FLOMAX GOLA 0.25% Mouthwash

Зміст інструкції

1. FLOMAX GOLA 0,25% Mouthwash, Oral Mucosa Spray
   1. What is Flomax Gola and what is it used for
   2. What you need to know before taking Flomax Gola
   3. How to take Flomax Gola
   4. Possible side effects
   5. How to store Flomax Gola
   6. Contents of the pack and other information

FLOMAX GOLA 0,25% Mouthwash, Oral Mucosa Spray

Flurbiprofen

Read this leaflet carefully before taking this medicine as it contains important information for you.
Always take 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 of treatment.

Contents of this leaflet:

• 1. What Flomax Gola is and what it is used for
• 2. What you need to know before you take Flomax Gola
• 3. How to take Flomax Gola
• 4. Possible side effects
• 5. How to store Flomax Gola
• 6. Contents of the pack and other information

1. What is Flomax Gola and what is it used for

Flomax Gola is a medicine that contains flurbiprofen, a non-steroidal anti-inflammatory drug that acts against
inflammation and pain of the throat, mouth and gums.
Flomax Gola is used in the treatment of symptoms of pain and irritation of the gums, mouth and
throat (e.g. gingivitis, stomatitis, pharyngitis), even as a result of conservative or
extraction dental therapy (e.g. treatment of cavities or 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 taking Flomax Gola

Do not take Flomax Gola if:

• you are allergic to flurbiprofen or any of the other ingredients of this medicine (listed in section 6);
• you have had allergy or asthma after taking other medicines used for pain and inflammation (non-steroidal anti-inflammatory drugs, NSAIDs) such as aspirin;
• you have previously experienced bleeding or perforation of the stomach or intestine due to taking NSAIDs;
• you have had two or more distinct episodes of peptic ulcer (lesion of the stomach or the first part of the intestine) or bleeding in the stomach or intestine (including blood in vomit or during bowel movements or black, tarry stools);
• you suffer from or have suffered from inflammatory bowel disease or small intestine disease (ulcerative colitis and Crohn's disease);
• you suffer from severe reduction of heart function (heart failure);
• you suffer from severe reduction of liver function;
• you suffer from severe reduction of kidney function
• you are in the last three months of pregnancy (see section “Pregnancy and breastfeeding”);
• you are under 12 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking Flomax Gola .
In particular, tell your doctor if:

• you have suffered from bronchial asthma (a respiratory disease) in the past, as this increases the risk that you may experience bronchospasm (narrowing of the bronchi causing severe breathing difficulties due to reduced airflow);
• you have suffered from allergies in the past;
• you are taking other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs);
• you suffer from systemic lupus erythematosus or mixed connective tissue disease;
• you suffer from reduced kidney, heart or liver function (renal, cardiac or hepatic insufficiency);
• you suffer from high blood pressure (hypertension);
• you have been taking other pain relievers for a long time or without respecting the dosage, as headache may occur;
• you have previously suffered from peptic ulcer (stomach lesion) and other diseases of the stomach and intestines 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 the peptic ulcer has been complicated by bleeding or perforation of the stomach and intestine (see section “4 Possible side effects”);
• you are elderly (because you are more likely to experience side effects);
• you have problems with the heart or blood vessels, as medicines like Flomax Gola may be associated with a modest increase in the risk of heart attack (myocardial infarction) or stroke. The risk of experiencing side effects increases with high doses and prolonged treatments; do not exceed the dose of Flomax 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 for these conditions (for example if you have high blood pressure, diabetes or high cholesterol or smoke);
• you have an infection - refer to the “Infections” section below.

Infections
Non-steroidal anti-inflammatory drugs (NSAIDs) can mask signs of infections such as fever and pain.
This can delay appropriate treatment of the infection, which in turn can lead to an increase in the
risk of complications. If you are taking this medicine during an infection and the symptoms of the infection
persist or worsen, see your doctor or pharmacist immediately.
Tell your doctor about any unusual abdominal symptoms.
The use of this medicine, especially if prolonged, can cause allergic or local irritation reactions
(see section 4 “Possible side effects”); in such cases, stop treatment and consult your doctor
who, if necessary, will prescribe appropriate therapy.
If you experience irritation of the mouth, stop treatment.

Other medicines and Flomax Gola
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
In particular, tell your doctor if you are taking any of the following medicines, as concomitant use
with flurbiprofen should be avoided:

