Leaflet: information for the user

Strefen 8.75 mg lozenges, honey and eucalyptus flavor

Flurbiprofen

Read this leaflet carefully before you start taking 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.
• For advice on any matter relating to this medicine or for information about any aspect of its use, consult your pharmacist.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.
• You must see a doctor if your symptoms worsen or do not improve after 3 days.

1. What Strefen is and what it is used for.

2. What you need to know before you start taking Strefen.

3. How to take Strefen.

4. Possible side effects.

5. Storage of Strefen.

6. Contents of the pack and additional information.

Strefencontainsflurbiprofeno. Theflurbiprofenobelongs to a group of medications called nonsteroidal anti-inflammatory drugs (NSAIDs) that have analgesic, antipyretic, and anti-inflammatory properties.Strefenis used for the occasional reliefof symptoms of sore throat such aspain,irritation,throat inflammation, anddifficulty swallowing in adults and adolescents 12 years of age and older.

You should consult a doctor if symptoms worsen or do not improve after3daysof treatment.

Do not takeStrefen:

• if you are allergic (hypersensitive) to flurbiprofen or any of the other components ofthis medication (listed in section 6)
• if you have ever experienced asthma, sudden wheezing or difficulty breathing, nasal secretion, facial swelling or an itchy rash (urticaria) after taking acetylsalicylic acid (Aspirin) or any other nonsteroidal anti-inflammatory drug (NSAID)
• if you have or have had two or more episodes of stomach ulcers, intestinal ulcers or gastrointestinal bleedingl
• if you have ever had gastrointestinal bleeding or perforation, severe colitis (intestinal inflammation) or blood disorders after taking any other NSAID
• if you are in the last trimester of pregnancy
• ifyou have or have had severe heart, kidney or liver failure.

Warnings and Precautions

Consult your doctor orpharmacist before starting to takeStrefenif:

• you have ever had asthma or allergies
• you have tonsillitis (inflammation of the tonsils) or think you may have a bacterial throat infection (as you may need antibiotics)
• you have an infection - see the section "Infections" below
• you have heart, kidney or liver problems
• you have had a stroke
• you have a history of intestinal disease (ulcerative colitis, Crohn's disease)
• you have a chronic autoimmune disease such as systemic lupus erythematosus or connective tissue disease
• you are an elderly patient, as you are more likely to experience the side effects described in this leaflet
• you are in the first 6 months of pregnancy or breastfeeding
• you have high blood pressure
• you have headache induced by taking analgesics.

Infections

Nonsteroidal 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, leading to a higher 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

• At the first sign of a skin reaction (rash, exfoliation, blisters) or other allergic reaction, stop taking this medication 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 medications containing flurbiprofen may be associated with a small increase in the risk of having a heart attack (myocardial infarction) or stroke. Any risk is more likely at high doses and with prolonged treatment. Do not exceed the recommended dose or treatment duration (3 days).

Children

This medication cannot be used by children under 12 years old.

Other medicationsandStrefen

Inform your doctor or pharmacist ifyou are taking, have taken recently or may need to take any other medication.

• Acetylsalicylic acid (Aspirin) at low doses (up to 75 mg per day).
• Medications for high blood pressure or heart failure (anti-hypertensives, cardiac glycosides).
• Diuretics (including potassium-sparing diuretics).
• Medications to thin the blood (anticoagulants, antiplatelet agents).
• Medications for gout (probencid, sulfinpyrazone).
• Other NSAIDs, including selective cyclooxygenase-2 inhibitors or corticosteroids (such as celecoxib, ibuprofen, diclofenac sodium or prednisolone).
• Mifepristone (a medication used for abortion).
• Quinolone antibiotics (such as ciprofloxacin).
• Ciclosporin or tacrolimus (to inhibit the immune system).
• Phenytoin (to treat epilepsy).
• Methotrexate (to treat autoimmune diseases or cancer).
• Lithium or selective serotonin reuptake inhibitors (to treat depression).
• Oral antidiabetic medications (to treat diabetes).
• Zidovudine (to treat HIV).

Taking Strefen with food, drinks and alcohol.

It is recommended to avoid consuming alcohol during treatment withthis medication, as it may increase the risk of stomach or intestinal bleeding.

Pregnancy,breastfeedingand fertility

If you are pregnant or breastfeeding,consult your doctor or pharmacist before usingthis medication.

Do not take this medication?if you are in the last trimester of pregnancy?Strefen. If you are in the first 6 months of pregnancy or breastfeeding, consult your doctor before taking this medication.

?

Flurbiprofen belongs to a group of medications that may alter fertility in women. This effect is reversible when the medication is stopped. It is unlikely that occasional use of this medication will affect your chances of becoming pregnant, but inform your doctor before taking this medication if you have difficulty conceiving.

Driving and operating machinery

No studies have been conducted on the effects of the medication on the ability to drive or operate machinery. However, dizziness and visual disturbances are possible side effects after taking NSAIDs. If you are affected, do not drive or operate machinery.

