ERREFLOG 1 мг/мл Полоскание для рта

Содержание инструкции

1. ERREFLOG 1 mg/ml Collutorio
   1. What is ERREFLOG and what is it used for
   2. What you need to know before using ERREFLOG
   3. How to use ERREFLOG
   4. Possible side effects
   5. How to store ERREFLOG
   6. Contents of the pack and other information
2. ERREFLOG 30mg/g gel
   1. What is ERREFLOG and what is it used for
   2. What you need to know before using ERREFLOG
   3. How to use ERREFLOG
   4. Possible side effects
   5. How to store ERREFLOG
   6. Contents of the pack and other information
3. ERREFLOG 30 mg/g Cutaneous Foam
   1. What is ERREFLOG and what is it used for
   2. What you need to know before using ERREFLOG
   3. How to use ERREFLOG
   4. Possible side effects
   5. How to store ERREFLOG
   6. Contents of the pack and other information

ERREFLOG 1 mg/ml Collutorio

Nimesulide

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 have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is ERREFLOG and what is it used for

ERREFLOG contains the active ingredient nimesulide which belongs to a group of medicines
called non-steroidal anti-inflammatory drugs that work by reducing inflammation.
ERREFLOG is indicated for the treatment of symptoms due to inflammation or irritation
of the mouth, gums and teeth (gingivitis, stomatitis, pharyngitis), even in the presence of
pain or as a result of dental surgery (conservative or extraction therapy).

2. What you need to know before using ERREFLOG

Do not use ERREFLOG

• if you are allergic to nimesulide, to other medicines of the same class as ERREFLOG (non-steroidal anti-inflammatory drugs) or to any of the other components of this medicine;
• if in the past, after using other medicines for the treatment of inflammation (acetylsalicylic acid, non-steroidal anti-inflammatory drugs), you have had an allergic reaction, which manifested with allergic rhinitis (rhinitis), skin irritation (urticaria) and difficulty breathing (bronchospasm).

Warnings and precautions
Consult your doctor or pharmacist before using ERREFLOG.
Do not ingest ERREFLOG if you suffer from swallowing problems, avoid using this
medicine. It is also not recommended if you are an elderly person with severe disability (debilitated elderly).
However, if you accidentally swallow a small amount of solution during rinsing or
gargling, this will not cause any harm to your health, as the dose ingested is
minimal.
Prolonged use of this medicine may cause allergic reactions (sensitization phenomena), in which case discontinue treatment with ERREFLOG and consult your
doctor.
For those who play sports: the use of medicines containing ethyl alcohol may determine
positive doping tests in relation to the concentration limits of alcohol indicated by
some sports federations.

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

Other medicines and ERREFLOG
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
No interactions of ERREFLOG with other medicines have been reported.

Pregnancy and breastfeeding
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 using this medicine.
If you are pregnant or breastfeeding, avoid using ERREFLOG.

Driving and operating machinery
This medicine does not affect the ability to drive and operate machinery.

ERREFLOG contains sodium benzoate,slightly irritating to skin, eyes and mucous
membranes

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

3. How to use ERREFLOG

Use this medicine following the instructions of your doctor or pharmacist exactly as given.
If you have any doubts, consult your doctor or pharmacist.
Use ERREFLOG three times a day performing rinses and/or gargles with 15 ml of
mouthwash each time (measure with the supplied measuring cup, 15 ml of mouthwash corresponds to
15 mg of nimesulide). You can use the mouthwash pure or diluted with a little water.
If you use more ERREFLOG than you should
It is highly unlikely that taking an excessive dose of ERREFLOG may lead to
adverse effects. However, if you ingest/take an excessive dose of ERREFLOG
contact your doctor.

If you forget to use ERREFLOG
Do not use a double dose of this medicine to make up for the missed dose.
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 everybody gets them.
ERREFLOG may cause irritation and allergic reactions (sensitization reactions) in the
area where it is used.

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 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 ERREFLOG

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 packaging after
“Exp.”. The expiry date refers to the last day of that month.
Do not use the medicine after more than three months from opening the bottle.
Do not dispose of any medicine in waste water 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 ERREFLOG contains

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

Description of the appearance of ERREFLOG and contents of the pack
Bottle of 200 ml.

