Strefen 8.75 mg orange-flavoured pastilles for oral use

Patient Information Leaflet

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Strefen 8.75 mg lozenges with orange flavour

Flurbiprofen

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

Always follow exactly the instructions for taking this medicine as described in this leaflet or as 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 side effects not listed in this leaflet. See section 4.
• You must consult a doctor if your condition worsens or if you do not improve after 3 days of treatment.

Leaflet Contents:

1. What Strefen is and what it is used for
2. What you need to know before taking Strefen
3. How to take Strefen
4. Possible side 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 to relieve symptoms of sore throat 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 wheezing or difficulty breathing, nasal discharge, swelling of the face, or itchy rash (urticaria)
• if you currently have or have ever 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 another NSAID (such as celecoxib, ibuprofen, sodium diclofenac, etc.)
• if you are in the last trimester of pregnancy
• if you currently have or have ever 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 suffer from allergies
• if you have tonsillitis (inflammation of the tonsils) or suspect 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 elderly, 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 are breastfeeding

if 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 without delay.

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

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

• Acetylsalicylic acid (Aspirin) at low doses (up to 75 mg per day)
• Medicines for high blood pressure or heart failure (antihypertensives, cardiac glycosides)
• Diuretics (including potassium-sparing diuretics)
• Medicines to thin the blood (anticoagulants, antiplatelet agents)
• Medicines for gout (probenecid, sulfinpyrazone)
• Other NSAIDs, including selective cyclooxygenase-2 inhibitors 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 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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Do not take this medicine 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 medicine.

Flurbiprofen belongs to a group of medicines that may affect fertility in women. This effect is reversible upon discontinuation of the medicine. Occasional use of this medicine is unlikely to affect your chances of becoming pregnant; however, inform your doctor before taking this medicine if you have difficulty conceiving.

Driving and using machines

No studies on the effects of the medicine on the ability to drive or operate machinery have been conducted. 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 medicine contains isomalt (E953) and liquid maltitol (E965). If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine. It may produce a mild laxative effect because it contains 2033.29 mg of isomalt (E953) and 509.31 mg of liquid maltitol (E965) per lozenge.

Calorific value: 2.3 kcal/g maltitol or isomalt.

This medicine 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 exactly the administration instructions provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Recommended dose:

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:

This medicine must not be given to children under 12 years of age.

How to take:

• Place 1 tablet in the mouth and suck it slowly.
• Move the tablet around the mouth while sucking.
• The effect of the tablets will be felt within 30 minutes.

These tablets are intended only for short-term treatment. 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 irritation in the mouth occurs, you must stop treatment with the 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

Call a doctor or go to the nearest hospital immediately. Symptoms of overdose may include: nausea or vomiting, stomach pain, or more rarely, diarrhoea, ringing in the ears, headache, and gastrointestinal bleeding.

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

If you have any further 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 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 causing 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:

Common (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
• itching and pruritus of the skin

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 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 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, talk to your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. You can 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.

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

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 packaging after EXP. The expiry date refers to the last day of the month indicated.

• This medicine does not require any special storage conditions.

Medicines should 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 dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Strefen

The active substance (the component responsible for the medicinal effect) is flurbiprofen 8.75 mg. The other components (excipients) are: macrogol 300, potassium hydroxide (E525), orange flavor, levomenthol, potassium acesulfame (E950), liquid maltitol (E965), and isomalt (E953).

Appearance of the product and contents of the pack

The lozenges are round, white to pale yellow in color, with the brand logo imprinted. The pack 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 medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the most recent review of this leaflet: February 2024

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