2,4-dichlorobenzyl alcohol + amylmetacresol
Please read all of this leaflet carefully before you take/give the child this medicine because it contains important information for you.
Always take/give the child 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 need more advice or information, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice improvement or if symptoms worsen after a short period of treatment.

Contents of this leaflet:

What BENAGOL is and what it is used for
What you need to know before taking/giving the child BENAGOL
How to take/give the child BENAGOL
Possible side effects
How to store BENAGOL
Contents of the pack and other information

1. What BENAGOL is and what it is used for

BENAGOL contains the active ingredients 2,4-dichlorobenzyl alcohol and amylmetacresol and is used to
disinfect the mouth and throat.
BENAGOL Honey and Lemon flavour, BENAGOL Lemon flavour Sugar Free, and BENAGOL Strawberry flavour
Sugar Free are intended for use in adults and children over 6 years of age.
BENAGOL Ginger and Spice flavour and BENAGOL Cold Mint flavour are intended for use in adults and children over 12 years of age.
BENAGOL Lemon flavour Sugar Free and BENAGOL Strawberry flavour Sugar Free are suitable if you/your child need to control sugar and calorie intake.
Consult your doctor if you/your child do not feel better or feel worse after a short period of treatment.

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

Do not take/do not give BENAGOL to the child

if allergic to 2,4-dichlorobenzyl alcohol and amylmetacresol or to any of the other ingredients of
this medicine (listed in section 6);
if the child is under 6 years of age.

Do not give BENAGOL flavour Ginger and Spice and BENAGOL flavour Cool Mint to children under 12
years of age.
Warnings and precautions
Talk to 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 not give BENAGOL to children under 6 years of age.
Do not give BENAGOL flavour Ginger and Spice and BENAGOL flavour Cool Mint to children under 12
years of age.
Be cautious with preschool-aged children, as swallowing the tablets whole may cause choking.
Other medicines and BENAGOL
Inform 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 may be pregnant, planning a pregnancy, or breastfeeding, consult your
doctor or pharmacist before taking this medicine.
BENAGOL is not recommended during pregnancy or while breastfeeding.
Driving and using machines
BENAGOL does not affect the ability to drive or operate machinery.
BENAGOL Ginger and Spice Flavour Tablets contain liquid glucose (containing sulphites and wheat
starch), liquid sucrose, spice flavouring and ginger flavouring (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 your doctor before taking/giving this medicine.
This medicine contains 1.10 g of glucose and 1.38 g of sucrose per tablet. This should be taken into
account in people with diabetes mellitus.
Sulphites: may 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 coeliac disease. One
tablet contains no more than 22.04 micrograms of gluten. Do not take this medicine if you are allergic
to wheat (a condition different from coeliac disease).
Cinnamal, citral, citronellol, eugenol, farnesol, geraniol, isoeugenol, linalool: may cause allergic
reactions.
BENAGOL Ginger and Spice Flavour may produce a warming sensation in the mouth and throat during
sucking of the tablet due to its flavourings.
BENAGOL Lemon and Honey Flavour contains liquid sucrose, liquid glucose (containing sulphites
and wheat starch), honey (invert sugar), peppermint oil and lemon oil (containing citral,
d-limonene, geraniol and linalool)
Liquid glucose, liquid sucrose and honey (invert sugar): if your doctor has diagnosed you/the child
with an intolerance to certain sugars, contact your doctor before taking/giving this medicine.
This medicine contains 0.98 g of glucose and 1.44 g of sucrose per tablet. This should be taken into
account in people with diabetes mellitus.
Sulphites: may 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 coeliac disease. One
tablet contains no more than 19.52 micrograms of gluten. Do not take this medicine if you are allergic
to wheat (a condition different from coeliac disease).
Citral, d-limonene, geraniol and linalool: may cause allergic reactions.
BENAGOL Cool Mint Flavour contains liquid sucrose, liquid glucose (containing sulphites and wheat
starch), mint flavouring and eucalyptus oil (containing propylene glycol, benzyl alcohol,
cinnamyl 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 your doctor before taking/giving this medicine.
This medicine contains 1.10 g of glucose and 1.38 g of sucrose per tablet. This should be taken into
account in people with diabetes mellitus.
Sulphites: may 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 coeliac disease. One
tablet contains no more than 22.04 micrograms of gluten. Do not take this medicine if you are allergic
to wheat (a condition different from coeliac disease).
Benzyl alcohol, cinnamyl alcohol, citral, citronellol, d-limonene, eugenol and linalool: may cause
allergic reactions.
Propylene glycol: this medicine contains 1.89 mg of propylene glycol in each tablet.
BENAGOL Sugar-Free Lemon Flavour contains liquid maltitol, isomalt, lemon flavouring (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 your doctor before taking/giving this medicine. May have a laxative effect. The
calorific value of maltitol and isomaltitol is 2.3 kcal/g.
Benzyl alcohol, citral, citronellol, d-limonene, geraniol and linalool: may cause allergic reactions.
BENAGOL Sugar-Free Strawberry Flavour contains liquid maltitol, isomalt, strawberry flavouring
(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 your doctor before taking/giving this medicine. May have a laxative effect. The
calorific value of maltitol and isomaltitol is 2.3 kcal/g.
Benzyl alcohol: may cause allergic reactions.
Propylene glycol: this medicine contains 7.30 mg of propylene glycol in each tablet.
BENAGOL Ginger and Spice Flavour Tablets, BENAGOL Sugar-Free Lemon Flavour and BENAGOL
Sugar-Free Strawberry Flavour
These medicines contain less than 1 mmol (23 mg) of sodium per dose, i.e. essentially “sodium-free”.

3. How to take/give BENAGOL to a child

Take/give this medicine to the child exactly as described in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Adults and adolescents
The recommended dose is 1 tablet every 2–3 hours. Warning: Do not exceed the recommended doses without consulting your doctor.
For BENAGOL Cold Mint flavour, do not exceed the maximum daily dose of 8 tablets.
For other BENAGOL flavours, do not exceed the maximum daily dose of 12 tablets.
You may take/give BENAGOL at any time of day, allowing each tablet to dissolve slowly in the mouth.
Warning: Use this medicine only for short-term treatment.
Consult your doctor if symptoms recur frequently or if you notice any recent changes in their characteristics.
Children
Do not give BENAGOL to children under 6 years of age.
Do not give BENAGOL Ginger & Spice flavour and BENAGOL Cold Mint flavour to children under 12 years of age.
For children over 6 years of age, consult your doctor, who will determine the appropriate dose for the child.
If you take/give the child more BENAGOL than you should
In case of accidental ingestion/overdose of BENAGOL, contact your doctor immediately or go to the nearest hospital.
Accidental ingestion of an excessive dose of this medicine may cause stomach and intestinal disturbances.
If you forget to take/give the child BENAGOL
Do not take/give a double dose to make up for the missed tablet.
If you stop treatment with BENAGOL
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
When using Benagol, the following side effects may occur. If this happens, STOP taking 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 the available data)
Abdominal pain
Nausea
Gastrointestinal discomfort
Rash

Reporting of side effects
If you/your child experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the website
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 stated on the packaging after "Exp". The expiry date refers to the last day of that month.
Use BENAGOL Honey and Lemon Flavour Tablets in the tube packaging within 3 months after first opening.
Do not store above 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What BENAGOL contains
BENAGOL Lozenges flavour Ginger and Spices

The active substances are: 2,4-dichlorobenzyl alcohol 1.2 mg; amylmetacresol 0.6 mg
The other components are: liquid sucrose, liquid glucose (containing sulphites and 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 section “BENAGOL Lozenges flavour Ginger and Spices 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 flavour Honey and Lemon

The active substances are: 2,4-dichlorobenzyl alcohol 1.2 mg; amylmetacresol 0.6 mg
The other components are: liquid sucrose, liquid glucose (containing sulphites and wheat starch), honey (invert sugar), peppermint oil, lemon oil (containing citral, d-limonene, geraniol and linalool), tartaric acid (see section “BENAGOL Lozenges flavour Honey and Lemon contains liquid sucrose, liquid glucose (containing sulphites and wheat starch), honey (invert sugar), peppermint oil and lemon oil (containing citral, d-limonene, geraniol and linalool)”).

BENAGOL Lozenges flavour Cool Mint

The active substances are: 2,4-dichlorobenzyl alcohol 1.2 mg; amylmetacresol 0.6 mg
The other components are: liquid sucrose, liquid glucose (containing sulphites and wheat starch), xylitol, levomenthol, mint flavour and eucalyptus oil (containing propylene glycol,
benzyl alcohol, cinnamyl alcohol, citral, citronellol, eugenol, d-limonene and linalool) (see section “BENAGOL Lozenges flavour Cool Mint contains liquid sucrose, liquid glucose (containing sulphites and wheat starch), mint flavour and eucalyptus oil (containing propylene glycol, benzyl alcohol, cinnamyl alcohol, citral, citronellol, d-limonene, eugenol and linalool)”).
BENAGOL Sugar-Free Lozenges flavour Lemon
The active substances are: 2,4-dichlorobenzyl alcohol 1.2 mg; amylmetacresol 0.6 mg
The other components are: lemon flavour (containing benzyl alcohol, citral, citronellol, d-limonene, geraniol and linalool), sodium saccharin, tartaric acid, liquid maltitol, isomalt (see section “BENAGOL Sugar-Free Lozenges flavour Lemon contains liquid maltitol, isomalt, lemon flavour (containing benzyl alcohol, citral, citronellol, d-limonene, geraniol and linalool)”).

BENAGOL Sugar-Free Lozenges flavour Strawberry

The active substances are: 2,4-dichlorobenzyl alcohol 1.2 mg; amylmetacresol 0.6 mg
The other components are: strawberry flavour (containing propylene glycol and benzyl alcohol), anthocyanins (E163) (containing sodium), sodium saccharin, tartaric acid, liquid maltitol, isomalt (see section “BENAGOL Sugar-Free Lozenges flavour Strawberry contains liquid maltitol, isomalt, 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 flavour Cool Mint, BENAGOL 1.2 mg + 0.6 mg Lozenges flavour Ginger and Spices are presented as lozenges in blister packs of 16 lozenges.
BENAGOL 1.2 mg + 0.6 mg Sugar-Free Lozenges flavour Strawberry are presented as lozenges in blister packs of 16 or 24 lozenges.
BENAGOL 1.2 mg + 0.6 mg Sugar-Free Lozenges flavour Lemon are presented as lozenges in blister packs of 16, 24 or 36 lozenges.
BENAGOL Lozenges flavour Honey and Lemon are presented as lozenges in blister packs of 16, 24 or 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, Italy

Manufacturer
Reckitt Benckiser Healthcare International Limited, Nottingham Site, Thane Road, Nottingham, NG90 2DB (UK)
RB NL Brands B.V., Schiphol Boulevard 207, Schiphol 1118BH, The Netherlands

Package leaflet: Information for the user

BENAGOL 1.2 mg + 0.6 mg + 74.9 mg + 33.5 mg Effervescent Tablets with Vitamin C, Orange Flavour

2,4-dichlorobenzyl alcohol + amylmetacresol + sodium ascorbate + ascorbic acid
Please read this leaflet carefully before taking/giving this medicine to your child because it contains important information for you.
Always take/give 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 any adverse reaction occurs, 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 symptoms worsen after a short period of treatment.

Contents of this leaflet:

What BENAGOL is and what it is used for
What you need to know before taking/giving BENAGOL to your child
How to take/give BENAGOL to your child
Possible side effects
How to store BENAGOL
Contents of the pack and other information

1. What BENAGOL is and what it is used for

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

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

Do not take/do not give BENAGOL to the child

if 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
Talk to 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 not give BENAGOL to children under 6 years of age.
Take care with preschool-aged children, as the tablets may cause choking if swallowed whole.
Other medicines and BENAGOL
Inform 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, think you might be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
BENAGOL is not recommended during pregnancy or breastfeeding.
Driving and using machines
BENAGOL does not affect the ability to drive or operate machinery.
BENAGOL with Orange-flavoured Vitamin C 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 your doctor before taking/giving this medicine.
This medicine contains 0.97 g of glucose and 1.44 g of sucrose per tablet. This should be taken into consideration in patients with diabetes mellitus.
Sulphites: Rarely may 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 is very unlikely to cause problems if you have coeliac disease. One tablet contains no more than 19.38 micrograms of gluten. If you are allergic to wheat (a condition different from coeliac 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 BENAGOL to the child

Take/give this medicine to the child exactly as stated in this leaflet or according to the instructions provided by your doctor or pharmacist. If you have any doubts, consult your 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 your doctor.
You may take/give BENAGOL to the child at any time of the day, allowing each tablet to dissolve slowly in the mouth.
Caution: Use this medicine only for short-term treatment.
Consult your doctor if symptoms recur or if you notice any recent changes in their characteristics.
Children
Do not give BENAGOL to children under 6 years of age.
For children over 6 years of age, consult your doctor, who will determine the appropriate dose for the child.
If you take/give the child more BENAGOL than you should
In case of accidental ingestion/overdose of BENAGOL, contact your doctor immediately or go to the nearest hospital.
Accidental ingestion of an excessive dose of this medicine may cause stomach and intestinal disturbances.
If you forget to take/give the child BENAGOL
Do not take/give a double dose to make up for the missed tablet.
If you stop treatment with BENAGOL
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects may occur with the use of BENAGOL. If this happens, STOP taking 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 the available data)
Abdominal pain
Nausea
Gastrointestinal discomfort
Rash

Reporting of side effects
If you or the child experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist. You can also report side effects directly via the national reporting system at the website
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 stated on the packaging after "Exp." The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What BENAGOL contains

The active substances are: 2,4-dichlorobenzyl alcohol 1.2 mg; amylmetacresol 0.6 mg; sodium ascorbate 74.9 mg; ascorbic acid 33.5 mg.
The other components are: liquid sucrose, liquid glucose (containing sulphites and wheat starch), tartaric acid, orange flavour (containing citral, citronellol, d-limonene, geraniol and linalool), levomenthol, propylene glycol (see section “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 as tablets packed in blisters of 16, 24 or 36 tablets.
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 Milan, Italy

Manufacturer
Reckitt Benckiser Healthcare International Limited, Nottingham Site, Thane Road, Nottingham,
NG90 2DB (UK)
RB NL Brands B.V., Schiphol Boulevard 207, Schiphol 1118BH, The Netherlands

Patient Information Leaflet

BENAGOL 1.2 mg + 0.6 mg + 8 mg Tablets, Menthol-Eucalyptus Flavour

2,4-dichlorobenzyl alcohol + amylmetacresol + menthol
Please read this leaflet carefully before taking/giving this medicine to your 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 instructed.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If any adverse reaction occurs, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice any improvement or if symptoms worsen after 3 days of treatment.

Contents of this leaflet:

What BENAGOL is and what it is used for
What you need to know before taking/giving BENAGOL to your child
How to take/give BENAGOL to your child
Possible side effects
How to store BENAGOL
Contents of the pack and other information

1. What BENAGOL is and what it is used for

BENAGOL contains the active substances 2,4-dichlorobenzyl alcohol, amylmetacresol, and menthol, and is used
to disinfect the mouth and throat.
BENAGOL is used in adults and in children over 6 years of age.
Consult a doctor if you/your child do not feel better or feel worse after 3 days of treatment.

2. What you should know before taking/giving BENAGOL to a child

Do not take/do not give BENAGOL to the child if:

he/she is allergic to 2,4-dichlorobenzyl alcohol, amylocresol, and menthol, or to any of the other components of this medicine (listed in section 6);
the child is under 6 years of age;
the child suffers or has suffered from epilepsy (a disease characterized by recurrent and sudden episodes involving sudden loss of consciousness and violent muscle convulsions) or febrile convulsions (involuntary muscle contractions caused by high fever).

Warnings and precautions
Talk to 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 e.g. camphor, cineole, niaouli, wild thyme, terpineol, terpine, citral, menthol and essential oils of pine needles, eucalyptus and turpentine) which may cause neurological disturbances in adults, newborns and children (such as seizures).
BENAGOL Menthol-Eucalyptus flavour is flammable; do not bring it near flames.

Children and adolescents
Do not give BENAGOL to children under 6 years of age.
Exercise caution with preschool-aged children, as swallowing the tablets whole may cause choking.

Other medicines and BENAGOL
Inform 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 must not be taken simultaneously with other products (medicinal or cosmetic) containing terpene derivatives, regardless of the route of administration.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
BENAGOL Menthol-Eucalyptus flavour is not recommended during pregnancy, in women of childbearing age who do not use contraceptive measures, or during breastfeeding.

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

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

Liquid glucose and liquid sucrose: if your doctor has diagnosed you/the child with an intolerance to certain sugars, contact him/her before taking/giving this medicine.
This medicine contains 1.01 g of glucose and 1.50 g of sucrose per tablet. This should be taken into account in patients with diabetes mellitus.

Sulphites: rarely may 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 is very unlikely to cause problems if you have coeliac disease. One tablet 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: may 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 exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Adults and adolescents
The recommended dose is 1 tablet every 2–3 hours. Warning: do not exceed the recommended doses without consulting a doctor. Do not exceed the maximum daily dose of 12 tablets.
You may take/give BENAGOL to the child at any time of day, allowing each tablet to dissolve slowly in the mouth.
Warning: use this medicine only for short-term treatment.
The duration of treatment should not exceed 3 days due to the presence of terpene derivatives (menthol and eucalyptol) which may cause neuropsychological disturbances.
Consult your doctor if symptoms recur or if you notice any recent changes in their characteristics.
Children
Do not give BENAGOL to children under 6 years of age.
For children over 6 years of age, consult your doctor, who will determine the appropriate dose for the child.
If you take/give the child more BENAGOL than you should
In case of accidental ingestion/overdose of BENAGOL, contact your doctor immediately or go to the nearest hospital.
Accidental ingestion of an excessive dose of this medicine may cause gastrointestinal disturbances. In neonates and children, neurological disturbances such as convulsions may also occur.
If you forget to take/give the child BENAGOL
Do not take/give a double dose to make up for the forgotten tablet.
If you stop treatment with BENAGOL
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur with the use of BENAGOL. If this happens, 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 the available data)
Abdominal pain
Nausea
Gastrointestinal discomfort
Rash

Additional side effects in neonates and children

Seizures

Reporting of side effects
If you or the child experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website:
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 stated on the packaging after Exp. The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What BENAGOL contains

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

Description of the appearance of BENAGOL and contents of the pack
BENAGOL is available as tablets in blister packs containing 16 or 24 tablets.
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, The Netherlands