Diclomed

Package leaflet: Information for the user

Diclomed 0.74 mg/ml mouthwash

Diclofenac
Please read all of this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, please ask your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, please 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 Diclomed is and what it is used for
2. What you need to know before using Diclomed
3. How to use Diclomed
4. Possible side effects
5. How to store Diclomed
6. Contents of the pack and other information

1. What Diclomed is and what it is used for

Diclomed contains the active ingredient diclofenac, which belongs to a class of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
This medicine is indicated for the treatment of symptoms of irritation or inflammation causing pain in the mouth or throat, such as inflammation of the gums, oral mucosa or pharynx (gingivitis, stomatitis, pharyngitis).
Diclomed may also be used when these symptoms are related to dental treatment for the care or extraction of teeth.
If you do not feel better or feel worse, talk to your doctor.

2. What you need to know before using Diclomed

Do not use Diclomed

• if you are allergic to diclofenac or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to acetylsalicylic acid (aspirin) or to other similar medicines (non-steroidal anti-inflammatory drugs)

Warnings and precautions
Talk to your doctor or pharmacist before using Diclomed.
The use, especially if prolonged, of topical preparations may cause allergic-type reactions. If this
occurs, discontinue treatment with Diclomed and consult your doctor to establish, if necessary, an
appropriate therapy.
Any accidental swallowing of the solution dose used for rinsing or gargling will not cause you any harm, as it corresponds to one-fifth/sixth of the dose intended for systemic use (oral or injectable administration).
Other medicines and Diclomed
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No negative interactions with other medicines have been reported.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
During pregnancy and breastfeeding, use Diclomed only if strictly necessary and under direct medical supervision.
Driving and using machines
No adverse effects on the ability to drive vehicles or use machinery are known.
Diclomed contains sodium benzoate (E211)
Sodium benzoate may cause local irritation. Diclomed 0.74 mg/ml Mouthwash contains 2000 mg of sodium benzoate (E211) in 200 ml, equivalent to 10 mg/ml.

3. How to use Diclomed

Use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 2–3 rinses or gargles per day using one measuring cup (15 ml) of undiluted mouthwash or diluted in a small amount of water.
If you use more Diclomed than you should
There have been no reports of overdose with Diclomed.
In case of accidental ingestion of a large amount of Diclomed, contact your doctor immediately or go to the nearest hospital.
If you forget to use Diclomed
Do not use a double dose to make up for the missed dose.
If you stop using Diclomed
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Diclomed 0.74 mg/ml mouthwash is generally well tolerated and adverse reactions rarely occur.
Mild adverse reactions:

• irritation inside the mouth

Other adverse reactions:

• cough

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist.
You may also report adverse reactions directly via the national reporting system at the following address:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store Diclomed

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. The expiry date applies to the product in its original intact packaging and properly stored.
Store at a temperature not exceeding 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 Diclomed contains

• The active substance is diclofenac acid. 1 ml of mouthwash contains 0.74 mg of diclofenac acid.
• The other components are: sorbitol, choline, sodium benzoate (E211), sodium edetate, acesulfame potassium, natural mint flavour, natural peach flavour, colour E124, purified water.

Description of the appearance of Diclomed and contents of the pack
Diclomed is a mouthwash.
200 ml bottle.
Marketing Authorization Holder
Farmaka s.r.l. – Via Villapizzone, 26 – 20156 Milan (MI)
Manufacturer
Doppel Farmaceutici Srl
Via Martiri delle Foibe, 1 - 29016 Cortemaggiore (PC)
Vamfarma Srl
Via John Fitzgerald Kennedy, 5 – 26833 Comazzo (LO)

Package leaflet: Information for the user

Diclomed 0.3 mg/spray, oral mucosa spray

Diclofenac
Please read this leaflet carefully before using this medicine because it contains important information for you.

• 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 improvement or if your symptoms worsen.

Contents of this leaflet:

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

1. What Diclomed is and what it is used for

Diclomed is a dental preparation for local use containing diclofenac.
This medicinal product is indicated for the treatment of symptoms of irritation and inflammation causing pain in the mouth or throat, such as inflammation of the gums, oral mucosa, or pharynx (gingivitis, stomatitis, pharyngitis).
Diclomed may also be used when these symptoms occur following dental treatment for the care or extraction of teeth.
Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before using Diclomed

Do not use Diclomed

• if you are allergic to diclofenac or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to acetylsalicylic acid (aspirin) or to other similar medicines (non-steroidal anti-inflammatory drugs).

Warnings and precautions
Talk to your doctor or pharmacist before using Diclomed.
The use, especially if prolonged, of topical preparations may cause allergic reactions.
If this occurs, stop treatment with Diclomed and consult your doctor to establish, if necessary, an appropriate therapy.

Other medicines and Diclomed
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No negative interactions with other medicines have been reported.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
During pregnancy and breastfeeding, use Diclomed only if clearly needed and under direct medical supervision.

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

Diclomed contains sodium benzoate (E211)
Sodium benzoate (E211) may cause local irritation. Diclomed 0.3 mg/spray, oral mucosa spray contains 150 mg of sodium benzoate (E211) in 15 ml, equivalent to 10 mg/ml.

3. How to use Diclomed

Use this medicinal product exactly as stated in this leaflet or according to the instructions given by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 2 sprays three times a day, directed directly to the affected area.
If you use more Diclomed than you should
Cases of overdose with Diclomed have not been reported.
In case of accidental ingestion of an excessive dose of Diclomed, contact your doctor immediately or go to the nearest hospital.
If you forget to use Diclomed
Do not use a double dose to make up for the missed dose.
If you stop using Diclomed
If you have any doubts about the use of this medicinal product, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Diclomed 0.3 mg/spray spray is generally well tolerated and side effects rarely occur.

Mild side effects:

• nausea
• drop in blood pressure
• chills
• visual disturbances
• indigestion

Moderate side effects:

• headache
• mucous membrane disorders

Other side effects:

• burning sensation in the mouth (frequency not known)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please consult your doctor or pharmacist.
You can also report side effects directly via the national reporting system at 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 Diclomed

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. The expiry date applies to the product in its original, unopened packaging and properly stored.
Caution: Do not use the medicine more than 1 year after first opening the multidose container (record the date of first opening in the designated space on the carton).
Store at a temperature not exceeding 25°C.
Do not dispose of medicines 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 Diclomed contains

• The active substance is diclofenac acid. One spray (corresponding to 0.2 ml) contains 0.3 mg of diclofenac acid.
• The other ingredients are: sorbitol, choline chloride, sodium edetate, sodium benzoate (E211), acesulfame potassium, peppermint essential oil, natural peach flavor, E129, ethanol, sodium hydroxide, purified water.

Description of the appearance of Diclomed and package contents
Diclomed is an oral mucosa spray.
Multidose container of 15 ml.
Marketing Authorization Holder
Farmaka s.r.l. – Via Villapizzone, 26 – 20156 Milano (MI)
Manufacturer
ITC Farma s.r.l. – Via Pontina, 5 – 00071 Pomezia (RM)