STREPSILS 8.75 mg Lozenge

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
2. What is Strepsils Intensive sugar-free orange and what is it used for
3. Important information before taking Strepsils Intensive sugar-free orange
   1. When not to take Strepsils Intensive sugar-free orange:
   2. Warnings and precautions
   3. Children and adolescents
   4. Strepsils Intensive sugar-free orange and other medicines
   5. Taking Strepsils Intensive sugar-free orange with alcohol
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Strepsils Intensive sugar-free orange contains maltitol and isomalt
   9. Strepsils Intensive sugar-free orange contains orange flavor (including ethanol, citral, citronellol, d-limonene, geraniol, and linalol)
4. How to take Strepsils Intensive sugar-free orange
   1. Recommended dose:
   2. Do not take more than 5 hard lozenges in 24 hours.
   3. Use in children and adolescents
   4. Medicine intended for short-term use only.
   5. Taking a higher dose of Strepsils Intensive sugar-free orange than recommended
5. Possible side effects
   1. The patient should stop taking the medicine and contact their doctor immediately if they experience any of the following symptoms:
   2. Side effects that may occur:
   3. Reporting side effects
6. How to store Strepsils Intensive sugar-free orange
7. Package contents and other information
   1. What Strepsils Intensive sugar-free orange contains
   2. What Strepsils Intensive sugar-free orange looks like and what the package contains
   3. Marketing authorization holder and importer
   4. Marketing authorization holder:
   5. Importer:
   6. Date of last revision of the leaflet:

Leaflet attached to the packaging: patient information

Strepsils Intensive sugar-free orange, 8.75 mg, hard lozenges
Flurbiprofen

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, consult a doctor or pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor or pharmacist.
• If there is no improvement after three days or if the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Strepsils Intensive sugar-free orange and what is it used for
• 2. Important information before taking Strepsils Intensive sugar-free orange
• 3. How to take Strepsils Intensive sugar-free orange
• 4. Possible side effects
• 5. How to store Strepsils Intensive sugar-free orange
• 6. Package contents and other information

1. What is Strepsils Intensive sugar-free orange and what is it used for

Strepsils Intensive sugar-free orange hard lozenges contain flurbiprofen.
This substance belongs to the group of nonsteroidal anti-inflammatory drugs (NSAIDs).
Strepsils Intensive sugar-free orange has a strong analgesic and anti-inflammatory effect in the treatment of sore throat.
Strepsils Intensive sugar-free orange is indicated for short-term symptomatic treatment of sore throat in adults and adolescents over 12 years old.
The soothing and coating effect of the medicine starts within two minutes of administration and lasts for up to 4 hours.

2. Important information before taking Strepsils Intensive sugar-free orange

When not to take Strepsils Intensive sugar-free orange:

• if the patient is allergic to flurbiprofen, acetylsalicylic acid, and other nonsteroidal anti-inflammatory drugs (NSAIDs) or any of the other ingredients of this medicine (listed in section 6),
• in patients with existing or previous stomach or duodenal ulcer, severe ulcerative colitis,
• in patients who have experienced allergic symptoms (such as runny nose, angioedema, difficulty breathing (asthma), rash) after taking acetylsalicylic acid or any other nonsteroidal anti-inflammatory drug,
• in patients with bleeding or perforation of the gastrointestinal tract, bleeding or blood disorders associated with previous NSAID treatment,

when using NSAIDs,

• in patients taking other nonsteroidal anti-inflammatory drugs (including cyclooxygenase-2 inhibitors, such as celecoxib) at the same time,
• in pregnant women in the last three months of pregnancy,
• in patients with severe heart, liver, or kidney failure,
• in children under 12 years old.

Warnings and precautions

Before taking Strepsils Intensive sugar-free orange, the patient should discuss it with their doctor or pharmacist:

• if the patient has or has had asthma or an allergy,
• if the patient is already taking any other nonsteroidal anti-inflammatory drugs (NSAIDs) or acetylsalicylic acid,
• if the patient is elderly (may be more susceptible to side effects),
• if the patient has a chronic autoimmune disease (including systemic lupus erythematosus and mixed connective tissue disease),
• if the patient has tonsillitis or suspects they may have a bacterial throat infection (may require an antibiotic),
• if the patient has an infection - see "Infections" below,
• if the patient has heart, kidney, or liver disease,
• in patients with heart failure, after a stroke, or with increased risk of such disorders as high blood pressure, diabetes, or high cholesterol, or in smokers,
• if the patient has high blood pressure,
• if the patient has persistent headache,
• if the patient has gastrointestinal diseases,
• if the patient is pregnant or breastfeeding.

Infections
Nonsteroidal anti-inflammatory drugs (NSAIDs) may mask the symptoms of infection, such as fever and pain. This may delay appropriate treatment of infections, which can lead to increased risk of complications. If the patient is taking this medicine during an ongoing infection and their symptoms persist or worsen, they should consult their doctor or pharmacist immediately.
When taking Strepsils Intensive sugar-free orange:

• At the first signs of any hypersensitivity reaction (rash, desquamation, blisters) or other allergic reaction symptoms, the patient should stop taking the medicine and consult their doctor.
• The patient should report any unusual abdominal symptoms (especially bleeding) to their doctor.
• If there is no improvement or new symptoms appear, the patient should consult their doctor.
• Medicines like flurbiprofen may slightly increase the risk of heart attack (myocardial infarction) or stroke. The risk is more likely with higher doses or long-term treatment. The patient should not exceed the recommended dose or duration of treatment (see section 3).

Children and adolescents

The medicine should not be taken by children under 12 years old.

Strepsils Intensive sugar-free orange and other medicines

The patient should tell their doctor or pharmacist about all the medicines they are taking, including those obtained without a prescription. In particular, before taking the medicine, the patient should inform their doctor or pharmacist about taking any of the following medicines:

• medicines for high blood pressure or heart failure (angiotensin-converting enzyme inhibitors (ACE), such as captopril, enalapril, perindopril, and angiotensin II receptor antagonists, such as losartan, valsartan, telmisartan),
• diuretics (including potassium-sparing diuretics), such as hydrochlorothiazide, furosemide, spironolactone, indapamide,
• medicines that reduce blood clotting, such as warfarin or acetylsalicylic acid,
• antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs) used to treat depression, such as fluoxetine, citalopram, sertraline,
• medicines for gout (probenecid, sulfinpyrazone),
• other nonsteroidal anti-inflammatory drugs or steroids (prednisolone),
• cardiac glycosides, such as digoxin,
• cyclosporine (a medicine used to suppress the immune system),
• phenytoin (a medicine used to treat epilepsy),
• methotrexate (a medicine used to treat psoriasis, arthritis, and cancer),
• antibiotics from the quinolone group used in bacterial infections, such as ciprofloxacin, levofloxacin,
• tacrolimus (an immunosuppressive medicine used after organ transplantation),
• zydovudine (a medicine used to treat HIV infection),
• lithium (an antidepressant medicine).

Taking medicines like flurbiprofen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. The risk increases with long-term use of high doses. The patient should not take higher doses or use the medicine for longer than recommended.

Taking Strepsils Intensive sugar-free orange with alcohol

Alcohol may increase the risk of side effects, especially gastrointestinal bleeding.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to become pregnant, they should consult their doctor or pharmacist before taking this medicine.
Strepsils Intensive sugar-free orange should not be taken in the last three months of pregnancy.
Strepsils Intensive sugar-free orange should not be taken during the first six months of pregnancy unless absolutely necessary and recommended by a doctor. If treatment is necessary during this period, the patient should take the smallest dose for the shortest possible time.
Flurbiprofen belongs to a group of medicines that may adversely affect female fertility. This effect is reversible after stopping the medicine. It is unlikely that occasional use of Strepsils Intensive sugar-free orange will affect the chances of becoming pregnant. However, the patient should inform their doctor before taking this medicine if they have problems becoming pregnant.

Driving and using machines

Strepsils Intensive sugar-free orange does not affect the ability to drive or use machines.

Strepsils Intensive sugar-free orange contains maltitol and isomalt

This medicine contains maltitol and isomalt. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
The medicine may have a mild laxative effect.
The caloric value of maltitol and isomalt is 2.3 kcal/g.

Strepsils Intensive sugar-free orange contains orange flavor (including ethanol, citral, citronellol, d-limonene, geraniol, and linalol)

This medicine contains 0.05 mg of alcohol (ethanol) per hard lozenge. The amount of alcohol in one hard lozenge of this medicine is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will not have noticeable effects.
Citral, citronellol, d-limonene, geraniol, and linalol may cause allergic reactions.

3. How to take Strepsils Intensive sugar-free orange

Strepsils Intensive sugar-free orange should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
Strepsils Intensive sugar-free orange is intended for adults and adolescents over 12 years old.

Recommended dose:

One hard lozenge every 3 to 6 hours as needed.
The lozenge should be sucked slowly. During sucking, the position of the lozenge in the mouth should be changed to avoid local irritation.

Do not take more than 5 hard lozenges in 24 hours.

Use in children and adolescents

Do not take in children under 12 years old.

Medicine intended for short-term use only.

The patient should take the smallest effective dose for the shortest period necessary to relieve symptoms. If the patient has an infection, they should consult their doctor or pharmacist immediately if their symptoms (such as fever and pain) persist or worsen (see section 2).
Strepsils Intensive sugar-free orange should not be taken for more than 3 days, unless otherwise directed by a doctor.
If the patient's symptoms do not improve or new symptoms appear, they should consult their doctor or pharmacist.

Taking a higher dose of Strepsils Intensive sugar-free orange than recommended

If the patient takes a higher dose of Strepsils Intensive sugar-free orange than recommended, they should contact their doctor as soon as possible.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

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

The patient should stop taking the medicine and contact their doctor immediately if they experience any of the following symptoms:

• allergic reaction symptoms, such as asthma, unexplained wheezing or shortness of breath, itching, nasal congestion, skin rash, and others,
• swelling of the face, tongue, or throat causing difficulty breathing, rapid heartbeat, low blood pressure leading to shock (may occur even with the first use of the medicine),
• severe skin reactions such as desquamation, blistering.

If the patient experiences any of the following symptoms or side effects not listed in this leaflet, they should consult their doctor or pharmacist.

Side effects that may occur:

Very common(may affect more than 1 in 10 people)

• mouth disorders such as a feeling of heat or burning or tingling in the mouth, taste disorders.

Common(may affect up to 1 in 10 people)

• dizziness, headache,
• throat irritation, sore throat
• mouth ulcers, mouth pain, paresthesia in the mouth (abnormal sensations in the mouth such as a feeling of heat, burning, tingling, numbness, etc.),
• xerostomia (dry mouth caused by disturbed or absent saliva secretion).
• abdominal pain, diarrhea, nausea

Uncommon(may affect up to 1 in 100 people)

• insomnia,
• worsening of asthma and bronchospasm, shortness of breath, wheezing,
• blisters in the mouth,
• hypoaesthesia of the throat (reduced surface sensitivity in the throat), tongue pain,
• bloating, constipation, indigestion, flatulence, vomiting,
• rash, itching.

Rare(may affect up to 1 in 1000 people)

• blood disorders,
• hypersensitivity, anaphylactic reaction,
• heart failure, edema,
• kidney failure,
• liver failure.

Very rare(may affect up to 1 in 10,000 people)

• thrombocytopenia (low platelet count, which can cause bruising and bleeding), neutropenia (reduced granulocyte count), agranulocytosis (reduced neutrophil count in the blood, which are the primary defensive cells of the body), aplastic anemia (reduced count of all blood cells), hemolytic anemia (reduced red blood cell count),
• Stevens-Johnson syndrome, toxic epidermal necrolysis (blistering, peeling of the skin, or bleeding in the skin with an itchy, lumpy rash (or without) on the lips, eyes, mouth, nose, genitals, hands, or feet, sometimes with flu-like symptoms).

Frequency not known(frequency cannot be estimated from the available data)

• high blood pressure,
• gastrointestinal bleeding, gastrointestinal ulcer, gastrointestinal perforation (vomiting blood, severe abdominal pain, or black tarry stools),
• erythema multiforme (rash with blisters, or without, on the skin of the limbs or other areas, or mucous membranes, often merging with each other),
• fever,
• pain,
• hepatitis,
• anemia.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Strepsils Intensive sugar-free orange

Do not store above 25°C.
Store in the original packaging to protect from light.
Medicines should be kept out of the sight and reach of children.
Do not take Strepsils Intensive sugar-free orange after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Package contents and other information

What Strepsils Intensive sugar-free orange contains

• The active substance of the medicine is flurbiprofen. One hard lozenge contains 8.75 mg of flurbiprofen.
• The other ingredients of the medicine are: macrogol 300, potassium hydroxide, orange flavor [main component: trioctan glycerol (triacetin), also contains: citral, citronellol, d-limonene, geraniol, linalol, and ethanol], levomenthol, acesulfame potassium, liquid maltitol, isomalt.

What Strepsils Intensive sugar-free orange looks like and what the package contains

Strepsils Intensive sugar-free orange is a hard lozenge.
White to light yellow, round hard lozenge with a diameter of 18 mm, thickness of 7 mm, with a characteristic groove in the shape of the letter S on both sides.
The package contains: 8, 16, 24, or 32 hard lozenges.
Not all pack sizes may be marketed.

Marketing authorization holder and importer

Marketing authorization holder:

Reckitt Benckiser (Poland) S.A.
ul. Okunin 1
05-100 Nowy Dwór Mazowiecki
Poland
phone: 801 88 88 07

Importer:

RB NL Brands B.V.
WTC Schiphol Airport,
Schiphol Boulevard 207,
1118 BH Schiphol,
Netherlands

Date of last revision of the leaflet: