ROFIXDOL 16 mg /Ml Mouthwash

Зміст інструкції

1. ROFIXDOL INFLAMMATION AND PAIN 16 mg/ml mouthwash
   1. What is ROFIXDOL INFLAMMATION AND PAIN and what is it used for
   2. What you need to know before using ROFIXDOL INFLAMMATION AND PAIN
   3. How to use ROFIXDOL INFIAMMAZIONE E DOLORE
   4. Possible side effects
   5. How to store ROFIXDOL INFIAMMAZIONE E DOLORE
   6. Contents of the pack and other information
2. ROFIXDOL INFLAMMATION AND PAIN 1.6 mg/ml oral mucosal spray
   1. What is ROFIXDOL INFLAMMATION AND PAIN and what is it used for
   2. What you need to know before using ROFIXDOL INFLAMMATION AND PAIN
   3. How to use ROFIXDOL INFLAMMATION AND PAIN
   4. Possible side effects
   5. How to store ROFIXDOL INFIAMMAZIONE E DOLORE
   6. Contents of the pack and other information

ROFIXDOL INFLAMMATION AND PAIN 16 mg/ml mouthwash

Ketoprofene lysine salt

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.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after a short period.

Contents of this leaflet:

• 1. What ROFIXDOL INFLAMMATION AND PAIN is and what it is used for
• 2. What you need to know before using ROFIXDOL INFLAMMATION AND PAIN
• 3. How to use ROFIXDOL INFLAMMATION AND PAIN
• 4. Possible side effects
• 5. How to store ROFIXDOL INFLAMMATION AND PAIN
• 6. Contents of the pack and other information

1. What is ROFIXDOL INFLAMMATION AND PAIN and what is it used for

ROFIXDOL INFLAMMATION AND PAIN contains the active ingredient lysine ketoprofen salt,
a substance that belongs to a group of medicines called “non-steroidal anti-inflammatory drugs (NSAIDs)” used to relieve pain and inflammation.
This medicine is used as symptomatic treatment in case of irritation and/or inflammation of the
mouth and pharynx (for example gingivitis, stomatitis, pharyngitis), even following conservative dental therapy (such as caries treatment) or extractive therapy (tooth extraction).
See 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 any of the other ingredients of this medicine (listed in section 6);
• if you know you are allergic or have suffered from allergic reactions such as asthma, urticaria or (allergic rhinitis), following the use of other non-steroidal anti-inflammatory drugs (NSAIDs);
• if you are pregnant, suspect you may be pregnant or are breastfeeding (see “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) can give rise to
sensitization (allergy) or local irritation.
In these cases, stop treatment and consult your doctor who will be able to define 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 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 or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist for advice before using this medicine.
Do not use ROFIXDOL INFLAMMATION AND PAIN if you are pregnant, suspect you are pregnant
or are breastfeeding.
Do not use Rofixdol inflammation and pain during pregnancy.
Oral formulations of Ketoprofen can cause adverse effects on the fetus. It is not known whether
Ketoprofen carries the same risk when used on the skin.

Driving and operating machinery
The use of this medicine does not alter the ability to drive vehicles or operate machinery.

ROFIXDOL INFLAMMATION AND PAIN contains ethanol (ethyl alcohol), para-
hydroxybenzoates and green coloring (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 para-hydroxybenzoates (methyl parahydroxybenzoate and propyl-
parahydroxybenzoate) which can cause allergic reactions (including delayed reactions).
This medicine contains the dye quinoline yellow (E104) and the dye patent blue V
(E131) which can cause allergic reactions.

3. How to use ROFIXDOL INFIAMMAZIONE E DOLORE

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is two rinses or gargles a day with 10 ml of Rofixdol infiammazione e
dolore 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, pressing firmly on the cap and rotating it counterclockwise at the same time.
• Perform the rinse or gargle.

If you use more ROFIXDOL INFIAMMAZIONE E DOLORE than you should
No cases of overdose have been reported.
Any accidental swallowing of solution used for rinses and gargles corresponding
to the recommended dose of ROFIXDOL INFIAMMAZIONE E DOLORE does not cause any particular problems.
In case of accidental ingestion/intake of an excessive dose of this medicine, immediately inform
your doctor or go to the nearest hospital.

If you forget to use ROFIXDOL INFIAMMAZIONE E DOLORE
Do not use a double dose to make up for a 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 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 allergic to non-steroidal anti-inflammatory drugs (“NSAIDs”).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell 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 to 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 which is stated on the pack after “Scad”. The expiry
date refers to the last day of that month.
The product must be used within 9 weeks from the first opening of the bottle. Unused product must be
discarded.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What ROFIXDOL INFIAMMAZIONE E DOLORE contains

• The active ingredient is ketoprofene lysine salt: 1 ml of mouthwash contains 16 mg of ketoprofene lysine salt, corresponding to 10 mg of ketoprofene.
• The other ingredients are: glycerol 85%, ethyl alcohol 96%, sodium saccharin, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, mint aroma, levomenthol, green colorant[(containing quinoline yellow (E104) and Patent Blue V(131)], monobasic sodium phosphate, purified water.

