Rofixdol inflammation and pain
Italy
Table of Contents
Package leaflet: Information for the user
ROFIXDOL INFLAMMATION AND PAIN 16 mg/ml mouthwash
Lysine ketoprofen
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 told you to do.
- Keep this leaflet. You may need to read it again.
- If you need more information or advice, consult your pharmacist.
- If any of the side effects occur, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
- Consult your doctor if you do not notice any improvement or if your symptoms worsen after a short time.
Contents of this leaflet:
- What ROFIXDOL INFLAMMATION AND PAIN is and what it is used for
- What you need to know before using ROFIXDOL INFLAMMATION AND PAIN
- How to use ROFIXDOL INFLAMMATION AND PAIN
- Possible side effects
- How to store ROFIXDOL INFLAMMATION AND PAIN
- Contents of the pack and other information
1. What ROFIXDOL INFIAMMAZIONE E DOLORE is and what it is used for
ROFIXDOL INFIAMMAZIONE E DOLORE contains the active substance ketoprofen lysine salt,
a substance belonging to a group of medicines known as "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 after conservative 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 ROFIXDOL INFLAMMATION AND PAIN
Do not use ROFIXDOL INFLAMMATION AND PAIN
- if you are allergic to ketoprofen or to any of the other ingredients of this medicine (listed in section 6);
- if you know you are allergic or have previously experienced allergic reactions such as asthma, urticaria, or allergic-type rhinitis (nasal congestion due to allergy), after taking other non-steroidal anti-inflammatory drugs (NSAIDs);
- if you are pregnant, suspect you may be pregnant, or are breastfeeding (see section “Pregnancy, breastfeeding and fertility”).
Warnings and precautions
Talk to your doctor or pharmacist before using ROFIXDOL INFLAMMATION AND PAIN.
The use, especially if prolonged, of topical medicines (for local use) may lead to sensitization (allergy) or local irritation.
In such cases, stop treatment and consult your doctor, who will determine appropriate management.
Do not use this medicine for long periods.
Other medicines and ROFIXDOL INFLAMMATION AND PAIN
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, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Do not use ROFIXDOL INFLAMMATION AND PAIN if you are pregnant, suspect you may be pregnant, or are breastfeeding.
Do not use Rofixdol Inflammation and Pain during pregnancy.
Oral formulations of ketoprofen may cause adverse effects on the fetus. It is not known whether ketoprofen poses the same risk when applied to the skin.
Driving and using machines
This medicine does not affect the ability to drive or operate machinery.
ROFIXDOL INFLAMMATION AND PAIN contains ethanol (ethyl alcohol), parahydroxybenzoates and the colouring agents green (quinoline yellow and patent blue V)
This medicine contains 400 mg of alcohol (ethanol) in each 10 ml dose. It may cause a burning sensation on damaged skin.
This medicine contains parahydroxybenzoates (methyl parahydroxybenzoate and propyl parahydroxybenzoate) which may cause allergic reactions (including delayed reactions).
This medicine contains the colouring agent quinoline yellow (E104) and patent blue V (E131), which may cause allergic reactions.
3. How to use ROFIXDOL INFLAMMATION AND PAIN
Use this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is two mouth rinses or gargles per day, using 10 ml of Rofixdol Inflammation and
Pain diluted in approximately 100 ml of water.
Do not exceed the recommended doses.
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 mouth rinse or gargle.
If you use more ROFIXDOL INFLAMMATION AND PAIN than you should
No cases of overdose have been reported.
Accidental swallowing of the solution used for rinsing or gargling, corresponding to the recommended dose of ROFIXDOL INFLAMMATION AND PAIN, does not cause any particular effects.
In case of accidental ingestion/overdose of this medicine, contact your doctor immediately or go to the nearest hospital.
If you forget to use ROFIXDOL INFLAMMATION AND PAIN
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 local side effects may occur:
- irritation;
- allergic reactions such as swelling of the face, particularly around the mouth and eyes, tongue or throat (angioedema); this occurs especially in individuals 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 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 ROFIXDOL INFIAMMAZIONE E DOLORE
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton 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. Unused product must be discarded.
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. Package contents and other information
What ROFIXDOL INFIAMMAZIONE E DOLORE contains
- The active substance is ketoprofen lysine salt: 1 ml of mouthwash contains 16 mg of ketoprofen lysine salt, corresponding to 10 mg of ketoprofen.