• medicines containing acetylsalicylic acid(medicine for inflammation, pain, fever and heart disorders), as they may increase side effects;
• antiplatelet agents(medicines that make the blood more fluid, such as low-dose daily aspirin), as it increases the risk of bleeding in the stomach and intestines;
• anticoagulants(medicines that slow down or inhibit the blood clotting process, such as warfarin), as their effect may be potentiated by NSAIDs;
• selective serotonin reuptake inhibitors(medicines used for depression), as it increases the risk of bleeding in the stomach and intestines;
• antihypertensive medicines(ACE inhibitors, angiotensin II antagonists and diuretics), as NSAIDs may reduce the effect of diuretics or some antihypertensive medicines may increase renal toxicity;
• alcohol, as it may increase the risk of side effects, especially the risk of bleeding in the stomach and intestines;
• cardiac glycosides(medicines that affect heart function), as NSAIDs may worsen heart failure and increase the level of glycosides in the blood;
• cyclosporine(medicine that prevents organ rejection after transplantation), as it increases the risk of renal toxicity;
• corticosteroids(medicines used against inflammation/allergies), as it increases the risk of having lesions or bleeding in the stomach and intestines;
• lithium(medicine used for behavioral disorders), as the level of lithium in the blood may increase;
• methotrexate(medicine used for psoriasis, arthritis and tumors), as the level of methotrexate in the blood may increase;
• mifepristone(medicine used to terminate a pregnancy): NSAIDs should not be used for 8 - 12 days after taking mifepristone, as they reduce its effect;
• quinolone antibiotics(medicines used for bacterial infections), as NSAIDs may increase the risk of developing seizures;
• tacrolimus(immunosuppressant medicine used after organ transplantation), as NSAIDs may increase the risk of renal toxicity;
• zidovudine(medicine used for AIDS), as NSAIDs increase the risk of blood toxicity;
• Cox-2 inhibitors and other NSAIDs(medicines used against inflammation and pain), as it may increase the effect of these medicines and the risk of side effects.

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, if you suspect or are planning a pregnancy,
ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Oral formulations (e.g. tablets) of flurbiprofen can cause adverse effects in the unborn child. It is
not known whether the same risk applies to FLOMAX GOLA.
Do not take FLOMAX GOLA in the last three months of pregnancy. Do not take FLOMAX GOLA in the first 6
months of pregnancy unless absolutely necessary and as directed by your doctor. If treatment is necessary
during this period, you should take the minimum dose for the shortest possible time.

Breastfeeding
The use of flurbiprofen during breastfeeding is not recommended; your doctor will decide whether to let you take
Flomax Gola.

Fertility
Flurbiprofen belongs to a group of medicines that can affect female fertility. This
effect is reversible when the medicine is discontinued. Occasional use of
this medicine is unlikely to affect the chances of becoming pregnant. However, ask your doctor if
you have fertility problems before taking the medicine.

Driving and using machines
No studies have been conducted on the ability to drive vehicles and operate machinery.

For athletes
The use of medicines containing ethyl alcohol may result in a positive doping test in relation to the concentration limits
of alcohol indicated by some sports federations.

Flomax Gola contains

Hydrogenated castor oil-40-polyoxyethylene: may cause localized skin reactions.

Parahydroxybenzoates: may cause allergic reactions (even delayed).

Patent blue V dye (E131): may cause allergic reactions.

3. How to take Flomax Gola

Take this medicine following exactly as indicated in this leaflet, or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The lowest effective dose should be used for the shortest time necessary to relieve symptoms. If you have an infection, consult your doctor or pharmacist immediately if symptoms (such as fever and pain)
persist or worsen (see section 2).
Caution: do not exceed the indicated doses without your doctor's advice.

Mouthwash
The recommended dose is 2 or 3 rinses or gargles per day with 10 ml of mouthwash. It may be diluted with
water.

Oral mucosal spray
For the first use of the product, press the applicator several times into the air until a regular spray is obtained.
The recommended dose is 2 sprays 3 times a day.
Spray the solution, directing it directly onto the affected area (mouth, throat). You can rotate the applicator nozzle to the right or left, being careful not to tamper with the applicator.
At the recommended doses, accidental ingestion does not cause any harm, although it is advisable not to
swallow the product.

Duration of treatment
Use Flomax Gola only for short periods of treatment.
Consult your doctor if the disorder occurs repeatedly or if you have noticed any recent change in its
characteristics.

If you take more Flomax Gola than you should
Immediately inform your doctor or go to the nearest hospital.
In the event of accidental ingestion of significant amounts of flurbiprofen, you may experience
symptoms such as nausea, vomiting and irritation of the stomach or intestines. In such cases, appropriate
treatments will be adopted.

If you forget to take Flomax Gola
Do not take a double dose to make up for the forgotten dose.

If you stop taking Flomax Gola
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 everyone will experience them.
STOP taking Flomax Gola immediately and contact your doctor if you experience severe

allergic reactionssuch as: swelling (angioedema) of the face, eyes, lips, throat; sudden
drop in blood pressure (anaphylactic shock).
The following side effects may also occur, reported particularly after taking
formulations for non-local (systemic) use, the frequency of which is unknown:

Disorders affecting the blood

• reduction in the number of platelets in the blood (thrombocytopenia);
• reduction in the amount of red blood cells in the blood (anemia);
• reduction in the amount of all types of blood cells (aplastic anemia);
• reduction in the number of granulocytes, a type of white blood cells in the blood (agranulocytosis).

Disorders affecting the mind

• depression;
• confusion;
• perception of things that do not exist in reality (hallucination).