Description of the appearance of ROFIXDOL INFIAMMAZIONE E DOLORE and contents of the pack
Pack containing a 150 ml bottle of solution, equipped with a "child-resistant" safety closure, and a measuring cup.

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)

ROFIXDOL INFLAMMATION AND PAIN 1.6 mg/ml oral mucosal spray

Ketoprofene lysine salt

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 do.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after a short period.

Contents of this leaflet:

• 1. What ROFIXDOL INFLAMMATION AND PAIN is and what it is used for
• 2. What you need to know before using ROFIXDOL INFLAMMATION AND PAIN
• 3. How to use ROFIXDOL INFLAMMATION AND PAIN
• 4. Possible side effects
• 5. How to store ROFIXDOL INFLAMMATION AND PAIN
• 6. Contents of the pack and other information

1. What is ROFIXDOL INFLAMMATION AND PAIN and what is it used for

ROFIXDOL INFLAMMATION AND PAIN contains the active ingredient lysine ketoprofen salt,
a substance that belongs to a group of medicines called non-steroidal anti-inflammatory drugs (“NSAIDs”) used to relieve pain and inflammation.
This medicine is used as symptomatic treatment in case of irritation and/or inflammation of the
mouth and pharynx (for example gingivitis, stomatitis, pharyngitis), also following conservative (such as caries treatment) or extractive (tooth extraction) dental therapy.
See 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, 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 breathing problem called previous bronchial asthma;
• if taking medicines such as acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs) has caused you problems in the past such as asthma attacks, difficulty breathing due to temporary narrowing of the bronchi (bronchospasm) or the presence of nodules inside the nose (nasal polyps), cold (acute rhinitis), allergic reactions affecting the skin such as hives or swelling of the face around the eyes and mouth (angioedema);
• if you are pregnant, suspect you are pregnant or are breastfeeding (see section “Pregnancy, breastfeeding and fertility”).

Warnings and precautions
Consult your doctor or pharmacist before using ROFIXDOL INFLAMMATION AND PAIN.
The use, especially if prolonged, of topical medicines can give rise to sensitization phenomena
(allergy) or local irritation.
In these cases, stop treatment and consult your doctor who will be able to define a suitable therapy.
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 interactions with other medicines are known.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before using this medicine.
Do not use ROFIXDOL INFLAMMATION AND PAIN if you are pregnant, suspect you are or are
breastfeeding with breast milk.
Do not use Rofixdol inflammation and pain during pregnancy.
Oral formulations of Ketoprofen can cause adverse effects on the fetus. It is not known whether
Ketoprofen carries the same risk when used on the skin.

Driving and operating machinery
The use of this medicine does not alter the ability to drive vehicles or operate machinery.

ROFIXDOL INFLAMMATION AND PAIN contains para-hydroxybenzoates
This medicine contains para-hydroxybenzoates (methyl parahydroxybenzoate and propyl-
parahydroxybenzoate) which can cause allergic reactions (including delayed reactions).

3. How to use ROFIXDOL INFLAMMATION AND PAIN

Use this medicine following the instructions of your doctor or pharmacist exactly. 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 contains 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 your mouth
• Direct the spray directly towards the affected area.
• Press the applicator to allow the medicine to be released.

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 ingestion/accidental intake of an excessive dose of this medicine, immediately notify
your doctor 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, do so as soon as you remember, unless it is
almost time to use the next dose.
Do not use a double dose to make up for a 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 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 allergic to non-steroidal anti-inflammatory drugs (“NSAIDs”).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell 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 ROFIXDOL INFIAMMAZIONE E DOLORE

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 pack after “Scad”. The expiry
date refers to the last day of that month.
The product must be used within 21 weeks of first opening the bottle. Unused product must be discarded.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What ROFIXDOL INFIAMMAZIONE E DOLORE contains

• The active ingredient is ketoprofene lysine salt: 1 ml of oral mucosal spray contains 1.6 mg of ketoprofene lysine salt, corresponding to 1 mg of ketoprofene.
• The other ingredients are: glycerol 85%, xylitol, methyl parahydroxybenzoate, propyl para-hydroxybenzoate, monobasic sodium phosphate, poloxamer, mint flavour, purified water.

Description of the appearance of ROFIXDOL INFIAMMAZIONE E DOLORE and contents of the
pack
Pack containing a 15 ml bottle of solution with spray pump, cannula and applicator.

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)