Strefen 8.75 mg lozenges honey and lemon flavour

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

STREFEN 8.75 mg lozenges with honey and lemon flavour

Flurbiprofen

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

Follow exactly the instructions for taking this medicine contained in this leaflet or those provided by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. See section 4.
• You must consult a doctor if you worsen or do not improve after 3 days.

Contents of the leaflet:

1. What Strefen is and what it is used for.
2. What you need to know before taking it.
3. How to take Strefen.
4. Possible adverse effects.
5. How to store Strefen.
6. Contents of the pack and other information.

1. What Strefen is and what it is used for

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

You should consult a doctor if 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 to any of the other ingredients of this medicine (listed in section 6)
• if after taking acetylsalicylic acid (Aspirin) or any other NSAID you have ever experienced asthma, sudden onset of "wheezing" or difficulty breathing, runny nose, facial swelling, or skin rash with itching (urticaria)
• if you currently have or have previously had two or more episodes of stomach ulcer, intestinal ulcer, or gastrointestinal bleeding
• if after taking any other NSAID you have experienced 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, sodium diclofenac, etc.)
• if you are in the last trimester of pregnancy
• if you have severe heart, liver, or kidney failure.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Strefen if:

• you have ever had asthma or suffer from allergies
• you have tonsillitis (inflamed tonsils) or suspect you may have a bacterial throat infection (as you may need antibiotics)
• you have an infection – see section "Infections" 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 mixed connective tissue disease
• you are elderly, as you are more likely to experience the adverse reactions mentioned in this leaflet
• you are in the first 6 months of pregnancy or are breastfeeding
• your doctor has told you that you have an intolerance to certain sugars.

Infections

Non-steroidal anti-inflammatory drugs (NSAIDs) may mask signs of infection such as fever and pain. This could delay the start of appropriate treatment for the infection, increasing the risk of complications. If you take this medicine while having an infection and your symptoms persist or worsen, consult your doctor or pharmacist immediately.

While using Strefen

• At the first sign of a skin reaction (rash, peeling, blisters) or any other sign of an allergic reaction, stop taking this medicine and consult a doctor immediately.
• Inform your doctor of any unusual abdominal symptoms you may experience (especially bleeding).
• Consult your doctor if your condition does not improve, worsens, or if new symptoms appear.
• The use of medicines containing flurbiprofen may be associated with a small increased risk of heart attack or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment (3 days).

Children

This medicine must not be used in children or adolescents under 12 years of age.

Taking Strefen with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. 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, sodium diclofenac, or prednisolone).
• Mifepristone (a medicine used for abortion).
• Quinolone antibiotics (such as ciprofloxacin).
• Cyclosporine or tacrolimus (to suppress the immune system).
• Phenytoin (for treating epilepsy).
• Methotrexate (for treating autoimmune diseases or cancer).
• Lithium or selective serotonin reuptake inhibitors (for depression).
• Oral antidiabetics (for treating diabetes).
• Zidovudine (for treating 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 discontinued. It is unlikely that occasional use of this medicine will affect your chances of becoming pregnant; however, inform your doctor before taking this medicine if you have difficulty conceiving.

Driving and using machines

Strefen should not affect your ability to drive or operate machinery. 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 him before taking this medicine.

This medicine 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 coeliac disease.

One lozenge contains no more than 21.38 micrograms of gluten. If you have a wheat allergy (distinct from coeliac 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) may rarely cause severe hypersensitivity reactions and bronchospasm.

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

3. How to take Strefen

Follow exactly the instructions for use provided in this leaflet, or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The recommended dose is: Adults and adolescents over 12 years of age:

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 of age must not take this medicine.

How to take

• Place 1 tablet in the mouth and suck it slowly.
• Move the tablet around in the mouth while sucking.
• You will start to feel the effect of the tablet after about 30 minutes.

These tablets are intended 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 a doctor or pharmacist without delay if symptoms (such as fever and pain) persist or worsen (see section 2). If mouth irritation occurs, discontinue treatment with this medicine.

Do not take Strefen for more than 3 days, unless otherwise advised by your doctor.

If symptoms do not improve, worsen, or new symptoms appear, consult your doctor or pharmacist.

If you take more Strefen than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, stating the medicine and the amount taken.

Symptoms of overdose may include nausea or vomiting, stomach pain, or more rarely, diarrhea. Other possible symptoms include ringing in the ears (tinnitus), headache, and gastrointestinal bleeding.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience 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 rashes, etc.
• Swelling of the face, tongue or throat causing difficulty breathing, palpitations, drop in blood pressure leading to shock (these effects may occur even when the medicine is used for the first time).
• Skin reactions such as peeling, blisters or skin shedding.

Inform your doctor or pharmacist if you notice 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
• skin itching and pruritus.

Uncommon (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
• burning sensation in the mouth, altered taste sensation
• skin rashes, skin itching
• fever, pain
• drowsiness or difficulty sleeping
• worsening of asthma, wheezing, shortness of breath
• reduced throat sensitivity.

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 which may lead to bruising and bleeding)
• swelling (edema), high blood pressure, heart failure or heart attack
• severe forms of skin reaction such as blistering reactions, including Stevens-Johnson syndrome, Lyell's syndrome and toxic epidermal necrolysis
• hepatitis (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 not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products (www.notificaram.es). By reporting adverse 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 stated on the container after EXP. The expiry date is the last day of the month indicated.
• Store in the original packaging.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Pack contents and additional information

Composition of Strefen

The active substance (the one responsible for the medicinal effect) is flurbiprofen 8.75 mg. The other components (excipients) are: macrogol 300, potassium hydroxide (E525), lemon flavour (contains butylated hydroxyanisole (E320)), levomenthol, invert sugar (honey), liquid glucose (contains wheat starch and sulphur dioxide (E220)) and liquid sucrose.

Appearance of the product and pack contents

The tablets are circular, pale yellow, opaque, with the brand logo imprinted.

The package contains 16 tablets.

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,

The Netherlands

This medicinal product 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 and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/