Disorders affecting the nervous system

• dizziness;
• illness caused by a lack of blood flow to an area of the brain by an artery (cerebrovascular accidents);
• severe inflammation of the optic nerve, which can lead to reduced vision up to blindness (optic neuritis);
• headache (migraine);
• alteration of the sensitivity of the limbs or other parts of the body consisting of the onset of tingling, prickling, itching (paresthesia);
• drowsiness.

Disorders affecting the eye

• visual disturbances.

Disorders affecting the ear

• vertigo;
• ringing in the ears (tinnitus).

Disorders affecting the heart and blood vessels

• edema;
• high blood pressure (hypertension);
• reduced heart function (heart failure). Clinical studies and epidemiological data suggest that taking some NSAIDs (especially at high doses and in case of long-term treatment) may be associated with an increased risk of blood clot formation in blood vessels, which reduce blood flow to the heart or brain, for example (arterial thrombotic events such as heart attack or stroke).

Respiratory disorders

• difficulty breathing or shortness of breath (asthma, bronchospasm, dyspnea);
• blisters in the mouth or throat;
• decreased sensitivity or feeling of numbness in the oral cavity (oral dysesthesia)

Disorders affecting the mouth, stomach and intestines (gastrointestinal)

• nausea;
• vomiting;
• diarrhea;
• release of gas from the intestines (flatulence);
• difficulty evacuating (constipation);
• difficulty digesting (dyspepsia);
• sensation of pain/burning in the tongue (glossodynia);
• altered taste (dysgeusia);
• pain in the mouth and throat;
• dry mouth;
• abdominal swelling;
• abdominal pain;
• blood, black in color, in the stool (melena);
• vomiting blood (hematemesis);
• ulcers inside the mouth (ulcerative stomatitis);
• bleeding from the stomach and intestines (gastrointestinal hemorrhage);
• worsening of inflammatory diseases of the colon and small intestine (colitis and Crohn's disease);
• inflammation of the stomach (gastritis);
• lesion of the stomach and the first part of the intestine (peptic ulcer);
• perforation of the stomach or intestine;
• inflammation of the pancreas (pancreatitis); (very rare).

Disorders affecting the skin and underlying tissue

• skin rash (also localized);
• itching;
• redness with rounded raised areas of the skin accompanied by itching (urticaria);
• appearance of patches of skin of various sizes, purple in color (purpura);
• severe skin rashes with redness, blistering and exfoliation (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme); (very rare).

Disorders affecting the kidneys and urinary tract

• kidney disorders including, inflammation of the kidney (interstitial nephritis), loss of blood proteins through the kidney (nephrotic syndrome), reduced kidney function (renal insufficiency), (rare).

Systemic disorders

• malaise;
• fatigue;
• fever;
• pain. Disorders affecting the liver
• hepatitis.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at http://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 Flomax Gola

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the pack after Exp. The expiry date
refers to the last day of that month.

Mouthwash
This medicine does not require any special storage conditions
After first opening the bottle, use the product within 9 weeks.

Oral mucosal spray
This medicine does not require any special storage conditions
After first opening the bottle, use the product within 21 weeks.
Do not dispose of any medicine in the wastewater or household waste. Ask your pharmacist how to dispose of the
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Flomax Gola contains

Mouthwash

• the active ingredient is: flurbiprofen (100 ml of solution contains 0.25 g of flurbiprofen)
• the other ingredients are: glycerol (98%), ethanol, non-crystallizing liquid sorbitol, hydrogenated castor oil-40 polyoxyethylene, methyl parahydroxybenzoate, propyl parahydroxybenzoate, coloring agentPatent Blue V (E131)(see paragraph “Flomax Gola contains”), sodium saccharin, mint flavour, anhydrous citric acid, sodium hydroxide, purified water.

Oral mucosal spray

• the active ingredient is: flurbiprofen (100 ml of solution contains 0.25 g of flurbiprofen)
• the other ingredients are: glycerol (98%), ethanol, non-crystallizing liquid sorbitol, hydrogenated castor oil-40 polyoxyethylene, methyl parahydroxybenzoate, propyl parahydroxybenzoate, coloring agentPatent Blue V (E131)(see paragraph “Flomax Gola contains”), sodium saccharin, mint flavour, anhydrous citric acid, sodium hydroxide, purified water.

Description of the appearance of Flomax Gola and contents of the pack

Mouthwash
Flomax Gola Mouthwash is presented in the form of a blue-coloured solution, contained in an amber glass bottle
of 160 ml. The pack contains a measuring cup and a safety cap.

Oral mucosal spray
Flomax Gola Oral mucosal spray is presented in the form of a blue-coloured solution, contained in a
white glass vial of 15 ml.

Marketing Authorisation Holder
Chiesi Italia S.p.A. Via Giacomo Chiesi, 1 - 43122 Parma

Manufacturer
Doppel Farmaceutici S.r.l. – Via Martiri delle Foibe, 1 – 29016 Cortemaggiore (PC)