Euspidol for sore throat
Italy
Table of Contents
Package leaflet: Information for the user
EUSPIDOL GOLA 0.16% oral mucosa spray
Lysine ketoprofen
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.
- Keep this leaflet. You may need to read it again.
- If you need further 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 you notice worsening of symptoms after a short time.
Contents of this leaflet:
- What EUSPIDOL GOLA is and what it is used for
- What you need to know before using EUSPIDOL GOLA
- How to use EUSPIDOL GOLA
- Possible side effects
- How to store EUSPIDOL GOLA
- Contents of the pack and other information
1. What EUSPIDOL GOLA is and what it is used for
EUSPIDOL GOLA contains the active substance ketoprofen lysine salt, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs ("NSAIDs") used to relieve pain and inflammation.
This medicine is used for the symptomatic treatment of irritation and/or inflammation of the mouth and pharynx (e.g. gingivitis, stomatitis, pharyngitis), including cases following dental procedures such as treatment of caries 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 EUSPIDOL GOLA
Do not use EUSPIDOL GOLA
- if you are allergic to ketoprofen lysine salt, to other non-steroidal anti-inflammatory drugs ("NSAIDs") or to any of the other ingredients of this medicine (listed in section 6);
- if you have suffered from a respiratory disorder known as previous bronchial asthma.
- if taking medicines such as acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs) has previously caused you problems such as asthma attacks, breathing difficulties due to temporary narrowing of the bronchi (bronchospasm), nasal polyps, acute rhinitis, skin allergic reactions such as urticaria, or swelling of the face around the eyes and mouth (angioedema);
- if you are pregnant or breastfeeding (see section “Pregnancy and breastfeeding”).
Warnings and precautions
Talk to your doctor or pharmacist before using EUSPIDOL GOLA.
The use of this medicine, especially if prolonged, may lead to sensitization phenomena (increased response upon repeated administration of the same dose of the drug) or local irritation; in such cases treatment must be discontinued and you should consult your doctor, who will determine an appropriate therapy.
Do not use this medicine for long periods.
Other medicines and EUSPIDOL GOLA
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions with other medicines are known.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Do not use EUSPIDOL GOLA if you are pregnant or breastfeeding.
Driving and using machines
This medicine does not affect the ability to drive vehicles or operate machinery.
EUSPIDOL GOLA contains parahydroxybenzoates
This medicine contains parahydroxybenzoates which may cause allergic reactions (including delayed reactions).
3. How to use EUSPIDOL 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.
Instructions for use
- Lift the cannula and insert it into the mouth
- Direct the spray directly towards the affected area.
- Press the dispenser to release the medicine. The recommended dose is 1-2 sprays, up to 3 times a day. Each spray delivers approximately 0.2 ml of solution, corresponding to 0.32 mg of ketoprofen lysine salt. Do not exceed the recommended doses.
If you use more EUSPIDOL GOLA than you should
No cases of overdose have been reported during treatment with this medicine.
In case of accidental ingestion/overdose of this medicine, contact your doctor immediately or go to the nearest hospital.
If you forget to use EUSPIDOL GOLA
If you forget to use a dose of the medicine, use it as soon as you remember, unless it is almost time for your next dose.
Do not use a double dose to make up for the missed dose.
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 may cause side effects, although not everyone experiences them.
The following side effects may occur:
Very rare (may affect less than 1 in 10,000 people):
- throat irritation;
- allergic reactions such as swelling of the face, particularly around the mouth and eyes, tongue or throat (angioedema); this occurs especially in people who are allergic to non-steroidal anti-inflammatory drugs ("NSAIDs").
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist.
You may 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 EUSPIDOL 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 product should be used within 21 weeks of first opening the bottle. Any excess product should be discarded.
Do not dispose of medicines 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 EUSPIDOL GOLA contains
- The active substance is ketoprofen lysine salt: 100 ml of oral mucosa spray contain 0.16 g of ketoprofen lysine salt, equivalent to 0.10 g of ketoprofen.
- The other components are: glycerol 85%, xylitol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, monobasic sodium phosphate, poloxamer, mint flavour, purified water.
Description of the appearance of EUSPIDOL GOLA and contents of the pack
Pack containing one 15 ml bottle of solution with spray pump, cannula and dispenser.
Marketing Authorization Holder
Zentiva Italia S.r.l. - Via P. Paleocapa, 7 - 20121 Milan
Manufacturer
Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe, 1 - Cortemaggiore (PC)
Package leaflet: information for the user
EUSPIDOL GOLA 1.6% mouthwash
Lysine ketoprofen
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.
- Keep this leaflet. You may need to read it again.
- If you need further 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.
