Flurbiprofen farmak

Patient Information Leaflet

Flurbiprofen Farmak, 8.75 mg/dose, oral spray, solution
Flurbiprofenum
Please read all of this leaflet carefully before you start using this medicine, because it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by
your 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 side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days, or if you feel worse, you should contact your doctor.

Contents of the leaflet

1. What Flurbiprofen Farmak is and what it is 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 pack and other information

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

The active substance is flurbiprofen. Flurbiprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which work by altering the body's response to pain, swelling, and high temperature.
Flurbiprofen Farmak is intended for the short-term relief of symptoms of inflammatory sore throat, 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 non-steroidal anti-inflammatory drugs (NSAIDs), aspirin (acetylsalicylic acid), or any of the ingredients (listed in section 6);
• if the patient has previously experienced an allergic reaction after taking non-steroidal anti-inflammatory drugs (NSAIDs) or aspirin (acetylsalicylic acid), such as asthma, wheezing, itching, rhinitis, skin rash, or swelling;
• if the patient has or has had two or more episodes of gastric ulcer, gastrointestinal bleeding, or intestinal ulcers;
• if the patient has ever had severe colitis (inflammation of the large intestine);
• if the patient has ever experienced blood clotting disorders or bleeding problems 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 treatment with Flurbiprofen Farmak, discuss with 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 ever 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 hypertension;
• if the patient has previously had intestinal diseases (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 has an infection - see section "Infections" below.

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, immediate
consultation with a doctor or pharmacist is necessary.

While using Flurbiprofen Farmak

• At the first signs of any hypersensitivity reaction (rash, peeling, blisters) or other symptoms of an allergic reaction, stop using the spray immediately and consult a doctor.
• Report any unusual abdominal 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 prolonged treatment. Do not exceed the recommended dose or duration of treatment (see section 3).

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

Flurbiprofen Farmak with 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:

• 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 antiplatelet drugs;
• angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor antagonists (medicines that 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 during the 8–12 days following 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).

Flurbiprofen Farmak with food, drink, and alcohol
While using this medicine, avoid consuming alcohol, as it may increase the risk of gastrointestinal bleeding.

Pregnancy, breastfeeding, and fertility
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 Flurbiprofen Farmak.

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

• Do not use this medicine during the last three months of pregnancy.
• Do not use this medicine during the first six months of pregnancy or while breastfeeding, unless otherwise advised by a doctor. If treatment is necessary during this period, use the lowest effective dose for the shortest possible duration.

Flurbiprofen belongs to a group of medicines that may impair fertility in women. This effect is reversible after discontinuation of the medicine. Occasional use of this medicine is unlikely to affect the chances of becoming pregnant; however, if the patient has difficulty conceiving, she should inform her doctor before using this medicine.

Driving and operating machinery
This medicine is unlikely to 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 Farmak contains methyl 4-hydroxybenzoate (E218), which may cause allergic reactions (possibly delayed).
This medicine contains less than 1 mmol of sodium (23 mg) per dose, meaning it is essentially "sodium-free".
This medicine contains 22.68 mg of cyclodextrin per dose, equivalent to 42 mg/mL.

3. How to use Flurbiprofen Farmak

This medicine should always be used according to the instructions provided by your doctor or pharmacist. If in doubt,
consult your 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 take
more than 5 doses within a 24-hour period.
One dose (3 sprays of aerosol) contains 8.75 mg of flurbiprofen.
Do not use this medicine 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 aerosol administration.
• Do not take more than 5 doses (15 aerosol sprays) within 24 hours.

Flurbiprofen Farmak is intended for short-term use only.
Use several doses as needed, for the shortest duration necessary to relieve symptoms.
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.
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 there is no improvement, if the patient feels worse, or if new symptoms appear, consult a doctor or pharmacist.
Priming the pump
Before first use of the pump (or after prolonged storage), prepare it for use.
Point the nozzle away from you and spray the aerosol at least four times until a uniform, fine 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 at least once to obtain a uniform, fine mist. Before each administration, always ensure that a uniform, fine mist is produced.
Using the aerosol
Direct the nozzle toward 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. Remove your finger from the top of the pump between each spray.
Do not inhale during aerosol administration.
Accidental overdose of Flurbiprofen Farmak
Consult a doctor or pharmacist or go to the nearest hospital immediately. Symptoms of overdose may include: nausea or vomiting, stomach pain, or less commonly, diarrhoea. Tinnitus, headache, and gastrointestinal bleeding may also occur.
If you have any further questions 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 A DOCTOR IMMEDIATELY
if any of the following symptoms occur:

• symptoms of an allergic reaction, e.g. asthma, unexplained wheezing or shortness of breath, itching, runny nose or skin rash;
• swelling of the face, tongue or throat causing difficulty in breathing, rapid heartbeat, drop in blood pressure leading to shock (these may occur even after first use of the medicine);
• symptoms of hypersensitivity and skin reactions such as redness, swelling, peeling, formation of blisters or ulceration of the skin and mucous membranes. If any of the following symptoms or any adverse effects not listed in this leaflet occur, consult a doctor or pharmacist:

Common (may occur in 1 out of 10 people)

• dizziness, headache
• sore throat
• oral ulceration, pain and numbness in the mouth
• sore throat
• discomfort (sensation of warmth, burning or tingling) in the mouth
• nausea and diarrhoea
• tingling and itching of the skin

Uncommon (may occur in 1 out of 100 people)

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

Rare (may occur in less than 1 out of 1,000 patients)

• anaphylactic reaction Frequency unknown (cannot be estimated from available data)
• anaemia, thrombocytopenia (low platelet count, which may lead to bruising and bleeding)
• oedema, high blood pressure, heart failure or heart attack
• severe forms of skin reactions, such as blistering eruptions, including Stevens-Johnson syndrome and toxic epidermal necrolysis (rare diseases caused by severe adverse reactions to medicines or infections, leading to severe mucous membrane and skin reactions)
• red, scaly, localized rash with subcutaneous nodules and blisters accompanied by fever (acute localized exanthematous pustulosis)
• hepatitis

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform a doctor, pharmacist or nurse. 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 Farmak

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.
No special storage instructions apply.
Do not use the medicine for more than 6 months 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 pack and other information

What Flurbiprofen Farmak contains
The active substance is flurbiprofen. One dose (3 sprays of aerosol) contains 8.75 mg of flurbiprofen, corresponding to 16.2 mg/ml of flurbiprofen.
Other ingredients: betadex (E459), disodium phosphate dodecahydrate, citric acid monohydrate, methylparahydroxybenzoate (E218), sodium saccharin (E954), hydroxypropylbetadex, sodium hydroxide (for pH adjustment), mint flavour (contains natural peppermint oil, natural peppermint extract, maltodextrin, menthofuran, pulegone, gum arabic (E414)), cherry flavour (contains synthetic flavouring substances, flavouring preparations, natural flavouring substances, maltodextrin, triacetin (E1518), gum arabic (E414)), N,2,3-trimethyl-2-isopropylbutanamide, purified water.

What Flurbiprofen Farmak looks like and contents of the pack
Flurbiprofen Farmak is a colourless or slightly yellow solution with a characteristic odour. The medicinal product is packed in 15 ml HDPE bottles with a dosing pump and adapter.

Marketing Authorisation Holder and Manufacturer/Importer
Marketing Authorisation 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 authorised in the European Economic Area countries under the following names:
Lithuania: Flurbiprofen Farmak 8.75 mg/dose oromucosal spray, solution
Poland: Flurbiprofen Farmak