Froben Gola

Package leaflet: Information for the patient

FROBEN GOLA 250mg/100ml Mouthwash, Oral Mucosa Spray

flurbiprofen
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 instructed you to do.

• Keep this leaflet. You may need to read it again.
• If you would like more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement or if you notice a worsening of symptoms.

Contents of this leaflet:

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

1. What FROBEN GOLA is and what it is used for

FROBEN GOLA contains flurbiprofen and belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), used to relieve pain, redness, heat and swelling caused by inflammation.
FROBEN GOLA is used to reduce burning, redness, pain and inflammation of the mouth and throat, for example due to:

• gingivitis;
• stomatitis;
• pharyngitis;
• dental procedures (dental treatments).

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

2. What you need to know before using FROBEN GOLA

Do not use FROBEN GOLA

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• if you have had asthma, urticaria, or any other allergic reaction after taking acetylsalicylic acid (known as aspirin) or other NSAIDs;
• if you have a peptic ulcer (stomach or duodenal ulcer), Crohn’s disease, or suffer or have suffered from ulcerative colitis; if you have had two or more episodes of stomach or intestinal ulcer or bleeding; or if you have ever experienced a single episode of stomach and/or intestinal bleeding or perforation due to NSAIDs;
• if you have severe heart, kidney, or liver problems;
• during the last three months of pregnancy.

Warnings and precautions
Talk to your doctor before taking FROBEN GOLA if:

• you are elderly, as you may be more likely to develop adverse reactions to this medicine;
• you are pregnant or planning to become pregnant, or you are breastfeeding;
• you have liver or kidney problems;
• you have heart or blood vessel problems, as medicines like FROBEN GOLA may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. The risk of side effects increases with higher doses and prolonged treatment; do not exceed the recommended dose of FROBEN GOLA or 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, high cholesterol, or smoke);
• you have had a peptic ulcer (stomach or duodenal ulcer) or other stomach or intestinal disorders;
• you have asthma;
• you suffer from systemic lupus erythematosus (SLE, commonly known as lupus) or mixed connective tissue disease, conditions affecting connective tissue and causing joint or muscle pain, skin changes, and problems in other organs;
• you are dehydrated, as you may be more likely to develop kidney problems;
• you have an infection – refer to the section “Infections” below.

BE CAREFUL, because during treatment with all pain and anti-inflammatory medicines (NSAIDs):

• at any time, with or without warning symptoms, even in patients without previous serious gastrointestinal problems, gastrointestinal bleeding, ulceration, or perforation of the stomach or intestine may occur, which can be fatal. The risk of ulceration or bleeding may increase if you are also taking medicines such as oral corticosteroids, anticoagulants, antiplatelet agents, or selective serotonin reuptake inhibitors (see “Other medicines and FROBEN GOLA”).
• very rarely, severe skin reactions have been reported, some of which have been fatal, manifesting as redness, blistering, and skin peeling (e.g., exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis). During the initial phase of therapy, patients appear to be at higher risk: such reactions occur mostly within the first month of treatment.
• infections may worsen, for example, necrotizing fasciitis may develop, characterized by fever, chills, weakness, sweating, diarrhea, vomiting, redness, pain, swelling, and bruising in an area of the body due to tissue necrosis (death of tissue cells).
• headache may occur if used for prolonged periods; in such cases, do not increase the dose of FROBEN GOLA to relieve pain.
• concomitant use of alcohol may increase the risk of gastrointestinal or nervous system side effects.

STOP treatment and contact your doctor if:

• you notice any gastrointestinal symptoms, especially if they involve bleeding;
• a skin rash, mucosal lesions, or any other sign of an allergic reaction appears (e.g., redness, itching, swelling of the face and throat, sudden drop in blood pressure).

Infections
Non-steroidal anti-inflammatory drugs (NSAIDs) may mask signs of infection such as fever and pain. This may delay appropriate treatment of the infection, thereby increasing the risk of complications. If you are taking this medicine during an infection and infection symptoms persist or worsen, consult your doctor or pharmacist immediately.
The above effects have been particularly reported after administration of systemic formulations based on flurbiprofen.
Other medicines and FROBEN GOLA
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines, as some drugs may interact with FROBEN GOLA or increase the risk of adverse events, even serious ones.
In particular, contact your doctor if you are taking:

