Flurbiprofen naiax

Package leaflet: Information for the user

Flurbiprofen Naiax, 8.75 mg/dose, oral spray, solution
Flurbiprofenum
Please read all of this leaflet carefully before use, as it contains important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days, or if your condition worsens, consult your doctor.

Leaflet contents

1. What Flurbiprofen Naiax is and what it is used for
2. Important information before using Flurbiprofen Naiax
3. How to use Flurbiprofen Naiax
4. Possible side effects
5. How to store Flurbiprofen Naiax
6. Contents of the pack and other information

1. What Flurbiprofen Naiax is and what it is used for

The active substance is flurbiprofen. Flurbiprofen belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs), which work by altering the body's response to pain, swelling, and fever.
Flurbiprofen Naiax is intended for short-term relief of symptoms of inflammatory sore throat, such as throat pain, swelling, and difficulty swallowing, in adults aged 18 years and over.
If there is no improvement after 3 days, or if you feel worse, consult your doctor.

2. Important information before using Flurbiprofen Naiax

When not to use Flurbiprofen Naiax:

• if the patient is allergic to flurbiprofen or any of the other ingredients of this medicine (listed in section 6);
• if the patient has previously experienced an allergic reaction after using non-steroidal anti-inflammatory drugs (NSAIDs) or aspirin (acetylsalicylic acid), e.g. asthma, wheezing, itching, runny nose, skin rash, swelling;
• if the patient has or has had two or more episodes of stomach ulcers or bleeding or
• intestinal ulcers;
• if the patient has ever had severe colitis (inflammation of the large intestine);
• if the patient has ever had bleeding disorders or bleeding after taking NSAIDs;
• if the patient is in the last three months of pregnancy;
• if the patient has severe heart, kidney or liver failure.

Warnings and precautions
Before starting to use Flurbiprofen Naiax, consult a doctor or pharmacist:

• if the patient is already taking any other non-steroidal anti-inflammatory drugs (NSAIDs) or acetylsalicylic acid;
• if the patient has tonsillitis or suspects a bacterial throat infection (antibiotic treatment may be required);
• if the patient is elderly (may be more susceptible to adverse effects);
• if the patient has or has previously had asthma or suffers from allergies;
• if the patient has a skin condition called systemic lupus erythematosus or mixed connective tissue disease;
• if the patient has been diagnosed with high blood pressure (hypertension);
• if the patient has previously had intestinal disease (ulcerative colitis, Crohn's disease);
• if the patient has heart, kidney or liver disease;
• if the patient has had a stroke;
• if the patient is in the first six months of pregnancy or is breastfeeding.
• if the patient suffers from medication-overuse headaches.
• if the patient has diabetes.
• if the patient develops an infection - see subsection "Infections" below.

While using Flurbiprofen Naiax

• At the first signs of any hypersensitivity reaction (rash, peeling, blisters) or other symptoms of an allergic reaction, stop using the aerosol immediately and consult a doctor.
• Report any unusual gastrointestinal symptoms (especially bleeding) to a doctor.
• If the patient's condition does not improve, worsens or new symptoms appear, consult a doctor.
• Medicines such as flurbiprofen may slightly increase the risk of heart attack (myocardial infarction) or stroke. The risk is higher with higher doses or long-term treatment. Do not exceed the recommended dose or duration of treatment (see section 3).

Infections
Non-steroidal anti-inflammatory drugs (NSAIDs) may mask symptoms of infection such as fever and pain. This may delay appropriate treatment of infections, potentially increasing the risk of complications. If the patient is taking this medicine during an ongoing infection and symptoms persist or worsen, seek immediate advice from a doctor or pharmacist.

Children and adolescents
This medicine must not be used in children and adolescents under 18 years of age.

Flurbiprofen Naiax and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those available without a prescription. In particular, these include:

• other non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors used for pain or inflammation, as they may increase the risk of gastrointestinal bleeding;
• warfarin, acetylsalicylic acid, and other anticoagulant and antithrombotic medicines;
• angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor antagonists (medicines used to lower blood pressure);
• diuretics (water tablets), including potassium-sparing diuretics;
• SSRIs (selective serotonin reuptake inhibitors) used to treat depression;
• cardiac glycosides (used in heart conditions) such as digoxin;
• cyclosporine (prevents organ rejection after transplantation);
• corticosteroids (reduce inflammation);
• lithium (used to treat mood disorders);
• methotrexate (used to treat psoriasis, arthritis and cancer);
• mifepristone (used to terminate pregnancy): NSAIDs should not be used within 8–12 days after mifepristone administration, as they may reduce the effectiveness of mifepristone;
• oral antidiabetic medicines;
• phenytoin (used to treat epilepsy);
• probenecid, sulfinpyrazone (used to treat gout and arthritis);
• quinolone antibiotics (used to treat bacterial infections), such as ciprofloxacin, levofloxacin;
• tacrolimus (an immunosuppressant used after organ transplantation);
• zidovudine (used in HIV infection);
• fluconazole (an antifungal medicine used to treat various fungal infections);
• acid-neutralizing medicines (used to treat stomach acidity);
• acetazolamide (used to treat glaucoma or fluid retention).

Flurbiprofen Naiax with food, drink and alcohol
While using this medicine, avoid consuming alcohol, as it may increase the risk of gastrointestinal bleeding.
Taking the medicine with food may delay the onset of its effect.

Pregnancy, breastfeeding and fertility
Pregnancy
Oral forms (e.g. tablets) of flurbiprofen may cause adverse effects in the unborn child. It is not known whether the same risk applies to Flurbiprofen Naiax in the form of an oral aerosol solution.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine. Do not use Flurbiprofen Naiax during the last three months of pregnancy. Do not use Flurbiprofen Naiax during the first six months of pregnancy unless clearly necessary and specifically recommended by a doctor. If treatment is required during this period, use the lowest dose for the shortest possible duration.

Breastfeeding
This medicine is not recommended during breastfeeding.

Fertility
This medicine belongs to a group of medicines (NSAIDs) which may affect fertility in women. This effect is reversible after stopping the medicine.

Driving and using machines
This medicine should not affect the ability to drive or operate machinery. However, dizziness and visual disturbances may occur after taking NSAIDs. In such cases, do not drive or operate machinery.

Flurbiprofen Naiax contains sodium, ethanol and flavouring agents containing d-limonene, citral and eugenol.
The medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free".
This medicine contains 0.14 mg of alcohol (ethanol) per dose. The amount of alcohol in a dose of this medicine is equivalent to less than 0.0035 mL of beer or 0.0014 mL of wine.
The small amount of alcohol in this medicine will not cause noticeable effects.
This medicine contains flavouring agents containing d-limonene, citral and eugenol, which may cause allergic reactions.

3. How to use Flurbiprofen Naiax

This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.

Recommended dose:
Adults aged 18 years and above
One dose (3 sprays of aerosol) to the back of the throat every 3–6 hours, as needed. Do not use
more than 5 doses (15 sprays of aerosol) within 24 hours.
One dose (3 sprays of aerosol) contains 8.75 mg of flurbiprofen.

Use in children and adolescents
This medicine must not be used in children and adolescents under 18 years of age.
For oral use only.

• Spray the aerosol only onto the back wall of the throat.
• Do not inhale during spraying of the aerosol.
• Do not use more than 5 doses (15 sprays of aerosol) within 24 hours.

Flurbiprofen Naiax is intended for short-term use only.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms.
If the patient has an infection, consult a doctor or pharmacist immediately if symptoms (such as fever and pain) persist or worsen (see section 2).
If irritation of the oral cavity occurs, discontinue use of flurbiprofen.
Do not use the medicine for longer than 3 days unless otherwise advised by a doctor.
If there is no improvement, if the patient feels worse, or if new symptoms appear, consult a doctor or pharmacist.

Priming the pump
At first use (or after storing for a prolonged period), shake the applicator and prime the pump.
Point the nozzle away from you and spray the aerosol at least four times until a fine, uniform mist is obtained. The pump is now ready for use.
If the product has not been used for some time, point the nozzle away from you and spray the aerosol at least once to obtain a fine, uniform mist.
Before each administration, always ensure that a fine, uniform mist is produced.

Using the aerosol
Direct the nozzle towards the back of the throat.

With a quick, smooth motion, press the pump three times, ensuring that the pump is fully depressed with each spray, and remove your finger from the top of the pump between each spray.

Do not inhale during spraying of the aerosol.

Use of more than the recommended dose of Flurbiprofen Naiax
Consult a doctor or pharmacist or go to the nearest hospital. Symptoms of overdose may include: nausea or vomiting, abdominal pain or, less commonly, diarrhoea. Tinnitus, headache, and gastrointestinal bleeding may also occur.

