OKI 1.6% Mouthwash

Зміст інструкції

1. OKi gola 0,16% spray per mucosa orale
   1. What OKi gola is and what it is used for
   2. What you need to know before using OKi gola
   3. How to use OKi gola
   4. Possible side effects
   5. How to store OKi gola
   6. Contents of the pack and other information
2. OKi gola 1,6% mouthwash
   1. What OKi gola is and what it is used for
   2. What you need to know before using OKi gola
   3. How to use OKi gola
   4. Possible side effects
   5. How to store OKi gola
   6. Contents of the pack and other information

OKi gola 0,16% spray per mucosa orale

ketoprofene lysine salt

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 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 a short period of treatment.

Contents of this leaflet:

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

1. What OKi gola is and what it is used for

OKi gola 0.16% spray for oral mucosa contains ketoprofene lysine salt as its active ingredient, a substance
that belongs to a group of medicines called “Non-Steroidal Anti-Inflammatory Drugs” (NSAIDs), and it is
a dental medicine used for the local treatment of the oral cavity.
OKi gola is used for the symptomatic treatment of irritant-inflammatory conditions, also associated with pain in the
oro-pharyngeal cavity (for example, gingivitis, stomatitis, pharyngitis), even as a result of conservative dental therapy (tooth care) or extraction therapy (tooth extraction).
Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.

2. What you need to know before using OKi gola

Do not use OKi gola

• if you are allergic to ketoprofen or any of the other ingredients of this medicine (listed in section 6 “Contents of the pack and other information”);
• if you have a history of bronchial asthma or adverse reactions caused by the use of other non-steroidal anti-inflammatory drugs such as asthma attacks, bronchospasm (narrowing of the bronchi, causing difficulty breathing), acute rhinitis, nasal polyps, urticaria or angioedema (swelling of the face and mucous membranes);
• if you are pregnant, suspect you are pregnant or if you are breastfeeding (see subsection “Pregnancy and breastfeeding”).

Warnings and precautions
Consult your doctor or pharmacist before using OKi gola.
Ask your doctor for advice before using OKi gola if you suffer or have suffered in the past from bronchial asthma.
The use, especially if prolonged, of topical medicines (for local use) may lead to sensitization (allergy). In this case, discontinue treatment and consult your doctor to adopt appropriate therapeutic measures.
After a short period of treatment without appreciable results, consult your doctor. Do not use OKi gola for prolonged treatments.

Other medicines and OKi gola
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 are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not use Oki gola during pregnancy.
Oral formulations (e.g. tablets) of ketoprofen can cause adverse effects on the fetus. It is not known whether Ketoprofen poses the same risk when used on the skin.
Breastfeeding
Do not use OKi gola if you are breastfeeding.

Driving and using machines
This medicine does not impair the ability to drive vehicles or operate machinery.

OKi gola contains methyl parahydroxybenzoate
This medicine contains methyl parahydroxybenzoate (parabens), known for its potential to cause allergic reactions (even delayed ones).

Oki gola contains the mint flavour
This medicine contains the mint flavour, which in turn contains d-limonene, eugenol and linalool. D-limonene, eugenol and linalool can cause allergic reactions.

Oki gola contains the ever cool flavour
This medicine contains the ever cool flavour, which in turn contains linalool. Linalool can cause allergic reactions.

3. How to use OKi gola

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.

The recommended dose is: 1-2 sprays, up to three times a day.
Each spray delivers approximately 0.2 ml of solution, equivalent to 0.32 mg of ketoprofen lysine salt.

Method of use
Lift the applicator. Introduce the applicator into your mouth and direct the spray towards the affected area.
Spray the solution by pressing the dispenser.

Warning: do not exceed the indicated doses.
Use only for short periods of treatment.
Consult your doctor if the disorder occurs repeatedly or if you notice any recent change in its characteristics.

If you use more OKi gola than you should
No cases of overdose have been reported.
In case of ingestion/accidental intake of an excessive dose of OKi gola, immediately notify your doctor or go to the nearest hospital.
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 side effects that may occur following topical administration of ketoprofene lysine salt solution on the oral
mucosa are extremely rare and consist of irritative or allergic phenomena, such as angioedema (swelling of the
face and mucous membranes), especially in subjects with hypersensitivity to NSAIDs.
No side effects on the body are known considering the route of administration and the administered dosage.

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
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 OKi gola

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the packaging after Scad.. 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 dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What OKi gola contains

• The active ingredient is ketoprofen lysine salt. 1 ml of solution contains 1.6 mg of ketoprofen lysine salt, corresponding to 1 mg of ketoprofen.
• The other ingredients are: 85% glycerol, xylitol, methyl parahydroxybenzoate, monobasic sodium phosphate, poloxamer 407, mint aroma (containing d-Limonene, eugenol, linalool), ever cool aroma (containing linalool), purified water.

Description of the appearance of OKi gola and contents of the pack
Oral mucosal spray - 15 ml bottle.

