FLURBIPROFEN 8.75 mg/dose Aerosol

Contents of the leaflet

1. Leaflet accompanying the packaging: information for the user
   1. You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
2. What is Flurbiprofen Farmak and what is it used for
3. Important information before using Flurbiprofen Farmak
   1. When not to use Flurbiprofen Farmak:
   2. Warnings and precautions
   3. During the use of Flurbiprofen Farmak
   4. Children and adolescents
   5. Flurbiprofen Farmak and other medicines
   6. Flurbiprofen Farmak with food, drink, and alcohol
   7. Pregnancy, breastfeeding, and fertility
   8. Driving and using machines
4. How to use Flurbiprofen Farmak
   1. Recommended dose
   2. Adults over 18 years of age:
   3. The medicine should not be used in children and adolescents under 18 years of age.
   4. For oral use only
   5. Preparing the pump
   6. Using the aerosol
   7. Using a higher dose of Flurbiprofen Farmak than recommended
5. Possible side effects
   1. THE PATIENT SHOULD STOP TAKING THE MEDICINE AND CONTACT THEIR DOCTOR IMMEDIATELY IF THEY EXPERIENCE ANY OF THE FOLLOWING SYMPTOMS:
   2. IF THE PATIENT EXPERIENCES ANY OF THE FOLLOWING SYMPTOMS OR SIDE EFFECTS NOT LISTED IN THE LEAFLET, THEY SHOULD CONSULT THEIR DOCTOR OR PHARMACIST:
   3. Reporting side effects
6. How to store Flurbiprofen Farmak
7. Contents of the packaging and other information
   1. What Flurbiprofen Farmak contains
   2. What Flurbiprofen Farmak looks like and what the pack contains
   3. Marketing authorization holder and manufacturer/importer
   4. Marketing authorization holder
   5. Importer
   6. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   7. Date of last revision of the leaflet:

Leaflet accompanying the packaging: information for the user

Flurbiprofen Farmak, 8.75 mg/dose, oral spray, solution
Flurbiprofenum

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the patient leaflet or as directed by your doctor or pharmacist.

• You should keep this leaflet so that you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

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

The active substance is flurbiprofen. Flurbiprofen belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs), which work by changing the body's response to pain, swelling, and high temperature.
Flurbiprofen Farmak is intended for short-term relief of symptoms of inflammatory throat conditions, such as sore throat, difficulty swallowing, and swelling in adults over 18 years of age.

2. Important information before using Flurbiprofen Farmak

When not to use Flurbiprofen Farmak:

• if the patient is allergic to flurbiprofen, other nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin (acetylsalicylic acid), or any of the ingredients (listed in section 6);
• if the patient has had an allergic reaction in the past after using nonsteroidal anti-inflammatory drugs (NSAIDs) or aspirin (acetylsalicylic acid), such as asthma, wheezing, itching, rhinitis, skin rash, swelling;
• if the patient has had two or more episodes of stomach ulcers or bleeding or intestinal ulcers;
• if the patient has had severe colitis (inflammation of the large intestine);
• if the patient has had coagulation disorders or bleeding problems after taking NSAIDs;
• if the patient is in the last three months of pregnancy;

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• if the patient has severe heart, kidney, or liver failure.

Warnings and precautions

Before starting to use Flurbiprofen Farmak, you should discuss it with your doctor or pharmacist:

• if the patient is already taking any other nonsteroidal anti-inflammatory drugs (NSAIDs) or acetylsalicylic acid;
• if the patient has tonsillitis or suspects that they may have a bacterial throat infection (an antibiotic may be required);
• if the patient is elderly (may be more prone to side effects);
• if the patient has or has had asthma or suffers from allergies;
• if the patient suffers from a skin disease called systemic lupus erythematosus or mixed connective tissue disease;
• if the patient has been diagnosed with high blood pressure;
• if the patient has had intestinal disease (ulcerative colitis, Crohn's disease);
• if the patient suffers from heart, kidney, or liver disease;
• if the patient has had a stroke;
• if the patient is breastfeeding or in the first six months of pregnancy;
• if the patient has an infection - see "Infections" below.

Infections
Nonsteroidal anti-inflammatory drugs (NSAIDs) may mask the symptoms of infection, such as fever and pain.
This may delay appropriate treatment of infections, which can lead to increased risk of complications. If the patient is taking this medicine during an ongoing infection and their symptoms persist or worsen, they should consult their doctor or pharmacist immediately.

During the use of Flurbiprofen Farmak

• At the first signs of any hypersensitivity reaction (rash, scaling, blisters) or other symptoms of an allergic reaction, the patient should stop using the spray and consult a doctor.
• The patient should report any unusual abdominal symptoms (especially bleeding) to their doctor.
• If the patient's condition does not improve, worsens, or new symptoms appear, they should consult a doctor.
• Medicines like flurbiprofen may slightly increase the risk of heart attack (myocardial infarction) or stroke. Any risk is more likely with higher doses or longer treatment. The patient should not exceed the recommended dose or duration of treatment (see section 3).

Children and adolescents

The medicine should not be used in children and adolescents under 18 years of age.

Flurbiprofen Farmak and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those available without a prescription. In particular:

• other nonsteroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 inhibitors, for the treatment of pain or inflammation, as they may increase the risk of stomach or intestinal bleeding;
• warfarin, acetylsalicylic acid, and other blood-thinning and anticoagulant medicines;

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• angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor antagonists (blood pressure-lowering medicines);
• diuretics (including potassium-sparing diuretics);
• selective serotonin reuptake inhibitors (SSRIs) for the treatment of depression;
• cardiac glycosides (used in heart conditions) such as digoxin;
• cyclosporine (to prevent organ rejection after transplantation);
• corticosteroids (to reduce inflammation);
• lithium (for mood disorders);
• methotrexate (for the treatment of psoriasis, arthritis, and cancer);
• mifepristone (used to terminate pregnancy): NSAIDs should not be used for 8-12 days after mifepristone administration, as they may reduce the effectiveness of mifepristone;
• oral antidiabetic medicines;
• phenytoin (for the treatment of epilepsy);
• probenecid, sulfinpyrazone (for the treatment of gout and arthritis);
• quinolone antibiotics (for the treatment of bacterial infections), such as ciprofloxacin, levofloxacin;
• tacrolimus (an immunosuppressive medicine used after organ transplantation);
• zydovudine (for HIV infection).

Flurbiprofen Farmak with food, drink, and alcohol

While using this medicine, the patient should avoid consuming alcohol, as it may increase the risk of stomach or intestinal bleeding.

Pregnancy, breastfeeding, and fertility

Oral forms (e.g., tablets) of flurbiprofen may cause side effects in the unborn child. It is not known if the same risk applies to Flurbiprofen Farmak.
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.

• The medicine should not be used in the last three months of pregnancy.
• The medicine should not be used in the first six months of pregnancy or during breastfeeding, unless the doctor recommends otherwise. If treatment is necessary during this period, the lowest dose should be used for the shortest possible time.

Flurbiprofen belongs to a group of medicines that may impair fertility in women. This effect is reversible after stopping the medicine. It is unlikely that occasional use of this medicine will affect the chances of becoming pregnant; however, the patient should tell their doctor before using the medicine if they have problems becoming pregnant.

Driving and using machines

This medicine should not affect the ability to drive or use machines.
However, after taking medicines from the NSAID group, dizziness and vision disturbances may occur. In such cases, the patient should not drive or use machines.
Flurbiprofen Farmak contains methyl parahydroxybenzoate (E218), which may cause allergic reactions (possibly delayed).
This medicine contains less than 1 mmol of sodium (23 mg) per dose, which means it is essentially "sodium-free".
This medicine contains 22.68 mg of cyclodextrin per dose, which corresponds to 42 mg/mL.
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3. How to use Flurbiprofen Farmak

This medicine should always be used in accordance with the doctor's or pharmacist's instructions. If you are unsure, you should consult your doctor or pharmacist.

Recommended dose

Adults over 18 years of age:

One dose (3 sprays of the spray) on the back of the throat every 3-6 hours, as needed. Do not take more than 5 doses in 24 hours.
One dose (3 sprays of the spray) contains 8.75 mg of flurbiprofen.

The medicine should not be used in children and adolescents under 18 years of age.

For oral use only

• Spray the aerosol only on the back of the throat.
• Do not inhale while spraying the aerosol.
• Do not take more than 5 doses (15 sprays of the aerosol) in 24 hours.

Flurbiprofen Farmak is intended for short-term use only.
The patient should use several doses as needed for the shortest time necessary to relieve symptoms. If irritation of the oral cavity occurs, the patient should stop using flurbiprofen.
The medicine should not be used for more than 3 days unless advised by a doctor.
The patient should use the lowest effective dose for the shortest duration necessary to relieve symptoms.
If the patient has an infection, they should consult their doctor or pharmacist immediately if their symptoms (such as fever and pain) persist or worsen (see section 2).

Preparing the pump

When using the pump for the first time (or after a long period of storage), it should be prepared for use.
Point the nozzle away from yourself and spray the aerosol at least four times until a uniform, light mist is obtained. The pump is ready for use. If the product is not used for some time, point the nozzle away from yourself and spray the aerosol at least once to obtain a uniform, light mist. Before administering the product, always make sure that a uniform, light mist is produced.