Missed dose of Flurbiprofen Naiax
Do not use a double dose to make up for a missed dose.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
YOU MUST STOP TAKING THE MEDICINE AND CONTACT YOUR DOCTOR IMMEDIATELY IF
ANY OF THE FOLLOWING SYMPTOMS OCCUR:

• Severe skin reactions, such as blistering reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis (rare conditions caused by serious adverse drug reactions or infections, in which there is a severe reaction affecting the skin and mucous membranes). Frequency: not known (frequency cannot be estimated from available data);
• Symptoms of anaphylactic shock characterized by swelling of the face, tongue or throat, causing difficulty in breathing, palpitations, drop in blood pressure leading to shock (may occur even after first use of the medicine). Frequency: rare (may affect up to 1 in 1,000 people);
• Symptoms of hypersensitivity and skin reactions, such as redness, swelling, peeling, blistering or ulceration of the skin and mucous membranes. Frequency: not common (may affect up to 1 in 100 people);
• Symptoms of allergic reactions, e.g. asthma, unexplained wheezing or shortness of breath, itching, runny nose or skin rash. Frequency: not common (may affect up to 1 in 100 people);
• Swelling of various body parts (angioedema). Frequency: very rare (may affect up to 1 in 10,000 people).

If any of the following symptoms or adverse effects not listed in this leaflet occur,
consult your doctor or pharmacist:
Very common (may affect more than 1 in 10 people)

• Inflammation of the oral mucosa (inflammation of the mouth)

Common (may affect up to 1 in 10 people)

• Dizziness, headache
• Throat irritation
• Mouth ulceration, pain and numbness in the mouth
• Sore throat
• Discomfort (sensation of warmth, burning or tingling) in the mouth
• Nausea and diarrhoea
• Skin tingling and itching

Not common (may affect up to 1 in 100 people)

• Blisters in the mouth or throat, sensation of throat numbness
• Abdominal distension, abdominal pain, flatulence, constipation, indigestion, vomiting
• Dry mouth
• Burning sensation in the mouth, taste disturbances
• Fever, pain
• Drowsiness or difficulty sleeping
• Reduced sensation in the throat

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

• Anaphylactic reaction
• Jaundice

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

• Gastrointestinal bleeding (black, tarry stools accompanied by abdominal pain, possible presence of blood in stool or vomiting blood)

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

• Anaemia, thrombocytopenia (low platelet count, which may lead to bruising and bleeding)
• Swelling, high blood pressure, heart failure or heart attack
• Hepatitis

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Flurbiprofen Naiax

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle after: EXP.
The expiry date refers to the last day of the stated month.
Do not use this medicine for longer than 1 month after first opening.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Flurbiprofen Naiax contains

• The active substance is flurbiprofen. One dose (3 sprays of aerosol) contains 8.75 mg of flurbiprofen. One pump actuation contains 2.92 mg of flurbiprofen. One mL of oral aerosol solution contains 16.2 mg of flurbiprofen.
• Other ingredients are: betadex (E 459), hydroxypropylbetadex, disodium phosphate dodecahydrate, citric acid (E 330), sodium hydroxide, sodium saccharin (E 954), purified water, cherry flavour (contains natural flavourings: d-limonene, citral, eugenol; ethanol, glyceryl triacetate (E 1518), water, propylene glycol (E 1520), ascorbic acid (E 300), alpha-tocopherol (E 307), citric acid (E 330)), mint flavour (contains natural flavourings: d-limonene; propylene glycol (E 1520); glyceryl triacetate (E 1518), alpha-tocopherol (E 307), ethanol, pulegone, menthofuran).

What Flurbiprofen Naiax looks like and contents of the pack
Flurbiprofen Naiax 8.75 mg/dose, oral aerosol solution is a clear solution with a mint and cherry flavour, packed in HDPE bottles with a PE/PP/POM metering pump, in a cardboard box.
Each bottle contains 15 mL of solution, equivalent to 83 pump actuations.

Marketing Authorisation Holder and Importer
Marketing Authorisation Holder
Naiax Pharma S.L.
Calle Berroa 19, 5º, Tajonar
31192, Navarra,
Spain
Tel. +34 633 142 438

Importer
Infarmade S.L.,
C/ Torre de los Herberos, 35, P.I.
Carretera de la Isla, Dos Hermanas,
41703 Seville,
Spain

This medicinal product is authorised in the European Economic Area countries under the following names:
Poland: Flurbiprofen Naiax
Slovakia: Flurbiprofen Naiax orálny roztokový sprej