Strefencontainsisomalta(E953),maltitolliquid (E965) and fragrances withanisic alcohol, benzyl alcohol, benzyl benzoate, cinnamyl benzoate, benzyl salicylate, cinnamal, anisic alcohol, citral,geraniol, limoneneandlinalool.

This medication containsisomalta(E953)and maltitol liquid(E965). If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication may cause a mild laxative effect because it contains 2032.18 mgof Isomaltaper lozenge and 509.03 mg of maltitol liquidper lozenge.

Caloric value: 2.3 kcal/g of maltitol/isomalta.

Anisic alcohol, benzyl alcohol, benzyl benzoate, cinnamyl benzoate, benzyl salicylate, cinnamal, anisic alcohol, citral, geraniol, limonene and linaloolmay cause allergic reactions.

This medication contains 0.00169 mg of benzyl alcohol in each lozenge.

Consult your doctor or pharmacist if you are pregnant or breastfeeding (see section 2. Pregnancy, breastfeeding and fertility). This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

Benzyl alcohol may cause allergic reactions.

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

The recommended dose in adults and adolescents 12 years and older is:

• Insert 1 lozenge into the mouth and suck it slowly.
• Movethe lozenge around in the mouth while sucking it.
• You will notice the effect of the lozenges within 30 minutes.
• Take 1 lozenge every 3-6 hours as needed.
• Do not take more than 5 lozenges in 24 hours.

Use in children:

Children under 12 years old cannot take this medication.

These lozenges are only for short treatments.Use the lowest effective dose 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 mouth irritation appears, discontinue flurbiprofen treatment.

Do not take Strefen for more than 3 days, unless your doctor tells you to. If it does not improve, worsens, or new symptoms appear, consult your doctor or pharmacist.

If you take more Strefen than you should

Call a doctor or go to the nearest hospital immediately. Symptoms of overdose may include the following: nausea or vomiting, stomach pain or, less frequently, diarrhea, ringing in the ears, headache, and gastrointestinal bleeding.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20 indicating the medication and the amount ingested.

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

If you forgot to take Strefen

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

Like all medications, this medication may cause side effects, although not everyone will experience them.

STOP TAKING this medication and consult your doctor immediately if you notice:

• allergic reactions such as asthma, sudden wheezing or shortness of breath, itching, nasal discharge, skin rashes, etc.
• swelling of the face, tongue, or throat that causes difficulty breathing, palpitations, a drop in blood pressure that causes shock (these effects can occur even when the medication is used for the first time).
• skin reactions such as peeling, blisters, or skin flaking.

Inform your doctor or pharmacist if you observe 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 or mouth pain
• sore throat
• unusual sensations in the mouth (sensation of heat, burning, itching, tingling, etc.)
• nausea and diarrhea
• sensation of itching and pruritus on the skin.

Rare(may affect up to 1 in 100 people)

• numbness
• mouth or throat blisters, throat numbness
• abdominal distension, abdominal pain, gas, constipation, indigestion, vomiting
• dry mouth
• sensation of burning in the mouth, altered sense of taste
• skin rashes, itching on the skin
• fever, pain
• drowsiness or difficulty falling asleep
• worsening of asthma, wheezing, shortness of breath
• reduced sensitivity in the throat.

Uncommon(may affect up to 1 in 1,000 people)

• anaphylactic reaction.

Unknown frequency(cannot be estimated from available data)

• anemia, thrombocytopenia (low platelet count in the blood that may cause bruising and bleeding)
• swelling (edema), high blood pressure, heart failure, or heart attack
• severe forms of skin reactions such as blistering, including Stevens-Johnson syndrome, Lyell syndrome, and toxic epidermal necrolysis
• 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 theSpanish System for 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 medication.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store above 25°C.

Medicines should not be thrown into the drains or trash. Dispose of the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacisthow to dispose ofthepackaging and of themedications that you no longerneed.By doing so, you will help protect the environment.

Composition of Strefen

The active ingredient (the component that makes the medicine effective) is flurbiprofen 8.75 mg. The other components (excipients) are: macrogol 300, potassium hydroxide (E525), ammonium caramel (E150c), curcumin (E100) (contains propylene glycol (E1520) and polisorbate 80), honey and eucalyptus aroma (contains preparations, natural flavorings, flavorings, triacetin (E1518), propylene glycol (E1520), anisic alcohol, benzyl alcohol, benzoate of benzyl, cinnamyl benzoate, salicylate of benzyl, cinnamal, cinnamyl alcohol, citral, geraniol, limonene, and linalol), acesulfame potassium (E950), liquid maltitol (E965), and isomalt (E953).

Appearance of the product and contents of the package

The lozenges are round, pale brown to yellow in color with the brand logo engraved, packaged in opaque PVC/PVdC/Aluminum blisters in a cardboard box with 16 lozenges.

Holder of the marketing authorization

Reckitt Benckiser Healthcare, S.A.

C/ Mataró, 28

08403 Granollers, Barcelona (Spain)

Responsible for manufacturing

RB NL Brands B.V.,

WTC Schiphol Airport,Schiphol Boulevard 207,

1118 BH Schiphol, Netherlands.

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: February 2024

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).