Marketing Authorisation Holder
Dompé farmaceutici S.p.A.
Via San Martino, 12 - 20122 Milano

Manufacturer
Dompé farmaceutici S.p.A. - Via Campo di Pile - 67100 L'Aquila

OKi gola 1,6% mouthwash

ketoprofene lysine salt

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 a short period of treatment.

Contents of this leaflet:

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

1. What OKi gola is and what it is used for

OKi gola 1.6% mouthwash contains ketoprofene lysine salt as its active ingredient, a substance that belongs
to a group of medicines called “Non-Steroidal Anti-Inflammatory Drugs” (NSAIDs), and is a dental
medicinal product used for the local treatment of the oral cavity.
OKi gola 1.6% mouthwash is used for the symptomatic treatment of irritant - inflammatory states also associated
with pain of the oro-pharyngeal cavity (for example gingivitis, stomatitis, pharyngitis), even as a consequence of
conservative (tooth care) or extractive (tooth extraction) dental therapy.
See a doctor if you do not feel better or if you feel worse after a short period of treatment.

2. What you need to know before using OKi gola

Do not use OKi gola

• if you are allergic to ketoprofen or any of the other ingredients of this medicine (listed in section 6 “Contents of the pack and other information”);
• if you have a history of allergic reactions, such as asthma, urticaria or rhinitis, caused by the use of other non-steroidal anti-inflammatory drugs;
• if you are pregnant, suspect you may be pregnant or if you are breastfeeding (see subsection “Pregnancy and breastfeeding”).

Warnings and precautions
Consult your doctor or pharmacist before using OKi gola.
Ask your doctor for advice before using OKi gola if you suffer from or have suffered from bronchial asthma in the past.
If you use OKi gola for prolonged periods and at high doses, be aware of the possibility of competition between the
ketoprofen absorbed and other medicines with high protein binding.
The use, especially if prolonged, of topical medicines (for local use) may lead to sensitization (allergy). In this case, stop treatment and consult your doctor to adopt
appropriate therapeutic measures.
After a short period of treatment without appreciable results, consult your doctor. Do not use OKi gola
for prolonged treatments.

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

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not use Oki gola during pregnancy.
Oral formulations (e.g. tablets) of ketoprofen can cause adverse effects on the fetus. It is
not known whether Ketoprofene carries the same risk when used on the skin.
Breastfeeding
Do not use Oki gola if you are breastfeeding.

Driving and using machines
This medicine does not impair the ability to drive vehicles or operate machinery.

OKi gola contains methyl parahydroxybenzoate
This medicine contains methyl parahydroxybenzoate, which can cause allergic reactions (including delayed reactions).

OKi gola contains mint flavour
This medicine contains mint flavour, which in turn contains d-Limonene, linalool. D-limonene and
linalool can cause allergic reactions.

3. How to use OKi gola

Use 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.

The recommended dose is: one rinse or gargle with 10 ml of OKi gola diluted in approximately 100 ml of water, twice a day.

Method of use
A dosing cup with a mark corresponding to 10 ml is included in the package.
To open the package, press firmly on the cap and rotate it counterclockwise simultaneously.
Accidental swallowing of the solution used for rinsing and gargling does not cause any particular harm.

Caution: do not exceed the indicated doses.
Use only for short periods of treatment.
Consult your doctor if the disorder occurs repeatedly or if you notice any recent change in its characteristics.

If you use more OKi gola than you should
No cases of overdose have been reported.
In case of accidental ingestion/intake of an excessive dose of OKi gola, immediately inform your doctor or go to the nearest hospital.
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 everybody gets them.
Local irritative phenomena and angioedema (swelling of the lips, face, throat or tongue) have been reported, especially in subjects with hypersensitivity to NSAIDs, with very rare frequency.
the risk of side effects.

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 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 OKi gola

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated 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 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.

6. Contents of the pack and other information

What OKi gola contains

• The active ingredient is ketoprofen lysine salt. 1 ml of solution contains 16 mg of ketoprofen lysine salt.
• The other ingredients are: glycerol, ethanol, methyl parahydroxybenzoate, mint aroma(containingd-limonene, linalool), menthol, sodium saccharin, chlorophyll green colorant, monobasic sodium phosphate, poloxamer 407, purified water.

Description of the appearance of OKi gola and contents of the pack
Oral mucosa mouthwash - 150 ml bottle.

Marketing Authorisation Holder
Dompé farmaceutici S.p.A.
Via San Martino, 12 – 20122 Milan

Manufacturer
Alfasigma S.p.A. – Via Enrico Fermi, 1 - Alanno (PE)
or
Alfasigma S.p.A. - Via Enrico Fermi, 1 - Alanno (PE) with secondary packaging and final controls
at Dompé farmaceutici S.p.A. - Via Campo di Pile - 67100 L'Aquila
or
Dompé farmaceutici S.p.A. - Via Campo di Pile - 67100 L'Aquila