TANTUM 3 mg Lozenge

Зміст інструкції

1. Tantum Verde P 3 mg eucalyptus flavored lozenges
   1. WHAT TANTUM VERDE P IS AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TANTUM VERDE P
   3. HOW TO TAKE TANTUM VERDE P
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE TANTUM VERDE P
   6. CONTENTS OF THE PACK AND OTHER INFORMATION
2. Tantum Verde P 3 mg orange and honey flavored lozenges
   1. WHAT TANTUM VERDE P IS AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TANTUM VERDE P
   3. HOW TO TAKE TANTUM VERDE P
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE TANTUM VERDE P
   6. PACKAGE CONTENTS AND OTHER INFORMATION
3. Tantum Verde P 3 mg lemon flavored lozenges
   1. WHAT TANTUM VERDE P IS AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TANTUM VERDE P
   3. HOW TO TAKE TANTUM VERDE P
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE TANTUM VERDE P
   6. PACKAGE CONTENTS AND OTHER INFORMATION
4. Tantum Verde P 3 mg mint flavored lozenges
   1. WHAT TANTUM VERDE P IS AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TANTUM VERDE P
   3. HOW TO TAKE TANTUM VERDE P
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE TANTUM VERDE P
   6. PACKAGE CONTENTS AND OTHER INFORMATION

Tantum Verde P 3 mg eucalyptus flavored lozenges

Benzidamine hydrochloride

Read this leaflet carefully before taking this medicine as it contains important
information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told 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 worsen after 3 days.

Contents of this leaflet:

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

1. WHAT TANTUM VERDE P IS AND WHAT IT IS USED FOR

Tantum Verde P contains the active ingredient benzydamine, which acts against irritation and local pain.
Tantum Verde P is used in adults and children over 6 years of age, for the symptomatic local treatment
of pain and irritation of the mouth and throat.
See your doctor if you do not feel better or if you feel worse after 3 days.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TANTUM VERDE P

Do not use Tantum Verde P:

• if you are allergic to benzydamine or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Tantum Verde P:

• if you have had episodes of asthma in the past.
• if you are allergic to aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs)
• if your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine
• if, after using the tablets, the pain in your mouth or throat worsens or does not improve within 3 days, or if fever or other symptoms appear, you should contact your doctor or dentist.

Other medicines and Tantum Verde P
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.

Tantum Verde P with food and drink
It is not affected by food and drink.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, if you suspect or are planning a
pregnancy, ask your doctor or pharmacist for advice before taking this medicine.
Tantum Verde P should not be used during pregnancy.
Tantum Verde P should not be used during breastfeeding.

Driving and operating machinery
Tantum Verde P does not alter the ability to drive or operate machinery.

Tantum Verde P contains:
Isomalt: If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking
this medicine.
This medicine contains eucalyptus oil, which in turn contains D-Limonene. D-Limonene can
cause allergic reactions.

3. HOW TO TAKE TANTUM VERDE P

Take this medicine following exactly the instructions in this leaflet or as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:
Adults and children over 6 years of age: one tablet 3 times a day. Do not take more than 3 tablets a day.

Use in children
In children from 6 to 11 years, the product must be taken under the supervision of an adult.
The “tablet” pharmaceutical form should not be taken by children under 6 years of age.
Tantum Verde P should not be taken for more than 7 days.
Oropharyngeal use.
Allow one tablet to dissolve slowly in the mouth.
Do not swallow.
Do not chew.

If you take more Tantum Verde P than you should
In case of accidental intake of an excessive dose of tablets, immediately inform your pharmacist, your doctor or go to the nearest hospital.
tablets.
Although very rarely, after oral administration of benzydamine at a dosage 100 times higher than that of one tablet, the following overdose symptoms have been observed in children:
excitation, convulsions, sweating, ataxia, tremor and vomiting.
If you have further doubts about the use of this product, consult your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Uncommon (may affect up to 1 in 100 people):

• Skin sensitivity to light (which may cause redness or sunburn).

