STREFEN 8.75 mg LOZENGES HONEY & LEMON FLAVOURED

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 medicine (listed in section 6)
• if after taking acetylsalicylic acid (Aspirin) or any other NSAID medicine you have ever experienced asthma, sudden onset of "wheezing" or difficulty breathing, runny nose, swelling of the face or skin rash with itching (urticaria)
• if you have or have had 2 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 problems
• 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 have 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 mixed connective tissue disease
• if you are an elderly patient, as you are more likely to suffer from the adverse reactions mentioned in this leaflet
• if you are in the first 6 months of pregnancy or are breastfeeding
• if your doctor has told you that you have an intolerance to certain sugars.

Infections

Non-steroidal anti-inflammatory drugs (NSAIDs) may hide signs of infections 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 medicine 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 medicine and consult a doctor immediately.
• Inform your doctor of any unusual abdominal symptoms that you may experience (especially bleeding).
• Consult your doctor if it does not improve, worsens, or if new symptoms appear.
• The use of medicines 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 treatments. Do not exceed the recommended dose or treatment duration (3 days).

Children

This medicine must not be used in children under 12 years old.

Taking Strefen with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine. In particular, if you are taking:

• Acetylsalicylic acid (Aspirin) at low doses (up to 75 mg per day).
• Medicines for high blood pressure or heart problems (antihypertensives, cardiac glycosides).
• Diuretics (including potassium-sparing diuretics).
• Medicines to thin the blood (anticoagulants, antiplatelet agents).
• Medicines for gout (probenecid, sulfinpyrazone).
• Other NSAIDs or corticosteroids (such as celecoxib, ibuprofen, diclofenac sodium, or prednisolone).
• Mifepristone (a medicine used for abortion).
• Quinolone antibiotics (such as ciprofloxacin).
• Cyclosporin 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 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 medicine if you are in the third trimester of pregnancy. If you are in the first 6 months of pregnancy or are breastfeeding, consult your doctor before taking this medicine.

Flurbiprofen belongs to a group of medicines that may affect fertility in women. This effect is reversible when the medicine is stopped. It is unlikely that occasional use of this medicine can affect your chances of getting pregnant; however, inform your doctor before taking this medicine if you have problems conceiving.

Driving and using machines

Strefen should not affect your ability to drive or use machines. However, if adverse reactions such as dizziness and/or visual disturbances occur, do not drive or use machines.

Important information about some of the ingredients of Strefen

This medicine 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 him before taking this medicine.

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

A lozenge does not contain more than 21.38 micrograms of gluten. If you have a wheat allergy (different from celiac disease), you should not take this medicine.

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

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

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

Butylhydroxyanisole (E320) may cause local skin reactions (e.g., contact dermatitis) or eye and mucous membrane irritation.

3. How to take Strefen

Follow exactly the administration instructions of the medicine contained in this 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 old:

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 must not take this medicine.

How to take

• Put 1 lozenge in your mouth and suck it slowly.
• Move the lozenge around in your mouth while sucking it.
• You will notice the effect of the lozenge from 30 minutes.

These lozenges are for short-term treatment only.The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If you have an infection, consult your doctor or pharmacist without delay if symptoms (such as fever and pain) persist or worsen (see section 2). If irritation occurs in the mouth, you should stop treatment with this medicine.

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

If it does not improve, worsens, or if 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• Allergic reactions such as asthma, wheezing, or shortness of breath, itching, runny nose, skin rash, etc.
• Swelling of the face, tongue, or throat that causes difficulty breathing, palpitations, drop in blood pressure that causes shock (all these effects can occur even when using the medicine for the first time).
• Skin reactions such as exfoliation, blisters, or skin peeling.

Tell your doctor or pharmacist if you notice any of the following effects or any effect not described in this 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 rash, 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 the 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 of side effects

If you experience any side effect, consult your doctor or pharmacist, even if it is a side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Strefen

• Keep out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date is the last day of the month indicated.
• Store in the original package.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Strefen

The active substance (which makes the medicine effective) is flurbiprofen 8.75 mg. The other ingredients (excipients) are: macrogol 300, potassium hydroxide (E525), lemon flavor (contains butylhydroxyanisole (E320)), levomenthol, inverted sugar (honey), liquid glucose (contains wheat starch and sulfur dioxide (E220)), and liquid sucrose.

Appearance of the product and pack contents

The lozenges are pale yellow, circular, and opaque with the brand logo embossed.

The pack contains 16 lozenges.

Marketing authorization holder and manufacturer

Marketing authorization holder

Reckitt Benckiser Healthcare, S.A.

C/ Mataró, 28

08403 Granollers-Barcelona

Manufacturer

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 under the following names:

Date of last revision of this leaflet:February 2024

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