• diuretics (medicines that increase urine production, e.g., furosemide and spironolactone);
• cardiac glycosides (medicines used for heart conditions, such as digoxin);
• ACE inhibitors (e.g., captopril) or angiotensin II antagonists (e.g., losartan), medicines used for high blood pressure (hypertension);
• anticoagulant medicines (e.g., warfarin), used to prevent blood clotting;
• antiplatelet medicines, used to thin the blood;
• lithium, used in depression;
• zidovudine, an antiviral medicine;
• methotrexate, used to treat certain cancers and certain immune system disorders, such as rheumatoid arthritis;
• cyclosporine and tacrolimus, immunosuppressive medicines used to reduce your immune response;
• medicines known as corticosteroids, used to treat inflammatory diseases (e.g., prednisone, dexamethasone, hydrocortisone);
• antidepressant medicines called selective serotonin reuptake inhibitors (SSRIs) (e.g., paroxetine, fluoxetine);
• antibiotics known as quinolones (e.g., ciprofloxacin);
• mifepristone, a medicine used for abortion (taken now or within the last 12 days);
• any other medicine used for inflammation (NSAIDs), including acetylsalicylic acid (aspirin) and medicines belonging to the COX-2 inhibitor class (e.g., celecoxib).

The interactions listed above have been particularly reported after administration of systemic formulations based on flurbiprofen.
No interactions with other medicines or of any other kind have been reported at the recommended doses.
Pregnancy, breastfeeding, and fertility
If you are planning a pregnancy or have fertility problems, consult your doctor, as this medicine may impair fertility. Oral formulations (e.g., tablets) of flurbiprofen may cause adverse effects in the unborn child. It is not known whether the same risk applies to FROBEN GOLA.
If you are pregnant or breastfeeding, or if you suspect or are planning a pregnancy, ask your doctor or pharmacist for advice before taking this medicine. Do not take FROBEN GOLA during the last three months of pregnancy. Do not take FROBEN GOLA during the first six months of pregnancy unless absolutely necessary and under medical advice. If treatment is necessary during this period, you should take the lowest effective dose for the shortest possible time.
Driving and using machines
Drowsiness, visual disturbances, dizziness, fatigue, and vertigo may occur following the use of NSAIDs. If these side effects occur, do not drive or operate machinery.
FROBEN GOLA 250 mg/100 ml Mouthwash contains

• polyoxyl 40 hydrogenated castor oil, which may cause allergic reactions;
• ethanol. This medicine contains 1 g of alcohol (ethanol) in each 10 ml dose. It may cause a burning sensation on damaged skin.
• mint flavor containing limonene. Limonene may cause allergic reactions.

FROBEN GOLA 250 mg/100 ml Oral Spray contains:

• polyoxyl 40 hydrogenated castor oil, which may cause allergic reactions.
• ethanol. This medicine contains 40 mg of alcohol (ethanol) per dose (2 sprays). It may cause a burning sensation on damaged skin.
• mint flavor containing limonene. Limonene may cause allergic reactions.

3. How to use FROBEN GOLA

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
FROBEN GOLA Mouthwash: 2–3 rinses or gargles per day with 10 ml of undiluted mouthwash or diluted in a small amount of water, without swallowing the medicine. Use this medicine for a maximum of three days.
FROBEN GOLA Spray: 2 sprays, three times a day, directed directly to the affected area. Use this medicine for a maximum of three days.
Do not use FROBEN GOLA for prolonged periods and do not exceed the recommended doses. Consult your doctor if you do not feel better or feel worse after a short period of treatment.
The lowest effective dose for the shortest necessary duration should be used to relieve symptoms.
If you have an infection, contact your doctor or pharmacist immediately if symptoms (such as fever and pain) persist or worsen (refer to section 2).

Use in children and adolescents
No data are available; therefore, the use of FROBEN GOLA in the pediatric population is not recommended.

Method of administration
FROBEN GOLA can be used at any time of day.
FROBEN GOLA is intended for local oral use only and must not be swallowed.

FROBEN GOLA Mouthwash
Use the dosing cup provided in the package to measure the correct dose.
Accidental swallowing of the recommended dose does not pose particular risks, as the amount of flurbiprofen ingested is much lower than the dose commonly taken orally.

FROBEN GOLA Spray
To administer the medicine:

Fig. 1: rotate the nozzle to the right or left, without tampering with the dispenser.
Fig. 2: press the dispenser.
At first use of FROBEN GOLA Spray, press the dispenser several times without product until a regular spray is obtained.

If you take more FROBEN GOLA than you should
If you accidentally ingest an excessive dose of FROBEN GOLA, inform your doctor immediately or go to the nearest hospital. Remember to bring the FROBEN GOLA package with you.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them. In particular, some side effects observed with other medicines containing flurbiprofen, taken orally or topically (e.g. tablets or patches), or with other anti-inflammatory drugs (NSAIDs), may also occur during treatment with FROBEN GOLA.

