Flomax for sore throat

Italy
Brand name Flomax for sore throat
Form mouthwash
Active substance / Dosage
FLURBIPROFENE
Prescription type Over-the-counter
ATC code
A01AD11
Registration number 042000
Manufacturer CHIESI ITALIA S.P.A
Flomax for sore throat mouthwash

Table of Contents

Patient Information Leaflet: Information for the User

FLOMAX GOLA 0.25% Mouthwash, Oral Spray

Flurbiprofen
Please read this entire leaflet carefully before using this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

  • 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, consult your doctor or pharmacist. See section 4.
  • Consult your doctor if you do not notice improvement 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 using Flomax Gola
  3. How to use Flomax Gola
  4. Possible side effects
  5. How to store Flomax Gola
  6. Package contents and other information

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

Flomax Gola is a medicine containing flurbiprofen, a non-steroidal anti-inflammatory agent that acts against inflammation and pain in the throat, mouth and gums.
Flomax Gola is used to treat symptoms of pain and irritation affecting the gums, mouth and throat (e.g. gingivitis, stomatitis, pharyngitis), including cases following conservative or extraction dental procedures (e.g. treatment of dental caries or tooth extraction).
Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.

2. What you should know before taking Flomax Gola

Do not take Flomax Gola if:

  • you are allergic to flurbiprofen or to any of the other ingredients of this medicine (listed in section 6);
  • you have had an allergic reaction or asthma after taking other medicines used for pain and inflammation (non-steroidal anti-inflammatory drugs, NSAIDs), such as aspirin;
  • in the past, you experienced gastrointestinal bleeding or perforation after taking NSAIDs;
  • you have had two or more separate episodes of peptic ulcer (lesion of the stomach or first part of the intestine) or gastrointestinal bleeding (including blood in vomit or during bowel movements, or black, tarry stools);
  • you currently have or have previously suffered from inflammatory diseases of the colon or small intestine (ulcerative colitis or Crohn's disease);
  • you have severe impairment of heart function (heart failure);
  • you have severe impairment of liver function;
  • you have severe impairment 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, inform your doctor if:

  • you have previously suffered from bronchial asthma (a respiratory disease), as this increases the risk that you may develop bronchospasm (narrowing of the airways causing severe breathing difficulties due to reduced airflow);
  • you have previously suffered from allergies;
  • you are currently taking other non-steroidal anti-inflammatory drugs (NSAIDs);
  • you suffer from systemic lupus erythematosus or mixed connective tissue disease;
  • you have impaired kidney, heart, or liver function (renal, cardiac, or hepatic insufficiency);
  • you have high blood pressure (hypertension);
  • you have been taking other analgesics for a long time or without following the recommended dosage, as this may lead to headache;
  • you have previously suffered from peptic ulcer (stomach ulcer) or other stomach and intestinal diseases, as this increases the risk of recurrence. This risk is especially increased with high doses of flurbiprofen, if you are elderly, or if your peptic ulcer was complicated by gastrointestinal bleeding or perforation (see section “4 Possible side effects”);
  • you are elderly (as you are more likely to experience side effects);
  • you have heart or blood vessel problems, as medicines like Flomax 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 Flomax Gola or take it for extended periods. Inform your doctor if you have heart problems, a history of stroke, or think you may be at risk for these conditions (e.g. if you have high blood pressure, diabetes, high cholesterol, or smoke);
  • you 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, which in turn may increase the risk of complications.
If you take this medicine during an infection and symptoms of infection persist or worsen, consult your doctor or pharmacist immediately.
Inform your doctor of any unusual abdominal symptoms.
The use of this medicine, especially if prolonged, 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.

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, inform your doctor if you are taking any of the following medicines, as concomitant use with flurbiprofen should be avoided:

  • medicines containing acetylsalicylic acid (used for inflammation, pain, fever, and heart conditions), as they may increase side effects;
  • antiplatelet agents (medicines that make the blood thinner, such as low-dose daily aspirin), as they increase the risk of stomach and intestinal 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 effectiveness of diuretics or some antihypertensive drugs may increase the risk of kidney toxicity;
  • alcohol, as it may increase the risk of side effects, especially the risk of stomach and intestinal bleeding;
  • cardiac glycosides (medicines affecting heart function), as NSAIDs may worsen heart failure and increase blood levels of cardiac 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 and intestinal ulcers or 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 may increase the risk of blood toxicity;
  • Cox-2 inhibitors and other NSAIDs (medicines used for inflammation and pain), as their combined use may enhance effects and increase the risk of side effects.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, suspect you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.

Pregnancy
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 FLOMAX GOLA.
Do not take FLOMAX GOLA during the last three months of pregnancy. Do not take FLOMAX GOLA during the first 6 months of pregnancy unless absolutely necessary and under medical supervision. If treatment is required during this period, use the lowest effective dose for the shortest possible duration.

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

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

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

For those engaged in sports activities
The use of medicines containing ethyl alcohol may result in a positive doping test, depending on the alcohol concentration limits set by certain sports federations.

Flomax Gola contains
Hydrogenated castor oil-40-polyethylene glycol: may cause localized skin reactions.
Parabens: may cause allergic reactions (including delayed reactions).
Patent Blue V dye (E131): may cause allergic reactions.

3. How to take Flomax 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.
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.
Oral rinse
The recommended dose is 2 or 3 rinses or gargles per day with 10 ml of oral rinse. It may be diluted with water.
Oral mucosa spray
Before first use, prime the spray by pressing the pump several times into the air until a fine mist is produced.
The recommended dose is 2 sprays, 3 times a day.
Spray the solution directly onto the affected area (mouth, throat). You may rotate the spray nozzle to the right or left, taking care not to damage the spray device.
At the recommended doses, accidental ingestion is unlikely to cause harm, although swallowing the product is not advised.
Duration of treatment
Use Flomax Gola only for short-term treatment.
Consult your doctor if symptoms recur frequently or if you have noticed any recent changes in their pattern.
If you take more Flomax Gola than you should
Contact your doctor immediately or go to the nearest hospital.
In case of accidental ingestion of large amounts of flurbiprofen, you may experience symptoms such as nausea, vomiting, and irritation of the stomach or intestines. In such cases, appropriate treatment will be administered.
If you forget to take Flomax Gola
Do not take a double dose to make up for the missed dose.
If you stop using Flomax Gola
If you have any questions 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 everybody gets them.
STOP taking Flomax Throat immediately and contact your doctor if you experience serious allergic reactions such as: swelling (angioedema) of the face, eyes, lips, or throat; sudden drop in blood pressure (anaphylactic shock).

Additionally, the following side effects may occur, particularly reported after systemic (non-local) formulations, whose frequency is unknown:

Blood disorders

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

Mental disorders

  • depression;
  • confusion;
  • perception of things not existing in reality (hallucination).

Nervous system disorders

  • dizziness;
  • illness caused by lack of blood flow to an area of the brain due to a blood vessel (cerebrovascular accidents);
  • severe inflammation of the optic nerve, which may lead to vision loss up to blindness (optic neuritis);
  • headache (migraine);
  • altered sensation in limbs or other body parts, such as tingling, pricking, or itching (paraesthesia);
  • drowsiness.

Eye disorders

  • visual disturbances.

Ear disorders

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

Heart and blood vessel disorders

  • oedema;
  • high blood pressure (hypertension);
  • reduced heart function (heart failure).
    Clinical studies and epidemiological data suggest that the use of some NSAIDs (especially at high doses and during long-term treatment) may be associated with an increased risk of blood clots in blood vessels, reducing blood flow to organs such as the heart or brain (arterial thrombotic events such as heart attack or stroke).

Respiratory disorders

  • difficulty breathing or sensation of breathlessness (asthma, bronchospasm, dyspnoea);
  • blisters in the mouth or throat;
  • reduced sensitivity or numbness in the oral cavity (oral dysaesthesia).

Mouth, stomach and intestine (gastrointestinal) disorders

  • nausea;
  • vomiting;
  • diarrhoea;
  • passage of gas from the intestine (flatulence);
  • difficulty evacuating (constipation);
  • difficulty digesting (dyspepsia);
  • sensation of pain/burning of the tongue (glossodynia);
  • altered taste (dysgeusia);
  • pain in mouth and throat;
  • dry mouth;
  • bloating;
  • abdominal pain;
  • black, tarry stools (melena);
  • vomiting blood (haematemesis);
  • ulcers inside the mouth (ulcerative stomatitis);
  • bleeding from the stomach or intestine (gastrointestinal haemorrhage);
  • worsening of inflammatory diseases of the colon and small intestine (colitis and Crohn's disease);
  • inflammation of the stomach (gastritis);
  • injury to the stomach and the first part of the intestine (peptic ulcer);
  • perforation of the stomach or intestine;
  • inflammation of the pancreas (pancreatitis); (very rare).

Skin and subcutaneous tissue disorders

  • skin rash (also localized);
  • itching (pruritus);
  • red, raised, roundish areas of skin accompanied by itching (urticaria);
  • appearance of purplish skin patches of varying sizes (purpura);
  • severe skin rashes with redness, blistering, and skin peeling (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme); (very rare).

Renal and urinary disorders

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

General disorders

  • malaise;
  • fatigue;
  • fever;
  • pain.

Liver disorders

  • hepatitis.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report side effects directly via 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 stated on the packaging after "Exp". The expiry date refers to the last day of that month.
Gargle
This medicine does not require any special storage conditions.
After first opening the bottle, use the product within 9 weeks.
Oral mucosa 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 via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Flomax Gola contains
Oral rinse

  • The active substance is: flurbiprofen (100 ml of solution contain 0.25 g of flurbiprofen)
  • The other components are: glycerol (98%), ethanol, liquid non-crystallizable sorbitol, castor oil hydrogenated-40 polyoxylated, methyl parahydroxybenzoate, propyl parahydroxybenzoate, colouring agent patent blue V (E131) (see section "Flomax Gola contains"), sodium saccharin, peppermint flavour, anhydrous citric acid, sodium hydroxide, purified water.

Oral spray

  • The active substance is: flurbiprofen (100 ml of solution contain 0.25 g of flurbiprofen)
  • The other components are: glycerol (98%), ethanol, liquid non-crystallizable sorbitol, castor oil hydrogenated-40 polyoxylated, methyl parahydroxybenzoate, propyl parahydroxybenzoate, colouring agent patent blue V (E131) (see section "Flomax Gola contains"), sodium saccharin, peppermint flavour, anhydrous citric acid, sodium hydroxide, purified water.

Description of the appearance of Flomax Gola and contents of the pack
Oral rinse
Flomax Gola Oral Rinse is a blue-coloured solution supplied in a 160 ml amber glass bottle. The pack includes a dosing cup and a safety cap.
Oral spray
Flomax Gola Oral Spray is a blue-coloured solution supplied in a 15 ml white glass bottle.
Marketing Authorization 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)