Name
BENACTIV THROAT 8.75 mg Lemon and Honey flavoured lozenges
BENACTIV THROAT 8.75 mg Sugar Free Lozenges Orange Flavor
BENACTIV THROAT 8.75 mg Sugar-Free Lozenges Eucalyptus and Manuka Honey Flavour
Flurbiprofen


What it is and what it is used for
BENACTIV GOLA contains flurbiprofen, a non-steroidal anti-inflammatory and analgesic (painkiller) medicine, which acts against inflammation and pain in the throat, mouth and gums.

BENACTIV THROAT Lemon and Honey flavoured Lozenges, BENACTIV THROAT Sugar-Free Lozenges Orange flavoured and BENACTIV THROAT Sugar-Free Lozenges Eucalyptus and Manuka Honey flavoured are used in adults and adolescents over 12 years of age to treat the symptoms of pain and irritation of the gums, mouth and throat (e.g. gingivitis, stomatitis, pharyngitis).
BENACTIV THROAT Sugar-Free Lozenges Orange Flavour are indicated if you and/or your teenager need to control their sugar and calorie intake.

Talk to your doctor if you do not feel better or if you feel worse after 3 days of treatment (see section 3).


What you need to know before taking the medicine
Do not take BENACTIV THROAT
- If you are allergic to flurbiprofen or any of the other ingredients of this medicine (listed in section 6);
- if you are allergic to acetylsalicylic acid (a medicine used to treat inflammation, pain, fever and heart problems) or to other non-steroidal anti-inflammatory drugs (NSAIDs) (see section "Other medicines and BENACTIV THROAT");
- if you have suffered in the past from 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 suffer frequently from peptic ulcer (stomach sore) or bleeding from 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 renal failure (reduced kidney function).

Do not take/give BENACTIV GOLA in the last 3 months of pregnancy (see section "Pregnancy, breastfeeding and fertility").

Do not give BENACTIV THROAT Lozenges to children under 12 years of age.


Warnings and precautions
Talk to your doctor or pharmacist before taking BENACTIV THROAT.

In particular, tell your doctor if you:
- have suffered from bronchial asthma (a breathing disease) in the past, as this increases the risk that you may develop bronchospasm (narrowing of the bronchi which causes severe breathing difficulty due to reduced airflow);
- has suffered from allergies in the past;
- are taking other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs);
- suffers from systemic lupus erythematosus or mixed connective tissue disease;
- suffer from reduced kidney, heart or liver function (renal, cardiac or hepatic failure);
- suffer from hypertension (high blood pressure);
- you are taking other painkillers for a long time or without respecting the dosage, as headache may occur;
- have suffered from peptic ulcer (stomach lesion) and other stomach and intestinal diseases in the past as this increases the risk that these diseases may recur.
This risk increases especially with high doses of flurbiprofen, if you are elderly or if your peptic ulcer has been complicated by bleeding or perforation of the stomach and intestine (see section 4 "Possible side effects");
- if you are elderly (as you are more likely to experience side effects);
- if you have heart or blood vessel problems, as medicines such as BENACTIV GOLA may be associated with a small increase in the risk of heart attack (myocardial infarction) or stroke. The risk of side effects increases with high doses and prolonged treatment; do not exceed the dose of BENACTIV GOLA and do not take it for long periods. Tell your doctor if you have heart problems, a history of stroke or think you may be at risk of these conditions (for example if you have high blood pressure, diabetes or high cholesterol or if you smoke);
- have an infection – see “Infections” below.

Infections
Nonsteroidal anti-inflammatory drugs (NSAIDs) may hide signs of infection such as fever and pain. This may delay appropriate treatment of the infection, which may increase the risk of complications. If you take this medicine during an infection and the symptoms of the infection 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, may give rise to allergic or local irritation phenomena (see paragraph 4 "Possible side effects"); in such cases, stop the treatment and consult your doctor who, if necessary, will carry out an appropriate therapy.

If you experience mouth irritation, stop treatment.

Children and adolescents
Do not give BENACTIV THROAT Lozenges 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 during treatment with BENACTIV 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 may occur with the tablets)
• respiratory phenomena: asthma, bronchospasm, wheezing or shortness of breath
• various skin disorders: various types of skin rashes, itching, redness, swelling, skin loss, blisters, peeling or ulceration of the skin and mucous membranes.

If you experience the following side effects at the beginning of treatment with BENACTIV GOLA, 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 suffered from stomach and intestinal diseases in the past.

Additionally, you may experience the following side effects:

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

Uncommon (may affect up to 1 in 100 people)
- drowsiness;
- asthma;
- bronchospasm (narrowing of the bronchi which causes severe breathing difficulty due to reduced airflow);
- dyspnea (shortness of breath);
- blisters in the mouth or throat;
- numbness of the mouth or throat;
- abdominal distension;
- stomach pain;
- constipation;
- dry mouth;
- difficulty digesting;
- flatulence (emission of gas from the intestine);
- inflammation of the tongue, including pain and burning of the tongue;
- alteration of taste;
- vomit;
- 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 a 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 and even blindness);
- migraine (chronic disease characterized by recurrent headaches);
- confusion;
- dizziness;
- angioedema (inflammatory reaction of the skin);
- hypersensitivity;
- tinnitus (ringing in the ears);
- heart failure;
- edema (swelling);
- hypertension (high blood pressure);
- blood in the stool;
- blood in vomit;
- loss of blood from the stomach and intestines;
- colitis;
- worsening of inflammatory diseases of the colon and intestine (Crohn's disease);
- inflammation of the stomach lining (gastritis);
- stomach injury (peptic ulcer);
- gastric perforation;
- bleeding due to stomach injury;
- hives (redness of the skin accompanied by itching);
- purpura (appearance of purple skin patches of various 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 (inflammation of the kidneys);
- nephrotic syndrome (alteration of the renal glomeruli which causes a loss of proteins in the urine);
- renal failure (reduced kidney function);
- unease;
- fatigue;
- hepatitis;
- depression;
- hallucination.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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.