STREFEN 8.75 mg lozenges honey and eucalyptus flavor

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 discharge, facial swelling, 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 (inflammation of the intestine), or blood disorders
• 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 taking Strefen if:

• 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 "Infections" section 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 package leaflet
• you are in the first 6 months of pregnancy or are breastfeeding
• you have high blood pressure
• you have headache induced by taking analgesics.

Infections

Non-steroidal anti-inflammatory drugs (NSAIDs) may hide signs of infections such as fever and pain. This can delay the start of appropriate treatment for the infection, which can lead to a greater risk of complications. If you take this medication while having 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, peeling, 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 it does not improve, worsens, or if new symptoms appear.
• Taking 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 in prolonged treatments. Do not exceed the recommended dose or treatment duration (3 days).

Children

This medication is not for use in children under 12 years of age.

Other medications and Strefen

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

• 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

Consumption of alcohol should be avoided during treatment with this medication, 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 medication if 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.

The flurbiprofen belongs to a group of medications that can 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.

Strefen contains isomalt (E953), liquid maltitol (E965), and fragrances with aniseed alcohol, benzyl alcohol, benzyl benzoate, benzyl cinnamate, benzyl salicylate, cinnamal, cinnamic alcohol, citral, geraniol, limonene, and linalol.

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 produce a slight laxative effect because it contains 2032.18 mg of isomalt per lozenge and 509.03 mg of liquid maltitol per lozenge.

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

Aniseed alcohol, benzyl alcohol, benzyl benzoate, benzyl cinnamate, benzyl salicylate, cinnamal, cinnamic alcohol, citral, geraniol, limonene, and linalol may 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 can accumulate in your body and cause adverse effects (metabolic acidosis).

Benzyl alcohol may cause allergic reactions.

3. How to take Strefen

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

The recommended dosein adults and adolescents from 12 years of age is:

• Insert 1 lozenge into the mouth and suck it slowly.
• Move the lozenge around in the mouth while sucking it.
• The effect of the lozenges will be noticed from 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 of age cannot take this medication.

These lozenges are for short-term use only. The effective lowest 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 flurbiprofen should be discontinued.

Do not take Strefen for more than 3 days, unless indicated by your doctor. If it does not improve, worsens, 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.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology 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 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, sudden 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 peeling, blisters, or skin exfoliation.

Tell your doctor or pharmacist if you notice 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
• discomfort or an unusual sensation in the mouth (feeling of heat, burning, itching, tingling, etc.)
• nausea and diarrhea
• itching sensation and pruritus on 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 on the skin
• fever, pain
• drowsiness or difficulty falling asleep
• 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 forms of 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 side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Monitoring System for Human Use: www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Strefen

Keep this medication 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.

Do not store above 25°C.

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 medicine effective) is flurbiprofen 8.75 mg. The other components (excipients) are: macrogol 300, potassium hydroxide (E525), ammoniac caramel (E150c), curcumin (E100) (contains propylene glycol (E1520) and polysorbate 80), honey and eucalyptus flavor (contains flavoring preparations, natural flavoring substances, flavoring substances, triacetin (E1518), propylene glycol (E1520), anisic alcohol, benzyl alcohol, benzyl benzoate, benzyl cinnamate, benzyl salicylate, cinnamal, cinnamic alcohol, citral, geraniol, limonene, and linalool), acesulfame potassium (E950), liquid maltitol (E965), and isomalt (E953).

Appearance of the Product and Package Contents

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

Marketing Authorization Holder

Reckitt Benckiser Healthcare, S.A.

C/ Mataró, 28

08403 Granollers, Barcelona (Spain)

Manufacturer

RB NL Brands B.V.,

WTC Schiphol Airport, Schiphol Boulevard 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 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/).