FLURBIPROFEN SEJMET 8.75 mg/dose ORAL SPRAY SOLUTION

Introduction

Package Leaflet: Information for the User

Flurbiprofen Sejmet 8.75 mg/dose Oral Spray Solution

Flurbiprofen

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

Follow the administration instructions of the medication contained in this package leaflet or as indicated by your doctor or pharmacist.

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

Package Leaflet Contents

1. What is Flurbiprofen Sejmet and what is it used for.
2. What you need to know before using Flurbiprofen Sejmet.
3. How to use Flurbiprofen Sejmet.
4. Possible side effects.
5. Storage of Flurbiprofen Sejmet
6. Package Contents and Additional Information

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

The active ingredient is flurbiprofen. Flurbiprofen belongs to a group of medications called non-steroidal anti-inflammatory drugs (NSAIDs) that 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 for adults over 18 years old.

2. What you need to know before using Flurbiprofen Sejmet

Do not use Flurbiprofen Sejmet:

• If you are allergic to flurbiprofen, other non-steroidal anti-inflammatory drugs (NSAIDs), aspirin (acetylsalicylic acid), or any of the other components included in section 6.
• If you have experienced an allergic reaction after taking non-steroidal anti-inflammatory drugs (NSAIDs) or aspirin (acetylsalicylic acid); e.g., asthma, wheezing, itching, nasal discharge, skin rash, swelling.
• If you have or have had two or more episodes of stomach or intestinal ulcers or bleeding.
• If you have or have had severe colitis (inflammation of the intestine).
• If you have or have had 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

Consult your doctor or pharmacist before starting to use Flurbiprofen 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 an elderly patient (as you are more likely to experience side effects).
• If you have or have had asthma or allergies.
• If you have a skin disease called systemic lupus erythematosus or mixed connective tissue disease.
• If you have high blood pressure (hypertension).
• If you have or have had intestinal 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 "Infections" section below.

While using Flurbiprofen Sejmet

• At the first sign of a skin reaction (rash, exfoliation, blisters) or other sign of an allergic reaction, stop using this medication and consult a doctor immediately.
• Inform your doctor of any unusual abdominal symptoms that may occur (especially bleeding).
• Consult your doctor if it does not improve, worsens, or if new symptoms appear.
• The use of medications containing flurbiprofen may be associated with a small increased risk of suffering a heart attack or stroke (cerebrovascular accident). Any risk is more likely at high doses and with prolonged treatments. Do not exceed the recommended dose or treatment durationindicated in this package leaflet (see section 3).

Infections

Non-steroidal anti-inflammatory drugs (NSAIDs) may hide signs of infections such as fever and pain. This may delay the start of adequate treatment for the infection, which can lead to a higher risk of complications. If you take this medication while having an infection and your symptoms persist or worsen, consult your doctor or pharmacist without delay.

Children and Adolescents

This medication should not be used by children or adolescents under 18 years old.

Using Flurbiprofen Sejmet with other medications.

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take other medications, including those purchased without a prescription. In particular, if you are taking:

• Other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), including selective cyclooxygenase-2 inhibitors for pain or inflammation, as they may increase the risk of stomach or intestinal bleeding.
• Warfarin, aspirin (acetylsalicylic acid), and other anticoagulant medications.
• ACE inhibitors (angiotensin-converting enzyme), angiotensin II antagonists (medications that lower blood pressure).
• Diuretics (including potassium-sparing diuretics).
• SSRIs (selective serotonin reuptake inhibitors) for the treatment of depression.
• Cardiac glycosides (for heart problems) such as digoxin.
• Cyclosporine (to prevent organ rejection after a transplant).
• Corticosteroids (to reduce inflammation).
• Lithium (for mood disorders).
• Methotrexate (for psoriasis, arthritis, and cancer).
• Mifepristone (medication used to induce abortion): as NSAIDs may reduce the effect of mifepristone, they should not be used in the 8-12 days following mifepristone administration.
• Oral antidiabetics.
• Phenytoin (for the treatment of epilepsy).
• Probenecid, sulfinpyrazone (for gout and arthritis).
• Quinolone antibiotics (for bacterial infections) such as ciprofloxacin, levofloxacin.
• Tacrolimus (immunosuppressant used after organ transplantation).
• Zidovudine (for HIV - human immunodeficiency virus).

Taking Flurbiprofen Sejmet with food and drinks

Alcohol consumption should be avoided during treatment with this medication, as it may increase the risk of stomach or intestinal bleeding.

Pregnancy, Breastfeeding, and Fertility

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

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

Pregnancy

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

Breastfeeding

• Do not use this medication if you are breastfeeding.

Fertility

Flurbiprofen belongs to a group of medications that may affect fertility in women. This effect is reversible when the medication is stopped. It is unlikely that occasional use of this medication can affect your chances of becoming pregnant; however, inform your doctor before taking this medication if you have problems becoming pregnant.

