Zeroflog

Package leaflet: Information for the patient

Zeroflog 0.022 g/15 ml solution, oral mucosa spray

Diclofenac acid
Please read all of this leaflet carefully before you start 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 information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if your symptoms worsen.

Contents of this leaflet

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

1. What Zeroflog is and what it is used for

The active ingredient of Zeroflog is diclofenac acid. This medicine is used to treat symptoms
of irritation and inflammation, including pain, in the mouth and throat (oropharyngeal cavity),
such as inflammation of the gums, mouth or throat (gingivitis, stomatitis, pharyngitis). This medicine
is also used when these symptoms occur following dental treatment for the care or extraction of
teeth.
Consult your doctor if you do not feel better or if you feel worse.

2. What you should know before using Zeroflog

Do not use Zeroflog

• if you are allergic to diclofenac acid or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to aspirin (acetylsalicylic acid) or to other similar medicines (non-steroidal anti-inflammatory drugs);
• if you are in the last 3 months of pregnancy.

Warnings and precautions
Talk to your doctor or pharmacist before using Zeroflog.
Do not worry if you accidentally swallow the dose of solution used for rinsing and gargling. This will not cause you any harm, as the amount of active ingredient contained in one dose of mouthwash is equivalent to one-fifth to one-sixth of the dose intended for systemic use (dose of pills, tablets or capsules to be swallowed). You can use Zeroflog even if you suffer from coeliac disease (gluten intolerance, a protein found in certain cereals).
Take special care with Zeroflog:

• if you use this medicine for prolonged periods, as this may cause allergic-type reactions (sensitization). In this case, stop using the medicine and consult your doctor for appropriate treatment;
• if you have a history of stomach bleeding (gastrointestinal haemorrhage) or stomach perforation related to previous active treatments;
• if you have a history of stomach bleeding or recurrent mucosal damage in the stomach (recurrent peptic ulcer, two or more distinct episodes of proven ulceration or bleeding).

Other medicines and Zeroflog
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Zeroflog is not absorbed into the bloodstream in significant amounts, so it is unlikely to interact with other medicines you are taking.
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 taking this medicine.
Do not use Zeroflog if you are in the last 3 months of pregnancy. Do not use Zeroflog during the first 6 months of pregnancy unless strictly necessary and under medical advice. If treatment is required during this period, the lowest effective dose for the shortest possible duration should be used.
Oral forms (e.g. tablets) of diclofenac-containing medicines may cause adverse effects in the unborn child. It is not known whether the same risk applies with Zeroflog when used in the mouth.
During breastfeeding, use this medicine only if clearly necessary and under direct medical supervision.
Driving and using machines
Zeroflog does not affect the ability to drive vehicles or operate machinery.
Zeroflog contains sodium benzoate (E211) and alcohol
This medicine contains 2 mg of sodium benzoate per 0.2 ml spray, which may cause local irritation.
This medicine contains 19 mg of alcohol (ethanol) per 0.2 ml spray. It may cause a burning sensation on damaged skin.

3. How to use Zeroflog

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.
The recommended dose is 2 sprays three times a day, directed directly at the affected area.
Each spray delivers 0.2 ml of solution, equivalent to 0.3 mg of active substance.
If you use more Zeroflog than you should
Cases of overdose with this medicine have not been reported.
In case of accidental ingestion of an excessive dose of Zeroflog, inform your doctor immediately or go to the nearest hospital.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine may cause adverse reactions, although not everyone experiences them.
Diclofenac is generally well tolerated and adverse reactions rarely occur. Prolonged treatments may lead to cough.

Frequency not known (frequency cannot be estimated from the available data)
Burning sensation in the mouth

In clinical studies with ZEROFLOG 0.022 g/15 ml solution, oral mucosa spray, the following adverse reactions were observed only in a small number of treated patients:
a) mild in severity
Nausea, dyspepsia
Hypotension
Chills
Visual disturbances
b) moderate in severity
Headache
Mucous membrane disorders

The use, especially if prolonged, of topical preparations may lead to allergic-type reactions (sensitization). In such case, discontinue treatment and consult your doctor.
Following the instructions provided in this leaflet reduces the risk of adverse reactions.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse reactions, you can help provide further information on the safety of this medicine.

5. How to store Zeroflog

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 "Expires". The expiry date refers to the last day of that month for the product in its original, unopened packaging, correctly stored.
The shelf life of the product after first opening the container is 1 year (please record the date of first opening in the designated space on the carton). Store the medicine at a temperature not exceeding 25°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 Zeroflog oral mucosa spray solution contains

• The active substance is diclofenac acid. 15 ml of solution contain 0.022 g of diclofenac acid.
• The other components are: non-crystallizable liquid sorbitol, choline chloride, disodium edetate, sodium benzoate, acesulfame potassium, peppermint essential oil, natural peach flavor, Ponceau red dye (E 124), ethanol 96%, sodium hydroxide, purified water.

Description of the appearance of Zeroflog and contents of the pack
Zeroflog is a solution for oral mucosa spray.
Multidose container of 15 ml.
Marketing Authorization Holder
NEOPHARMED GENTILI S.p.A. – Via San Giuseppe Cottolengo 15 – 20143 Milan
Manufacturer
FRANCIA Farmaceutici – Industria Farmaco-Biologica srl
Via dei Pestagalli, 7 - 20138 Milan

Package leaflet: information for the patient

Zeroflog 0.074 g/100 ml mouthwash, 1 bottle

Diclofenac acid
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 information or advice, consult your pharmacist.
• If any adverse reaction occurs, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice improvement or if you notice worsening of symptoms.

Contents of this leaflet

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

1. What Zeroflog is and what it is used for

The active ingredient of Zeroflog is diclofenac acid. This medicine is used to treat symptoms
of irritations and inflammations, including pain, in the oral and pharyngeal cavity (oropharyngeal cavity),
such as inflammations of the gums, mouth or throat (gingivitis, stomatitis, pharyngitis). This medicine
is also used when these symptoms occur following dental treatment for the care or extraction of
teeth.
Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before using Zeroflog

Do not use Zeroflog

• if you are allergic to diclofenac acid or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to aspirin (acetylsalicylic acid) or to other similar medicines (non-steroidal anti-inflammatory drugs);
• if you are in the last 3 months of pregnancy.

Warnings and precautions
Talk to your doctor or pharmacist before using Zeroflog.
Do not worry if you accidentally swallow the amount of solution used for rinsing and gargling. This will not cause you any harm, as the amount of active substance present in one dose of mouthwash is equivalent to one-fifth to one-sixth of the dose intended for systemic use (dose of tablets, pills, or capsules to be swallowed). You may use Zeroflog even if you have coeliac disease (gluten intolerance, a protein found in certain cereals).
Take special care with Zeroflog:

• if you use this medicine for a prolonged period, as this may lead to allergic-type reactions (sensitization). In this case, stop using the medicine and consult your doctor for appropriate therapy;
• if you have a history of stomach bleeding (gastrointestinal haemorrhage) or stomach perforation related to previous treatments;
• if you have a history of stomach bleeding or mucosal damage in the stomach that recurs (recurrent peptic ulcer, two or more distinct episodes of confirmed ulceration or bleeding).

Other medicines and Zeroflog
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Zeroflog is not absorbed into the bloodstream in significant amounts; therefore, it is unlikely to interact with other medicines you are taking.

Pregnancy and breastfeeding
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 Zeroflog if you are in the last 3 months of pregnancy. Do not use Zeroflog during the first 6 months of pregnancy unless strictly necessary and as directed by your doctor. If treatment is needed during this period, the lowest possible dose for the shortest possible time should be used.
Oral forms (e.g. tablets) of diclofenac-containing medicines may cause adverse effects in the unborn child. It is not known whether the same risk applies with Zeroflog when used in the mouth.
During breastfeeding, use this medicine only if clearly necessary and under the direct supervision of your doctor.

Driving and using machines
Zeroflog does not affect the ability to drive or operate machinery.

Zeroflog contains sodium benzoate (E211)
This medicine contains 150 mg of sodium benzoate per 15 ml dose, which may cause local irritation.

3. How to use Zeroflog

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.
The recommended dose is 2-3 rinses or gargles per day using 15 ml (1 measuring cup) of undiluted mouthwash,
or diluted in a small amount of water.
If you use more Zeroflog than you should
Cases of overdose with this medicine have not been reported.
In case of accidental ingestion of an excessive dose of Zeroflog, inform your doctor immediately or go to the nearest hospital.
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 may cause side effects, although not everybody gets them.
Diclofenac is generally well tolerated and side effects rarely occur. Prolonged treatment may lead to cough.
Frequency not known (frequency cannot be estimated from the available data)
Burning sensation in the mouth.
In clinical studies with ZEROFLOG 0.074 g/100 ml mouthwash, the following adverse reactions were observed only in a small number of treated patients:
a) Mild in severity
Nausea, dyspepsia
Hypotension
Chills
Visual disturbances
b) Moderate in severity
Headache
Mucous membrane disorders
The use, especially if prolonged, of topical preparations may result in allergic-type reactions (sensitization). If this occurs, discontinue treatment and consult your doctor.
Following the instructions provided in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may 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 Zeroflog

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 "Expiry". The expiry date refers to the last day of that month for the product in its original, unopened packaging, correctly stored.
The shelf life of the product after first opening the container is 6 months (please record the date of first opening in the designated space on the carton). Store the medicine at a temperature not exceeding 25°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. Contents of the pack and other information

What Zeroflog mouthwash contains, 1 bottle

• The active substance is diclofenac acid. 100 ml of mouthwash contains 0.074 g of diclofenac acid.
• The other components are: non-crystallizable liquid sorbitol, choline (base), sodium benzoate, disodium edetate, potassium acesulfame, natural mint flavor, natural peach flavor, Ponceau red dye (E124), purified water.

