Gola Action

Package leaflet: information for the patient

GOLA ACTION 3 MG + 1 MG

SUGAR-FREE ORAL DISSOLVING TABLETS
benzidamine hydrochloride/cetylpyridinium chloride
Read this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to do.

• 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, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement 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 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

1. What GOLA ACTION is and what it is used for

GOLA ACTION contains the active substances benzidamine hydrochloride and cetylpyridinium chloride, which act locally on the mouth and throat as anti-inflammatory (counteracts inflammation) and analgesic (relieves pain), and as antiseptic (fights infections), respectively.
GOLA ACTION is used in adults (including elderly people) and in children from 12 years of age onwards for the anti-inflammatory, analgesic and antiseptic treatment of throat, mouth and gum irritations, in gingivitis, pharyngitis and laryngitis (sore throat).
GOLA ACTION is also indicated before and after dental extractions.
Consult 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 benzidamine hydrochloride, cetylpyridinium chloride, or any of the other ingredients of this medicine (listed in section 6).
• If you have phenylketonuria (an inherited disease diagnosed at birth, characterized by accumulation in the blood of a substance called phenylalanina), because this medicine contains aspartame, which is a source of phenylalanine.
• In children under 6 years of age, because the pharmaceutical form (slowly dissolving tablet in the mouth) is not suitable for use in children of this age group.
• In children aged between 6 and 12 years, unless prescribed by a 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 any significant improvement, consult your doctor.
• The use, especially if prolonged, of topical medicines such as GOLA ACTION may cause sensitization phenomena (allergic reactions). In such case, discontinue treatment and consult your doctor.
• GOLA ACTION must not be used together with detergent substances (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 using, have recently used, or might use any other
medicines.
Avoid simultaneous use of other antiseptics (products against infections).
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not use GOLA ACTION tablets during pregnancy unless clearly necessary and under medical advice. If treatment is required, the lowest possible dose for the shortest possible time should be used.
Breastfeeding
Use GOLA ACTION during breastfeeding only under medical supervision.
Driving and using machines
GOLA ACTION does not affect the ability to drive 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 disorder causing accumulation of
phenylalanine due to the body's inability to properly metabolize it (see the section “Do not use 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 the child) are intolerant to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients cannot metabolize fructose, speak with your doctor before you (or the child) take this medicine.
It may cause gastrointestinal problems and has a mild laxative effect.
GOLA ACTION tablets can be taken by people with diabetes or those on a low-calorie diet.

3. How to take GOLA ACTION

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.
Dosage
Caution: Do not exceed the recommended dose.
Use in adults (including elderly) and children aged 12 years and above
The recommended dose is 1 tablet 3–4 times a day.
Use in children under 12 years of age
Do not use GOLA ACTION in children under 6 years of age.
In children aged between 6 and 12 years, use GOLA ACTION only if prescribed by a doctor
(see section “Do not use GOLA ACTION”).
How to take
Allow the tablets to dissolve slowly in the mouth.
When and for how long
For optimal effect, do not take GOLA ACTION immediately before or after brushing your teeth
(see section “Warnings and precautions”).
After taking a tablet, wait at least 2 hours before taking another one.
Do not use this medicine for more than 10 days. If you do not notice any significant improvement, consult your doctor.
Consult your doctor if symptoms recur repeatedly or if you notice any recent changes in their characteristics.
If you take more GOLA ACTION than you should
Toxic manifestations from benzidamine overdose include excitement, seizures, sweating, lack of motor coordination (ataxia), tremors, and vomiting; hallucinations and psychosis may also occur.
Signs and symptoms of poisoning following ingestion of significant amounts of cetylpyridinium chloride include nausea, vomiting, difficulty in breathing (dyspnoea), which may become severe (asphyxia), bluish discoloration of the skin (cyanosis), sedation and drowsiness, lowering of blood pressure (hypotension), and coma.
If you take more GOLA ACTION than you should, contact your doctor immediately or go to the nearest hospital.
If you forget to take GOLA ACTION
Do not take a double dose to make up for the forgotten dose.
If you stop using GOLA ACTION
If you have any questions 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.
Side effects of benzidamine.
Burning sensation and anaesthesia of the oral mucosa (reduced sensitivity inside the mouth); rarely, hypersensitivity reactions (allergic reactions) may occur, including urticaria, photosensitivity (sensitivity to light), and bronchospasm (narrowing of the airways causing severe breathing difficulties).
Side effects of cetylpyridinium.
Very rarely, local irritation or a mild burning sensation in the mouth or throat may occur. These can be prevented by avoiding leaving the tablet in contact with the same area of oral mucosa for prolonged periods.
These side effects are generally temporary. Following the instructions in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You may 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 GOLA ACTION

Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the blister and the carton after EXP.
The expiry date refers to the last day of that month.
The expiry date applies to the product in its original, undamaged packaging, when correctly stored.
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.
It is important to always keep the medicine information available; therefore, retain both the carton
and the package leaflet.

6. Package contents and other information

What GOLA ACTION contains

• The active substances are benzidamine hydrochloride and cetylpyridinium chloride. Each sugar-free orosoluble tablet contains 3.0 mg of benzidamine hydrochloride and 1.0 mg of cetylpyridinium chloride.
• The other components are sorbitol, mannitol, magnesium stearate, mint flavouring, aspartame.

Description of the appearance of GOLA ACTION and contents of the pack
GOLA ACTION is presented as white, round tablets.
Each pack contains 20 tablets, divided into five opaque blisters.
Marketing Authorization Holder
IODOSAN S.p.A. - Via Monte Rosa 91 - 20149 Milan, Italy.
Manufacturer
Famar Italia S.p.A. - Via Zambeletti 25 - Baranzate (MI), Italy.

Package leaflet: information for the patient

GOLA ACTION

1.5 mg/ml + 5 mg/ml
Oromucosal spray, solution
hydrochloride benzidamine/cetylpyridinium chloride
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Use 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 adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement 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. Package contents and other information

1. What GOLA ACTION is and what it is used for

GOLA ACTION contains the active substances benzalkonium chloride and cetilpiridinium chloride, which act locally in the mouth and throat as an anti-inflammatory (reducing inflammation) and analgesic (relieving pain), and as an antiseptic (fighting infections), respectively.
GOLA ACTION is used in adults (including the elderly) and children from 12 years of age onwards, for the anti-inflammatory, analgesic and antiseptic treatment of throat, mouth and gum irritations, gingivitis, pharyngitis and laryngitis (sore throat).
GOLA ACTION is also indicated before and after tooth extractions.
Consult your 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 benzidamine hydrochloride, cetylpyridinium chloride, or to any of the other ingredients of this medicine (listed in section 6).
• In children under 6 years of age, as the pharmaceutical form (oral and throat spray) is not suitable for use in children of this age group.
• In children aged between 6 and 12 years, unless prescribed by a doctor.

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

• Do not use this medicine for more than 10 days. If you do not notice any significant improvement, consult your doctor.
• The use, especially if prolonged, of locally acting medicines such as GOLA ACTION may cause sensitization (allergic reactions). If this occurs, discontinue treatment and consult your doctor.
• Avoid contact with the eyes.
• GOLA ACTION must 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
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines.
Avoid simultaneous use of other antiseptics (products against infections).

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Do not use GOLA ACTION during pregnancy unless clearly necessary and under medical advice. If treatment is required, the lowest effective dose for the shortest possible duration should be used.

Breastfeeding
Use GOLA ACTION during breastfeeding only under medical supervision.

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

GOLA ACTION spray contains peppermint flavour and polyoxyl 40 hydrogenated castor oil
GOLA ACTION spray contains polyoxyl 40 hydrogenated castor oil, which may cause localized skin reactions.
GOLA ACTION spray contains a flavour which in turn contains 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 exactly as described in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Dosage
Warning: Do not exceed the recommended dose.
Use in adults (including elderly) and children from 12 years of age
The recommended dose is 1-2 sprays, repeated 3-5 times a day.
Use in children under 12 years of age
Do not use GOLA ACTION in children under 6 years of age.
In children aged between 6 and 12 years, use GOLA ACTION only if prescribed by a doctor (see section "Do not use GOLA ACTION").
How to use
Turn the nozzle and press the dosing button 1-2 times as shown in the illustration:

