Leaflet: information for the user

Strefen Spray 8.75 mg/dose oral solution for buccal sprayhoney and lemon flavor

flurbiprofen

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

Follow exactly the administration instructions contained in this leaflet or those given 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 3 days.

1. What isStrefen Sprayand what it is used for.

2. What you need to know before starting to useStrefen Spray.

3. How to useStrefen Spray.

4. Possible side effects.

5. Storage ofStrefen Spray.

6. Contents of the pack and additional information.

The active ingredient is flurbiprofen. Flurbiprofen belongs to a group of medications called nonsteroidal anti-inflammatory drugs (NSAIDs) that act by modifying the body's response to pain, inflammation, and fever.

Strefen Spray is used for the relief of symptoms of acute sore throat such as irritation, pain, difficulty swallowing, and inflammation in adults aged 18 years and older.

No use Strefen Spray:

• If you are allergic to flurbiprofen, other nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin (acetylsalicylic acid), or any of the other ingredients (listed in section 6).
• If you have had an allergic reaction after taking NSAIDs or aspirin (acetylsalicylic acid); for example, asthma, sneezing, itching, nasal discharge, skin rashes, swelling.
• If you have or have had two or more episodes of stomach ulcers or bleeding, or intestinal ulcers.
• If you have had a severe case of colitis (inflammation of the intestine).
• If you have had problems with blood clotting or bleeding after taking NSAIDs.
• If you are in the last trimester of pregnancy.
• If you have severe heart, kidney, or liver failure.
• If you are a child or adolescent under 18 years old.

Warnings and Precautions.

Consult your doctor or pharmacist before starting to use Strefen Spray:

• If you are taking another 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 have an infection - see the section "Infections" below.
• If you are an elderly patient (as you are more likely to experience side effects).
• If you have asthma or allergies.
• If you have a skin disease called systemic lupus erythematosus or mixed connective tissue disease.
• If you have high blood pressure.
• If you have a history of intestinal disease (ulcerative colitis, Crohn's disease).
• If you have heart, kidney, or liver problems.
• If you have had a stroke.
• If you are in the first 6 months of pregnancy or breastfeeding.

Infections

Nonsteroidal anti-inflammatory drugs (NSAIDs) can mask signs of infections such as fever and pain. This can delay the start of appropriate treatment for the infection, which can lead to a higher risk of complications. If you take this medicine while you have an infection and your symptoms persist or worsen, consult your doctor or pharmacist without delay.

While using Strefen Spray

• At the first sign of a skin reaction (rash, exfoliation, blisters) or other allergic reaction, stop using this medicine and consult a doctor immediately.
• Inform your doctor of any unusual abdominal symptoms that may occur (especially bleeding).
• Consult your doctor if you do not improve, worsen, or if new symptoms appear.
• The use of medicines containing flurbiprofen may be associated with a small increase in the risk of having a heart attack or stroke. Any risk is more likely at high doses and with prolonged treatment.Do not exceed the recommended dose or treatment duration(See Section 3).

Children

This medicine cannot be used by children or adolescents under 18 years old.

Other medicines and Strefen Spray

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

• Other Nonsteroidal Anti-Inflammatory Drugs (NSAIDs), including cyclooxygenase-2 inhibitors for pain or inflammation, as they may increase the risk of stomach or intestinal bleeding.
• Warfarin, aspirin (acetylsalicylic acid), and other anticoagulants.
• ACE inhibitors, angiotensin II antagonists (medicines that reduce 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.
• Ciclosporin (to prevent organ rejection after a transplant).
• Corticosteroids (to reduce inflammation).
• Lithium (for depression).
• Methotrexate (for psoriasis, arthritis, and cancer).
• Mifepristone (medicine used for abortion): as NSAIDs may reduce the effect of mifepristone, they should not be used in the 8-12 days after administration of mifepristone.
• 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 transplant).
• Zidovudine (for HIV).

Strefen Spray with food, drinks, and alcohol

Alcohol should be avoided during treatment with this medicine, 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 medicine.

• Do not take this medicine if you are in the last trimester of pregnancy.
• If you are in the first trimester of pregnancy or breastfeeding, consult your doctor before taking this medicine.

Flurbiprofen belongs to a group of medicines (NSAIDs) that may affect fertility in women. This effect is reversible when the medicine is stopped.

Driving and operating machines

This medicine should not affect your ability to drive or operate machines. However, if you experience side effects such as dizziness and/or visual disturbances, do not drive or operate machines.

Important information about some ingredients in Strefen Spray:

Strefen Spray contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216)which may cause allergic reactions (possibly delayed).

This medicine contains less than 23 mg of sodium (1mmol) per dose; that is, it is essentially "sodium-free".

This medicine contains fragrances with anisyl alcohol, citral, citronellol, d-limonene, geraniol, and linalol.

Anisyl alcohol, citral, citronellol, d-limonene, geraniol, and linalol may cause allergic reactions.

