BENAGOL Lozenge

Зміст інструкції

1. BENAGOL 1.2 mg + 0.6 mg Lozenges Ginger and Spices flavour, 1.2 mg + 0.6 mg Lozenges Honey and Lemon flavour, 1.2 mg + 0.6 mg Lozenges Cold Mint flavour, 1.2 mg + 0.6 mg Lozenges Lemon Sugar-Free flavour, 1.2 mg + 0.6 mg Lozenges Strawberry Sugar-Free flavour
   1. What is BENAGOL and what is it used for
   2. What you need to know before taking/giving BENAGOL to the child
   3. How to take/give to the child BENAGOL
   4. Possible side effects
   5. How to store BENAGOL
   6. Package contents and other information
2. BENAGOL 1.2 mg + 0.6 mg + 74.9 mg + 33.5 mg Tablets with Vitamin C Orange Flavor
   1. What is BENAGOL and what is it used for
   2. What you need to know before taking/giving BENAGOL to the child
   3. How to take/give to the child BENAGOL
   4. Possible side effects
   5. How to store BENAGOL
   6. Contents of the pack and other information
3. BENAGOL 1.2 mg + 0.6 mg + 8 mg Lozenges Menthol-Eucalyptus flavour
   1. What is BENAGOL and what is it used for
   2. What you need to know before you take/give BENAGOL to the child
   3. How to take/give BENAGOL to the child
   4. Possible side effects
   5. How to store BENAGOL
   6. Contents of the pack and other information

BENAGOL 1.2 mg + 0.6 mg Lozenges Ginger and Spices flavour, 1.2 mg + 0.6 mg Lozenges Honey and Lemon flavour, 1.2 mg + 0.6 mg Lozenges Cold Mint flavour, 1.2 mg + 0.6 mg Lozenges Lemon Sugar-Free flavour, 1.2 mg + 0.6 mg Lozenges Strawberry Sugar-Free flavour

2,4-dichlorobenzyl alcohol + amylmetacresol

Read this leaflet carefully before taking/giving this medicine to the child, as it
contains important information for you.
Always take/give this medicine to the child 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 would like 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 a short period of treatment.

Contents of this leaflet:

• 1. What BENAGOL is and what it is used for
• 2. What you need to know before taking/giving BENAGOL to the child
• 3. How to take/give BENAGOL to the child
• 4. Possible side effects
• 5. How to store BENAGOL
• 6. Contents of the pack and other information

1. What is BENAGOL and what is it used for

BENAGOL contains the active ingredients 2,4-dichlorobenzyl alcohol, amylmetacresol and is used to
disinfect the mouth and throat.

BENAGOL Honey and Lemon flavour, BENAGOL Lemon Sugar-Free flavourand BENAGOL Strawberry flavour

Sugar-Freeare used in adultsand in children over 6 years of age.

BENAGOL Ginger and Spice flavourand BENAGOL Cool Mint flavourare used in adultsand in children
over 12 years of age.

BENAGOL Lemon Sugar-Free flavourand BENAGOL Strawberry Sugar-Free flavourare suitable if you/the
child need to control sugar and calorie intake.
Contact your doctor if you/the child do not feel better or if you feel worse after a short period of
treatment.

2. What you need to know before taking/giving BENAGOL to the child

Do not take/give BENAGOL to the child

• if you are allergic to 2,4-dichlorobenzyl alcohol and amyl metacresol or to any of the other components of

this medicine (listed in section 6);

• if the child is under 6 years of age.

Do notgive BENAGOL Ginger and Spice flavourand BENAGOL Cool Mint flavourto children under 12
years of age.

Warnings and precautions
Consult your doctor or pharmacist before taking/giving BENAGOL to the child.
If you/the child experience allergic reactions or irritation, stop taking this medicine and
consult your doctor (see section “Possible side effects”).

Children and adolescents
Do notgive BENAGOL to children under 6 years of age.

Do notgive BENAGOL Ginger and Spice flavourand BENAGOL Cool Mint flavourto children under 12
years of age.
Be careful with preschool children as swallowing the tablets whole can
cause choking.

Other medicines and BENAGOL
Tell your doctor or pharmacist if you/the child are taking, have recently taken or might
take any other medicines.