- Consult your doctor if you do not notice improvement or if your symptoms worsen after a short period of time.
Contents of this leaflet:
- What EUSPIDOL GOLA is and what it is used for
- What you need to know before using EUSPIDOL GOLA
- How to use EUSPIDOL GOLA
- Possible side effects
- How to store EUSPIDOL GOLA
- Contents of the pack and other information
1. What EUSPIDOL GOLA is and what it is used for
EUSPIDOL GOLA contains the active substance ketoprofen lysine salt, which belongs to a group of
medicines called non-steroidal anti-inflammatory drugs ("NSAIDs") used to relieve pain and
inflammation.
This medicine is used for the symptomatic treatment of irritation and/or inflammation of the mouth and
pharynx (e.g. gingivitis, stomatitis, pharyngitis), including cases following dental procedures such as
cavity treatment 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 EUSPIDOL GOLA
Do not use EUSPIDOL GOLA
- if you are allergic to ketoprofen lysine salt or to any of the other ingredients of this medicine (listed in section 6);
- if you know you are allergic or have experienced asthma, allergic-type urticaria, or allergic rhinitis (nasal allergy), after taking this medicine or other medicines belonging to the class of non-steroidal anti-inflammatory drugs (NSAIDs), such as aspirin;
- if you are pregnant or breastfeeding (see section “Pregnancy and breastfeeding”).
Warnings and precautions
Talk to your doctor or pharmacist before using EUSPIDOL GOLA.
The use of this medicine, especially if prolonged, may lead to sensitization (increased response upon repeated administration of the same dose of the drug) or local irritation; in such cases, treatment must be discontinued and you should consult your doctor, who will determine an appropriate therapy.
Do not use this medicine for long periods.
For individuals engaged in sports activities, the use of medicines containing ethyl alcohol may result in a positive anti-doping test, depending on the blood alcohol concentration limits established by certain sports federations.
Other medicines and EUSPIDOL GOLA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions with other medicines are known.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Do not use EUSPIDOL GOLA if you are pregnant or breastfeeding.
Driving and using machines
The use of this medicine does not impair the ability to drive or operate machinery.
EUSPIDOL GOLA contains ethanol (ethyl alcohol), parahydroxybenzoates, and the dyes green (quinoline yellow and patent blue V)
This medicine contains small amounts of ethanol (ethyl alcohol), less than 100 mg per dose.
This medicine contains parahydroxybenzoates (methyl parahydroxybenzoate and propyl parahydroxybenzoate) which may cause allergic reactions (including delayed reactions).
This medicine contains the dyes quinoline yellow (E104) and patent blue V (E131), which may cause allergic reactions.
3. How to use EUSPIDOL GOLA
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.
The recommended dose is 10 ml, diluted in 100 ml of water, twice daily.
The package includes a measuring cup with a mark indicating 10 ml.
Instructions for use
- Open the bottle by pressing firmly on the cap and simultaneously turning it counterclockwise.
- Perform the mouthwash or gargle. Do not exceed the recommended doses.
If you use more EUSPIDOL GOLA than you should
No cases of overdose have been reported during treatment with this medicine.
If you accidentally swallow the amount corresponding to the recommended dose of EUSPIDOL GOLA, this will not cause harm, as this dose is equivalent to the dose usually used orally.
In case of accidental ingestion/overdose of a large amount of this medicine, inform your doctor immediately or go to the nearest hospital.
If you forget to use EUSPIDOL GOLA
Do not use a double dose to make up for the forgotten dose.
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 will experience them.
The following adverse reactions may occur:
Very rare (may affect fewer than 1 in 10,000 people):
- throat irritation;
- allergic reactions such as swelling of the face, particularly around the mouth and eyes, tongue or throat (angioedema); this occurs especially in people allergic to non-steroidal anti-inflammatory drugs ("NSAIDs").
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to 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 EUSPIDOL 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 product should be used within 9 weeks of first opening the bottle. Any excess product should be discarded.
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 EUSPIDOL GOLA contains
- The active substance is ketoprofen lysine salt: 100 ml of mouthwash contains 1.6 g of ketoprofen lysine salt, equivalent to 1 g of ketoprofen.
- The other components are: glycerol 85%, ethyl alcohol 96%, sodium saccharin, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, mint flavour, levomenthol, green dye, monobasic sodium phosphate, purified water.
Description of the appearance of EUSPIDOL GOLA and contents of the pack
Pack containing one 150 ml bottle of solution, equipped with a safety closure and a dosing cup.
Marketing Authorization Holder
Zentiva Italia S.r.l. - Via P. Paleocapa, 7 - 20121 Milan
Manufacturer
Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe, 1 - Cortemaggiore (PC)