ROFIXDOL INFLAMMATION PAIN*SPRAY

ROFIXDOL INFLAMMATION AND PAIN 1.6 mg/ml oral mucosa spray
Ketoprofen lysine salt

What it is and what it is used for
ROFIXDOL INFLAMMATION AND PAIN contains the active ingredient ketoprofen lysine salt, a substance belonging to a group of medicines called non-steroidal anti-inflammatory drugs ("NSAIDs") used to relieve pain and inflammation.

This medicine is used as a symptomatic treatment for irritation and/or inflammation of the mouth and throat (e.g., gingivitis, stomatitis, pharyngitis), including following conservative dental treatment (such as cavity fillings) or extractive treatment (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 taking the medicine
Do not use ROFIXDOL INFLAMMATION AND PAIN
- if you are allergic to ketoprofen, other non-steroidal anti-inflammatory drugs ("NSAIDs"), or any of the other ingredients of this medicine (listed in paragraph 6);
- if you have a history of a breathing problem called bronchial asthma;
- if taking medicines such as acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs) has previously caused problems such as asthma attacks, breathing difficulties due to temporary narrowing of the bronchi (bronchospasm) or the presence of polyps inside the nose (nasal polyps), rhinitis (acute rhinitis), allergic skin reactions 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 and breastfeeding").

Warnings and precautions
Consult your doctor or pharmacist before using ROFIXDOL INFLAMMATION AND PAIN.

The use of topical medicines, especially if prolonged, can lead to sensitization (allergy) or local irritation.
In these cases, discontinue treatment and consult your doctor, who can determine an appropriate therapy.

Do not use this medicine for long periods.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The following local side effects may occur:
- irritation;
- allergic phenomena such as swelling of the face, particularly around the mouth and eyes, tongue or throat (angioneurotic edema); this occurs especially in people allergic to non-steroidal anti-inflammatory drugs (NSAIDs).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please consult your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.