Strepsils Intensive o smaku miodu i eukaliptusa

Leaflet attached to the packaging: information for the user

Strepsils Intensive honey and eucalyptus flavor, 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 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 further information, consult a pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or you feel worse, consult a doctor.

Table of contents of the leaflet

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

1. What is Strepsils Intensive honey and eucalyptus flavor and what is it used for

Strepsils Intensive honey and eucalyptus flavor contains flurbiprofen. Flurbiprofen is a non-steroidal anti-inflammatory drug (NSAID) with analgesic, antipyretic, and anti-inflammatory properties. Strepsils Intensive honey and eucalyptus flavor, 8.75 mg, hard lozenges are used for the short-term relief of symptoms associated with sore throat, such as pain, soreness, swelling, and difficulty swallowing in adults and adolescents over 12 years old.
If after 3 days there is no improvement or you feel worse, consult a doctor.

2. Important information before taking Strepsils Intensive honey and eucalyptus

eucalyptus

When not to take Strepsils Intensive honey and eucalyptus flavor

• if you are allergic (hypersensitive) to flurbiprofen or any of the other ingredients of this medicine (listed in section 6),
• if you have ever had asthma, unexpected wheezing, or shortness of breath, nasal polyps, or a runny nose, swelling of the face, or itchy rash (hives) after taking aspirin or any other NSAID,
• if you have or have had at least two episodes of stomach or duodenal ulcers, stomach or duodenal bleeding, or perforation,
• if you have ever had bleeding or perforation of the stomach or intestines after taking NSAIDs,
• if you are in the last three months of pregnancy,
• if you have severe heart, kidney, or liver failure.

Warnings and precautions

Before taking Strepsils Intensive honey and eucalyptus flavor, consult a doctor or pharmacist

• if you have or have had asthma or allergies,
• if you have tonsillitis or suspect you have a bacterial throat infection (you may need an antibiotic),
• if you have an infection - see "Infections" below.
• if you have heart, kidney, or liver disease,
• if you have had a stroke,
• if you have had intestinal diseases (ulcerative colitis, Crohn's disease),
• if you have an autoimmune disease, such as systemic lupus erythematosus and mixed connective tissue disease,
• if you are elderly, as there is a greater risk of side effects mentioned in this leaflet,
• if you are pregnant or breastfeeding,
• if you have high blood pressure,
• if you have headache caused by taking painkillers.

Infections
NSAIDs may mask the symptoms of an infection, such as fever and pain. This may delay the proper treatment of infections, which may lead to an increased risk of complications. If you are taking this medicine while an infection is present and your symptoms persist or worsen, consult a doctor or pharmacist immediately.

While taking Strepsils Intensive honey and eucalyptus flavor

• If you experience any signs of a skin reaction (rash, peeling, blisters) or other signs of an allergic reaction, stop taking the medicine and consult a doctor immediately.
• Report any unusual abdominal symptoms (especially bleeding) to your doctor.
• If there is no improvement or new symptoms appear, consult a doctor.
• Taking such medicines as flurbiprofen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. The risk is more likely with higher doses or longer treatment. Do not exceed the recommended dose or duration of treatment (3 days).

Children

Do not give this medicine to children under 12 years old.

Strepsils Intensive honey and eucalyptus flavor and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, and about any medicines you plan to take. In particular, inform your doctor or pharmacist if you are taking:

• low-dose aspirin (up to 75 mg per day),
• medicines used to treat high blood pressure or heart failure (antihypertensives, cardiac glycosides),
• diuretics (including potassium-sparing diuretics),
• blood thinners (anticoagulants, antiplatelet agents),
• medicines for gout (probenecid, sulfinpyrazone),
• other NSAIDs, including selective cyclooxygenase-2 inhibitors or corticosteroids (e.g., celecoxib, ibuprofen, diclofenac, or prednisolone),
• mifepristone (a medicine used to terminate pregnancy),
• quinolone antibiotics (such as ciprofloxacin),
• cyclosporine or tacrolimus (used to suppress the immune system),
• phenytoin (used to treat epilepsy),
• methotrexate (used to treat autoimmune diseases or cancer),
• lithium or selective serotonin reuptake inhibitors (used in depression),
• oral antidiabetic medicines (used to treat diabetes),
• zydovudine (used to treat HIV).

Strepsils Intensive honey and eucalyptus flavor with food, drink, and alcohol

Avoid alcohol while taking this medicine, as it increases the risk of stomach or intestinal bleeding.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, consult a doctor or pharmacist before taking this medicine.
Do not takethis medicine if you are in the last trimester of pregnancy.If you are in the first or second trimester of pregnancy or breastfeeding, discuss with your doctor before taking this medicine.
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 this medicine will affect the chances of becoming pregnant. However, inform your doctor before taking this medicine if you have difficulty becoming pregnant.

Driving and using machines

No studies have been conducted on the effects on the ability to drive and use machines. However, dizziness and visual disturbances are possible side effects of NSAIDs. If you experience such symptoms, do not drive or operate machinery.

Strepsils Intensive honey and eucalyptus flavor contains isomalt (E 953), liquid maltitol (E 965), and a flavor with aniseed alcohol, benzyl alcohol, benzyl benzoate, benzyl cinnamate, benzyl salicylate, cinnamon, cinnamaldehyde, citral, geraniol, limonene, and linalool.

Strepsils Intensive honey and eucalyptus flavor contains 2032.18 mg of isomalt (E 953) and 509.03 mg of liquid maltitol (E 965) per hard lozenge.
The medicine may have a mild laxative effect.
The energy value of maltitol and isomalt is 2.3 kcal/g.
If you have previously been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.
Aniseed alcohol, benzyl alcohol, benzyl benzoate, benzyl cinnamate, benzyl salicylate, cinnamon, cinnamaldehyde, citral, geraniol, limonene, and linalool may cause allergic reactions.
This medicine contains 0.00169 mg of benzyl alcohol in each hard lozenge.
Patient with liver or kidney disease, pregnant or breastfeeding women (see "Pregnancy, breastfeeding, and fertility") should consult a doctor or pharmacist, as large amounts of benzyl alcohol may accumulate in their body and cause side effects (metabolic acidosis).
Benzyl alcohol may cause mild local irritation.

3. How to take Strepsils Intensive honey and eucalyptus flavor

Always take this medicine exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If you are unsure, consult a doctor or pharmacist.

Recommended dose: Adults and adolescents over 12 years old

• Suck one lozenge slowly.
• While sucking, change the position of the lozenge in your mouth.
• The lozenge should start working within 30 minutes.
• Then, take one lozenge every 3-6 hours as needed.
• Do not take more than 5 lozenges in 24 hours.

Do not give this medicine to children under 12 years old.
The medicine is intended for short-term use only. Use the smallest effective dose for the shortest duration necessary to relieve symptoms. If you have an infection, consult a doctor or pharmacist immediately if your symptoms (such as fever and pain) persist or worsen (see section 2). If mouth irritation occurs, discontinue treatment with flurbiprofen.

Do not take Strepsils Intensive honey and eucalyptus flavor for more than 3

days, unless your doctor tells you to. If there is no improvement or you feel worse, or if new symptoms appear, consult a doctor or pharmacist.

Taking a higher dose of Strepsils Intensive honey and eucalyptus flavor than recommended

Consult a doctor or pharmacist immediately or go to the nearest hospital.
Symptoms of overdose include: nausea or vomiting, stomach pain, or, less often, diarrhea.
It is also possible to experience ringing in the ears, headache, and stomach bleeding.
If you have any further questions about the use of this medicine, consult a doctor or pharmacist.

Missing a dose of Strepsils Intensive honey and eucalyptus flavor

Do not take a double dose to make up for a missed dose.

4. Possible side effects

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

Stop taking the medicine and consult a doctor immediately if you experience any of the following symptoms:

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

If you experience any of the following symptoms or side effects not listed in this leaflet, consult a doctor or pharmacist.

Common(may occur in less than 1 in 10 people)

• dizziness, headache
• throat irritation
• mouth ulcers or mouth pain
• throat pain
• discomfort or unusual sensations in the mouth (such as a feeling of warmth, burning, tingling, pricking, etc.)
• nausea and diarrhea
• prickling or itching of the skin Uncommon(may occur in less than 1 in 100 people)
• drowsiness
• blisters in the mouth or throat, numbness in the throat
• abdominal bloating, stomach pain, gas, constipation, indigestion, vomiting
• dry mouth
• burning sensation in the mouth, taste disturbances
• skin rashes, itching
• fever, pain
• feeling of drowsiness or difficulty sleeping
• worsening of asthma, wheezing, shortness of breath
• reduced sensation in the throat

Rare(may occur in less than 1 in 1000 people)

• anaphylactic reaction

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

• anemia, thrombocytopenia (low platelet count, which can cause bruising and bleeding)
• edema, high blood pressure, heart failure, or heart attack
• severe skin reactions, such as blistering and peeling of the skin, including Stevens-Johnson syndrome and Lyell's syndrome, and toxic epidermal necrolysis
• hepatitis.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse.
Side effects can also be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C,
02-222 Warsaw,
phone: 22 49-21-301,
fax: 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 honey and eucalyptus flavor

• Keep the medicine out of the sight and reach of children.
• Do not take this medicine after the expiry date stated on the carton and blister after: EXP. The expiry date refers to the last day of the month stated.
• Store in a temperature below 25°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Strepsils Intensive honey and eucalyptus flavor contains

The active substance (the ingredient that makes the medicine work) is flurbiprofen 8.75 mg. The other ingredients are: macrogol 300, potassium hydroxide (E 525), ammoniacal caramel (E 150c), curcuma (E 100) (containing propylene glycol (E 1520) and polysorbate 80), honey and eucalyptus flavor (containing flavoring preparations, natural flavoring substances, flavoring substances, trioctanoin (E 1518), propylene glycol (E 1520), aniseed alcohol, benzyl alcohol, benzyl benzoate, benzyl cinnamate, benzyl salicylate, cinnamon, cinnamaldehyde, citral, geraniol, limonene, and linalool), acesulfame potassium (E 950), liquid maltitol (E 965), and isomalt (E 953).

What Strepsils Intensive honey and eucalyptus flavor looks like and what the pack contains

The hard lozenges are round in shape, with the brand logo embossed, and are light brown to yellow in color, in non-transparent, white PVC/PVDC/Aluminum blisters, packaged in cardboard boxes.
The pack contains 8, 16, 24, 32, or 36 hard lozenges. Not all pack sizes may be marketed.

Marketing authorization holder

Reckitt Benckiser (Poland) S.A.
Okunin 1

• 05 – 100 Nowy Dwór Mazowiecki phone: (22) 211 26 92

Importer

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

This medicine is authorized in the member states of the European Economic Area under the following names:

Date of last revision of the leaflet: