Fenecox gola

Italy
Brand name Fenecox gola
Form mouthwash
Active substance / Dosage
FLURBIPROFENE
Prescription type Over-the-counter
ATC code
S01BC04
Registration number 043508
Manufacturer DYMALIFE PHARMACEUTICAL S.R.L.
Fenecox gola mouthwash

Table of Contents

Patient Information Leaflet

FENECOX GOLA 2.5 mg/ml mouthwash, oral mucosa spray

Read this leaflet carefully before using this medicine, as it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.

  • Keep this leaflet. You may need to read it again.
  • If you need more information or advice, consult your pharmacist.
  • If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.
  • Consult your doctor if you do not notice improvement 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 using FENECOX GOLA
  3. How to use 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 that acts against inflammation and pain in the throat, mouth, and gums.
FENECOX GOLA is used in adults and adolescents over 12 years of age for the treatment of symptoms of pain and irritation of the gums, mouth, and throat (e.g. gingivitis, stomatitis, pharyngitis), including those occurring after conservative dental treatment or tooth extraction (e.g. filling of cavities or tooth removal).

Consult your 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 take FENECOX GOLA

  • if you are allergic to flurbiprofen or to any of the other ingredients of this medicine (listed in section 6);
  • if you are allergic to flurbiprofen or to any of the other ingredients of this medicine (listed in section 6);
  • if you are allergic to acetylsalicylic acid (a medicine used for inflammation, pain, fever and heart conditions) or to other non-steroidal anti-inflammatory drugs (NSAIDs) (see section “Other medicines and FENECOX GOLA”);
  • if you have previously experienced bleeding or perforation of the stomach or intestine related to prior treatment 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 ulcer (stomach ulcer) or gastrointestinal bleeding (two or more distinct episodes of ulcer or bleeding);
  • if you have severe heart failure (reduced heart function), severe liver failure (reduced liver function), or severe kidney failure (reduced kidney function). Do not take/give FENECOX GOLA during 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
Talk to your doctor or pharmacist before taking FENECOX GOLA.
In particular, inform your doctor if you:

  • have previously suffered from bronchial asthma (a respiratory disease), as this increases the risk of developing bronchospasm (narrowing of the airways causing severe breathing difficulties due to reduced airflow);
  • 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 (kidney, heart or liver failure);
  • suffer from hypertension (high blood pressure);
  • have been taking other analgesics for a long time or without following the recommended dosage, as this may lead to headache;
  • have previously suffered from peptic ulcer (stomach ulcer) or other stomach and intestinal diseases, as this increases the risk of recurrence. This risk increases especially with high doses of flurbiprofen, if you are elderly, or if the peptic ulcer was complicated by gastrointestinal bleeding or perforation (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 FENECOX 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 FENECOX 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);
  • have an infection – refer to the section “Infections” below.

Infections
Non-steroidal anti-inflammatory drugs (NSAIDs) may mask signs of infection such as fever and pain. This could delay appropriate treatment of the infection, thereby increasing the risk of complications. If you take this medicine during an infection and infection symptoms persist or worsen, consult your doctor or pharmacist immediately.
Inform your doctor of any unusual abdominal symptoms.
Prolonged or long-term use of this medicine may cause allergic reactions or local irritation (see section 4 “Possible side effects”); in such cases, discontinue treatment and consult your doctor, who will prescribe appropriate therapy if necessary.
If you experience mouth irritation, stop treatment.
Flurbiprofen, like other NSAIDs, may 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
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Inform your doctor if you are taking any of the following medicines:

  • Aspirin and medicines containing acetylsalicylic acid (medicines for inflammation, pain, fever and heart conditions), as they may increase the risk of side effects;
  • antiplatelet agents (medicines that make the blood thinner, such as low-dose daily aspirin), as they increase the risk of gastrointestinal bleeding;
  • anticoagulants (medicines that slow down or inhibit blood clotting, such as warfarin), as their effect may be enhanced by NSAIDs;
  • selective serotonin reuptake inhibitors (medicines used for depression), as they increase the risk of gastrointestinal bleeding;
  • antihypertensive medicines (ACE inhibitors, angiotensin II antagonists and diuretics), as NSAIDs may reduce the effect of diuretics or increase renal toxicity;
  • alcohol, as it may increase the risk of side effects, especially gastrointestinal bleeding;
  • cardiac glycosides (medicines affecting heart function), as NSAIDs may worsen heart failure and increase blood levels of glycosides;
  • cyclosporine (a medicine used to prevent organ transplant rejection), as it increases the risk of kidney toxicity;
  • corticosteroids (medicines used for inflammation/allergies), as they increase the risk of stomach or intestinal ulcers and bleeding;
  • lithium (a medicine used for behavioral disorders), as blood levels of lithium may increase;
  • methotrexate (a medicine used for psoriasis, arthritis and cancer), as blood levels of methotrexate may increase;
  • mifepristone (a medicine used to terminate pregnancy): NSAIDs should not be used for 8–12 days after taking mifepristone, as they reduce its effectiveness;
  • quinolone antibiotics (medicines used for bacterial infections), as NSAIDs may increase the risk of seizures;
  • tacrolimus (an immunosuppressant used after organ transplantation), as NSAIDs may increase the risk of kidney toxicity;
  • zidovudine (a medicine used for AIDS), as NSAIDs increase the risk of blood toxicity;
  • COX-2 inhibitors and other NSAIDs (medicines used for inflammation and pain), as their combined use may enhance their effects and increase the risk of side effects.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Oral formulations (e.g. tablets) of flurbiprofen may cause adverse effects in the newborn. It is not known whether the same risk applies to FENECOX GOLA.
Do not take FENECOX GOLA during the last three months of pregnancy.
Do not take FENECOX GOLA during the first 6 months of pregnancy unless absolutely necessary and under medical advice. If treatment is needed during this period, use the lowest effective dose for the shortest possible duration.

Breastfeeding
The use of flurbiprofen during breastfeeding is not recommended unless strictly necessary and advised by a doctor.

Fertility
Flurbiprofen belongs to a group of medicines that may affect female fertility. This effect is reversible when the medicine is discontinued. Occasional use of this medicine is unlikely to affect the ability to conceive. However, consult your doctor if you have fertility problems before taking this medicine.

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

FENECOX GOLA mouthwash and oral spray contain parahydroxybenzoates, polyoxyl 40 hydrogenated castor oil, ethanol (alcohol), and patent blue dye

  • Parahydroxybenzoates: may cause allergic reactions (including delayed reactions).

  • Polyoxyl 40 hydrogenated castor oil: may cause localized skin reactions.

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

  • Ethanol:

  • Mouthwash: This medicine contains 816.8 mg of alcohol (ethanol) in 10 ml (1 measuring cup). Oral spray: This medicine contains 34.56 mg of alcohol (ethanol) in 0.4 ml (2 sprays).

May cause a burning sensation on damaged skin.

3. How to take FENECOX GOLA

Take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The lowest effective dose for the shortest duration necessary to relieve symptoms should be used. 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).
Warning: do not exceed the recommended doses without medical advice.

Adults and adolescents over 12 years of age
Gargle/Mouthwash
The recommended dose is 2–3 rinses or gargles per day (hold in the mouth for up to 1 minute).
You may use/give the mouthwash:

  • undiluted (without mixing with water): use 10 ml (1 measuring cup) of mouthwash
  • diluted: mix 10 ml (1 measuring cup) of mouthwash with half a glass of water.

At the recommended doses, accidental ingestion is unlikely to cause harm, although ingestion of the product should be avoided.

Oral mucosa spray
The recommended dose is 2 sprays, 3 times daily. Spray the solution directly onto the affected area (mouth, throat). Each spray delivers 0.2 ml of solution, equivalent to 0.5 mg of flurbiprofen.
If you are elderly or have previously suffered from peptic ulcer (stomach lesion), it is advisable to use the lowest recommended dose, as the risk of serious consequences from adverse effects is higher, and the risk of developing stomach or intestinal ulcers, bleeding, or perforation is increased (see section 4 “Possible side effects”).

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

Duration of treatment
Use FENECOX GOLA only for short-term treatment, not exceeding 7 days. If no significant improvement is observed after 3 days of treatment, the cause may be a different medical condition; therefore, consult your doctor.
Contact your doctor if the condition recurs frequently or if you have noticed any recent changes in its characteristics.

If you take more FENECOX GOLA than you should
If you accidentally ingest/overdose on FENECOX GOLA, contact your doctor immediately or go to the nearest hospital. In case of accidental ingestion of large amounts of flurbiprofen, symptoms such as nausea, vomiting, irritation of the stomach or intestine, stomach ache, or rarely diarrhoea may occur. Tinnitus, headache, and gastrointestinal bleeding may also occur. In such cases, the doctor will initiate appropriate treatment.