Stop taking FROBEN GOLA immediately and contact your doctor if any of the following conditions occur:

• severe burning or abdominal pain due to stomach or duodenal (peptic) ulcer. These side effects are uncommon;
• sudden, severe pain in the upper abdomen (perforation of the ulcer). This side effect is uncommon;
• vomiting blood (haematemesis) or black stools (melena), associated with bleeding of the stomach or intestines, unusual tiredness with reduced urine output (due to non-visible bleeding). These side effects are common;
• allergic reactions, even severe ones, such as swelling (angioedema) of the face, eyes, lips, or throat with breathing difficulties (these side effects are uncommon), accompanied by a sudden drop in blood pressure (anaphylactic reaction) (these side effects are rare);
• severe skin rashes with redness, peeling and/or blistering (e.g. erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis). These side effects are very rare;
• breathing problems, even severe such as asthma and dyspnoea (these side effects are uncommon), or bronchospasm (this side effect is uncommon);
• inflammation of the pancreas (pancreatitis). This side effect is very rare;
• swelling of the face, hands, legs (oedema), reduced urine output or difficulty urinating (fluid retention). These side effects are common;
• fatigue, shortness of breath, and leg swelling, symptoms of heart failure; high blood pressure. These side effects are uncommon;
• blood clots in the arteries (which may cause, for example, heart attack or stroke), diseases of the brain's blood vessels (cerebrovascular accidents). The frequency of these side effects is unknown;
• inflammation of the meninges (aseptic meningitis) presenting with: high fever, sudden headache, inability to bend the neck, nausea, vomiting, confusion, drowsiness, and sensitivity to light. The frequency of these side effects is unknown.

Common side effects (may affect up to 1 in 10 people)

• nausea, vomiting, diarrhoea, flatulence, difficulty passing stools (constipation), indigestion, abdominal pain;
• changes in liver function tests, prolonged bleeding time;
• dizziness, migraine, fatigue, malaise.

Uncommon side effects (may affect up to 1 in 100 people)

• reduction in red blood cells (anaemia);
• gastritis, mouth ulcers;
• more or less sudden appearance of skin lesions, such as discoloured spots or widespread rash (skin eruption, purpura), even after exposure to sunlight (photosensitivity reactions), urticaria, itching;
• ringing, buzzing, whistling, or other persistent noises in the ears;
• visual disturbances, altered sensation, vertigo.

Rare side effects (may affect up to 1 in 1,000 people)

• depression, confusion, drowsiness, difficulty falling asleep (insomnia);
• kidney problems (nephrotoxicity) such as nephrotic syndrome, inflammation of the kidney (tubulointerstitial nephritis), changes in kidney function (renal failure).

Very rare side effects (may affect up to 1 in 10,000 people)

• changes in blood parameters: reduced platelet count (thrombocytopenia), reduced white blood cells (leucopenia) or neutrophils (neutropenia), severe reduction in granulocytes (agranulocytosis), reduced red blood cells due to bone marrow problems (aplastic anaemia), destruction of red blood cells leading to reduced numbers (haemolytic anaemia);
• yellowing of the eyes or skin (jaundice, cholestatic jaundice), dark urine, pale stools, itching or abdominal pain, possible signs of liver problems;
• hallucinations.

Side effects not known (frequency cannot be estimated from available data)

• inflammation of the colon and Crohn’s disease;
• eye problems due to inflammation of the optic nerve (optic neuritis), headache (cephalalgia);
• inflammation of the kidneys (glomerulonephritis);
• liver inflammation (hepatitis).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may 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 FROBEN GOLA

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of that month.
FROBEN GOLA Mouthwash: this medicine must not be stored above 25 °C. Use the medicine within 1 year of first opening the bottle.
FROBEN GOLA Spray: this medicine must not be stored above 25 °C; keep the bottle in the outer packaging to protect the medicine from light. Use the medicine within 1 year of first opening the bottle.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What FROBEN GOLA contains
The active substance is flurbiprofen.
100 ml of medicinal product contains: 0.25 g of flurbiprofen.
The other components are: purified water, ethanol, patent blue V (E131), glycerol, mint flavour
(containing limonene), hydrogenated castor oil 40-polyoxyethylene, potassium bicarbonate, sodium
saccharin, sorbitol.
Description of the appearance of FROBEN GOLA and package contents
FROBEN GOLA Mouthwash: 160 ml bottle with dosing cup.
FROBEN GOLA Spray: 15 ml bottle with micro-dosing pump and dispenser.
Marketing Authorization Holder
Cooper Consumer Health B.V.
Verrijn Stuartweg 60 – 1112 AX Diemen
(The Netherlands)
Manufacturer
AbbVie S.r.l – S.R. 148 Pontina Km 52 snc - 04011 Campoverde di Aprilia (LT).