Tantum Verde P: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE USER

Tantum Verde P 3 mg eucalyptus-flavoured tablets

Benzidamine hydrochloride
Please read all of 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 instructed you.

Keep this leaflet. You may need to read it again.
If you would like more information or advice, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contact your doctor if you do not notice any improvement or if you experience worsening of symptoms after 3 days.

Contents of this leaflet:

What Tantum Verde P is and what it is used for
What you need to know before taking Tantum Verde P
How to take Tantum Verde P
Possible side effects
How to store Tantum Verde P
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 substance benzidamina, which acts against local irritation and pain.
Tantum Verde P is used in adults and children over 6 years of age for the local symptomatic treatment of pain and irritation in the mouth and throat.
Consult your doctor if you do not feel better or if you feel worse after 3 days.

2. WHAT YOU SHOULD KNOW BEFORE TAKING 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 previously experienced asthma attacks.
if you are allergic to aspirin or to other non-steroidal anti-inflammatory drugs (NSAIDs).
if your doctor has diagnosed you with an intolerance to certain sugars, consult him/her before taking this medicine.
if after using the tablets your mouth or throat pain worsens or does not improve within 3 days, or if fever or other symptoms develop, you must 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
Not affected by food or drink.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, if you suspect you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Do not use Tantum Verde P during pregnancy unless clearly necessary and on medical advice. If treatment is required, the lowest dose for the shortest possible duration should be used. Tantum Verde P must 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, consult him/her before taking this medicine.
This medicine contains eucalyptus oil, which in turn contains D-Limonene. D-Limonene may cause allergic reactions.

3. HOW TO TAKE TANTUM VERDE P

Take 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:
Adults and children over 6 years: one tablet three times a day. Do not take more than 3 tablets per day.
Use in children
For children aged 6 to 11 years, this product should be taken under the supervision of an adult.
The tablet formulation must not be administered to children under 6 years of age.
Tantum Verde P must 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 overdose, contact your pharmacist or doctor immediately, or go to the nearest hospital.
Always carry this patient information leaflet and the package, even if the package is empty.
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: excitement, convulsions, sweating, ataxia, tremor, and vomiting.
If you have further questions about the use of this product, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.

Uncommon (may affect up to 1 in 100 people):

Skin photosensitivity (which may cause erythema or sunburn).

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

Burning sensation and dryness of the mouth. If this occurs, 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).
Breathing difficulty (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), the signs of which may include breathing difficulty, chest pain or tightness in the chest, and/or dizziness/weakness, intense 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 at risk.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, please inform 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 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 stated on the pack after Exp.
The expiry date refers to the last day of the month.
Do not store above 30°C.
Store in the original packaging to protect the medicine from moisture.
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 PACKAGE AND OTHER INFORMATION

What Tantum Verde P contains:
The active substance is benzidamine hydrochloride, equivalent to 2.68 mg of benzidamine.
The other components are: isomalt (E 953), acesulfame potassium, citric acid monohydrate, eucalyptus oil,
levomenthol, quinoline yellow (E 104), indigotine (E 132).

Description of the appearance of Tantum Verde P and pack contents:
This medicinal product 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.
Pack sizes contain 20 or 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 European Economic Area countries under the following names:
Italy: Tantum Verde P, 3 mg eucalyptus flavoured lozenges
Spain: Juanolgar 3 mg pastillas para chupar sabor eucalipto
Denmark: ZYX eukalyptus
Sweden: Zyx eucalyptus 3 mg sugtabletter
United Kingdom: DIFFLAM 3 mg Lozenges, eucalyptus flavour

PATIENT LEAFLET: INFORMATION FOR THE USER

Tantum Verde P 3 mg orange and honey flavoured tablets

Benzidamine hydrochloride
Please read this entire 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 instructed.

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, contact your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice any improvement or if your symptoms worsen after 3 days.

