Strepsils Intensive

Leaflet attached to the packaging: patient information.

Strepsils Intensive, 8.75 mg, 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 this patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or the patient feels worse, they should contact a doctor.

Table of contents of the leaflet

• 1. What is Strepsils Intensive and what is it used for
• 2. Important information before taking Strepsils Intensive
• 3. How to take Strepsils Intensive
• 4. Possible side effects
• 5. How to store Strepsils Intensive
• 6. Contents of the pack and other information

1. What is Strepsils Intensive and what is it used for

Strepsils Intensive lozenges contain flurbiprofen. This substance belongs to the group of nonsteroidal anti-inflammatory drugs (NSAIDs). Strepsils Intensive has a strong analgesic and anti-inflammatory effect in the treatment of sore throat. Strepsils Intensive is indicated for short-term symptomatic treatment of sore throat in adults and children over 12 years of age.

2. Important information before taking Strepsils Intensive

When not to take Strepsils Intensive:

• 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 and/or duodenal ulcer, severe ulcerative colitis;
• in patients who have had allergic symptoms (such as runny nose, angioedema, difficulty breathing (asthma)) after taking acetylsalicylic acid or any other nonsteroidal anti-inflammatory drug;
• in patients with bleeding or perforation of the gastrointestinal tract, bleeding or blood clotting disorders associated with previous NSAID treatment;
• in patients taking other nonsteroidal anti-inflammatory drugs (including cyclooxygenase-2 inhibitors, such as celecoxib) at the same time;
• during the last 3 months of pregnancy;
• in patients with severe heart, liver, or kidney failure,
• in children under 12 years of age.

Warnings and precautions

Before starting treatment with Strepsils Intensive, the patient should discuss it with their doctor or pharmacist:

• if the patient has or has had asthma or allergies;
• 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 systemic lupus erythematosus and mixed connective tissue disease;
• if the patient has tonsillitis or suspects they may have a bacterial throat infection (may require antibiotic treatment);
• if the patient has an infection - see "Infections" below;
• if the patient has been diagnosed with 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 in the first or second trimester of pregnancy.

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.
During treatment with Strepsils Intensive:

• 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 be associated with a small increased risk of heart attack (myocardial infarction) or stroke. The risk is more likely with high doses and 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 and adolescents under 12 years of age.

Strepsils Intensive and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take, even those that are available without a prescription. In particular, before taking the medicine, the patient should inform their doctor or pharmacist if they are taking any of the following medicines:

• medicines for high blood pressure or heart failure,
• diuretics (including potassium-sparing diuretics),
• medicines that reduce blood clotting,
• antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs),
• medicines for gout,
• other nonsteroidal anti-inflammatory drugs or steroids (such as prednisolone),
• cardiac glycosides,
• cyclosporin (a medicine used to suppress the immune system),
• phenytoin (a medicine used to treat epilepsy),
• methotrexate (an anticancer medicine),
• quinolone antibiotics,
• tacrolimus,
• zidovudine,
• lithium (an antidepressant).

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 more than the recommended dose or use the medicine for longer than recommended.
This medicine belongs to a group of medicines - nonsteroidal anti-inflammatory drugs, which may adversely affect female fertility. This effect is transient and reverses after the end of treatment.
If the patient is having trouble getting pregnant, they should consult their doctor before taking flurbiprofen.

Strepsils Intensive with alcohol

Alcohol may increase the risk of adverse reactions, 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. The patient should not take Strepsils Intensive during the last 3 months of pregnancy.
The patient should not take Strepsils Intensive during the first 6 months of pregnancy unless it is absolutely necessary and recommended by a doctor. If treatment is necessary during this period, the patient should use the smallest effective dose for the shortest possible time.
Flurbiprofen belongs to a group of medicines that may adversely affect female fertility. This effect is reversible after the end of treatment.
It is unlikely that occasional use of Strepsils Intensive will affect female fertility. However, the patient should inform their doctor before taking this medicine if they have trouble getting pregnant.

Driving and using machines

Strepsils Intensive does not affect the ability to drive or use machines.

Strepsils Intensive contains sucrose and glucose

Each lozenge contains approximately 1.407g of sucrose and 1.069g of glucose.
Each lozenge contains 2.5g of carbohydrates, which corresponds to approximately 0.25 bread units. This should be taken into account in patients with diabetes.
If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

Strepsils Intensive contains inverted sugar (present in honey)

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

Strepsils Intensive contains gluten (derived from wheat starch present in glucose syrup)

Strepsils Intensive contains very small amounts of gluten (derived from wheat starch present in glucose syrup) and is considered "gluten-free". Therefore, it is very unlikely to cause any problems in patients with celiac disease.
One lozenge contains no more than 21.38 micrograms of gluten.
Patient with wheat allergy (other than celiac disease) should not take this medicine.

