Strefen 8.75 mg lozenges with honey and eucalyptus flavour

Patient Information Leaflet

Introduction

Patient Information Leaflet

Strefen 8.75 mg lozenges with honey and eucalyptus flavour

Flurbiprofen

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

Follow exactly the instructions for administration provided in this leaflet or as directed 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 adverse effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or does 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 Strefen
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. Strefen is used for the occasional relief of sore throat symptoms such as pain, irritation, throat inflammation, and difficulty swallowing in adults and adolescents aged 12 years and older.

You should consult a doctor if your condition worsens or does 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, facial swelling or itchy rash (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 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 currently have or have previously 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 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 the 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 connective tissue disease
• you are elderly, as you are more likely to experience the side effects described in this leaflet
• you are in the first 6 months of pregnancy or are breastfeeding
• you have high blood pressure
• you have analgesic-induced headache.

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, potentially 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 you do not improve, worsen, or develop new symptoms.
• The use of medicines containing flurbiprofen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. Any such 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 under 12 years of age.

Other medicines and Strefen

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

• 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 this medicine, 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 when the medicine is discontinued. 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.

Strefen contains isomalt (E953), liquid maltitol (E965), and fragrances with anisyl alcohol, benzyl alcohol, benzyl benzoate, benzyl cinnamate, benzyl salicylate, cinnamal, cinnamyl alcohol, citral, geraniol, limonene and linalool.

This medicine contains isomalt (E953) and liquid maltitol (E965). If your doctor has told you that you have an intolerance to certain sugars, consult him before taking this medicine.

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

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

Anisyl alcohol, benzyl alcohol, benzyl benzoate, benzyl cinnamate, benzyl salicylate, cinnamal, cinnamyl alcohol, citral, geraniol, limonene and linalool may cause allergic reactions.

This medicine 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 may accumulate in your body and cause adverse effects (metabolic acidosis).

Benzyl alcohol may cause allergic reactions.

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 again.

The recommended dose for adults and adolescents aged 12 years and older is:

• Place 1 lozenge in the mouth and suck it slowly.
• Move the lozenge around in the mouth while sucking.
• You will start to feel the effect of the lozenges after about 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 must not take this medicine.

These lozenges 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 mouth irritation occurs, discontinue treatment with flurbiprofen.

Do not take Strefen for more than 3 days, unless otherwise directed by your doctor. If you do not improve, if your condition 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount ingested.

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 missed doses.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

• allergic reactions such as asthma, sudden 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, blistering, or flaking of the skin.

Inform your doctor or pharmacist if you notice any of the following side 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
• discomfort or unusual sensation in the mouth (feeling 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, flatulence, 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 reactions 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 a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es.

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

5. Storage of Strefen.

Keep this medicine 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.

Do not store above 25°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and empty containers at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers 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 that makes the medicine effective) is flurbiprofen 8.75 mg. The other components (excipients) are: macrogol 300, potassium hydroxide (E525), ammonium caramel (E150c), curcumin (E100) (containing propylene glycol (E1520) and polysorbate 80), honey and eucalyptus flavour (containing flavouring preparations, natural flavouring substances, flavouring substances, triacetin (E1518), propylene glycol (E1520), anisyl alcohol, benzyl alcohol, benzyl benzoate, benzyl cinnamate, benzyl salicylate, cinnamal, cinnamyl alcohol, citral, geraniol, limonene and linalool), acesulfame potassium (E950), maltitol liquid (E965) and isomalt (E953).

Appearance of the product and contents of the pack

The lozenges are round, pale brown to yellow in colour, with the brand logo imprinted, packed in opaque PVC/PVdC/Aluminium blisters, white in colour, in a cardboard carton containing 16 lozenges.

Marketing Authorisation 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, The Netherlands.

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