GOLA 3 mg/1 mg Orally Disintegrating Tablet

Зміст інструкції

1. GOLA ACTION 3 MG + 1 MG
   1. What is GOLA ACTION and what is it for
   2. What you need to know before taking GOLA ACTION
   3. How to take GOLA ACTION
   4. Possible side effects
   5. How to store GOLA ACTION
   6. Contents of the pack and other information
2. GOLA ACTION
   1. What is GOLA ACTION and what is it for
   2. What you need to know before using GOLA ACTION
   3. How to use GOLA ACTION
   4. Possible side effects
   5. How to store GOLA ACTION
   6. Contents of the pack and other information
3. GOLA ACTION 1.5 mg/ml + 0.5 mg/ml mouthwash

GOLA ACTION 3 MG + 1 MG

SUCKABLE TABLETS WITHOUT SUGAR
benzydamine hydrochloride/cetylpyridinium chloride
Read this leaflet carefully before taking this medicine as it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your
doctor or pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after 10 days.

Contents of this leaflet

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

1. What is GOLA ACTION and what is it for

GOLA ACTION contains the active ingredients benzydamine hydrochloride and cetylpyridinium chloride, which
act locally on the mouth and throat, respectively as an anti-inflammatory (counteracts
inflammation) and analgesic (relieves pain), and as an antiseptic (fights infections).
GOLA ACTION is used in adults (including the elderly) and in children aged 12 years and over for
the anti-inflammatory, analgesic and antiseptic treatment of irritation of the throat, mouth and gums, in gingivitis, pharyngitis and laryngitis (sore throat).
GOLA ACTION is also indicated before and after tooth extractions.
See a doctor if you do not feel better or if you feel worse after 10 days.

2. What you need to know before taking GOLA ACTION

DO NOT take GOLA ACTION

• If you are allergic to benzydamine hydrochloride, cetylpyridinium chloride or any of the other ingredients of this medicine (listed in section 6).
• If you suffer from phenylketonuria (a hereditary disease diagnosed at birth, with accumulation in the blood of a substance called phenylalanine), as this medicine contains aspartame, which is a source of phenylalanine.
• In children under 6 years of age, as the pharmaceutical form (slowly dissolving tablet in the mouth) is not suitable for use in children of this age group.
• In children between 6 and 12 years of age, unless prescribed by your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking GOLA ACTION.

• Do not take this medicine for more than 10 days. If you do not notice appreciable results, consult your doctor.
• The use, especially if prolonged, of medicines for local use, such as GOLA ACTION, can cause sensitization phenomena (allergic reactions). In this case, stop the treatment and consult your doctor.
• GOLA ACTION should not be used together with detergents (anionic compounds) that may be present, for example, in toothpastes, therefore do not use the product immediately before or after brushing your teeth.

Other medicines and GOLA ACTION
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Avoid the simultaneous use of other antiseptics (products against infections).

Pregnancy, breastfeeding and fertility
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.

Driving and operating machinery
GOLA ACTION does not impair the ability to drive vehicles or operate machinery.

GOLA ACTION contains aspartame and sorbitol
This medicine contains 8 mg of aspartame per tablet. Aspartame is a source of
phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disease
that causes the accumulation of phenylalanine because the body cannot dispose of it correctly
(see section “Do not take GOLA ACTION”).
This medicine contains 1138 mg of sorbitol per tablet.
Sorbitol is a source of fructose. If your doctor has told you that you (or your child) are intolerant
to some sugars, or if you have a diagnosis of hereditary fructose intolerance, a rare genetic
disease in which patients cannot transform fructose, talk to your doctor before
you (or your child) take this medicine.
It may cause gastrointestinal problems and have a mild laxative effect.
GOLA ACTION tablets can be taken by people who suffer from diabetes or
who need to follow a low-calorie diet.

3. How to take GOLA ACTION

Take this medicine following exactly as indicated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

How much
Caution: do not exceed the recommended dose.

Use in adults (including the elderly) and children 12 years and over
The recommended dose is 1 tablet 3-4 times a day.