Strepsils Intensive contains lemon flavor

Strepsils Intensive contains lemon flavor with citral, citronellol, d-limonene, farnesol, geraniol, and linalool. Citral, citronellol, d-limonene, farnesol, geraniol, and linalool may cause allergic reactions.

Strepsils Intensive contains sulfur dioxide (E 220)

Due to the presence of sulfur dioxide (E 220) (present in glucose syrup), Strepsils Intensive may rarely cause severe hypersensitivity reactions and bronchospasm.

Strepsils Intensive contains butylhydroxyanisole (E 320)

Due to the presence of butylhydroxyanisole (E 320) (present in lemon flavor), Strepsils Intensive may cause local skin reactions (such as contact dermatitis) or eye and mucous membrane irritation.

3. How to take Strepsils Intensive

This medicine 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 is intended for adults and children over 12 years of age.

Recommended dose

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

Do not take more than 5 lozenges in 24 hours.

Use in children and adolescents

Do not take in children under 12 years of age.

Medicine intended for short-term use only.

The patient should use the smallest effective dose for the shortest possible time. 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).
Treatment with Strepsils Intensive should not last longer than 3 days, unless a doctor recommends otherwise.
If the patient's symptoms do not improve or worsen despite taking the medicine, they should consult their doctor or pharmacist.

Overdose of Strepsils Intensive

In case of taking a higher dose of Strepsils Intensive than recommended, the patient should contact their doctor as soon as possible.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If the patient experiences any of the following symptoms, they should stop treatment and consult their doctor.
Side effects are ranked according to frequency of occurrence using the following terms:
Very common: ≥ 1/10
Common: ≥ 1/100, <1>Uncommon: ≥ 1/1000, <1>Rare: ≥ 1/10 000, <1>Very rare: <1>Frequency not known (frequency cannot be estimated from available data).

Blood and lymphatic system disorders

Rare: Blood disorders (including anemia with prolonged bleeding time)
Very rare: 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 number of all blood cells), hemolytic anemia (reduced number of red blood cells).
Frequency not known: Anemia

Nervous system disorders

Common: Dizziness, headache, paresthesia

Psychiatric disorders

Uncommon: Insomnia

Immune system disorders

Rare: Hypersensitivity, anaphylactic shock

Cardiac disorders

Rare: Heart failure, edema

Vascular disorders

Frequency not known: Hypertension

Respiratory, thoracic, and mediastinal disorders

Common: Throat irritation
Uncommon: Asthma exacerbation and bronchospasm, dyspnea, wheezing, blisters in the mouth, oral hypoaesthesia

Gastrointestinal disorders

Very common: Oral disorders, taste disorders
Common: Diarrhea, oral ulcers, nausea, oral pain, paresthesia in the mouth, throat pain, abdominal pain, xerostomia (dry mouth caused by disturbed or absent saliva secretion)
Uncommon: Flatulence, constipation, dyspepsia, bloating with gas passage, tongue pain, oral sensation disorders, vomiting
Frequency not known: Gastrointestinal bleeding, gastrointestinal ulceration, gastrointestinal perforation

Skin and subcutaneous tissue disorders

Uncommon: Rash, pruritus
Very rare: Stevens-Johnson syndrome, toxic epidermal necrolysis
Frequency not known: Erythema multiforme

Renal and urinary disorders

Rare: Renal failure

General disorders and administration site conditions

Frequency not known: Fever, pain

Hepatobiliary disorders

Rare: Liver failure
Frequency not known: Hepatitis

Reporting of side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. 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
Al. 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 the medicine.

5. How to store Strepsils Intensive

Store in a temperature below 25°C. Protect from moisture.
The medicine should be stored out of sight and reach of children.
Do not take Strepsils Intensive 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 that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Strepsils Intensive contains:

• The active substance of the medicine is flurbiprofen. One lozenge contains 8.75 mg of flurbiprofen.
• The other ingredients of the medicine are: macrogol 300, potassium hydroxide, lemon flavor, menthol, glucose syrup, sucrose syrup, honey.

What Strepsils Intensive looks like and contents of the pack

Pack contents:
8, 16, 24, 32, 36 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 tel. 0 801 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: