Strefen Spray 8.75 mg/dose solution for oral spray, honey and lemon flavor

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Strefen Spray 8.75 mg/dose oral spray solution, honey and lemon flavour

flurbiprofen

Read the entire 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 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 effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
• You must consult a doctor if your condition worsens or does not improve after 3 days.

Contents of the leaflet

1. What Strefen Spray is and what it is used for.
2. What you need to know before using Strefen Spray.
3. How to use Strefen Spray.
4. Possible adverse effects.
5. How to store Strefen Spray.
6. Contents of the pack and other 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 altering 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, 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 ever 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 ever had two or more episodes of stomach ulcer, gastrointestinal bleeding, or intestinal ulcers.
• If you have ever had severe colitis (inflammation of the intestine).
• If you have ever had blood clotting problems or bleeding issues 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 suspect 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 elderly (as you may be more likely to experience adverse effects).
• If you have asthma or allergies, or have had them in the past.
• If you suffer from systemic lupus erythematosus or mixed connective tissue disease.
• If you have high blood pressure (hypertension).
• 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 could delay the start of appropriate treatment for the infection, 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 immediately.

While using Strefen Spray

• 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 (especially bleeding).
• Consult your doctor if you do not improve, if your condition 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. This risk is higher with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment (See Section 3).

Children

This medicine must not be used in 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 need to take any 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) used to treat depression.
• Cardiac glycosides (for heart problems), such as digoxin.
• Cyclosporine (to prevent organ rejection after transplantation).
• 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 within 8–12 days after mifepristone administration.
• Oral antidiabetic agents.
• Phenytoin (for epilepsy treatment).
• 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 intake 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 are planning 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 six months 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 upon discontinuation of the medicine.

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.

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 (1 mmol) per dose; essentially “sodium-free”.

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

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

3. How to use Strefen Spray

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The recommended dose is:

Adults from 18 years of age:

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

• Administer the spray only to the back of the throat.
• Do not inhale during spraying.
• Do not exceed 5 applications (15 sprays) in 24 hours.

Strefen Spray 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). If mouth irritation occurs, treatment with flurbiprofen should be discontinued.

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.

Preparation (priming) of the pump

You must prepare (prime) the pump before first use (or after storing it for a prolonged period).

Point the nozzle away from yourself and press the pump at least 4 times until a fine, even spray is produced. The pump is now ready for use (primed). If you have not used the medicine for a prolonged period, point the nozzle away from yourself and spray at least once, ensuring a fine, even mist is produced. Always ensure a fine, even spray is produced before using the medicine.

Using the spray

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

Correct Incorrect

Press the pump 3 times, with a quick, smooth motion, making sure to press it fully down with each spray. Remove 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

Symptoms of overdose may include: nausea or vomiting, stomach pain, or more rarely, diarrhea. Tinnitus, headache, and 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 experiences 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 serious adverse reactions to medicines or infections, in which there is a severe reaction affecting the skin and mucous membranes). Frequency: Not known (cannot be estimated from available data).
• Signs of anaphylactic shock characterized by swelling of the face, tongue, or throat causing difficulty breathing, palpitations, drop in blood pressure leading to shock (all of these effects may 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, desquamation, 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, runny nose, or skin rash. Frequency: Uncommon (may affect up to 1 in 100 people).

Inform your doctor or pharmacist if you experience any of the following side effects or any side effect not listed 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.
• Itching and pruritus of the skin.

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.
• Fever, pain.
• Drowsiness or difficulty sleeping.
• Worsening of asthma, wheezing, shortness of breath.
• Reduced sensitivity in the throat.

Frequency not known (cannot be estimated from 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.
• Hepatitis (inflammation of the liver).

Reporting of adverse effects

If you experience any 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 Medicines (www.notificaram.es). By reporting adverse 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 expiry date stated on the bottle and carton following EXP. The expiry date refers to 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 must not be disposed of via wastewater drains or household waste. Unused medicines and their containers should be returned to the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Strefen Spray

The active substance 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 4-hydroxybenzoate (E218), propyl 4-hydroxybenzoate (E216), sodium hydroxide, honey flavour (contains flavouring substance(s), flavouring preparation(s) and propylene glycol (E1520)), lemon flavour (contains flavouring substance(s), flavouring preparation(s) 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 pack

Strefen Spray is a colourless or slightly yellowish, transparent solution with a honey and lemon flavour.

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

Each container holds 15 ml of solution, providing approximately 83 sprays.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Reckitt Benckiser Healthcare, S.A.

C/ Mataró, 28

08403 Granollers

Spain

Manufacturer

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

The Netherlands

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

Date of the last review of this leaflet: February 2024

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es)