Strefen Spray 8.75 mg/dose solution for oral spray, peppermint flavor

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Strefen spray 8.75 mg/dose oral spray solution, mint flavour

flurbiprofen

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

Follow exactly the instructions for administration of the medicine provided 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 further information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. See section 4.
• You must consult a doctor if your condition worsens or if you do not improve after 3 days.

Leaflet contents

1. What Strefen spray mint flavour is and what it is used for.
2. What you need to know before using Strefen spray mint flavour.
3. How to use Strefen spray mint flavour.
4. Possible adverse effects.
5. Storage of Strefen spray mint flavour.

Pack contents and additional information.

1. What Strefen Mint-Flavored Spray Is and What It Is Used For

The active substance is flurbiprofen. Flurbiprofen belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs), which work by altering the body's response to pain, inflammation, and fever.

Strefen spray with mint flavor 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 mint-flavoured spray:

• If you are allergic to flurbiprofen, to other non-steroidal anti-inflammatory drugs (NSAIDs), acetylsalicylic acid, or to any of the other ingredients listed in section 6.
• If you have ever experienced an allergic reaction after taking non-steroidal anti-inflammatory drugs (NSAIDs) or acetylsalicylic acid; for example, asthma, wheezing, itching, runny nose, skin rash, swelling.
• If you currently have or have previously had two or more episodes of stomach ulcer or stomach bleeding or intestinal ulcers.
• If you have ever had severe colitis (inflammation of the intestine).
• If you have ever had blood clotting disorders 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 mint-flavoured spray:

• If you are taking another Non-Steroidal Anti-Inflammatory Drug (NSAID) or acetylsalicylic acid.
• If you have tonsillitis (inflammation of the tonsils) or suspect you may have a bacterial throat infection (since you may require antibiotics).
• If you have an infection – see the section «Infections» below.
• If you are an elderly patient (since you are more likely to experience adverse effects).
• If you currently have or have previously had asthma or have allergies.
• If you suffer from a skin condition called systemic lupus erythematosus or mixed connective tissue disease.
• If you have hypertension (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 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 mint-flavoured 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 you may experience (especially bleeding).
• Consult your doctor if you do not improve, your condition worsens, or new symptoms appear.
• The use of medicines containing flurbiprofen may be associated with a small increased risk of heart attack or stroke. Any risk is greater at high doses and with prolonged treatment. Do not exceed the recommended dose or duration of treatment stated in this leaflet (see section 3).

Children and adolescents

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

Use of Strefen mint-flavoured spray with other medicines

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, 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, 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
• Cyclosporine (to prevent organ rejection after transplant)
• Corticosteroids (to reduce inflammation)
• Lithium (for depression)
• Methotrexate (for psoriasis, arthritis, and cancer)
• Mifepristone (a medicine used for abortion): since NSAIDs may reduce the effect of mifepristone, they should not be used within 8–12 days after administration of mifepristone
• Oral antidiabetic medicines
• 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)

Strefen mint-flavoured 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 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.
• Avoid using this medicine during the first six months of pregnancy or while breastfeeding, unless your doctor advises otherwise.

This product 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 use machinery.

Strefen mint-flavoured spray contains parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216), therefore it may cause allergic reactions (possibly delayed).

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

This medicine contains fragrances with citral, d-limonene, eugenol, and linalool.

Citral, d-limonene, eugenol, and linalool may cause allergic reactions.

3. How to use strefen throat spray, peppermint flavour

Follow exactly the instructions for administering this medicine as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Recommended dose:

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 oropharyngeal spray use only

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

Strefen spray, peppermint flavour, 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 irritation in the mouth occurs, treatment with flurbiprofen should be discontinued.

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

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

Priming the pump

You must 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.

How to spray

Hold the bottle in an upright position with the nozzle directed towards 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 forget to use Strefen spray, peppermint flavour

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

If you use more Strefen spray, peppermint flavour than you should

In case of overdose or accidental ingestion, contact a doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, stating the medicine and the amount ingested.

Symptoms of overdose may include nausea or vomiting, stomach pain, or, more rarely, diarrhoea. 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 reaction such as blistering, 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, and a drop in blood pressure leading to shock (all 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, blistering, 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, 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, mouth pain or numbness.
• Sore throat.
• Mouth discomfort (burning or tingling sensation, or prickling).
• 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, mint flavour

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

Do not use this medicine after the expiry date shown on the bottle and the 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 or household waste. Dispose of empty containers and unused medicines at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Strefen mint-flavoured 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, mint flavour (containing d-limonene, eugenol, linalool, propylene glycol (E1520) and glyceryl triacetate (triacetin) (E1518)), cherry flavour (containing citral, d-limonene, propylene glycol (E1520) and water), N,2,3-trimethyl-2-isopropyl butanamide, sodium saccharin, hydroxypropylbetadex and purified water.

Appearance of Strefen mint-flavoured spray and contents of the pack

Strefen mint-flavoured spray is a colourless or slightly yellowish transparent solution with a cherry and mint flavour.

Strefen mint-flavoured spray is presented in an opaque white plastic bottle equipped with a mechanical pump spray dispenser and a polypropylene protective cap.

Each pack contains 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 Medical Devices (AEMPS) (http://www.aemps.gob.es)