Strepsils intensive sugar-free orange

Patient Information Leaflet

Strepsils Intensive Sugar Free Orange, 8.75 mg, hard pastilles
Flurbiprofen
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed
by a doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your doctor or pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist.
• If there is no improvement after three days, or if you feel worse, consult your doctor.

Leaflet Contents

1. What Strepsils Intensive Sugar Free Orange is and what it is used for
2. Important information before using Strepsils Intensive Sugar Free Orange
3. How to use Strepsils Intensive Sugar Free Orange
4. Possible side effects
5. How to store Strepsils Intensive Sugar Free Orange
6. Contents of the pack and other information

1. What Strepsils Intensive Sugar Free Orange is and what it is used for

Strepsils Intensive Sugar Free Orange hard pastilles contain flurbiprofen as the active substance.
This belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
Strepsils Intensive Sugar Free Orange has strong analgesic and anti-inflammatory effects in the treatment of sore throat.
Strepsils Intensive Sugar Free Orange is indicated for short-term symptomatic relief of sore throat in adults and adolescents aged 12 years and older.
The soothing and coating effect of the medicine begins as early as two minutes after administration and lasts up to 4 hours.

2. Important information before using Strepsils Intensive Sugar Free Orange

When not to use Strepsils Intensive Sugar Free Orange:

• if the patient is allergic to flurbiprofen, acetylsalicylic acid, or other non-steroidal anti-inflammatory drugs (NSAIDs), or to any of the other ingredients of this medicine (listed in section 6),
• in patients with existing or past peptic ulcer disease of the stomach and/or duodenum, or with severe colitis,
• in patients who previously experienced allergic reactions after taking acetylsalicylic acid or any other NSAIDs, such as nasal discharge (rhinitis), angioedema, breathing difficulties (bronchial asthma), or skin rash,
• in patients with gastrointestinal bleeding or perforation, haemorrhagic disorders, or blood cell production disorders related to previous treatment with NSAIDs,
• in patients currently taking other medicines from the group of non-steroidal anti-inflammatory drugs (including cyclooxygenase-2 inhibitors such as celecoxib),
• in pregnant women 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 to use Strepsils Intensive Sugar Free Orange, consult a doctor or pharmacist:

• if the patient has or has ever had asthma or any allergy,
• if the patient is already taking any other NSAIDs or acetylsalicylic acid,
• if the patient is elderly (may be more susceptible to adverse effects),
• if the patient suffers from chronic autoimmune diseases (including systemic lupus erythematosus or mixed connective tissue disease),
• if the patient has tonsillitis or suspects a bacterial throat infection (which may require antibiotic treatment),
• if the patient has an infection – see subsection “Infections” below,
• if the patient has heart, kidney, or liver disease,
• in patients with heart failure, history of stroke, or increased risk of such conditions such as high blood pressure, diabetes, elevated blood cholesterol levels, or in smokers,
• if the patient has been diagnosed with hypertension,
• if the patient suffers from chronic headaches,
• if the patient has gastrointestinal disorders,
• if the patient is in the first or second trimester of pregnancy.

Infections
Non-steroidal anti-inflammatory drugs (NSAIDs) may mask symptoms of infection such as fever and pain. This may delay appropriate treatment of infections, increasing the risk of complications. If the patient takes this medicine during an ongoing infection and symptoms persist or worsen, immediate consultation with a doctor or pharmacist is necessary.

While using Strepsils Intensive Sugar Free Orange:

• At the first sign of any hypersensitivity reaction (rash, peeling, blisters) or other allergic symptoms, discontinue use immediately and consult a doctor.
• Report any unusual gastrointestinal symptoms (especially bleeding) to a doctor.
• If there is no improvement or new symptoms appear, consult a doctor.
• Medicines such as flurbiprofen may slightly increase the risk of heart attack (myocardial infarction) or stroke. This risk is greater with higher doses or prolonged treatment. Do not exceed the recommended dose or duration of treatment (see section 3).

Children and adolescents
This medicine should not be used in children under 12 years of age.

Strepsils Intensive Sugar Free Orange and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, including those available without a prescription. In particular, before taking this medicine, inform your doctor or pharmacist if you are taking any of the following:

• antihypertensive or heart failure medications (angiotensin-converting enzyme [ACE] inhibitors 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,
• anticoagulant medicines, 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 non-steroidal 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),
• quinolone antibiotics used for bacterial infections, such as ciprofloxacin, levofloxacin,
• tacrolimus (an immunosuppressive medicine used after organ transplantation),
• zidovudine (a medicine used in HIV infection),
• lithium (a mood-stabilizing medicine).

Taking medicines such as flurbiprofen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. This risk increases with long-term use of high doses. Do not use higher doses or longer treatment duration than recommended.

Use of Strepsils Intensive Sugar Free Orange with alcohol
Alcohol may increase the risk of adverse effects, especially gastrointestinal bleeding.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.

Do not use Strepsils Intensive Sugar Free Orange during the last 3 months of pregnancy.
Do not use Strepsils Intensive Sugar Free Orange during the first 6 months of pregnancy unless absolutely necessary and advised by a doctor. If treatment is required during this period, the lowest effective dose should be used for the shortest possible time.

Flurbiprofen belongs to a group of medicines that may adversely affect female fertility. This effect is reversible after discontinuation of the medicine. It is unlikely that occasional use of Strepsils Intensive Sugar Free Orange will affect the chances of becoming pregnant. However, patients with difficulty conceiving should inform their doctor before using this medicine.