Driving and Using Machines

This medication should not affect your ability to drive or use machines. However, if you experience adverse reactions such as dizziness and/or visual disturbances, do not drive or use machines.

Flurbiprofen Sejmet contains cyclodextrins (Betadex and Hydroxypropyl betadex)

This medication 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 the administration instructions of the medication contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults from 18 years old:

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

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

Use in children and adolescents

Do not use this medication in children or adolescents under 18 years old.

For oral spray use only.

• Perform the spray in the back of the throat.
• Do not inhale while performing the spray.
• Do not apply more than 5 doses (15 sprays) every 24 hours.

Flurbiprofen Sejmet is for short-term use only.

The lowest effective dose should be used for the shortest time 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 medication for more than 3 days, unless advised by your doctor.

If it does not improve, worsens, or if new symptoms appear, consult your doctor or pharmacist.

Pumping the spray

You must shake and prime the spray before using it for the first time (or after storing it for a prolonged period).

Point the nozzle away from you and perform a minimum of 4 sprays until a fine and homogeneous spray appears. The spray is ready for use (primed).

If you have not used the medication for a prolonged period, point the nozzle away from you and perform a minimum of 1 spray, ensuring that a fine and homogeneous spray appears.

Always ensure that a fine and homogeneous spray appears before using the medication.

Performing the spray

Hold the bottle in a vertical position with the nozzle directed towards the back of the throat.

Press the pump 3 times, with a quick and smooth motion, ensuring that you press it all the way down for each spray. Remove your finger from the top of the pump between each spray.

Do not inhale while performing the spray.

If you use more Flurbiprofen Sejmet than you should

In case of overdose or accidental ingestion, consult a doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

The symptoms of overdose may be: nausea or vomiting, stomach pain, or, more rarely, diarrhea. You may also experience ringing in the ears, headache, or gastrointestinal bleeding.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

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

• Signs of an allergic reaction such as asthma, shortness of breath or wheezing without explanation, itching, nasal discharge, or skin rash.
• Swelling of the face, tongue, or throat that causes difficulty breathing, palpitations, decreased blood pressure that causes shock (all these effects can occur even when using the medication for the first time).
• Signs of hypersensitivity and skin reactions such as redness, swelling, exfoliation, blisters, peeling, or ulceration of the skin and mucous membranes.

Other side effects may also occur:

Tell your doctor or pharmacist if you observe any of the following effects or any effect not described in this package leaflet:

Frequent(may affect up to 1 in 10 people)

• Dizziness, headache.
• Throat irritation.
• Ulcers in the mouth, pain, or numbness in the mouth.
• Sore throat.
• Discomfort in the mouth (feeling of heat or burning or tingling).
• Nausea and diarrhea.
• Itching and pruritus of the skin.

Uncommon(may affect up to 1 in 100 people)

• Numbness.
• Blisters in the mouth or throat, numbness in the throat.
• Abdominal distension, abdominal pain, gas, constipation, indigestion, vomiting.
• Dry mouth.
• Burning sensation in the mouth, altered taste.
• Skin rash, itching of the skin.
• Fever, pain.
• Somnolence or difficulty falling asleep.
• Worsening of asthma, wheezing, shortness of breath.
• Decreased sensitivity in the throat.

Rare(may affect up to 1 in 1000 people)

• Anaphylactic reaction.

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

• Anemia, thrombocytopenia (low platelet count in the blood that can lead to bruising and bleeding).
• Swelling (edema), high blood pressure, heart failure, or heart attack.
• Severe skin reactions such as blistering reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis (rare medical conditions that are due to severe adverse reactions to medications or infections in which a severe skin or mucous membrane reaction occurs).
• Hepatitis (inflammation of the liver).

Reporting side effects

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

You can also report them directly through the Spanish Medication Monitoring System for Human Use (www.notificaram.es). By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Flurbiprofen Sejmet

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the bottle and carton after EXP. The expiration date is the last day of the month indicated.

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE Collection Point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Flurbiprofen Sejmet

The active ingredient 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 flavor

Sodium saccharin (E954)

Purified water

Qualitative composition of cherry flavor:

Flavoring substance(s)

Flavoring preparation(s)

Ethanol

Triacetin (E1518)

Propylene glycol (E1520)

Ascorbic acid (E300)

DL-alpha-tocopherol (E307)

Water

Appearance of Flurbiprofen Sejmet and package contents

Flurbiprofen Sejmet 8.75 mg oral spray solution is a clear to transparent solution with a cherry flavor and odor.

Flurbiprofen Sejmet is contained in a plastic bottle with a mechanical spray pump.

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

Marketing Authorization Holder and Manufacturer

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 medication is authorized in the Member States of the European Economic Area with the following names

Date of the last revision of this package leaflet:October 2023.