At first use, press the spray pump several times without dispensing (into the air) to ensure regular delivery.
When and for how long
For optimal effect, do not use GOLA ACTION immediately before or after brushing your teeth (see section "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 any significant improvement, consult your doctor.
Consult your doctor if symptoms recur frequently or if you notice any recent changes in their characteristics.
If you use more GOLA ACTION than you should
Toxic manifestations due to benzidamine overdose include excitement, convulsions, sweating, lack of motor coordination (ataxia), tremors, and vomiting; hallucinations and psychosis may also occur.
Signs and symptoms of intoxication following ingestion of significant amounts of cetylpyridinium chloride include nausea, vomiting, difficulty in breathing (dyspnea), which may become severe (asphyxia), bluish discoloration of the skin (cyanosis), sedation and drowsiness, low blood pressure (hypotension), and coma.
If you use more GOLA ACTION than recommended, contact your doctor immediately or go to the nearest hospital.
If you forget to use GOLA ACTION
Do not use a double dose to make up for a forgotten dose.
If you stop using GOLA ACTION
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 experiences them.
Side effects of benzocaine.
Burning and anaesthetic sensation of the oral mucosa (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 in the mouth or throat may occur.
These side effects are generally temporary. Following the instructions provided in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report side effects directly via the national reporting system at the following 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 above 25°C.
Do not use this medicine after the expiry date stated on the bottle and the carton after
EXP. The expiry date refers to the last day of that month.
The expiry date applies to the product in its original, unopened packaging and properly stored.
Do not use this medicine more than 6 months after first opening the bottle.
Do not use this medicine if you notice that the bottle seal is broken or not intact.
Do not dispose of medicines via 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 keep the information available; therefore, retain both the carton and the
package leaflet.

6. Package contents and other information

What GOLA ACTION contains

• The active substances are benzidamine hydrochloride and cetylpyridinium chloride. 1 ml of oral spray solution contains 1.5 mg of benzidamine hydrochloride and 5 mg of cetylpyridinium chloride.
• The other components are glycerol, peppermint flavour (containing citral, citronellol, eugenol, D-limonene, linalool), polyoxyl 40 hydrogenated castor oil, sodium saccharin, purified water.

Description of the appearance of GOLA ACTION and contents of the pack
GOLA ACTION is a clear, colourless solution.
Each pack contains a 10 ml plastic-coated glass bottle closed with a cap equipped with a spray dispenser.
Marketing Authorization Holder
IODOSAN S.p.A. - Via Monte Rosa 91 - 20149 Milan, Italy.
Manufacturer
Farmaclair - 440, Avenue du Général de Gaulle – Hérouville Saint-Clair – France.
or:
Famar Italia S.p.A. – Via Zambeletti 25 - Baranzate (MI), Italy.
GOLA ACTION 1.5 mg/ml + 0.5 mg/ml oral rinse
benzidamine hydrochloride + cetylpyridinium chloride
BEFORE USE
READ CAREFULLY ALL INFORMATION CONTAINED IN THE

PACKAGE LEAFLET

This is a self-medication medicine that can be used to treat mild and
transient disorders which are easily recognizable and resolvable without the need for medical advice.
It can therefore be purchased without a prescription, but must be used correctly to ensure its effectiveness
and reduce the risk of adverse effects.

• For further information and advice, consult your pharmacist.
• Consult a doctor if the condition does not resolve after a short period of treatment.

