Golasept inflammation and pain
ItalyTable of Contents
Package leaflet: Information for the user
GOLASEPT INFLAMMATION AND PAIN 0.16% oral mucosa spray
Ketoprofen lysine salt
Please read all of 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 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 after a short period.
Contents of this leaflet:
- What GOLASEPT INFLAMMATION AND PAIN is and what it is used for
- What you need to know before using GOLASEPT INFLAMMATION AND PAIN
- How to use GOLASEPT INFLAMMATION AND PAIN
- Possible side effects
- How to store GOLASEPT INFLAMMATION AND PAIN
- Contents of the pack and other information
1. What GOLASEPT INFIAMMAZIONE E DOLORE is and what it is used for
GOLASEPT INFIAMMAZIONE E DOLORE contains the active substance ketoprofene 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 throat (e.g. gingivitis, stomatitis, pharyngitis), including conditions following dental procedures such as treatment of dental 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 GOLASEPT INFLAMMATION AND PAIN
Do not use GOLASEPT INFLAMMATION AND PAIN
- 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 previously suffered from a respiratory disorder known as 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 GOLASEPT INFLAMMATION AND PAIN.
The use of this medicine, especially if prolonged, may lead to sensitization phenomena (increased response upon repeated administration of the same drug dose) or local irritation; in these 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 GOLASEPT INFLAMMATION AND PAIN
Tell your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
No interactions with other medicines are known.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Do not use GOLASEPT 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 GOLASEPT INFLAMMATION AND PAIN if you are breastfeeding.
Driving and using machines
The use of this medicine does not impair the ability to drive or operate machinery.
GOLASEPT INFLAMMATION AND PAIN contains parahydroxybenzoates
This medicine contains parahydroxybenzoates which may cause allergic reactions (including delayed reactions).
3. How to use GOLASEPT 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 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 GOLASEPT INFLAMMATION AND PAIN than you should
No cases of overdose have been reported during treatment with this medicine.
In case of accidental ingestion/overdose of an excessive dose of this medicine, inform your doctor immediately or go to the nearest hospital.
If you forget to use GOLASEPT 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 your next dose.
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):
- 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 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, 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 GOLASEPT 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 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 GOLASEPT INFLAMMATION AND PAIN 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, sodium monobasic phosphate, poloxamer, peppermint flavour, purified water.
Description of the appearance of GOLASEPT 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
Zeta Farmaceutici S.p.A. – Via Mentana, 38 – 36100 Vicenza (VI)
Manufacturer
Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe, 1 - Cortemaggiore (PC)
Package leaflet: Information for the user
GOLASEPT INFLAMMATION AND PAIN 1.6% mouthwash
Lysine ketoprofen
Please 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 to.
- Keep this leaflet. You may need to read it again.
- If you need more information or advice, contact 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 period.
Contents of this leaflet:
- What GOLASEPT INFLAMMATION AND PAIN is and what it is used for
- What you need to know before using GOLASEPT INFLAMMATION AND PAIN
- How to use GOLASEPT INFLAMMATION AND PAIN
- Possible side effects
- How to store GOLASEPT INFLAMMATION AND PAIN
- Contents of the pack and other information
1. What GOLASEPT INFLAMMATION AND PAIN is and what it is used for
GOLASEPT INFLAMMATION AND PAIN 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 (for example, gingivitis, stomatitis, pharyngitis), including following dental procedures such as caries 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 GOLASEPT INFLAMMATION AND PAIN
Do not use GOLASEPT INFLAMMATION AND PAIN
- 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-type rhinitis (nasal inflammation), 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 GOLASEPT INFLAMMATION AND PAIN.
The use of this medicine, especially if prolonged, may lead to sensitization phenomena (increased response upon repeated dosing) or local irritation; in such cases, treatment must be discontinued and you should consult your doctor, who may prescribe an appropriate therapy.
Do not use this medicine for long periods.
For individuals engaged in sports activities, the use of medicines containing ethanol may result in a positive anti-doping test, depending on the blood alcohol concentration limits set by certain sports federations.
Other medicines and GOLASEPT INFLAMMATION AND PAIN
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 breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
Do not use GOLASEPT 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 GOLASEPT INFLAMMATION AND PAIN if you are breastfeeding.
Driving and using machines
The use of this medicine does not impair the ability to drive or operate machinery.
GOLASEPT INFLAMMATION AND PAIN contains ethanol (ethyl alcohol), parahydroxybenzoates, and
green dye (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 GOLASEPT 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 10 ml, diluted in 100 ml of water, twice daily.
The package includes a dosing 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 GOLASEPT INFLAMMATION AND PAIN 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 GOLASEPT INFLAMMATION AND
PAIN, this will not cause harm, as this dose is equal to that usually used for oral administration.
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 GOLASEPT INFLAMMATION AND PAIN
Do not take 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 gets 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 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 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 GOLASEPT 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 should be used within 9 weeks after first opening the bottle. Any excess product must 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 GOLASEPT INFIAMMAZIONE E DOLORE 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, mint flavor, levomenthol, green dye, monobasic sodium phosphate, purified water.
Description of the appearance of GOLASEPT INFIAMMAZIONE E DOLORE and contents of the pack
Pack containing a 150 ml bottle of solution, equipped with a safety closure and a dosing cup.
Marketing Authorization Holder
Zeta Farmaceutici S.p.A. – Via Mentana, 38 – 36100 Vicenza (VI)
Manufacturer
Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe, 1 - Cortemaggiore (PC)