DEQUADIN

Package leaflet: Information for the user

Dequadin 0.25 mg tablets

Dequalinium chloride
Please 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, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement or if your symptoms worsen.

Contents of this leaflet:

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

1. What Dequadin is and what it is used for

Dequadin contains the active substance dequalinium chloride (also known as decamethylene bis aminoquinoline chloride), and is a broad-spectrum antibacterial and antifungal (antimycotic) medicinal product. It is active against Gram-positive and Gram-negative bacteria, Borrelia vincenti, Candida albicans, and some species of Tricophyton. Dequadin is used in topical (local) treatment of pharyngitis (inflammation of the pharynx and/or tonsils), stomatitis (inflammation of the mouth), pharyngitis (inflammation of the pharynx), and tonsillitis (inflammation of the tonsils).
After dental extractions, Dequadin is useful in the prevention of infections.

2. What you need to know before taking Dequadin

Do not take Dequadin

• if you are allergic to dequalinium chloride or to any of the other ingredients of this medicine (listed in section 6);
• if you are using other antiseptics or oral hygiene detergents;
• in children under three years of age, especially if prone to laryngospasm (spasmodic contraction of laryngeal muscles) or seizures (involuntary muscle contractions).

Warnings and precautions
Talk to your doctor or pharmacist before taking Dequadin.
The use of Dequadin, especially if prolonged, may lead to sensitization to the drug or to the development of resistance by microorganisms. If this occurs, stop treatment and consult your doctor. Contact your doctor if you do not notice improvement or if your symptoms worsen.
Children
Dequadin must not be used in children under 3 years of age, especially if prone to laryngospasm (spasmodic contraction of laryngeal muscles) or seizures (involuntary muscle contractions).
Other medicines and Dequadin
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor or pharmacist if you are using other antiseptics or oral hygiene detergents.
Dequadin with food and drink
Dequadin can be taken safely by people with celiac disease.
Pregnancy and breastfeeding
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.
Driving and using machines
No effects on the ability to drive or use machinery are known.
Dequadin contains sucrose and glucose. If your doctor has diagnosed you with an intolerance to certain sugars, please consult them before taking this medicine. Dequadin may be harmful to teeth.

3. How to take Dequadin

Take this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist.
Adults:
The recommended dose is 1 tablet to be dissolved slowly in the mouth every 2 or 3 hours during the initial phase of treatment. Afterwards, the interval between tablets may be increased.
Children over 3 years of age:
The recommended dose is 3 or 4 tablets per day.
Do not exceed the recommended doses without medical advice.
Use only for short treatment periods.
Method of administration:
Dissolve the tablet slowly in the mouth.
If you take more Dequadin than you should
If you accidentally ingest an excessive dose of Dequadin, inform your doctor.
If you forget to take Dequadin
Do not take a double dose to make up for the forgotten tablet.
If you stop taking Dequadin
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.
Local irritation may occur during treatment with Dequadin.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please consult your doctor or pharmacist. You may also report side effects directly through the national reporting system at the following address:
http://www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dequadin

Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
Do not store below 8°C.
Store in the original packaging to protect the medicine from moisture.
Do not use this medicine after the expiry date stated on the carton.
The expiry date refers to the last day of that month.
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.

6. Package contents and other information

What Dequadin contains

• The active substance is dequalinium chloride (also known as decamethylene bis-aminochinoline chloride);
• The other components are sucrose, citric acid monohydrate, gelatin, glucose, magnesium stearate, peppermint essence, and lime essence.

Description of the appearance of Dequadin and package contents
Dequadin is presented as oral tablets, contained in blisters of 10 tablets.
Pack size: 20 tablets.
Marketing Authorization Holder
Eurospital S.p.A.,
Via Flavia 122
34147 Trieste
Italy
Manufacturer
Doppel Farmaceutici S.r.l.
Via Volturno 48
Quinto De’ Stampi
20089 Rozzano (MI)
Italy

Package leaflet: information for the user

Dequadin 0.5% oral mucosa solution, 0.5% oral mucosa spray

Dequalinium chloride
Please read this entire 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 directed by your doctor or pharmacist.

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

Contents of this leaflet:

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

1. What Dequadin is and what it is used for

Dequadin contains the active substance dequalinium chloride (also known as decamethylene bis aminoquinoline chloride), and is a broad-spectrum antibacterial and antifungal (antimycotic) medicinal product. It is active against Gram-positive and Gram-negative bacteria, Borrelia vincenti, Candida albicans, and certain species of Tricophyton. Dequadin is used in topical (local) treatment of gingivitis (inflammation of the gums), stomatitis (inflammation of the mouth), tonsillitis (inflammation of the tonsils), and pharyngitis (inflammation of the pharynx).
After tooth extractions, Dequadin is useful in the prevention of infections.

2. What you need to know before using Dequadin

Do not use Dequadin

• if you are allergic to dequalinium chloride or to any of the other ingredients of this medicine (listed in section 6);
• if you are using other antiseptics or detergents for oral hygiene;
• in children under three years of age, especially if prone to laryngospasm (spasmodic contraction of laryngeal muscles) or seizures (involuntary muscle contractions).

Warnings and precautions
Talk to your doctor or pharmacist before using Dequadin.
Dequadin should only be used for mouth and throat lesions.
The use of Dequadin, especially if prolonged, may lead to drug sensitization or development of resistance by microorganisms. If this occurs, stop treatment and consult your doctor. Consult your doctor if you do not notice improvement or if symptoms worsen.
Dequadin can be taken safely by people with celiac disease.

Children
Dequadin must not be used in children under 3 years of age, especially if prone to laryngospasm (spasmodic contraction of laryngeal muscles) or seizures (involuntary muscle contractions).

Other medicines and Dequadin
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor or pharmacist if you are using other antiseptics or detergents for oral hygiene.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.

Driving and using machines
No effects on the ability to drive vehicles or operate machinery are known.

Dequadin contains propylene glycol, which may cause skin irritation.

3. How to use Dequadin

Use 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.

Adults:
The recommended dose is 1 local application every 2 or 3 hours.

Children over 3 years of age:
The recommended dose is 2 to 5 daily local applications.

For mild to moderate infections, Dequadin oral mucosa solution may be used as a mouthwash or for gargling: dilute 10–20 drops of solution in a glass of water and use 3 times a day.

After application, it is advisable to keep the mouth open and avoid swallowing saliva for a few minutes to achieve greater therapeutic effectiveness.

Do not exceed the recommended doses without medical advice.

Use only for short treatment periods.

Method of administration:

• Dequadin oral mucosa solution: Apply using a brush or a cotton swab wrapped around a stick.
• Dequadin oral mucosa spray: Use the dedicated spray dispenser. Press the pump several times until the spray is obtained. Then direct the diffuser tube and apply the product to the area to be treated.

If you use more Dequadin than you should
In case of accidental ingestion of an excessive dose of Dequadin, inform your doctor.

If you forget to use Dequadin
Do not use a double dose to make up for the missed dose.

If you stop using Dequadin
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.
Local irritation may occur during treatment with Dequadin.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist.
You can also report side effects directly via the national reporting system at the website
http://www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dequadin

Keep this medicine out of the sight and reach of children.
Do not store at temperatures above 30°C.
Do not store at temperatures below 8°C.
Store in the original packaging to protect the medicine from moisture.
Do not use this medicine after the expiry date stated on the carton.
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Dequadin contains

• The active substance is dequalinium chloride (also known as decamethylene bis-aminochinoline chloride);
• The other ingredients are propylene glycol, ethyl alcohol, saccharin, purified water, benzyl alcohol, rose flavour, geranium essential oil.

Description of the appearance of Dequadin and the contents of the pack
Dequadin oral mucosa solution is supplied as a 28 ml amber glass bottle.
Dequadin oral mucosa spray is supplied as a 10 ml amber glass bottle with a non-gas mechanical spray dispenser.

Marketing Authorization Holder
Eurospital S.p.A.,
Via Flavia 122
34147 Trieste
Italy

Manufacturer
Doppel Farmaceutici S.r.l.
Via Volturno 48
Quinto De’ Stampi
20089 Rozzano (MI)
Italy