NAME OF THE MEDICINAL PRODUCT
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 anti-inflammatory, analgesic and antiseptic treatment of
irritations of the throat, mouth and gums, in gingivitis, pharyngitis and laryngitis. Also indicated before and after
dental extractions.
WHEN IT MUST NOT BE USED
Hypersensitivity to the active substances or to any of the excipients.
Due to its 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 improvement is observed, consult a doctor.
Prolonged topical use, particularly, may lead to sensitization reactions; in such cases treatment must be discontinued and appropriate therapy initiated.
The product must 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
toothbrushing.
WHICH MEDICINES OR FOODS CAN MODIFY THE EFFECT OF THE
MEDICINE
Inform your doctor or pharmacist if you have recently taken any other medicines, including those obtained without a prescription.
Avoid concomitant use of other antiseptics.
IMPORTANT INFORMATION
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not use Gola Action mouthwash during pregnancy unless clearly necessary and under medical advice. If treatment is necessary, the lowest effective dose for the shortest possible duration should be used.
Breastfeeding
Use GOLA ACTION during breastfeeding only under medical supervision.
Effects on ability to drive and use machines
GOLA ACTION does not impair the ability to drive vehicles or operate machinery.
GOLA ACTION mouthwash contains polyoxyl 40 hydrogenated castor oil, which may cause localized skin reactions.
HOW TO USE THIS MEDICINE
Dosage
Caution: do not exceed the recommended doses.
Adults (including elderly) and children from 12 years of age:
Rinse with 15 ml, 2–3 times daily, using the provided dosing 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 administrations: 2 hours.
For optimal effect, do not use the product immediately before or after toothbrushing.
Do not use for more than 10 days. If no appreciable improvement is observed, consult a doctor.
Consult a doctor if the condition recurs repeatedly or if you notice any recent changes in its characteristics.
How to use
Mouthwash.
The bottle is equipped with a child-resistant closure cap.

WHAT TO DO IF YOU HAVE TAKEN TOO MUCH MEDICINE
Toxic manifestations from benzidamine overdose include agitation, convulsions, sweating, lack of motor coordination (ataxia), tremors and vomiting; hallucinations and psychosis may also occur.
Signs and symptoms of poisoning following ingestion of significant amounts of cetylpyridinium chloride
include nausea, vomiting, breathing difficulties (dyspnea) which may become severe (asphyxia), bluish discoloration of the skin (cyanosis), sedation and drowsiness, drop in blood pressure (hypotension) and coma.
In case of accidental ingestion of an excessive dose of GOLA ACTION, contact a doctor immediately or go to the nearest hospital.
If you have any doubts about the use of GOLA ACTION, consult your doctor or pharmacist.
ADVERSE REACTIONS
Like all medicines, GOLA ACTION can cause adverse reactions, although not everyone experiences them.
Following topical application of benzidamine to the oral cavity and throat, burning sensation and anaesthesia of the oral mucosa have been reported; hypersensitivity reactions, including urticaria, photosensitivity and bronchospasm, may rarely occur.
With cetylpyridinium chloride, very rare cases of local irritation or mild burning sensation in the oral cavity may occur.
These adverse effects are generally transient. However, if they occur, it is advisable to consult a doctor or pharmacist.
Following the instructions in this leaflet reduces the risk of adverse reactions.
If any of the adverse effects worsens, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.
Request and complete the adverse reaction reporting form available from your pharmacist.
EXPIRY DATE AND STORAGE
Expiry date: see the date on the packaging.
The expiry date refers to the product stored in its original, unopened packaging under recommended conditions.
Caution: do not use the medicine after the expiry date stated on the packaging.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
Keep the medicine out of the reach and sight of children.
It is important to always have medicine information available; therefore, keep both the carton and the package leaflet.
COMPOSITION
Each 1 ml of mouthwash contains: Active substances: benzidamine hydrochloride 1.5 mg; cetylpyridinium chloride 0.5 mg. Excipients: sodium saccharin, mint flavour, polyoxyl 40 hydrogenated castor oil, glycerol, alcohol, quinoline yellow (E104), patent blue V (E131), purified water.
PRESENTATION
Mouthwash
150 ml bottle.
MARKETING AUTHORISATION HOLDER
IODOSAN S.p.A. - Via Monte Rosa 91 - 20149 Milan, Italy
MANUFACTURER
Farmaclair - 440, Avenue du Général de Gaulle – Hérouville Saint-Clair – France.
or:
Alfa Wassermann S.p.A. – Via Enrico Fermi, 1 – Alanno (PE), Italy.
REVISION OF THE PACKAGE LEAFLET BY THE ITALIAN MEDICINES AGENCY: