Solket inflammation and pain
ItalyTable of Contents
Package leaflet: Information for the user
SOLKET inflammation and pain 1.6% mouthwash
Ketoprofen lysine salt
Generic Medicine
Please read this leaflet carefully before using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.
- Keep this leaflet. You may need to read it again.
- If you need more advice or information, 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 after a short time.
Contents of this leaflet:
- What SOLKET inflammation and pain is and what it is used for
- What you need to know before using SOLKET inflammation and pain
- How to use SOLKET inflammation and pain
- Possible side effects
- How to store SOLKET inflammation and pain
- Contents of the pack and other information
1. What SOLKET inflammation and pain is and what it is used for
SOLKET inflammation and pain 1.6% mouthwash contains the active substance ketoprofen lysine salt, a
medicine 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.
SOLKET inflammation and pain 1.6% mouthwash is used for the symptomatic treatment of irritative-inflammatory conditions, sometimes associated with pain in the oropharyngeal area (e.g. gingivitis, stomatitis, pharyngitis), including those occurring after conservative dental treatment (dental filling) or tooth extraction.
Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.
- What you need to know before using SOLKET inflammation and pain and Do not use SOLKET inflammation and pain
- 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 suffered from a respiratory disorder known as bronchial asthma;
- 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 are breastfeeding (see subsection “Pregnancy and breastfeeding”).
Warnings and precautions
Talk to your doctor or pharmacist before using SOLKET inflammation and pain.
Ask your doctor for advice before using Solket inflammation and pain if you suffer or have previously suffered from bronchial asthma.
If you use Solket inflammation and pain for prolonged periods and at high doses, be aware of the possibility of competition between absorbed ketoprofen and other medicines that are highly bound to plasma proteins.
The use, especially if prolonged, of topical medicines (for local use) may lead to sensitization (allergy). In such a 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 Solket inflammation and pain for prolonged treatments.
For individuals engaged in sports, the use of medicines containing ethyl alcohol may result in a positive anti-doping test, depending on the alcohol concentration limits set by certain sports federations.
Other medicines and SOLKET inflammation and pain
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, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not use SOLKET inflammation and pain 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 topically to the skin.
Breastfeeding
Do not use SOLKET inflammation and pain if you are breastfeeding.
Driving and operating machinery
This medicine does not affect the ability to drive or operate machinery.
SOLKET inflammation and pain contains ethanol (ethyl alcohol), parahydroxybenzoates and colourants
(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 colourants quinoline yellow (E104) and patent blue V (E131), which may cause allergic reactions.
3. How to use SOLKET inflammation and pain
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: one mouth rinse or gargle with 10 ml of Solket inflammation and pain diluted in approximately 100 ml of water, twice daily.
Instructions for use
A dosing cup with a mark corresponding to 10 ml is included in the package.
To open the container, press firmly on the cap and simultaneously rotate it counterclockwise.
Accidental swallowing of the solution used for rinsing and gargling does not cause
any particular harm.
Warning: Do not exceed the recommended doses.
Use only for short treatment periods.
Consult your doctor if symptoms recur or if you notice any recent changes in their characteristics.
If you use more SOLKET inflammation and pain than you should
Cases of overdose have not been reported.
In case of accidental ingestion/overdose of an excessive amount of this medicine, contact your doctor immediately or go to the nearest hospital.
If you forget to use SOLKET inflammation and pain
Do not use a double dose to make up for the missed 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 gets them.
The following side effects may occur:
Very rare (may affect less than 1 in 10,000 people):
- local irritative phenomena (throat irritation);
- allergic reactions such as swelling of the face, particularly around the mouth and eyes, or of the tongue or throat (angioedema); this occurs especially in individuals with hypersensitivity to non-steroidal anti-inflammatory drugs ("NSAIDs").
Systemic side effects are not known.
If you experience any side effects, consult your doctor.
Following the instructions contained 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, please inform 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 SOLKET inflammation and pain
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.
The product must be used within 9 weeks after 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 SOLKET inflammation and pain contains
- The active substance is ketoprofen lysine salt: 100 ml of mouthwash contain 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, peppermint flavour, levomenthol, green colourant, monobasic sodium phosphate, purified water.
Description of the appearance of SOLKET inflammation and pain and the contents of the pack
Pack containing a 150 ml bottle of solution, equipped with a safety closure and a measuring cup dispenser.
Marketing Authorisation Holder
Aesculapius Farmaceutici S.r.l. - Via Cefalonia, 70 - 25124 Brescia.
Manufacturer
Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe, 1 - Cortemaggiore (PC)
Package leaflet: information for the user
SOLKET inflammation and pain 0.16% oral mucosa spray
Lysine ketoprofen
Equivalent medicine
Please read this leaflet carefully before using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed 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 you notice worsening of symptoms after a short time.
Contents of this leaflet:
- What SOLKET inflammation and pain is and what it is used for
- What you need to know before using SOLKET inflammation and pain
- How to use SOLKET inflammation and pain
- Possible side effects
- How to store SOLKET inflammation and pain
- Package contents and other information
1. What SOLKET inflammation and pain is and what it is used for
SOLKET inflammation and pain oral mucosa spray contains the active substance ketoprofen lysine salt, a medicine belonging to a group of drugs known as Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). It is a dental medicine used for local treatment in the oral cavity.
SOLKET inflammation and pain is used for the symptomatic treatment of irritative-inflammatory conditions of the oropharyngeal cavity, sometimes 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 SOLKET inflammation and pain
Do not use SOLKET inflammation and pain
- 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 suffered from a respiratory disorder known as previous bronchial asthma;
- 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 or mucous membranes);
- if you are pregnant, suspect you may be pregnant, or are breastfeeding (see section “Pregnancy and breastfeeding”).
Warnings and precautions
Talk to your doctor or pharmacist before using SOLKET inflammation and pain.
Consult your doctor before using Solket inflammation and pain if you suffer or have previously suffered from bronchial asthma.
The use, especially if prolonged, of topical medicines (for local use) may lead to sensitization (allergy). If this occurs, stop treatment and consult your doctor to adopt appropriate therapeutic measures.
If after a short period of treatment no appreciable improvement is observed, consult your doctor. Do not use Solket inflammation and pain oral mucosa spray for prolonged treatments.
Other medicines and SOLKET inflammation and pain
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, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not use SOLKET inflammation and pain 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 SOLKET inflammation and pain if you are breastfeeding.
Driving and using machines
This medicine does not affect the ability to drive or operate machinery.
SOLKET inflammation and pain contains parahydroxybenzoates
This medicine contains parahydroxybenzoates (methyl parahydroxybenzoate and propyl parahydroxybenzoate) which may cause allergic reactions (including delayed reactions).
3. How to use SOLKET inflammation and pain
Use this medicine exactly as described 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 three times a day. Each spray delivers approximately 0.2 ml of solution, corresponding to 0.32 mg of ketoprofen lysine salt.
Caution: Do not exceed the recommended dosage.
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 SOLKET inflammation and pain than you should
Cases of overdose have not been reported.
In case of accidental ingestion/absorption of an excessive dose of Solket inflammation and pain oral mucosa spray, contact your doctor immediately or go to the nearest hospital.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.
If you forget to use SOLKET inflammation and pain
If you forget to use a dose of the medicine, take it as soon as you remember, unless it is almost time for the next dose.
Do not use a double dose to make up for a forgotten dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
The following adverse reactions may occur:
Very rare (may affect less than 1 in 10,000 people):
- local irritative phenomena (throat irritation);
- allergic reactions such as swelling of the face, particularly around the mouth and eyes, or of the tongue or throat (angioedema); this occurs especially in individuals with hypersensitivity to non-steroidal anti-inflammatory drugs ("NSAIDs").
Systemic adverse reactions are not known.
If you experience any adverse reactions, consult your doctor.
Following the instructions 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, contact 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 more information on the safety of this medicine.
5. How to store SOLKET inflammation and pain
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 must be used within 21 weeks of first opening the bottle. Any excess product must 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. Pack contents and other information
What SOLKET inflammation and pain contains
- The active substance is ketoprofen lysine salt: 100 ml of oral mucosal 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, monosodium phosphate, poloxamer, mint flavour, purified water.
Description of the appearance of SOLKET inflammation and pain and contents of the pack
Pack containing a 15 ml bottle of solution with spray pump, cannula and dispenser.
Marketing Authorization Holder
Aesculapius Farmaceutici S.r.l. - Via Cefalonia, 70 - 25124 Brescia.
Manufacturer
Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe, 1 - Cortemaggiore (PC)