Flurbiprofen Sejmet 8.75 mg/dose solution for oral spray

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Flurbiprofen Sejmet 8.75 mg/dose Oral spray solution

Flurbiprofen

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

Follow exactly the instructions for administration of the medicine contained in this leaflet or as indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are possible adverse reactions not listed in this leaflet.
• You should consult a doctor if your condition worsens or if you do not improve after 3 days.

Contents of the leaflet

1. What Flurbiprofen Sejmet is and what it is used for.
2. What you need to know before using Flurbiprofen Sejmet.
3. How to use Flurbiprofen Sejmet.
4. Possible adverse effects.
5. How to store Flurbiprofen Sejmet.
6. Contents of the pack and other information.

1. What Flurbiprofen Sejmet 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 modifying the body's response to pain, inflammation, and fever.

Flurbiprofen Sejmet is used for the relief of symptoms of sore throat, such as irritation, pain, difficulty swallowing, and inflammation, in individuals aged 18 years and over.

2. What you need to know before using Flurbiprofeno Sejmet

Do not use Flurbiprofeno Sejmet:

• If you are allergic to flurbiprofen, to other non-steroidal anti-inflammatory drugs (NSAIDs), to aspirin (acetylsalicylic acid), or to any of the other ingredients listed in section 6.
• If you have had an allergic reaction after taking non-steroidal anti-inflammatory drugs (NSAIDs) or aspirin (acetylsalicylic acid); for example, asthma, wheezing, itching, runny nose, skin rash, swelling.
• If you currently have or have previously had two or more episodes of stomach ulcer or bleeding, or intestinal ulcers.
• If you have ever had severe colitis (inflammation of the intestine).
• If you have ever experienced blood clotting problems or bleeding problems after taking NSAIDs.
• If you are in the last trimester of pregnancy.
• If you have severe heart, kidney, or liver failure.

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Flurbiprofeno Sejmet:

• If you are taking another non-steroidal anti-inflammatory drug (NSAID) or aspirin.
• If you have tonsillitis (inflammation of the tonsils) or think you may have a bacterial throat infection (as you may need antibiotics).
• If you are elderly (as you may be more likely to experience adverse effects).
• If you currently have or have previously had asthma or allergies.
• If you have a skin condition called systemic lupus erythematosus or mixed connective tissue disease.
• If you have high blood pressure (hypertension).
• If you have ever had a bowel disease (ulcerative colitis, Crohn's disease).
• If you have heart, kidney, or liver problems.
• If you have had a stroke (or cerebrovascular accident).
• If you are in the first 6 months of pregnancy or are breastfeeding.
• If you have an infection – see the section "Infections" below.

While using Flurbiprofeno Sejmet

• At the first sign of a skin reaction (rash, peeling, blisters) or any other sign of an allergic reaction, stop using this medicine and consult a doctor immediately.
• Inform your doctor of any unusual abdominal symptoms you may experience (especially bleeding).
• Consult your doctor if your condition does not improve, worsens, or if new symptoms appear.
• The use of medicines containing flurbiprofen may be associated with a small increased risk of heart attack or stroke (cerebrovascular accident). Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment stated in this leaflet (see section 3).

Infections

Non-steroidal anti-inflammatory drugs (NSAIDs) may mask signs of infection such as fever and pain. This could delay the start of appropriate treatment for the infection, potentially increasing the risk of complications. If you take this medicine while having an infection and your symptoms persist or worsen, consult your doctor or pharmacist without delay.

Children and adolescents

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

Using Flurbiprofeno Sejmet with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription. In particular, if you are taking:

• Other non-steroidal anti-inflammatory drugs (NSAIDs), including selective COX-2 inhibitors for pain or inflammation, as they may increase the risk of gastrointestinal bleeding
• Warfarin, aspirin (acetylsalicylic acid), and other anticoagulant medicines
• ACE inhibitors (angiotensin-converting enzyme inhibitors), angiotensin II antagonists (medicines that lower blood pressure)
• Diuretics (including potassium-sparing diuretics)
• SSRIs (selective serotonin reuptake inhibitors), used to treat depression
• Cardiac glycosides (for heart problems) such as digoxin
• Cyclosporine (to prevent organ rejection after transplant)
• Corticosteroids (to reduce inflammation)
• Lithium (for mood disorders)
• Methotrexate (for psoriasis, arthritis, and cancer)
• Mifepristone (a medicine used to induce abortion): since NSAIDs may reduce the effect of mifepristone, they should not be used within 8–12 days after administration of mifepristone
• Oral antidiabetic medicines
• Phenytoin (for treatment of epilepsy)
• Probenecid, sulfinpyrazone (for gout and arthritis)
• Quinolone-type antibiotics (for bacterial infections) such as ciprofloxacin, levofloxacin
• Tacrolimus (an immunosuppressant used after organ transplantation)
• Zidovudine (for HIV – human immunodeficiency virus).

Taking Flurbiprofeno Sejmet with food and drink

Alcohol should be avoided during treatment with this medicine, as it may increase the risk of gastrointestinal bleeding.

Pregnancy, breastfeeding, and fertility

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

Oral forms (e.g., tablets) of flurbiprofen may cause adverse effects in unborn babies. It is unknown whether the same risk exists with Flurbiprofeno Sejmet.

Pregnancy

• Do not take this medicine if you are in the last trimester of pregnancy.
• You should not take Flurbiprofeno Sejmet during the first six months of pregnancy unless clearly necessary and advised by your doctor. If treatment is needed during this period, the lowest possible dose should be used for the shortest possible duration.

Breastfeeding

• Do not use this medicine if you are breastfeeding.

Fertility

Flurbiprofen belongs to a group of medicines that may affect fertility in women. This effect is reversible upon discontinuation of the medicine. Occasional use of this medicine is unlikely to affect your chances of becoming pregnant; however, inform your doctor before taking this medicine if you have difficulty becoming pregnant.

Driving and using machines

This medicine should not affect your ability to drive or operate machinery. However, if adverse reactions such as dizziness and/or visual disturbances occur, do not drive or operate machinery.

Flurbiprofeno Sejmet contains cyclodextrins (Betadex and Hydroxypropyl betadex)

This medicine contains 9.91 mg of cyclodextrins (betadex 9.58 mg and hydroxypropyl betadex 0.33 mg) per dose (3 sprays), equivalent to 19.15 mg/mL of cyclodextrins (betadex 18.50 mg and hydroxypropyl betadex 0.65 mg) per dose (3 sprays).

3. How to use Flurbiprofen Sejmet

Follow exactly the instructions for administering this medicine provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults aged 18 years and over:

Apply 3 sprays to the back of the throat every 3–6 hours as needed, up to a maximum of 5 doses in 24 hours.

1 dose (3 sprays) contains 8.75 mg of flurbiprofen.

Use in children and adolescents

Do not use this medicine in children or adolescents under 18 years of age.

For oropharyngeal spray use only

• Administer the spray to the back of the throat.
• Do not inhale during spraying.
• Do not apply more than 5 doses (15 sprays) in any 24-hour period.

Flurbiprofen Sejmet is intended for short-term use only.

The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If you have an infection, consult a doctor or pharmacist without delay if symptoms (such as fever and pain) persist or worsen (see section 2).

Do not use this medicine for more than 3 days unless otherwise directed by your doctor.

If symptoms do not improve, worsen, or new symptoms appear, consult your doctor or pharmacist.

Priming the pump

Shake and prime the pump before first use (or after storing it for a prolonged period).

Point the nozzle away from yourself and spray at least 4 times until a fine, uniform mist is produced. The pump is now ready for use (primed).

If the medicine has not been used for a prolonged period, point the nozzle away from yourself and spray at least once, ensuring a fine, uniform mist is produced.

Always ensure a fine, uniform mist is produced before using the medicine.

Administering the spray

Hold the bottle in an upright position with the nozzle directed towards the back of the throat.

Press the pump 3 times, using a quick, smooth motion, ensuring full depression of the pump with each spray. Remove your finger from the top of the pump between sprays.

Do not inhale while spraying.

If you use more Flurbiprofen Sejmet than you should

In case of overdose or accidental ingestion, contact a doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

Symptoms of overdose may include nausea or vomiting, stomach pain, or more rarely, diarrhoea. Tinnitus, headache, or gastrointestinal bleeding may also occur.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

STOP TAKING this medicine and consult a doctor immediately if you notice:

• Signs of an allergic reaction such as asthma, shortness of breath or wheezing without explanation, itching, runny nose, or skin rash.
• Swelling of the face, tongue, or throat causing difficulty breathing, palpitations, or drop in blood pressure leading to shock (these effects may occur even when the medicine is used for the first time).
• Signs of hypersensitivity and skin reactions such as redness, swelling, peeling, blisters, shedding, or ulceration of the skin and mucous membranes.

Other adverse effects may also occur:

Inform your doctor or pharmacist if you experience any of the following effects or any effect not described in this leaflet:

Frequent (may affect up to 1 in 10 people)

• Dizziness, headache.
• Throat irritation.
• Mouth ulcers, pain or numbness in the mouth.
• Sore throat.
• Mouth discomfort (sensation of heat, burning, or tingling).
• Nausea and diarrhea.
• Skin itching and pruritus.

Uncommon (may affect up to 1 in 100 people)

• Numbness.
• Blisters in the mouth or throat, throat numbness.
• Abdominal distension, abdominal pain, flatulence, constipation, indigestion, vomiting.
• Dry mouth.
• Burning sensation in the mouth, altered taste sensation.
• Skin rash, skin itching.
• Fever, pain.
• Drowsiness or difficulty sleeping.
• Worsening of asthma, wheezing, shortness of breath.
• Reduced sensitivity 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)

• Anaemia, thrombocytopenia (low platelet count in the blood which may lead to bruising and bleeding).
• Swelling (oedema), high blood pressure, heart failure or heart attack.
• Severe forms of skin reactions such as blistering reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis (rare medical conditions due to serious adverse reactions to medicines or infections, in which a severe reaction of the skin or mucous membranes occurs).
• Hepatitis (inflammation of the liver).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet.

You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products (www.notificaram.es). By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Flurbiprofen Sejmet

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the bottle and on the carton after EXP. The expiry date is the last day of the month indicated.

Do not use this medicine for more than 1 month after first use.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Flurbiprofeno Sejmet

The active substance is flurbiprofen. One dose (3 sprays) contains 8.75 mg of flurbiprofen. One spray contains 2.92 mg of flurbiprofen. 1 ml of oral spray solution contains 17.16 mg of flurbiprofen.

The other components (excipients) are:

Betadex (E459)

Hydroxypropyl betadex

Disodium phosphate dodecahydrate

Citric acid

Sodium hydroxide

Cherry flavour

Sodium saccharin (E954)

Purified water

Qualitative composition of cherry flavour:

Flavouring substance(s)

Flavouring preparation(s)

Ethanol

Glycerol triacetate (E1518)

Propylene glycol (E1520)

Ascorbic acid (E300)

Di-alpha tocopherol (E307)

Water

Appearance of Flurbiprofeno Sejmet and contents of the container

Flurbiprofeno Sejmet 8.75 mg oral spray solution is a clear to transparent solution with a cherry taste and odour.

Flurbiprofeno Sejmet consists of a plastic bottle containing a solution in a mechanical pump spray dispenser.

Each bottle contains 15 ml of oral spray solution, providing 88 sprays.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sejmet Pharmaceuticals S.L.

Avenida Baja Navarra, 1

31002, Pamplona (Navarra)

Spain

Manufacturer

Laboratorios Bohm SA

Calle de Molinaseca, 23

28947 Fuenlabrada, Madrid

Spain

or

Laboratorium Sanitatis

P.T. Alava, Calle Leonardo Da Vinci, 11

01510 Miñano, Álava

Spain

or

S.C Terapia SA

Strada Fabricii nr. 124, Cluj-Napoca

400632 Judet Cluj

Romania

or

Industria Quimica y Farmaceutica Vir S.A.

C/ Laguna 66-68-70

Polígono Industrial Urtinsa II

28923 Alcorcón, Madrid

Spain

This medicine is authorised in the Member States of the European Economic Area under the following names

Romania	Faringo Intensiv 8.75 mg/dose oropharyngeal spray, solution
Poland	PoloVox spray
Lithuania	PoloVox spray 8.75 mg/dose oral mucosa spray (solution)
Latvia	Polovox 8.75 mg/dose spray for oral cavity, solution

Date of the last review of this leaflet: October 2023.