Package Leaflet: Information for the user

STREFEN 8.75 mg Lozenges, Honey and Lemon Flavor

Flurbiprofen

Read this leaflet carefully before you start to take this medicine because it contains important information for you.

Follow exactly the administration instructions for the medicine contained in this leaflet or those 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 side effects, consult your doctor or pharmacist, even if they appear in this leaflet. See section 4.
• You must consult a doctor if it worsens or does not improve after 3 days.

Strefen contains flurbiprofen. Flurbiprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs) that have analgesic, antipyretic, and anti-inflammatory properties. It is used for the relief of symptoms of sore throat, such as irritation, pain, difficulty swallowing, and throat inflammation in adults and adolescents 12 years of age and older.

You should consult a doctor if symptoms worsen or do not improve after 3 days of treatment.

Do not take Strefen

• if you are allergic (hypersensitive) to flurbiprofen or any of the other components of this medication (listed in section 6)
• if after taking acetylsalicylic acid (Aspirin) or any other nonsteroidal anti-inflammatory drug (NSAID) you have ever experienced asthma, sudden onset of "buzzing" or difficulty breathing, nasal discharge, facial swelling, or skin rash with itching (urticaria)
• if you have or have had 2 or more episodes of stomach ulcers, intestinal ulcers, or gastrointestinal bleeding
• if after taking any other NSAID you have had gastrointestinal bleeding or perforation, severe colitis, or blood disorders
• if you are taking high doses of acetylsalicylic acid (Aspirin) or other NSAIDs (such as celecoxib, ibuprofen, diclofenac sodium, etc)
• if you are in the last trimester of pregnancy
• if you have or have had severe heart, liver, or kidney failure

Warnings and precautions

Consult your doctor or pharmacist before starting to take Strefen.

• if you have ever had asthma or allergies
• 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 have heart, kidney, or liver problems
• if you have had a stroke
• if you have a history of intestinal disease (ulcerative colitis, Crohn's disease)
• if you have a chronic autoimmune disease such as systemic lupus erythematosus or mixed connective tissue disease
• if you are an elderly patient, as you are more likely to experience the adverse reactions mentioned in this leaflet
• if you are in the first 6 months of pregnancy or breastfeeding
• if your doctor has told you that you have an intolerance to certain sugars.

Infections

Nonsteroidal anti-inflammatory drugs (NSAIDs) can mask signs of infections such as fever and pain. This can delay the start of appropriate treatment for the infection, which can lead 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 suffering 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 duration (3 days).

Children

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

Taking Strefen with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take another medication. In particular, if you are taking:

• Acetylsalicylic acid (Aspirin) at low doses (up to 75 mg per day).
• Medications for high blood pressure or heart problems (anti-hypertensives, cardiac glycosides).
• Diuretics (including potassium-sparing diuretics).
• Medications to thin the blood (anticoagulants, antiplatelet agents).
• Medications for gout (probencid, sulfinpyrazone).
• Other NSAIDs or corticosteroids (such as celecoxib, ibuprofen, diclofenac sodium, or prednisolone).
• Mifepristone (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

Alcohol should be avoided during treatment with Strefen, as it may increase the risk of stomach or intestinal bleeding.

Pregnancy, breastfeeding, and fertility

Do not take this medication if you are in the third trimester of pregnancy. 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 affect 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 getting pregnant, but inform your doctor before taking this medication if you have difficulty conceiving.

Driving and operating machinery

Strefen should not affect your ability to drive or operate machinery. However, if you experience adverse reactions such as dizziness and/or visual disturbances, do not drive or operate machinery.

Important information about some of the components of Strefen

This medication contains 1,069 g of glucose and 1,407 g of sucrose per lozenge. This should be taken into account in patients with diabetes mellitus.

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains very low levels of gluten (from wheat starch). It is considered "gluten-free," and it is very unlikely to cause problems if you have celiac disease.

One lozenge does not contain more than 21.38 micrograms of gluten. If you have a wheat allergy (other than celiac disease), do not take this medication.

This medication contains fragrances with citral, citronellol, d-limonene, farnesol, geraniol, and linalol.

Citral, citronellol, d-limonene, farnesol, geraniol, and linalol may cause allergic reactions.

Sulfur dioxide (E220) may rarely cause severe hypersensitivity reactions and bronchospasm.

Butilhydroxyanisole (E320) may cause local skin reactions (e.g., contact dermatitis) or irritation of the eyes and mucous membranes.

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

Therecommended doseis:Adults and adolescents over 12 years:

1 tablet every 3-6 hours, as needed.

Use in children:

Children under 12 years cannot take this medication.

How to take

• Insert 1 tablet in the mouth and suck it slowly.
• Movethe tablet in the mouth while sucking it.
• The effect of the tablet will be noticed from 30 minutes.

These tablets are only for short treatments.You should use the most 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, you must suspend treatment with this medication.

Do not take Strefen for more than 3 days, unless your doctor recommends it.

If it does not improve, worsens, or new symptoms appear, consult your doctor or pharmacist.

If you take more Strefen than you should

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 taken.

The symptoms of overdose may be: nausea or vomiting, stomach pain, or, less frequently, diarrhea. You may also experience ringing in the ears, headache, and gastrointestinal bleeding.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

STOP taking this medicine and consult your doctor immediately if you notice:

• Allergic reactions such as asthma, sneezing, 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 (all these effects can occur even when the medicine 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
• Mouth discomfort (sensation of heat, burning, itching, tingling, etc.)
• Nausea and diarrhea
• Sensation of itching and pruritus on the skin.

Rarely(may affect up to 1 in 100 people)

• Numbness
• Blisters in the mouth or throat, 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, sneezing, shortness of breath
• Reduced sensitivity in the throat.

Very rare(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
• Heptatitis (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 an adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish 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 medicine.

• Keep out of sight and reach of children.
• Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.
• Store in the original packaging.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Strefen

The active ingredient (the one that makes the medicine effective) is flurbiprofen 8.75 mg. The other components (excipients) are: macrogol 300, potassium hydroxide (E525), lemon aroma (contains butylhydroxyanisole (E320)), levomenthol, inverted sugar (honey), liquid glucose (contains wheat starch and sulfur dioxide (E220)) and liquid saccharose.

Appearance of the product and contents of the package

The tablets are pale yellow, opaque, and have the brand logo engraved.

The blister pack contains 16 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Reckitt Benckiser Healthcare, S.A.

C/ Mataró, 28

08403 Granollers-Barcelona

Responsible for manufacturing

RB NL Brands B.V.

Schiphol Blvd 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

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