Using the aerosol

Point the nozzle towards the back of the throat.
Press the pump quickly and smoothly three times, making sure to press the pump completely at each spray, and remove your finger from the top of the pump between each spray.
Do not inhale while spraying the aerosol.

Using a higher dose of Flurbiprofen Farmak than recommended

The patient should consult their doctor or pharmacist or go to the nearest hospital. Symptoms of overdose may include: nausea or vomiting, abdominal pain, or less frequently, diarrhea. There may be ringing in the ears, headache, and gastrointestinal bleeding.
If the patient has any further doubts about the use of this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
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THE PATIENT SHOULD STOP TAKING THE MEDICINE AND CONTACT THEIR DOCTOR IMMEDIATELY IF THEY EXPERIENCE ANY OF THE FOLLOWING SYMPTOMS:

• symptoms of an allergic reaction, such as asthma, unexplained wheezing or shortness of breath, itching, rhinitis, or skin rash;
• swelling of the face, tongue, or throat, causing difficulty breathing, palpitations, low blood pressure leading to shock (may occur even after the first use of the medicine);
• symptoms of hypersensitivity and skin reactions, such as redness, swelling, scaling, blistering, or ulcers of the skin and mucous membranes.

IF THE PATIENT EXPERIENCES ANY OF THE FOLLOWING SYMPTOMS OR SIDE EFFECTS NOT LISTED IN THE LEAFLET, THEY SHOULD CONSULT THEIR DOCTOR OR PHARMACIST:

Common(may affect up to 1 in 10 people)

• dizziness, headache
• irritation of the throat
• ulcers in the mouth, pain, and numbness in the mouth
• sore throat
• discomfort (feeling of heat, burning, or tingling) in the mouth
• nausea and diarrhea
• tingling and itching of the skin

Uncommon(may affect up to 1 in 100 people)

• drowsiness
• blisters in the mouth or throat, feeling of numbness in the throat
• abdominal bloating, abdominal pain, gas, constipation, indigestion, vomiting
• dry mouth
• burning sensation in the mouth, taste disturbances
• skin rash, itching
• fever, pain
• drowsiness or difficulty sleeping
• worsening of asthma, wheezing, shortness of breath
• reduced sensation in the throat

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

• anaphylactic reaction Frequency not known(cannot be estimated from the available data)
• anemia, thrombocytopenia (low platelet count, which can cause bruising and bleeding)
• edema, high blood pressure, heart failure, or heart attack
• severe skin reactions, such as blistering, including Stevens-Johnson syndrome and toxic epidermal necrolysis (rare diseases caused by severe side effects of the medicine or infection, in which there is a strong reaction of the mucous membranes and skin)
• red, scaly, localized rash with nodules under the skin and blisters, accompanied by fever (acute localized exanthematous pustulosis)
• hepatitis

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring 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.
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Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Flurbiprofen Farmak

The medicine should be stored 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 month.
There are no special precautions for storage.
The medicine should not be used for more than 6 months after the first opening.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Flurbiprofen Farmak contains

The active substance of the medicine is flurbiprofen. One dose (3 sprays of the spray) contains 8.75 mg of flurbiprofen, which corresponds to 16.2 mg/mL of flurbiprofen.
Other ingredients: betadex (E459), disodium phosphate dodecahydrate, citric acid monohydrate, methyl parahydroxybenzoate (E218), sodium saccharin (E954), hydroxypropylbetadex, sodium hydroxide (to adjust pH), peppermint flavor (contains natural peppermint oil, natural peppermint extract, maltodextrin, menthofuran, pulegone, gum arabic (E414)), cherry flavor (contains synthetic flavoring substances, flavor preparations, natural flavoring substances, maltodextrin, triacetin (E1518), gum arabic (E414)), N,2,3-trimethyl-2-isopropylbutanamide, purified water.

What Flurbiprofen Farmak looks like and what the pack contains

Flurbiprofen Farmak is a colorless or slightly yellow solution with a characteristic odor.
The medicinal product is packaged in 15 mL HDPE bottles with a dosing pump and adapter.

Marketing authorization holder and manufacturer/importer

Marketing authorization holder

Farmak International Sp. z o.o.
ul. Koszykowa 65
00-667 Warsaw

Importer

Farmak International Sp. z o.o.
al. Piłsudskiego 141
92-318 Łódź

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Lithuania: Flurbiprofen Farmak 8.75 mg/dose oromucosal spray, solution
Poland: Flurbiprofen Farmak

Date of last revision of the leaflet:

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