user

ACTALIDE 1 mg/ml Mouthwash

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What ACTALIDE is and what it is used for

ACTALIDE contains the active substance nimesulide, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs) that work by reducing inflammation.
ACTALIDE is indicated for the treatment of symptoms caused by inflammation or irritation of the mouth, gums and teeth (gingivitis, stomatitis, pharyngitis), whether associated with pain or following dental surgery (conservative or extraction procedures).

2. What you need to know before using ACTALIDE

Do not use ACTALIDE

• if you are allergic to nimesulide, to other medicines in the same class as ACTALIDE (non-steroidal anti-inflammatory drugs), or to any of the other ingredients of this medicine;
• if in the past, after taking other medicines used to treat inflammation (acetylsalicylic acid, non-steroidal anti-inflammatory drugs), you experienced an allergic reaction manifested by allergic-type cold symptoms (rhinitis), skin irritation (urticaria), or breathing difficulties (bronchospasm);
• if you are in the last trimester of pregnancy.

Warnings and precautions
Talk to your doctor or pharmacist before using ACTALIDE.
Do not swallow ACTALIDE. If you have swallowing difficulties, avoid using this medicine. Its use is also not recommended in elderly individuals with severe physical impairment (debilitated elderly).
However, if you accidentally swallow a small amount of the solution during rinsing or gargling, this will not cause any harm to your health, as the amount swallowed is minimal.
Prolonged use of this medicine may cause allergic-type reactions (sensitization phenomena). In such cases, discontinue treatment with ACTALIDE and consult your doctor.
For those engaged in sports activities: the use of medicines containing ethyl alcohol may lead to a positive result in doping tests, depending on the blood alcohol concentration limits indicated by certain sports federations.

Children
This medicine is not recommended for children, as its efficacy and safety have not been established.

Other medicines and ACTALIDE
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
No interactions between ACTALIDE and other medicines have been reported.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Avoid using ACTALIDE if you are pregnant or breastfeeding.
Oral forms (e.g., tablets) of nimesulide may cause adverse effects in the unborn child. It is not known whether the same risk applies to ACTALIDE when applied to the skin.
If you are pregnant, think you might be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not use ACTALIDE if you are in the last trimester of pregnancy. You should not use ACTALIDE during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor. If treatment is required during this period, the lowest possible dose for the shortest possible duration should be used.

Driving and using machines
This medicine does not affect your ability to drive or operate machinery.

ACTALIDE contains sodium benzoate, which is mildly irritating to the skin, eyes, and mucous membranes.

ACTALIDE contains 96% ethanol
This medicine contains small amounts of ethanol (alcohol), less than 100 mg per dose.

3. How to use ACTALIDE

Use this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Use ACTALIDE three times a day, rinsing and/or gargling with 15 ml of
mouthwash each time (measure with the provided dosing cup; 15 ml of mouthwash corresponds to
15 mg of nimesulide). You may use the mouthwash undiluted or diluted with a little water.
If you use more ACTALIDE than you should
It is highly unlikely that taking an excessive dose of ACTALIDE would cause adverse effects. However, if you accidentally ingest or take an excessive amount of ACTALIDE, contact your doctor.
If you forget to use ACTALIDE
Do not use a double dose of this medicine to make up for a forgotten dose.
If you have any doubts 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 everybody gets them.
ACTALIDE may cause irritation and allergic reactions (sensitisation reactions) in the area where it is used.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You may also report side effects directly via the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ACTALIDE

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.
Do not use the medicine more than three months after opening the bottle.
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 ACTALIDE contains

• The active substance is nimesulide. Each 100 ml of solution contains 100 mg of nimesulide.
• The other components are ethanol 96%, sodium bicarbonate, sodium benzoate, acesulfame potassium, poloxamer, sodium hydroxide, toothpaste flavour, disodium edetate, methylene blue chloride, purified water.

Description of the appearance of ACTALIDE and package contents
200 ml bottle.
Marketing Authorization Holder
Errekappa Euroterapici S.p.A. – Via Ciro Menotti 1/A – 20129 Milan
Manufacturer
Francia Farmaceutici Industria Farmaco Biologica – Via dei Pestagalli 7 – Milan
Special Product’s Line S.p.A. - Via Fratta Rotonda Vado Largo, 1 - Anagni (FR)

Package leaflet: Information for the user

ACTALIDE 30 mg/g gel

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What ACTALIDE is and what it is used for

ACTALIDE contains the active substance nimesulide, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs) that work by reducing pain and inflammation.
ACTALIDE is indicated for the relief of pain associated with trauma (sprains, acute traumatic tendinitis).

2. What you need to know before using ACTALIDE

Do not use ACTALIDE

• if you are allergic to nimesulide, to other medicines of the same class as ACTALIDE (non-steroidal anti-inflammatory drugs), or to any of the other ingredients of this medicine;
• if in the past, after taking other medicines used to treat inflammation (salicylic acid, non-steroidal anti-inflammatory drugs), you experienced an allergic reaction such as allergic-type cold (rhinitis), skin irritation (urticaria), or breathing difficulties (bronchospasm);
• on open wounds (lacerated or denuded skin) or on areas affected by infection;
• together with other topical medicines (local application);
• if the patient is a child under 12 years of age (see section “Children”);
• if you are in the last trimester of pregnancy.

Warnings and precautions
Talk to your doctor or pharmacist before using ACTALIDE.
You can reduce the likelihood of unwanted side effects by using the lowest effective dose for the shortest possible duration.
Use ACTALIDE with caution:

• if you suffer from stomach or intestinal disorders associated with bleeding or lesions (gastrointestinal hemorrhage, peptic ulcer);
• if you have serious blood coagulation disorders;
• if you suffer from severe liver or kidney problems (severe hepatic or renal insufficiency);
• if you suffer from heart problems (severe heart failure not controlled by appropriate treatment);
• if you have previously experienced allergic reactions (hypersensitivity) after taking medicines similar to ACTALIDE (non-steroidal anti-inflammatory drugs), as you may experience allergic reactions during treatment with ACTALIDE.

Like other topical anti-inflammatory medicines, ACTALIDE may cause burning, skin irritation, especially following exposure to light (photosensitivity dermatitis). Therefore, avoid direct sunlight or sunbeds during treatment with this medicine.
Consult your doctor if symptoms persist or if you notice worsening of your health condition.

Children
This medicine is not recommended for children under 12 years of age.

Other medicines and ACTALIDE
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
No interactions between ACTALIDE and other topical medicines (local application) have been reported (see section “Do not use ACTALIDE”).

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Do not use ACTALIDE if you are pregnant or breastfeeding, except in cases of absolute necessity and under direct medical supervision.
Oral forms (e.g., tablets) of nimesulide may cause adverse effects in the newborn. It is not known whether the same risk applies to ACTALIDE when applied to the skin.
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not use ACTALIDE if you are in the last trimester of pregnancy. You should not use ACTALIDE during the first 6 months of pregnancy unless absolutely necessary and on medical advice. If treatment is required during this period, the lowest possible dose for the shortest possible duration should be used.

Driving and using machines
The effects of ACTALIDE on the ability to drive or operate machinery are unknown.

ACTALIDE contains parahydroxybenzoates
This medicine contains parahydroxybenzoates (methyl parahydroxybenzoate and propyl parahydroxybenzoate) which may cause allergic reactions (including delayed reactions).

3. How to use ACTALIDE

Use this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Apply a thin layer of ACTALIDE to the affected area, massaging gently until completely absorbed. Repeat the application 2 or 3 times daily. The recommended dose is approximately 3 g of gel per application (a strip of gel 6–7 cm long).
The duration of treatment ranges from 7 to 15 days.
Apply ACTALIDE only to intact skin; do not apply this medicine to damaged skin or open wounds. After application, avoid contact with eyes and mucous membranes, and wash your hands immediately.
In case of accidental contact, rinse immediately with water. This medicine is a topical gel and must not be swallowed.
Do not use ACTALIDE if the affected area is to be covered with an occlusive dressing (non-breathable dressing with films).

If you use more ACTALIDE than you should
Nimesulide intoxication is not expected following topical application of ACTALIDE, as the amount of nimesulide absorbed after application is very low.

If you forget to use ACTALIDE
Do not use a double dose of this medicine to make up for a forgotten dose.
If you have any doubts 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 everybody gets them.
ACTALIDE may cause:
Common (may affect up to 1 in 10 people)

• skin reactions such as itching, redness (irritation), and allergic-type problems (erythema) in the area where you applied this medicine.

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 through the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ACTALIDE

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month.
Store this medicine away from sources of heat and at temperatures below 30°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 ACTALIDE contains

• The active substance is nimesulide. Each gram of gel contains 30 mg of nimesulide.
• The other components are lactic acid, ethanol 96%, glycerol, polyacrylamide copolymer, perfluoropoly(methylisopropyl ether), lecithin, methyl parahydroxybenzoate, propyl parahydroxybenzoate, purified water.

Description of the appearance of ACTALIDE and contents of the pack
Aluminum tube containing 50 g.
Marketing Authorization Holder
Errekappa Euroterapici S.p.A. – Via Ciro Menotti 1/A – 20129 Milan
Manufacturer
Francia Farmaceutici Industria Farmaco Biologica – Via dei Pestagalli 7 - Milan

Package leaflet: Information for the user

ACTALIDE 30 mg/g Cutaneous Foam

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What ACTALIDE is and what it is used for

ACTALIDE contains the active substance nimesulide, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs) that work by reducing pain and inflammation.
ACTALIDE is indicated for the relief of pain associated with injuries (sprains, acute traumatic tendinitis).