Use in children under 12 years
Do not use GOLA ACTION in children under 6 years of age.
In children aged 6 to 12 years, use GOLA ACTION only if it has been prescribed
by your doctor (read the paragraph “Do not use GOLA ACTION”).

How
Dissolve the tablets slowly in your mouth.

When and for how longFor optimal effect, do not take GOLA ACTION
immediately before or after brushing your teeth (read the paragraph “Warnings and
precautions”).
After taking a tablet, wait at least 2 hours before taking another.
Do not use this medicine for more than 10 days. If you do not notice any appreciable results, consult your
doctor.
Consult your doctor if the disorder recurs or if you notice any recent change
in its characteristics.

If you take more GOLA ACTION than you should
The toxic manifestations of benzydamine overdose consist of excitation,
convulsions, sweating, incoordination of movements (ataxia), tremors and vomiting;
hallucinations and psychosis may also occur.
Signs and symptoms of intoxication resulting from the ingestion of significant amounts of
cetylpyridinium chloride include nausea, vomiting, difficulty breathing (dyspnea) which
can also become extreme (asphyxia), bluish discoloration of the skin (cyanosis), a feeling
of sedation and drowsiness, low blood pressure (hypotension) and coma.
If you take more GOLA ACTION than you should, immediately inform your doctor or
go to the nearest hospital.

If you forget to take GOLA ACTION
Do not take a double dose to make up for a missed dose.

If you stop taking GOLA ACTION
If you have any doubts 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.
Side effects of benzydamine.
Burning and a sensation of oral mucosa anesthesia (sensation of reduced
sensitivity inside the mouth); rarely, hypersensitivity reactions
(allergic reactions) may occur, including urticaria, photosensitivity (sensitivity to light) and bronchospasm
(narrowing of the bronchi causing severe breathing difficulty).
Side effects of cetylpyridinium.
Very rarely, local irritation or a slight burning sensation may be observed
at the level of the mouth or throat, which can be prevented by avoiding leaving the tablet in contact with the same area of oral mucosa for a long time.
These side effects are generally transient. Following the instructions contained

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please
tell your doctor or pharmacist. You can also report side effects directly
through the national reporting system at the web address
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 GOLA ACTION

Keep this medicine out of the sight and reach of children.
Do not store at a temperature above 25°C.
Do not use this medicine after the expiry date which is reported on the blister and on the package
after EXP.
The expiry date refers to the last day of that month.
The expiry date refers to the product in intact packaging, correctly
stored.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to eliminate medicines that you no longer use. This will help protect the environment.
It is important to always have the information about the medicine available, therefore keep

6. Contents of the pack and other information

What GOLA ACTION contains

• The active ingredients are benzydamine hydrochloride and cetylpyridinium chloride. One sugar-free orodispersible tablet contains 3.0 mg of benzydamine hydrochloride and 1.0 mg of cetylpyridinium chloride.
• The other ingredients are sorbitol, mannitol, magnesium stearate, mint flavour, aspartame.

Description of the appearance of GOLA ACTION and contents of the pack
GOLA ACTION is available in the form of round, white tablets.
Each pack contains 20 tablets, divided into five opaque blisters.

Marketing Authorisation Holder
IODOSAN S.p.A. – Via Zambeletti – Baranzate (MI).

Manufacturer
Famar Italia S.p.A. - Via Zambeletti 25 - Baranzate (MI).

GOLA ACTION

1.5 mg/ml + 5 mg/ml
Oral mucosal spray, solution
benzydamine hydrochloride/cetylpyridinium chloride
Read this leaflet carefully before using this medicine as it contains
important information for you
Always use this medicine exactly as described in this leaflet or as your doctor
or pharmacist has told you.

• 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 10 days.

Contents of this leaflet

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

1. What is GOLA ACTION and what is it for

GOLA ACTION contains the active ingredients benzydamine hydrochloride and cetylpyridinium chloride, which
act locally on the mouth and throat, respectively as an anti-inflammatory (counteracts
inflammation) and analgesic (relieves pain), and as an antiseptic (fights infections).
GOLA ACTION is used in adults (including the elderly) and in children aged 12 years and over for
the anti-inflammatory, analgesic and antiseptic treatment of irritation of the throat, mouth and gums, in gingivitis, pharyngitis and laryngitis (sore throat).
GOLA ACTION is also indicated before and after tooth extractions.
See a doctor if you do not feel better or if you feel worse after 10 days.

2. What you need to know before using GOLA ACTION

DO NOT use GOLA ACTION

• If you are allergic to benzydamine hydrochloride, cetylpyridinium chloride or any of the other ingredients of this medicine (listed in section 6). In children under 6 years of age, as the pharmaceutical form (spray to be nebulized in the mouth and throat) is not suitable for use in children of this age group.
• In children between 6 and 12 years of age, unless it has been prescribed by your doctor.

Warnings and precautions
Consult your doctor or pharmacist before using GOLA ACTION.

• Do not use this medicine for more than 10 days. If you do not notice appreciable results, consult your doctor.
• The use, especially if prolonged, of medicines for local use, such as GOLA ACTION, can cause sensitization phenomena (allergic reactions). In this case, discontinue treatment and consult your doctor.
• Avoid contact with eyes.
• GOLA ACTION should not be used together with detergents (anionic compounds) which may be present for example in toothpastes, therefore do not use the product immediately before or after brushing your teeth.

Other medicines and GOLA ACTION
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Avoid the simultaneous use of other antiseptics (products against infections).

Pregnancy, breastfeeding and fertility
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.

Driving and operating machinery
GOLA ACTION does not impair the ability to drive vehicles or operate machinery.

GOLAACTIONspraycontainsmintaromaandhydrogenatedcastoroil
polyoxyethylene
GOLA ACTION spray contains hydrogenated castor oil polyoxyethylene which may cause
localized skin reactions.
GOLA ACTION spray contains a flavor in turn containing citral, citronellol,
eugenol, D-limonene, linalool. These allergens may cause allergic reactions.
GOLA ACTION spray contains less than 1 mmol (23 mg) of sodium per dose, i.e.
essentially ‘sodium-free’.

3. How to use GOLA ACTION

Use this medicine following exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have doubts, consult your doctor or pharmacist.

How much
Caution: do not exceed the recommended dose.

Use in adults (including the elderly) and children 12 years and over
The recommended dose is 1-2 sprays, to be repeated 3-5 times a day.

Use in children under 12 years
Do not use GOLA ACTION in children under 6 years of age.
In children between 6 and 12 years of age, use GOLA ACTION only if it has been prescribed
by your doctor (see paragraph “Do not use GOLA ACTION”).

How
Turn the applicator and press the dosing button 1-2 times as shown in the illustration:

For the first use of the product, to obtain a regular spray, press the dispenser button several times
into the air.

When and for how long
For optimal effect, do not use GOLA ACTION immediately before or after brushing your
teeth (see paragraph “Warnings and precautions”).
After using GOLA ACTION, wait at least 2 hours before using it again.
Do not use this medicine for more than 10 days. If you do not notice appreciable results, consult your
doctor.
Consult your doctor if the disorder recurs or if you notice any recent change
in its characteristics.

If you use more GOLA ACTION than you should
The toxic manifestations of benzydamine overdose consist of excitation,
convulsions, sweating, incoordination of movements (ataxia), tremors and vomiting;
hallucinations and psychosis may also occur.
Signs and symptoms of poisoning resulting from the ingestion of significant amounts of
cetylpyridinium chloride include nausea, vomiting, difficulty breathing (dyspnea) which
may also become extreme (asphyxia), bluish discoloration of the skin (cyanosis), a feeling
of sedation and drowsiness, low blood pressure (hypotension) and coma.
If you use more GOLA ACTION than you should, immediately inform your doctor or go to the
nearest hospital.

If you forget to use GOLA ACTION
Do not use a double dose to make up for a missed dose.

