STREFEN SPRAY 8.75 mg/dose ORAL SPRAY, honey and lemon flavor

Introduction

Package Leaflet: Information for the User

Strefen Spray 8.75 mg/dose oral spray solutionhoney and lemon flavor

flurbiprofen

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Follow 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 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.

Contents of the Package Leaflet

1. What Strefen Spray is and what it is used for.
2. What you need to know before you start using Strefen Spray.
3. How to use Strefen Spray.
4. Possible side effects.
5. Storage of Strefen Spray.
6. Contents of the pack and further information.

1. What Strefen Spray 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) that work 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 over 18 years of age.

2. What you need to know before using Strefen Spray

Do not use Strefen Spray:

• If you are allergic to flurbiprofen, other non-steroidal 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 non-steroidal anti-inflammatory drugs (NSAIDs) or aspirin (acetylsalicylic acid); e.g., asthma, wheezing, itching, nasal discharge, skin rash, swelling.
• If you have had two or more episodes of stomach or intestinal ulcers or bleeding.
• If you have had severe colitis (inflammation of the intestine).
• If you 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.
• If you are a child or adolescent under 18 years of age.

Warnings and precautions.

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

• 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 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 are breastfeeding.

Infections

Non-steroidal anti-inflammatory drugs (NSAIDs) may hide signs of infections such as fever and pain. This may 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 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 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 duration of treatment(see Section 3).

Children

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

Other medicines and Strefen Spray

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

• 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 medicines.
• ACE inhibitors, angiotensin II antagonists (medicines 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 (a medicine used for abortion): as NSAIDs may reduce the effect of mifepristone, they should not be used in the 8-12 days following 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 (an immunosuppressant used after organ transplantation).
• Zidovudine (for HIV).

Taking 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 semester of pregnancy or are 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 using machines

This medicine 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.

Important information about some ingredients of 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; i.e., it is essentially "sodium-free".

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

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

3. How to use Strefen Spray

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

The recommended doseis:

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 medicine in children or adolescents under 18 years of age.

For oral spray use only

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

Strefen Sprayis forshort-term use only.

Use the lowest effective dose for the shortest necessary duration 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 medicine 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 a prolonged period).

Point the nozzle 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 medicine for a prolonged period, point the nozzle 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 medicine.

Using the spray

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

Correct Incorrect

Press the pump 3 times, with a quick and smooth movement, making sure to 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 use more Strefen Spray 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 medicine and the amount ingested.

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 medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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 that are caused by severe allergic reactions to medicines or infections, resulting in a severe skin and mucous membrane reaction). Frequency: Unknown (cannot be estimated from the 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 medicine 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, exfoliation, blisters, peeling, 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 listed in this leaflet:

Common(may affect up to 1 in 10 people)

• Dizziness, headache.
• Sore throat.
• 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.
• Somnolence or difficulty sleeping.
• Worsening of asthma, wheezing, shortness of breath.
• Decreased sensitivity in the throat.

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).
• Edema (swelling), high blood pressure, heart failure, or heart attack.
• Hepatitis (inflammation of the liver).

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

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

5. Storage of Strefen Spray

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

Do not use this medicine after the expiration date stated 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 medicine for more than 6 months after first use.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Container contents and additional information

Composition of Strefen Spray

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, honey flavor (contains flavoring substance(s), flavoring preparation(s) and propylene glycol (E1520)), lemon flavor (contains flavoring substance(s), flavoring preparation(s) and propylene glycol (E1520)), N,2,3-trimethyl-2-isopropyl butanamide, sodium saccharin, hydroxypropylbetadex and purified water.

Appearance of Strefen Spray and container contents

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

Strefen Spray is presented in a white opaque high-density polyethylene (HDPE) bottle with a multi-component 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)