ROFIXDOL GOLA*16PAST. LEMON HONEY

RofixDol Throat 8.75 mg lemon and honey flavor lozenges
Flurbiprofen

What it is and what it is used for
RofixDol Throat contains the active ingredient flurbiprofen, belonging to the class of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). These medicines are used to relieve pain and inflammation.

RofixDol Throat is used to relieve symptoms such as irritation and/or inflammation of the mouth and pharynx (e.g., gingivitis, stomatitis, pharyngitis).

Consult your doctor if you do not feel better or if you feel worse after short periods of treatment.

What you need to know before taking the medicine
Do not take RofixDol Throat
- if you are allergic to flurbiprofen or any of the ingredients of this medicine (listed in section 6);
- if you are allergic to acetylsalicylic acid (medicine for inflammation, pain, fever, and heart conditions) or other non-steroidal anti-inflammatory drugs (NSAIDs) (see section Other medicines and RofixDol Throat);
- if you have a history of bleeding or perforation of the stomach or intestine related to previous treatments with non-steroidal anti-inflammatory drugs (NSAIDs);
- if you suffer from chronic inflammatory bowel diseases (ulcerative colitis and Crohn's disease);
- if you frequently suffer from peptic ulcers (stomach lesions) or bleeding of the stomach or intestine (two or more distinct episodes of ulcer or bleeding);
- if you suffer from severe heart failure (reduced heart function), severe liver failure (reduced liver function), and severe kidney failure (reduced kidney function).

Do not take/give RofixDol Throat during the last 3 months of pregnancy (see section Pregnancy, breastfeeding, and fertility).

Do not give this medicine to children under 12 years of age (see Children).

Warnings and precautions
Consult your doctor or pharmacist before taking RofixDol Throat.
In particular, inform your doctor if you:
- have a history of bronchial asthma (a respiratory illness), as it increases the risk of bronchospasm (narrowing of the bronchi causing severe breathing difficulties due to reduced air passage);
- have a history of allergies;
- are taking other Non-Steroidal Anti-inflammatory Drugs (NSAIDs);
- suffer from systemic lupus erythematosus or mixed connective tissue disease;
- suffer from reduced kidney, heart, or liver function (renal, cardiac, or hepatic insufficiency);
- suffer from hypertension (high blood pressure);
- are taking other analgesics for a long time or without respecting the dosage, as headache may occur;
- have a history of peptic ulcers (stomach lesions) and other stomach and intestinal diseases, as the risk of these diseases recurring increases;
- This risk increases especially with high doses of flurbiprofen, if you are elderly, or if the peptic ulcer has been complicated by bleeding or perforation of the stomach and intestine (see section 4 Possible side effects);
- If you are elderly (because you are more likely to experience side effects);
- if you have heart or blood vessel problems, as medicines like RofixDol Throat may be associated with a modest increased risk of heart attack (myocardial infarction) or stroke. The risk of side effects increases with high doses and prolonged treatments; do not exceed the dose of RofixDol Throat and do not take it for long periods. Inform your doctor if you have heart problems, a history of stroke, or think you may be at risk for these conditions (for example, if you have high blood pressure, diabetes, or high cholesterol, or if you smoke);
- have an infection - refer to the Infections section below.

Infections
Non-steroidal anti-inflammatory drugs (NSAIDs) can mask signs of infection such as fever and pain. This can delay appropriate treatment of the infection, which, in turn, can lead to an increased risk of complications. If you take this medicine during an infection and the infection symptoms persist or worsen, contact your doctor or pharmacist immediately.

Report any unusual abdominal symptoms to your doctor.

The use of this medicine, especially if prolonged, can give rise to allergic phenomena or local irritation (see section 4 Possible side effects); in such cases, stop treatment and consult your doctor who, if necessary, will carry out appropriate therapy.

If you experience mouth irritation, stop treatment.

Side effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see How to take RofixDol Throat).