If you stop treatment with GOLA ACTION
If you have any doubts 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.
Side effects of benzydamine.
Burning and a sensation of anaesthesia of the oral mucosa (sensation of reduced
sensitivity inside the mouth); rarely, hypersensitivity reactions (allergic reactions) may occur,
including urticaria, photosensitivity (sensitivity to light) and bronchospasm (narrowing of the
bronchi causing severe breathing difficulty).
Side effects of cetylpyridinium.
Very rarely, local irritation or a slight burning sensation at the level of the mouth or throat
may be observed.
These side effects are generally transient. Following the instructions contained

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please
tell your doctor or pharmacist. You can also report side effects directly through the national
reporting system at the web address
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 GOLA ACTION

Keep this medicine out of the sight and reach of children.
Do not store at a temperature above 25°C.
Do not use this medicine after the expiry date which is stated on the bottle and on the packaging
after EXP. The expiry date refers to the last day of that month.
The expiry date refers to the product in intact packaging, correctly
stored.
Do not use this medicine after 6 months from the first opening of the bottle.
Do not use this medicine if you notice that the bottle seal is not intact.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.
It is important to always have the information about the medicine available, therefore keep

6. Contents of the pack and other information

What GOLA ACTION contains

• The active ingredients are benzydamine hydrochloride and cetylpyridinium chloride. 1 ml of oral spray solution contains 1.5 mg of benzydamine hydrochloride and 5 mg of cetylpyridinium chloride.
• The other ingredients are glycerol, mint flavour(containing citral, citronellol, eugenol, D-limonene, linalool), hydrogenated castor oil polyoxyethylenated, sodium saccharin, purified water.

Description of the appearance of GOLA ACTION and contents of the pack
GOLA ACTION is a clear and colourless solution.
Each pack contains a 10 ml glass bottle coated in plastic, closed with a
cap fitted with a dispenser.

Marketing Authorisation Holder
IODOSAN S.p.A. – Via Zambeletti – Baranzate (MI).

Manufacturer
Farmaclair - 440, Avenue du Général de Gaulle – Hérouville Saint-Clair – France.

or:
Famar Italia S.p.A . -Via Zambeletti 25 - Baranzate (MI).

GOLA ACTION 1.5 mg/ml + 0.5 mg/ml mouthwash

Benzydamine hydrochloride + cetylpyridinium chloride
BEFORE USE
READ CAREFULLY ALL THE INFORMATION CONTAINED IN
This is a self-medication medicine that can be used to treat mild and transient disorders
easily recognizable and resolvable without resorting to the help of a doctor.

It can therefore be purchased without a prescription but must be used correctly to ensure its
effectiveness and reduce unwanted effects.

• For more information and advice, consult your pharmacist.
• Consult your doctor if the disorder does not resolve after a short period oftreatment.

MEDICINE NAME
GOLA ACTION 1.5 mg/ml + 0.5 mg/ml mouthwash
WHAT IT IS
Anti-inflammatory, analgesic and antiseptic for local oral use.

WHY IT IS USED
GOLA ACTION mouthwash is used for the anti-inflammatory, analgesic and
antiseptic treatment of irritation of the throat, mouth and gums, in gingivitis, pharyngitis
and laryngitis. Also indicated before and after dental extractions.

WHEN IT SHOULD NOT BE USED
Hypersensitivity to the active ingredients or to any of the excipients.
Due to the type of pharmaceutical form, GOLA ACTION mouthwash is contraindicated in children
under 6 years of age.
Do not use in children aged between 6 and 12 years, unless otherwise prescribed
by a doctor.

PRECAUTIONS FOR USE
Do not use for more than 10 days. If no appreciable results are noticed, consult your doctor.
Use, especially if prolonged, of topical preparations may lead to sensitization phenomena, in which case it is necessary to stop the treatment and institute appropriate therapy.
The product should not be used together with anionic compounds, such as those present for
example in toothpastes, therefore it is recommended not to use the product immediately
before or after brushing your teeth.

WHICH MEDICINES OR FOODS CAN MODIFY THE EFFECT OF THE
MEDICINE
Inform your doctor or pharmacist if you have recently taken any other medicine
even those without a prescription.
Avoid the simultaneous use of other antiseptics.

IT IS IMPORTANT TO KNOW THAT
What to do during pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.

Effects on the ability to drive and operate machinery
GOLA ACTION does not impair the ability to drive vehicles or operate machinery.

GOLA ACTION mouthwashcontains hydrogenated polyoxyethylene castor oil which may
cause localized skin reactions.

HOW TO USE THIS MEDICINE
How much
Caution: do not exceed the indicated doses.
Adults (including the elderly) and children over 12 years of age:
Rinses of 15 ml, 2-3 times a day, using the appropriate measuring cup.
Contraindicated in children under 6 years of age.
Do not use in children aged between 6 and 12 years, unless otherwise prescribed
by a doctor.

When and for how long
Minimum interval between two administrations: 2 hours.
For optimal effect, it is recommended not to use the product immediately before or
after brushing your teeth.
Do not use for more than 10 days. If no appreciable results are noticed, consult your doctor.
Consult your doctor if the disorder recurs or if you notice any
recent change in its characteristics.

How
Mouthwash.
The bottle is equipped with a child-resistant closure cap.

WHAT TO DO IF YOU HAVE TAKEN TOO MUCH MEDICINE
The toxic manifestations of an overdose of benzydamine consist of excitation,
convulsions, sweating, lack of coordination of movements (ataxia), tremors and vomiting;
hallucinations and psychosis may also occur.

Signs and symptoms of intoxication resulting from the ingestion of significant amounts of
cetylpyridinium chloride include nausea, vomiting, difficulty breathing (dyspnea) which
can also become extreme (asphyxia), bluish discoloration of the skin (cyanosis), a feeling
of sedation and drowsiness, lowering of blood pressure (hypotension) and coma.
In case of accidental ingestion of an excessive dose of GOLA ACTION, immediately notify
your doctor or go to the nearest hospital.

If you have any doubts about the use of GOLA ACTION, ask your doctor or
pharmacist.
UNDESIRABLE EFFECTS
Like all medicines, GOLA ACTION can cause side effects, although not everyone
will experience them.
Following topical application of benzydamine to the oral cavity and throat, burning and a feeling of anesthesia of the oral mucosa have been
reported; rarely, hypersensitivity reactions may occur, including urticaria, photosensitivity and bronchospasm.
With cetylpyridinium, local irritation or a slight
burning sensation at the level of the oral cavity can be observed, very rarely.
These side effects are generally transient. However, it is advisable to consult your doctor or pharmacist when they occur.
undesirable.
If any of the side effects worsen, or if you notice any
pharmacist.
Request and complete the side effects reporting form available in
pharmacy.

EXPIRY DATE AND STORAGE
Expiry date: see the expiry date indicated on the packaging.
The expiry date refers to the product in intact packaging, stored correctly.
Caution: do not use the medicine after the expiry date indicated on the
packaging.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines you no longer use. This will help to
protect the environment.
Keep the medicine out of the reach and sight of children.

It is important to always have the information about the medicine available, therefore
COMPOSITION
1 ml of mouthwash contains: Active ingredients:benzydamine hydrochloride 1.5 mg; cetylpyridinium
chloride 0.5 mg. Excipients:sodium saccharin, mint aroma, hydrogenated castor oil
polyoxyethylene, glycerol, alcohol, quinoline yellow (E104), patent blue V (E131), purified water
.

HOW IT IS PRESENTED
Mouthwash
Bottle of 150 ml.

MARKETING AUTHORISATION HOLDER
IODOSAN S.p.A. - Via Zambeletti s.n.c. - Baranzate (MI)

MANUFACTURER
Farmaclair - 440, Avenue du Général de Gaulle – Hérouville Saint-Clair – France.

or:
Alfa Wassermann S.p.A. – Via Enrico Fermi, 1 – Alanno (PE).

ITALIAN DRUG AGENCY: