DEQUADIN 0.5% Roztwór doustny

Treść ulotki

1. Dequadin 0.25 mg tablets
   1. What is Dequadin and what is it 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
2. Dequadin 0.5% solution for oral mucosa, 0.5% spray for oral mucosa
   1. What is Dequadin and what is it 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

Dequadin 0.25 mg tablets

Dequalinium 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.

Contents of this leaflet:

• 1. What Dequadin is and what it is used for
• 2. What you need to know before you take 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 is Dequadin and what is it used for

Dequadin contains the active ingredient dequalinium chloride (also known as decamethylene bis
aminochinaldina chloride), and is a broad-spectrum antibacterial and antifungal
(antimycotic) drug. It is active against Gram-positive and Gram-negative bacteria, on Borrelia vincenti,
Candida albicans and some species of Tricophyton. Dequadin is used in the topical (local) treatment of
sore throats (inflammation of the pharynx and/or tonsils), stomatitis (inflammation of the mouth),
pharyngitis (inflammation of the pharynx) and tonsillitis (inflammation of the tonsils).
After tooth 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 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 predisposed to laryngospasm (spasmodic contraction of the laryngeal muscles) or convulsions (involuntary muscle contractions).

Warnings and precautions
Talk to your doctor or pharmacist before taking Dequadin.
The use of Dequadin, especially if prolonged, may give rise to sensitization
to the drug or resistance by microorganisms. If this occurs, stop treatment and consult
your doctor. See your doctor if you do not notice any improvement or if your
symptoms worsen.

Children
Dequadin should not be used in children under 3 years of age, especially if predisposed
to laryngospasm (spasmodic contraction of the laryngeal muscles) or convulsions (involuntary
muscle contraction).

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

Dequadin with food and drink
Dequadin can be taken without risk by people with celiac disease.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.

Driving and operating machinery
No effects on the ability to drive and operate machinery have been reported.

Dequadin contains sucrose and glucose.If your doctor has diagnosed you with an intolerance to
certain sugars, contact him/her before taking this medicine. Dequadin may be harmful to your
teeth .

3. How to take Dequadin

Take this medicine following exactly the instructions in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, ask 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. Subsequently, the interval between one tablet and the next 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 the advice of your doctor.
Use only for short periods of treatment.
Method of administration:
Dissolve the tablet slowly in your mouth.

If you take more Dequadin than you should
In case of accidental ingestion of 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 missed tablet.

If you stop taking Dequadin
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
During treatment with Dequadin, local irritation may occur.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please
inform your doctor or pharmacist. You can also report side effects directly
through the national reporting system at
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 a temperature above 30°C.
Do not store at a temperature below 8°C.
Store in the original package to protect the medicine from moisture.
Do not use this medicine after the expiry date which is stated on the pack.
The expiry date refers to the last day of that month.
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.

6. Contents of the pack and other information

What Dequadin contains

• The active ingredient is dequalinium chloride (also known as decamethylene bis aminochinaldina chloride);
• The other ingredients are sucrose, citric acid monohydrate, gelatin, glucose, magnesium stearate, peppermint essence and lime flavour.

Description of the appearance of Dequadin and contents of the pack
Dequadin is available in the form of oral tablets, contained in blisters of 10 tablets.
Pack of 20 tablets.

Marketing Authorisation 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

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

Dequalinium 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 want more information or advice, ask your pharmacist.
• If any side effects occur, including effects 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.

Contents of this leaflet:

• 1. What Dequadin is and what it is used for
• 2. What you need to know before you use 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 is Dequadin and what is it used for

Dequadin contains the active substance dequalinium chloride (also known as decamethylene bis
aminochinaldina chloride), and is a broad-spectrum antibacterial and antifungal
(antimycotic) drug. It is active against Gram-positive and Gram-negative bacteria, on Borrelia vincenti,
Candida albicans and some species of Tricophyton. Dequadin is used in the 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 preventing 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 predisposed to laryngospasm (spasmodic contraction of the laryngeal muscles) or convulsions (involuntary muscle contraction).

Warnings and precautions
Consult your doctor or pharmacist before using Dequadin.
Dequadin should only be used for lesions of the mouth and throat.
The use of Dequadin, especially if prolonged, may lead to sensitization
to the drug or resistance by microorganisms. If this occurs, discontinue treatment and consult
your doctor. Consult your doctor if you do not notice any improvement or if your
symptoms worsen.
Dequadin can be taken without risk by people with celiac disease.

Children
Dequadin should not be used in children under 3 years of age, especially if predisposed
to laryngospasm (spasmodic contraction of the laryngeal muscles) or convulsions (involuntary
muscle contraction).

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

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before using this medicine.

Driving and operating machinery
No effects on the ability to drive and operate machinery have been reported.

Dequadin contains propylene glycol, which can cause skin irritation.

3. How to use Dequadin

Use this medicine following exactly as stated in this leaflet or as instructed 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 local applications per day.
For mild or moderate infections, you can use Dequadin oral mucosa solution as a
mouthwash or gargle: dilute 10-20 drops of solution in a glass of water 3 times a
day.
It is recommended to keep your mouth open and not swallow saliva for a few minutes after
application, in this way a greater therapeutic efficacy is obtained.
Do not exceed the recommended doses without the advice of your doctor.
Use only for short periods of treatment.
Method of administration:
Dequadin oral mucosa solution: use a brush or a cotton swab wrapped
around a stick.
Dequadin oral mucosa spray: use the specific spray dispenser. Press the pump button several times until the spray is obtained. Subsequently 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 a missed dose.

If you stop using 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 everyone will experience them.
During treatment with Dequadin, local irritation may occur.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please
inform your doctor or pharmacist. You can also report side effects directly
through the national reporting system at
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 a temperature above 30°C.
Do not store at a temperature below 8°C.
Store in the original packaging to protect the medicine from moisture.
Do not use this medicine after the expiry date which is stated on the pack.
The expiry date refers to the last day of that month.
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.

6. Contents of the pack and other information

What Dequadin contains

• The active ingredient is dequalinium chloride (also known as decamethylene bis aminochinaldina 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 contents of the pack
Dequadin oral mucosal solution is presented in a 28 ml amber glass bottle.
Dequadin oral mucosal spray is presented in a 10 ml amber glass bottle with a mechanical spray dispenser without gas.

Marketing Authorisation 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