STREFEN 8.75 mg lozenges orange flavour

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Strefen 8.75 mg orange-flavored lozenges

Flurbiprofen

Read the package leaflet carefully before starting to take this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 3 days of treatment.

Contents of the package leaflet:

1. What is Strefen and what is it used for
2. What you need to know before taking Strefen
3. How to take Strefen
4. Possible side effects
5. Storing Strefen
6. Package contents and additional information

1. What is Strefen and what is it used for

Strefen contains flurbiprofen. Flurbiprofen belongs to a group of medications 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 from 12 years of age.

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

2. What you need to know before taking Strefen

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 NSAID, you have ever experienced asthma, sudden wheezing, or difficulty breathing, nasal secretion, swelling of the face, or itchy rash (urticaria).
• if you have or have had two or more episodes of stomach ulcer, intestinal ulcer, 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 another NSAID (such as celecoxib, ibuprofen, diclofenac sodium, etc.)
• if you are in the last trimester of pregnancy.
• if you have or have had severe heart, kidney, or liver 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 "Infections" section 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 package leaflet
• if you are in the first 6 months of pregnancy or are breastfeeding.

if you are intolerant to some sugars

Infections

Non-steroidal 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, which may lead to a greater 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 sign of an allergic reaction, stop taking this medication 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, 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 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 should not be used by children or adolescents under 12 years of age.

Taking Strefen with other medications

Inform your doctor or pharmacist if you are taking, have recently taken, 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 hypertension or heart failure (antihypertensives, cardiac glycosides).
• Diuretics (including potassium-sparing diuretics).
• Medications to thin the blood (anticoagulants, antiplatelet agents).
• Medications for gout (probenecid, 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).
• Cyclosporine or tacrolimus (to inhibit the immune system).
• Phenytoin (to treat epilepsy).
• Methotrexate (to treat autoimmune diseases or cancer).
• Lithium or selective serotonin reuptake inhibitors (for depression).
• Oral antidiabetics (to treat diabetes).
• Zidovudine (to treat HIV).

Taking 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 plan to become pregnant, consult your doctor or pharmacist before using this medication.

Do not take this medicationif you are in the last trimester of pregnancy. If you are in the first 6 months of pregnancy or are 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 can affect your chances of becoming pregnant; however, inform your doctor before taking this medication if you have problems conceiving.

Driving and using machines

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

Important information about some of the components of Strefen:

This medication contains isomalt (E953) and liquid maltitol (E965). If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication. It may have a mild laxative effect because it contains 2033.29 mg of isomalt (E953) and 509.31 mg of liquid maltitol (E965) per lozenge.

Caloric value: 2.3 kcal/g maltitol or isomalt.

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

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

3. How to take Strefen

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

The recommended doseis:

Adults and adolescents over 12 years of age:

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 of age should not take this medication.

How to take:

• Insert 1 lozenge into the mouth and suck slowly.
• Move the lozenge around in the mouth while sucking.
• The effect of the lozenges will be noticed from 30 minutes.

These lozenges are for short-term treatment only.The lowest effective dose should be used for the shortest necessary duration 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 occurs in the mouth, treatment with the medication should be discontinued.

Do not take Strefen for more than 3 days, unless recommended by your doctor. If you do not improve, worsen, or if 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: nausea or vomiting, stomach pain, or more rarely, diarrhea, ringing in the ears, headache, and gastrointestinal bleeding.

Call a doctor or go to the nearest hospital immediately or call the Toxicology 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 forget to take Strefen

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

4. Possible side effects

Like all medications, this medication can 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, wheezing, or shortness of breath, itching, nasal discharge, skin rashes, etc.
• Swelling of the face, tongue, or throat that causes difficulty breathing, palpitations, decreased blood pressure that causes shock (all these effects can occur even when using the medication for the first time).
• Skin reactions such as exfoliation, blisters, or skin peeling.

Inform your doctor or pharmacist if you observe any of the following effects or any effect not described in this package leaflet:

Common(may affect up to 1 in 10 people)

• dizziness, headache
• throat irritation
• mouth ulcers or mouth pain
• throat pain
• mouth discomfort (feeling of heat, burning, itching, tingling, etc.)
• 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, numbness in the throat
• abdominal distension, abdominal pain, gas, constipation, indigestion, vomiting
• dry mouth
• burning sensation in the mouth, altered taste
• skin rashes, itching of the skin
• fever, pain
• drowsiness or difficulty sleeping
• worsening of asthma, wheezing, shortness of breath
• reduced sensitivity in the throat

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

• anaphylactic reaction

Frequency not known(cannot be estimated from available data)

• anemia, thrombocytopenia (low platelet count in the blood that can lead to bruising and bleeding)
• edema, high blood pressure, heart failure, or heart attack
• severe skin reactions such as blistering reactions, including Stevens-Johnson syndrome, Lyell syndrome, and toxic epidermal necrolysis
• hepatitis (inflammation of the liver).

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use (www.notificaram.es). By reporting side effects, you can help provide more information on the safety of this medication.

If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet.

5. Storing Strefen

• Keep out of sight and reach of children.

• Do not use this medication after the expiration date stated on the package after EXP. The expiration date is the last day of the month indicated.

• This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Strefen

The active ingredient (the component that makes the medication effective) is flurbiprofen 8.75 mg. The other components (excipients) are: macrogol 300, potassium hydroxide (E525), orange flavor, levomenthol, acesulfame potassium (E950), liquid maltitol (E965), and isomalt (E953).

Appearance of the product and package contents

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

Marketing authorization holder and manufacturer:

Marketing authorization holder

RECKITT BENCKISER HEALTHCARE, S.A.

C/ Mataró, 28

08403 Granollers (Spain)

Manufacturer

RB NL Brands B.V.

Schiphol Blvd 207, 1118 BH Schiphol, Netherlands

This medication is authorized in the member states of the European Economic Area under the following names:

Date of the last revision of this package leaflet:February 2024

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/