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

Driving and operating machinery
BENAGOL does not affect the ability to drive vehicles or operate machinery.

BENAGOL Ginger and Spice flavour lozenges contain liquid glucose (containing sulphites and wheat starch), liquid sucrose, spice aroma and ginger aroma (containing cinnamal, citral,
citronellol, eugenol, farnesol, geraniol, isoeugenol, linalool)

Liquid glucose and liquid sucrose:if your doctor has diagnosed you/the child with
an intolerance to certain sugars, contact them before taking/giving this medicine to the child.
This medicine contains 1.10 g of glucoseand 1.38 g of sucroseper lozenge. This should be taken into
consideration in people with diabetes mellitus.

Sulphites:can rarely cause severe hypersensitivity reactions and bronchospasm.

Gluten:this medicine contains only a very small amount of gluten (from wheat starch). This medicine is considered “gluten-free” and it is very unlikely to cause you problems if you have coeliac disease. One lozenge contains no more than 22.04 micrograms of gluten. If
you are allergic to wheat (a condition different from coeliac disease) do not take this medicine.

Cinnamal, citral, citronellol, eugenol, farnesol, geraniol, isoeugenol, linalool:can
cause allergic reactions.
BENAGOL Ginger and Spice flavour contains aromas that can induce a sensation of warmth in the
mouth and throat during sucking of the lozenge.

BENAGOL Honey and Lemon flavour contains liquid sucrose, liquid glucose (containing sulphites
and wheat starch), honey (inverted sugar), mint essence and lemon essence (containing
citral, d-limonene, geraniol and linalool)

Liquid glucose, liquid sucrose and honey (inverted sugar):if your doctor has diagnosed you/the child with an intolerance to certain sugars, contact them before taking/giving this medicine to the child.
This medicine contains 0.98 g of glucoseand 1.44 g of sucroseper lozenge. This should be taken into
consideration in people with diabetes mellitus.

Sulphites:can rarely cause severe hypersensitivity reactions and bronchospasm.

Gluten:this medicine contains only a very small amount of gluten (from wheat starch). This medicine is considered “gluten-free” and it is very unlikely to cause you problems if you have coeliac disease. One lozenge contains no more than 19.52 micrograms of gluten. If
you are allergic to wheat (a condition different from coeliac disease) do not take this medicine.

Citral, d-limonene, geraniol and linalool:can cause allergic reactions.

BENAGOL Cool Mint flavour contains liquid sucrose, liquid glucose (containing sulphites and
wheat starch), mint aroma and eucalyptus essence (containing propylene glycol, benzyl alcohol,
cinnamic alcohol, citral, citronellol, d-limonene, eugenol and linalool)

Liquid glucose and liquid sucrose:if your doctor has diagnosed you/the child with an intolerance to certain sugars, contact them before taking/giving this medicine to the child.
This medicine contains 1.10 g of glucoseand 1.38 g of sucroseper lozenge. This should be taken into
consideration in people with diabetes mellitus.

Sulphites:can rarely cause severe hypersensitivity reactions and bronchospasm.

Gluten:this medicine contains only a very small amount of gluten (from wheat starch). This medicine is considered “gluten-free” and it is very unlikely to cause you problems if you have coeliac disease. One lozenge contains no more than 22.04 micrograms of gluten. If
you are allergic to wheat (a condition different from coeliac disease) do not take this medicine.

Benzyl alcohol, cinnamic alcohol, citral, citronellol, d-limonene, eugenol and linalool:can
cause allergic reactions.

Propylene glycol:this medicine contains 1.89 mg of propylene glycol in each lozenge.

BENAGOL Lemon Sugar-Free flavour contains liquid maltitol, isomalt, lemon aroma
(containing benzyl alcohol, citral, citronellol, d-limonene, geraniol and linalool)

Liquid maltitol and isomalt:if your doctor has diagnosed you/the child with an intolerance to
certain sugars, contact them before taking/giving these medicines to the child. It may have a
laxative effect. The caloric value of maltitol and isomalt is 2.3 kcal/g.

Benzyl alcohol, citral, citronellol, d-limonene, geraniol and linalool:can cause allergic
reactions.

BENAGOL Strawberry Sugar-Free flavour contains liquid maltitol, isomalt, strawberry aroma
(containing propylene glycol and benzyl alcohol)

Liquid maltitol and isomalt:if your doctor has diagnosed you/the child with an intolerance to
certain sugars, contact them before taking/giving these medicines to the child. It may have a
laxative effect. The caloric value of maltitol and isomalt is 2.3 kcal/g.

Benzyl alcohol:can cause allergic reactions.

Propylene glycol:this medicine contains 7.30 mg of propylene glycol in each lozenge

BENAGOL Ginger and Spice flavour lozenges, BENAGOL Lemon Sugar-Free flavour and BENAGOL
Strawberry Sugar-Free flavour
These medicines contain less than 1 mmol (23 mg) of sodium per dose, i.e. essentially
“sodium-free”.

3. How to take/give to the child BENAGOL

Take/give to the child this medicine following always exactly what reported in this leaflet or the
instructions of the doctor or pharmacist. If you have doubts consult the doctor or pharmacist.

Adults and adolescents
The recommended dose is 1 lozenge every 2-3 hours. Attention: do not exceed the recommended doses without consulting
the doctor.
For BENAGOL gusto Menta Freddado not exceed the maximum daily dose of 8 lozenges.
For the other flavours of BENAGOL, do not exceed the maximum daily dose of 12 lozenges.
You can take/give to the child BENAGOL at any time of the day, dissolving slowly in the mouth
each lozenge.
Attention: use this medicine only for short periods of treatment.
Consult the doctor if the disorder occurs repeatedly or if you notice any recent change of its
characteristics.

Children
Donot give BENAGOL to children under 6 years of age.

Donot give BENAGOL gusto Gingerand Spezie and BENAGOL gusto Menta Freddato children under
12 years of age.
In children over 6 years of age, consult your doctor who will indicate the appropriate dose for the
child.

If you take/give to the child more BENAGOL than you should
In case of accidental ingestion/taking of an excessive dose of BENAGOL immediately warn
the doctor or go to the nearest hospital.
Accidental ingestion of an excessive dose of this medicine can cause stomach and
intestinal disorders.

If you forget to take/give to the child BENAGOL
Do not take/give to the child a double dose to compensate for the forgotten lozenge.

If you stop the treatment with BENAGOL
If you have any doubt about the use of this medicine, consult the doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
With the use of Benagol, the following side effects may occur; in such cases STOP
taking this medicine and consult your doctor immediately:

• Rare (may affect up to 1 in 1000 people)
• Hypersensitivity (allergic reaction)
• Glossitis (inflammation of the tongue)
• Not known(frequency cannot be estimated from available data)
• Abdominal pain
• Nausea
• Gastrointestinal discomfort
• Skin rash

Reporting of side effects
If you/your child experiences any side effects, including those not listed in
this leaflet, please inform 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 to provide more information on the safety of
this medicine.

5. How to store BENAGOL

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 pack after Exp. The expiry date
refers to the last day of that month.
Use BENAGOL Pastilles Honey and Lemon flavour in the tube pack within 3 months from the date of first
opening.
Do not store at a temperature above 25°C.
Do not dispose of any medicine in the 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 BENAGOL contains

BENAGOL Lozenges Ginger and Spice flavour

• The active ingredients are: 2,4-dichlorobenzyl alcohol 1.2 mg; amylmetacresol 0.6 mg
• The other ingredients are: liquid sucrose, liquid glucose(containing sulphitesand wheat starch), tartaric acid, anthocyanins (E163) (containing sodium), plum flavour, cream flavour, spice flavour and ginger flavour (containing cinnamal, citral, citronellol, eugenol,farnesol, geraniol, isoeugenol and linalool), medium chain saturated triglycerides (see paragraph “BENAGOL Lozenges Ginger and Spice flavour contains liquid glucose (containing sulphites and wheat starch), liquid sucrose, spice flavour and ginger flavour (containing cinnamal, citral, citronellol, eugenol, farnesol, geraniol, isoeugenol, linalool)”).