Rare (may affect up to 1 in 1000 people):

• Burning and dryness of the mouth. If this happens, try sipping a glass of water to reduce the effect.

Very rare (may affect up to 1 in 10,000 people):

• Sudden swelling of the mouth/throat and mucous membranes (angioedema).
• Difficulty breathing (laryngospasm).

Not known (frequency cannot be estimated from available data):

• Local loss of sensitivity of the oral mucosa (Oral hypoesthesia).
• Allergic reaction (hypersensitivity)
• Severe allergic reaction (anaphylactic shock) whose signs may include difficulty breathing, chest pain or chest tightness, and/or dizziness/weakness, severe skin itching or the appearance of swellings on the skin, swelling of the face, lips, tongue and/or throat, which can potentially put the patient's life in danger.

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 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 TANTUM VERDE P

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is stated on the pack after Exp.
The expiry date refers to the last day of the month.
Do not store at a temperature above 30° C.
Store in the original packaging to protect the medicine from moisture.
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 Tantum Verde P contains:
The active ingredient is benzydamine hydrochloride equivalent to 2.68 mg of benzydamine.
The other components are: isomalt (E 953), potassium acesulfame, citric acid monohydrate, eucalyptus oil,
levomenthol, quinoline yellow (E 104), indigotine (E 132).

Description of the appearance of Tantum Verde P and contents of the pack
This medicine is presented as dark green, square-shaped lozenges with a central indentation.
The lozenges may be packaged in PVC/PE/PVDC - ALU blisters or wrapped in paraffin paper.
The packs contain 20 and 30 lozenges.
Not all pack sizes may be available.

Marketing Authorisation Holder and Manufacturer
The marketing authorisation holder is:
Angelini Pharma S.p.A. Viale Amelia 70 - 00181 Rome, Italy

Manufacturer
A.C.R.A.F. S.p.A., Via Vecchia del Pinocchio, 22 - 60131 Ancona

This medicinal product is authorised in the Member States of the European Economic Area under the following
denominations:

Italy:Tantum Verde P, 3 mg eucalyptus flavored lozenges

Spain:Juanolgar 3 mg lozenges for sucking eucalyptus flavor

Denmark:ZYX eucalyptus

Sweden: Zyx eucalyptus 3 mg suckable tablets

United Kingdom:DIFFLAM 3 mg Lozenges, eucalyptus flavour

Tantum Verde P 3 mg orange and honey flavored lozenges

Benzydamine hydrochloride

Read this leaflet carefully before taking this medicine as it contains important
information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told 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 worsen after 3 days. Contents of this leaflet:
• 1. What is Tantum Verde P and what it is used for
• 2. What you need to know before you take Tantum Verde P
• 3. How to take Tantum Verde P
• 4. Possible side effects
• 5. How to store Tantum Verde P
• 6. Contents of the pack and other information

1. WHAT TANTUM VERDE P IS AND WHAT IT IS USED FOR

Tantum Verde P contains the active ingredient benzydamine, which acts against irritation and local pain.
Tantum Verde P is used in adults and children over 6 years of age, for the symptomatic local treatment
of pain and irritation of the mouth and throat.
See your doctor if you do not feel better or if you feel worse after 3 days.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TANTUM VERDE P

Do not use Tantum Verde P:
if you are allergic to benzydamine or to any of the other ingredients of this medicine (listed in
section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Tantum Verde P:

• if you have had episodes of asthma in the past
• if you are allergic to aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs)
• if your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine
• if, after using the tablets, the pain in your mouth or throat gets worse or does not improve within 3 days, or if fever or other symptoms appear, you should contact your doctor or dentist. Other medicines and Tantum Verde PTell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Tantum Verde P with food and drink
It is not affected by food and drink.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, if you suspect or are planning a
pregnancy, ask your doctor or pharmacist for advice before taking this medicine.
Tantum Verde P should not be used during pregnancy.
Tantum Verde P should not be used during breastfeeding.

Driving and operating machinery
Tantum Verde P does not impair the ability to drive or operate machinery.

Tantum Verde P contains:

• Isomalt: if your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
• Yellow sunset (E110): may cause allergic reactions.
• Orange flavour also containing citral, citronellol, D-Limonene, geraniol and linalool. Citral, citronellol, D-Limonene, geraniol and linalool may cause allergic reactions.

3. HOW TO TAKE TANTUM VERDE P

Take this medicine following exactly as indicated 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:
Adults and children over 6 years of age: one tablet 3 times a day. Do not take more than 3 tablets a day.

Use in children
In children from 6 to 11 years, the product must be taken under the supervision of an adult.
The “tablet” pharmaceutical form should not be taken by children under 6 years of age.
Tantum Verde P should not be taken for more than 7 days.
Oropharyngeal use.
Allow one tablet to dissolve slowly in the mouth.
Do not swallow.
Do not chew.

If you take more Tantum Verde P than you should
In case of accidental intake of an excessive dose of tablets, immediately inform your pharmacist, your doctor or go to the nearest hospital.
tablets.
Although very rarely, after oral administration of benzidamine at a dosage 100 times higher than that of one tablet, the following overdose symptoms have been observed in children:
excitation, convulsions, sweating, ataxia, tremor and vomiting.
If you have further doubts about the use of this product, consult your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Not uncommon (may affect up to 1 in 100 people):

• Skin sensitivity to light (which may cause redness or sunburn).

Rare (may affect up to 1 in 1,000 people):

• Burning and dryness of the mouth. If this happens, try sipping a glass of water to reduce the effect.

Very rare (may affect up to 1 in 10,000 people):

• Sudden swelling of the mouth/throat and mucous membranes (angioedema).
• Difficulty breathing (laryngospasm).

Not known (frequency cannot be estimated from available data):

• Local loss of sensitivity of the oral mucosa (Oral hypoesthesia).
• Allergic reaction, (hypersensitivity)

Severe allergic reaction (anaphylactic shock), whose signs may include difficulty breathing,
chest pain or tightness, and/or dizziness/weakness, severe skin itching or
appearance of swellings on the skin, swelling of the face, lips, tongue and/or throat, which
can potentially put the patient's life in danger.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through 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 TANTUM VERDE P

Expiry date: see the expiry date printed on the packaging.
Do not use this medicine after the expiry date which is reported on the pack after EXP. The expiry
date refers to the last day of the month.
Do not store at a temperature above 30° C.
Store in the original packaging to protect the medicine from moisture.
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.

Keep this medicine out of the sight and reach of children.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What Tantum Verde P contains:
The active ingredient is benzydamine hydrochloride equivalent to 2.68 mg of benzydamine.
The other ingredients are: isomalt (E953), acesulfame potassium, citric acid monohydrate, orange flavour,
honey flavour, levomenthol, quinoline yellow (E104), sunset yellow (E110).

Description of the appearance of Tantum Verde P and package contents
This medicine is presented as lozenges of yellow-orange colour, square in shape with a central indentation.
The lozenges may be packaged in PVC/PE/PVDC - ALU blister packs or wrapped in paraffin paper.
Pack sizes of 20 and 30 lozenges.
Not all pack sizes may be marketed

Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder is:
Angelini Pharma S.p.A. Viale Amelia 70 - 00181 Rome, Italy

Manufacturer
A.C.R.A.F. S.p.A., Via Vecchia del Pinocchio, 22 - 60131 Ancona

This medicinal product is authorised in the Member States of the European Economic Area with the following
denominations:

Italy:Tantum Verde P 3 mg orange and honey flavoured lozenges

Portugal:Tantum Verde pastilhas, 3 mg, orange-honey flavour

Spain:Juanolgar 3 mg lozenges with orange-honey flavour

Germany:Tantum Verdewith orange-honey flavour 3 mg lozenges

Denmark:Zyx appelsin-honning

Sweden:Zyx Apelsin & Honung 3 mg lozenges

United Kingdom:Difflam3 mg lozenges, orange-honey flavour

Tantum Verde P 3 mg lemon flavored lozenges

Benzydamine hydrochloride

Read this leaflet carefully before taking this medicine as it contains important
information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist
has told you to.