- The other components are: glycerol 85%, ethyl alcohol 96%, sodium saccharin, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, peppermint flavour, levomenthol, green colouring [(containing quinoline yellow (E104) and patent blue V (E131))], monobasic sodium phosphate, purified water.
Description of the appearance of ROFIXDOL INFIAMMAZIONE E DOLORE and contents of the
package
Pack containing one 150 ml bottle of solution, equipped with a "child-resistant" safety closure, and a dosing spoon.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pool Pharma S.r.l. - Via Basilicata, 9 - 20098 San Giuliano Milanese (MI)
Manufacturer
Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe, 1 - Cortemaggiore (PC)
Package leaflet: Information for the user
ROFIXDOL INFLAMMATION AND PAIN 1.6 mg/ml oral mucosa spray
Ketoprofen lysine salt
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 any side effects occur, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
- Consult your doctor if you do not notice improvement or if you notice worsening of symptoms after a short period of time.
Contents of this leaflet:
- What ROFIXDOL INFLAMMATION AND PAIN is and what it is used for
- What you need to know before using ROFIXDOL INFLAMMATION AND PAIN
- How to use ROFIXDOL INFLAMMATION AND PAIN
- Possible side effects
- How to store ROFIXDOL INFLAMMATION AND PAIN
- Contents of the pack and other information
1. What is ROFIXDOL INFIAMMAZIONE E DOLORE and what is it used for?
ROFIXDOL INFIAMMAZIONE E DOLORE contains the active substance ketoprofen lysine salt,
a compound belonging to a group of medicines called non-steroidal anti-inflammatory drugs (“NSAIDs”),
used to relieve pain and inflammation.
This medicine is indicated for the symptomatic treatment of irritation and/or inflammation of the
mouth and throat (e.g. gingivitis, stomatitis, pharyngitis), including that following conservative 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 should know before using ROFIXDOL INFLAMMATION AND PAIN
Do not use ROFIXDOL INFLAMMATION AND PAIN
- if you are allergic to ketoprofen, 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 had 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 facial swelling around the eyes and mouth (angioedema);
- if you are pregnant, suspect you may be pregnant, or are breastfeeding (see section "Pregnancy, breastfeeding and fertility").
Warnings and precautions
Talk to your doctor or pharmacist before using ROFIXDOL INFLAMMATION AND PAIN.
The use, especially if prolonged, of topical medicines may lead to sensitization (allergy) or local irritation.
If this occurs, stop treatment and consult your doctor, who will determine appropriate therapy.
Do not use this medicine for long periods.
Other medicines and ROFIXDOL INFLAMMATION AND PAIN
Tell your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines.
No interactions with other medicines are known.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Do not use ROFIXDOL INFLAMMATION AND PAIN if you are pregnant, suspect pregnancy, or are breastfeeding.
Do not use Rofixdol Inflammation and Pain during pregnancy.
Oral formulations of ketoprofen may cause adverse effects on the fetus. It is not known whether ketoprofen poses the same risk when applied to the skin.
Driving and using machines
This medicine does not affect the ability to drive or operate machinery.
ROFIXDOL INFLAMMATION AND PAIN contains para-hydroxybenzoates
This medicine contains para-hydroxybenzoates (methyl parahydroxybenzoate and propyl parahydroxybenzoate), which may cause allergic reactions (including delayed reactions).
3. How to use ROFIXDOL INFLAMMATION AND PAIN
Use this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
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.
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.
If you use more ROFIXDOL 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 a large amount of this medicine, contact your doctor immediately or go to the nearest hospital.
If you forget to use ROFIXDOL INFLAMMATION AND PAIN
If you forget to use a dose of the medicine, use 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 the missed dose.
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 can cause side effects, although not everybody gets them.
The following local side effects may occur:
- 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, 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 ROFIXDOL 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 pack 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. Unused product must be discarded.
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. Package contents and other information
What ROFIXDOL INFLAMMATION AND PAIN contains
- The active substance is ketoprofen lysine salt: 1 ml of oral mucosa spray contains 1.6 mg of ketoprofen lysine salt, equivalent to 1 mg 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 ROFIXDOL INFLAMMATION AND PAIN and contents of the
packaging
Packaging containing one 15 ml bottle of solution with spray pump, cannula and dispenser.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
POOL PHARMA S.r.l. - Via Basilicata, 9 - 20098 San Giuliano Milanese (MI)
Manufacturer
Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe, 1 - Cortemaggiore (PC)