OKI GOLA

Package leaflet: Information for the user

OKi gola 0.16% oral mucosa spray

ketoprofen lysine salt
Please read this leaflet carefully before using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed 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 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 0.16% oral mucosa spray contains as its active substance ketoprofen lysine salt, a substance belonging to a group of medicines known as "Non-Steroidal Anti-Inflammatory Drugs" (NSAIDs), and is a dental medicine used for local treatment in the oral cavity.
OKi gola is used for the symptomatic treatment of irritative-inflammatory conditions of the oropharyngeal cavity, even when associated with pain (e.g. gingivitis, stomatitis, pharyngitis), including those occurring after conservative dental treatment (dental care) or 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 to 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 (NSAIDs), such as asthma attacks, bronchospasm (narrowing of the airways causing breathing difficulties), acute rhinitis, nasal polyps, urticaria, or angioedema (swelling of the face and mucous membranes);
• if you are pregnant, suspect you may be pregnant, or are breastfeeding (see subsection “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before using OKi gola.
Consult your doctor before using OKi gola if you suffer or have previously suffered from bronchial asthma.
Prolonged use, especially, of topical medicines (for local use) may lead to sensitization (allergy). If this occurs, stop treatment immediately and consult your doctor for appropriate therapeutic measures.
If there is no noticeable improvement after a short period of treatment, consult your doctor. Do not use OKi gola for prolonged treatments.

Other medicines and OKi gola
Inform 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, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Do not use OKi gola during pregnancy.
Oral formulations (e.g. tablets) of ketoprofen may cause adverse effects on the fetus. It is not known whether ketoprofen poses the same risk when applied to the skin.

Breastfeeding
Do not use OKi gola if you are breastfeeding.

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

OKi gola contains methyl 4-hydroxybenzoate
This medicine contains methyl 4-hydroxybenzoate (parabens), which are known to possibly cause allergic reactions (including delayed reactions).

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

OKi gola contains ever cool flavour
This medicine contains ever cool flavour, which in turn contains linalool. Linalool may cause allergic reactions.

3. How to use OKi gola

Use this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Recommended dose: 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.
Instructions for use
Lift the cannula. Insert the cannula into the mouth and direct the spray towards the affected area.
Spray the solution by pressing the dispenser.
Warning: Do not exceed the recommended doses.
Use only for short treatment periods.
Consult your doctor if symptoms recur frequently or if you notice any recent changes in their characteristics.
If you use more OKi gola than you should
No cases of overdose have been reported.
In case of accidental ingestion/overdose of a large amount of OKi gola, contact your doctor immediately or go to the nearest hospital.
If you have any doubts about how to use 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.
Local adverse reactions following topical administration of ketoprofen lysine salt solution onto the oral mucosa are extremely rare and consist of irritative or allergic phenomena, such as angioedema (swelling of the face and mucous membranes), particularly in subjects with hypersensitivity to NSAIDs.
No systemic adverse effects are known, considering the route of administration and the dosage used.
Following the instructions provided in this leaflet reduces the risk of adverse reactions.
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 through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting adverse reactions, you can help provide further information on the safety of this medicine.

5. How to store OKi Throat

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 applies to the product in its original, unopened packaging, stored correctly.
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. Pack contents and other information

What OKi gola contains

• The active substance is ketoprofen lysine salt. 1 ml of solution contains 1.6 mg of ketoprofen lysine salt, equivalent to 1 mg of ketoprofen.
• The other components are: glycerol 85%, xylitol, methyl 4-hydroxybenzoate, monosodium phosphate, poloxamer 407, peppermint flavour (containing d-Limonene, eugenol, linalool), ever cool flavour (containing linalool), purified water.

Description of the appearance of OKi gola and pack contents
Oromucosal spray – 15 ml bottle.
Marketing Authorization Holder
Dompé farmaceutici S.p.A.
Via San Martino, 12 - 20122 Milan
Manufacturer
Dompé farmaceutici S.p.A. - Via Campo di Pile - 67100 L'Aquila

Package leaflet: information for the user

OKi gola 1.6% mouthwash

ketoprofen lysine salt
Please read this leaflet carefully before using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you to do.