2. What you need to know before using ACTALIDE

Do not use ACTALIDE

• if you are allergic to nimesulide, to other medicines of the same class as ACTALIDE (non-steroidal anti-inflammatory drugs), or to any of the other ingredients of this medicine;
• if in the past, after taking other medicines for inflammation (salicylic acid, non-steroidal anti-inflammatory drugs), you experienced an allergic reaction such as allergic-type cold (rhinitis), skin irritation (urticaria), or breathing difficulties (bronchospasm);
• on open wounds (lacerated or denuded skin) or on areas affected by infection;
• together with other topical medicines (topical use);
• if the patient is a child under 12 years of age (see section “Children”);
• if you are in the last trimester of pregnancy.

Warnings and precautions
Talk to your doctor or pharmacist before using ACTALIDE.

You can reduce the occurrence of unwanted effects by using the lowest effective dose for the shortest possible duration.
Use ACTALIDE with caution:

• if you suffer from stomach or intestinal disorders associated with bleeding and lesions (gastrointestinal hemorrhage, peptic ulcer);
• if you have serious blood coagulation disorders;
• if you have severe liver or kidney problems (severe hepatic or renal insufficiency);
• if you suffer from heart problems (severe heart failure not controlled by appropriate treatment);
• if you have previously experienced allergic reactions (hypersensitivity) after using medicines similar to ACTALIDE (non-steroidal anti-inflammatory drugs), as you may experience allergic reactions during treatment with ACTALIDE.

Like other locally applied anti-inflammatory medicines, ACTALIDE may cause burning, skin irritation, especially upon exposure to light (photosensitivity dermatitis). Therefore, avoid direct sunlight or tanning lamps during treatment with this medicine.
Consult your doctor if symptoms persist or if you notice worsening of your health condition.

Children
This medicine is not recommended for children under 12 years of age.

Other medicines and ACTALIDE
Tell your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
No interactions between ACTALIDE and other topical medicines (topical use) have been reported (see section “Do not use ACTALIDE”).

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Do not use ACTALIDE if you are pregnant or breastfeeding, except in cases of absolute necessity and under direct medical supervision.
Oral forms (e.g., tablets) of nimesulide may cause adverse effects in the unborn child. It is not known whether the same risk applies to ACTALIDE when used on the skin.
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not use ACTALIDE if you are in the last trimester of pregnancy. You should not use ACTALIDE during the first 6 months of pregnancy unless strictly necessary and on medical advice. If treatment is required during this period, the lowest possible dose for the shortest possible time should be used.

Driving and using machines
The effects of ACTALIDE on the ability to drive vehicles and use machinery are unknown.

ACTALIDE contains parahydroxybenzoates
This medicine contains parahydroxybenzoates (methyl parahydroxybenzoate and propyl parahydroxybenzoate) which may cause allergic reactions (including delayed reactions).

3. How to use ACTALIDE

Use this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Apply a thin layer of ACTALIDE to the affected area, massaging gently until completely absorbed. Repeat the application 2 or 3 times a day. The recommended dose is approximately 3 g of foam per application (a foam strip of 6–7 cm). Before using this medicine, turn the container upside down and shake it, then press the dispenser button to release the foam.
The duration of treatment ranges from 7 to 15 days.
Apply ACTALIDE only to intact skin; do not apply this medicine to damaged skin or open wounds. Wash your hands immediately after application.
Avoid contact of this medicine with eyes and mucous membranes. In case of accidental contact, rinse immediately with water. This medicine is a topical foam and must not be swallowed.
Do not use ACTALIDE if the affected area is to be treated with an occlusive, non-breathable dressing (e.g. plastic film dressings).
If you use more ACTALIDE than you should
Nimesulide intoxication is not expected following topical application of ACTALIDE, as the amount of nimesulide absorbed after application is very low.
If you forget to use ACTALIDE
Do not use a double dose of this medicine to make up for a forgotten dose.
If you have any questions 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 experiences them.
ACTALIDE may cause:
Common (may affect up to 1 in 10 people)

• skin reactions such as itching, redness (irritation), and allergic skin reactions (erythema) at the site where you applied this medicine.

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 through the national reporting system at the website
www.agenziafarmaco.gov.it/it/responsabili . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ACTALIDE

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month.
Store away from heat sources and at temperatures below 50°C.
Do not pierce or burn after use.
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 ACTALIDE contains

• The active substance is nimesulide. Each gram of foam contains 30 mg of nimesulide.
• The other components are lactic acid, benzyl alcohol, 96% ethanol, glycerol, polyacrylamide copolymer, perfluoropoly-methylisopropyl ether, hydrogenated soybean lecithin (Phospholipon 80H), polysorbate 80, alpha-tocopheryl acetate, methyl parahydroxybenzoate, propyl parahydroxybenzoate, purified water. Propellant mixture 5%: isobutane, n-butane, propane.

Description of the appearance of ACTALIDE and contents of the pack
Pressurized container of 50 g, with dispensing valve.
Marketing Authorization Holder
Errekappa Euroterapici S.p.A. – Via Ciro Menotti 1/A – 20129 Milan
Manufacturer
Aerosol Service Italiana Srl – Via del Maglio, 6 – Valmadrera (Lecco)