Contents of this leaflet:

What Tantum Verde P is and what it is used for
What you need to know before taking Tantum Verde P
How to take Tantum Verde P
Possible side effects
How to store Tantum Verde P
Contents of the pack and other information

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

2. WHAT YOU NEED TO KNOW BEFORE TAKING 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 previously experienced asthma attacks
if you are allergic to aspirin or to other non-steroidal anti-inflammatory drugs (NSAIDs)
if your doctor has diagnosed you with an intolerance to certain sugars, consult him/her before taking this medicine
if after using the lozenges your mouth or throat pain worsens or does not improve within 3 days, or if fever or other symptoms develop, you must contact your doctor or dentist.

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

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

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, if you suspect you may be pregnant or are planning a pregnancy, consult your doctor or pharmacist before taking this medicine.
Do not use Tantum Verde P during pregnancy unless clearly necessary and on medical advice. If treatment is required, the lowest possible dose for the shortest possible duration should be used.
Tantum Verde P must 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, consult him/her before taking this medicine.
Sunset Yellow (E110): may cause allergic reactions.
Orange flavour, which in turn contains 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 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:
Adults and children over 6 years: one tablet three times a day. Do not take more than 3 tablets per day.
Use in children
Children aged 6 to 11 years should take this product under adult supervision.
The tablet formulation must not be used in children under 6 years of age.
Tantum Verde P must not be taken for longer 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 overdose, contact your pharmacist or doctor immediately, or go to the nearest hospital.
Always bring this patient information leaflet and the package, even if the pack is empty.
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: excitement, convulsions, sweating, ataxia, tremor, and vomiting.
If you have any further doubts about the use of this product, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.

Uncommon (may affect up to 1 in 100 people):

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

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

Burning sensation and dryness of the mouth. If this occurs, 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).
Breathing difficulty (laryngospasm).

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

Local loss of sensitivity of the oral mucosa (oral hypoaesthesia).
Allergic reaction (hypersensitivity). Severe allergic reaction (anaphylactic shock), the signs of which may include breathing difficulties, chest pain or chest 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 could potentially place the patient at life-threatening risk.

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

5. HOW TO STORE TANTUM VERDE P

Expiry: see the expiry date stated on the packaging.
Do not use this medicine after the expiry date shown on the package following EXP. The expiry date refers to the last day of the month.
Do not store above 30°C.
Keep in the original packaging to protect the medicine from moisture.
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.
Keep this medicine out of the sight and reach of children.

6. PACK CONTENT AND OTHER INFORMATION

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

Description of the appearance of Tantum Verde P and pack contents:
This medicinal product appears as yellow-orange, square-shaped tablets with a central depression.
The tablets may be packaged in PVC/PE/PVDC - ALU blisters or wrapped in paraffin paper.
Pack sizes: 20 and 30 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
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, Italy

This medicinal product is authorised in the European Economic Area countries under the following
names:
Italy: Tantum Verde P 3 mg pastiglie gusto arancia e miele
Portugal: Tantum Verde pastilhas, 3 mg, sabor a orange-mel
Spain: Juanolgar 3 mg pastillas para chupar sabor naranja-miel
Germany: Tantum Verde mit Orange-Honiggeschmack 3 mg Lutschtabletten
Denmark: Zyx appelsin-honning
Sweden: Zyx Apelsin & Honung 3 mg sugtabletter
United Kingdom: Difflam 3 mg lozenges, orange-honey flavour

PACKAGE LEAFLET: INFORMATION FOR THE USER

Tantum Verde P 3 mg lemon-flavored tablets

Benzidamine hydrochloride
Please 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 instructed you.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If any side effects occur, 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 after 3 days.

Contents of this leaflet:

What Tantum Verde P is and what it is used for
What you need to know before taking Tantum Verde P
How to take Tantum Verde P
Possible side effects
How to store Tantum Verde P
Package contents and other information

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

2. WHAT YOU SHOULD KNOW BEFORE TAKING 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 phenylketonuria
if you have previously experienced asthma attacks
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 your mouth or throat pain worsens or does not improve within 3 days, or if fever or other symptoms occur, you must contact your doctor or dentist.

Other medicines and Tantum Verde P
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Tantum Verde P with food and drinks
Not affected by food or drink.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, if you suspect you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Do not use Tantum Verde P during pregnancy unless clearly necessary and as directed by your doctor. If treatment is required, the lowest possible dose for the shortest possible time should be used. Tantum Verde P must 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 causing phenylalanine to accumulate because the body cannot eliminate it properly.
Peppermint flavour which 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 contains benzyl alcohol, citral, citronellol, D-Limonene, geraniol and linalool. Benzyl alcohol, citral, citronellol, D-Limonene, geraniol and linalool may cause allergic reactions.
Lemon flavour which contains butylated hydroxyanisole (E 320). Butylated hydroxyanisole may cause local skin reactions (e.g. contact dermatitis) or irritation to eyes and mucous membranes.

3. HOW TO TAKE TANTUM VERDE P

Take 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:
Adults and children over 6 years of age: one tablet three times a day. Do not take more than 3 tablets per day.
Use in children
For children aged 6 to 11 years, the product should be taken under the supervision of an adult.
The "tablet" formulation must not be used in children under 6 years of age.
Tantum Verde P must not be taken for longer 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 overdose, contact your pharmacist or doctor immediately or go to the nearest hospital.
Always bring this patient information leaflet and the package, even if the package is empty.
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: excitement, convulsions, sweating, ataxia, tremor, and vomiting.
If you have further questions about the use of this product, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

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

Skin photosensitivity (which may cause erythema or sunburn).

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

Burning sensation and dryness of the mouth. If this occurs, 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).
Breathing difficulties (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), the signs of which may include breathing difficulties, chest pain or chest 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 could potentially place the patient at risk of life-threatening complications.

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 the website
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse reactions, 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 stated on the packaging.
Do not use this medicine after the expiry date indicated on the package following EXP. The expiry date refers to the last day of the month.
Do not store above 25°C.
Keep in the original packaging to protect the medicine from moisture.
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.
Keep this medicine out of the sight and reach of children.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Tantum Verde P contains:
The active substance is benzidamine hydrochloride, equivalent to 2.68 mg of benzidamine.
The other components 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 contents of the pack
This medicinal product appears as light green, square-shaped lozenges with a central indentation.
The lozenges may be packaged in PVC/PE/PVDC - ALU blisters or wrapped in paraffin paper.
Pack sizes: 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, Italy
Pierre Fabre Médicament Production, Site Diététique et Pharmacie, Zone Industrielle de la Coudette, 32290 Aignan, France

This medicinal product is authorised in the European Economic Area Member States under the following names:
Italy: Tantum Verde P, 3mg lemon-flavoured lozenges
Portugal: Tantum Verde , 3 mg tablets, lemon flavour
Spain: Juanolgar 3 mg lemon-flavoured pastilles
Germany: TANTUM VERDE mit Zitronengeschmack 3 mg Lutschtabletten
Denmark: Zyx citron 3mg sugetabletter
Sweden: Zyx Citron 3 mg sugtabletter
United Kingdom: Difflam 3 mg lozenges, lemon taste

PACKAGE LEAFLET: INFORMATION FOR THE USER

Tantum Verde P 3 mg peppermint-flavored tablets

Benzalkonium chloride
Please 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 instructed you.

Keep this leaflet. You may need to read it again.
If you would like more information or advice, please consult your pharmacist.
If any side effects occur, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contact your doctor if you do not notice any improvement or if your symptoms worsen after 3 days.

Contents of this leaflet:

What Tantum Verde P is and what it is used for
What you need to know before taking Tantum Verde P
How to take Tantum Verde P
Possible side effects
How to store Tantum Verde P
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 substance benzidamina, which acts against local irritation and pain.
Tantum Verde P is used in adults and children over 6 years of age for the local symptomatic treatment of mouth and throat pain and irritation.
Consult your doctor if you do not feel better or if you feel worse after 3 days.

2. WHAT YOU SHOULD KNOW BEFORE TAKING 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 phenylketonuria
if you have previously experienced episodes of asthma
if you are allergic to aspirin or to other non-steroidal anti-inflammatory drugs (NSAIDs)
if your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine
if after using the tablets your mouth or throat pain worsens or does not improve within 3 days, or if fever or other symptoms develop, you must 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 drinks

The effectiveness of Tantum Verde P is not affected by food or drinks.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, suspect you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.

Do not use Tantum Verde P during pregnancy unless clearly necessary and as directed by your doctor. If treatment is required, the lowest effective dose for the shortest possible duration should be used.

Tantum Verde P must not be used during breastfeeding.

Driving and using machines

Tantum Verde P does not impair your ability to drive or operate machinery.

Tantum Verde P contains:

Isomalt: If your doctor has diagnosed you with an intolerance to certain sugars, contact them 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 have phenylketonuria, a rare genetic disorder causing phenylalanine to accumulate because the body cannot properly metabolize it.
Mint flavour, which 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 contains benzyl alcohol, citral, citronellol, D-Limonene, geraniol, linalool and butylated hydroxyanisole. Benzyl alcohol, citral, citronellol, D-Limonene, geraniol and linalool may cause allergic reactions.
Lemon flavour, which contains butylated hydroxyanisole (E 320). Butylated hydroxyanisole may cause local skin reactions (e.g. contact dermatitis) or irritation to eyes and mucous membranes.

3. HOW TO TAKE TANTUM VERDE P

Take 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:
Adults and children over 6 years: one tablet three times a day. Do not take more than 3 tablets per day.
Use in children
Children aged 6 to 11 years should take this product under the supervision of an adult.
The tablet formulation must not be taken by children under 6 years of age.
Tantum Verde P must not be taken for longer 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 overdose, contact your pharmacist or doctor immediately, or go to the nearest hospital.
Always carry this package leaflet and the container with you, even if the package no longer contains any 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: excitement, convulsions, sweating, ataxia, tremor and vomiting.
If you have further doubts about the use of this product, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Uncommon (may affect up to 1 in 100 people):

Skin photosensitivity (which may cause erythema or sunburn).

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

Burning sensation and dryness of the mouth. If this occurs, 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).
Breathing difficulties (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), the signs of which may include breathing difficulties, chest pain or chest 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 may potentially place the patient at risk of life-threatening complications.

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 more information on the safety of this medicine.

5. HOW TO STORE TANTUM VERDE P

Expiry date: see the date stated on the packaging.
Do not use this medicine after the expiry date indicated on the package after EXP. The expiry date refers to the last day of the month.
Do not store above 25°C.
Keep in the original packaging to protect the medicine from moisture.
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.
Keep this medicine out of the sight and reach of children.

6. PACK CONTENTS AND OTHER INFORMATION

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

Description of the appearance of Tantum Verde P and pack contents:
This medicine is presented as green, square-shaped lozenges with a central indentation.
The lozenges may be packaged in PVC/PE/PVDC - ALU blisters or wrapped in paraffin paper.
Pack sizes: 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, Italy
PIERRE FABRE MEDICAMENT PRODUCTION, Site Diététique et Pharmacie, Zone Industrielle de la
Coudette, 32290 Aignan, France

This medicine is authorised in the European Economic Area member states under the following names:
Italy: Tantum Verde P, 3 mg lozenges, mint flavour
Portugal: TANTUM VERDE, lozenges, 3 mg, mint flavour
Spain: Juanolgar 3 mg mint-flavoured pastilles
Germany: TANTUM VERDE mit Minzgeschmack 3 mg Lutschtabletten
Denmark: Zyx mint 3 mg lozenges
Sweden: Zyx mint 3 mg lozenges
United Kingdom: Difflam 3 mg lozenges, mint taste