• Keep this leaflet. You may need to read it again.
• If you would like more information or advice, consult your pharmacist.
• If you experience any of the 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 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 as the active substance ketoprofen lysine salt, a compound belonging to a group of medicines known as "Non-Steroidal Anti-Inflammatory Drugs" (NSAIDs), and is a medicinal product for oral use intended for local treatment of the oral cavity.
OKi gola 1.6% mouthwash is indicated for the symptomatic treatment of irritative-inflammatory conditions of the oropharyngeal cavity, even when associated with pain (e.g. gingivitis, stomatitis, pharyngitis), including those occurring as a consequence of conservative dental treatment (dental care) or 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 throat

Do not use OKi throat

• if you are allergic to ketoprofen or to 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, triggered 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
Talk to your doctor or pharmacist before using OKi throat.
Seek medical advice before using OKi throat if you suffer or have previously suffered from bronchial asthma.
If you use OKi throat for prolonged periods and at high doses, be aware of the possibility of competition between absorbed ketoprofen and other medicines that highly bind to plasma proteins.
The use, especially if prolonged, of topical medicines (for local use) may lead to sensitization (allergy). In such case, discontinue treatment and consult your doctor to adopt appropriate therapeutic measures.
If there is no noticeable improvement after a short period of treatment, consult your doctor. Do not use OKi throat for prolonged treatments.

Other medicines and OKi throat
Inform 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 taking this medicine.

Pregnancy
Do not use OKi throat during pregnancy.
Oral formulations (e.g. tablets) of ketoprofen may 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 throat if you are breastfeeding.

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

OKi throat contains methyl 4-hydroxybenzoate
This medicine contains methyl 4-hydroxybenzoate, which may cause allergic reactions (including delayed reactions).

OKi throat contains mint flavour
This medicine contains mint flavour, which in turn contains d-Limonene and linalool. d-Limonene and linalool may cause allergic reactions.

3. How to use OKi gola

Use this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Recommended dose : one mouthwash or gargle using 10 ml of OKi gola diluted in approximately 100 ml of water, twice daily.
Instructions for use
A dosing cup with a mark indicating 10 ml is supplied in the package.
To open the container, press down firmly on the cap and simultaneously turn it counterclockwise.
Accidental swallowing of the solution used for mouthwashes and gargles does not cause any particular harm.
Caution : do not exceed the recommended doses.
Use only for short-term treatment.
Consult your doctor if symptoms recur or if you notice any recent changes in their characteristics.
If you use more OKi gola than you should
No cases of overdose have been reported.
In case of accidental ingestion/overdose of a large amount of OKi gola, contact your doctor immediately or go to the nearest hospital.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine may cause side effects, although not everybody gets them.
Local irritation and angioedema (swelling of the lips, face, throat or tongue) have been reported, especially in subjects with hypersensitivity to NSAIDs, with very rare frequency.
Systemic side effects are not known. 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, talk to your doctor or pharmacist. You may also report side effects directly through the national reporting system at the website https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . Reporting side effects 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 stated on the packaging after "Exp." The expiry date refers to the last day of that month. The expiry date refers to the product kept in its original, unopened packaging and stored correctly.
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 OKi gola contains

• The active substance is ketoprofen lysine salt. 1 ml of solution contains 16 mg of ketoprofen lysine salt.
• The other components are: glycerin, ethanol, methyl 4-hydroxybenzoate, peppermint flavour (containing d-limonene, linalool), menthol, sodium saccharin, brilliant green dye, monosodium phosphate, poloxamer 407, purified water.

Description of the appearance of OKi gola and the contents of the pack
Mouthwash for oral mucosa – 150 ml bottle.
Marketing Authorization 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
carried out 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