• 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 worsen after 3 days.

Contents of this leaflet:

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

1. WHAT TANTUM VERDE P IS AND WHAT IT IS USED FOR

Tantum Verde P contains the active ingredient benzydamine, which acts against irritation and local pain.
Tantum Verde P is used in adults and children over 6 years of age, for the symptomatic local treatment
of pain and irritation of the mouth and throat.
See your doctor if you do not feel better or if you feel worse after 3 days.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TANTUM VERDE P

Do not use Tantum Verde P:

• if you are allergic to benzydamine or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Tantum Verde P:

• if you have phenylketonuria
• if you have had episodes of asthma in the past
• if you are allergic to aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs)
• if your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine
• if the pain in your mouth or throat gets worse or does not improve within 3 days after using the tablets, or if fever or other symptoms appear, you should contact your doctor or dentist.

Other medicines and Tantum Verde P
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.

Tantum Verde P with food and drink
It is not affected by food and drink.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, if you suspect you are pregnant, or are planning a pregnancy,
ask your doctor or pharmacist for advice before taking this medicine.
Tantum Verde P is not recommended during pregnancy.
Tantum Verde P should not be used during breastfeeding.

Driving and using machines
Tantum Verde P does not impair the ability to drive or operate machinery.

Tantum Verde P contains:

• Isomalt: If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
• Aspartame: this medicine contains 3.26 mg of aspartame per tablet, equivalent to 3.26 mg /3237 mg. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder that causes a build-up of phenylalanine because the body cannot process it properly.
• Mint flavour which in turn contains benzyl alcohol, citronellol, D-Limonene, eugenol, geraniol and linalool. Benzyl alcohol, citronellol, D-Limonene, eugenol, geraniol and linalool may cause allergic reactions.
• Lemon flavour which in turn contains benzyl alcohol, citral, citronellol, D-Limonene, geraniol, linalool. Benzyl alcohol, citral, citronellol, D-Limonene, geraniol, linalool may cause allergic reactions.
• Lemon flavour which in turn contains butylated hydroxyanisole (E 320). Butylated hydroxyanisole may cause local skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes.

3. HOW TO TAKE TANTUM VERDE P

Take 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.
The recommended dose is:
Adults and children over 6 years of age: one tablet 3 times a day. Do not take more than 3 tablets a day.

Use in children
In children from 6 to 11 years, the product must be taken under the supervision of an adult.
The “tablet” pharmaceutical form should not be taken by children under 6 years of age.
Tantum Verde P should not be taken for more than 7 days.
Oropharyngeal use.
Allow one tablet to dissolve slowly in the mouth.
Do not swallow.
Do not chew.

If you take more Tantum Verde P than you should
In case of accidental intake of an excessive dose of tablets, immediately inform your pharmacist, your doctor or go to the nearest hospital.
tablets.
Although very rarely, after oral administration of benzidamine at a dosage 100 times higher than that of one tablet, the following overdose symptoms have been observed in children: excitation,
convulsions, sweating, ataxia, tremor and vomiting.
If you have further doubts about the use of this product, consult your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Uncommon (may affect up to 1 in 100 people):

• Skin sensitivity to light (which may cause redness or sunburn).

Rare (may affect up to 1 in 1,000 people):

• Burning and dryness of the mouth. If this happens, try sipping a glass of water to reduce the effect.

Very rare (may affect up to 1 in 10,000 people):

• Sudden swelling of the mouth/throat and mucous membranes (angioedema).
• Difficulty breathing (laryngospasm).

Not known (frequency cannot be estimated from the available data):

• Local loss of sensitivity of the oral mucosa (Oral hypoesthesia).
• Allergic reaction (hypersensitivity)
• Severe allergic reaction (anaphylactic shock) whose signs may include difficulty breathing, chest pain or tightness, and/or dizziness/weakness, severe skin itching or appearance of swellings on the skin, swelling of the face, lips, tongue and/or throat, which can potentially put the patient's life in danger.

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 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 TANTUM VERDE P

Expiry date: see the expiry date printed on the packaging.
Do not use this medicine after the expiry date stated on the pack after EXP. The expiry date refers to the last day of the month.
Do not store at a temperature above 25°C.
Store in the original packaging to protect the medicine from moisture.
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.

Keep this medicine out of the sight and reach of children.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What Tantum Verde P contains:
The active ingredient is benzydamine hydrochloride equivalent to 2.68 mg of benzydamine.
The other ingredients are: isomalt (E953), aspartame (E 951), citric acid monohydrate, lemon flavour, mint
flavour, quinoline yellow (E 104), indigotine (E 132)

Description of the appearance of Tantum Verde P and package contents
This medicine is presented as light green, square-shaped lozenges with a central indentation.
The lozenges may be packaged in PVC/PE/PVDC - ALU blister packs or wrapped in paraffin paper.
Pack sizes of 20 and 30 lozenges.
Not all pack sizes may be marketed

Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder is:
Angelini Pharma S.p.A. Viale Amelia 70 - 00181 Rome, Italy
Manufacturers:
A.C.R.A.F. S.p.A., Via Vecchia del Pinocchio, 22 - 60131 Ancona
PIERRE FABRE MEDICAMENT PRODUCTION, Site Diététique et Pharmacie, Zone Industrielle de la
Coudette, 32290 Aignan, France
This medicine is authorised in the Member States of the European Economic Area under the following
denominations:

Italy:Tantum Verde P, 3mg lemon flavoured lozenges

Portugal:Tantum Verde, lozenges, 3 mg, lemon flavour

Spain:Juanolgar 3 mg lemon flavoured lozenges

Germany:TANTUM VERDE with lemon flavour 3 mg lozenges

Denmark:Zyx lemon 3mg lozenges

Sweden:Zyx Lemon 3 mg lozenges

United Kingdom:Difflam 3 mg lozenges, lemon taste

Tantum Verde P 3 mg mint flavored lozenges

Benzydamine hydrochloride

Read this leaflet carefully before taking this medicine as it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told 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 effects 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 worsen after 3 days.

Contents of this leaflet:

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

1. WHAT TANTUM VERDE P IS AND WHAT IT IS USED FOR

Tantum Verde P contains the active ingredient benzydamine, which acts against irritation and local pain.
Tantum Verde P is used in adults and children over 6 years of age, for the symptomatic local treatment
of pain and irritation of the mouth and throat.
See your doctor if you do not feel better or if you feel worse after 3 days.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TANTUM VERDE P

Do not use Tantum Verde P:
if you are allergic to benzydamine or to any of the other ingredients of this medicine (listed in
section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Tantum Verde P:

• if you suffer from phenylketonuria
• if you have had episodes of asthma in the past
• if you are allergic to aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs)
• if your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine
• if the pain in your mouth or throat gets worse or does not improve within 3 days after using the tablets, or if fever or other symptoms appear, you should contact your doctor or dentist.

Other medicines and Tantum Verde P
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.

Tantum Verde P with food and drink
It is not affected by food and drink.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, if you suspect you are pregnant or are planning a pregnancy,
ask your doctor or pharmacist for advice before taking this medicine.
Tantum Verde P should not be used during pregnancy.
Tantum Verde P should not be used during breastfeeding.
Driving and using machines
Tantum Verde P does not affect the ability to drive or operate machinery.

Tantum Verde P contains:

• Isomalt: If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
• Aspartame: this medicine contains 3.5 mg of aspartame per tablet, equivalent to 3.5 mg /3202 mg. Aspartame is a source of phenylalanine. It may be harmful if you suffer from phenylketonuria, a rare genetic disease that causes a build-up of phenylalanine because the body cannot eliminate it properly.
• Mint flavour which in turn contains benzyl alcohol, citronellol, D-Limonene, eugenol, geraniol and linalool. Benzyl alcohol, citronellol, D-Limonene, eugenol, geraniol and linalool may cause allergic reactions.
• Lemon flavour which in turn contains benzyl alcohol, citral, citronellol, D-Limonene, geraniol, linalool and butylated hydroxyanisole. Benzyl alcohol, citral, citronellol, D-Limonene, geraniol, linalool may cause allergic reactions.
• Lemon flavour which in turn contains butylated hydroxyanisole (E 320). Butylated hydroxyanisole may cause local skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes.

3. HOW TO TAKE TANTUM VERDE P

Take this medicine following exactly as indicated 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:
Adults and children over 6 years of age: one tablet 3 times a day. Do not take more than 3 tablets a day.

Use in children
In children from 6 to 11 years, the product must be taken under the supervision of an adult.
The “tablet” pharmaceutical form should not be taken by children under 6 years of age.
Tantum Verde P should not be taken for more than 7 days.
Oropharyngeal use.
Allow one tablet to dissolve slowly in the mouth.
Do not swallow.
Do not chew.

If you take more Tantum Verde P than you should
In case of accidental intake of an excessive dose of tablets, immediately inform your pharmacist, your doctor or go to the nearest hospital.
tablets.
Although very rarely, after oral administration of benzidamine at a dosage 100 times higher than that of one tablet, the following overdose symptoms have been observed in children: excitation, convulsions, sweating, ataxia, tremor and vomiting.
If you have further doubts about the use of this product, consult your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Uncommon (may affect up to 1 in 100 people):

• Skin sensitivity to light (which may cause redness or sunburn).

Rare (may affect up to 1 in 1,000 people):

• Burning and dryness of the mouth. If this happens, try sipping a glass of water to reduce the effect.

Very rare (may affect up to 1 in 10,000 people):

• Sudden swelling of the mouth/throat and mucous membranes (angioedema).
• Difficulty breathing (laryngospasm).

Not known (frequency cannot be estimated from the available data):

• Local loss of sensitivity of the oral mucosa (Oral hypoesthesia)
• Allergic reaction (hypersensitivity)
• Severe allergic reaction (anaphylactic shock), whose signs may include difficulty breathing, chest pain or tightness, and/or feeling dizzy/weak, severe skin itching or appearance of swellings on the skin, swelling of the face, lips, tongue and/or throat, which may potentially put the patient's life in danger.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through 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 TANTUM VERDE P

Expiry date: see the expiry date printed on the packaging.
Do not use this medicine after the expiry date which is reported on the pack after EXP. The expiry
date refers to the last day of the month.
Do not store at a temperature above 25°C.
Store in the original packaging to protect the medicine from moisture.
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 protect the environment.

Keep this medicine out of the sight and reach of children.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What Tantum Verde P contains:
The active ingredient is benzydamine hydrochloride equivalent to 2.68 mg of benzydamine.
The other ingredients are: isomalt (E 953), aspartame (E 951), levomenthol, citric acid monohydrate, lemon aroma, mint aroma, quinoline yellow (E 104), indigotine (E 132)

Description of the appearance of Tantum Verde P and contents of the pack
This medicine is presented in the form of green, square-shaped lozenges with a central indentation.
The lozenges may be packaged in PVC/PE/PVDC - ALU blister packs or wrapped in paraffin paper.
Pack sizes of 20 and 30 lozenges.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Angelini Pharma S.p.A. Viale Amelia 70 - 00181 Rome, Italy
Manufacturers:
A.C.R.A.F. S.p.A., Via Vecchia del Pinocchio, 22 - 60131 Ancona
PIERRE FABRE MEDICAMENT PRODUCTION, Site Diététique et Pharmacie, Zone Industrielle de la
Coudette, 32290 Aignan, France
This medicine is authorised in the Member States of the European Economic Area under the following
denominations:

Italy:Tantum Verde P, 3mg mint flavored lozenges

Portugal:TANTUM VERDE, lozenges, 3 mg, mint flavor

Spain:Juanolgar 3 mg mint flavored lozenges

Germany:TANTUM VERDE with mint flavor 3 mg lozenges

Denmark:Zyx mint 3 mg lozenges

Sweden: Zyx mint 3 mg lozenges

United Kingdom:Difflam 3 mg lozenges, mint taste