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

If you stop using FENECOX GOLA
If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

  • Allergic reactions (sensitization phenomena):
  • Allergic reaction or anaphylactic reactions (severe allergic reactions) or angioedema (sudden swelling of the mouth/throat and mucous membranes)
  • Local irritation
  • Sensations of warmth or tingling in the mouth and throat (this effect may occur with lozenges)
  • Respiratory events: asthma, bronchospasm, breathlessness or shortness of breath
  • Various skin disorders: skin rashes of different types, itching, redness, swelling, skin peeling, blisters, desquamation or ulceration of the skin and mucous membranes.

If you experience any of the following side effects at the beginning of treatment with FENECOX 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 are especially likely if you are elderly or have previously suffered from stomach or intestinal diseases.

Additionally, you may experience the following side effects:

Common (may affect up to 1 in 10 people)

  • Dizziness
  • Headache
  • Paresthesia (numbness of limbs or other body parts, including the mouth)
  • Throat irritation
  • Diarrhea
  • Mouth sores
  • Nausea
  • Mouth and throat pain
  • Sensation of warmth or burning, tingling in the mouth

Uncommon (may affect up to 1 in 100 people)

  • Drowsiness
  • Asthma
  • Bronchospasm (narrowing of the airways causing severe breathing difficulty due to reduced airflow)
  • Dyspnea (shortness of breath)
  • Blisters in the mouth or throat
  • Numbness of mouth or throat
  • Abdominal distension
  • Abdominal pain
  • Constipation
  • Dry mouth
  • Indigestion
  • Flatulence (passing intestinal gas)
  • Inflammation of the tongue, including pain and burning sensation of the tongue
  • Taste disturbances
  • Vomiting
  • Skin rash
  • Itching
  • Fever
  • Pain
  • Insomnia

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

  • Anaphylactic reactions (severe allergic reaction)

Frequency not known (cannot be estimated from the available data)

  • Anemia (reduced number of red blood cells in the blood)
  • Thrombocytopenia (reduced number of platelets in the blood)
  • Aplastic anemia (reduced number of all types of blood cells: red blood cells, white blood cells, platelets)
  • Agranulocytosis (reduced number of granulocytes, a type of white blood cells, in the blood)
  • Cerebrovascular events (diseases caused by lack of blood flow to an area of the brain)
  • Visual disturbances
  • Optic neuritis (severe inflammation of the optic nerve, which may lead to vision loss up to 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
  • Gastrointestinal bleeding
  • Colitis
  • Worsening of inflammatory bowel diseases (Crohn's disease)
  • Inflammation of the stomach lining (gastritis)
  • Stomach lesion (peptic ulcer)
  • Gastric perforation
  • Bleeding due to stomach lesion
  • Urticaria (red, itchy skin rashes)
  • Purpura (appearance of purple-colored skin patches of varying sizes)
  • Bullous dermatoses (severe skin lesions characterized by erythema, blistering and 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 kidney glomeruli leading to protein loss in urine)
  • Renal failure (reduced kidney function)
  • Malaise
  • Fatigue
  • Hepatitis
  • Depression
  • Hallucination

Reporting of side effects

If you experience any side effect, including those 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/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 stated on the packaging. The expiry date refers to the last day of that month.
FENECOX GOLA 2.5 mg/ml mouthwash
After opening the bottle, use within 9 weeks.
FENECOX GOLA 2.5 mg/ml oral mucosa spray
After opening, use within 21 weeks.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What FENECOX GOLA contains
Mouthwash

  • The active substance is flurbiprofen. Each 1 ml of solution contains 2.5 mg of flurbiprofen.
  • Other components are: glycerol (98%), ethanol, liquid non-crystallizable sorbitol, polyoxyl 40 hydrogenated castor oil, sodium saccharin, methyl parahydroxybenzoate, propyl parahydroxybenzoate, peppermint flavour, patent blue V (E131), anhydrous citric acid, sodium hydroxide, purified water.

Oromucosal spray

  • The active substance is flurbiprofen. Each 1 ml of solution contains 2.5 mg of flurbiprofen.
  • Other components are: glycerol (98%), ethanol, liquid non-crystallizable sorbitol, polyoxyl 40 hydrogenated castor oil, sodium saccharin, methyl parahydroxybenzoate, propyl parahydroxybenzoate, peppermint flavour, 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 one bottle with measuring dispenser and child-resistant cap, 160 ml.
FENECOX GOLA 2.5 mg/ml oromucosal spray
Pack containing one bottle with dosing pump and spray applicator, 15 ml.

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

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