Description of the appearance of Zeroflog and contents of the pack
Zeroflog is a mouthwash.
200 ml bottle.
Marketing Authorization Holder
NEOPHARMED GENTILI S.p.A – Via San Giuseppe Cottolengo 15 – 20143 Milan
Manufacturer
Doppel Farmaceutici srl
Via Martiri delle Foibe, 1
29016 Cortemaggiore (PC)

Patient Information Leaflet

Zeroflog 0.011 g/15 ml mouthwash, 12 sachets

Diclofenac acid
Please read this leaflet carefully before using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to do.

• 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 effect, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if your symptoms worsen.

Contents of this leaflet

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

1. What Zeroflog is and what it is used for

The active ingredient of Zeroflog is diclofenac acid. This medicine is used to treat symptoms of irritations and inflammations, including pain, in the oral and pharyngeal cavity (oropharyngeal cavity), such as inflammation of the gums, mouth or throat (gingivitis, stomatitis, pharyngitis). This medicine is also used when these symptoms occur following dental treatment for the care or extraction of teeth.

Consult your doctor if you do not feel better or if you feel worse.

2. What you should know before using Zeroflog

Do not use Zeroflog

• if you are allergic to diclofenac acid or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to aspirin (acetylsalicylic acid) or to other similar medicines (non-steroidal anti-inflammatory drugs);
• if you are in the last 3 months of pregnancy.

Warnings and precautions
Talk to your doctor or pharmacist before using Zeroflog.
Do not worry if you accidentally swallow the dose of solution used for mouth rinsing and gargling. This
will not cause you any harm, as the amount of active substance contained in one dose of mouthwash
is equivalent to one-fifth to one-sixth of the dose intended for systemic use (tablet, pill, or capsule dosage).
You may use Zeroflog even if you have coeliac disease (gluten intolerance, a protein found in certain cereals).
Exercise particular caution with Zeroflog:

• if you use this medicine for prolonged periods, as this may lead to allergic-type reactions (sensitization). In this case, stop using the medicine and consult your doctor for appropriate treatment;
• if you have a history of gastrointestinal bleeding or stomach perforation related to previous treatments with active drugs;
• if you have a history of stomach bleeding or recurrent mucosal lesions of the stomach (recurrent peptic ulcer, two or more distinct episodes of confirmed ulceration or bleeding).

Other medicines and Zeroflog
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Zeroflog is not absorbed into the bloodstream in significant amounts; therefore, it is unlikely to interact with other medicines you may be taking.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Do not use Zeroflog if you are in the last 3 months of pregnancy. Do not use Zeroflog during the first 6 months of pregnancy unless strictly necessary and under medical advice. If treatment is required during this period, the lowest possible dose for the shortest duration should be used.
Oral forms (e.g. tablets) of diclofenac-containing medicines may cause adverse effects in the unborn child. It is not known whether the same risk applies with Zeroflog when used in the mouth.
During breastfeeding, use this medicine only when strictly necessary and under direct medical supervision.

Driving and using machines
Zeroflog does not impair the ability to drive or operate machinery.

Zeroflog contains sodium benzoate (E211)
This medicine contains 150 mg of sodium benzoate per sachet, which may cause local irritation.

3. How to use Zeroflog

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.
The recommended dose is 2–3 rinses or gargles per day using 15 ml (1 sachet) of undiluted mouthwash or diluted in a small amount of water.
If you use more Zeroflog than you should
No cases of overdose with this medicine have been reported.
In case of accidental ingestion of an excessive dose of Zeroflog, inform your doctor immediately or go to the nearest hospital.
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 everyone experiences them.
Diclofenac is generally well tolerated and side effects rarely occur. Prolonged treatments may lead to cough.

Frequency not known (frequency cannot be estimated from the available data)
Burning sensation in the mouth

In clinical studies with ZEROFLOG 0.011 g/15 ml mouthwash, 12 sachets, the following adverse reactions were observed only in a small number of treated patients:

a) Mild in severity
Nausea, dyspepsia
Hypotension
Chills
Visual disturbances

b) Moderate in severity
Headache
Mucous membrane disorders

The use, especially if prolonged, of locally applied preparations may lead to allergic-type reactions (sensitization). If this occurs, discontinue treatment and consult your doctor.
Following the instructions provided in this leaflet reduces the risk of side effects.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may 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 Zeroflog

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 "Expiry". The expiry date refers to the last day of that month, provided the product remains in its original, undamaged packaging and has been correctly stored.
Store the sachets in the outer packaging to protect the medicine from light.
Store the medicine below 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Zeroflog mouthwash contains, 12 sachets

• The active substance is diclofenac acid. Each 15 ml of mouthwash (1 sachet) contains 0.011 g of diclofenac acid.
• The other components are: non-crystallizable liquid sorbitol, choline (base), sodium benzoate, disodium edetate, potassium acesulfame, natural mint flavour, natural peach flavour, Ponceau red dye (E124), purified water.

Description of the appearance of Zeroflog and contents of the pack
Zeroflog is a mouthwash.
Pack of 12 sachets.
Marketing Authorization Holder
NEOPHARMED GENTILI S.p.A – Via San Giuseppe Cottolengo 15 – 20143 Milan
Manufacturer
Doppel Farmaceutici srl
Via Martiri delle Foibe, 1
29016 Cortemaggiore (PC)