PATIENT INFORMATION LEAFLET

Strefen 8,75 mg Lozenges, Orange 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 are not listed in this leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 3 days of treatment.

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 and older.

Consult a doctor if symptoms worsen or do not improve after 3 days of treatment.

Do not take Strefen:

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 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 connective tissue disease
• if you are an elderly patient, as you are more likely to experience the side effects described in this leaflet
• if you are in the first 6 months of pregnancy or breastfeeding

if you have intolerance to some sugars

Infections

Nonsteroidal anti-inflammatory drugs (NSAIDs) can mask signs of infections such as fever and pain. This may delay the start of appropriate treatment for the infection, which may lead to a higher risk of complications. If you are taking 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.

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 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).

Strefen with food, drinks and alcohol

Alcohol consumption should be avoided during treatment with Strefen, 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 intend to become pregnant, consult your doctor or pharmacist before using this medication.

Do not take this medicationif you arein the last 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 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.

Important information about some of the components of Strefen:

This medication contains isomalta (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. It may cause a mild laxative effect because it contains 2033.29 mg of isomalta (E953) and 509.31 mg of maltitol liquid (E965) per lozenge.

Caloric value: 2.3 kcal/g maltitol or isomalta.

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

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

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.

• Do not take more than 5 tablets in 24 hours.

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 tablets 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, discontinue treatment with the 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

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.

Call a doctor or go to the nearest hospital immediately or call the Toxicological Information Service, phone: 91 562 04 20 indicating the medication and the amount taken.

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 compensate for the missed doses.

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
• Throat pain
• Mouth discomfort (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
• Blisters in the mouth or throat, numbness in the throat
• 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

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

Unknown frequency(cannot be estimated from available data)

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 the 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.

If you experience adverse effects, consult your doctor or pharmacist, even if it is an adverse effect that does not appear in this leaflet.

• 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.

• This medication does not require special storage conditions.

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 component that makes the medicine effective) is flurbiprofen 8.75 mg. The other components (excipients) are: macrogol 300, potassium hydroxide (E525), orange aroma, levomentol, potassium acesulfame (E950), liquid maltitol (E965) and isomalta (E953).

Appearance of the product and contents of the package

The lozenges are round, white to light yellow in color with the brand logo engraved. The package contains 16 lozenges.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization

RECKITT BENCKISER HEALTHCARE, S.A.

C/ Mataró, 28

08403 Granollers (Spain)

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

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