STREFEN SPRAY 8.75 mg/dose ORAL SPRAY, mint flavored

2. What you need to know before using Strefen spray

Do not use Strefen spray menthol flavor:

• If you are allergic to flurbiprofen, other non-steroidal anti-inflammatory drugs(NSAIDs), or any of the other ingredients included in section 6.
• If after taking non-steroidal anti-inflammatory drugs(NSAIDs) or acetylsalicylic acid, you have experienced an allergic reaction; 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.
• Children and adolescents under 18 years of age.

Warnings and precautions.

Consult your doctor or pharmacist before starting to use Strefen spray menthol flavor:

• If you are taking another Non-Steroidal Anti-Inflammatory Drug (NSAID) oracetylsalicylic acid.
• 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 "Infections" section below.
• If you are an elderly patient(as you are more likely to experience side effects).
• If you have or have had asthmaor allergies.
• If you suffer from a skin disease called systemic lupus erythematosus or mixed connective tissue disease.
• If you have high blood pressure(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 are breastfeeding.

Infections

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

While using Strefen spray menthol flavor

• At the first sign of a skin reaction (rash, peeling, 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 you may experience (especially bleeding).
• Consult your doctor if you do not improve, worsen, or if new symptoms appear.
• The use of medications 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 durationindicated in this package leaflet (see section 3).

Children and adolescents

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

Using Strefen spray menthol flavor 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 inhibitorsfor pain or inflammation, as they may increase the risk of stomach or intestinal bleeding.
• Warfarin, acetylsalicylic acid, and other anticoagulant medications.
• ACE inhibitors, 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.
• Cyclosporin(to prevent organ rejection after a transplant).
• Corticosteroids(to reduce inflammation).
• Lithium(for depression).
• Methotrexate(for psoriasis, arthritis, and cancer).
• Mifepristone(medication used for 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).

Strefen spray menthol flavor with food, drinks, and alcohol

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.

• Do not take this medication if you are in the last trimester of pregnancy.
• Avoid using this medication if you are in the first semester of pregnancy or are breastfeeding, unless your doctor advises you otherwise.

The product belongs to a group of medications (NSAIDs) that may affect fertility in women. This effect is reversible when the medication is stopped.

Driving and using machines

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

Strefen spray menthol flavor contains parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216), which may causeallergic reactions (possibly delayed).

This medication contains less than 23 mg of sodium (1mmol) per dose; i.e., it is essentially "sodium-free". This medication contains fragrances with citral, d-limonene, eugenol, and linalol. Citral, d-limonene, eugenol, and linalol may cause allergic reactions.

3. How to use Strefen spray menthol flavor

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

The recommended dose is:

Adults from 18 years:

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

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

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

For oral spray only

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

Strefen spray menthol flavoris for short-term use only.

The effective lowest 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). If irritation occurs in the mouth, treatment with flurbiprofen should be discontinued.

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

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

Preparing (priming) the pump

You need to prepare (prime) the pump before using it for the first time (or after storing it for an extended period).

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

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

Always ensure a fine, 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.

Correct Incorrect

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

Do not inhale while spraying.

If you forgot to take Strefen spray menthol flavor

Do not take a double dose to make up for missed doses.

If you use more Strefen spray menthol flavor 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, and 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 experiences them.

STOP TAKING this medication 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, resulting 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, decreased blood pressure that causes shock (all effects may occur even when using the medication 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: Uncommon (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 rash. Frequency: Uncommon (may affect up to 1 in 100 people).

Tell your doctor or pharmacist if you notice 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.
• Mouth ulcers, 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.
• Fever, pain.
• Drowsiness or difficulty falling asleep.
• Worsening of asthma, wheezing, shortness of breath.
• Reduced sensitivity in the throat.

Frequency not known(cannot be estimated from 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.
• 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 Pharmacovigilance System for Human Use Medications (www.notificaram.es). By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Strefen spray menthol flavor

Keep this medication out of the 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 refrigerate or freeze.

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

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

6. Container contents and additional information

Composition of Strefen spray mint flavor

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

The other components (excipients) are: betadex, disodium phosphate dodecahydrate, citric acid monohydrate, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sodium hydroxide, mint flavor (contains d-limonene, eugenol, linalol, propylene glycol (E1520) and triacetin (E1518)), cherry flavor (contains citral, d-limonene, propylene glycol (E1520) and water), N,2,3-trimethyl-2-isopropyl butanamide, sodium saccharin, hydroxypropylbetadex and purified water.

Appearance of Strefen spray mint flavor and container contents

Strefen spray mint flavor is a clear or slightly yellowish transparent solution with a cherry and mint flavor.

Strefen spray mint flavor is presented in a white opaque plastic bottle with a mechanical spray pump and a polypropylene protective cap.

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

Marketing authorization holder and manufacturer

Marketing authorization holder

Reckitt Benckiser Healthcare, S.A.

c/ Mataró, 28

08403 Granollers

Spain

Manufacturer

RB NL Brands B.V.

Schiphol Blvd 207,

1118 BH Schiphol,

Netherlands

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

Date of last revision of this leaflet: February 2024

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es)