FENECOX 0.25% Mouthwash

Зміст інструкції

1. FENECOX GOLA 2,5 mg/ml mouthwash
   1. What you need to know before taking FENECOX GOLA
   2. How to take FENECOX GOLA
   3. Possible side effects
   4. How to store FENECOX GOLA
   5. Contents of the pack and other information

FENECOX GOLA 2,5 mg/ml mouthwash

FENECOX GOLA 2,5 mg/ml oral mucosal spray
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 to do.

• 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 3 days of treatment.

Contents of this leaflet:

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

What FENECOX GOLA is and what it is used for
FENECOX GOLA contains flurbiprofen, a non-steroidal anti-inflammatory and analgesic
(pain relieving) medicine, which acts against inflammation and pain of the throat, mouth and
gums.
FENECOX GOLA is used in adults and adolescents aged over 12 years in the treatment
of symptoms of pain and irritation of the gums, mouth and throat (for example
gingivitis, stomatitis, pharyngitis), even as a result of conservative or
extraction dental therapy (e.g. caries treatment or tooth extraction.
See a doctor if you do not feel better or if you feel worse after 3 days of treatment
(see section 3).

2. What you need to know before taking FENECOX GOLA

Do not takeFENECOX GOLA

• if you are allergic to flurbiprofen or any of the other ingredients of this medicine (listed in section 6);
• 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 against inflammation, pain, fever and heart disorders) or other non-steroidal anti-inflammatory drugs (NSAIDs) (see section “Other medicines and FENECOX GOLA”);
• -if you have previously suffered from bleeding or perforation of the stomach or intestines related to previous treatments with non-steroidal anti-inflammatory drugs (NSAIDs);
• if you suffer from chronic inflammatory diseases of the intestine (ulcerative colitis and Crohn's disease);
• if you frequently suffer from peptic ulcer (lesion of the stomach) 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 FENECOX GOLA in the last 3 months of pregnancy (see section “Pregnancy, breastfeeding and fertility”) Do not give FENECOX GOLA Spray and Mouthwash to children under 12 years of age

Warnings and precautions
Consult your doctor or pharmacist before taking FENECOX GOLA.
In particular, tell your doctor if you:

• have previously suffered from bronchial asthma (a respiratory disease), as it increases the risk that you may experience bronchospasm (narrowing of the bronchi that causes severe breathing difficulties due to reduced air passage);
• have previously suffered from 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 pain relievers for a long time or without respecting the dosage, as headache (headache) may occur;
• have previously suffered from a peptic ulcer (lesion of the stomach) and other diseases of the stomach and intestines as it 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 intestines (see section 4 “Possible side effects”);
• if you are elderly (because you are more likely to experience side effects);
• have problems with the heart or blood vessels, as medicines like FENECOX GOLA may be associated with a modest increase in the 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 FENECOX 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);
• have an infection - see section “Infections” 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 increased risk of complications. If you are taking this medicine during an
infection and the symptoms of the infection persist or worsen, consult
your doctor or pharmacist immediately.
Tell your doctor about any unusual abdominal symptoms.
The use of this medicine, especially if prolonged, can give rise to allergic or local
irritation phenomena (see section 4 “Possible side effects”); in such cases interrupt
treatment and consult your doctor who, if necessary, will carry out suitable therapy.
If you experience irritation of the mouth, stop treatment.
Flurbiprofen, like other NSAIDs, can inhibit platelet aggregation and prolong
bleeding time.

Children and adolescents
Do not give FENECOX GOLA Spray and Mouthwash to children under 12 years of age.

Other medicines and FENECOX GOLA
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
Tell your doctor if you are taking any of the following medicines:

• Aspirin and medicines containing acetylsalicylic acid (a medicine against inflammation, pain, fever and heart disorders) as they may increase the side effects;
• antiplatelet agents (medicines that make the blood more fluid, such as low-dose daily aspirin), as it increases the risk of bleeding from 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 against depression), as it increases the risk of bleeding from 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 (a medicine that prevents rejection after organ 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 (a medicine used for behavioral disorders), as the level of lithium in the blood may increase;
• methotrexate (a medicine used for psoriasis, arthritis and tumors), as the level of methotrexate in the blood may increase;
• mifepristone (a 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 (a 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, suspect you are pregnant or are planning a pregnancy, or if you are
breastfeeding, 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
newborn. It is not known whether the same risk applies to FENECOX GOLA.
Do not take FENECOX GOLA in the last three months of pregnancy.
Do not take FENECOX 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 unless strictly
necessary and advised by your doctor.

Fertility
Flurbiprofen belongs to a group of medicines that can affect female fertility.
This effect is reversible when taking the medicine is stopped. It is
unlikely that occasional use of this medicine will have an effect on the chances of
getting pregnant. However, ask your doctor if you have fertility problems before
taking the medicine.

Driving and operating machinery
FENECOX GOLA may cause drowsiness, visual disturbances, dizziness, fatigue and
vertigo. Make sure you do not suffer from these side effects before driving
vehicles or using machinery.
This medicine does not interfere with the ability to drive vehicles and operate machinery

FENECOX GOLA mouthwash and oral mucosa spray contains para-
hydroxybenzoates, hydrogenated castor oil-40 polyoxyethylene, ethanol (alcohol) and
the dye patent blue

• Para-hydroxybenzoates: may cause allergic reactions (even delayed).

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

It may cause a burning sensation on damaged skin.

3. How to take FENECOX GOLA

Take this medicine following exactly as indicated in this leaflet or by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
The minimum 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 (refer to paragraph 2).
Caution: do not exceed the indicated doses without the advice of your doctor.

Adults and adolescents over 12 years of age

Mouthwash
The recommended dose is 2-3 rinses or gargles per day (hold in mouth for up to 1
minute).
You can use/give the mouthwash:

• pure (without diluting with water): use 10 ml (1 measuring cap) of mouthwash
• diluted: pour 10 ml (1 measuring cap) of mouthwash into half a glass of water.

At the recommended doses, occasional ingestion does not cause any harm, although it is advisable not to ingest the product.

Oral mucosal spray
The recommended dose is 2 sprays 3 times a day. Spray the solution, directing it
directly onto the affected area (mouth, throat). Each spray corresponds to 0.2 ml of
solution, equivalent to 0.5 mg of flurbiprofen. If you are elderly or have suffered in the past from
ulcer (stomach lesion) If you are elderly or have suffered in the past from peptic ulcer
(stomach lesion) it is recommended to use the lowest recommended dose, as there is
a greater risk of serious consequences in case of side effects and the risk of
developing ulcer, bleeding or perforation of the stomach and intestines is greater
(see paragraph 4 “Possible side effects”).

Use in children and adolescents
Do not give FENECOX GOLA Spray and Mouthwash to children under 12 years of age.

Duration of treatment
Use FENECOX GOLA only for short periods of treatment, not exceeding 7 days. If you do not
notice appreciable results after 3 days of treatment, the cause may be a
different pathological condition, therefore consult your doctor.
Consult your doctor if the disorder occurs repeatedly or if you have noticed any
recent change in its characteristics.

If you take more FENECOX GOLA than you should
If you take more FENECOX GOLA than you should In case you accidentally ingest/take
an excessive dose of FENECOX GOLA, inform your doctor immediately or go to the
nearest hospital. In case of accidental ingestion/ingestion of considerable quantities of
flurbiprofen, you may experience symptoms such as: nausea, vomiting, irritation of the
stomach or intestines, stomach pain or rarely diarrhea. Ringing in the ears, headache and bleeding of the stomach or intestines can also occur. In such cases, the doctor will adopt
appropriate treatments

If you forget to use FENECOX GOLA
Do not take a double dose to make up for a missed dose.

If you stop taking FENECOX GOLA
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If you experience the following side effects during treatment with FENECOX GOLA, STOP treatment and consult your doctor immediately:

• allergic reactions (hypersensitivity reactions):
• allergic reaction or anaphylactic reactions (severe allergic reactions) or 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 the lozenges)
• respiratory problems: asthma, bronchospasm, shortness of breath or difficulty breathing
• various skin disorders: skin rashes of various types, itching, redness, swelling, skin loss, blisters, scaling or ulceration of the skin and mucous membranes. If you experience the following side effects at the beginning of treatment with FENECOX GOLA, consult your doctor immediately:
• abdominal pain
• peptic ulcer (lesion of the stomach)
• 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 are especially likely to occur if you are elderly or if you have previously suffered from stomach and intestinal diseases.

In addition, you may experience the following side effects:

Common (may affect up to 1 in 10 people)

• dizziness;
• headache;
• paresthesia (numbness of the limbs or other parts of the body, including the mouth);
• throat irritation;
• diarrhea;
• lesions inside the mouth;
• nausea;
• pain in the mouth and throat;
• feeling of warmth or burning, tingling of the mouth.

Uncommon (may affect up to 1 in 100 people)

• drowsiness;
• asthma;
• bronchospasm (narrowing of the bronchi that causes severe difficulty breathing due to reduced airflow);
• dyspnea (shortness of breath);
• blisters in the mouth or throat;
• numbness of the mouth or throat;
• abdominal distension;
• abdominal pain;
• constipation;
• dry mouth;
• difficulty digesting;
• flatulence (release of gas from the intestines);
• 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 available data)

• anemia (reduction in the number of red blood cells in the blood)
• thrombocytopenia (reduction in the number of platelets in the blood)
• aplastic anemia (reduction in the number 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 cells, in the blood)
• cerebrovascular accidents (diseases caused by insufficient 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
• vertigo
• 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 the vomit
• bleeding from the stomach and intestines
• colitis
• worsening of inflammatory diseases of the colon and intestines (Crohn's disease)
• inflammation of the stomach lining (gastritis)
• stomach lesion (peptic ulcer)
• gastric perforation
• bleeding due to stomach lesion
• urticaria (reddening of the skin accompanied by itching)
• purpura (appearance of skin patches of various sizes, purplish in color)
• bullous dermatoses (severe skin lesions characterized by erythema, blistering lesions with areas of skin detachment), including Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme
• renal toxicity - tubulo-interstitial nephritis (inflammation of the kidneys)
• nephrotic syndrome (alteration of the renal glomeruli that causes a loss of protein in the urine)
• renal failure (reduction of kidney function)
• discomfort
• fatigue
• hepatitis
• depression
• hallucination Reporting of side effectsIf you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through 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 FENECOX GOLA

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

FENECOX GOLA 2,5 mg/ml mouthwash
Once opened, use within 9 weeks.

FENECOX GOLA 2,5 mg/ml oral mucosal spray.
Once opened use within 21 weeks.
Do not dispose of any medicine in wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.

6. Contents of the pack and other information

What FENECOX GOLA contains
Mouthwash

• The active ingredient is flurbiprofen. 1ml of solution contains 2.5 mg of flurbiprofen.
• The other ingredients are: glycerol (98%), ethanol, non-crystallizing liquid sorbitol, hydrogenated castor oil-40 polyoxyethylene, sodium saccharin, methyl parahydroxybenzoate, propyl parahydroxybenzoate, mint aroma, Patent Blue V (E131), anhydrous citric acid, sodium hydroxide, purified water.

Oral mucosal spray

• The active ingredient is flurbiprofen. 1ml of solution contains 2.5 mg of flurbiprofen.
• The other ingredients are: glycerol (98%), ethanol, non-crystallizing liquid sorbitol, hydrogenated castor oil-40 polyoxyethylene, sodium saccharin, methyl parahydroxybenzoate, propyl parahydroxybenzoate, mint aroma, Patent Blue V (E131), anhydrous citric acid, sodium hydroxide, purified water.

Description of the appearance of FENECOX GOLA and contents of the pack
FENECOX GOLA 2.5 mg/ml mouthwash
Pack containing a bottle with a dosing measuring cup and safety cap of 160 ml.
FENECOX GOLA 2.5 mg/ml oral mucosal spray
Pack containing a bottle, with a dosing pump and dispenser of 15 ml.

Marketing Authorisation Holder
Dymalife Pharmaceutical S.r.l. Via Bagnulo, 95 Piano di Sorrento 80063 (NA)

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