BENAGOL Lozenges Honey and Lemon flavour

• The active ingredients are: 2,4-dichlorobenzyl alcohol 1.2 mg; amylmetacresol 0.6 mg
• The other ingredients are: liquid sucrose, liquid glucose(containing sulphitesand wheat starch) , honey(inverted sugar), peppermint essence, lemon essence (containing citral, d-limonene, geraniol and linalool), tartaric acid (see paragraph “BENAGOL Honey and Lemon flavour contains liquid sucrose, liquid glucose (containing sulphites and wheat starch), honey (inverted sugar), peppermint essence and lemon essence (containing citral, d-limonene, geraniol and linalool)”).

BENAGOL Lozenges Cool Mint flavour

• The active ingredients are: 2,4-dichlorobenzyl alcohol 1.2 mg; amylmetacresol 0.6 mg
• The other ingredients are: liquid sucrose, liquid glucose(containing sulphitesand wheat starch), xylitol, levomenthol, mint flavour and eucalyptus essence (containing propylene glycol, benzyl alcohol, cinnamyl alcohol, citral, citronellol, eugenol, d-limonene and
  linalool) (see paragraph “BENAGOL Cool Mint flavour contains liquid sucrose,
  liquid glucose (containing sulphites and wheat starch), mint flavour and eucalyptus essence
  (containing propylene glycol, benzyl alcohol, cinnamyl alcohol, citral, citronellol, d-
  limonene, eugenol and linalool)”).

BENAGOL Lemon Sugar-Free Lozenges flavour

• The active ingredients are: 2,4-dichlorobenzyl alcohol 1.2 mg; amylmetacresol 0.6 mg
• The other ingredients are: lemon flavour (containing benzyl alcohol, citral,citronellol, d-limonene, geraniol and linalool), sodium saccharin, tartaric acid, liquid maltitol, isomalto(see paragraph “BENAGOL Lemon Sugar-Free flavour contains liquid maltitol, isomalto, lemon flavour (containing benzyl alcohol, citral, citronellol, d-limonene, geraniol and linalool)”).

BENAGOL Strawberry Sugar-Free Lozenges flavour

• The active ingredients are: 2,4-dichlorobenzyl alcohol 1.2 mg; amylmetacresol 0.6 mg
• The other ingredients are: strawberry flavour (containing propylene glycoland benzylalcohol), anthocyanins (E163) (containing sodium), sodium saccharin, tartaric acid, liquid maltitol, isomalto(see paragraph “BENAGOL Strawberry Sugar-Free flavour contains liquid maltitol, isomalto, strawberry flavour (containing propylene glycol and benzyl alcohol)”).

Description of the appearance of BENAGOL and contents of the pack
BENAGOL 1.2 mg + 0.6 mg Lozenges Cool Mint flavour, BENAGOL 1.2 mg + 0.6 mg Lozenges Ginger and Spice flavour are presented in lozenges packaged in blisters of 16 lozenges.
BENAGOL 1.2 mg + 0.6 mg Lozenges Strawberry Sugar-Free flavour is presented in lozenges
packaged in blisters of 16, 24 lozenges.
BENAGOL 1.2 mg + 0.6 mg Lozenges Lemon Sugar-Free flavour is presented in lozenges
packaged in blisters of 16, 24, 36 lozenges.
BENAGOL Lozenges Honey and Lemon flavour is presented in lozenges packaged in blisters of 16, 24,
36 lozenges and in tubes of 10 lozenges, in packs of 10 lozenges (1 X 10) or 20 lozenges (2 X
10).
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Reckitt Benckiser Healthcare (Italia) S.p.A., via G. Spadolini 7, 20141 Milano
Manufacturer
Reckitt Benckiser Healthcare International Limited, Nottingham Site, Thane Road, Nottingham, NG90 2DB
(UK)
RB NL Brands B.V., Schiphol Boulevard 207, Schiphol 1118BH, Netherlands

BENAGOL 1.2 mg + 0.6 mg + 74.9 mg + 33.5 mg Tablets with Vitamin C Orange Flavor

2,4-dichlorobenzyl alcohol + amylmetacresol + sodium ascorbate + ascorbic acid

Read this leaflet carefully before taking/giving this medicine to the child, as it contains important information for you.
Always take/give this medicine to the child 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 would like 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 a short period of treatment.