Driving and operating machinery
Strepsils Intensive Sugar Free Orange has no influence on the ability to drive or operate machinery.

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 certain sugars, they should consult a doctor before taking this medicine.
This 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 flavour (including ethanol, citral, citronellol, d-limonene, geraniol, and linalool)
This medicine contains 0.05 mg of alcohol (ethanol) per hard lozenge. The amount of alcohol in one lozenge is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will not cause noticeable effects.
Citral, citronellol, d-limonene, geraniol, and linalool may cause allergic reactions.

3. How to use Strepsils Intensive Sugar Free Orange

Strepsils Intensive Sugar Free Orange should always be used exactly as described
in this patient leaflet, or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Strepsils Intensive Sugar Free Orange is intended for adults and adolescents over the age of 12.
Recommended dose:
One lozenge every 3 to 6 hours as needed.
Allow the lozenge to dissolve slowly in the mouth. While sucking, change the position of the lozenge in the mouth to avoid local irritation.
Do not use more than 5 lozenges in 24 hours.
Use in children and adolescents
Do not use in children under 12 years of age.
This medicine is intended for short-term use only.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms. If the patient has an infection, consult a doctor or pharmacist promptly if symptoms (such as fever and pain) persist or worsen (see section 2).
Do not use Strepsils Intensive Sugar Free Orange for longer than 3 days unless otherwise advised by a doctor.
If symptoms do not improve or new symptoms occur despite using the medicine, consult a doctor or pharmacist.
Use of a higher than recommended dose of Strepsils Intensive Sugar Free Orange
If more Strepsils Intensive Sugar Free Orange lozenges are taken than recommended, contact a doctor immediately.
If you have any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
You should stop taking the medicine and contact your doctor immediately if any of the
following symptoms occur:

• signs of allergic reactions, e.g. asthma, unexplained wheezing or shortness of breath, itching, nasal mucosal inflammation, skin rashes and others,
• swelling of the face, tongue or throat causing difficulty in breathing, palpitations, drop in blood pressure leading to shock (these may occur even after the first use of the medicine),
• severe skin reactions such as peeling, blistering.

If any of the following symptoms or adverse reactions not listed in
this leaflet occur, consult your doctor or pharmacist.
Adverse reactions that may occur:
Very common (may affect more than 1 in 10 people)

• oral cavity disorders such as sensation of warmth, burning or tingling in the mouth, taste disturbances.

Common (may affect less than 1 in 10 people)

• dizziness, headache,
• throat irritation, sore throat,
• oral ulcers, oral pain, oral paraesthesia (abnormal sensations in the mouth such as warmth, burning, tingling, numbness, etc.),
• xerostomia (dryness of the mouth due to impaired or absent saliva secretion),
• abdominal pain, diarrhoea, nausea.

Uncommon (may affect less than 1 in 100 people)

• insomnia,
• asthma exacerbation and bronchospasm, dyspnoea, wheezing,
• blisters in the mouth,
• pharyngeal hyposensitivity (reduced superficial sensation in the throat), tongue pain,
• bloating, constipation, dyspepsia, flatulence, vomiting,
• rash, itching.

Rare (may affect less than 1 in 1,000 people)

• blood disorders,
• hypersensitivity, anaphylactic reaction,
• heart failure, oedema,
• renal failure,
• hepatic failure.

Very rare (may affect less than 1 in 10,000 people)

• thrombocytopenia (low platelet count which may cause bruising and bleeding), neutropenia (reduced number of neutrophil granulocytes), agranulocytosis (reduction in neutrophil count in the blood, which are the body's primary defence cells), aplastic anaemia (reduction in all blood cell counts), haemolytic anaemia (reduction in red blood cells),
• Stevens-Johnson syndrome, toxic epidermal necrolysis (blistering, skin peeling or bleeding in the skin with itchy, nodular rash (or without rash) affecting lips, eyes, mouth, nose, genital organs, hands or feet, sometimes with symptoms resembling influenza).

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

• hypertension,
• gastrointestinal bleeding, gastrointestinal ulceration, perforation (damage to the wall) of the gastrointestinal tract (vomiting blood, severe abdominal pain or tarry (black) stools),
• erythema multiforme (skin lesions (rash) with or without blisters on limbs or other areas or mucous membranes, ring-shaped, often coalescing),
• fever,
• pain,
• hepatitis,
• anaemia.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions
can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Strepsils Intensive sugar-free orange

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

6. Contents of the pack and other information

What Strepsils Intensive Sugar Free Orange contains

• The active substance is flurbiprofen. Each hard pastille contains 8.75 mg of flurbiprofen.
• Other ingredients are: macrogol 300, potassium hydroxide, orange flavour [main component: glyceryl triacetate (triacetin), also contains: citral, citronellol, d-limonene, geraniol, linalool and ethanol], levomenthol, potassium acesulfame, liquid maltitol, isomalt.

What Strepsils Intensive Sugar Free Orange looks like and contents of the pack
Strepsils Intensive Sugar Free Orange is a hard pastille.
White to slightly yellow, round hard pastille, 18 mm in diameter and 7 mm thick, with a characteristic groove in the shape of the letter S on both sides.
Pack contents: 8, 16, 24 or 32 hard pastilles.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Importer
Marketing Authorisation Holder:
Reckitt Benckiser (Poland) S.A.
ul. Okunin 1
05-100 Nowy Dwór Mazowiecki
Poland
tel: 801 88 88 07

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