Children and adolescents
Do not give this medicine to children under 12 years of age

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience the following side effects while being treated with Rofixdol Throat, STOP treatment and contact your doctor immediately:
• allergic phenomena (sensitization phenomena):
- allergic reaction
- anaphylactic reactions (severe allergic reactions)
- angioedema (sudden swelling of the mouth/throat and mucous membranes)
• local irritation
• sensations of heat or tingling in the mouth and throat (this effect can occur with lozenges)
• respiratory phenomena: asthma, bronchospasm, shortness of breath or dyspnea
• various skin disorders: skin rashes of various types, itching, redness, swelling, skin loss, blisters, desquamation or ulceration of the skin and mucous membranes.

If you experience the following side effects at the beginning of treatment with Rofixdol Throat, contact your doctor immediately:
- abdominal pain
- peptic ulcer (stomach lesion)
- perforation and bleeding of the stomach or intestine.
These side effects can be fatal and you may experience them with or without warning symptoms. These side effects occur especially if you are elderly or if you have a history of stomach and intestinal diseases.

In addition, you may experience the following side effects:

Common (may affect up to 1 in 10 people)
- dizziness;
- headache;
- paraesthesia (numbness of the limbs or other body parts, including the mouth);
- throat irritation;
- diarrhea;
- lesions inside the mouth;
- nausea;
- mouth and throat pain;
- sensation of heat or burning, tingling of the mouth.

Uncommon (may affect up to 1 in 100 people)
- drowsiness;
- asthma;
- bronchospasm (narrowing of the bronchi causing severe breathing difficulties due to reduced air passage);
- dyspnea (shortness of breath);
- blisters in the mouth or throat;
- numbness of the mouth or throat;
- abdominal distension;
- abdominal pain;
- constipation;
- dry mouth;
- inflammation of the oral cavity with lesions (ulcerative stomatitis);
- indigestion;
- flatulence (gas emission from the intestine);
- inflammation of the tongue, including pain and burning of the tongue;
- altered taste;
- vomiting;
- skin rash;
- itching;
- fever;
- pain;
- insomnia.

Rare (may affect up to 1 in 1,000 people)
- anaphylactic reactions (severe allergic reaction).

Not known (frequency cannot be estimated from the available data)
- anemia (reduction in the amount of red blood cells in the blood)
- thrombocytopenia (reduction in the number of platelets in the blood)
- aplastic anemia (reduction in the amount of all types of blood cells, red blood cells,
- white blood cells, platelets)
- agranulocytosis (reduction in the number of granulocytes, a type of white blood cell, in the blood)
- cerebrovascular accidents (diseases caused by lack of blood flow to an area of the brain)
- visual disturbances
- optic neuritis (severe inflammation of the optic nerve, which can lead to reduced vision up to blindness)
- migraine (chronic disease characterized by recurrent headaches)
- confusion
- dizziness
- angioedema (inflammatory skin reaction)
- hypersensitivity
- tinnitus (ringing in the ears)
- heart failure
- edema (swelling)
- hypertension (high blood pressure)
- blood in stools
- blood in vomit
- blood loss from the stomach and intestine
- colitis
- worsening of inflammatory diseases of the colon and intestine (Crohn's disease)
- inflammation of the stomach lining (gastritis)
- stomach lesion (peptic ulcer)
- gastric perforation
- bleeding due to stomach lesion
- urticaria (skin redness accompanied by itching)
- purpura (appearance of purplish skin patches of different sizes)
- bullous dermatoses (severe skin lesions characterized by erythema, bullous lesions with areas of skin detachment), including Stevens-Johnson syndrome, toxic epidermal necrolysis, and erythema multiforme
- renal toxicity
- tubulointerstitial nephritis (kidney inflammation)
- nephrotic syndrome (alteration of the renal glomeruli leading to protein loss in the urine)
- renal failure (reduced kidney function)
- discomfort
- fatigue
- hepatitis
- depression
- hallucination.

Reporting of side effects
If you get any side effects, including any 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/segnalazionireazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.