Contents of this leaflet:

• 1. What BENAGOL is and what it is used for
• 2. What you need to know before taking/giving BENAGOL to the child
• 3. How to take/give BENAGOL to the child
• 4. Possible side effects
• 5. How to store BENAGOL
• 6. Contents of the pack and other information

1. What is BENAGOL and what is it used for

BENAGOL contains the active ingredients 2,4-dichlorobenzyl alcohol, amylmetacresol, vitamin C (sodium
ascorbate, ascorbic acid) and is used to disinfect the mouth and throat.
BENAGOL Lozenges with Vitamin C Orange flavour is used in adultsand in children over the age of
6 years.
Consult a doctor if you/the child do not feel better or if you feel worse after a short
period of treatment.

2. What you need to know before taking/giving BENAGOL to the child

Do not take/give BENAGOL to the child

• if they are allergic to 2,4-dichlorobenzyl alcohol, amylmetacresol, ascorbic acid or sodium ascorbate or to any of the other ingredients of this medicine (listed in section 6);
• if the child is under 6 years of age.

Warnings and precautions
Consult your doctor or pharmacist before taking/giving BENAGOL to the child.
If you/the child experience allergic reactions or irritation, stop taking this
medicine and consult your doctor (see section “Possible side effects”).

Children and adolescents
Donot give BENAGOL to children under 6 years of age.
Be careful with preschool children as if the tablets are swallowed whole
they may cause choking.

Other medicines and BENAGOL
Tell your doctor or pharmacist if you/the child are taking, have recently taken or
may take any other medicines.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
BENAGOL is not recommended during pregnancy or breastfeeding.

Driving and operating machinery
BENAGOL does not affect the ability to drive vehicles or operate machinery.

BENAGOL with Vitamin C Orange flavour contains liquid sucrose, liquid glucose
(containing sulphites and wheat starch), orange flavour (containing citral, citronellol, d-
limonene, geraniol and linalool), propylene glycol

Liquid glucose and liquid sucrose:if your doctor has diagnosed you/the child with an
intolerance to certain sugars, contact them before taking/giving this medicine to the child.
This medicine contains 0.97 g of glucoseand 1.44 g of sucroseper tablet. This should be taken into
consideration in people with diabetes mellitus.

Sulphites:can rarely cause severe hypersensitivity reactions and bronchospasm.

Gluten:this medicine contains only a very small amount of gluten (from wheat starch). This medicine is considered “gluten-free” and it is very unlikely to cause
problems if you have celiac disease. One tablet contains no more than 19.38 micrograms of gluten. If
you are allergic to wheat (a condition different from celiac disease) do not take this medicine.

Citral, citronellol, d-limonene, geraniol and linalool:may cause allergic reactions.

Propylene glycol: this medicine contains 3 mg of propylene glycol per tablet.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially
“sodium-free”.

3. How to take/give to the child BENAGOL

Take/give to the child this medicine following always exactly as reported in this
leaflet or the instructions of the doctor or pharmacist. If you have doubts consult the doctor or pharmacist.

Adults and adolescents
The recommended dose is 1 tablet every 2-3 hours.
Caution: do not exceed the maximum daily dose of 8 tablets without consulting the doctor.
You can take/give to the child BENAGOL at any time of the day, dissolving slowly in
mouth each tablet.
Caution: use this medicine only for short periods of treatment.
Consult the doctor if the disorder occurs repeatedly or if you notice any change
recent of its characteristics.

Children
Donot give BENAGOL to children under 6 years of age.
In children over 6 years of age, consult your doctor who will indicate the appropriate dose
for the child.

If you take/give to the child more BENAGOL than you should
In case of accidental ingestion/assumption of an excessive dose of BENAGOL, immediately notify
the doctor or go to the nearest hospital.
Accidental ingestion of an excessive dose of this medicine can cause gastrointestinal disturbances.

If you forget to take/give to the child BENAGOL
Do not take/give to the child a double dose to compensate for the forgotten tablet.

If you stop the treatment with BENAGOL
If you have any doubts about the use of this medicine, consult the doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
With the use of BENAGOL, the following side effects may occur, in which case

STOPtaking this medicine and consult your doctor immediately:

• Rare (may affect up to 1 in 1,000 people)
• Hypersensitivity (allergic reaction)
• Glossitis (inflammation of the tongue)
• Not known(frequency cannot be estimated from available data)
• Abdominal pain
• Nausea
• Gastrointestinal discomfort
• Skin rash

Reporting of side effects
If you or your child experiences any side effects, including those not listed in
this leaflet, please inform 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 to provide more information on the safety of
this medicine.

5. How to store BENAGOL

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after Exp. The expiry
date refers to the last day of that month.
Do not store at a temperature above 25°C.
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 BENAGOL contains

• The active ingredients are: 2,4-dichlorobenzyl alcohol 1.2 mg; amylmetacresol 0.6 mg; sodium ascorbate 74.9 mg; ascorbic acid 33.5 mg.
• The other ingredients are: liquid sucrose, liquid glucose(containing sulphitesand wheat starch), tartaric acid, orange flavour (containing citral, citronellol, d-limonene, geraniol and linalool), levomenthol, propylene glycol(see paragraph “BENAGOL with Vitamin C orange flavour contains liquid sucrose, liquid glucose (containing sulphites and wheat starch), orange flavour (containing citral, citronellol, d-limonene, geraniol and linalool), propylene glycol”).

Description of the appearance of BENAGOL and contents of the pack
BENAGOL is available in lozenges packaged in blisters of 16, 24 or 36 lozenges.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Reckitt Benckiser Healthcare (Italia) S.p.A., via G. Spadolini 7, 20141 Milano
Manufacturer
Reckitt Benckiser Healthcare International Limited, Nottingham Site, Thane Road, Nottingham,
NG90 2DB (UK)
RB NL Brands B.V., Schiphol Boulevard 207, Schiphol 1118BH, Netherlands

BENAGOL 1.2 mg + 0.6 mg + 8 mg Lozenges Menthol-Eucalyptus flavour

2,4-dichlorobenzyl alcohol + amylmetacresol + menthol

Read this leaflet carefully before you take/give this medicine to the child as it
contains important information for you.
Always take/give 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 would like 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.
• Talk to your doctor if you do not feel better or if your symptoms get worse after 3 days of treatment.

Contents of this leaflet:

• 1. What BENAGOL is and what it is used for
• 2. What you need to know before you take/give BENAGOL to the child

• 3. How to take/give BENAGOL to the child
• 4. Possible side effects
• 5. How to store BENAGOL
• 6. Contents of the pack and other information

1. What is BENAGOL and what is it used for

BENAGOL contains the active ingredients 2,4-dichlorobenzyl alcohol, amylmetacresol, menthol and is used
to disinfect the mouth and throat.

BENAGOLis used in adultsand in children over 6 years of age.
Consult your doctor if you/the child do not feel better or if you feel worse after 3 days of treatment.

2. What you need to know before you take/give BENAGOL to the child

Do not take/give BENAGOL to the child

• if you are allergic to 2,4-dichlorobenzyl alcohol, amylmetacresol and menthol or to any of the other ingredients of this medicine (listed in section 6);
• if the child is under 6 years of age;
• if the child suffers or has suffered from epilepsy (a disease characterized by recurrent and sudden manifestations with sudden loss of consciousness and violent muscle convulsions) or febrile convulsions (involuntary muscle contractions caused by high fever).

Warnings and precautions
Consult your doctor or pharmacist before taking/giving BENAGOL to the child.
If you/the child experience allergic reactions or irritation, stop taking this medicine and
consult your doctor (see section “Possible side effects”).
BENAGOL Menthol-Eucalyptus flavour contains terpene derivatives (such as for example camphor, cineole,

niaouli, wild thyme, terpineol, terpin, citral, menthol and essential oils of pine needles, eucalyptus and

turpentine) which can cause neurological disorders in adults and infants and children (such as
convulsions).
BENAGOL Menthol-Eucalyptus flavour is flammable, do not bring it near flames.

Children and adolescents
Donot give BENAGOL to children under 6 years of age.
Be careful with preschool children as if the lozenges are swallowed whole they can
cause choking.

Other medicines and BENAGOL
Tell your doctor or pharmacist if you/the child are taking, have recently taken or might
take any other medicines.
In particular, BENAGOL Menthol-Eucalyptus flavour should not be taken at the same time as other
products (medicines or cosmetics) containing terpene derivatives, regardless of how they are
administered.

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 taking this medicine.
BENAGOL Menthol-Eucalyptus flavour is not recommended during pregnancy, in women of childbearing potential who do not
use contraception or during breastfeeding.

Driving and operating machinery
BENAGOL does not affect the ability to drive vehicles or operate machinery.

BENAGOL Menthol-Eucalyptus flavour contains liquid sucrose, liquid glucose (containing
sulphites and wheat starch), eucalyptus essence (containing d-limonene).

Liquid glucose and liquid sucrose:if the doctor has diagnosed you/the child with
intolerance to certain sugars, contact them before taking/giving this medicine.
This medicine contains 1.01 g of glucoseand 1.50 g of sucroseper lozenge. To be taken into
consideration in people affected by diabetes mellitus.

Sulphites:rarely can cause severe hypersensitivity reactions and bronchospasm.

Gluten:this medicine contains only a very small amount of gluten (from wheat
starch). This medicine is considered “gluten-free” and it is very unlikely to cause
problems if you are coeliac. One lozenge contains no more than 20.26 micrograms of gluten. If
you are allergic to wheat (a condition different from coeliac disease) do not take this medicine.

D-limonene:can cause allergic reactions.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially
“sodium-free”.

3. How to take/give BENAGOL to the child

Take/give this medicine to the child following exactly what is reported in this leaflet or the instructions of the doctor or pharmacist. If you have doubts, consult the doctor or pharmacist.

Adults and adolescents
The recommended dose is 1 tablet every 2-3 hours. Caution: do not exceed the recommended doses without consulting the doctor. Do not exceed the maximum daily dose of 12 tablets.
You can take/give BENAGOL to the child at any time of the day, dissolving slowly in the mouth each tablet.
Caution: use this medicine only for short periods of treatment.
The duration of treatment should not exceed 3 days due to the presence of terpene derivatives (menthol and eucalyptus oil) which may cause neuropsychological disorders.
Consult the doctor if the disorder occurs repeatedly or if you notice any recent change in its characteristics.

Children
Donot give BENAGOL to children under 6 years of age.
In children over 6 years of age, consult your doctor who will indicate the appropriate dose for the child.

If you take/give the child more BENAGOL than you should
In case of accidental ingestion/intake of an excessive dose of BENAGOL, immediately notify the doctor or go to the nearest hospital.
Accidental ingestion of an excessive dose of this medicine can cause stomach and intestinal disorders. In newborns and children, neurological disorders such as convulsions may also occur.

If you forget to take/give BENAGOL to the child
Do not take/give the child a double dose to compensate for the forgotten tablet.

If you stop the treatment with BENAGOL
If you have any doubts about the use of this medicine, consult the doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
With the use of BENAGOL, the following side effects may occur; in such cases STOP
taking this medicine and consult your doctor immediately:

• Rare (may affect up to 1 in 1000 people)
• Hypersensitivity (allergic reaction)
• Glossitis (inflammation of the tongue)
• Not known(frequency cannot be estimated from available data)
• Abdominal pain
• Nausea
• Gastrointestinal discomfort
• Skin rash

Additional side effects in newborns and children

• convulsions.

Reporting of side effects
If you/the child gets any side effect, 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 BENAGOL

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 pack after Exp. The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C.
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 BENAGOL contains

• The active ingredients are: 2,4-dichlorobenzyl alcohol 1.2 mg; amylmetacresol 0.6 mg; menthol 8 mg
• The other ingredients are: liquid sucrose, liquid glucose(containing sulphitesand wheat starch), indigo carmine (E132) (containing sodium), eucalyptus essence (containing d-limonene), tartaric acid (see section “BENAGOL Menthol-Eucalyptus flavour contains liquid sucrose, liquid glucose (containing sulphites and wheat starch), eucalyptus essence (containing d-limonene)”).

Description of the appearance of BENAGOL and contents of the pack
BENAGOL is available in lozenges packaged in blisters of 16 or 24 lozenges.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Reckitt Benckiser Healthcare (Italia) S.p.A., via G. Spadolini 7, 20141 Milano
Manufacturer
Reckitt Benckiser Healthcare International Limited, Nottingham Site, Thane Road, Nottingham, NG90 2DB
(UK)
RB NL Brands B.V., Schiphol Boulevard 207, Schiphol 1118BH, Netherlands