Follow exactly the administration instructions of the medication contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

Therecommended doseis:

Adults 18 years and older:

Apply 3 pulses in the back of the throat every 3-6 hours as needed, up to a maximum of 5 applications (15 pulses) in 24 hours.

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

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

Only for buccal spray use

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

Strefen Sprayis only forshort-term use.

The 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). If mouth irritation appears, discontinue flurbiprofen treatment.

Do not use this medication for more than 3 days, unless prescribed by your doctor.

If there is no improvement, worsening, or new symptoms, consult your doctor or pharmacist.

Preparation (priming) of the pump

You must prime the pump 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 pulses until a fine and homogeneous spray appears. The pump 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 a fine and homogeneous spray appears. Always ensure a fine and homogeneous spray appears before using the medication.

Use of the spray

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

Correct Incorrect

Press the pump3 times, with a quick and smooth motion, ensuring it is pressed firmly in each pulse. Remove your finger from the top of the pump between each pulse.

Do not inhale while performing the pulse.

If you use more Strefen Spray than you should

In case of overdose or accidental ingestion, consult a doctor or pharmacist immediately or call the Toxicological 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, less frequently, diarrhea. Also, tinnitus, headache, and gastrointestinal bleeding may appear.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

• Severe forms of skin reactions such as blisters, including Stevens-Johnson syndrome and toxic epidermal necrolysis (rare medical conditions caused by severe adverse reactions to medications or infections that result in a severe skin and mucous membrane reaction). Frequency: Unknown (cannot be estimated from available data).
• Signs of anaphylactic shock characterized by swelling of the face, tongue, or throat that causes difficulty breathing, palpitations, a drop in blood pressure that causes shock (all effects can occur even when the medicine is used for the first time). Frequency: Rare (may affect up to 1 in 1,000 people).
• Signs of hypersensitivity and skin reactions such as redness, swelling, peeling, blisters, scaling, or ulceration of the skin and mucous membranes. Frequency: Infrequent (may affect up to 1 in 100 people).
• Signs of an allergic reaction such as asthma, unexplained wheezing, or shortness of breath, itching, nasal discharge, or skin eruptions. Frequency: Uncommon (may affect up to 1 in 100 people).

Inform your doctor or pharmacist if you notice 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, mouth pain, or numbness.
• Sore throat.
• Mouth discomfort (sensation of heat or burning or tingling).
• Nausea and diarrhea.
• Sensation of itching and pruritus on the skin.

Infrequent(may affect up to 1 in 100 people)

• Numbness.
• Blisters in the mouth or throat, throat numbness.
• Abdominal distension, abdominal pain, gas, constipation, indigestion, vomiting.
• Dry mouth.
• Sensation of burning in the mouth, altered sense of taste.
• Fever, pain.
• Drowsiness or difficulty falling asleep.
• Worsening of asthma, wheezing, shortness of breath.
• Reduced sensitivity in the throat.

Unknown frequency(cannot be estimated from available data)

• Anemia, thrombocytopenia (low platelet count in the blood that may lead to bruising and bleeding).
• Swelling (edema), high blood pressure, heart failure, or heart attack.
• 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 that does not appear in this leaflet.

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

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

Do not use this medication after the expiration date that appears on the bottle and on the box afterCAD. The expiration date is the last day of the month indicated.

Do not refrigerate or freeze.

Do not use this medication more than 6 months after its first use.

Medicines should not be thrown down the drain or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Strefen Spray

The active ingredient is flurbiprofen. A dose (3 sprays) contains 8.75 mg of flurbiprofen, equivalent to 16.2 mg/ml of flurbiprofen.

The other components (excipients) are: Betadex, disodium dodecahydrate phosphate, citric acid monohydrate, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sodium hydroxide, honey aroma (contains flavoring substances, flavoring preparations, and propylene glycol (E1520)), lemon aroma (contains flavoring substances, flavoring preparations, and propylene glycol (E1520)), N,2,3-trimethyl-2-isopropyl butanamide, sodium saccharin, hydroxypropylbetadex, and purified water.

Appearance of Strefen Spray and contents of the container

Strefen Spray is a transparent, colorless or slightly yellowish solution with a honey and lemon flavor.

Strefen Spray is presented in a white opaque high-density polyethylene (HDPE) bottle equipped with a multi-component spray pump and a polypropylene protective cap.

Each container contains 15 ml of solution, which provides approximately 83 sprays.

Holder of the marketing authorization and manufacturer responsible

Holder of the marketing authorization

Reckitt Benckiser Healthcare, S.A.

c/ Mataró, 28

08403 Granollers

Spain

Manufacturer responsible

RB NL Brands B.V., Schiphol Blvd 207, 1118 BH Schiphol,

Netherlands

This medicine is authorized in the member states of the European Economic Area with the followingnames

Last review date of this leaflet: February 2024

For detailed and updated information on this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es)