Marketing Authorisation Holder
Errekappa Euroterapici S.p.A. – Via Ciro Menotti 1/A – 20129 Milano

Manufacturer
Francia Farmaceutici Industria Farmaco Biologica – Via dei Pestagalli 7 - Milano

ERREFLOG 30mg/g gel

Nimesulide

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 have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is ERREFLOG and what is it used for

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

2. What you need to know before using ERREFLOG

Do not use ERREFLOG

• if you are allergic to nimesulide, to other medicines of the same class as ERREFLOG (non-steroidal anti-inflammatory drugs) or to any of the other components of this medicine;
• if in the past, after using other medicines for the treatment of inflammation (salicylic acid, non-steroidal anti-inflammatory drugs), you have had an allergic reaction, such as allergic rhinitis (rhinitis), skin irritation (urticaria) and difficulty breathing (bronchospasm);
• on open wounds (lacerated or desquamated skin) or on areas with infection;
• together with other medicines for topical application (local use);
• if the patient is a child under 12 years of age (see section “Children”).

Warnings and precautions
Consult your doctor or pharmacist before using ERREFLOG.
You can reduce the occurrence of undesirable effects by using the minimum effective dose and for the
shortest possible time.
Use ERREFLOG with caution:

• if you suffer from stomach or intestinal disorders associated with bleeding and the presence of lesions (gastrointestinal hemorrhages, peptic ulcer);
• if you have severe blood coagulation problems;
• if you suffer from severe liver or kidney problems (severe hepatic or renal insufficiency);
• if you suffer from heart problems (severe uncontrolled heart failure with appropriate treatment);
• if you have previously experienced allergic reactions (hypersensitivity) after using medicines similar to ERREFLOG (non-steroidal anti-inflammatory drugs), as you may experience allergic reactions during treatment with ERREFLOG.

Like other anti-inflammatory drugs for local use, ERREFLOG may cause burning, skin irritation,
especially in case of exposure to light (photodermatitis). Therefore, avoid exposure to
direct sunlight or tanning lamps during treatment with this medicine.
Consult your doctor if the symptoms persist or if you notice a worsening of your health conditions.

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

Other medicines and ERREFLOG
Inform your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
No interactions of ERREFLOG with other medicines for topical application have been reported
(local use, see section “Do not use ERREFLOG”).

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before using this medicine.
Do not use ERREFLOG if you are pregnant or breastfeeding, unless in cases of absolute
necessity and under the direct control of the doctor.

Driving and operating machinery
The effects of ERREFLOG on the ability to drive vehicles and operate machinery are not known.

ERREFLOG contains parabens
This medicine contains parabens (methyl paraben and propyl
paraben) which may cause allergic reactions (including delayed reactions).

3. How to use ERREFLOG

Use this medicine following exactly the instructions of your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Apply a thin layer of ERREFLOG to the area to be treated, massaging until
complete absorption. Repeat the application 2 or 3 times a day. The recommended dose
is approximately 3 g of gel per application (a strip of gel 6-7 cm long).
The duration of treatment varies from 7 to 15 days.
Apply ERREFLOG 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, wash immediately with water. This medicine is a gel for external use and must not be ingested.
Do not use ERREFLOG if the affected area needs to be treated with a non-
breathable bandage (occlusive bandage with films).

If you use more ERREFLOG than you should
Intoxication from nimesulide due to the topical application of ERREFLOG is not expected
because the amounts of nimesulide absorbed after application are very low.

If you forget to use ERREFLOG
Do not use a double dose of this medicine to make up for a missed dose.
If you have any doubts 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.
ERREFLOG may cause:

Common (may affect up to 1 in 10 people)

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

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 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 ERREFLOG

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 packaging after
“Exp.”. The expiry date refers to the last day of that month.
Keep this medicine away from heat sources and at temperatures below 30°C.
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 ERREFLOG contains

• The active ingredient is nimesulide. Each gram of gel contains 30 mg of nimesulide.
• The other ingredients are lactic acid, 96% ethanol, glycerol, polyacrylamide copolymer, perfluoropolymethylisopropyl ether, lecithin, methyl parahydroxybenzoate, propyl parahydroxybenzoate, purified water.

Description of the appearance of ERREFLOG and contents of the pack
Aluminum tube containing 50 g.

Marketing Authorisation Holder
Errekappa Euroterapici S.p.A.– Via Ciro Menotti 1/A – 20129 Milan

Manufacturer
Francia Farmaceutici Industria Farmaco Biologica – Via dei Pestagalli 7 - Milan

ERREFLOG 30 mg/g Cutaneous Foam

Nimesulide

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 have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is ERREFLOG and what is it used for

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

2. What you need to know before using ERREFLOG

Do not use ERREFLOG

• if you are allergic to nimesulide, to other medicines of the same class as ERREFLOG (non-steroidal anti-inflammatory drugs) or to any of the other components of this medicine;
• if in the past, after using other medicines for the treatment of inflammation (salicylic acid, non-steroidal anti-inflammatory drugs), you have had an allergic reaction, such as allergic rhinitis, skin irritation (urticaria) and difficulty breathing (bronchospasm);
• on open wounds (lacerated or desquamated skin) or on areas with infections;
• together with other medicines for topical application (local use);
• if the patient is a child under 12 years of age (see paragraph “Children”).

Warnings and precautions
Consult your doctor or pharmacist before using ERREFLOG.
You can reduce the occurrence of undesirable effects by using the lowest effective dose and for the
shortest possible time.
Use ERREFLOG with caution:

• if you suffer from stomach or intestinal disorders associated with bleeding and the presence of lesions (gastrointestinal hemorrhages, peptic ulcer);
• if you have severe blood coagulation problems;
• if you suffer from severe liver or kidney problems (severe hepatic or renal insufficiency);
• if you suffer from heart problems (severe uncontrolled heart failure with appropriate treatment);
• if you have previously experienced allergic reactions (hypersensitivity) after using medicines similar to ERREFLOG (non-steroidal anti-inflammatory drugs), as you may experience allergic reactions during treatment with ERREFLOG.

Like other anti-inflammatory drugs for local use, ERREFLOG may cause burning, skin irritation,
especially in case of exposure to light (photodermatitis). Therefore, avoid exposure to
direct sunlight or tanning lamps during treatment with this medicine.
Consult your doctor if the symptoms persist or if you notice a worsening of your health conditions.

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

Other medicines and ERREFLOG
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
No interactions of ERREFLOG with other topical medicines (local use, see paragraph “Do not use ERREFLOG”) have been reported.

Pregnancy and breastfeeding
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 using this medicine.
Do not use ERREFLOG if you are pregnant or breastfeeding, unless in cases of absolute
necessity and under the direct control of your doctor.

Driving and using machines
The effects of ERREFLOG on the ability to drive vehicles and operate
machinery are not known.

ERREFLOG contains parabens
This medicine contains parabens (methyl paraben and propyl
paraben) which may cause allergic reactions (including delayed reactions).

3. How to use ERREFLOG

Use this medicine following exactly the instructions of your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Apply a thin layer of ERREFLOG to the area to be treated, massaging until
complete absorption. Repeat the application 2 or 3 times a day. The recommended dose
is approximately 3 g of foam per application (a strip of foam 6-7 cm long). Before
using this medicine, turn the container upside down and shake it, then press the dispenser button to
dispense the foam.
The duration of treatment varies from 7 to 15 days.
Apply ERREFLOG 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 the eyes and mucous membranes. In case of accidental
contact, wash immediately with water. This medicine is a foam for external use and should not
be ingested.
Do not use ERREFLOG if the affected area needs to be treated with a non-
breathable bandage (occlusive bandage with films).

If you use more ERREFLOG than you should
Intoxication due to nimesulide is not expected due to the topical application of ERREFLOG
because the amounts of nimesulide absorbed after application are very low.

If you forget to use ERREFLOG
Do not use a double dose of this medicine to make up for a missed dose.
If you have any doubts about the use of 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.
ERREFLOG may cause:

Common (may affect up to 1 in 10 people)

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

Reporting of side effects
If you get any side effect, even if not listed in this leaflet, tell 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 ERREFLOG

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 packaging after
“Exp.”. The expiry date refers to the last day of that month.
Store away from sources of heat and at temperatures below 50°C.
Do not puncture or burn after use.
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 ERREFLOG contains

• The active ingredient is nimesulide. Each gram of foam contains 30 mg of nimesulide.
• The other components are lactic acid, benzyl alcohol, 96% ethanol, glycerol, polyacrylamide copolymer, perfluoropolymethylisopropyl ether, hydrogenated soy 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 ERREFLOG and contents of the pack
Pressurized container of 50 g, with dispensing valve.

Marketing Authorisation Holder
Errekappa Euroterapici S.p.A. – Via Ciro Menotti 1/A – 20129 Milan

Manufacturer
Aerosol Service Italiana Srl – Via del Maglio, 6 – Valmadrera (Lecco)